AIRO 

Mobile CT System
USER MANUAL

Rx ONLY

Copyright © 2023 Stryker. All rights reserved.

MI-42-0001 Rev. 22
Copyright © 2014-2023 Stryker. All rights reserved.
This manual contains proprietary information protected by copyright. No part of this manual may be
reproduced in any form or by any means - graphic, electronic, or mechanical, including
photocopying, recording, taping, or information storage and retrieval systems - without the prior
written permission of Stryker.

Mobius Imaging®, AIRO®, TruCT®, and MobiCT® are registered trademarks of Stryker. In addition,
the following trademarks appear:
• Brainlab® and Curve™ Image Guided Surgery are trademarks of Brainlab AG.
• Gammex® is a registered trademark of Gammex, Inc.
• TruSystem® is a registered trademark of TRUMPF Medizin Systeme GmbH + Co. KG.
• CaviWipes1™ is a trademark of Metrex Research, LLC.

Other brand and product names that appear in the manual may be trademarks or registered
trademarks and are the property of their respective owners.

Stryker makes no representations or warranties regarding the contents of this manual. Stryker
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.
Document Version 22
Released: January 2023

MI-42-0001 Rev. 22
 TABLE OF CONTENTS

TABLE OF CONTENTS
1 GENERAL INFORMATION .................................................... 1

1.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.2 Contact Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.2.1 Contacting the Company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.3 User Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.3.1 System Described . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.2 Symbols Used in This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.3 Software Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.4 AIRO Mobile CT System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.4.2 Pediatric Use Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.5 Overview of Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.5.1 Transport Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.5.2 Scan Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.6 Legal Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

1.6.1 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

1.7 Training and Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

1.7.1 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.7.2 Applications Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.7.3 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2 SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2.2 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.2.1 After-Sale Operating and Safety Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

2.3 In Case of Emergency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

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2.4 CPR Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.4.1 Performing CPR on Patient in System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.5 Draping and Sterile Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

2.5.1 Operating Room Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

2.6 Data Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

2.6.1 Protecting AIRO from Computer Viruses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

2.7 Radiation Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

2.7.1 General Radiation Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.7.2 Safety Features Against Excessive Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
2.7.3 Dose Notifications and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
2.7.4 Profile of Stray Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.7.5 Protective Barriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.7.6 Protection by Distance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.7.7 Assessing Patient Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.7.8 Reducing Risk from X-ray Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.7.9 Laser Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
2.7.10 Reducing Risk from Incorrect Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
2.7.11 Reduce Risk of Skin Burns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

2.8 Mechanical Motion Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

2.8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
2.8.2 Patient Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
2.8.3 Safety Precautions in the Patient Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
2.8.4 Column Movement Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

2.9 Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

2.9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

2.10 Transportation Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

2.10.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

2.11 Fire Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

2.11.1 Fire Extinguishers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

2.12 Power Failure/Interruption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

2.12.1 In Case of Power Failure/Interruption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
2.12.2 Restoring a Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

3 TRANSPORT MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

3.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

3.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

3.2 Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
3.2.1 Pendant and Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
3.2.2 Power Switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.2.3 Power and Network Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

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3.3 Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.3.1 Turn On Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.3.2 Logging In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.3.3 Starting from Parked Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
3.3.4 Menu in Transport Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
3.3.5 Starting from Scan Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
3.3.6 Rotating and Latching the Ring in Transport or Scan Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3.3.7 Raising the System for Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
3.3.8 Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
3.3.9 After Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
3.3.10 Setting Up for Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
3.3.11 Lowering the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
3.3.12 Unlocking and Rotating the Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
3.3.13 Setting the Orientation for Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
3.3.14 Temporary Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

3.4 Powering Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

3.4.1 Set to Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

4 COLUMN AND TABLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

5 TRANSFERRING THE TABLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

6 SCANNING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

6.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

6.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

6.2 System and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

6.2.1 AIRO System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
6.2.2 Pendant Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

6.3 Before Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

6.3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
6.3.2 Choosing Scan Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
6.3.3 Connecting System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

6.4 Moving the Ring in Scan Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

6.4.1 Translating the Ring (Z-axis) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

6.5 Prepare Scan Field of View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

6.5.1 Position and Diameter of Scan Field of View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
6.5.2 Remove Non-Essential Objects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
6.5.3 Remove Metal Objects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

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6.6 Welcome Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

6.6.1 Welcome Screen and Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

6.7 Daily Warm Up Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

6.7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.7.2 Preparing for Warm Up Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.7.3 Performing Warm Up Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.7.4 Menu in Scan Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

6.8 Typical Scan Sequence: New Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

6.8.1 New Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
6.8.2 Entering New Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
6.8.3 Select Existing Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
6.8.4 Entering Patient Data from Hospital Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
6.8.5 Entering Patient Data from Navigation System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
6.8.6 Confirming Scan Direction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
6.8.7 Selecting Patient Type and Patient Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
6.8.8 Selecting Exam Region, Protocol, and Scan Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
6.8.9 Selecting Patient Orientation and Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
6.8.10 Selecting 2D Scout Scan View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
6.8.11 Positioning With Lasers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
6.8.12 Setting 2D Scout Scan End Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
6.8.13 Setting the 2D Start Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
6.8.14 Verifying 2D Parameters and Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
6.8.15 Selecting 3D Scan Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
6.8.16 Selecting a Constant or Modulated Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
6.8.17 Move Ring to Start Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
6.8.18 Verifying 3D Parameters and Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
6.8.19 Summary of 3D Image Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
6.8.20 Main Image View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
6.8.21 Window/Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
6.8.22 Image Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
6.8.23 Setting Slice Thickness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
6.8.24 Sending Scan to DICOM or USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
6.8.25 Next Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

6.9 View an Existing Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

6.10 Emergency Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

6.10.1 Taking Emergency Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

6.11 Editing Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

6.11.1 Editing or Adding Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

6.12 After Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

6.12.1 Post-Scanning Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

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6.13 Head Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

6.13.1 Setup Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
6.13.2 Setup AIRO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

7 MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

7.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

7.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

7.2 Service Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

7.2.1 Service Functions Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
7.2.2 Hospital Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
7.2.3 Option: Configure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
7.2.4 Option: Add New Phantom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
7.2.5 E-Stop Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
7.2.6 Option: Using Custom kV Settings in Manual or Single Shot Scans . . . . . . . . . . . . . . . . . . . . . . . . . 149
7.2.7 Option: Manual Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
7.2.8 Option: Single Shot Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
7.2.9 Quality Check Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
7.2.10 Option: Dose Check Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
7.2.11 Brainlab Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

7.3 Daily Gain Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

7.3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
7.3.2 Preparing for Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
7.3.3 Perform Gain Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
7.3.4 Image Quality Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

7.4 Cleaning, Disinfection, and Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

7.4.1 Cleanable Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
7.4.2 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
7.4.3 Application of Mineral Oil to AIRO Base Rails . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

7.5 Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

7.5.1 Daily . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

7.6 Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

7.6.1 Preventative Maintenance is Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

7.7 Temporary Disuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

7.7.1 Temporary Disuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

7.8 Disposal Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

7.8.1 Disposal of System and Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

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8 QUALITY TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

8.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

8.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

8.2 Test Object and Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

8.2.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

8.3 Testing Image Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

8.3.1 Testing Image Quality with the Phantom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
8.3.2 Scan a Phantom for Quality Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

8.4 Quality Check Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

8.4.1 Examining Image Quality Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

8.5 Exposure Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200

8.5.1 Responsible Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200
8.5.2 Measure and Verify CTDI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200

9 TECHNICAL DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

9.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

9.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

9.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204

9.2.1 Obtaining More Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
9.2.2 Warning Regarding Modifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
9.2.3 Combining Accessories, Sub-assemblies, and Compatible Equipment with AIRO . . . . . . . . . . . . . 204

9.3 Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

9.3.1 Brief Description and Operating Principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
9.3.2 Significant Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
9.3.3 How the Device Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
9.3.4 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
9.3.5 Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
9.3.6 Pendant Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
9.3.7 Operating Table Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
9.3.8 Column Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
9.3.9 Wireless Remote Controls for Columns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
9.3.10 Chargers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
9.3.11 Detachable Power Cable Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215

9.4 Special Installation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

9.4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

9.5 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218

9.5.1 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218

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9.6 X-ray Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

9.6.1 Generator (High Voltage Power Supply) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219
9.6.2 X-ray Source Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
9.6.3 Battery System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

9.7 Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

9.7.1 General Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
9.7.2 Range, Accuracy, and Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222

9.8 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

9.9 Safety Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
9.9.1 List of Safety Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224

9.10 Replacing Fuses and Other Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

9.10.1 Replacing Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

9.11 Network/Data Coupling to Other Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

9.11.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

9.12 Regulatory Compliances and Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227

9.12.1 Summary of Standards Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
9.12.2 General Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
9.12.3 Electromagnetic Emissions and Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

9.13 RF Communications Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

9.13.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

9.14 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232

9.14.1 Symbols Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232

9.15 Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233

9.15.1 Labels Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233

9.16 Location of Certification and Safety Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237

9.16.1 System Chassis Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237

10 CT USER INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239

10.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239

10.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239

10.2 No Quick-change X-ray Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240

10.2.1 No Quick-change X-ray Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240

10.3 Dosage Factors and Image Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241

10.3.1 Conditions of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
10.3.2 Dose Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
10.3.3 Statement of Maximum Deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
10.3.4 Imaging Performance Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248

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10.3.5 Technical Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

10.3.6 Definitions of the Measurement Bases of the Technique Factors . . . . . . . . . . . . . . . . . . . . . . . . . . 254
10.3.7 60601 Requirements: CT USERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254

10.4 Deterministic Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256

10.4.1 Radiation Dose Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256
10.4.2 Prevailing Radiation Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256

11 ALLOWED EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257

11.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257

11.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257

11.2 Compatibility with Other Medical Devices and Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

11.2.1 Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
11.2.2 Medical Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
11.2.3 Accessories List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

12 TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261

12.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261

12.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261

12.2 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262

12.2.1 Problems and Suggested Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262

12.3 Metal Artifacts in Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268

12.3.1 Recognizing Metal Artifacts in CT Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268

12.4 Rotation Sensor Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269

12.4.1 Verifying Scan Direction During Scan Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269

12.5 Transport Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270

12.5.1 Transport Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270
12.5.2 Base is Lifted but System Will Not Move . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270
12.5.3 Cannot Raise System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272

12.6 Table Transfer Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275

12.7 Table Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276

12.8 Detachable Power Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

12.8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
12.8.2 Maintaining the Detachable Power Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278

12.9 Malfunctions and Return Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

12.9.1 Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
12.9.2 Return Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

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 TABLE OF CONTENTS

13 DETACHABLE PENDANT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

13.1 Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

13.1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

13.2 Detachable Pendant and Holster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284

13.2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284

13.3 Maintenance with Detachable Pendants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285

13.3.1 Connecting Detachable Pendants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285
13.3.2 Disconnecting Detachable Pendants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286

13.4 Technical Description for Detachable Pendants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288

13.4.1 Detachable Pendant Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288
13.4.2 Electromagnetic Emissions and Immunity with Detachable Pendant . . . . . . . . . . . . . . . . . . . . . . . 289
13.4.3 Location of Certification and Safety Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290

INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291

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x MI-42-0001 Rev. 22
 GENERAL INFORMATION: Chapter Overview

1 GENERAL INFORMATION
1.1 Chapter Overview
1.1.1 Contents

Topics Covered
Section See
Contact Data 1.2
User Manual 1.3
AIRO Mobile CT System 1.4
Overview of Components 1.5
Legal Information 1.6
Training and Documentation 1.7

MI-42-0001 Rev. 22 1
GENERAL INFORMATION: Contact Data

1.2 Contact Data

1.2.1 Contacting the Company

Support If you cannot find information you need in this manual, or if you have questions or problems, contact
support:

Region Telephone Email

North America
Stryker - Shirley
+1-978-386-9619 [email protected]
2 Shaker Road, Suite F100
Shirley, MA 01464 USA

Europe
Denmark +45 78 15 20 01
France +33 4 87 94 02 80
Germany +49 32 212 249 041 [email protected]
Italy +39 06 8596 0008
Spain +34 919 01 13 99
United Kingdom and Ireland +44 20 7880 1805

Authorized EU STRYKER European Operations Limited

Representative Anngrove
IDA Business & Technology Park, Carrigtwohill
CO. CORK
IRELAND
T45HX08

Manufacturer Mobius Imaging, LLC.

2 Shaker Road
Suite F100
Shirley, MA 01464
USA
www.mobiusimaging.com
Tel: +1 (978) 796-5068 
[email protected]

2 MI-42-0001 Rev. 22
 GENERAL INFORMATION: User Manual

1.3 User Manual

1.3.1 System Described

Catalog Number/
Model Reference
Model(s) described in User Manual
MobiCT®-32

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. They contain safety-critical

information regarding possible injury, death, or other serious consequences
associated with equipment misuse.

Cautions

Cautions are indicated by triangular caution symbols. They contain safety-critical

information regarding possible moderate or minor injury, and problems with the
device. Such problems include device malfunctions, device failure, damage to device,
or damage to property.

Notes NOTE: Notes are formatted in italic type and indicate additional useful hints.

Commands The names of keys (“buttons”) and icons are in bold.

1.3.3 Software Screens

Default Size of AIRO systems support Pendants with two different screen sizes.
Software Screens
• Hardwired Pendant: 20.3 cm (8 in.) screen with a resolution of 800 x 600 pixels
in this Manual
• Detachable Pendant: 25.4 cm (10 in.) screen with a resolution of 1280 x 800 pixels
While software screens are scaled for both Pendants, figures and examples in this manual show
images from the 800 x 600 pixel, hardwired Pendant. For information about the larger Detachable
Pendant, see chapter 13 DETACHABLE PENDANT.
For information about upgrading to a Detachable Pendant with the larger screen, contact technical
support. See section 1.2.1 Contacting the Company.

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GENERAL INFORMATION: AIRO Mobile CT System

1.4 AIRO Mobile CT System

1.4.1 Overview

Device Description AIRO Mobile CT System (“AIRO”) is a mobile computed tomography (CT) system. AIRO includes
a mobile base that supports the Gimbal, Ring, and a Column for controlling compatible operating
tables (typical). In addition, AIRO systems with no integrated Columns are available. These enable
the use of other compatible, radiolucent patient support systems depending on the specific
procedure being performed.
For more detailed information, on:
• AIRO systems - see chapter 9 TECHNICAL DESCRIPTION
• Original Trumpf TruSystem 7500 Column - see MI-42-0167 AIRO Original Trumpf Column
Supplement
• Updated Trumpf TruSystem 7500 Column - see MI-42-0165 AIRO Updated Trumpf Column
Supplement

Figure 1

Catalog/Model MobiCT®-32
Number

Indications for Use The AIRO system is intended to be used for X-ray computed tomography applications for anatomy
that can be imaged in the 107 cm aperture excluding patients weighing over 182 kg (400 lbs).

4 MI-42-0001 Rev. 22
 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.

Intended Use AIRO is intended for use in several environments such as mobile or fixed General Radiology,
Intensive Care Unit (ICU), Emergency Department (ED), Surgical/Operating Room (OR), Clinic or
Office. AIRO will provide CT images that assist in a range of clinical applications which includes
neuro (cranial and spinal), ENT, head and neck, orthopedic and general surgery.

Medical Purpose AIRO can provide an aid to diagnosis when used by a qualified physician and is intended for
computed tomography applications that can be imaged in the 107cm aperture.

AIRO is not designed to be relied on as the principal means of guidance during

invasive procedures when real time imaging is needed. (e.g., CT Fluoro). Risk of
patient injury.

The physician must verify navigation accuracy using known anatomical landmarks or
an equivalent verification method.

Intended Users and AIRO is intended to be operated by medical personnel trained in its operation by authorized trainers.
Operators CT functions may be further limited by local regulations.
AIRO is only intended to be shipped or serviced by qualified service personnel and manufacturing
technicians.

Only trained medical personnel may operate system components and accessory
instrumentation.
See section 1.7 Training and Documentation.

Patient Group AIRO is to be used at the request of the supervising physician on pediatric and adult patients
weighing less than 182 kg (400 lbs).

This instrument is designed to image patients with a mass of less than 182 kg (400
lbs). For patients heavier than 182 kg, device X-ray exposure limitations result in poor
image quality and unused dose.
Refer to the instruction manual for the operating table you will be using to determine the respective
effective load limits.

Do not exceed the indicated load limit of the operating tabletop. Failure to adhere to
proper loading limits can lead to patient injury due to tabletop structural integrity
failure.
For more information about using AIRO on Pediatric patients, see section 1.4.2 Pediatric Use
Summary.

MI-42-0001 Rev. 22 5
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.

Place of Control AIRO is controlled inside the treatment room during scan mode. For scanning purposes, AIRO is not
intended to be controlled from outside the treatment room. The operator of the equipment needs to
have a direct and clear line of sight to the device and to the patient when in use and when moving
the equipment.

Tolerance to Water The moisture tolerance of the device is component dependent. Nothing more wet than a wrung out
drip-less towel should be used anywhere near the device. The column is rated IPX4. Overall system
is IPX0.

Improper Use

Improper use is defined as using AIRO or any part of AIRO in any way inconsistent
with the methods and precautions described in this manual, or with the methods
described in authorized training, or use by anyone who is not properly trained and
medically qualified.

1.4.2 Pediatric Use Summary

Overview Exercise special care when imaging patients with physiques that fall outside the typical adult size
range. This applies especially to smaller pediatric patients whose size does not overlap the adult
size range (e.g., patients less than 50 kg (110 lb) in weight and 150 cm (59 in) in height,
measurements which approximately correspond to those of an average 12 year old or a 5th
percentile U.S. adult female).
Exposure to ionizing radiation is of particular concern for pediatric patients because:
• For certain organs and tumor types, younger patients are more radio-sensitive than adults. As a
result, the cancer risk per unit dose of ionizing radiation is typically higher for younger patients.
• Use of AIRO with Protocols and exposure settings designed for adults can result in excessive
and unnecessary radiation exposure of smaller patients.
• Younger patients have a longer expected lifetime over which the effects of radiation exposure
may manifest as cancer.
To help reduce the risk of excessive radiation exposure, you should follow the ALARA (As Low As
Reasonably Achievable) principle and seek to reduce radiation dose to only the amount necessary
to obtain images that are clinically adequate.

Reference for The following resource provides information about pediatric and general imaging radiation safety for
Pediatric Dose AIRO systems:
Optimization
• MI-42-0005 AIRO Application Guide Protocols and Principles

6 MI-42-0001 Rev. 22
 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:
• 6.8.7 Selecting Patient Type and Patient Category
• 6.8.8 Selecting Exam Region, Protocol, and Scan Type
• 10.3 Dosage Factors and Image Quality
Protocol and
• 10.4 Deterministic Effects
exposure indices
See MI-42-0005 AIRO Application Guide Protocols and Principles
sections:
• 2 Dose Information
• 3 Scan Protocols
See AIRO User Manual sections:
• 2.7.8 Reducing Risk from X-ray Dose
• 6.8.8 Selecting Exam Region, Protocol, and Scan Type
• 6.8.10 Selecting 2D Scout Scan View
Automatic Exposure
• 6.8.16 Selecting a Constant or Modulated Scan
Control
See MI-42-0005 AIRO Application Guide Protocols and Principles
sections:
• 2.4 Weight Adaptation (For Some Protocols)
• 3 Scan Protocols

AIRO Specific To ensure that AIRO can safely scan pediatric and adult patients, the various tests are performed
Pediatric Testing during system configuration (SC), in preventative maintenance (PM), and for daily preparation (DP).

Tests When Tested References

See AIRO User Manual sections:
• 8.5 Exposure Testing
Estimated pediatric
and adult patient SC See MI-42-0005 AIRO Application Guide Protocols
dosimetry and Principles sections:
• 2 Dose Information
• 3 Scan Protocols
See AIRO User Manual sections:
Image Quality
SC, PM, DP • 8.4 Quality Check Reporting > 8.4.1 Examining
Assessment
Image Quality Report
See AIRO User Manual sections:
Image Quality
SC, PM, DP • 7.3 Daily Gain Calibration
Checks
• 8.3 Testing Image Quality

MI-42-0001 Rev. 22 7
GENERAL INFORMATION: Overview of Components

1.5 Overview of Components

1.5.1 Transport Mode

Diagram: Transport
Mode

;
a
l
s
k
d

f j

g
h
Figure 2

No. Component Function/Usage

a Ring Scans patient and sends data to Pendant. Also called gantry.
Touchscreen that controls system movement, imaging, and data
s Pendant Display
storage.
d Control Panel Key switch and On button, USB port.
f Gimbal Holds the Ring and Pendant Display.
Supports and moves the system. Power and network
g Base
connections.
Allow system to be moved.
h Casters NOTE: Not shown: A mechanically driven main drive wheel
located under the base. The main drive wheel powers the motion.
Supports some models of Trumpf surgical tabletops and other
j Column
patient supports (see parts list for specific part numbers).
Provides power and motion to some models of Trumpf surgical
tabletops and other patient supports.
k Column Interface
For information about which integrated column your AIRO
features, see chapter 4 COLUMN AND TABLE.
Allows operator to see path on display. Used when moving the
l Front View Camera
system for safe transportation.
; Window Opening in bore through which scan is taken.

The inside of the Ring is not designed to support weight. When transporting,
operating, cleaning, or disinfecting AIRO, do not lean, sit, or kneel on the inside of the

8 MI-42-0001 Rev. 22
 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
Mode k
a

j
s

d
f g
Figure 3

No. Component Function/Usage

a Ring Scans patient and sends data to Pendant. Also called gantry.
s Window Opening in bore through which scan is taken.
Supports and moves the system. Location of power and network
d Base connections.
NOTE: Casters are retracted into the base.
f Gimbal Holds the Ring and Pendant Display.
Holds key switch, On button, USB port, and both power and
g Control Panel
battery-charging indicator lights.
Supports some models of Trumpf radiolucent surgical tabletops
and other patient supports.
h Column
For information about which integrated column your AIRO
features, see chapter 4 COLUMN AND TABLE.
Interchangeable with some models of Trumpf patient supports.
j Surgical Table
See chapter 11 ALLOWED EQUIPMENT.
Touchscreen that controls system movement, imaging, and data
k Pendant Display
storage.

The inside of the Ring is not designed to support weight. When transporting,
operating, cleaning, or disinfecting AIRO, do not lean, sit, or kneel on the inside of the
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.

MI-42-0001 Rev. 22 9
GENERAL INFORMATION: Legal Information

1.6 Legal Information

1.6.1 Summary

Copyright This manual contains proprietary information protected by copyright. No part of this manual may be
reproduced or translated without express written permission of Stryker.

Trademarks • Brainlab® and Curve™ Image Guided Surgery are trademarks of Brainlab AG.
• Mobius Imaging®, AIRO®, TruCT®, and MobiCT® are registered trademarks of Stryker.
• Gammex® is a registered trademark of Gammex, Inc.
• TruSystem® is a registered trademark of TRUMPF Medizin Systeme GmbH + Co. KG.
• CaviWipes1™ is a trademark of Metrex Research, LLC.
The respective owners reserve all rights to their trademark(s).

Restrictions on Use

US Federal law restricts the sale, distribution and use of this device to, or on the order
of, a physician.

This device is limited by US federal law to investigational use for indications not in the
“indications for use” statement.

DICOM A DICOM Conformance Statement is available upon request.

Conformance
Statement

Restriction of The AIRO System complies with the Directive on the restriction of the use of certain hazardous
Hazardous substances (RoHS) in electrical and electronic equipment. A RoHS compliance statement is
Substances available upon request.
Directive (RoHS)

Disposal
Instructions
Only dispose of electrical and electronic equipment in accordance with statutory
regulations. For information regarding the WEEE (Waste Electrical and Electronic
Equipment) directive, contact Technical Support
([email protected]). 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/patents and one or more
additional patents or pending patent applications in the US and other countries.

10 MI-42-0001 Rev. 22
 GENERAL INFORMATION: Training and Documentation

1.7 Training and Documentation

1.7.1 Training

Required Training Users must receive and complete training from Mobius Imaging or its authorized agents before using
AIRO.
For training, contact your distributor or Mobius Imaging.
NOTE: The User Manual does not replace training.

Required Training Hours

Applications Training 40 hours or 5 days (recommended minimum)
Refresher Training As requested

1.7.2 Applications Training

Description Medical personnel that will be operating AIRO shall attend a 5-day applications training course
(recommended minimum). Curriculum must include:
• Training Specialist scheduled for training.
• Training Presentation (including safety information, basic setup and use of the system).
• User’s Manual (hard-copy supplied with system).
• AIRO Mobile CT System (including all components).
• Hands-on training including transportation and maneuvering the system in a simulated typical
environment.
• Trumpf Column hands-on training including table transfer, operational controls, and
programming.
• A test at the end of the training course appropriate to the practice/user.
NOTE: All other users (non-operators) will be trained in the areas relevant to their interactions with
the AIRO CT System. For example, nurses will be trained on patient handling, table controls, and
preparation of sterile fields.

Training Materials Training materials include, but are not limited to:
• User Manual
• AIRO system

1.7.3 Documentation

Intended Audience This User Manual is intended for all members of the clinical team who are trained in the use of the
AIRO system.

Reading the User This User Manual contains the information necessary to operate AIRO in accordance with its
Manual specifications and intended use.
It is important that AIRO users:
• Read the User Manual carefully as part of training and before attempting to use AIRO.
• Always have access to the User Manual.

MI-42-0001 Rev. 22 11
GENERAL INFORMATION: Training and Documentation

Available Manuals
Document Part Number
AIRO User Manual MI-42-0001
AIRO Pre-installation Guide MI-42-0002
AIRO System Without Column 
MI-42-0139
Pre-Installation Guide
MI-42-0003 (AIRO systems with software v2.x and
original Trumpf Columns)
MI-42-0140 (AIRO systems with software v2.x and
without columns)
AIRO Emergency Instructions
MI-42-0168 (AIRO systems with software v1.3 and
updated Trumpf Columns)
MI-42-0174 (AIRO systems with software v2.x and
updated Trumpf Columns)
AIRO Application Guide Protocols and
MI-42-0005
Principles
AIRO Original Trumpf Column MI-42-0167 (AIRO systems with original Trumpf
Supplement Columns)
AIRO Updated Trumpf Column MI-42-0165 (AIRO system with updated Trumpf
Supplement Column)
Quick Reference Guide: AIRO System MI-42-0206 (all AIRO systems)
Quick Reference Guide: AIRO System MI-42-0207 (AIRO systems with updated Trumpf
with column Columns)

Other Information Additional information on this product may be available by request. Contact technical support. See
section 1.2.1 Contacting the Company

12 MI-42-0001 Rev. 22
 SAFETY: Chapter Overview

2 SAFETY
2.1 Chapter Overview

2.1.1 Contents

Topics Covered
Section See
Responsibilities 2.2
In Case of Emergency 2.3
CPR Mode 2.4
Draping and Sterile Fields 2.5
Data Safety 2.6
Radiation Safety 2.7
Mechanical Motion Safety 2.8
Electrical Safety 2.9
Transportation Safety 2.10
Fire Safety 2.11
Power Failure/Interruption 2.12

MI-42-0001 Rev. 22 13
SAFETY: Responsibilities

2.2 Responsibilities

2.2.1 After-Sale Operating and Safety Practices

Manufacturer The manufacturer assumes no responsibility or liability for after-sale operating and safety practices;
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. It is the responsibility of the owner to ensure that all
personnel follow the manufacturer’s radiological safety recommendations. The owner is also
responsible for ensuring compliance with additional local requirements, regulations, or
organizational safety practices such as wearing protective clothing and radiation monitoring devices
while using this system, and inspecting equipment.

14 MI-42-0001 Rev. 22
 SAFETY: In Case of Emergency

2.3 In Case of Emergency

2.3.1 Overview

How to Respond to
an Emergency
s
a

Figure 4

Steps
1. Press Emergency Stop a on the System Controls.
2. Follow emergency safety procedures established by your organization.
3. Press the Reset Button s to regain system functionality.

Emergency An interface to the Emergency interlock is available upon request.

Interlock Device
In order to interface to the Emergency interlock (when installed), the user must provide a normally-
closed Interlock switch with 2-wires for connection to a mating connector, provided by Mobius.
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 technical support or your distributor. See section 1.2.1 Contacting the Company.

When to Press Press the Emergency Stop button:

Emergency Stop
• If the system moves without a command from the user.
• If releasing a key does not stop the movement.
• If the Ring does not stop as expected.
• If the Ring moves in the wrong direction during a scan.
• If for any reason during scanning or transportation it becomes necessary to stop motion.
If any system malfunctions are detected, immediately shut down the system and contact technical
support. See section 1.2.1 Contacting the Company.
NOTE: Using Emergency Stop terminates all motorized system and Column functions.
Responding in other ways to patient emergencies not related to system motion can avoid this. See
section How to Respond to Patient Emergencies Not Related to AIRO or Table Motion.

MI-42-0001 Rev. 22 15
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. Push the Ring away from the pedestal/column as far as possible.
2. Remove the patient manually, for example, transfer the patient to a gurney.

Malfunction If you used Emergency Stop because AIRO malfunctioned, do not use the system until it is
evaluated by technical support. See section 1.2.1 Contacting the Company.

How to Respond  When an AIRO scan needs to stop to allow medical personnel to respond to a patient emergency
to Patient that is not related to AIRO or Table motion during the scan, simply release the green Scan button.
Emergencies Not
Do not press Emergency Stop, because the button terminates motorized Ring, or gantry, motion and
Related to AIRO 
disables both Column and Table functions—potentially blocking patient care or movement.
or Table Motion

How to Release  With motorized Ring, or gantry, motion and both Column and Table functions available, medical
the Patient for personnel will be able to perform any of the following, as appropriate:
Emergencies Not
• Move the Ring away from the patient using the Pendant.
Related to AIRO
Motion • Translate the tabletop, rotate the Column, or both to place the patient at a position required to
perform the emergency medical procedures (e.g., CPR).
For AIRO-specific CPR information, see section 2.4 CPR Mode.
• Perform required emergency medical procedures on the tabletop without removing the patient.
• Manually transfer the patient to a gurney, so that required emergency medical procedures may
be performed elsewhere in the facility.
• Manually transfer the tabletop with the patient to a shuttle, so that required emergency medical
procedures may be performed elsewhere in the facility.

16 MI-42-0001 Rev. 22
 SAFETY: CPR Mode

2.4 CPR Mode

2.4.1 Performing CPR on Patient in System

Table Position The equipment positions for performing CPR are:

a s d
Figure 5

NOTE: Table lengths and positions relative to column are exaggerated for emphasis

Position of Table for Performing CPR

Parallel to base, column at lowest shuttle-
a Acceptable
accessible position
Parallel to base, column at lowest shuttle-
s Acceptable
accessible position
d Any other orientation Not Acceptable

CPR Options
Option Keypad Buttons Action

Patient is in the Move the Ring out of the way.

bore of the NOTE: You can use the controls or push the Gimbal
system manually to move it out of the way.
Original Column:

Rotate the table into a position parallel to the base.

The table is not
parallel to the NOTE: If the table will not rotate, release the table
base Updated Column: rotation brake. The rotation brake control is on the
column keypad and on the wireless remote control.

Original Column:
Lower and level the table or patient support. See:
• MI-42-0167 AIRO Original Column Supplement
The table or section 2.7.6 Lift and Lower
patient support is Or:
not lowered and Updated Column: • MI-42-0165 AIRO Updated Column Supplement
level section 2.7.6 Lift and Lower
For information about which integrated column your
AIRO features, see chapter 4 COLUMN AND TABLE.

MI-42-0001 Rev. 22 17
SAFETY: Draping and Sterile Fields

2.5 Draping and Sterile Fields

2.5.1 Operating Room Use

Drape the Patient When AIRO is used in a sterile field environment during intra-operative procedures, add an
additional transparent plastic drape over the patient to maintain the sterile environment while
scanning. AIRO should not be draped.
NOTE: It is important to use transparent (clear) plastic drapes to ensure accurate laser positioning.

18 MI-42-0001 Rev. 22
 SAFETY: Data Safety

2.6 Data Safety

2.6.1 Protecting AIRO from Computer Viruses

Responsibility The organization using the system is solely responsible for protecting AIRO from computer viruses.
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.
The following operating system safeguards are in place: the Windows Firewall is enabled, auto-run
and auto-play features are disabled for devices, and no services are running that connect to the
Internet. Periodic AIRO Software upgrades require a format of the hard drive to remove any potential
infections.
See section 9.11 Network/Data Coupling to Other Equipment.

MI-42-0001 Rev. 22 19
SAFETY: Radiation Safety

2.7 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. For information about stopping
scans, see section 2.7.2 Safety Features Against Excessive Radiation.
NOTE: Restrict access to AIRO in accordance with local regulations for radiation protection.

Radiation Warning When X-rays are being produced, AIRO alerts personnel by these means:
Signals
• Yellow lights illuminate on the Gimbal.
• A yellow light illuminates on the Pendant display.
• The Pendant display screen says “Performing Scan.”
• AIRO emits a beeping tone.
NOTE: For helical scans, the audible X-ray alert is a constant beeping tone through entire length
of the scans. An audible X-ray alert that is not constant indicates a failure. If this occurs, terminate
the helical scan.
For axial scans, the audible X-ray alert is not constant through the entire length of the scan because
the scans use a sequential “step and shoot” format. In this format, the Gantry, or Ring, moves in the
z-direction, stops, scans in place with the audible alert tone, and then moves in the z-direction to the
next “step” of the scan. The number of “steps” is based on the length of the scan, with the alerts
beeping tone only active when the Ring has stopped and is performing the in place “shoot” portion
of the scan. An intermittent beeping tone during the x-ray portion of any of the “steps” indicates a
failure. If this occurs, discontinue use of system and contact technical support. See section
1.2.1 Contacting the Company.

Operator During scans when radiation warning signals are visible and audible, operators must visually monitor
Requirement Ring movement from starting to ending point throughout the duration of the scan. If at any time the
During Scans Ring stops moving as expected, terminate the scan.

20 MI-42-0001 Rev. 22
 SAFETY: Radiation Safety

2.7.2 Safety Features Against Excessive Radiation

How to Stop a Scan

Figure 6

Step
Release Scan a button.

2.7.3 Dose Notifications and Alerts

Overview Both previous and current releases of the AIRO scanning system provide warnings that performing
multiple scans on patients may result in excess dosage. To proceed with multiple scans, users are
required to acknowledge this by selecting Yes. See Figure 99.
In addition to the existing warning concerning multiple scans, the current release also complies with
the NEMA XR 25 Computed Tomography Dose Check standard. As articulated by AAPM, the
purpose of dosage Notifications and Alerts is to prompt users to confirm settings that might lead to
“higher than usual” dose index values prior to scanning the patient.
Because the XR 25 standard does not provide a mechanism to take patient size into account when
evaluating dose indices, scans may require doses that exceed recommended “dose check” levels,
especially when scanning obese patients. For these scans, Dose Notification or Dose Alert
messages provide “time-out” opportunities for confirming scan parameters.
By default, AIRO includes standard Computed Tomography Dose Index volume (CTDIvol) 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. Please contact your certified service representative if standard
CTDIvol or Dose Length Product (DLP) levels for Notifications or Alerts need to be modified.

Notification When When a scan’s estimated CTDIvol or DLP values exceed the maximum CTDIvol or DLP settings of
Dosage Level the scan protocol, the values are highlighted on the Location Selection and Set Scan Parameters
Exceeds screens. See a, s, and d in Figure 7 (CTDIvol values shown in this example).
Recommended
Value

MI-42-0001 Rev. 22 21
SAFETY: Radiation Safety

d
s

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 CTDIvol value f or DLP value to the
protocol’s listed dose check notification value. See Figure 8.
NOTE: When both CTDIvol and DLP notification values are set, CTDIvol Dose Notifications
and DLP Dose Notifications occur on different screens.
2. Verify that the value(s) are appropriate for the patient.
3. (Optional) Type in a diagnostic reason for exceeding the recommended dosage levels g.
See Figure 8.
4. Touch Next to display the next notification or set patient position. See section 
6.8.9 Selecting Patient Orientation and Position.

Alert When AIRO tracks accumulated radiation doses and can provide CTDIvol and DLP totals for both single
Accumulated scans and studies. For each scan, AIRO estimates the radiation dose and compares the estimated
Dosage Level dose to the system’s global CTDIvol and DLP settings, If a single scan exceeds either setting, the
Exceeds system displays a Dose Alert screen. If a patient’s study includes multiple scans, the system both
Recommended tracks the accumulated dose and estimates the dose of the next scan. When the total exceeds the
Value maximum global CTDIvol or DLP settings, the system displays Dose Alert screens (see Figure 9 for
an example of the DLP Dose Alert).

22 MI-42-0001 Rev. 22
 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
1. On the Dose Alert screen, compare the scan’s CTDIvol value or DLP value a to the
protocol’s global dose check alert values.
NOTE: When both the global CTDIvol and DLP values are set, CTDIvol Dose Alerts and DLP
Dose Alerts occur on different screens.
2. Verify that the value is appropriate for the patient.
3. (Optional) Type in an Operator ID and a diagnostic reason for exceeding the
recommended daily dosage levels s.
4. Touch Next.
5. On the security screen, type in a password for manager-level or higher users d.
6. Touch Next to display the next alert or start the scan. See section 6.8.9 Selecting Patient
Orientation and Position.

MI-42-0001 Rev. 22 23
SAFETY: Radiation Safety

Dose Notifications Because AIRO estimates the CTDIvol or DLP dose for the next scan and tracks the CTDIvol 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:
• Is greater than the protocol’s dose check notification value.
• Pushes the estimated total dosage of the study over the maximum global CTDIvol or DLP
settings.
When the system sees these potential dosage issues, it displays and logs the Notification or Alert.
However, the dose of the actual scan may not exceed the Notification and Alert limits when a scan
sequence includes the following options:
1. Scout scan
2. Optimized the field of view
3. Modulated Tube Current option (Helical scans only)
As a result, AIRO includes the actual scan data in the record of the Notification or Alert. This
indicates that the estimated dose exceeded system settings, but that the optional dose reduction
features allowed the scan or study to fall within the set limits.
For more information on:
• Using Scout scans, see 6.8.10 Selecting 2D Scout Scan View on page 103.
• Optimizing field of view, see 6.8.15 Selecting 3D Scan Region on page 112.
• Selecting Modulated Tube Current, see 6.8.16 Selecting a Constant or Modulated Scan on
page 117.
• Viewing and exporting Dose Reports, see 7.2.10 Option: Dose Check Report on page 153.

2.7.4 Profile of Stray Radiation

Technique Factors Stray radiation was measured with a PMMA body dosimetry phantom (32 cm diameter) placed at
isocenter on the patient table, as specified in IEC standard 60601-2-44:203.13.1 (2016). A RaySafe
X2 Solid State Sensor was used to measure exposures. Measurements on the horizontal plane were
made at isocenter height, and on the vertical plane at the centerline of the table, at 50 cm intervals.
Single axial scans were made at 120 kV, 25 mA, 2 sec (50 mAs), and exposure readings were
recalculated to 192 mAs. Measurements were collected from three individual AIRO systems and the
tables below show the mean of those results.
NOTE: The choice of an ion-chamber survey meter vs. a solid state detector, as well as subtle
changes in orientation and positioning of the survey instrument can result in deviations from the
observed values by as much as 50%.

24 MI-42-0001 Rev. 22
 SAFETY: Radiation Safety

Horizontal Profile
Values in mR/
Values in mR/exposure
Exposure
kV 120, mAs 192, mA 100, Sec. 1.92
cm 150 100 50 0 50 100 150
150 1.085 1.509 1.929 1.929 1.929 1.509 1.085
100 1.589 2.614 4.018 4.481 4.018 2.614 1.589
50 2.271 4.692 10.999 18.588 10.999 4.692 2.271
0 0.239 0.292 Gantry Phantom Gantry 0.292 0.239
50 0.135 2.368 10.128 15.854 10.128 2.368 0.135
100 1.039 2.384 3.623 4.130 3.623 2.384 1.039
150 0.940 1.361 1.669 1.747 1.669 1.361 0.940
200 0.684 0.841 0.933 0.935 0.933 0.841 0.684
Table

Horizontal Profile
Values in uGy/mAs
Values in uGy/mAs

kV 120, mAs 192, mA 100, Sec. 1.92

cm 150 100 50 0 50 100 150
150 0.050 0.069 0.088 0.088 0.088 0.069 0.050
100 0.073 0.120 0.184 0.205 0.184 0.120 0.073
50 0.104 0.215 0.504 0.852 0.504 0.215 0.104
0 0.011 0.013 Gantry Phantom Gantry 0.013 0.011
50 0.006 0.109 0.464 0.727 0.464 0.109 0.006
100 0.048 0.109 0.166 0.189 0.166 0.109 0.048
150 0.043 0.062 0.076 0.080 0.076 0.062 0.043
200 0.031 0.039 0.043 0.043 0.043 0.039 0.031
Table

Vertical Profile
Values in mR/
Values in mR/exposure
Exposure
kV 120, mAs 192, mA 100, Sec. 1.92
cm 150 100 50 0 50 100 150 200
150 1.188 1.517 1.441 0.509 0.214 1.325 1.083 0.821
100 1.614 2.654 3.917 1.259 1.684 2.441 1.548 0.959
50 1.867 4.020 11.054 Gantry 8.808 3.666 1.882 1.062
0 1.929 4.481 12.547 Phantom 15.854 4.130 1.747 0.935
50 1.798 3.613 6.806 Gantry Table Table Table Table

MI-42-0001 Rev. 22 25
SAFETY: Radiation Safety

Vertical Profile
Values in uGy/mAs
Values in uGy/mAs

kV 120, mAs 192, mA 100, Sec. 1.92

cm 150 100 50 0 50 100 150 200
150 0.054 0.070 0.066 0.023 0.010 0.061 0.050 0.038
100 0.074 0.122 0.180 0.058 0.077 0.112 0.071 0.044
50 0.086 0.184 0.507 Gantry 0.404 0.168 0.086 0.049
0 0.088 0.205 0.575 Phantom 0.727 0.189 0.080 0.043
50 0.082 0.166 0.312 Gantry Table Table Table Table

2.7.5 Protective Barriers

How to Minimize The recommended practices for minimizing radiation to staff are:
Radiation Exposure
Personnel Recommended Location During Scan
CT operator and essential staff IEC 60601-1-6 Classifications:
Behind protective barriers (mobile shields) as needed
Other medical support staff Outside of the room

Specification for For personnel remaining in the room, mobile shields, lead aprons, and thyroid collars must be
Protective Barrier utilized. Mobile barriers should have a leaded glass window. All protective barriers (shields, collars,
and aprons) must be rated 0.25 mm Pb equivalent or higher.
The CT operator must be able to view the patient at all times when a scan is performed to be able
to act promptly in case of an emergency.

2.7.6 Protection by Distance

Use the Pendant AIRO is designed to be operated from a distance to protect the CT operator from exposure to stray
Display radiation. The CT operator must be able to view the patient at all times when a scan is performed to
be able to act promptly in case of a collision.

Step
Use the long cord on the Pendant Display to control the scanner at a distance from behind
protective barriers.

26 MI-42-0001 Rev. 22
 SAFETY: Radiation Safety

2.7.7 Assessing Patient Risk

How to Assess
Patient Risk
Steps See
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
3. Ensure that you set scan direction, patient head orientation, and patient
position parameters in AIRO Software to match the required direction of
the scan, head orientation, and position of the patient.
NOTE: AIRO Software shows systems with integrated columns and 6.8.6 & 6.8.9
carbon-fiber operating tabletops. On an AIRO system with no Column,
use the end of the system that has the power, network, and ground
connections panel as a reference point. For more information, see the
listed sections.
NOTE: Always check the displayed projected radiation dose before initiating the scan.

2.7.8 Reducing Risk from X-ray Dose

How to Reduce AIRO offers two means of reducing risk from X-Ray dose via Automatic Exposure Control (AEC) –
Risk from X-ray weight adapted scan protocols and X-ray Tube Current Modulation.
Dose
• AEC
The general aim of an AEC system for CT is to reduce the variation in radiation doses to
different patient cross sections.
The AIRO adjusts the X-ray tube current based upon the size of the patient, which is configured
by the user through the selection of patient weight, and exam region (body part).
A constant tube current is used for an entire examination or scan series.
AIRO uses preset dosages based on the parameters entered for each scan (area, duration,
patient weight, etc.).
There is no manual mode with AIRO. As identified in the MI-42-0005 AIRO Application Guide
for Protocols and Principles, certain protocols use patient weight as an input to a calculation of
constant tube mA. The calculation is:
Adapted mA = Standard mA * Patient Weight / Standard Patient Weight
Where:
- Standard mA = mA for body region in specified patient category
- Standard Patient Weight = value specified in patient category (see MI-42-0005)
- Custom Patient Weights can be specified in user defined protocols.
• X-ray Tube Current Modulation (optional)
In addition, AIRO Software 1.2 and higher supports Z-axis X-ray Tube Current Modulation
(optional). Based on a scout scan, this feature modulates tube current automatically as the Ring
moves along the specified length of the scan. The dose is limited to not exceed that which
would normally be applied based on the selected patient weight and exam region, but may
reduce dose in areas of the patient with a smaller cross section based on the scout scan.

MI-42-0001 Rev. 22 27
SAFETY: Radiation Safety

With either AEC alone or both AEC and X-ray Tube Current Modulation, to reduce the risk of patient
overexposure:

Steps See
1. Enter patient data and scan area. 6.8.2–6.8.17
2. Review the automatically calculated radiation dosage on the display. 6.8.18
3. Evaluate the result.

Options
Dose is appropriate Initiate scan.
Dose is inappropriate Check patient data and scan selections.
NOTE: Using preset dosages does not replace the expertise of the operator.

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. These precautions include isolation from:
- Metal Parts
- Conductive pads
- Damp Towels

2.7.9 Laser Safety

How to Use the Be sure to avoid crossing a patient’s eyes with the light beam from a positioning laser.
Positioning Lasers
Safely

a
a

Figure 11

The class II laser modules a in the Ring emit visible laser radiation that is harmful to the human eye.

28 MI-42-0001 Rev. 22
 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
Release Scan a button.

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
interior of the system bore during scanning.

Step
Check the source-to-skin distance. Be sure all patient anatomy will remain at least 5 cm (2 in.)
away from the inner surface of the Ring bore during a scan.

MI-42-0001 Rev. 22 29
SAFETY: Mechanical Motion Safety

2.8 Mechanical Motion Safety

2.8.1 Overview

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

2.8.2 Patient Environment

Definition The Patient Environment is the space in which intentional or unintentional contact can occur
between a patient and parts of the system, or between a patient and other persons touching the
system.

Dimensions of the NOTE: The diagrams below show AIRO systems with the Trumpf Column and operating tabletop.
Patient Because all use of the system requires compatible patient support, AIRO systems without columns
Environment will require similar-sized patient environments.
(United States and
Top-Down View:
European Union)

Figure 13

30 MI-42-0001 Rev. 22
 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.
The operator should be able to observe any potential collisions while setting start and end points for
the scout scan or with the lasers. The operator can then be confident that the patient will clear the
inner bore of the Ring. The operator should observe the patient during the scan (either wearing lead
apron or standing behind lead barrier) to abort the scan should the patient move/fall during the scan.
Stand back from moving parts and use the long cord on the Pendant display and the wireless
Column remote control to operate the system.

Injuries could result from power driven equipment parts colliding with other moving
or stationary items in the environment. To avoid collisions:
- Be sure the patient is placed according to the instructions.
- For AIRO systems without integrated columns, ensure the proper placement of AIRO
system with respect to your patient table or support.
- Clear the surrounding area of equipment that is within range of the motion of the Ring.
- Place AIRO so that surgical personnel can move easily around it and access all
equipment without collisions.
- Do not place any unnecessary objects on or near AIRO.
- Anticipate the path of movement. Prevent clothing, drapes, IVs, and equipment from
getting caught in moving parts.
- Keep continuous visual contact with the system and the patient.

Ensure that the AIRO system is moved out of the room when performing Proton
Therapy.

MI-42-0001 Rev. 22 31
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.

Moving the Ring or the operating Monitor all movements.

table Stop movements by releasing the button on the controls.

Positioning tubing, other surgical Anticipate the system path.

equipment Place items so there is no danger of collision or pinching.
Changing table incline Monitor the changes in patient incline.
Select Zero Position on the column only after evaluating
Moving the column to zero the area for possible collisions.
position Pay particular attention to patient incline and any table
accessories that are angled downward.
Positioning an AIRO system that Evaluate the area for possible collisions.
has no integrated column for use
Ensure that the AIRO system is aligned correctly to avoid
with a compatible, radiolucent
any table, patient support, or patient contact with the
operating table or other
system during system motion.
compatible patient support

Do Not Lift There are no parts of AIRO that need to be lifted during authorized use with the exceptions of the
Pendant display and, for systems including a Trumpf TS7500 Operating Table Column, a remote
control for the Column and compatible tabletops.

2.8.4 Column Movement Considerations

Overview

Some table movement, due to column movement, is expected when using an AIRO
provided with an attached column. By design, the column “floats” with respect to the
rest of the system to ensure proper operation.
This movement will not affect image quality, but may be noticeable when the table is
in the unloaded state. Due to the numerous site-specific variables, placing a precise
column movement limit that would encompass all potential circumstances is not
possible.
If table movement is still considered excessive, after attempting the mitigation
suggestions provided in this section, contact technical support. See section
1.2.1 Contacting the Company.
The AIRO system is a mobile CT solution. The baseline configuration features an attached column.
To minimize any influence that the weight of a patient-laden table may have on image quality, the
column and its interface plate move independently from the rest of the base via a floating coupling
mechanism. Attaching the column to the system in this manner allows the column interface plate to
contact the floor, independent from the base.

32 MI-42-0001 Rev. 22
 SAFETY: Mechanical Motion Safety

Although this provides the convenience of system mobility, it also makes some degree of column
movement expected. This may be influenced by unique physical elements in the particular theater
of operation coupled with the chosen system configuration. Potential related factors are:
• Orientation of the loaded table, such as perpendicular (90-degree) vs. parallel (in-line)
orientations
• Amount of table extension and retraction
• Orientation of the tabletop in relation to the column (e.g., Trendelenburg or Anti-Trendelenburg)

External Variables Potential external variables that can have an aggregate effect on observed Column motion include,
but are not limited to, the following:
• Floor/sub-flooring surface flatness
• Overall floor condition
• Floor/sub-flooring surface texture
• Floor surface material hardness
• Patient positioning
• Patient weight - not to exceed 182kg (400 lbs.)
Due to the numerous site-specific variables, placing a precise column movement limit that would
encompass all potential circumstances is not possible.

Minimizing Column To mitigate observed column movement the following operating table positioning suggestions are
Movement offered:
NOTE: The following suggestions are for a system with an installed table that has a patient-weight-
equivalent load.
1. When feasible, utilize the table positioned parallel to, or in-line with, the AIRO base.
Additionally, the parallel position is the only authorized position for the performance of CPR.
2. If possible when not active scanning, utilize a lower table height to reduce the arc of any
observed movement.
3. Extend or retract the table longitudinally to reduce movement observed at the “centered” or
“balanced” table position.
By shifting the installed table's center of gravity longitudinally, the profile between interface-
plate contact points and the floor surface changes. Consequently, this shift can provide
increased stability and reduce any “rock” or “wobble” that is present when the table's center of
gravity is located directly above the column's center of gravity.
If the observed column movement is still considered to be excessive after attempting the mitigating
suggestions above, contact technical support (see section 1.2.1) to schedule a service visit.

MI-42-0001 Rev. 22 33
SAFETY: Electrical Safety

2.9 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. There are no internal user-serviceable parts.
- Do not remove equipment covers. Do not attempt to override safety features.
- Do not use AIRO in Oxygen Rich environments or with flammable anesthetics.
- Avoid tripping over or driving over the power and network cables as this can damage
them.
- Do not use any electrical cables with damaged insulation or that appear to have been
crushed.

AIRO is not waterproof. Water, soap, or other liquids, if allowed to drip into the
equipment, can cause electrical short circuits leading to electric shock and fire
hazards.

If liquids should accidentally spill into the system, DO NOT apply power or turn the
system on until the liquids have dried or evaporated completely.

34 MI-42-0001 Rev. 22
 SAFETY: Transportation Safety

2.10 Transportation Safety

2.10.1 Overview

Safety Precautions Follow user instructions.

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.

Always drive AIRO with the Pendant Display in the holster. Driving with the display out
of the holster creates a danger of both collision and entanglement.

Never allow untrained persons to move or operate AIRO as this creates a hazard of
collision and equipment damage. To avoid the hazard of tipping, observe the following
safety procedures:
- Never push or attempt to move AIRO from the side. Only push using the hand grips on
the system control holster.
- Do not attempt to transport AIRO over damaged flooring.
- Never attempt to transport AIRO with the Ring outside of transport position.

Only attempt to transport or operate AIRO on surfaces and inclines designated as

appropriate for use by the responsible organization following the criteria established
by the manufacturer. Failure to do so creates hazards of collision, tipping, and
equipment damage. AIRO is designed to move on level flooring. Inclines cannot
exceed 5°. Thresholds must not exceed 9.5 mm (3/8 inch).

Transporting objects, devices or material on the operating tabletop is not permitted as

this creates a hazard of equipment damage.

To avoid the potential of serious injury, observe these safety warnings:

- Never transport the system up or down a ramp at an angle. Transporting at an angle on
a ramp creates a hazard of tipping which can cause injury.
- Do not attempt to turn while on an incline or decline. Turning creates a hazard of
tipping which can cause injury.
- Never unlatch the Gimbal while on a ramp. Turning the Ring creates a hazard of tipping
which can cause injury.
- Never disable the main drive wheel while on a ramp. Disabling the main drive wheel
creates a hazard of uncontrolled movement which can cause injury.
- Never store AIRO on a ramp.
- Never put AIRO in Scan mode while on a ramp.
- When backing up the system, always monitor the route and surrounding area to avoid
colliding with corners, walls, and projections.

MI-42-0001 Rev. 22 35
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.

36 MI-42-0001 Rev. 22
 SAFETY: Fire Safety

2.11 Fire Safety

2.11.1 Fire Extinguishers

CO2 Only Each AIRO system uses seven battery packs with state-of-the-art Lithium Iron Phosphate cells.
These are much more stable than other types of Lithium batteries. As a result, the risk of “thermal
runaway” chain reactions is minimal compared to more widely used Lithium Ion batteries.
In addition to the reduced baseline risk, AIRO uses system-wide thermal management to monitor
the temperature of battery packs at all times. If an event that spikes battery temperature occurs, the
system cuts off the charging system and shuts down. This feature operates continuously unless the
batteries are completely discharged or removed from the system.
In the event of a fire in the vicinity of an AIRO system, do NOT use water to fight the fire. Only CO2
fire extinguishers are effective.
If the system is smoking:

Steps
1. Call your community's Emergency Services or Fire Department.
Tell them that the system uses “Lithium Iron Phosphate” batteries, not “Lithium Ion”
batteries.
2. If safely possible, unplug the system from the facility mains power outlet or otherwise cut
power to the system.
3. Evacuate the area and avoid breathing the smoke.
4. Use only CO2-based fire retardants on the system.
5. Wait until the system stops smoking before returning to the area.

MI-42-0001 Rev. 22 37
SAFETY: Power Failure/Interruption

2.12 Power Failure/Interruption

2.12.1 In Case of Power Failure/Interruption

Power Interruption AIRO recovers from brief power interruptions (e.g., accidental unplugging). The system can be
rebooted when the power is restored.

What Happens if
the Power Fails
Power Failure/Interruption
During a Scan
1. AIRO stops scanning and stops all movement within 50 mm of travel.
2. Partial scan data, with minimum scan distance reached (7.9 cm / 3.11 in. for Helical, one full
rotation for Axial), is recoverable on reboot.
3. AIRO powers down.

NOTE: You can move the Ring away from the table manually.

How to Restore
Limited Functions
During a Power
Failure

a
s

Figure 15

Steps

1. With the key in the ON position, press Start a on the Control Panel.

Original Column
2. Press On s on the Column keypad or Column remote control.

Updated Column

38 MI-42-0001 Rev. 22
 SAFETY: Power Failure/Interruption

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. This is highly unlikely.
NOTE: To protect the batteries when unplugged, AIRO powers down automatically when it has
been unused for one hour.

Battery Failure
1. Plug AIRO into a wall socket to recharge the batteries.
2. If batteries still fail, contact technical support. See section 1.2.1 Contacting the Company.

NOTE: Only qualified service personnel may replace the batteries.

2.12.2 Restoring a Session

General In the event of a power failure, when power is restored the acquired images will be under Existing
Information Scans.

What Happens AIRO behaves as if it has been turned on normally.

When Mains Power
is Restored
Options See
1. Recover data from previous session, if saved. 6.8.3 – 6.8.5
2. Re-scan patient. 6.8.6 – 6.8.18

MI-42-0001 Rev. 22 39
SAFETY: Power Failure/Interruption

This Page Intentionally Left Blank

40 MI-42-0001 Rev. 22
 TRANSPORT MODE: Chapter Overview

3 TRANSPORT MODE
3.1 Chapter Overview

3.1.1 Contents

Topics Covered
Section See
Controls 3.2
Transportation 3.3
Powering Down 3.4

MI-42-0001 Rev. 22 41
TRANSPORT MODE: Controls

3.2 Controls

3.2.1 Pendant and Power

Diagram of
Controls a
s
;
l

k
!
d j

f f

Figure 16

No. Component Function/Usage

All controls for transport and scanning except power
a Pendant
NOTE: The column has separate controls.
Transport mode: Displays front image for moving the system
s Pendant Display Scan mode: Displays features, options, and controls for
operating, configuring, and maintaining system
d Holster Holds Pendant
Molded into holster; user places hands here when driving and to
f Hand grips
turn the system
g Power Controls Key switch for mains power, and Start button to enable Pendant
h USB Port Data transfer
Move system forward and back (left and right are disabled in
j Motion Controls
Transport mode)
k Scan Button To initiate or stop a scan
Emergency Stop 
l Stops all functions immediately
button
; Reset Button Resets the system after an Emergency Stop

42 MI-42-0001 Rev. 22
 TRANSPORT MODE: Controls

3.2.2 Power Switches

Mains Power

g s

d
Figure 17

No. Component Icon Function/Usage

a Holster Holds Pendant

Standby position: No functions available except

battery charging

s Key Switch

On position: Turns on system power

Illuminates yellow when the key switch is in the On

Power position s and the Start button g is pressed.
d
Indicator Light
Blinks during system shut-down.

f USB port Enables data export

g Start Enables the Pendant

Illuminates green to show that the batteries are

Charging
h charging when system is plugged into an AC power
Indicator Light
connection.

MI-42-0001 Rev. 22 43
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.

a
s
d

a s d
Figure 18

No. Components
Equipotential stud used to provide a means of linking the earth ground of the system to
a
other equipment to minimize any electrical potential difference between them.
s Ethernet connectors for View Station (left) and hospital network (right).
d Power cable.

44 MI-42-0001 Rev. 22
 TRANSPORT MODE: Transportation

3.3 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.
• The best way to ensure a full charge is to leave AIRO plugged in whenever it is stationary.
• To preserve the batteries, the system automatically shuts off in one hour if left unplugged and
unused.

f d s a
Figure 19

Steps
1. Unplug power and network cable(s).
The green charging indicator light s goes off.

2. Insert key and turn to On a position.

3. Press Start f.
• The yellow power indicator light d slowly blinks and becomes steady
when AIRO Software loads.
• The Pendant displays the User log-in screen.
4. Log in on the Pendant with a user-level or higher password. See section 3.3.2 Logging In.

From the Choose Mode screen on the Pendant, select Transport. See
5.
Figure 37 on page 73.

NOTES:For AIRO systems that include Columns:

• Do not raise column height when utilizing Transport mode. The column can collide with the
Gimbal if it is not in the correct position.
• Transferring the table to the shuttle sets the correct height of the column for transport.

3.3.2 Logging In

How to Log In The system requires users to log in:

• On system start up.
• After System Lock from system-idle time out.
• Following an optional security lock out from main Menu.

MI-42-0001 Rev. 22 45
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.
NOTE: It is recommended that you log in within 5 minutes of startup to avoid having to wait several
minutes until the AIRO Ring is ready to be used.

Figure 20

Figure 21

Steps
1. Using the on-screen touch keypad, type in the password.
2. Touch either Next or Enter.

46 MI-42-0001 Rev. 22
 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. From the Choose Mode screen on the Pendant, select Transport. See Figure 37 on
page 73.
4. Unplug and secure power, network, and Pendant cables.
The images below show the required coiling directions on systems with and without
installed cable Strain Reliefs.

Power Cable: Coil counter-clockwise

from top-left hook.

MI-42-0001 Rev. 22 47
TRANSPORT MODE: Transportation

Steps

Pendant Cable without Strain Relief:

Coil counter-clockwise from bottom-right
hook.

Pendant Cable with Strain Relief a:

Coil clockwise from top-right hook.

5. Look at the base of the system and verify that:

• The base is raised.
• The system is on its casters.
6. Make sure that the Ring is latched in an orientation that:
• Is parallel to the base.
• Has the Gimbal in line with the column.
See section 3.3.6 Rotating and Latching the Ring in Transport or Scan Position.
7. View the forward-camera image on the Pendant Display.

48 MI-42-0001 Rev. 22
 TRANSPORT MODE: Transportation

Optional
Steps See
Conditions
System prompts you to unplug cord(s).

System is plugged in

1. Make sure there is room for the Ring to rotate.

2. From the Choose Mode screen, select Transport.
The screen shows instructions for latching the Ring into
the Transport position. See Figure 24.
3. Unlatch the Ring and follow on-screen instructions.
Make sure that the Ring latches:
• In line with the base.
• In the middle of the base’s Z-axis.
Ring is in Scan
For more information, see section 3.3.5 Starting from 3.3.5
position
Scan Mode.

Move the Ring slowly and carefully. Moving the Ring

quickly can damage the anchor points in the Ring and
Transport latches.
See cautions about rotating the Ring in section
3.3.6 Rotating and Latching the Ring in Transport or
Scan Position.

MI-42-0001 Rev. 22 49
TRANSPORT MODE: Transportation

Optional
Steps See
Conditions
1. Latch the Ring in Scan position.
NOTE: This is to keep the Ring from turning while you
push it.
2. Make sure there is room for the Ring to rotate.
3. From the Choose Mode screen, select Transport.
The screen shows instructions for latching the Ring into
the Transport position. See Figure 24.
4. Unlatch the Ring and follow the on-screen instructions.
Make sure that the Ring latches:
Ring is not latched  • In line with the base.
in one or both 3.3.6
• In the middle of the base’s Z-axis.
orientations
For more information, see section 3.3.5 Starting from
Scan Mode.

Move the Ring slowly and carefully. Moving the Ring

quickly can damage the anchor points in the Ring and
Transport latches.
See cautions about rotating the Ring in section
3.3.6 Rotating and Latching the Ring in Transport or
Scan Position.
Base is on the floor,
System prompts you to raise the system. 3.3.7
casters stowed

Universal Option

At any time, touch Menu and select Home from the dialog to return to the Choose
Mode screen. See section 3.3.4 Menu in Transport Mode.

50 MI-42-0001 Rev. 22
 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 a
Mode

s d f g
Figure 23

Step
Touch Menu a at any time to access the Menu with Transport mode options.

Transport Mode Options

Select Home s to return to the Choose Mode screen. See section 6.3.2 Choosing Scan Mode.
Select Scan d to exit Transport mode and enable scanning.
Select Info f to learn more about AIRO and your system’s customer support contact
information.
Select System Lock g to enable security requiring a password to access system functions.
See section 3.3.2 Logging In.

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TRANSPORT MODE: Transportation

3.3.5 Starting from Scan Mode

Using the Latch Use the latch to unlock the Ring.

Figure 24

s s

s 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. For systems with Columns, move, or translate, the Ring along Z-axis away from the Column
to make room to rotate Ring for Transport mode.
For systems without columns, make sure there is room for the Ring to rotate.
2. Using the main Menu, display the Choose Mode screen on the Pendant. See section 
6.7.4 Menu in Scan Mode.
3. From the Choose Mode screen, select Transport.
The screen shows instructions for locking the Ring into Transport position a.

52 MI-42-0001 Rev. 22
 TRANSPORT MODE: Transportation

Steps
4. Following the on-screen instructions, lift the latch s to release the lock and rotate the Ring
until it latches into the transport orientation parallel, and in line with the base. See 
Figure 25.

See cautions about rotating the Ring in section

3.3.6 Rotating and Latching the Ring in Transport or Scan Position.
5. Move, or translate, the Ring toward the middle of the base’s Z-axis until it latches.

Move the Ring slowly and carefully. Moving the Ring quickly can damage
the anchor points in the Ring and Transport latches.
6. Unplug power and network cables.
7. Raise the system to transport. See section 3.3.7 Raising the System for Transport.

3.3.6 Rotating and Latching the Ring in Transport or Scan Position

How to Rotate and The Ring has a Transport position in line with the base and column, and two Scan positions at 90°
Latch the Ring angles to the base. While the Transport position locks in the middle of the base, the two Scan
positions configure AIRO to scan in opposite directions along the Z-axis of the base.
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°
across the base and has the Mobius AIRO logo toward the column.

Rotate the Ring slowly and carefully. Rotating the Ring quickly can damage
the anchor point of the Ring latch.
If resistance occurs during Ring rotation, do not force the Ring into place.
Contact Technical Support immediately.

MI-42-0001 Rev. 22 53
TRANSPORT MODE: Transportation

Figure 26

Steps
1. Use the latch to unlock the Ring. See section Using the Latch.
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).
- Toward the column to scan away from base-column (SAB).

See cautions about rotating the Ring in section

3.3.6 Rotating and Latching the Ring in Transport or Scan Position.
3. (Transport mode only:) Push the Ring so it moves toward the middle of the base’s Z-axis
until it latches.

Move the Ring slowly and carefully. Moving the Ring quickly can damage
the anchor points in the Ring and Transport latches.

54 MI-42-0001 Rev. 22
 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 a until the camera window appears.
The system is ready for transport.
NOTE: System will not transport (camera window will not appear) if power cord is plugged in.

3.3.8 Transportation

Diagram

!
a
s

Figure 28

NOTE: Leave the Pendant in the holster when transporting the system.

MI-42-0001 Rev. 22 55
TRANSPORT MODE: Transportation

Steps
1. Use the display a to see in front of the system.
2. Use the buttons s 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. Look around the sides of the
system.

Avoid Collisions Transport this equipment following all safety guidelines.

Employ proper driving techniques to avoid any potentially hazardous situations. The intended
transportation path should be clear of any obstacles when moving in forward or reverse directions.

Never reverse AIRO within 1.0 m of any obstacle.

Hand Position While transporting or “driving” the AIRO system, placing your hands in locations other than the
holster side grips can result in personal injury.

Always place hands on holster side grips when driving.

Stopping To stop at any time, release the direction key.

Brakes AIRO engages its brakes when stopped.

AIRO is designed with a fail-safe brake to control movement. In the worst-case on a normal use floor
surface, AIRO will stop in less than 1.0 m.

Turning AIRO turns when you manually push left or right on the hand grips. It pivots on its main drive wheel.
NOTE: If you have any doubts about making a turn, stop and evaluate the area first.

Inclines/Declines

The only acceptable position for the system on a ramp is the transport position and
parallel with the direction of the incline or decline.

The Ring must remain latched in transport position. Inclines and declines
must be no more than 5°.

Never unlatch the Ring on a ramp.

Never disable the main drive wheel on a ramp.

56 MI-42-0001 Rev. 22
 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 in.).

Using Elevators When using elevators:

• Always travel in the elevator with the system.
• Transport only yourself and the system. There can be no additional passengers or equipment.
• Elevator capacity should be at least 1588 kg (3500 lbs).
• Elevator size must be at least 203 cm wide by 165 cm deep (6 ft. 8 in. by 5 ft. 5 in.).

3.3.9 After Transport

Options
Options See
Setting Up for Scan
Placing the system 3.3.10
Lowering the System 3.3.11
Evaluate Column movement 2.8.4
Unlocking and Rotating the Ring 3.3.12
Setting the Orientation for Scanning 3.3.13
Temporary Storage (Park) 3.3.14

3.3.10 Setting Up for Scan

Determine Location
Step
Before lowering the system to conduct scans, evaluate the area for optimal placement. Make
sure the floor of the target ___location:
• Is flat, level, and even.
• Does not flex because of the system.

Where to Place the System setup depends on the type of scan being taken or the procedure being performed.
System Regardless of the intended procedure, always be aware of the need for audio and visual
communication between operator and patient.
• Place the system so the operator and patient can always see and hear each other.
• Always place the system so that it can be easily unplugged in case of an emergency.
• The system and its controls should not restrict the movement of the medical team.
• The Ring must have a clear path for movement. Evaluate the area above the scanner as well as
the sides.
• The system ventilation system must not be blocked.

MI-42-0001 Rev. 22 57
TRANSPORT MODE: Transportation

Some table movement, due to column movement, is expected when using an AIRO
provided with an attached column. By design, the column “floats” with respect to the
rest of the system to ensure proper operation.
This movement will not affect image quality, but may be noticeable when the table is
in the unloaded state. Due to the numerous site-specific variables, placing a precise
column movement limit that would encompass all potential circumstances is not
possible.
If table movement is still considered excessive, after attempting the mitigation
suggestions provided in section 2.8.4, contact technical support. See section
1.2.1 Contacting the Company.

Example: Setup This diagram is one of many possible setups. The position of AIRO, accessories/compatible
During Scan equipment, medical personnel, and the patient varies according to need.

s
a

Figure 29

58 MI-42-0001 Rev. 22
 TRANSPORT MODE: Transportation

Components
No. Component
a CT technician holding Pendant
s Protective barriers
d Patient on operating table
f Gimbal
g Ring
h Other medical personnel

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.

a
Figure 30

Step
Allow air to circulate freely around the intake and exhaust vents a in Scan mode.

MI-42-0001 Rev. 22 59
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
1. options on the Pendant (see Figure 23), or access the Choose Mode screen
(see Figure 31).

2. Select Scan on the Menu dialog or the Choose Mode screen.

3. Press Down until the base is on the floor.

4. Plug in the power cord.

5. If applicable, plug in the network cable.

Be sure there are no objects under the base when it is being lowered, such as power
cords.

60 MI-42-0001 Rev. 22
 TRANSPORT MODE: Transportation

3.3.12 Unlocking and Rotating the Ring

How to Unlock and

Rotate the Ring

Figure 32

Step
Pull the release latch to unlock the Ring and rotate it manually. See section 3.3.6 Rotating and
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.

See cautions about rotating the Ring in section

3.3.6 Rotating and Latching the Ring in Transport or Scan Position.

MI-42-0001 Rev. 22 61
TRANSPORT MODE: Transportation

3.3.13 Setting the Orientation for Scanning

How to Set the 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 See
• MI-42-0167 AIRO Original Trumpf Column
Supplement chapters 2 and 3
Or:
Transfer patient using Column, Table, and • MI-42-0165 AIRO Updated Trumpf Column
Shuttle. Supplement chapters 2 and 3
For information about which integrated column
your AIRO features, see chapter 4 COLUMN
AND TABLE.

3.3.14 Temporary Storage

How to Park Leave AIRO on its wheels when you are not scanning. Only lower the base to the floor for scanning.
NOTE: Park on level surfaces only. Never store on a ramp.

Figure 33

62 MI-42-0001 Rev. 22
 TRANSPORT MODE: Transportation

Steps

1. Select Home to exit camera view.

2. Turn the key switch to the standby position.

3. Plug in the power cord.

MI-42-0001 Rev. 22 63
TRANSPORT MODE: Powering Down

3.4 Powering Down

3.4.1 Set to Standby Mode

Overview Whenever AIRO is not in use it should be in Transport position, plugged in, and set to Standby.

How to Enter
Standby Mode
Steps
1. Leave the system with the base up and on its casters.
2. Turn the Ring so it is aligned with the base.
3. Push the Ring toward the middle of the base’s Z-axis until it latches.
4. Plug in the power cord. The green charging indicator light illuminates.

Insert the key and turn it to Standby.

5.
The yellow power indicator light blinks while the PC shuts down.

NOTE: Always keep AIRO plugged in to maintain the batteries.

64 MI-42-0001 Rev. 22
 COLUMN AND TABLE

4 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.
To determine which integrated column your AIRO features, view the side of the column that shows
the column keypad.

Column Image Column Identifiers

Original Column
• Keypad has a curved bottom a.
• Does NOT have the “Follow Instructions
a For Use” symbol next to the keypad. See
Figure 34.

Updated Column
• Keypad has a straight bottom s.
• HAS the “Follow Instructions For Use”
d s symbol next to the keypad d. See 
Figure 34.

MI-42-0001 Rev. 22 65
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.

Using Trumpf Carbon Spine Surgical Tabletops with legacy columns that do not display
the Read Instructions label will result in no or limited table functionality.

Figure 34

66 MI-42-0001 Rev. 22
 TRANSFERRING THE TABLE

5 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.
For information about which integrated column your AIRO features, see chapter 4 COLUMN AND
TABLE.

MI-42-0001 Rev. 22 67
TRANSFERRING THE TABLE

This Page Intentionally Left Blank

68 MI-42-0001 Rev. 22
 SCANNING: Chapter Overview

6 SCANNING
6.1 Chapter Overview

6.1.1 Contents

Topics Covered
Section See
System and Controls 6.2
Before Scanning 6.3
Moving the Ring in Scan Mode 6.4
Prepare Scan Field of View 6.5
Welcome Screen 6.6
Daily Warm Up Scan 6.7
Typical Scan Sequence: New Scan 6.8
View an Existing Scan 6.9
Emergency Scanning 6.10
Editing Patient Data 6.11
After Scanning 6.12
Head Scanning 6.13

MI-42-0001 Rev. 22 69
SCANNING: System and Controls

6.2 System and Controls

6.2.1 AIRO System

Diagram of System
Configured for
Scanning

a
j

f g
Figure 35

No. Component Function/Usage

a Ring Scans patient and sends data to Pendant. Also called gantry.
s Window Opening through which scan is taken.
Supports and moves the system, includes power and data
d Base connections.
NOTE: Casters are retracted into the base.
f Gimbal Supports the Ring.
g Latch Releases Gimbal, enabling rotation.
Supports some models of surgical tables/chairs (see parts list
h Column
for specific part numbers).
Controls system movement, imaging, and data storage.
j Pendant Display
NOTE: The Pendant Display is shown stored in the holster.

Details In Scan mode, the base is lowered and locked. The Ring is around the surgical table. The system
operator has the Pendant display out of its holster and stands back from the system and/or behind
a protective barrier.
The operator runs the system and views the images on the Pendant display.
During a scan, the Ring moves down the patient axis and stops at the selected end point of the scan.
Image data is then transferred to the Pendant.

70 MI-42-0001 Rev. 22
 SCANNING: System and Controls

6.2.2 Pendant Display

Diagram of Pendant
Display

s
d

a f g

Figure 36

No. Component Function/Usage

Touch to enter data or select functions.
a Touchscreen
Serves as display for camera view.
s Reset Button Press to clear the Emergency Stop.
Emergency Stop or 
d Press to halt all scanning and mechanical motion functions.
E-Stop
• Green – Ready to scan
• Yellow – X-rays in Progress
f LED Lights (3) • Solid Orange – Ring is in motion
• Blinking Orange – E-Stop button has been pressed. Turn off
E-Stop by pressing the Reset button s.
g Scan Button Press to conduct a scan.
h Directional Keys Use to move Ring and Gimbal.

Details The CT operator uses the Pendant Display to move the Ring and Gimbal, turn the laser pointer on
and off, set the parameters for each scan, conduct the scan, and interact with the resulting images.

Options See
Move the Ring and Gimbal 6.4
Scan 6.8
Use Laser for Positioning 6.8.11

MI-42-0001 Rev. 22 71
SCANNING: Before Scanning

6.3 Before Scanning

6.3.1 Overview

Before Scanning
Steps See
1. Follow the instructions to set up for scan. 3.3.10
For intra-operative use, consider the
2. post-scan table position to mitigate 2.8.4
column movement.
Confirm Ring is facing the direction of the
3. intended scan before moving the patient 6.8.6
to the column.
• MI-42-0167 AIRO Original Trumpf Column
Supplement chapter 3
Or:
Transfer patient and patient support to • MI-42-0165 AIRO Updated Trumpf Column
4.
the surgical column. Supplement chapter 3
For information about which integrated column
your AIRO features, see chapter 4 COLUMN
AND TABLE.
Log in with a user-level or higher
5. 3.3.2
password.
6. Choose Scan mode. 6.3.2
7. Prepare scan field of view. 6.5

Some table movement, due to column movement, is expected when using an AIRO
provided with an attached column. By design, the column “floats” with respect to the
rest of the system to ensure proper operation.
This movement will not affect image quality, but may be noticeable when the table is
in the unloaded state. Due to the numerous site-specific variables, placing a precise
column movement limit that would encompass all potential circumstances is not
possible.
If table movement is still considered excessive, after attempting the mitigation
suggestions provided in section 2.8.4, contact technical support. See section
1.2.1 Contacting the Company.

72 MI-42-0001 Rev. 22
 SCANNING: Before Scanning

6.3.2 Choosing Scan Mode

How to Choose
Scan Mode

Figure 37

Step
Select Scan a 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.

MI-42-0001 Rev. 22 73
SCANNING: Before Scanning

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. Typically, this occurs after switching from Transport mode to Scan
mode or reorienting the Ring. See section 3.3.6 Rotating and Latching the Ring in Transport or Scan
Position. It can also occur after manually moving, or translating, the Ring along the Z-axis.

Figure 38

Step
Hold the green Scan Button on the Pendant (g in Figure 36) until the Connect the Mobile CT
System screen (Figure 40) or the Required Maintenance Scans dialog (Figure 39) appears.
NOTE: While holding the Scan Button, AIRO oscillates Ring tilt to find a precisely perpendicular
position.

Required If the system detects that valid Required Maintenance Scans have not been performed recently, you
Maintenance Scans are prompted with a dialog box indicating which Scans need to be performed. Some maintenance
check scans verify system setup and must be run daily, Others are required less often.
Each day, allow time for performing these maintenance scans prior to using the system clinically. At
a minimum, run the Warm-Up, E-Stop, Gain Calibration, and the Required Maintenance Scans that
match the scan types scheduled for the current day. If the schedule includes Helical, Axial, SAB,
STB, and Pediatric scans, perform all Required Maintenance Scans.

Figure 39

74 MI-42-0001 Rev. 22
 SCANNING: Before Scanning

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.
• An E-Stop test, or Emergency Stop test, must be performed
E-Stop test to ensure scanner safety overrides are functioning properly
in case of emergency. See section 7.2 Service Functions.
• You must calibrate the system to ensure the best image
Gain Calibration
quality possible. See section 7.3 Daily Gain Calibration.
Helical Daily Quality Check • Limited daily system testing of Helical Scan functionality.
• Full system testing of Helical Scan functionality.
Helical Full Quality Check
NOTE:Run this check at least once every 6 months.
Axial Daily Quality Check • Limited daily system testing of Axial Scan functionality.
• Full system testing of Axial Scan functionality.
Axial Full Quality Check
NOTE:Run this check at least once every 6 months.
NOTES:
• AIRO will allow patient scans to be performed when gain calibration and quality checks have
not been done. However, this is not recommended.
• When all required scans are complete, the dialog no longer appears.
Quality Checks must be performed per hospital requirements. The type of scanning needed (Axial
or Helical) in the clinical environment determines the type of quality checks that on-site hospital
technicians must run. In addition, performing the quality checks in the direction of required patient
scans is recommended.
Daily Quality Checks include testing for imaging system alignment, CT number accuracy, CT
number noise, and CT number uniformity. They expire after 18 hours.
Full Quality Checks are full tests of system alignment and functionality that expire after 6 months.
When required, they can be performed in place of Daily Quality Checks.
If maintenance scans fail, adjust the system and phantom alignment and try again. If the
maintenance scans consistently fail contact technical support. See section 1.2.1 Contacting the
Company.

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. However, both Gain Calibration and quality
checks can affect image quality.
In addition, the system must be powered on and in Scan mode for at least 30 minutes before running
a calibration when the system both:
• Requests Gain Calibration.
• Has been powered down, or in Transport mode, for more than 10 minutes.

MI-42-0001 Rev. 22 75
SCANNING: Before Scanning

6.3.3 Connecting System

How to Connect to
Power and Hospital
Network

f
d

g h j k l
Figure 40

Steps
1. Connect power cord to standard wall outlet a.
2. Option: Connect Ethernet wire to hospital network s.
3. Option: Connect to surgical navigation system d.
4. If required for electrostatic protection from other equipment, connect equipotential stud f
to ground.
5. Touch Next.

Task Bar icons

g Ring orientation
h Battery power/charging
j Ethernet connection to hospital network (green when connected)
k 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.
l
Orange - 66% to 100% of tube heat capacity is used.
Red - Over 100% of tube heat capacity is used. Call technical support; do not attempt to
use the system. See section 1.2.1 Contacting the Company.
NOTE: System temperature icon indicates status of the X-ray tube.

76 MI-42-0001 Rev. 22
 SCANNING: Moving the Ring in Scan Mode

6.4 Moving the Ring in Scan Mode

6.4.1 Translating the Ring (Z-axis)

How to Translate When in Scan mode, use the direction keys on the Pendant Display to control Ring translation.
the Ring on the
Base

a s

Figure 41

Step Action
Press and hold the left a or right s directional button
To move the Ring back and forth
on the Pendant Display.

MI-42-0001 Rev. 22 77
SCANNING: Prepare Scan Field of View

6.5 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 Remove all non-essential objects and equipment from the Ring bore and the scan field of view
Objects before scanning. When necessary, place IV tubes where the motion of the system will not affect
them.

Extra objects in the Ring bore, even when they are out of the scan field of view, may
degrade the scan image.

6.5.3 Remove Metal Objects

Keep Metal Objects Be sure there are no metal or other radiopaque objects in the bore or near the scan field of view.
Away from System
NOTE: This includes table accessories such as arm boards.

Metal objects in or near the scan field of view can degrade the scan image.

78 MI-42-0001 Rev. 22
 SCANNING: Welcome Screen

6.6 Welcome Screen

6.6.1 Welcome Screen and Functions

Options on the
Welcome Screen

Figure 43

Figure 44

Steps See
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 6.7
Warm-up Scan sequence.
3. Perform maintenance activities and scans as required. 7.2–7.3

MI-42-0001 Rev. 22 79
SCANNING: Welcome Screen

Options Function See

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

7.2
configuration and maintenance features.

Service warning icon:

• Appears when the system requires service.
• Touch to display a Service Warning dialog about the issue(s)
requiring service. Possible warnings are:
- Application settings have been changed
- Adjacent bad detectors
- Bad detector limit exceeded
- Detector verification failed
1.2.1
NOTE: If the Detector verification failed message appears, try
rebooting the system. If the warning persists, stop using the system
and contact technical support. See section 1.2.1 Contacting the
Company.

If the Service warning icon appears, stop using the system and
contact service or technical support for your region.
Maintenance warning icon:
• Appears when AIRO requires maintenance, quality scans, or both.
• Touch to display a Required Maintenance Scans dialog that lists all
required activities.
• See Figure 44 to view possible requirements. 6.7
• If the dialog lists Warm-up Scan, touching OK may launch the
scan. See section 6.7 Daily Warm Up Scan. 7.2.5

NOTE:If the dialog lists more than Warm-up Scan, ask the on-site 7.3
hospital technician to perform system maintenance. 7.2.9

Performing patient scans when the Maintenance warning icon

appears may result in poor image quality and unused dose.

Select to perform Emergency Scan (to skip patient data entry when
6.10
urgent scans are required).

Touch Laser at any time to turn on/off the positioning lasers.

• When the icon is Gray, the laser is OFF. 2.7.9
• When the icon is Orange, the laser is ON.

Select to open the universal option Menu in Scan mode. 6.7.4

80 MI-42-0001 Rev. 22
 SCANNING: Daily Warm Up Scan

6.7 Daily Warm Up Scan

6.7.1 Overview

Definition Daily Warm Up scans ensure that the system is configured for current operating conditions. As a
result, the Maintenance Warning icon appears every 18 hours to indicate that users must run
another Warm Up scan before continuing to scan patients. See Figure 44 on page 79.

6.7.2 Preparing for Warm Up Scan

How to Prepare for

Warm Up Scan
Steps See
1. Log in with a user-level or higher password. 3.3.2
2. Move AIRO to an area suitable for performing CT scans. 3.3.8
3. Place the system into Scan position. 3.3.6
4. Display the main Menu in Scan Mode. 6.7.4
5. Select the Warm Up icon. See Figure 47 on page 83.

6.7.3 Performing Warm Up Scan

How to Run Warm

Up Scan

a
Figure 45

MI-42-0001 Rev. 22 81
SCANNING: Daily Warm Up Scan

s
Figure 46

Steps
1. Verify that the system temperature icon a 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. Release the green Scan button as instructed.
5. Verify the Warm Up Scan result:
• Success - system temperature icon changes to green s. See Figure 46.
• Failure - see chapter 12 TROUBLESHOOTING.
6. If required, repeat the Warm Up Scan.

82 MI-42-0001 Rev. 22
 SCANNING: Daily Warm Up Scan

6.7.4 Menu in Scan Mode

Universal Option:
Menu in Scan Mode a

s d f g h j
Figure 47

Step
Touch Menu a at any time to access the main Menu with Scan mode options.

Scan Mode Options

Select s Home to return to the Choose Mode screen. See section 6.3.2 Choosing Scan Mode.
Select d New Scan to enter information and setup a new scan. See section 6.8 Typical Scan
Sequence: New Scan.
Select f Transport to exit Scan mode and enable system transport.
Select g Warm Up to initiate warm up scan sequence.
Select h Info to learn more about AIRO.
Select j Systemlock to enable security requiring a password to access system functions. See
section 3.3.2 Logging In.

MI-42-0001 Rev. 22 83
SCANNING: Typical Scan Sequence: New Scan

6.8 Typical Scan Sequence: New Scan

6.8.1 New Scan

How to Initiate a
New Scan

Figure 48

Step

Select New Scan a. AIRO displays the Patient Data screen.

84 MI-42-0001 Rev. 22
 SCANNING: Typical Scan Sequence: New Scan

Select Source of
Patient Data a s

d f
Figure 49

Options See

Select New Patient a to create a new patient record on AIRO. 6.8.2

Select Existing Patients s to access the list of patient records

6.8.3
currently on AIRO.

Select Hospital d to access the hospital network:

• Select a patient record and download basic information 6.8.4
• View the worklist

Select Navigation f to retrieve patient information from the

6.8.5
navigation system.

MI-42-0001 Rev. 22 85
SCANNING: Typical Scan Sequence: New Scan

6.8.2 Entering New Patient Data

How to Enter New

Patient Data

Figure 50

Figure 51

86 MI-42-0001 Rev. 22
 SCANNING: Typical Scan Sequence: New Scan

Steps
1.
Select New Patient from the Patient Data screen.

2. Type in patient name, date of birth, and if available patient ID a.

NOTE: Patient data entered here affects suggested scan protocols. However, specific scan
protocols may be manually specified later in the workflow.

For example, entering a birth date that indicates the patient is currently 12 years old
highlights both the Pediatric option for Patient Type and Pre-adolescent option for Patient
Category on the Select Patient Type screen. See Figure 65.
3. Select gender a.
4. Touch Next.
5. Fill in the patient’s height and weight s, and then touch Next.
NOTE: Patient data entered (see Figure 50) appears in the top-left corner of screens (see
Figure 51) throughout the scan workflow. Patient ages appear as:
• 0 M for ages of less than 30 days
• x M for ages of 30 days through one day less than 1 year (based on the calendar)
• x Y for ages of 1 year and greater (based on the calendar)
6. Touch Next. See section 6.8.6 Confirming Scan Direction.

How to Correct
Errors
Problem Correction
Edit the name using the Edit function under DICOM Viewer. See
Error in patient name
section 6.11 Editing Patient Data.

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SCANNING: Typical Scan Sequence: New Scan

6.8.3 Select Existing Patient Data

How to Select a
Patient With s
Existing Scans

Figure 52

Steps
1.
Select Existing Patients from the Patient Data Screen. See section 
6.8.1 New Scan.

2. Select an existing Patient Name from the list a or search by patient name or ID s.
To facilitate the search for patient records, the patient list includes:
• Patient name
• Birth date
• Gender
• Study count
• Patient ID either automatically generated by AIRO, or assigned by the operator or the
hospital
3. Touch Next.
4. Fill in the patient’s height and weight. See Figure 51.
5. Touch Next. See section 6.8.6 Confirming Scan Direction.

88 MI-42-0001 Rev. 22
 SCANNING: Typical Scan Sequence: New Scan

6.8.4 Entering Patient Data from Hospital Worklist

How to Enter
Patient Data from
Hospital Worklist

s d

Figure 53

Figure 54

j k

Figure 55

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SCANNING: Typical Scan Sequence: New Scan

Figure 56

Steps
1. Select Hospital from Patient Data Screen. See section 6.8.1 New Scan.
NOTE: The Network icon a must be green before Hospital patient lists and
worklists will be available.

2. From the screen showing configured servers, select a server s.

Available PACS servers have green status icons d.
3. Touch Next.
4. Select a patient name from the list f or search by patient name or ID g.
To facilitate the search for patient records, the Hospital patient list includes:
• Patient name
• Birth date
• Gender
• Study count
• Patient ID assigned by the hospital
5. Touch Next.
6. From the Worklist Details dialog, review patient and session DICOM data h.
7. Touch Select Worklist j to continue or Cancel k to return to the patient list.
8. After continuing from the Worklist Details dialog for a patient, fill in the patient’s height and
weight and then touch Next. See Figure 51.
9. Select either a listed worklist step l and touch Next, or select Create Extra Step ;.
10. Begin the scan setup sequence. See section 6.8.6 Confirming Scan Direction.

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6.8.5 Entering Patient Data from Navigation System

How to Enter
Patient Data from
Navigation System

s d

Figure 57

Figure 58

h j

Figure 59

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SCANNING: Typical Scan Sequence: New Scan

Figure 60

Steps
1. Select Navigation from the Patient Data Screen. See section 6.8.1 New
Scan.
NOTE: The Navigation icon a must be green before Navigation worklists
will be available.
2. From the screen showing navigation systems, select a system s.
Available systems have green status icons d.
3. Touch Next.
4. Select the listed patient name f.
NOTE: Only the patient record currently selected on the navigation system appears on this
screen.
To simplify verification of the patient record, the screen lists:
• Patient name
• Birth date
• Gender
• Study count
• Patient ID assigned by the hospital
5. From the Worklist Details dialog, review patient and session DICOM data g.
6. Touch Select Worklist h to continue, or Cancel j to return to the list.
7. After continuing from the Worklist Details dialog for a patient, fill in the patient’s height and
weight. See Figure 51.
8. Touch Next.
9. Select either a listed worklist step k and touch Next, or select Create Extra Step l.
10. Begin the scan setup sequence. See section 6.8.6 Confirming Scan Direction.

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6.8.6 Confirming Scan Direction

How to Confirm the

Scan Direction

s
d

a
Figure 61

g
d

f
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 a and scan direction indicator arrow s.
• Confirm Scan Direction Toward Column (Figure 62) shows the system in STB orientation with
the STB icon f and the indicator arrow g.
NOTES:
• AIRO Software shows systems with integrated columns and carbon-fiber operating
tabletops. As a result, when using AIRO systems without integrated columns, use the end
that has the power, network, and ground connection panel d as the reference. For this,
SAB scans move toward the panel end and STB scans move away from the panel end.
• Figure 61 shows this screen for scans on AIRO with connected Navigation systems.
• Figure 62 shows this screen for scans on AIRO without connected Navigation systems.
• The bore window should be at the beginning of the area to be scanned.

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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. See section 3.3.6 Rotating and Latching the Ring in Transport or Scan Position.
To change parameters, touch Back.
To proceed, touch Next.

Rotating the Ring If operators rotate the Ring at any screen in the scan setup workflow after this “Confirm Scan
After Confirm Scan Direction...” screen, AIRO interrupts scan setup with the “Ring Orientation” dialog.
Direction Screen

Figure 63

Options
• Resume the workflow in the initial scan direction.
1. Rotate the Ring back to the original orientation. See section 3.3.6 Rotating and Latching
the Ring in Transport or Scan Position.
The dialog closes when the Ring is locked into position.
2. If prompted, hold down the Pendant's Green Button to “home” the Ring's tilt.
3. Resume the original scan setup workflow where it was interrupted.
• Restart the workflow for scan setup in the new scan direction.
1. Press Cancel on the dialog.
2. If prompted, hold down the Pendant's Green Button to “home” the Ring's tilt.
The system returns to the Confirm Scan Direction screen, showing the new Ring
orientation and scan direction with the indicator arrow and icon. See Figure 61 and
Figure 62.
• If the initial screen was “Confirm Scan Direction Towards Column” (STC), the new
screen will be “Confirm Scan Direction Away From Column” (SAC).
• If the initial screen was “Confirm SAC,” the new screen will be “Confirm STC.”
3. Accept the new scan direction by touching Next.
4. Restart the scan setup process. See section 6.8.7 Selecting Patient Type and Patient
Category.

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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. More categories appear for
the Pediatric patient type.
NOTES:
• The Pediatric patient type and patient categories are not available when the Pediatrics
feature is disabled.
• For more information on Pediatric and Adult patient categories, scan protocols, and see
MI-42-0005 Application Guide Protocols and Principles.
• For age ranges, the initial month is 30 days. Each additional month is calculated on calendar
months. Each year is calculated on calendar years.

Standard Patient Categories

Pediatric
Patient Category Age Range Typical Weight Typical Height
• Newborn 0 - <1M 3.2 kg (7.1 lbs.) 52.2 cm (20.6 in.)
• Baby 1M - <1Y 8.2 kg (18.1 lbs.) 65.1 cm (25.6 in.)
• Toddler 1 - <3Y 12.7 kg (28 lbs.) 81 cm (31.9 in.)
• Pre-school 3 - <6Y 17.2 kg (37.9 lbs.) 102 cm (40.2 in.)
• School-aged 6 - <10Y 27.2 kg (60 lbs.) 125.2 cm (49.3 in.)
• Pre-adolescent 10 - <13Y 38.6 kg (85.1 lbs.) 144.4 cm (56.9 in.)
• Teenager 13 - <18Y 59 kg (130.1 lbs.) 166.3 cm (65.5 in.)
• Late Adolescent 18 - <21Y 70.3 kg (155 lbs.) 170.5 cm (67.1 in.)
Adult
Patient Category Age Range Weight Range Height Range
• Adult Original 21+ Y 49.9-182 kg  152.5+ cm 
(110.1-400 lbs.) (60+ in.)
• Adult Alternate 21+ Y 49.9-182 kg  152.5+ cm 
(110.1-400 lbs.) (60+ in.)

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SCANNING: Typical Scan Sequence: New Scan

g
j
d

Figure 64

l
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.

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Steps
1. For the listed patient a s, select the appropriate patient type d f.
Available patient categories for the selected patient type appear in the middle section of the
screen.
2. Select the required patient category g h.
NOTES:
• The highlighted parameters are suggested to optimize dosage based on averages for
the patient’s age range, weight, and height. See the Standard Patient Categories
table above.
• However, the appropriate protocol must be selected by the patient’s physician to
accommodate patient size and physique. For more information, see MI-42-0005
Application Guide Protocols and Principles.
• If the active patient’s height and weight are lower than the 5% level of default Patient
Category ranges, consider selecting the Patient Category one level below the
patient’s age.
• If the active patient’s height and weight are greater than the 95% level of default
Patient Category ranges, consider selecting a Patient Category one level above the
patient’s age.
3. Review Patient Info and Category Details j k.
NOTES:
• For Pediatric patients, Category Details k provides information for selecting an
appropriate Patient Category based on the size and physique of the patient. This
includes:
– Ranges for age, height, and weight 
– Typical sizes for Head Circumference and AP/LAT Thickness
• Any mismatches between the current, or active, patient and the default age, weight,
and height ranges of the selected category are highlighted in Category Details l.

Options
To change Scan direction, touch Back.
To proceed, touch Next.

Confirm Protocol When the current, or active, patient does not match the default ranges of the selected patient
Selection for Active category, AIRO displays the Confirm Patient Category dialog.
Patient

Figure 66

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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 or technical support about adding customized scan protocols to
your AIRO. See section 1.2.1 Contacting the Company.
• Select Cancel to select a different patient category.
AIRO returns to the previous screen and provides a list of available categories. See Figure 64
and Figure 65.
NOTE: For information about standard categories, see section How to Choose the Patient
Type and Patient Category on page 95 and the MI-42-0005 Application Guide Protocols and
Principles.

6.8.8 Selecting Exam Region, Protocol, and Scan Type

How to Select the After specifying Patient Type and Patient Category, select Exam Region, Protocol, and Scan
Exam Region, Type.
Protocol, and Scan
Type
Standard Exam Regions and Protocols

Exam Regions Protocols

Neonate Body Full Body
Head
Head Sinus
Orbit
Shoulder Shoulder
Chest Chest
Abdomen Abdomen
Pelvis Pelvis
Cervical
Thoracic
Spine
Lumbar
Sacrum
Extremities Extremities

NOTES:
• Helical and Axial scan types are available for all exam regions and protocols.
• The Neonate Body > Full Body options are only available for the Newborn patient category.
• Modulated mA is available for Helical scans of all protocols except for Extremities.
• Modulated mA is not available for Axial, or Scout scans.

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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. Touch Next.

Options
To change the patient type or patient category, touch Back.
To proceed, touch Next.

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SCANNING: Typical Scan Sequence: New Scan

How To Set the

Scan Parameters

a
s

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 a).
2. (Optional) Select to type a custom Series Description.
The value defaults to the selected scan type followed by the selected protocol (default
example shown s).
3. Adjust Kernel and Field of View if required.
4. Select with or without Navigation (if available).
The Summary display shows the kV and mA for the proposed scan.
NOTE: Navigation system must be connected and configured properly when utilizing the
Navigated scan option.
5. Touch Next.
6. If a Dose Notification or Dose Alert appears, provide requested information and
password, and then touch Next. See section 2.7.3 Dose Notifications and Alerts.

Options
To change the exam region, protocol, or scan type, touch Back.
To proceed, touch Next.

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 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.
• For Navigation scans, the icons for Navigation system connected and Calibration
correct should both be checked and green. If icons are not checked, verify your Navigation
System setup and retry.
• Navigation scans should not exceed 30 cm.

Options
To change parameters, touch Back.
To proceed, touch Next.

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6.8.9 Selecting Patient Orientation and Position

How to Select
Orientation and
Position

Figure 70

Figure 71

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 SCANNING: Typical Scan Sequence: New Scan

Steps
1. From the default screen, select patient orientation. See Figure 70.
2. Select patient position. See Figure 71.
NOTES:
• Display also shows direction of scan.
• AIRO Software shows systems with integrated columns and carbon-fiber operating tabletops.
For systems without integrated columns:
– Make sure that scan direction, patient orientation, and patient position shown by the 
software match the actual patient positioning in relation to the end of the system that 
has the power, network, and ground connections panel a.
– After selecting the patient orientation and position on the screen, make sure that the 
compatible, radiolucent patient support system positions the area of interest within the 
Ring, or gantry, as required.

Options
To change parameters, touch Back.
To proceed, touch Next.

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:
• A-P: Provides a low-intensity vertical scan from above the table or patient support.
• Lateral: Provides a low-intensity horizontal scan from the side of the table or patient support.
• Skip Scout Scan: Makes the main 3D scan use start and end points set with positioning lasers.
See section 6.8.11 Positioning With Lasers.
While scout scans allow field of view optimization for both Axial (see Figure 72) and Helical scans,
AIRO can also use scout-scan data to modulate the scan-intensity of Helical scans for each
individual patient. This feature can significantly reduce dosage while maintaining image quality.
As a result, a Modulated Scan icon appears for Helical scans and is checked when the feature is
available for current scan settings. See Figure 73.
NOTE: Minimum Scout Scan length is 7.9cm (3.11 in.).

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SCANNING: Typical Scan Sequence: New Scan

How to Select the

Scout Scan View

Figure 72

Figure 73

Step
Select the A-P or Lateral view.
When either are selected for Helical scans, Modulated Scan Available (see Figure 73 a) is
checked (see Figure 74 s).
NOTE: Modulated scanning is only available in the Helical Scan workflow after running either an
A-P or Lateral scout scan.

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 SCANNING: Typical Scan Sequence: New Scan

Figure 74

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.
However, unlike the initial parameter summaries for
scout scans, the result will show a summary of
To skip 2D Scout Scan, select Skip parameters for the main 3D scan that resembles the
Scout Scan, and then touch Next. Constant Tube Current list shown in Figure 86.
See section 6.8.18 Verifying 3D Parameters and
Scanning after setting start and end points.
See section 6.8.19 Summary of 3D Image Controls
after running the 3D scan.
To change parameters, touch Back.
To proceed, touch Next.

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Deciding Whether The standard dosage parameters of 3D Axial or Helical scans for some patients are low intensity by
to Use Scout Scan default. For these patients, the X-ray dose added by the constant 2D scout scan may exceed the
with Low Intensity possible dose reduction from optimizing the field of view and. for Helical 3D scans only, modulating
3D Scans the 3D scan mA. When the default scan parameters for specific patients approach this level, AIRO
highlights this on the Select 2D scout scan screen.

Figure 75

Steps
1. When the Select 2D scout scan screen shows the dose caution a, review:
• kV and mA parameters of the 3D scan s
• kV and mA parameters of the 2D scout scan d
2. When the field of view optimization and, for Helical scans, the mA modulation possible with
a Scout scan are likely to:
• Benefit the patient, continue with either A-P or Lateral, and touch Next to set the End and
Start positions for the Scout scan.
Or:
• Not benefit the patient, select Skip Scout Scan, and then touch Next to set the End and
Start positions for the 3D scan.

Options
To change the patient’s position settings, touch Back.
To proceed, touch Next.

When the dose caution appears on the Please select 2D scout scan view screen, the
selected scout scan and subsequent 3D scan may result in higher total dose than a
fixed mA 3D scan for the current protocol.

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6.8.11 Positioning With Lasers

In Helical Scan In Helical scan mode, start and end points set with lasers accurately represent the start and end of
Mode the scan region.

In Axial Scan Mode In Axial scan mode, the scan length will be a multiple of the axial scan step size (31 mm). The scan
region is centered between the start and end positions indicated by the lasers. What this means is:
• Coincident start and end points produce a single axial scan with the center slice indicated by
the laser line.
• Start and end points up to 31 mm apart produce a single axial scan centered around the
midpoint between the indicated start and end.
• Start and end points greater than 31 mm apart produce a sequential axial scan. A warning may
be displayed to inform the user that extension of the scan beyond the selected endpoints is
required to accommodate the axial step size. For example, start and end positions 50 mm apart
will produce a warning that the scan length has been increased by 12 mm. The scan region will
extend 6 mm beyond the lasers in each direction.

X-ray scan region overage is probable when using the Axial scan mode. When setting
the scan region close to areas sensitive to radiation, extra caution should be taken
when positioning the start and end points. Ensure that the extra scan length indicated
by the warning does not unintentionally cover these areas.

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. Then, turn them Off immediately afterwards. See
section 2.7.9 Laser Safety.

Figure 76

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Step
To turn positioning lasers On or Off, touch Laser a on the Pendant display.

Indicates that lasers are Off.

Indicates that lasers are On.

6.8.12 Setting 2D Scout Scan End Position

How to Set the 2D

End Position f

s d a
Figure 77

Step
Using the left and right arrows a 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.

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Options Action

To select the end position Touch Next d.

To redefine the previous settings Touch Back s.

Touch Laser.
To turn on the lasers to aid
Icon indicates that lasers are On f.
positioning
NOTE: Touch again to turn Laser off.

6.8.13 Setting the 2D Start Position

How to Set the 2D

Start Position f

d s a
Figure 78

Step
Using the arrows a 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.

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SCANNING: Typical Scan Sequence: New Scan

Options Action

To select the start position Touch s Next.

To redefine the end position Touch d Back and reposition the Ring.

Touch Laser.
To turn on the laser to aid
Icon indicates that lasers are On f.
positioning
NOTE: Touch again to turn Laser off.

6.8.14 Verifying 2D Parameters and Scanning

How to Verify
Parameters and
Scan

Figure 79

Figure 80

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Steps
1. Review the displayed scan parameters a.
NOTE: When the Green LED is illuminated the system is ready to scan. See Figure 36.
2. Carry the Pendant Display behind a protective barrier.
The CT operator moves behind a protective barrier.
3. Essential personnel move behind a protective barrier. Non-essential personnel exit the
room before the scan is conducted and do not re-enter until the ionizing radiation alerts
have stopped.
4. To scan when the Green LED is lit s, press and hold Scan d.

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.
• The scan image is streamed to the display as it is constructed.
• Follow on-screen instructions to ensure that the scout scan is complete and data is
available for setting up the 3D scan. See f in Figure 80 that shows the Pendant
during a 2D Scout scan.
• Occasionally the Scout image may not appear in real time due to wireless
communication issues.
• Allow approximately 2 minutes for completion of the Scout scan. The image should
then appear on the Set 3D scan area screen. See Figure 82.

AIRO produces ionizing radiation. Excessive exposure causes serious injury. Follow
the procedures in section 2.7 Radiation Safety.

Options
To stop the scan at any time, release Scan.
NOTE: Minimum Scout Scan length is 7.9cm (3.11 in.).
To go back, touch Back.

To stop the scan at any time, release the Scan button. The data will be saved.

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Result of Releasing AIRO Scout Scans can be stopped by releasing the Scan button after the scout shows the region of
Scan Button Before interest (ROI) and before the scan reaches the end point set during the scan preparation. Because
Scout End Point the set scan length is longer than the actual scan performed, AIRO shows a dialog that indicates the
Setting expected image-data buffer has not been filled in the expected time frame.
NOTE: This feature is limited by the minimum scan length of 7.9cm (3.11 in.). If the Scout Scan is
stopped before reaching the minimum scan length, the system will not allow a 3D scan to be run.

Figure 81

Step
Touch OK to acknowledge the message and continue optimizing the 3D 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.

The DICOM Viewer is used only for optimizing DFOV and evaluating the image. Use an
external diagnostic viewing device that meets local regulatory requirements when
examining images for diagnostic purposes.
NOTE: A fixed open collimator is used for both the CT scan and the optional scout scan.

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How to Select a 3D
Scan Region

s f d
Figure 82

Steps
1. Verify that the DICOM tags in the image for Head, Foot, Left, and Right (H,F,L,R) or Head,
Foot, Anterior, and Posterior (H, F, A, P) are correct in relation to the patient’s position.
2. If necessary adjust the contrast and magnification to locate the anatomical region of
interest.
• To adjust contrast, see the section How to Adjust Scout Scan View Settings below.
• To adjust magnification, see the section How to Zoom below.
3. Select Scan Area a. See Figure 82.
4. Set the length of the 3D scan using arrow buttons to manipulate both the Left Bound s and
the Right Bound d of the region. The minimum Helical scan length is 7.9cm (3.11 in.).
5. Adjust the Field of View of the 3D scan using the +/- Field of View buttons f.
6. Touch and release a button to move a setting by increments.
Press and hold it to move the setting faster.
7. After making all view settings and scan region adjustments (see Figure 83), touch Next to
proceed. See section 6.8.16 Selecting a Constant or Modulated Scan.

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SCANNING: Typical Scan Sequence: New Scan

d f
Figure 83

No. Category Adjustments Visible in Scout Scan Image (Figure 83)

a 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.
s Zoom 1x setting
d Windowing > Contrast Default - ~50%
Window
f Windowing > Center Level Default + ~15%

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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

s d
Figure 84

Steps
1. Select the Windowing icon a on the right side of the screen to enable Contrast Window s
and Center Level d controls.
2. Touch the +/- icons to adjust the image.

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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. A typical range can be acquired in a
single breath hold.

Steps
1. Select the Zoom icon a to expand the menu s and choose different zoom levels:
Fit - Fits the entire scout scan to the window.
Zoom 1x - Shows scout scan un-scaled.
Zoom 2x - Shows scout scan double size.
2. At Zoom 1x and 2x, press and drag on the touchscreen to pan within the view. Other
controls operate normally when zoomed.

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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. While the Constant scan parameters match the
standard dosages based on the patient’s current settings, the Modulated parameters are optimized
with data from the Scout Scan.

How to Select a
Constant or
Modulated Scan

Figure 86

Steps
1. Select Constant Tube Current or Modulated Tube Current.
NOTE: The constant/modulated mA parameter is not available for:
• Axial scans
• Scout scans
• Scans of the extremities exam region.
2. 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.

Options
To change parameters, touch Back.
To proceed, touch Next.

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6.8.17 Move Ring to Start Position

How to Move Ring

to Start Position

Figure 87

Step
Press and hold Scan a to move the Ring to the start position. After movement has stopped,
release the green button.

Keep continuous visual contact with the system and the patient
when system components are in motion.
NOTE: This is required only for main 3D scans following Scout Scans. For more information
about Scout Scans, see sections 6.8.10 through 6.8.16.

Options
To reset scan regions, touch Back.
To proceed, touch Next.

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6.8.18 Verifying 3D Parameters and Scanning

How to Verify the

3D Parameters and
Scan

a
g

Figure 88

f
s
g

Figure 89

d
g

Figure 90

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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. Review the displayed Navigated a / Helical s / Axial d scan parameters.
NOTES:
• For a helical scans using Modulated Tube Current, the screen shows an average mA
parameter f.
• When the Green LED is illuminated the system is ready to scan. See Figure 36.
3. Carry the Pendant Display behind a protective barrier.
The CT operator and essential staff move behind protective barriers.
4. Non-essential personnel exit the room before the scan is conducted and do not re-enter
until the ionizing radiation alerts have stopped.
5. To scan, press and hold g Scan.
The scan image is displayed as it is reconstructed.

Keep continuous visual contact with the system and the patient
when system components are in motion.

Options
To stop the scan at any time, release Scan.
Any collected data will be saved.
NOTE: The laser light indicates the ___location of the scanning beam during the scan.
To go back, touch Back.

AIRO produces ionizing radiation. Excessive exposure causes serious injury. Follow
the procedures in section 2.7 Radiation Safety.

To stop the scan at any time, release the Scan button. The data will be saved.

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 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.
• Orients axial image slices consistent with viewing a supine patient along an axis from feet to
head.
• Tags the image with DICOM markers for Head, Foot, Left, Right, Anterior and Posterior (H, F, L,
R, A, P) ends of anatomical axes defined by the selected patient orientation. See
6.8.9 Selecting Patient Orientation and Position.
• Provides a variety of viewing controls.

The DICOM Viewer is used only for evaluating the image. Use an external diagnostic
viewing device that meets local regulatory requirements when examining images for
diagnostic purposes.

a d

f g
Figure 91

No. Component Function/Usage

Thumbnails of main Image
a Changes main image orientation to selection.
View
s Window/Level Optimizes image for tissue level selected.
d Image Tools Manipulate image.
Send scan to DICOM or USB storage device. See
f Next
section 6.8.24 Sending Scan to DICOM or USB.

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SCANNING: Typical Scan Sequence: New Scan

No. Component Function/Usage

g Axes-end markers Show ends of anatomical axes on the 3D image.
Shows metrics for position in 3D image, and scan
values for kV, mA, mAs, CTDIvol, DLP, scan load time,
3D Position, kV, mA, mAs, and reference phantom.
h
Dosage, and Image metrics For helical scans with Modulated Tube Current, the mA
and mAs values are scan averages, with current slice
values also shown. See Figure 95.

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. In the default view, make sure that the DICOM markers correspond to the patient position
during the scan.
For example, in Figure 91 the axial view displays transverse slices of the scan with L, R, A,
and P markers for the left, right, anterior, and posterior ends of the anatomical axes.
2. If necessary, change the Main Image view by selecting a different thumbnail a and verify
that the new marker collection also corresponds to the patient position.

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 SCANNING: Typical Scan Sequence: New Scan

6.8.20 Main Image View

How to Change the

Main Image View

Figure 92

Step
Touch a a thumbnail image.
The main image changes to that view.
NOTE: Views are standard anatomical-plane views.

Options
Axial (transverse)
Sagittal
Coronal

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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 a to see menu.
NOTE: The menu in Figure 94 is an example. Different exam regions and protocols may
have different menu options.
2. Touch a menu item s to select.
The screen shows new values for window width and center level d.
3. Touch the button a again to hide menu.

Options Effect
Automatically chooses values for window width and center level based on
Auto
analyzing the intensities in the acquired CT image.
Bone
Cranial Soft
Presets the values of window width and center level based on the known
Brain
Hounsfield units of the tissue of interest.
Lung
Pelvis
Manually adjust the values of the window width and center level.
Custom • To adjust the window width, drag a finger horizontally across the screen.
• To adjust the center level, drag a finger vertically across the screen.

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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.

Options
To manipulate the image, touch the main image.
To change functions, touch a different button.
To proceed, touch Next. See section 6.8.24 Sending Scan to DICOM or USB.

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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. For example, item h of Figure 91 shows that the current slice is the 137th slice
of the 274-slice series. All other shown metrics apply to the whole scan.
Modulated Tube Current scans (Helical only) add per-slice metrics for mA and mAs to the slice
position and scan totals. These allow per-slice comparisons to average mA and mAs levels a.

6.8.23 Setting Slice Thickness

How to Set the Slice

Thickness

Figure 96

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 SCANNING: Typical Scan Sequence: New Scan

s
Figure 97

Steps
1. Touch Thickness button a to see menu.
2. Touch a menu item s selection.
3. Touch the button a again to hide menu.

6.8.24 Sending Scan to DICOM or USB

How to Send the

Scan

Figure 98

Steps Action

1. Touch Next.
A Warning dialog appears.

To proceed without
exporting scan

NOTE: The scan is already stored locally on AIRO.

2. On the dialog, touch OK to continue.

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Steps Action

1. Select the node name under Server.

To send the scan to
a DICOM node 2. Select Send to DICOM node a.
3. Touch OK to acknowledge data transfer.
1. Insert USB storage device into USB port on holster.
2. Select Export to USB s.
To export to USB
AIRO creates a DICOMDIR on the USB device and exports the file.
3. Touch OK to acknowledge data transfer.
1. Touch Next.
To take another scan
or exit scanning 2. If scan was not exported, touch OK on the dialog. See image above.
3. Select the next patient or task. See section 6.8.25 Next Steps.
To return to the scan • Touch Back.

Options Action
Slice Averaging Default is 1 mm (range is 1 mm to 10 mm).
Anonymize Send without patient data.
Dose Report Include the Dose Report for the current study.
For USB export only, adds the .dcm extension to filenames to allow
User Friendly Files
them to be recognized by extension.
NOTES:
• All patient data and all data within a study can be exported.
• An option to include the QC Report is available when exporting QC scans to USB storage
devices. See Figure 145.
• When exporting anonymized data after running or viewing a scan, only the images and dose
report (if selected) for current series are exported with patient data redacted.

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6.8.25 Next Steps

Continue with After saving and viewing the scan, the system warns users that radiation exposure is cumulative for
Same Patient? patients and provides two choices.

Figure 99

Option Result See

Goes to Confirm Scan Direction screen for a new scan in the current study.

Yes 6.8.6

Returns to Welcome screen for a new study and new or selected patient.

No 6.6.1

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6.9 View an Existing Scan

How to View an
Existing Scan

s
a

f g

Figure 100

h j

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 a.
To help ensure correct patient record selection, the screen provides:
• Patient Name
• Birth date
• Gender
• Count of studies contained in the record
• Patient ID
NOTE: If the patient name is not on the list, there are no existing scans for that patient on
this system.

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 SCANNING: View an Existing Scan

Steps
3. Select a study s.
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
• Study description
4. Select a series d (a scan identified by date/time, type, region, images, and description).
5. Touch Next to view selected scan.

NOTE: Through the DICOM Viewer, users can export a complete collection of patient scan data
f, a selected study g, and a selected series, or single Scout scan h.

After viewing the scan (see Figure 98):

Options Action
1. Select Export.

Export scan to network or USB. 2. Select options and then touch either Send to DICOM
node or Export to USB. See section 6.8.24 Sending
Scan to DICOM or USB.
1. Touch Next.
2. DICOM Viewer shows selected scan.
View other scans for this patient or
create a new scan for this patient. 3. Touch Next.
4. On the dialog, touch OK to return to the Welcome
screen. See section 6.8.1 New Scan.

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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 j in Figure 101.
Figure 102 shows an example details report.

Option Action
View currently selected scan. Touch Next.
1. Select Export.

Export series details 2. Select options and then touch either Send to DICOM
node or Export to USB. See section 6.8.24 Sending
Scan to DICOM or USB.
Select a different scan in the study. Touch Back.

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6.10 Emergency Scanning

6.10.1 Taking Emergency Scans

How to Take When urgent scans are needed, use Quick Scan to skip entry of most patient data. However,
Emergency Scans providing patient height and weight is still required.

Figure 103

Figure 104

Steps See

1. From the Welcome screen, or any other screen showing the icon, touch
Quick Scan a.
2. Fill in the patient’s height s and weight d.
3. Touch Next.
4. Continue scan steps as prompted by the screen.

6.8.6
to
6.8.25
Keep continuous visual contact with the system and the patient
when system components are in motion.
5. After the scan, use the Edit feature of the patient record under DICOM Viewer
6.11
to replace the default name and time stamp f with the patient’s name.

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6.11 Editing Patient Data

6.11.1 Editing or Adding Patient Data

How to Edit or
Delete Patient Data s

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. On the Welcome screen, select DICOM Viewer. See Figure 103.
3. Select a patient name from the list or search by patient name a or ID s.
4. Select Edit or Delete d for the selected Patient Name.

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 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.
2. Select Save a to save the patient information to the database or Cancel s to ignore
changes and return to the Patient Selection screen.

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6.12 After Scanning

6.12.1 Post-Scanning Steps

Where to Find
Instructions
Instructions See
• MI-42-0167 AIRO Original Trumpf Column
Supplement section 3.2.2
Or:
• 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
4 COLUMN AND TABLE.
• MI-42-0167 AIRO Original Trumpf Column
Supplement section 3.3.2
Transfer table to shuttle Or:
• MI-42-0165 AIRO Updated Trumpf Column
Supplement section 3.3.2
Put AIRO in transport position 3.3.5
Transport system 3.3.8
Park system 3.3.14

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 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.

Figure 107

To further reduce CT image artifacts caused by the cranial fixation head frame, ensure
that non-metallic skull pins are employed.

AIRO Software shows systems with integrated columns. Consequently, for AIRO
systems without integrated columns, always ensure that the compatible patient
support and patient head frame are properly aligned and oriented with the system. To
do this, make sure:
- Patient orientation matches that shown by the software
- Scan direction matches what the software shows. Use the end of the system that is
shown opposite the column by the software and has the power and network
connections panel (see a in Figure 108) as a point of reference.

Feet-first Patient
Orientation
(Optional)
When using a separate table system for patient cranial fixation, ensure that the scan
region of interest is extended beyond the leading edge of the table.

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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)
NOTES:
For AIRO systems without integrated columns:
• Compatible, radiolucent patient support systems may be used on either end of the system.
• To make sure patient orientation and scan direction are correct, use the end of the system
that is shown opposite the column and has the power and network connections panel a as
the reference.

Figure 108

Figure 109

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 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. Ensure that any required tools or equipment for patient treatment are positioned such that
the AIRO system can be introduced to the patient environment and used for imaging of the
patient.
3. Approach the mid-point (hips) of the patient perpendicularly by transporting the AIRO
system in the reverse direction. The distance of the AIRO control panel face to the patient
hips should be approximately 15 to 30 cm, so it most likely requires the transportation of the
AIRO by reaching over the patient.
NOTE: For intraoperative surgical procedures, a clear sterile drape over the patient is
recommended.
4. Once the AIRO system is in position, lower it onto the floor by entering Scan mode.
5. Follow the instructions on the Pendant. When rotating the Ring perpendicular to the base,
make sure that the optical navigation reflectors are towards the patient.
6. Translate the Ring towards the Trumpf pedestal of the AIRO system such that there is
sufficient clearance to rotate the patient. It is recommended that the patient head be
covered with a clear drape for intraoperative procedures.
7. Rotate the patient in-line with the rails of the AIRO, making sure that the head is
approximately centered left-to-right in the Ring bore (see Figure 109).
8. Translate the Ring over the patient head while continuously observing for potential
collisions of the Ring with the patient or patient support system.
9. Activate the laser positioning of the AIRO and center the patient's head by using the table
height adjustment. See Figure 110.
10. Continue to follow the scanning instructions displayed on the Pendant screen.

Keep continuous visual contact with the system and the patient
when system components are in motion.

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 MAINTENANCE: Chapter Overview

7 MAINTENANCE
7.1 Chapter Overview

7.1.1 Contents

Topics Covered
Section See
Service Functions 7.2
Daily Gain Calibration 7.3
Cleaning, Disinfection, and Sterilization 7.4
Inspections 7.5
Preventative Maintenance 7.6
Temporary Disuse 7.7
Disposal Instructions 7.8

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7.2 Service Functions

7.2.1 Service Functions Screen

Overview The Service Functions screen provides access to AIRO configuration and maintenance features.
Available categories are:
• Hospital Service — Includes routine maintenance and scan quality-check procedures for on-
site hospital technicians.
• Brainlab Service — Includes navigation-system configuration and protocol-customization
procedures on the Curve and the Q Guidance System with Spine Guidance Software for
authorized service personnel.

Select an option
from the Service a s
Functions Screen

Figure 111

Steps See
1. If necessary, power on the system. 3.3.1
2. If necessary, log in with a user-level or higher password. 3.3.2
3. From Choose Mode, select Scan. 6.3.2
4. From the Welcome screen, select Service. 6.6
5. Select either Hospital Service for routine maintenance, or Brainlab Service.

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 MAINTENANCE: Service Functions

Options See
1. To access the features available to on-site hospital
technicians, select Hospital Service a.
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 technical support to find out which options are
1.2.1
available.
2. Select Brainlab Service s.
3. On the Brainlab log-in screen, enter the Brainlab service-level
password.
4. Configure navigation settings. 7.2.11

7.2.2 Hospital Service

Hospital Service
Screen a s d f

g h j k
Figure 112

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MAINTENANCE: Service Functions

Options See

Select Configure a to export log files, export Gain Cal, calibrate

7.2.3
the Pendant, and view the QC pattern.

Select Add New Phantom s to add a new test phantom. 7.2.4

Select Gain Calibration d to perform the daily Gain Calibration. 7.3.3

Select E-Stop Test f to perform the daily Emergency Stop test. 7.2.5

Select Manual Scan g to perform a helical or axial scan

selecting a specific dosage (kV and mA), kernel, field of view and 7.2.7
navigation.

Select Single Shot Scan h to perform a place scan without

motion. Using a specific kV, mA, angle and duration. Used for 7.2.8
dosage testing.

Select Quality Check Scans j to perform daily and semi-

annual helical and/or axial self-check scans of the Gammex 464 7.2.9
phantom.

Select Dose Check Report k to view and export scan protocol

dosage settings and system scan-notification and scan-alert 7.2.10
data.

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 MAINTENANCE: Service Functions

7.2.3 Option: Configure

How to Select
Configuration a s
Options

d f
Figure 113

Options

Select Calibrate Touch a to run the Pendant/Touchscreen calibration

program. Follow on-screen instructions.

With a USB storage device connected, select Export logs to USB s to copy
log and system configuration files to the USB device.

Select QC Pattern d to view the Quality Check image pattern.

With a USB storage device connected, select Export Gail Cal to USB f to
copy Gain Cal files to the USB device.

NOTE: Export options are available only when a USB storage device is connected to the USB port
on the Control Panel below the Pendant Holster. See Figure 17.

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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. Select Current or Latest Candidate. See Figure 114.
4. Touch OK to copy gain calibration files to USB storage device.

How to View the

Pendant QC Pattern

Figure 115

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 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. From the Hospital Service screen, select Configure. See Figure 112.
2. From the System Configuration screen, select QC Pattern. See Figure 113.
The QC Pattern appears. See Figure 115.
3. Verify that the “Scaled to...” message matches the resolution of the Pendant.
• 600 x 600 for the hardwired Pendant a
• 800 x 800 for the Detachable Pendant
4. Touch the screen to move successively through each corner of the pattern at full pendant
resolution, and then back to the System Configuration screen. See Figure 113.

7.2.4 Option: Add New Phantom

How to Add a New

Phantom

Figure 116

Steps
1. Select Add New Phantom from the Hospital Service screen.
2. Type a first and last name for the new Phantom a.
3. Touch Next.

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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. Always perform the test daily before setting up for procedures.
AIRO requires the E-Stop test to be run daily. To simplify the process, the system provides on-
screen, step-by-step instructions to walk operators and technicians through a “simulated use” test.
NOTE: In the event of an E-Stop failure discontinue use of the system and contact technical
support. See section 1.2.1 Contacting the Company.

How to prepare for

a daily Emergency
Stop Test

Figure 117

Steps
1. Set up system for scanning. See sections 6.3 through 6.7.
2. Access Hospital Service. See sections 7.2.1 and 7.2.2.
3. Select E-Stop Test. See Figure 112.
4. Follow on-screen instructions.
5. Touch Next.
6. Set Start and End points for the scan.
NOTES:
• Scan length minimum is 7.9cm (3.11 in,).
• Set Start and End points for a scan length no longer than needed to press E-Stop
shortly after Z-axis translation starts and before the scan ends – approximately 10 to
15cm (4 to 6 in.).
• Pressing the E-Stop button at the end of a long scan can result in a cool down wait
period.

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 MAINTENANCE: Service Functions

How to perform the After preparing for an E-Stop test, start the scan.
E-Stop scan

d
s

Figure 118

Steps
1. Press and hold the green Scan button a.
2. Wait until Z-axis translation has started.
3. Press the red E-Stop button s.
4. Observe X-ray beeping tone stops within 0.5 seconds and Ring translation stops
immediately.
5. Touch Next to continue, or contact technical support if the E-Stop test fails. See section
1.2.1 Contacting the Company.
6. After the scan is complete, press the Reset button d next to the red E-Stop button to clear
the Emergency Stop.

7.2.6 Option: Using Custom kV Settings in Manual or Single Shot Scans

Setting Custom kV When technicians use custom kV settings in Manual or Single Shot scans, AIRO indicates that
Levels dosage results may not conform to typical scans because the entered values are not included in
standard calibration protocols.

Figure 119

Step
Select OK to continue Manual or Single Shot scan setup.

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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 See
1. Select Manual Scan from the Hospital Service screen. 7.2.2
2. Choose a Phantom from the Phantom Selection list.
3. Touch Next.
4. Confirm Ring Rotation is correct. 6.8.6
5. Touch Next.
6. Select and enter desired manual scan parameters for Type, Dosage, Kernel,
Field of View, and Navigation.
NOTE: For Dosage, only use kV values of 80, 100, or 120 kV, and mA values
from 5 to 250 mA.
7. Touch Next.
8. Select Patient’s Orientation and Position. 6.8.9
9. Select and perform 2D Scout scan if desired. 6.8.10
10. Select Start and End points of the scan. 6.8.11
6.8.18
11. Perform the Scan. &
6.8.19

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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 See
7.2.1
1. Select Single Shot from the Hospital Service screen. &
7.2.2
2. Confirm Ring Rotation is correct. 6.8.6
3. Touch Next.
4. Enter desired Single Shot Scan parameters.(kV, mA, Duration, Angle, Field of
View)
NOTE: For Dosage, only use kV values of 80, 100, or 120 kV, and mA values
from 5 to 250 mA.
5. Touch Next.
6.8.18
6. Perform the Scan. &
6.8.19

7.2.9 Quality Check Scans

How to Access Quality Check (QC) scans are required to verify and maintain the quality of scan images. All QC
Quality Control scans use the supplied Gammex 464 Phantom to test image quality against a known spacial profile.
Scans In this process, the Full Helical and Full Axial QC scans adjust system baseline parameters for
quality 120 kV, 100 kV, and 80 kV scans. The Daily Helical and Daily Axial QC scans verify that the
system and current operating conditions continue to match these parameters. For multi-kV QC
cycles, the baseline 120 kV parameters are configured for compliance with the ACR 2017 Computed
Tomography Quality Control Manual. 100 kV and 80 kV portions of QC cycles examine a subset of

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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.

a s

d f
Figure 122

Options

Select Daily Helical QC a to run required daily system quality checks for
Helical scanning.

Select Daily Axial QC s to run required daily system quality checks for Axial
scanning.

Select Full Helical QC d to run full system quality checks for Helical
scanning.

Select Full Axial QC f to run full system quality checks for Axial scanning.

NOTE: Full system quality checks expire after 6 months. Daily system quality checks are valid for
18 hours.

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 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
• Global Alert Settings for CTDIvol and DLP
• Notification History
• Alert History
For both Global and Local protocols, the report includes each protocol’s standard settings for patient
weight, kV, mA, and Notification levels for CTDIvol and DLP values. For system Notification History
and Alert History, the report includes the date and time of each alert along with its data type, limit
value, and all operator, scan protocol, and session data. As a result, the notification and alert data
can help technicians retrieve scan image data for regulatory or patient follow-up.

How to Access the Users with technician-level or higher passwords can view the system Dose Check Report on the
Dose Check Report Pendant screen.

Figure 123

Steps See
7.2.1
1. Select Dose Check Report from the Hospital Service screen. &
7.2.2
2. Using the scroll bar a, review report data s for:
• Global Protocols scan settings
• Local Protocols scan settings
• Global Alert Settings
• Notifications History
• Alerts History
3. Touch Back to return to the Hospital Service screen.

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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. See Figure 16 on page 42.
2. When the Export to USB button d is active, touch it.
The system saves report data to the storage device.
3. Touch OK from the Saved dialog. See Figure 124.
4. Touch Back to return to the Hospital Service screen.

7.2.11 Brainlab Service

Brainlab Service
Main Screen a s

d f
Figure 125

NOTE: Brainlab Service functions are to be performed by qualified personnel with service-level
passwords.

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Options See

Select SAB Navigation Calibration a to calibrate the

compatible navigation system in the Scan Away from Base-
column direction.

Select STB Navigation Calibration s to calibrate the

compatible navigation system in the Scan Towards Base-column
direction.

Select Manual Scan to run the verification portion of the

7.2.7
compatible navigation system calibration process.

Select Spiral Phantom Scan to run a scan on the Spiral

Phantom.

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7.3 Daily Gain Calibration

7.3.1 Overview

Calibrate Calibrations should be performed daily or according to the responsible organization’s procedure.
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:
• Performance checks are not a substitute for scheduled periodic maintenance performed by
an authorized service technician.
• Systems with the Pediatrics feature disabled only run 120 kV Daily Gain Calibration.
This section describes the steps for performing gain calibration.

Definition Calibration is an image correction procedure to preserve image quality. Calibration corrects for
inherent pixel-to-pixel gain variations, non-uniform background or offset signals, and non-linearities
in the response of the scanner to the X-ray dose. The non-uniformity of the X-ray beam is corrected
to provide a lower noise image across the detector array. [Source: ASTM WK7492 2008]

CT numbers are NOT absolute; misdiagnosis is possible. System and patient

variables may effect CT Number accuracy. If you rely solely upon CT numbers without
taking the following variables into consideration you could mis-diagnose an image.
The following variables effect CT Number accuracy:
• Partial volume effects of anatomy
• X-ray tube deterioration
• Improperly calibrated system (poorly centered phantom, used wrong phantom, replace current
calibration files with extremely old calibration files)
• Beam hardening due to patient anatomy, especially bone

To reduce CT Number variations:

• Warm-up the X-ray tube whenever the system recommends it.
• Center the patient anatomy of interest in the Ring opening. Select a Field of View that
encompasses the patient.

7.3.2 Preparing for Calibration

How to Prepare for

Calibration
Steps See
Move AIRO to an area suitable
1. 3.3.8
for performing CT scans.
• MI-42-0167 AIRO Original Trumpf Column
Supplement section 3.3.2.
Or:
Ensure that no objects, including
2. • MI-42-0165 AIRO Updated Trumpf Column
the table, are in the scan area.
Supplement section 3.3.2
For information about which integrated column your
AIRO features, see chapter 4 COLUMN AND TABLE.

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7.3.3 Perform Gain Calibration

Start Up and Enter

Scan Mode
Steps See
1. If necessary, transport and set up for scan. 3
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 See
Welcome Screen

1. Select Service Functions on the Welcome Screen. 6.6

2. Select Hospital Service on the Service Functions screen. 7.2.1

3. Log in with a technician-level or higher password. 3.3.2

Select Gain From the Hospital Service screen, access the Gain Calibration feature.
Calibration from the
Hospital Service
Step See
Screen

Select Gain Calibration on the Hospital Service screen. See

7.2.2
Figure 112.

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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.

Options
To proceed, touch Next.
To reset, touch Back.

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 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.

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Pass or Fail Notice After the scan, a notice appears.

Figure 128

s
d

Figure 129

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 MAINTENANCE: Daily Gain Calibration

Figure 130

Options
All performed gain calibrations for 120 kV, 100 kV, and 80 kV are within specified accuracy a.
• 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.
• Systems with the Pediatrics feature disabled only run a 120 kV Daily Gain Calibration.
AIRO does not accept gain calibration data.
1. Touch the Show/Hide Details button s and note the error message d.
2. Evaluate the scan area for objects that might interfere with the scan.
3. Remove any objects and re-scan.
If AIRO still fails gain calibration after several attempts, mark the system as not for use, contact
technical support, and provide the error. See section 1.2.1 Contacting the Company.
AIRO indicates that the Gain Calibration is successful with a new bad detector f.
• Verify that the new bad detector does not impair image quality. See section 7.3.4 Image
Quality Assessment.
NOTE: When this result appears, always perform the Image Quality Assessment procedure.

7.3.4 Image Quality Assessment

How to Collect and When the results screen of a Gain Calibration indicates that it was successful with a new bad
Assess Images detector, AIRO reconstructs the image compensating for the missing detector data. As a result,
after New Bad always check that scans retain image quality after a new bad detector is found. See Figure 130.
Detector Message

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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 
the remote.
- When the original Trumpf Column Remote is not available, use a metric measuring tape to 
measure table height and ensure accuracy.
• When setting up manual scans for Image Quality assessment, use the settings listed in
section Set Up Image Quality Assessment Scan on page 163.

Steps See Page

Align Gammex 464 Phantom at
1. Align phantom at isocenter. 162
Isocenter
2. Set up axial manual scan. Set Up Image Quality Assessment Scan 163
3. Run axial manual scan. Perform the Image Assessment Scan 164
4. Raise phantom to 75mm (2.95 in.) Raise Gammex 464 Phantom above
165
above isocenter. Isocenter
5. Verify phantom center alignment. Verify Gammex 464 Center Alignment 165
6. Run axial manual scan. Perform the Image Assessment Scan 164
7. Raise phantom to 150mm (5.9 in.) Raise Gammex 464 Phantom above
165
above isocenter. Isocenter
8. Verify phantom center alignment. Verify Gammex 464 Center Alignment 165
9. Run axial manual scan. Perform the Image Assessment Scan 164
10. View and export assessment DICOM
View an Existing Scan 130
images to a USB storage device.
11. Assess image quality of scans with
new bad detector with on-board or
Assess Image Quality 166
separate diagnostic-quality DICOM
viewer.

Align Gammex 464

Phantom at
Isocenter
f

Figure 131

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Steps
1. Place the Gammex holder on a radiolucent column tabletop or support.
NOTE: If the AIRO has a columnless configuration, ensure that the structure supporting the
Gammex 464 is radiolucent, and that it can position the Gammex at isocenter, 75mm (2.95
in.) above isocenter, and 150mm (5.9 in.) above isocenter.
2. Place the Gammex 464 into the Gammex Phantom Stand with the Foot facing away from
the back, or power-cord end, of the system a.
3. With the alignment lasers on, align the phantom to isocenter (see Figure 131) by:
• Raising and lowering the column tabletop or phantom support.
• Leveling the phantom with the stand’s adjustment knob.
• Rotating the phantom in the holder to line up with lasers showing isocenter along the “Y”
axis on each side s.
• Moving the phantom to line up with the laser showing isocenter along the “Z” axis d.
• Moving the phantom to line up with the laser showing isocenter along the “X” axis f.

Set Up Image Image Quality assessment scans provide 3D images for determining if a new bad detector affects
Quality image quality.
Assessment Scan

Figure 132

Steps
1. On the Pendant, navigate to the Hospital Service login from the Home/Choose Mode
screen by selecting Scan > Next > Service Functions > Hospital Service, and then log in
with a technician-level or higher password.
2. On the Hospital Service screen, select Manual Scan. See Figure 112.
3. From the patient data screen, select Phantom, Gammex and then touch Next.
4. Touch Next to confirm scan direction. See section 6.8.6 Confirming Scan Direction.
The Set Scan Parameters screen appears. See Figure 132.

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MAINTENANCE: Daily Gain Calibration

Steps
5. Select the following parameters, and then touch Next:
• Type: Axial
• Dosage
- kV: 120
- mA: 100
• Kernel: Standard
• Field Of View: Large
• Navigation: without
6. Select Head First and Supine, and then touch Next.
7. Select Skip Scout Scan, and then touch Next.

8. Using Pendant buttons , move the z-axis laser-line to the center-line in module 2 of
the phantom (see d in Figure 131), and then touch Next to set the End Position.
9. Touch Next to set the Start Position at the same Gammex ___location.

Perform the Image NOTE: Image assessment requires axial manual scans at isocenter, 75mm (2.95 in.) above
Assessment Scan isocenter, and 150mm (5.8 in.) above isocenter.

Steps
1. After setting the End and Start Positions of the manual scan, review the displayed axial
scan parameters.
NOTE: When the Green LED is illuminated the system is ready to scan. See Figure 36.
2. If the parameters are correct, carry the Pendant Display behind a protective barrier.
The CT operator and essential staff move behind protective barriers.
3. Non-essential personnel exit the room before the scan is conducted and do not re-enter
until the ionizing radiation alerts have stopped.
4. Press and hold Scan.
The scan image is displayed as it is reconstructed.

AIRO produces ionizing radiation. Excessive exposure causes serious injury. Follow
the procedures in section 2.7 Radiation Safety.

To stop the scan at any time, release the Scan button.

NOTE: An axial scan must complete approximately 2 seconds (360 degrees of rotation) before
scan data is saved.

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 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, radiolucent tables. For information about using
Trumpf columns see:
- MI-42-0167 AIRO Original Trumpf Column Supplement
- MI-42-0165 AIRO Updated Trumpf Column Supplement
• For columnless systems, make sure the platform supporting the Gammex 464 Phantom is
compatible, is radiolucent, has consistent thickness and density, and remains stable and level
relative to the AIRO base at all required heights.
NOTE: Image assessment requires axial manual scans at isocenter, 75mm (2.95 in.) above
isocenter, and 150mm (5.8 in.) above isocenter.

Steps
1. Raise the tabletop or support platform the required amount.
• For systems featuring Trumpf TruSystem Columns:
- If a remote for the original Trumpf column is available:
1. Ensure that the remote is paired with the column. See MI-42-0167 or MI-42-0165.
2. On the remote, read the measurement of Trumpf tabletop height at isocenter.
Measurements must be as precise as possible.
3. Mark or note the height shown on the remote.
4. Add the required distance above isocenter to the shown height.
5. Use the remote to raise the tabletop the calculated total height above isocenter.

- If a remote for the original Trumpf column is not available:

1. Using a metric tape measure, measure from the floor to the tabletop height at
isocenter.
Measurements must be as precise as possible.
2. Mark or note the measured height.
3. Add required distance above isocenter to the measured tabletop height and 
extend the tape measure to the calculated total.
4. Using the column keypad or updated column remote, raise the tabletop to the 
calculated total height shown on the tape measure.

• For columnless systems:

1. Using a metric tape measure, measure from the floor to the support platform 
height at isocenter.
Measurements must be as precise as possible.
2. Mark or note the measured height.
3. Add the required distance above isocenter to the measured height.
4. Raise the support platform to the calculated total height shown on the tape
measure.
5. Ensure that the phantom remains level at the new height.
2. Mark or make note of the new height.

Verify Gammex 464 After raising the phantom to the required height above isocenter, verify that the phantom is still
Center Alignment aligned along X-axis and Z-axis at the Module 2 center line. See d and f in Figure 131.

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Assess Image AIRO automatically addresses many bad detector issues. However, for certain detectors issues the
Quality compensation may not be adequate. Consequently, when Gain Calibration identifies a new bad
detector, always review the manual scan results. In the images below, Figure 133 shows the
difference between an unmapped bad detector and a successfully mapped bad detector with the
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.

Unmapped Bad Detector Successfully Mapped Bad Detector

Figure 133

Isocenter Artifact in Scan at 75mm FOV Edge Artifact in Scan at 150mm

Figure 134

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 MAINTENANCE: Daily Gain Calibration

Steps
1. From the Home/Choose Mode screen, select Scan > Next > DICOM Viewer.
2. From the patient records screen, select Phantom, Gammex.
3. Scroll through the study records, and select the study that matches the date and time of
the image assessment scan you need to view.
4. Touch Next.
5. Select the listed series, and touch Next.
6. Using the Scroll tool, step through the slices in the 3D image with an up/down motion on
the Pendant touchscreen.
For information on changing window/level, pan position, zoom, or other DICOM Viewer
settings, see sections 6.8.19 Summary of 3D Image Controls through 6.8.23 Setting Slice
Thickness.
7. If artifacts similar to those shown in Figure 133 and Figure 134 appear in the image
assessment scan results, contact your distributor or technical support. See section
1.2.1 Contacting the Company.

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MAINTENANCE: Cleaning, Disinfection, and Sterilization

7.4 Cleaning, Disinfection, and Sterilization

7.4.1 Cleanable Parts

Warnings and The CT system is not waterproof. It is not designed to protect the internal components from the
Cautions ingress of liquid.

Do not use sprays. Sprays may expose electrical components to moisture which can
damage the equipment.

Avoid using phenol-based, corrosive or solvent disinfection agents as they may harm
the surface material on the equipment.

Do not use high concentration (>500 ppm) sodium hypochlorite (bleach) solutions as
they may cause corrosion damage. Corrosion damage can lead to degradation of
structural elements that can result in patient/operator injury.
NOTE: If you are not sure of the properties of a cleaning or disinfectant agent, do not use it.

How to Prepare for Clean the system in a well-lit area that is acceptable for cleaning and disinfection of the AIRO, and
Cleaning and that contains enough room to perform this procedure. To clean the system, you will need:
Disinfection
• CaviWipes1
• Lint-free cloth wipes
• Cotton-tip swabs (as needed)
• Soft-bristle Nylon brush (e.g. Healthmark #200399 or equivalent)
• PPE as required by local regulations and your organization’s sanitation policies

Steps
1. If not already done, unplug the AIRO from the wall mains.
2. Wear PPE as defined by your facilities bio-safety process.
3. Rotate the Gimbal to the Scan position.

See cautions about rotating the Ring in section

3.3.6 Rotating and Latching the Ring in Transport or Scan Position.
4. Raise the Trumpf Column to its highest position to allow easier wipe down of the bellows.

When cleaning and disinfecting AIRO systems:

- Use caution as the batteries are still supplying power.
- Avoid wetting power, network, USB, or other accessory ports with CaviWipes1 or other
fluids as this may cause system issues.
- Remove compatible tabletops before wiping down the systems.
- Do not perform the steps for cleaning AIRO systems on compatible tabletops. For all
tabletops, follow manufacturer-specific cleaning and disinfection instructions.

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Cleaning
Steps
1. While avoiding all power, network, USB, and other accessory ports, thoroughly wipe down
external surfaces of the Ring, Gimbal, Base, Pendant, Pendant cord, system power cord,
and Trumpf Column (if present) with CaviWipes1 to remove dirt, stains, and stubborn build
up.
Use as many CaviWipes1 as necessary to ensure all surfaces remain visibly wet for a
minimum of one (1) minute.
NOTE: Pay attention to surface transitions such as seams and ridges.
If necessary to remove dirt, stains, and stubborn build up:
• Re-moisten difficult to clean areas with additional CaviWipes1.
• Loosen the build up with cotton-tipped swabs or a soft-bristled Nylon brush.
• Once build up is loosened, wipe the surfaces with fresh CaviWipes1 until all loosened
material is removed.
• Repeat if necessary.
2. Once sections of the Gimbal and Ring accessible in Scan position are clean, unscrew the
Tilt Stop and tilt the Ring in Hospital Service mode in accordance with section Tilting the
Ring for Cleaning.
3. Repeat step 1 on surfaces that are between the Ring and Gimbal during normal use.
4. Inspect the system to ensure that all surfaces are clean.
5. Following local regulations or your organization’s sanitation policies, recondition the soft-
bristle Nylon brush (if required).
6. Once all surfaces have been cleaned, allow to air dry, or dry with lint-free cloth wipes.

Disinfection
Steps
1. While avoiding all power, network, USB, and other accessory ports, thoroughly wipe down
all external surfaces of the Ring, Gimbal, Base, Pendant, Pendant cord, system power
cord, and Trumpf Column (if present) with CaviWipes1.
Use as many CaviWipes1 as necessary to ensure the surfaces remain visibly wet for a
minimum of one (1) minute.
NOTE: During disinfection, CaviWipes1 should not be used to remove dirt, stains, and
stubborn build up. If these are present, repeat the Cleaning procedure, and then re-start this
Disinfection process.
2. Allow to air dry.
3. When AIRO is dry, return the Ring to the upright position and reinstall the Tilt Stop in
accordance with section Tilting the Ring for Cleaning.
4. Dispose of all used wipes, swabs, and disposable PPE in the bio-hazard container.
5. Wash hands thoroughly with antibacterial soap.

Interval Clean and disinfect the system before or after each use, or more frequently as needed, following
your organization’s sanitation policies.

Tolerance to Water The moisture tolerance of the device is component dependent. Nothing more wet than a wrung out
drip-less towel should be used anywhere near the device. The column is rated IPX4. Overall system
is IPX0.

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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

d f

Figure 137

Steps
1. Decide in which direction the Ring needs to tilt and ensure there are no objects or obstacles
in the way.
NOTE: The Ring can be tilted up to 90° from the vertical, homed position in either direction.
2. Unscrew and retain the Tilt Stop a on the side of the Ring that will rise during the tilt.
3. On the Pendant, enter Hospital Service (see section 7.2 Service Functions).

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 MAINTENANCE: Cleaning, Disinfection, and Sterilization

Steps
4. Once in Hospital Service, press either the Up or Down button s, to tilt the Ring in the
required direction.
5. Once the tilt provides required access d, reseal the Tilt Stop mounting hole by carefully
screwing the Tilt Stop removed in step 2 back into position f.

To ensure that fluid and waste does not enter the system, always
reinstall Tilt Stops before cleaning the system.
6. Clean and disinfect all Gimbal and Ring surfaces that become accessible when tilting the
Ring as outlined above.
NOTE: Fluid and waste can collect on the access panel at the bottom of the Gimbal. This
panel is only visible when the Ring is titled in Hospital Service mode. Always ensure that this
area of your AIRO is clean.
7. After the disinfection is complete, unscrew and retain the Tilt Stop reinstalled in step 5.
8. Return the Ring to the upright position.
9. Carefully reinstall the Tilt Stop removed in step 7, and tighten until snug.

NOTE: Only trained personnel should be performing this cleaning.

Ensure the Ring is tilted back to the vertical position prior to entering Transport Mode.

7.4.2 Sterilization

No Sterilization AIRO is not intended to be sterilized.

Disclaimers 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.

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7.4.3 Application of Mineral Oil to AIRO Base Rails

Cleaning Solutions Cleaning solutions used on the base rails must be free of bleach, acetone, and all chemicals that
are potentially corrosive to metals.

Cleaning the Rails If any corrosion on the rails is observed, it must be removed using a very-fine grit Scotch-Brite pad
(or equivalent).

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

Figure 138

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 MAINTENANCE: Inspections

7.5 Inspections

7.5.1 Daily

Wear or Damage The responsible organization and personnel using the machine are responsible for performing daily
inspections.
Each day before using the system, inspect it and make sure that:
• No signs of wear or damage appear on the system
• System powers up normally
• Display screen illuminates correctly
• Movement controls operate correctly
• Air filter is unobstructed

Step
Reach down to the air-filter panel on the Gimbal below the Pendant holster, and manually verify
that the filter has no obstruction or debris blocking it.

If upon inspection the system appears damaged or displays functionality inconsistent with the
functions described in this manual, contact technical support. See section 1.2.1 Contacting the
Company for additional information.

For Damage or Malfunction

Contact technical support immediately. Mark the system as not for use until evaluated by
technical support.

Other Follow the responsible organization’s protocols for inspection. See chapter 8 QUALITY TESTING
for Quality Assurance tests.

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MAINTENANCE: Preventative Maintenance

7.6 Preventative Maintenance

7.6.1 Preventative Maintenance is Required

Interval Preventative maintenance must be performed twice a year to ensure functionality and safety. The
owner/responsible organization is responsible for timely maintenance.

Exceeding the six month period for preventative maintenance is considered improper
use.

Authorization Only authorized service engineers or technicians are qualified to perform maintenance.

Risk of electrical shock. There are no user-serviceable parts. All servicing is to be

carried out by authorized service technicians.

Arrangement
Service Contract Semi-annual Inspection
Automatically performed by authorized service engineers or
Yes
service technicians.
Contact technical support for arrangement. See section 
No
1.2.1 Contacting the Company.

Scope Preventative maintenance includes:

• Complete inspection of the AIRO system
• Potential adjustment of dosimetric accuracy
• Adjustment or lubrication of normally wearing components
• Replacement of system air filters

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7.7 Temporary Disuse

7.7.1 Temporary Disuse

Definition: Normally, AIRO is left plugged in whenever it is not being moved. Temporary disuse is defined as
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.
AIRO batteries require charging, even when the system is unused. Leaving AIRO unplugged causes
the batteries to deplete.

Over-discharge can permanently damage the batteries.

How to Maintain
Batteries

Leave AIRO plugged in whenever possible.

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MAINTENANCE: Disposal Instructions

7.8 Disposal Instructions

7.8.1 Disposal of System and Batteries

How to Dispose of Do not dispose of AIRO or its components. Only dispose of electrical and electronic equipment in
System accordance with statutory regulations. For information regarding the WEEE (Waste Electrical and
Electronic Equipment) directive, contact technical support. See section 1.2.1 Contacting the
Company.

How to Dispose of The batteries inside AIRO are not accessible by users. Do not attempt to access or dispose of any
Batteries batteries, which are potentially hazardous. Contact technical support for instructions. See section
1.2.1 Contacting the Company.

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 QUALITY TESTING: Chapter Overview

8 QUALITY TESTING
8.1 Chapter Overview

8.1.1 Contents

Topics Covered
Section See
Test Object and Software 8.2
Testing Image Quality 8.3
Quality Check Reporting 8.4
Exposure Testing 8.5

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8.2 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.
The phantom description and image are stored with all phantom scans and cannot be deleted.

Required Phantom When performing daily or full Image Quality tests, always place the Gammex 464 Phantom on a
Support compatible, radiolucent table or table attachment.
Many operating tabletops that are compatible with AIRO systems that feature the integrated column
comply with this requirement. In addition, Mobius Imaging can provide a radiolucent attachment for
some Trumpf tabletops.
However, when using an AIRO system that has no integrated column, any compatible tabletop used
to support the phantom must be fully radiolucent for Image Quality tests.

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8.3 Testing Image Quality

8.3.1 Testing Image Quality with the Phantom

Daily Image Quality

Test
Steps See
1. Scan phantom. 8.3.2
2. Evaluate image quality. 8.4

8.3.2 Scan a Phantom for Quality Testing

Pre-Scan Checks
Steps
1. AIRO warm-up procedure has been performed.
2. Valid Gain Calibration scan has been performed.

Start Up and Enter

Scan Mode
Steps See
1. If necessary, transport and set up for scan. 3
2. Log in with a user-level or higher password. 3.3.2
3. Choose Scan mode. 6.3.2

How to Setup
Quality Check
Scans

Figure 139

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QUALITY TESTING: Testing Image Quality

Figure 140

NOTE: Figure 139 does not appear when the Pediatrics feature is disabled.

Steps See
1. Select Service Functions from the Welcome screen. 6.6
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. Select Quality Check Scans from the Hospital Service screen. 7.2.2
5. Select one of the quality check scans: Daily Helical QC, Full Helical QC,
Daily Axial QC, Full Axial QC.
If the Pediatrics feature is disabled, skip to step 8.
NOTE: Both helical and axial QC scans should be performed every day in both
STB and SAB orientations. As a result, allow time for: 7.2.9
• Daily Helical QC in SAB orientation
• Daily Axial QC in SAB orientation
• Daily Helical QC in STB orientation
• Daily Axial QC in STB orientation
6. From the Select KV Levels screen, ensure that the required levels are checked
for the QC scan cycle a.
NOTES:
• Systems with Pediatrics enabled require Daily and bi-annual Full QC
scans at all available kV levels.
• Systems with Pediatrics disabled require only 120 kV QC scans. As a
result, QC scans start at the Position the Gammex screen (Figure 140).
7. Touch Next.
8. Ensure that alignment lasers are lit s and the total number of QC scans for the
QC cycle appears d.
NOTE: If either the Pediatrics feature is disabled or only one QC scan was 6.8.11
checked on the Select KV Levels screen, the message about the total number
of scans does not appear.

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 QUALITY TESTING: Testing Image Quality

Steps See
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.
10. Touch Next.

Options
To proceed, touch Next.
To reset, touch Back.

Perform the Scan

s

Figure 141

Steps
1. For each selected kV level in the scan cycle, verify that the screen lists:
• Correct QC scan type a.
Available types are listed as Daily Axial QC and Full Axial QC for axial QC scans, and
Daily QC and Full QC for helical scans.
• Correct scan number in the scan cycle for multi-scan QC selections s.
NOTE: If only one QC scan was checked on the Select KV Levels screen, the message
about the current scan in the scan sequence does not appear.
2. Press and hold the green button d to run a complete scan.
When the Green LED is illuminated the system is ready to scan.
3. When prompted, release the green button.
The Running Quality Checks screen indicates that the system is comparing the current
results to the archived baseline data.

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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.

Options
• Retry after a Length of Travel warning:
If the QC scan terminates and the System Warning dialog indicates that scan was longer than
the available length of travel:

1. Touch OK.
2. On the Pendant, move through the work flow for the terminated scan by touching Next
on:
• QC Failed result summary screen
• 3D-image viewer screen
• Select DICOM node screen
NOTE: Because the QC scan terminated, there is no significant data on these screens.
3. On the dialog asking to continue without sending results to a DICOM node, select OK.
See Figure 146.
4. Move the Gammex 464 Phantom closer to the center of the base along the z-axis.
5. Re-align it with the laser lines (horizontal and vertical) as shown in Figure 140.
6. Return to the start of the QC cycle:
• For systems with the Pediatrics feature enabled, go to the Select KV screen and
restart the QC scan cycle. See Figure 139.
• For systems with the Pediatrics feature disabled, go to the Position the Gammex
screen and restart the QC scan cycle. See Figure 140.
• Retry after an Endpoint Set Failure:
If a QC scan fails to start and the Endpoint Set Failure dialog appears:

1. Touch OK to return to the Position Gammex screen.

2. Move the Gammex 464 Phantom closer to the center of the base along the z-axis.
3. Re-align it with the laser lines (horizontal and vertical) as shown in Figure 140.
4. Touch OK to run the QC scan.

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 QUALITY TESTING: Testing Image Quality

Options
• Retry after a Phantom Orientation error:
If the QC scan terminates and a Warning screen indicates that the Phantom was incorrectly
oriented:

1. On the Pendant, move through the work flow for the terminated scan by touching Next
on:
• QC Failed result summary screen
• 3D-image viewer screen
• Select DICOM node screen
NOTE: Because the QC scan terminated, there is no significant data on these screens.
2. On the dialog asking to continue without sending results to a DICOM node, select OK.
See Figure 146.
3. Re-orient the Gammex 464 Phantom so that the “FOOT” and “TOP” indicators are as
shown in Figure 140.
4. Realign the Gammex 464 Phantom with the laser lines in all three axes, as shown in
Figure 140.
5. Return to the start of the QC cycle:
• For systems with the Pediatrics feature enabled, go to the Select KV screen and
restart the QC scan cycle. See Figure 139.
• For systems with the Pediatrics feature disabled, go to the Position the Gammex
screen and restart the QC scan cycle. See Figure 140.
• To proceed, touch Next.
• To reset, touch Back.

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QUALITY TESTING: Testing Image Quality

Review and Export

Image Quality
Result

Figure 142

Figure 143

NOTE: Figure 142 and Figure 143 are results summaries for Daily Quality Checks.

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 QUALITY TESTING: Testing Image Quality

Steps
1. Review the Image Quality results a.
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 188.
• Full QC results, see section Full Quality Check Results Summary Report on page 190.

Quality Checks may fail s. If this occurs, ensure the Phantom is correctly
aligned against the lasers and repeat the Quality Check. If the problem persists
contact technical support.
To contact technical support, see section 1.2.1 Contacting the Company.
2. If needed, export the QC Result to a USB storage device d.
For information on exporting daily and full QC reports, see section 8.4.1 Examining Image
Quality Report.
NOTE: In addition to the USB export options available for all scans or series (see section
6.8.24 Sending Scan to DICOM or USB), exports of QC scans can include the QC Report
when copying results to USB storage devices. See Figure 145.

Reviewing and
Exporting QC 3D
Images

Figure 144

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QUALITY TESTING: Testing Image Quality

Figure 145

Figure 146

Steps
1. Using the viewer tools a, 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.
2. After reviewing the QC images, touch Next.
3. On the Please select DICOM node screen s:
• If needed, export results image data to selected ___location, and then touch Next. For
information about exporting, see section 6.8.24 Sending Scan to DICOM or USB.
NOTES:
• QC Image Data is automatically stored on AIRO under Existing Scans with a patient
name of Phantom.
• In addition to the USB export options available for all scans or series, exports of QC
scans can include the QC Report d when copying results to USB storage devices.
Or:
• Touch Next to continue the QC scan cycle.

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Steps
4. On the dialog asking to continue without sending results to a DICOM node f, 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. See Figure 147.
NOTE: In multi-kV Daily or Full QC scan cycles, do not realign the lasers or move the
phantom between the selected kV scans.

Completing a
Multiple kV-level
QC Scan Cycle
a

Figure 147

Steps
1. After completing the first scan in a QC scan cycle with multiple kV levels, review the
parameters of each subsequent scan and verify that it has:
• Correct scan number in the cycle a
• Correct kV level s
2. Repeat the QC scan work flow for each of the selected kV levels.
NOTE: In multi-kV Daily or Full QC scan cycles, do not realign the lasers or move the
phantom between the selected kV scans.

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QUALITY TESTING: Quality Check Reporting

8.4 Quality Check Reporting

8.4.1 Examining Image Quality Report

AIRO QC Test and QC tests are based on American College of Radiology (ACR) Quality Control Testing and generate
Image Quality AIRO Image Quality Reports (QC Reports). Two test/report cycles exist. Daily QC tests and daily
Reports Overview QC Reports evaluate system imaging for daily procedures. Full QC tests are performed on
installation and then should be repeated every six months thereafter. Full QC Reports show whether
the system meets ACR requirements. On both cycles, the combined QC tests and QC Reports are
intended as system self-checks to help ensure the system is operating correctly before exposure of
patients to X-ray radiation. QC Reports are therefore not intended for local regulatory submission
related to ISO 61223-2-6 or to other regional variations of this or other standards.

Recommendations • Perform daily QC tests and view daily QC Reports on the required daily cycle to ensure system
imaging for daily procedures.
• Perform full QC tests and view full QC Reports on the six-month schedule.
• While the full QC Report may be used to support ACR Quality Control Testing, the ACR
standard may be different from other local or regional standards.
• Do not use the full QC Report for local regulatory submissions. It is not intended for regulatory
submissions related to ISO 61223-2-6 or any regional variations based on this standard.
• The ISO 61223-2-6 standard requires establishing a performance baseline at installation or
after significant service repairs, and then measuring full QC metrics relative to that baseline.
This differs from the full QC Report, which contains results of full QC tests designed to measure
metrics relative to ACR’s absolute performance standard. As a result, the ACR standard and
QC test results in the report may be different from the ISO 61223-2-6 requirements.
• Always consult a medical physicist to perform the quality checks and submit quality test results
required by local regulations.
• Individual test results from the full QC Report may be used for local regulatory submissions.
However, medical physicists must determine if the QC tests based on ACR standards satisfy
the requirements of local regulations before using the results.

How to View and

Export the Daily
Quality Check
Report

Figure 148

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 QUALITY TESTING: Quality Check Reporting

Figure 149

Steps See
1. Review the Daily Quality Check Report.
The report displayed on the Pendant screen includes information on:
• Phantom alignment a — Shows if the test setup matches the baseline.
• Calculated CT numbers s — Shows where in the valid range the AIRO’s CT
components operate.
If a test fails, the line in the report is highlighted d, providing data about
current results, typical results, and acceptable minimum/maximum values.
2. Insert a USB storage device into the available port on the Pendant Holster. 3.2
3. Choose Export to USB to copy the report files to the USB device.
NOTE: In addition to the USB export options available for all scans or series
(see section 6.8.24 Sending Scan to DICOM or USB), exports of QC scans can
include the QC Report when copying results to USB storage devices. See
Figure 145.
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.

NOTES:
• For multi-kV QC cycles, the baseline 120 kV parameters are configured for compliance with
the ACR 2017 Computed Tomography Quality Control Manual. 100 kV and 80 kV portions of
QC cycles examine a subset of the 120 kV metrics. 100kV and 80kV HU values are only
accurate for water. Other materials are not evaluated.
• Quality Checks may fail. Ensure the Phantom is correctly aligned against the lasers. If the
problem persists contact technical support. See section 1.2.1 Contacting the Company.
• The image review software on the AIRO scanner does not provide the ability to calculate
mean and standard deviation of CT numbers for user-selectable ROIs. However, the software
automatically calculates mean and standard deviations of CT numbers for pre-selected ROIs
when performing the daily IQ test. This information is presented in the IQ test report and can
be viewed using a standard Internet browser (Internet Explorer, Chrome, Safari, etc.) via

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QUALITY TESTING: Quality Check Reporting

exporting to 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.

Full Quality Check

Results Summary
Report

Figure 150

Steps See
1. Use the scroll bar a to view the metrics included in the report.
2. Insert a USB storage device into the available port on the Pendant Holster 3.2
3. Choose Export to USB to copy the report files to the USB device.
NOTE: For any QC scan, the QC Result Report is available for export on this
screen and the Please Select DICOM node screen that displays when viewing
a 3D image after a scan or through the DICOM Viewer. See Figure 145.
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.

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 QUALITY TESTING: Quality Check Reporting

NOTES:
• For multi-kV QC cycles, the baseline 120 kV parameters are configured for compliance with
the ACR 2017 Computed Tomography Quality Control Manual. 100 kV and 80 kV portions of
QC cycles examine a subset of the 120 kV metrics. 100kV and 80kV HU values are only
accurate for water. Other materials are not evaluated.
• Quality Checks may fail. Ensure the Phantom is correctly aligned against the lasers. If the
problem persists contact technical support. See section 1.2.1 Contacting the Company.
• The image review software on the AIRO scanner does not provide the ability to calculate
mean and standard deviation of CT numbers for user-selectable ROIs. However, the software
automatically calculates mean and standard deviations of CT numbers for pre-selected ROIs
when performing the daily IQ test. This information is presented in the IQ test report and can
be viewed using a standard Internet browser (Internet Explorer, Chrome, Safari, etc.) via
exporting to 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.
• The full version of the quality check results can be exported to a USB storage device on the
Please select DICOM Node screen of each QC scan. See Figure 145.

Example Full Image Full Image Quality Reports include details of the QC scan results and methodology. After exporting
Quality Report a Full Image Quality Report to a USB storage device (see above), view it in a browser on a separate
workstation or computer.

Steps
1. With a separate workstation or computer, navigate to the folder that contains the exported
Full Image Quality Report.
2. With a browser, launch Mobius Airo Image Quality Report Helical.html or Mobius Airo
Image Quality Report Axial.html
3. Scroll through the report.
The following pages show images of an anonymized report.

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QUALITY TESTING: Quality Check Reporting

$,52Š,PDJH4XDOLW\5HSRUW

Manufacturer: Mobius Imaging, LLC

Scan Date: 2017-11-30 12:47
Serial Number: XXXX
Scan Direction: SAB
Scan Type: Helical
Scan kV: 120
Scan mA: 110

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).

The Scanning Configuration was set as follows:

Helical Scan of the Gammex 464 ACR phantom via the Quality Check Scan function of the AIRO ®
System which defaults to:
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MI-42-0001 Rev. 22 197

QUALITY TESTING: Quality Check Reporting

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198 MI-42-0001 Rev. 22

 QUALITY TESTING: Quality Check Reporting

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MI-42-0001 Rev. 22 199

QUALITY TESTING: Exposure Testing

8.5 Exposure Testing

8.5.1 Responsible Organization

Safety Procedures AIRO meets standards for CT medical equipment cited in 9.12 at point of delivery. After delivery, the
responsible organization must comply with the manufacturer’s safety and maintenance
requirements and follow all standards established by the applicable laws for radiological testing of
medical equipment.
The method to measure and verify CTDI on AIRO is provided below.

8.5.2 Measure and Verify CTDI

Equipment 1. Polymethyl methacrylate (PMMA) CT dosimetry phantoms - Body phantom 32 cm diameter,

Required head phantom 16 cm diameter, at least 14 cm in length. Examples: Fluke Biomedical 76-415
(body) and 76-414 (head) phantom; Ludlum L-451 (body) and L-441 (head) phantom.

2. Electrometer / pencil ion chamber, 10 cm active detector length, with matched control unit.
Examples: Radcal 2026C control unit with 20X6-3CT ion chamber; Radcal Accu-Dose control
unit with 10X6-3CT in ion chamber.

Method 1. Place the body phantom on the patient table and position it at the isocenter using the Ring
alignment lasers. Ensure that the phantom is centered along the axial, sagittal and coronal
planes.

2. Position the pencil ion-chamber in the center hole of the phantom; plug all other holes with
acrylic rods (included with the phantom). Set the control unit to read integrated dose, typically in
milli-Roentgens.

3. Perform an axial (sequential) scan with no Ring translation, at a typical abdomen technique
(example, 120 kV, 200 mA, NxT = 32x1.06 = 33.92 mm). Record the exposure displayed on the
base unit (mR). Designate the exposure readings as 'Center mR'.

4. Position the pencil ion-chamber at the 12 o'clock position, plugging the center hole with an
acrylic rod. Repeat step 3. Designate the exposure readings as 'Entrance mR'.

5. Repeat the same procedure (steps 1-4) with the head phantom, positioned at isocenter.

6. Calculate CTDI 100 as follows, for both body and head phantoms:
- CTDI 100, center (mGy)= [Center mR x 100 mm x CF x 0.0088] / [N x T]
- CTDI 100, entrance (mGy) = [Entrance mR x 100 mm x CF x 0.0088] / [N x T] where the 100
mm in the numerator is the active length of the pencil ion chamber
- CF is the ion chamber correction factor, if specified by the manufacturer (typically 1.0),
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]
8. Compare the measured value against the calculated value. The calculated value is found by the
following formula;
- Body: (mA)*(0.0096)*(29.8229)
- Head: (mA)*(0.0096)*(39.7604)
9. Compare the measured results against the calculated results and calculate the percentage
difference. The percentage difference is required to be within 30% but the goal is to be within
20%. If the percentage difference is greater than 20%, refer to Sources of Variability below to
reduce it.

200 MI-42-0001 Rev. 22

 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. If the error in step 7 is found to
exceed 20%, it is recommended that the average of measurements at the 3, 6, 9, and 12
o’clock positions is used to calculate Entrance mR, to rule out variability associated with the ion
chamber at this ___location.

3. Operator error. If errors in step 7 exceeds 20% despite ruling out the variability at the 12 o'clock
position, verify the following:
- precise positioning of the dosimetry phantoms at isocenter
- stationary positioning of the Ring with respect to the table during the exposure
4. If errors continue to exceed 20% after addressing the above sources of variability, contact
technical support. See section 1.2.1 Contacting the Company.

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 TECHNICAL DESCRIPTION: Chapter Overview

9 TECHNICAL DESCRIPTION
9.1 Chapter Overview

9.1.1 Contents

Topics Covered
Section See
Introduction 9.2
Technical Description 9.3
Special Installation Requirements 9.4
Electrical Specifications 9.5
X-ray Specifications 9.6
Performance Characteristics 9.7
Environmental Requirements 9.8
Safety Classifications 9.9
Replacing Fuses and Other Parts 9.10
Network/Data Coupling to Other Equipment 9.11
Regulatory Compliances and Approvals 9.12
RF Communications Equipment 9.13
Symbols 9.14
Labels 9.15
Location of Certification and Safety Labels 9.16

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TECHNICAL DESCRIPTION: Introduction

9.2 Introduction

9.2.1 Obtaining More Information

Circuit Diagrams Your support contact will make available on request circuit diagrams, component part lists,
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. To contact technical support, see section
1.2.1 Contacting the Company.

9.2.2 Warning Regarding Modifications

No User-Modifiable There are no user modifiable parts. Unauthorized modifications may void your warranty or service
Parts contract.

Unauthorized modification may result in severe injury or death.

9.2.3 Combining Accessories, Sub-assemblies, and Compatible Equipment with

AIRO

See Allowed See chapter 11 ALLOWED EQUIPMENT.

Equipment List

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 TECHNICAL DESCRIPTION: Technical Description

9.3 Technical Description

9.3.1 Brief Description and Operating Principle

AIRO Description AIRO is a 3rd-generation high resolution, large bore (107 cm), 51.2 cm field of view, X-ray
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. Its design accommodates intra-operative use. The surgical
column and patient support are controlled using an integrated keypad or a wireless remote control.

AIRO includes a hand-held control unit for imaging, transport, service, calibration, and
remote control used for the integrated table column and associated tabletops.

Essential AIRO is a mobile system that delivers X-ray computed tomography in various environments. When
Performance in use, AIRO provides CT images with:
• No unrequested motion
• No unrequested X-rays
• No non-obvious image quality issues
• No incorrect transmission of image data

Helical Scan Mode AIRO combines a treatment-specific patient support system and an X-ray imaging device that
produces high resolution helical images of the body.
It operates by continuous rotation of an x-ray tube and opposing detector elements that irradiate the
scanned object from 360 degrees while simultaneously translating with respect to the patient along
the patient Z-axis a (Figure 151) following a precise motion profile.

Figure 151

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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 a (Figure 152).
This is repeated as often as needed to cover the required scan area and the discrete scans are
stitched together afterward. This sequence differs from helical mode, in which AIRO moves
continuously in the Z-axis while constantly imaging the scan area.

a
!

Figure 152

Unique Features System is mobile: The base incorporates casters, main drive wheel, and an electrical drive system.
The Ring is both lightweight and compact. The entire unit is designed to be driven down hallways,
on limited inclines, through doorways and onto elevators. The user sees the path of travel through
an integrated camera and display. AIRO can be run in any area that has been approved for use by
the responsible organization.
NOTE: The Installation Procedure contains the specific requirements for approved areas.
• Table is detachable and exchangeable: The column accommodates several models of
operating tables and patient supports. The user may change the table and table orientation
relative to the base to suit the procedure.
• Table is portable: The table and patient can be moved to the system on a shuttle. The table and
patient are then transferred onto the system column. Therefore the operating table can be used
in the system.

Main AIRO consists of six main subassemblies:

Subassemblies
• Base
• Ring
• Gimbal
• Pendant Holster and Control Panel
• User Interface Pendant
• Trumpf Column (optional)

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 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”)
threshold.
The primary application focus is providing diagnostic-quality
Soft Tissue Imaging
imaging of soft-tissue parts of the human anatomy.
Touchscreen User The CT operator enters information, makes selections, and
Interface manipulates the images using a touchscreen interface.
Interchangeable Tables AIRO’s column accepts transportable operating tables and other
and Patient Supports patient supports. The list is available from TRUMPF.
The Trumpf surgical column, table, and motion-enabled patient
Trumpf Wireless Remote
support accessories can be controlled either by a keypad on the
Control
column itself or by a Trumpf wireless remote control.
AIRO is powered from an ordinary hospital wall 15 amp outlet
Powered by Wall Outlet
(AC).
Network/Data Couplings There are 4 kV isolators on the Ethernet connection.
Users may export 2D and 3D images in DICOM format to a
DICOM Export Capability
DICOM service class user (SCU) functioning as a PACS server.
Users may also export images and patient data to a USB storage
External Memory Devices
device.
Designed to be re-positioned such that the surgeon has clear
Narrow Ring Width
access to the patient.

9.3.3 How the Device Functions

Modes AIRO has two main functional modes: Transport mode and Scan mode.

Transport Mode In Transport mode the Ring is aligned with the base and the entire system is powered from a battery
pack located on the Ring. In this mode AIRO can be driven and positioned by the control Pendant
attached to one side of the Gimbal. Moving AIRO typically requires only a single person even when
taking the system up or down a ramp. Once AIRO has been moved to the desired destination
(storage area or scanning area) it is powered from line power.

Scan Mode In Scan mode, the base is lowered onto the ground by retracting the casters in the support base.
The Ring is rotated 90 degrees perpendicular to the base. In Scan mode, all functionality other than
transport is available to the user, such as patient loading, system positioning, image acquisition, and
image processing. The user interface Pendant is used to view and manipulate stored images from
the patient database. Images can be archived to the USB digital storage media or pushed to a PACS
system through DICOM protocol.

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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.

9.3.4 Physical Characteristics

System
Category Feature Specification
Transport Position:
System with column 0.60 x 2.30 x 1.98 m (23.5 x 90.5 x 77.7 in.)*
System without column 0.60 x 1.96 x 1.98 m (23.5 x 77.2 x 77.7 in.)*
Scan Position:
System with column 1.96 x 1.95 x 1.91 m (77.2 x 76.8 x 75.0 in.)*
System without column 1.96 x 1.54 x 1.91 m (77.2 x 60.6 x 75.0 in.)*
Weight:
Physical System with column Without Trumpf table: 975 kg (2150 lbs.)
dimensions
With Trumpf table attached: Varies depending
on model and accessories.
System without column 816 kg (1800 lbs.)
Ring:
Exterior diameter 168 cm (66 in.)
Bore diameter 107cm (42 in.)
Image Field of View 51.2 cm diameter (20.2 in.)
Ring Width 38 cm (15 in.)
Electrical drive system
Wheel drive
Transport Integrated controls
Front-view camera
Viewing screen

Transport Forward = 1.6 kph (1 mph), Reverse = 0.8 kph

Speed:
motion (0.5 mph)
controls Braking: Typical: <15 cm (6 in.)

Ring (gantry) Linear Ring 

1 m (40 in.)
motion (translation – z):
(ranges) Rotation: 360° in 1.92 secs.
Applied parts Operating table or other patient support
System with column: 182 kg (400 lbs.)
The maximum load for the patient support may
Maximum
be lower than 182 kg. Do not exceed the
system load
maximum load for any applied part.
System without column: N/A
* Dimensions listed as width x length x height unit.

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 TECHNICAL DESCRIPTION: Technical Description

9.3.5 Diagrams

Ring and Base:

Scan Mode With PP
 LQ 
Column

PP
 LQ 

PP
LQ

)/225

PP
LQ

PP
LQ

Figure 153

Ring and Base:

PP
Transport Mode LQ
With Column PP
LQ

PP
LQ

PP
LQ

)/225

PP
LQ

PP
LQ

Figure 154

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TECHNICAL DESCRIPTION: Technical Description

Scan Position
Footprint With
Column

1960.4mm
77.2in

1949.5mm
76.8in

Figure 155

Transport Position
Footprint With
Column
598mm
23.5in

2299.7mm
90.5in
Figure 156

210 MI-42-0001 Rev. 22

 TECHNICAL DESCRIPTION: Technical Description

Ring and Base:

Scan Mode Without PP
LQ
Column

PP
LQ

PP
LQ
)/225

PP
LQ

PP
LQ

Figure 157

Ring and Base:

PP
Transport Mode LQ
Without Column
PP
LQ

PP
LQ

PP )/225
LQ

PP
LQ
PP
LQ
Figure 158

MI-42-0001 Rev. 22 211

TECHNICAL DESCRIPTION: Technical Description

Scan Position
Footprint Without
Column

Figure 159

Transport Position
Footprint Without
Column

Figure 160

212 MI-42-0001 Rev. 22

 TECHNICAL DESCRIPTION: Technical Description

9.3.6 Pendant Specifications

AIRO Hardwired
Pendant
Specifications

Figure 161

Figure 162

Figure 163

Category Specification
Physical Dimensions 26.2 cm (10.3 in.) x 4.1 cm (1.6 in.) x 17.2 cm (6.8 in.)
(width x thickness x height)
Weight 1.4 kg (3 lbs.)
Touchscreen 4-wire resistive touch display
(width x height) 17.1 cm (6.7 in.) x 12.8 cm (5.0 in.)
Storage None
Input Voltage 24 Vdc
Power Consumption 5W

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TECHNICAL DESCRIPTION: Technical Description

Hardwired Pendant
Holster
Specifications

Figure 164

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

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 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.

9.3.8 Column Specifications

Column specifications are available for:
• Original Trumpf TruSystem 7500 Column in section 4.2.2 Original Column Specifications of MI-
42-0167 AIRO Original Trumpf Column Supplement.
• Updated Trumpf TruSystem 7500 Column in section 4.2.2 Updated Column Specifications of
MI-42-0165 AIRO Updated Trumpf Column Supplement.

9.3.9 Wireless Remote Controls for Columns

Wireless remote specifications are available for:
• Original Trumpf TruSystem 7500 Column in section 4.2.3 Original Wireless Remote for Column
of MI-42-0167 AIRO Original Trumpf Column Supplement.
• Updated Trumpf TruSystem 7500 Column in section 4.2.3 Updated Wireless Remote for
Column of MI-42-0165 AIRO Updated Trumpf Column Supplement.

9.3.10 Chargers
Wireless remote charger specifications are available for:
• Original Trumpf TruSystem 7500 Column in section 4.2.4 Original Charger of MI-42-0167 AIRO
Original Trumpf Column Supplement.
• Updated Trumpf TruSystem 7500 Column in section 4.2.4 Updated Charger for Column of MI-
42-0165 AIRO Updated Trumpf Column Supplement.

9.3.11 Detachable Power Cable Specifications

North American
Power Cord –  s
MI-32-0570

d a

Figure 165

NOTE: Available throughout North America except in Mexico.

No. Description
a N.A. facility mains plug
s Part number and revision label
d Power Adapter connector

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TECHNICAL DESCRIPTION: Technical Description

EU Power Cord –
MI-32-0573 s

d a

Figure 166

NOTE: Available throughout the EU except in Italy, Switzerland, and Denmark.

No. Description
a EU facility mains plug
s Part number and revision label
d Power Adapter connector

Specifications
Category Specification

Total external mains line Length: 471.2 cm (185.5 in.)

cable assembly Tolerance: +8.4 cm (+3.3 in.) / -11.7 cm (-4.6 in.)
Length: 457.2 cm (180 in.)
Detachable cable
Tolerance: ± 5.1 cm (2.0 in.)
North America (except in Mexico) – MI-32-0570
Regions Available
EU (except in Italy, Switzerland, and Denmark) – MI-32-0573
North America (Figure 165):
• 15A / 125V
Current
EU (Figure 166):
• 16A / 250V

NOTE: Other detachable power cable setups are available. Please contact technical support. See
section 1.2.1 Contacting the Company.

216 MI-42-0001 Rev. 22

 TECHNICAL DESCRIPTION: Special Installation Requirements

9.4 Special Installation Requirements

9.4.1 Overview

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 technical support or your local service representative. See section
1.2.1 Contacting the Company.

Approved Areas The responsible organization is to designate areas for use that meet all characteristics specified in
Only the AIRO Pre-Installation Guide Part Number MI-42-0002 for AIRO systems with Columns or the
AIRO System Without Column Pre-Installation Guide, Part Number MI-42-0139.
AIRO systems are to be used only in areas approved for use by the responsible organization. Any
use outside of areas that are authorized by the responsible organization is considered improper use.

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TECHNICAL DESCRIPTION: Electrical Specifications

9.5 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 - 130 / 200 - 240 VAC
Rated Frequency Range 50/60 Hz
Power Requirements 1500 VA
Phase Single
Least Favorable Input Power
100 VAC, 50 Hz
Conditions
• Maximum current @ nominal voltage (120 kV): 250 mA
• Maximum voltage @ maximum current (250 mA): 125 kV
X-ray tube voltage x data
• Voltage, current @ maximum power: 125 kV, 250 mA
values
• Nominal electric power @ 120 kV: 30 kW (120 kV, 250 mA,
20s)
Fuses
North America • Current: 15 A, time delay
(and other regions Voltage: 250 VAC
with 100 - 130 VAC) Size: 3 AG, 1/4 in. x 1-1/4 in. (6.3 mm x 32 mm)
• Current: 8 A, time delay
European Union
Voltage: 250 VAC
(and other regions
Size: 3 AG, 1/4 in. x 1-1/4 in. (6.3 mm x 32 mm)
with 200 - 240 VAC)
Not applicable. The X-ray system does not operate on line
Voltage Statement
power.
Not applicable. The X-ray system does not operate on line
Current Statement
power.
Technique Factors for
Not applicable. The line does not power the X-ray system.
Maximum Line Current
Earth and Supply Terminal
Marked on the system using symbols listed in 9.14 Symbols.
Markings
Supply Mains Isolation External (wall plug)
Apparent Resistance of
R <= 0.6 ohms
Supply Mains
North America (115V supply mains)
• Length: not to exceed 5.0m (16.5ft)
Proper Length and Gauge of • Gauge: 14AWG
Supply Cable International (230V supply mains)
• Length: not to exceed 5.0m (16.5ft)
• Gauge: 1.0mm2

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 TECHNICAL DESCRIPTION: X-ray Specifications

9.6 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] 32
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 Lithium Iron Phosphate LiFePO4 battery system

Parameters Range
125 kV, 250 mA, 20 s
Rating
125 kV, 125 mA, 40 s
Output voltage 80 - 125 kV
Output current 5 - 250 mA
Nominal electric power (1s) 32 kW
Maximum average electric power 521 W
Minimum battery charge for proper operation 280 Vdc
120 kV, 250 mA, 21.75 s
120 kV, 125 mA, 43.5 s
Maximum Operating Points
30 minute cooling time between maximum
scans
Tube Voltage: +/-1%
Tube current: +/- 2%
Maximum Deviation from Indications Tomogram scan times: User-defined
Topogram scan times: User-defined
Spiral scan times: User-defined

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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 Fan
Target 7 degrees rhenium-tungsten-molybdenum
80, 100, 120 kV
Tube voltage and accuracy
Accuracy: +/- 2%
5 - 250 mA
Tube current and accuracy
Accuracy:+/- 2%
Focal spot size 1.0 mm x 1.0 mm
Total filtration at max kV (inherent +
beam shaping filter) on central axis 6.8
(mm Al equivalent @ 120 kV)
Anode heat capacity (MHU) 1.7
Maximum anode cooling rate (kHU/min) 219.6
Method of tube cooling (FP-1000) 50% water, 50% propylene glycol
Method of tube cooling (MCS-1000) Oil - Shell Diala 34 ZX-1
NOTE: Accuracy of the Automatic Control System (ACS) is the same as that of the Tube Voltage
and current, +/- 2%.

9.6.3 Battery System

Battery System
Category Specification
Battery type LiFePO4
Nominal terminal voltage 387 VDC
Total battery system energy storage 3580Wh
Battery Cell Rating Certificate UL1642 and IEC 62133
Battery Pack Rating Certificate UN/DOT 38.3 and IEC 62133

220 MI-42-0001 Rev. 22

 TECHNICAL DESCRIPTION: Performance Characteristics

9.7 Performance Characteristics

9.7.1 General Performance Characteristics

Scanning
Capabilities for
Category Specification
Helical Mode
Rotation time 1.92 sec
Scan range 1m
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
Capabilities for
Category Specification
Axial Mode
Rotation time 1.92 sec
Scan range 0.620 m
Scan time 71.04 sec for 0.589 m scan range
Slice thickness 32 x 1.0 mm
Image reconstruction time 24 images per sec

Image Quality
Category Specification
Reconstruction matrix 512 x 512

Scanned Projection
Radiography
Category Specification
Maximum SPR length 1m
SPR dimensions 512 x 1000 mm
Angular position available for SPR 0° and 90°

Connectivity Gigabit Ethernet

DICOM 3.1

MI-42-0001 Rev. 22 221

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
mA FS SDD
25 L 29”

Figure 167

Precision
Parameter Value
Pass/Fail Criteria 10%
Highest Percent Error 4.7% @ 60 kVp, 25 mA
Lowest Percent Error 1.2% @ 90 kVp, 25 mA

222 MI-42-0001 Rev. 22

 TECHNICAL DESCRIPTION: Environmental Requirements

9.8 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) 0°C (32°F) to 50°C (122°F)
Humidity 20% to 70% non-condensing 5% to 95% condensing
Pressure 70 kPa to 110 kPa 70 kPa to 110 kPa
• Do not store near chemical products or gas.
Local Restrictions • Do not expose to direct UV light.
• Protect from exposure to moisture, dust, and salinity.
Altitude < 3000 m (9840’) Not applicable
Minimum of twelve hours after
Adaptation Time Not applicable
extreme storage conditions
Minimum of twelve hours after
Humidity 
extreme transport or storage Not applicable
Preconditioning
conditions
NOTES:
1. AIRO is installed per the installation procedure.
2. AIRO remains in original transportation packaging.

Least Favorable The least favorable working conditions are:

Working Conditions
Parameter Least Favorable Condition
At or above the high limit of the environmental temperature range:
Temperature
25°C (77°F). Excessive temperature may degrade image quality.
At or above the high limit of the environmental humidity range: 70%
Humidity
non-condensing.
Atmospheric Pressure At or below the lowest limit of the atmospheric pressure: 70 kPa.

Least Favorable The least favorable operational conditions are:

Operational
Conditions
Parameter Condition
Scans per hour 2
Scan length 0.5 m
Tube loading 120 kV @ 250 mA

MI-42-0001 Rev. 22 223

TECHNICAL DESCRIPTION: Safety Classifications

9.9 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
Use in presence of flammable mixtures Environment in the presence of Flammable
Anesthetics
Mode of operation Non continuous

AIRO is not intended for use within an Oxygen Rich Environment. Risk of Fire.

Do not use AIRO with Flammable Anesthetics. Risk of Fire.

224 MI-42-0001 Rev. 22

 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.

Fuses Required for AIRO Supply Mains:

Current: 15 A, time delay
North America
Voltage: 250 VAC
(and other regions with 100-130 VAC)
Size: 3 AG, 1/4 in. x 1-1/4 in. (6.3 mm x 32 mm)
Current: 8 A, time delay
European Union
Voltage: 250 VAC
(and other regions with 200-240 VAC)
Size: 3 AG, 1/4 in. x 1-1/4 in. (6.3 mm x 32 mm)

The hardwired power supply cord is replaceable by authorized technical service personnel only.
The detachable power cable may be replaced by system operators. See section 12.8 Detachable
Power Cable.
Contact technical support for correct replacement of interchangeable or detachable parts that are
specified as replaceable (e.g., remote controls). See section 1.2.1 Contacting the Company.

MI-42-0001 Rev. 22 225

TECHNICAL DESCRIPTION: Network/Data Coupling to Other Equipment

9.11 Network/Data Coupling to Other Equipment

9.11.1 Overview

Network and Data AIRO is designed to be connected to other equipment by network and data couplings.
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
information.

Instructions The Responsible Organization is hereby instructed that:

• Connecting AIRO to a network/data coupling that includes other equipment could result in
previously unidentified risks to patients, operators or third parties.
• The Responsible Organization should identify, analyze, evaluate and control these risks.
• Subsequent changes to the network/data coupling could introduce new risks and require
additional analysis.
• Changes to the network/data coupling include:
- Changes in the network/data coupling configuration.
- Connection of additional items to the network/data coupling.
- Disconnecting items from the network/data coupling.
- Updating the equipment connected to the network/data coupling.
- Upgrading the equipment connected to the network/data coupling.

226 MI-42-0001 Rev. 22

 TECHNICAL DESCRIPTION: Regulatory Compliances and Approvals

9.12 Regulatory Compliances and Approvals

9.12.1 Summary of Standards Compliance

List and AIRO was tested to IEC 60601 requirements for ME systems and complies with the following
Description regulatory standards:

Performance Standards Description

Medical electrical equipment Part 1: General
IEC 60601-1:2005 + CORR. 1 (2006)
requirements for basic safety and essential
+ CORR. 2 (2007) + A1:2012
performance
Medical electrical equipment – Part 1-2: General
IEC 60601-1-2:2007 requirements for basic safety and essential
IEC 60601-1-2:2014 performance – Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests
Medical electrical equipment – Part 1-3: General
Requirements for basic safety and essential
IEC 60601-1-3:2008 + A1:2013
performance - Collateral Standard: Radiation
Protection in Diagnostic X-Ray Equipment
Medical electrical equipment - Part 1-6: General
IEC 60601-1-6:2010 +A1:2013 requirements for basic safety and essential
performance - Collateral standard: Usability
Medical electrical equipment – Part 2-44: Particular
IEC 60601-2-44:2009 + A1:2012 + requirements for the basic safety and essential
A2:2016 performance of X-ray equipment for computed
tomography
IEC 60825-1:2007 Safety of laser products
Evaluation and routine testing in medical imaging
departments - Part 3-5 Acceptance Tests – Imaging
IEC 61223:2004
Performance of Computed Tomography X-ray
equipment
Secondary cells and batteries containing alkaline or
other non-acid electrolytes - Safety requirements for
IEC 62133:2012
portable sealed secondary cells, and for batteries
made from them, for use in portable applications
IEC 62304:2006 +A1:2015 Medical device software - Software life cycle processes
Medical devices – Application of usability engineering
IEC 62366:2007 + A1:2014
to medical devices
Radiological Health – Part 1020: Performance
standards for ionizing radiation emitting products –
FDA 21 CFR 1020.30
Sec. 30: Diagnostic X-ray systems and their major
components
Radiological Health – Part 1020: Performance
FDA 21 CFR 1020.33 standards for ionizing radiation emitting products –
Sec. 33: Computed tomography (CT) equipment
Radiological Health Part 1040: Section 10:
FDA 21 CFR 1040 Performance standards for light-emitting products:
Laser products
NEMA XR 25-2010 Computed Tomography Dose Check
NEMA XR 29-2013 Standard Attributes on CT Equipment Related to Dose

MI-42-0001 Rev. 22 227

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.

Use of this equipment adjacent to other equipment should be avoided because it

could result in improper operation. If such use is necessary, this equipment and the
other equipment should be observed to verify that they are operating normally.

Expected No unwanted motions or X-ray, no incorrect/corrupt transmission of data, and no effect on image
Performance of ME quality.
Equipment During
NOTE: The operator can expect that the transmission of data may be interrupted, but it will not be
Immunity Testing
lost. Data may have to be sent again.

Electromagnetic The tables in the following sections provide guidance according to the manufacturer’s
Immunity electromagnetic immunity declaration.
Declaration

9.12.3 Electromagnetic Emissions and Immunity

Emissions:
CISPR-11 Emissions
IEC 61000-3-2
IEC 61000-3-3 Test Level and Electromagnetic Environment -
Test
 Compliance Level Guidance
Immunity:
Conducted and CISPR 11 The AIRO is suitable for use in a typical
IEC 61000-4-2,
Radiated RF Emissions commercial or hospital environment.
IEC 61000-4-4, Group 1, Class A
IEC 61000-4-5, NOTE: EMISSIONS characteristics of
IEC 61000-3-2
IEC 61000-4-8, Harmonic Distortion this equipment make it suitable for use in
IEC 61000-4-11, Class A industrial areas and hospitals (CISPR 11
IEC 61000-4-6, class A). If it is used in a residential
IEC 61000-4-3 environment (for which CISPR 11 class B
is normally required) this equipment might
Voltage Fluctuations IEC 61000-3-3 not offer adequate protection to radio-
and Flickers frequency communication services. The
Complies
user might need to take mitigation
measures, such as relocating or re-
orienting the equipment.

228 MI-42-0001 Rev. 22

 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)
+/- 15 kV air material, the relative humidity should be at
IEC 61000-4-2
least 30%.
+/- 2 kV for power
Electrical fast supply lines Mains power quality should be that of a
transient/burst IEC
61000-4-4 +/- 1 kV for  typical commercial or hospital environment.
input/output lines
+/- 1 kV differential
Surge IEC  modes Mains power quality should be that of a
61000-4-5 +/- 2 kV common typical commercial or hospital environment.
mode
Power frequency magnetic fields should be
Power frequency 
at levels characteristic of a typical ___location
(50/60 Hz) magnetic 3 A/m
in a typical commercial or hospital
field IEC 61000-4-8
environment.
< 5% UT (>95% dip in
UT ) for 0.5 cycle Mains power quality should be that of a
Voltage dips, short
40% UT (60% dip in typical commercial or hospital environment.
interruptions and
UT ) for 5 cycles If the AIRO user requires continued
voltage variations
operation during power mains interruptions,
on power supply 70% UT (30% dip in it is recommended that AIRO be powered
input lines IEC UT ) for 25 cycles from an uninterruptible power supply or a
61000-4-11
< 5% UT (>95% dip in battery.
UT ) for 5 seconds
NOTE: UT is the AC mains voltage prior to application of the test level.

MI-42-0001 Rev. 22 229

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 3V Portable and mobile RF communications

RF IEC 150 KHz equipment should be used no closer to any part of
61000-4-6 to 80 MHz the AIRO devices including cables, than the
recommended separation distance calculated
from the equation appropriate to the frequency of
Radiated 3 V/m 80 3 V/m the transmitter.
RF IEC MHz to 2.5
Recommend separation distance:
61000-4-3 GHz
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters as
determined by an electromagnetic site survey1,
should be less than the compliance level in each
frequency range.2
Interference may occur in the vicinity of
equipment marked with the following symbol:

NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
1. Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and
land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accu-
racy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the ___location in which the AIRO devices are used ex-
ceeds the applicable RF compliance level above, the AIRO device should be observed to verify normal oper-
ation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the AIRO device.
2. Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.

230 MI-42-0001 Rev. 22

 TECHNICAL DESCRIPTION: RF Communications Equipment

9.13 RF Communications Equipment

9.13.1 Overview

Electromagnetic Portable and mobile RF communications equipment can affect the systems.
Environment
AIRO is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled.
Users can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and AIRO as recommended
below, according to the maximum output power of the communications equipment.

RF Transmission When AIRO is generating X-rays, the system transmits data from the Rotor computer to the Gimbal
and Receipt computer via Wi-Fi. Since the AIRO incorporates RF transmission and receipt of data, the following
provides required RF/Wi-Fi specifications:

Category Specification
Frequency 2400 - 2483.5 MHz
Bandwidth 20/40 MHz
Type of Modulation DSSS/OFDM/FHSS
Effective Radiated Power (ER) 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. Interference in movement when using high frequency surgical
devices simultaneously with the wireless remote control is possible but uncommon, since no
remotely controlled movements are necessary at that time.

Separation Recommended separation distances between portable and mobile RF communications equipment
Distances and AIRO:

Separation Distance According to Frequency of Transmitter (m)

Output Power of
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Transmitter (W)
d = 1 2 P d = 1 2 P d = 2 3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

MI-42-0001 Rev. 22 231

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

Ethernet port for communication with the hospital network

Authorized representative in the European Community

X = Protection against ingress of solid objects

IPXY
Y = Protection against ingress of liquid
On/off push switch
When pressed On, a yellow indicator light next to the switch indicates that the
system is powered on.

Power On key switch position for enabling the On/Off push switch

Standby key switch position for shutting down the system software and putting the
device into standby mode

AC power connection indicator

When the indicator light is lit, the AIRO is plugged in and charging Ring batteries.

USB connection for exporting data

Emergency Stop
Available on Pendant (see Figure 169 on page 237)

Protective Earth Terminal

CAUTION: Federal law restricts this device to sale by or on the order of a

Rx ONLY physician.

232 MI-42-0001 Rev. 22

 TECHNICAL DESCRIPTION: Labels

9.15 Labels

9.15.1 Labels Used

Labels and
Explanations Label Explanation
System Name Plate/Rating Plate Label:
Indicates manufacturer and input power
requirements.
This equipment is certified to be in compliance
with the applicable standards of CFR, Title 21,
subchapter J as of the date of manufacture.
Location: On the base to the right of the sockets
for power and network cables.
NOTES:
• Values and information marked by label
components listed below may be different
on your system than on the sample label
shown.
• The label on your AIRO system may show
only one voltage range.

ETL Field Evaluated Mark: This equipment is

certified as compliant with relevant US and
Canadian product safety standards.

WEEE label: Electrical and electronic equipment

must be sent to separate collection facilities for
recovery and recycling.
CE mark: This system complies with the
requirements of all relevant standards and
directives in effect within the European
Community.

REF: System catalog/model number

SN: System serial number

NOTE: The “XXXX” shown here is replaced by
the 4-digit number in the system serial number.

Date of system manufacture

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.

MI-42-0001 Rev. 22 233

TECHNICAL DESCRIPTION: Labels

Label Explanation
System Name Plate/Rating Plate Label: Similar
to the MI-43-0001 System Name Plate/Rating
Plate label (see previous page), this label
indicates manufacturer and input power
requirements.
This equipment is certified to be in compliance
with the applicable standards of CFR, Title 21,
subchapter J as of the date of manufacture.
Location: On the base to the right of the sockets
for power and network cables.
NOTES:
• Values and information marked by label
components listed below may be different
on your system from those on the sample
label shown.
• The label on your AIRO system may show
only one voltage range.
• System Name Plate Label items listed
below cover only those components that
are different from those in the MI-43-0001
label.

ETL Field Evaluated Mark: This equipment is

certified as compliant with relevant US and
Canadian product safety standards.

SN: System serial number

NOTE: The “0123456789” shown here is
replaced by the 10-digit system serial number.

Mobius Imaging LLC system Unique Device

Identification (UDI) label

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.
NOTE: Although labels may not appear exactly
as shown, they will contain information shown. In
addition, software, REF, and SN numbers on
your system may differ from the sample label
shown.

X-ray Unit Warning

234 MI-42-0001 Rev. 22

 TECHNICAL DESCRIPTION: Labels

Label Explanation

X-ray Tube Label: This label certifies that the

water/propylene-glycol-cooled X-ray tube meets
all applicable federal and international standards
for X-ray equipment.
Location: On the bottom of the system Ring.

Varex X-ray Tube Label: This label certifies that

the oil-cooled X-ray tube meets all applicable
federal and international standards for X-ray
equipment.
Location: On the bottom of the system Ring.

Laser Warning Label in compliance with IEC

60825-1:2007
LASER LIGHT. DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT The laser product complies with 21CFR 1040.10
OUTPUT: 3.5mW, 635nm
IEC 60825-1:2007
and 1040.11, except for deviations pursuant to
Complies with 21 CFR 1040.10 and 1040.11, except for Laser notice No. 50, dated June 24, 2007.
deviations pursuant to laser notice No. 50, dated June 24, 2007
MI-43-0003 Location: On the base to the left of the sockets
for power and network cables.
Input panel:
a - Potential equalization point
s - Ethernet port for communication with the
MI-43-0005 image guidance system software from your
navigation system vendor.
a s d
d - Ethernet port for communication with the
hospital network.

Ionizing radiation label

Overbalancing Warning Label

MI-42-0001 Rev. 22 235

TECHNICAL DESCRIPTION: Labels

Label Explanation

High Voltage

Support contact label

• 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
Shirley, MA 01464, USA upper pivot housing between the Pendant
Phone: +1-978-608-8313 Holster and the Ring.
Toll Free: +1-866-432-1172
Email: [email protected] NOTE: The label shown is an example only. The
MI-43-0114 Rev 1
label on your AIRO may have different contact
information.
Hand position warning label

Backing up warning label

Pediatric warning label

7KLVGHYLFHLVQRWIRUXVHRQ
SHGLDWULFSDWLHQWVZKLFKLQFOXGHV
Appears only on systems running AIRO Software
SDWLHQWVOHVVWKDQDSSUR[LPDWHO\ v1.3 or earlier.
NJ OEV LQZHLJKWDQG Does not appear on systems running AIRO
FP LQ LQKHLJKW 0,
Software v2.0, v2.1, or later.

Columnless warning label

The AIRO System must be moved out of the
room when performing Proton Therapy Appears on Columnless AIRO systems used for
proton therapy.
MI-43-0088 Rev 1

236 MI-42-0001 Rev. 22

 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 168

No. Label
a X-Ray Tube certification

AIRO Certification
Labels on Systems
with Hardwired
Pendants
a
s
d
f
g
h
j

k
l
;
A
Figure 169

MI-42-0001 Rev. 22 237

TECHNICAL DESCRIPTION: Location of Certification and Safety Labels

No. Label in Location No. Label in Location

Pediatric Warning (only on systems
a j Emergency Stop button on Pendant
with AIRO Software v1.3 and earlier)
s Support Contact k X-Ray Unit Warning
Columnless Warning (only on
d l Laser Warning
columnless systems)
System Name Plate with CE, ETL,
f Backing Up System Warning ;
and WEEE certifications
g Overbalancing Warning A Ionizing Radiation Warning
h Hand Position Warning

Column Information about the labels attached to columns is available. For:

Certification Labels
• 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.
For information about which integrated column your AIRO features, see chapter 4 COLUMN AND
TABLE.

238 MI-42-0001 Rev. 22

 CT USER INFORMATION: Chapter Overview

10 CT USER INFORMATION
10.1 Chapter Overview

10.1.1 Contents

Topics Covered
Section See
No Quick-change X-ray Tubes 10.2
Dosage Factors and Image Quality 10.3
Deterministic Effects 10.4

MI-42-0001 Rev. 22 239

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

240 MI-42-0001 Rev. 22

 CT USER INFORMATION: Dosage Factors and Image Quality

10.3 Dosage Factors and Image Quality

10.3.1 Conditions of Operation

About this Section This section contains the information for CT users required by FDA 21CFR-1020.33.

kV 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.
NOTE: Prior to the initiation of a scan, the Pendant Display shows the CTDIvol expressed in units
of mGy and DLP in units of mGy.cm, for head and for body standards. It also displays the phantom
type and diameter on which CTDIvol values are based. These values are recorded in the scan data.

Scan Time Per Ring In clinical use, the Ring is made to rotate at 30.6 rpm, resulting in a radiation beam-on time per spin
Rotation of 1.92 sec.

mA The X-ray tube is capable of current output from 10 to 250 mA, resulting in tube current – time product
of 19 to 480 mAs. The typical CT condition of operation for an average size adult is expected to be
192 mAs. For Pediatric patients, typical mAs values will be different. See MI-42-0005 Application
Guide for Protocols and Principles.

Slice Thickness N = 32 data channels in the z direction (number of tomographic sections produced in a single axial
scan)
T = 1.06 mm acquisition slice thickness (nominal tomographic section thickness) N x T = 33.92 mm
(commonly called Beam Collimation or Detector Configuration)
Table Incrementation: At present, this is set at 48 mm per tube rotation (25 mm/sec) for helical
scanning mode. Future revisions may provide additional speeds.

Pitch Factor Table Incrementation / Beam Collimation = 48 / 33.92 = 1.415

(Helical Scanning
Future versions of the system may be provided with additional pitch values.
Mode)

10.3.2 Dose Information

Overview The following dose information is obtained by using Ludlum L-007N PMMA CT dosimetry phantoms
alone on the support platform. Separate dose information is provided for head and body
applications.
The dose information is provided at the following locations:
a. Along the axis of rotation of the phantom
b. Along a line parallel to the axis of rotation and 1.0 centimeter interior to the surface of the
phantom, with the phantom positioned so that the CTDI is the maximum obtainable at this
depth.
The CT conditions of operation are the typical values suggested for CT of the head or body.

MI-42-0001 Rev. 22 241

CT USER INFORMATION: Dosage Factors and Image Quality

CTDI Measured CTDI100 (center):

Around Axis of
Rotation
Position Center,
Phantom kV mA sec mAs
mGy
Body 120 100 1.92 192 12.54
Head 120 100 1.92 192 33.69

CTDI measured 1 CTDI100 at 1 cm interior to phantom surface, at the ___location where the exposure is maximum
cm below the obtainable at this depth. This is the entrance ___location directly above the center of the phantom, and
surface designated as the 12 o’clock position (if the phantom is viewed from the front of the scanner; i.e. the
side of the Ring where the patient table is attached).

Entrance,
Phantom kV mA sec mAs Positions
mGy
Body 120 100 1.92 192 46.33 12 o’clock
Head 120 100 1.92 192 45.58 12 o’clock

CTDI Measured at CTDI100 at positions 90˚, 180˚ and 270˚ from the 12 o’clock position, designated here as the 3
Other Angles o’clock, 6 o’clock and 9 o’clock positions, respectively.

Entrance,
Phantom kV mA sec mAs Position
mGy
120 100 1.92 192 37.48 3 o’clock
Body 120 100 1.92 192 29.43 6 o’clock
120 100 1.92 192 33.42 9 o’clock
120 100 1.92 192 41.74 3 o’clock
Head 120 100 1.92 192 35.47 6 o’clock
120 100 1.92 192 38.85 9 o’clock

Average CTDI CTDI100 as the average of the 4 entrance locations (CTDI100 peripheral):

Phantom kV mA sec mAs Peripheral mGy

Body 120 100 1.92 192 36.66
Head 120 100 1.92 192 40.41

242 MI-42-0001 Rev. 22

 CT USER INFORMATION: Dosage Factors and Image Quality

CTDI Per Condition CTDI100 (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).

Normalized
Phantom kV mA sec mAs mGy
mGy
80 25 1.92 48 0.85 0.07
Body 100 25 1.92 48 1.80 0.14
120 25 1.92 48 3.14 0.25
80 25 1.92 48 2.89 0.09
Head 100 25 1.92 48 5.47 0.16
120 25 1.92 48 8.42 0.25

80 50 1.92 96 1.71 0.14

Body 100 50 1.92 96 3.60 0.29
120 50 1.92 96 6.27 0.50
80 50 1.92 96 5.79 0.17
Head 100 50 1.92 96 10.93 0.32
120 50 1.92 96 16.85 0.50

80 100 1.92 192 3.41 0.27

Body 100 100 1.92 192 7.21 0.57
120 100 1.92 192 12.54 1.00
80 100 1.92 192 11.58 0.34
Head 100 100 1.92 192 21.87 0.65
120 100 1.92 192 33.69 1.00

80 125 1.92 240 4.27 0.34

Body 100 125 1.92 240 9.01 0.72
120 125 1.92 240 15.68 1.25
80 125 1.92 240 14.47 0.43
Head 100 125 1.92 240 27.33 0.81
120 125 1.92 240 42.12 1.25

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CTDI Per Peak Tube CTDI100 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. 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).

Normalized
Phantom kV mA sec mAs mGy
mGy
80 25 1.92 48 4.12 0.09
Body 100 25 1.92 48 7.12 0.15
120 25 1.92 48 11.58 0.25
80 25 1.92 48 4.42 0.10
Head 100 25 1.92 48 7.66 0.17
120 25 1.92 48 11.39 0.25

80 50 1.92 96 8.24 0.18

Body 100 50 1.92 96 14.24 0.31
120 50 1.92 96 23.16 0.50
80 50 1.92 96 8.84 0.19
Head 100 50 1.92 96 15.33 0.34
120 50 1.92 96 22.79 0.50

80 100 1.92 192 16.48 0.36

Body 100 100 1.92 192 28.48 0.61
120 100 1.92 192 46.33 1.00
80 100 1.92 192 17.68 0.39
Head 100 100 1.92 192 30.65 0.67
120 100 1.92 192 45.58 1.00

80 125 1.92 240 20.60 0.44

Body 100 125 1.92 240 35.60 0.77
120 125 1.92 240 57.91 1.25
80 125 1.92 240 22.10 0.48
Head 100 125 1.92 240 38.32 0.84
120 125 1.92 240 56.97 1.25

CTDI Free-In-Air CTDIfree air was measured using the 100 mm pencil ion chamber positioned at isocenter, in the
absence of the patient table or any other extraneous material. The exposures were made at 25 mA,
2 sec (50 mAs). Data is presented for 80, 100 and 120 kV, extrapolated to 192 mAs. The 120 kV,
192 mAs combination represents both typical head and body CT conditions of operation. There is
only one (fixed) collimation, with a nominal tomographic section thickness of 33.92 mm (N = 32
detectors, T = 1.06 mm).

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kV mA sec mAs CTDI100, mGy

80 100 1.92 192 21.13
100 100 1.92 192 35.47
120 100 1.92 192 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.
The exposure was made at 120 kV, 25 mA, 2 sec (50 mAs), in the absence of the patient table. The
LLD rod, which uses Optically Stimulated Luminescence (OSL) technology, has an active length of
150 mm. Exposure is presented in units of dose (mrad) at intervals of 0.05 mm, resulting in 3000
data points. Thickness of the radiation beam was calculated as 44 mm at full-width half maximum
(FWHM). CTDI100 free air was calculated using the integral of the dose profile over the central 100
mm span of the LLD. When extrapolated to 196 mAs, the CTDI100 free air obtained is 49.65 mGy.

Dose Profile: CTDI

Free-in-Air
Exposure

Figure 170

Variable Value
120 100m 1.92 192 Nominal Beam
Free Air at Isocenter
kVp A sec mAs Width 33.9
Max dose: Mean over position
3630.17 mrad
range 57 to 93
Half max dose 1815.08 mrad
Beam Thickness at Full Width
Half Maximum (FWHM) 43.9 mm
position range 54 to 98
Exposure length Integral
165031.03 mrad-mm
(central 100 mm)

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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)
Direction
Helical Scans
Dose integral over 33.9 mm nominal beam width (mrad) 123348.35
Dose integral over 100 mm LLD length (mrad) 165031.03
Efficiency (Helical) 74.7%
Axial Scans
Dose integral over 31.8 mm nominal beam width (mrad) 115862.90
Dose integral over 100 mm LLD length (mrad) 165031.03
Efficiency (Axial) 70.2%

Dose Profile: Head

Phantom

Figure 171

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 CT USER INFORMATION: Dosage Factors and Image Quality

Variable Value
Head phantom position Center
120 100 1.92 192 Beam collimation 
kVp mA sec mAs 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 172

Variable Value
Body phantom position Center
120 100 1.92 192 Beam collimation 
kVp mA sec mAs 33.92
Exposure length Integral 43781.62 mrad-mm
Nominal slice thickness 33.92 mm
CTDI (mrad) 1290.73
CTDI (mGy) 12.91

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10.3.3 Statement of Maximum Deviations

Maximum Unless specified, no value should exceed the allowable deviation of ± 10% (suggested). For CTDIw,
Deviations CTDIvol 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
CTDI100 at the 12 o’clock position, which can be higher than CTDI100 (peripheral) by >25%. Medical
Physics testing for ACR accreditation also employs measurement at the 12 o’clock position.

10.3.4 Imaging Performance Information

Noise, Mean CT
Number, and
Phantom: Conditions of Gammex 464 Uniformity Gammex 464 Uniformity
Uniformity – Head
Operation Module Module
Scan (16cm
Phantom) kVp 120/100/80 120/100/80
mA 110 78
Scan Mode Helical Axial
Pitch Scan Time 1.41 N/A
FOV 21.0 cm 21.0 cm
Recon Image Pixels 512 x 512 512 x 512
Recon Kernel Standard Standard
Tomographic Section Length 5.0 mm 5.0 mm

Typical Values
Circular ROI Diameters Mean CT NUMBER HU Noise HU Uniformity HU
60mm @ ISO 0 +- 5 4 +- 40%
15mm @ ISO 0 +- 5 5 +- 40%
15mm @ 12 o’clock 0 +- 5 3 +- 40% < 3 HU
15mm @ 3 o’clock 0 +- 5 3 +- 40% < 3 HU
15mm @ 6 o’clock 0 +- 5 3 +- 40% < 3 HU
15mm @ 9 o’clock 0 +- 5 3 +- 40% < 3 HU

Noise, Mean CT
Number, and
Gammex Body Ring and Gammex Body Ring and
Uniformity – Body Phantom: Conditions of
Gammex 464 Uniformity Gammex 464 Uniformity
Scan (30cm Operation
Module Module
Phantom)
kVp 120 120
mA 110 78
Scan Mode Helical Axial
Pitch Scan Time 1.41 N/A
FOV 51.2 cm 51.2 cm
Recon Image Pixels 512 x 512 512 x 512
Recon Kernel Standard Standard
Tomographic Section Length 5.0 mm 5.0 mm

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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% < 5 HU
15mm @ 3 o’clock 0 +- 7 6 +- 40% < 5 HU
15mm @ 6 o’clock 0 +- 7 6 +- 40% < 5 HU
15mm @ 9 o’clock 0 +- 7 6 +- 40% < 5 HU

Modulation
Transfer Function
Phantom: The CT conditions of Operation Gammex 464 MTF Module

kVp 120
mA 110
Scan Mode Helical
Pitch Scan Time 1.41
FOV 21.0 cm
Recon Image Pixels 512 x 512
Recon Kernel Standard
Tomographic Section Length 1.0 mm

Typical Results for

Standard Kernel

Figure 173

The deviations in the measured MTFs are within the range of +/- 10%.

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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 174

10.3.5 Technical Statements

Tube Housing
Assembly
Tube Model Characteristic Method of Derivation
< 0.88 mGy/h @ 125 kV/8 mA
Leakage technique The observed leakage was below the allowable
factors limit of 1.0 mGy in 1 hour (IEC regulations) and
FP-1000 0.88 mGy in 1 hour (FDA regulations).
Minimum Filtration
permanently in the useful 4.99 mm Al @ 80 kVp, HVL 4.6 mm Al
beam
Loading factors for
140 kV/9 mA
MCS-1000 Leakage Radiation
Permanent filtration 4.99 mm Al @ 80 kVp, HVL 4.6 mm Al

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Anode Heating and

Cooling Curves FP-1000

Figure 175

MCS-1000

Figure 176

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Tube Housing
Cooling Curves

Figure 177

Figure 178

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 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.
scan Starting Heat storage = Starting Heat Storage = Starting Heat Storage =
time 16% 33% 50%
(sec)
1 290 (c) 330 260 290 (c) 330 260 290 (c) 330 260

2 290 (c) 330 260 290 (c) 330 260 290 (c) 330 260

4 290 (c) 330 260 290 (c) 330 260 290 (c) 330 260

6 290 (c) 330 260 290 (c) 330 260 290 (c) 330 260

10 290 (c) 330 260 290 (c) 330 260 290 (c) 330 260

20 290 (c) 330 260 290 (c) 330 260 290 (c) 330 260

30 290 (c) 330 260 290 (c) 330 260 290 (c) 250 (a) 200 (a)

40 290 (c) 330 250 290 (c) 260 (a) 210 (a) 240 (a) 190 (a) 150 (a)

50 290 (c) 270 (a) 210 (a) 260 (c) 210 (a) 170 (a) 190 (a) 150 (a) 120 (a)

60 280 (a) 230 (a) 180 (a) 220 (a) 180 (a) 140 (a) 160 (a) 130 (a) 100 (a)

Key
(a) Limited by available heat storage
(b) Limited by window heating
(c) Limited by filament emission

X-ray Controls and

Generators
Parameters Range Accuracy
Power 31.25 kW Maximum
+/-10%
Reproducibility 60 - 125 kVp
(CV) of 0.05
Adjacent: (CV) of
0.05
Linearity 25 - 125 mAs
Non-adjacent:
<0.10
Generator
Rating and Duty Cycle 125 kV, 250 mA, 20 s
Output voltage 80 - 125kV
Output current 0 - 250 mA
Nominal electric power
326W
(1s)
Maximum average
500W
electric power

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Parameters Range Accuracy

Minimum battery
charge for proper 280 Vdc
operation

Maximum 120 kV, 250mA, 21.75 s

Operating Points 120 kV, 125mA, 43.5 s
30 minute cooling time between maximum scans
Tube Voltage: +/- 1%
Tube current: +/- 2%
Maximum
Deviation from Tomogram scan times: User-defined
Indications
Topogram scan times: User-defined
Spiral scan times: User-defined
Continuous anode input power: 1000 W
Statement of
Reference Loading Nominal X-ray tube voltage: 120 kVp
Conditions
Continuous current under this condition: 8.3 mA.

10.3.6 Definitions of the Measurement Bases of the Technique Factors

Tube Voltage The kVp can be measured software assisted during each scan via built-in HV-dividers. The values
have been verified at a prototype test by using additional devices like a hyper-pure Ge-detector and
an electronic penetrameter.

Tube Current The mA have been verified at a prototype test using a multimeter connected to the center ground
point of the high tension transformer. The tube current can be measured software assisted during
each scan.

Scan Time The scan time is the total exposure time (X-ray on) during a scan. It can be measured software
assisted during each scan and is verified at a prototype test measuring the X-ray on-signal with an
oscilloscope.

10.3.7 60601 Requirements: CT USERS

IEC 60601 IEC 60601-2-44 requires the following information in addition to requirements already met in this
chapter.

Nominal Focal Spot 1.0 x 1.0 mm

Value

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.

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Half-Value Layers Half-value layers (HVL) were measured using a Radcal 2026 with its 20X6-6 ion chamber placed at
isocenter.

Parameter Value
Tube Current 25 mA
Beam-on Time 2 sec (50 mAs)

kV 80 100 120
mm Al mR
0 489 811 1182
3 838
4 264.4 755
5 231.4 435
6 391 629
7
8 522

Half exposure 244.5 405.5 591

Measured HvL, mm Al 4.6 5.7 6.7
Minimum Required, mm Al 2.9 3.6 4.3

Filter Properties 4.99 mm Al @ 80 kVp, HVL 4.6 mm Al

There are no other user selectable filters on AIRO, including shaped filters for head protocols.

Protection Against The Ring-side radiologic exposure is 5.7% and 8% of the corresponding exposures on the axis of
Residual Radiation rotation, thereby meeting the IEC 60601-11 requirement of <25%.

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10.4 Deterministic Effects

10.4.1 Radiation Dose Levels

Managing There is a possibility in normal use that the patient can be exposed to radiation dose levels where
Radiation Dose deterministic effects may occur. Operators need to be aware of and manage the possibility of
Levels exposure to high radiation.

Number of Scans to Reach

Deterministic Effect: 1000 mGy CTDI100 (peripheral)
Effect
Typical/maximum head protocol: 120 kV, 326 effective
10
mAs
Typical body protocol: 120 kV, 149 effective mAs 25
Maximum body protocol: 120 kV, 326 effective mAs 
11
(e.g., obese patient)

10.4.2 Prevailing Radiation Dose

Factors Affecting AIRO selects a protocol based on the data entered for:
Prevailing
• Patient weight
Radiation Dose
• Body region being scanned
The operator sets the patient height and weight, both of which affect the radiation dose in normal
use. See chapter 6 SCANNING.
After a scout scan is performed, AIRO permits Z-axis tube current modulation as a dose optimization
method for helical scanning modes. For more information, see section 2.7.8 Reducing Risk from X-
ray Dose.
AIRO calculates and displays the kV and mA for the proposed scan.
The Pendant Display shows the CTDIvol expressed in units of mGy and DLP in units of mGy.cm, for
head and for body standards. It also displays the phantom type and diameter on which CTDIvol
values are based. These values are recorded in the scan data.
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).

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11 ALLOWED EQUIPMENT
11.1 Chapter Overview

11.1.1 Contents

Topics Covered
Section See
Compatibility with Other Medical Devices and Software 11.2

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11.2 Compatibility with Other Medical Devices and

Software

11.2.1 Medical Devices

Accessories are All components and accessories that can be removed in normal use are labeled on AIRO.
Marked Information on the label includes a part number, model number, and the name or trademark of the
manufacturer to reference for obtaining replacements.

Other Medical
Devices

Using medical device combinations which have not been authorized by the
manufacturer may adversely affect safety and/or effectiveness of the devices and
endanger safety of patient, user and/or environment. Use of unauthorized devices is
improper use.

Brainlab Navigation Brainlab Navigation Systems. Contact Brainlab for more information for proper connection and
Systems operation with the AIRO System.

11.2.2 Medical Software

Authorization

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. Pendants—two pendants MI-76-0238
Detachable 10-in Pendant Screen Protector MI-76-0244
Gantry Tilt Stopper MI-76-0218
Pendant-Cable Strain Relief MI-76-0240
QC Scan Phantom Platform MI-51-0094

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For Use With Compatible, commercially-available equipment includes:

Compatible Equipment Mobius P/N

Gammex 464 ACR CT Accreditation Phantom with Case and Stand MI-21-0080
Gammex 464 ACR CT Phantom Stand MI-71-0004
Gammex 464 ACR CT Phantom Case (soft) MI-71-0005
Brainlab Curve—Image Guided Surgery navigation system N/A
Stryker Q Guidance System (8900-100-000) with Spine Guidance Software 4.0
(6002-710-000) N/A
NOTE: Requires an AIRO system running a minimum of AIRO Software v2.1.
Trumpf Wireless Remote Kit—Gen1 wireless remote control and charging
MI-21-0114
stand for operating the Original Trumpf surgical column
Trumpf Remote, Wireless, TS 7500, 1633968—Gen1 wireless remote control MI-30-0086
Trumpf Charging Unit, Mobile, TS 7500, 1557243—Charging stand for Gen1 &
MI-30-0087
Gen2 remotes
AIRO Trumpf Wireless Remote Kit V2—Gen2 wireless remote control and
MI-21-0272
charging stand for operating the Updated Trumpf surgical column
Remote, Wireless, TS 7500, 2003863—Gen2 wireless remote control MI-30-0236
Trumpf Table tops
Only Trumpf Radiolucent Table Tops (360 Radiolucent only e.g., no metal
rails) should be used with the AIRO and integrated Trumpf Table Column.
Contact Trumpf to purchase associated Tabletops at:
- (860) 255-6324 (USA Only)
- +49 3671 586-0 (Europe and Rest of World)
If any other patient table is used it must be 360° radiolucent and meet the
requirements of FDA 21CFR1020.30 (n).
N/A
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.

Table tops marked as “Fully Radiolucent” are not sufficient for CT

scanning. Only 360 radiolucent tables and table sections that meet the
requirements specified in FDA 21CFR1020.30 (n) should be used in
conjunction with AIRO.

NOTE: Combinations of AIRO systems and other compatible equipment are not available in all
markets.

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This Page Intentionally Left Blank

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12 TROUBLESHOOTING
12.1 Chapter Overview

12.1.1 Contents

Topics Covered
Section See
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
Detachable Power Cable 12.8
Malfunctions and Return Instructions 12.9

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12.2 Troubleshooting

12.2.1 Problems and Suggested Actions

Possible Problems
Problem Possible Cause Steps
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 • Be sure you are using the compatible Trumpf
scan field of Radiolucent 360 patient supports. See section
Metal artifacts in view 11.2.3 Accessories List.
CT scans
• Re-evaluate patient, surroundings, and accessories
Metal in patient for metal.
Move closer. Confirm remote is charged and that this
remote is paired to the system.
For more information about:
Wireless remote
Out of range • Original wireless remote, see MI-42-0167 AIRO
cannot find table
Original Trumpf Column Supplement.
• Updated wireless remote, see MI-42-0165 AIRO
Updated Trumpf Column Supplement
AIRO still
connected to
facility mains.
Check if Transport image from the front viewing camera
Gantry, or Ring, is on Pendant.
not locked in
If Transport image does not appear:
position at
center of base. 1. Ensure that AIRO power cable is unplugged.
The drive 2. Ensure that Ring is locked in line with, and at
Transport failure mechanism center of, base.
failed.
3. If image still does not appear, see section 
The mechanism 12.5 Transport Failure for instructions to manually
to raise the base move AIRO.
failed, or the
4. Contact technical support. See section
system can’t
1.2.1 Contacting the Company.
transition from
Scan mode to
Transport mode.
Check if Transport image from the front viewing camera
is on Pendant.
If Transport image appears:
AIRO will not Main Drive
1. Restart AIRO.
drive when in motion controller
Transport mode. is disabled. 2. If image reappears but system will not move, see
section 12.5 Transport Failure to manually move
AIRO.
3. Contact technical support. See section 1.2.1.
AIRO warmup Internal Restart AIRO and repeat warmup scan. If problem
scans fail. operation issue. persists, contact technical support. See section 1.2.1.

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Problem Possible Cause Steps

Check to make sure AIRO is plugged in. Restart AIRO.
AIRO will not Power source
If problem persists contact technical support. See
power on. interrupted.
section 1.2.1 Contacting the Company.
AIRO displays a confirmation dialog.

Operator
Rotor not ready
pressed keys
for scanning.
too quickly.

1. Touch OK.
2. Wait for Lasers icon to appear, then retry.
AIRO
experiences
complete loss of Power source
See section 12.5 Transport Failure.
power and interrupted.
needs to be
moved.
Check under machine and remove obstacle if possible.
Move the machine in an opposite direction of travel
During transport then when the obstacle was encountered. Hold down
AIRO becomes the forward or reverse button and push the machine
Operator error. (may take a couple of people) in the same direction as
hung up on
obstacle. the button press would move the machine if under
power.
See instructions for complete loss of power.
Gain Calibration
attempted Object inside Make sure Ring is clear of all objects, If problem
multiple times, Ring scan area. persists contact technical support. See section 1.2.1.
will not pass.
Restart AIRO. If problem persists, contact technical
support. See section 1.2.1.
Service Mode
AIRO failed to
icon turns on
load gain
and Bad Gain
calibration or
Calibration
failed to initialize
message
reconstruction.
appears.

Maintenance
Mode icon turns At earliest convenience, perform a new Gain
on, requiring Calibration. See 7.3 Daily Gain Calibration.
The most
new Gain
recently saved
.

Calibration, and
calibration file
Gain Calibration
got corrupted.
Warning
message
appears.

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Problem Possible Cause Steps

When exporting scan, system, and dose data to USB
storage devices that are full or have other issues, AIRO
displays a confirmation dialog.

Patient, study,
series, system,
dose, and log USB device is
data will not full or damaged.
export to USB
storage
1. Touch OK.
2. Remove USB device from the USB port.
3. Using a laptop or other computer, verify that USB
storage device functions and has enough space for
the exported data.
All Pendants:
• Check for damage to Pendant, restart AIRO. If
problem persists contact technical support.
Detachable Pendant:
Pendant
Pendant • Power AIRO down.
hardware
touchscreen • Remove and reconnect Pendant.
damage or cable
does not • Install new Pendant.
connection
respond.
issue. • If problem persists, contact technical support.
To contact technical support, see section
1.2.1 Contacting the Company.
For information about Detachable Pendants, see
section 13.3 Maintenance with Detachable Pendants.

All Pendants:
• Check to see if the AIRO Pendant buttons get stuck
in the “on/pressed” position. If damage is evident
contact technical support.
Detachable Pendant:
Pendant
Pendant buttons
hardware • Power AIRO down.
do not respond.
damage • Install new Pendant.
• If problem repeats contact technical support.
To contact technical support, see section 1.2.1.
For information about Detachable Pendants, see
section 13.3 Maintenance with Detachable Pendants.

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Problem Possible Cause Steps

Hardwired Pendant:
• Restart AIRO. If the problem persists contact
technical support. See section 1.2.1 Contacting the
Company.
Mid Scan Workaround
A hardware If this issue occurs in the middle of the scan sequence,
Hardwired
issue or use a USB mouse to complete the scan and ensure
Pendant
software conflict that the patient’s accumulated dose is not increased.
touchscreen
has occurred To use a USB mouse:
locks up during
during the scan
scan sequence. 1. Plug a standard, wired USB mouse into the USB
sequence.
port of the system Control Panel located under the
Pendant Holster.
2. With the mouse, make all on-screen selections
required to complete the scan sequence.
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 — when powering down the system could
cause a lost scan or otherwise result in unused 
dose — do the following to ensure that the patient's
accumulated dose is not increased.
• Remove and reinstall Detachable Pendant
WITHOUT powering down AIRO.
Detachable • If the problem persists, contact technical support.
A hardware
Pendant
issue, a software Outside of Scan Sequence:
touchscreen
conflict, or an
locks up, shows If this issue occurs during normal operation while
electrostatic
distorted setting up scans, viewing 3D-scan results, performing
discharge (ESD)
images, or goes system maintenance, or transporting the system:
has occurred.
blank. • Restart AIRO.
• For systems with Detachable Pendants only:
- Power AIRO down.
- Disconnect and reconnect the pendant.
• If the problem persists, contact technical support.
To contact technical support, see section 1.2.1.
For information about disconnecting and connecting
Detachable Pendants, see sections 
13.3.2 Disconnecting Detachable Pendants and 
13.3.1 Connecting Detachable Pendants.

MI-42-0001 Rev. 22 265

TROUBLESHOOTING: Troubleshooting

Problem Possible Cause Steps

• Check system-side strain relief/Power Adapter Cable
Assembly for damage. If it is damaged for either a
hardwired or a Detachable Power Cable contact
technical support.
• System-side • Check power cord for damage. If it is damaged:
strain relief/ - Hardwired power cord – Contact technical support.
Power - Detachable Power cord – Disconnect cord from
Adapter Cable facility outlet and system power connector, and 
Assembly is then connect a replacement cord. See 
damaged. 12.8 Detachable Power Cable for instructions. 
AIRO will not
• Power cable is Contact technical support for a replacement 
power on. cable.
damaged.
• Power cable is • Check for disconnected power cable:
disconnected. - Hardwired power cord – Ensure cord is connected 
• Power at facility power outlet.
interruption - Detachable Power Cord – Ensure cable is
occurred. connected at both facility outlet and system power 
connector.
• Check facility power.
To contact technical support, see section
1.2.1 Contacting the Company.
Requires two Users:
• User 1:
1. Turn AIRO Power key on.
2. Press and hold start button on control panel.
Hold for 5 seconds and continue holding until User
2 is done.
• User 2:
AIRO will not
1. While User 1 holds down AIRO start button, turn on
power on,
Power the power to the Trumpf column.
Trumpf column
interruption. 2. Using column keypad, manipulate the table.
needs to be
moved. • User 1:
1. When User 2 is done, release start button to power
down the system.
For more information about using:
• Original Trumpf TruSystem 7500 Column, see MI-42-
0167 AIRO Original Trumpf Column Supplement.
• Updated Trumpf TruSystem 7500 Column, see MI-
42-0165 AIRO Updated Trumpf Column Supplement.

System Manager
Errors

Figure 179

When System Manager errors interrupt work-flows, restarting AIRO often resolves the system issue
described in the error message. Figure 179 shows an example System Manager Error.

266 MI-42-0001 Rev. 22

 TROUBLESHOOTING: Troubleshooting

Steps See
1. Note on-screen error message.
3.4
2. Follow on-screen instructions and re-start AIRO. &
3.3.1
3. Contact technical support or your distributor if the issue continues to occur. 1.2.1

Application
Failures

Figure 180

Application failures may indicate significant issues with the system.

Steps See
3.4
1. Re-start AIRO. &
3.3.1
2. If the Application Failure screen reappears, take AIRO out of service.
Use the on-screen contact information to contact your distributor, or contact
3. 1.2.1
technical support.

NOTE: Figure 180 is an example Application Failure screen. For technical support contact
information, see section 1.2.1 Contacting the Company.

MI-42-0001 Rev. 22 267

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 181

Metal objects in scans create streaks that degrade the image quality, and make the scan difficult to
interpret. X-ray beams that pass through or near metal implants are highly attenuated and have a
much larger error.
NOTE: Image provided for illustrative purposes only.

How to Avoid Metal

Artifacts in Scans
Likely Cause Steps
• Be sure you are using the compatible Trumpf
Radiolucent 360 patient supports. See subsection For
Metal outside scan field of view Use With on page 259.
• Re-evaluate patient, surroundings, and accessories for
metal.

268 MI-42-0001 Rev. 22

 TROUBLESHOOTING: Rotation Sensor Error

12.4 Rotation Sensor Error

12.4.1 Verifying Scan Direction During Scan Setup

How to Ensure When setting up or scanning a patient, the system verifies the orientation of the Ring. When
Rotation Sensor orientation or rotation issues are detected, the system shows a error.
Agrees with Scan
Setup

s
Figure 182

Steps
1. When the Gimbal Rotation Sensor Error screen appears a, shut down the system. See
section 3.4 Powering Down on page 64.
2. When the yellow power indicator LED stops blinking, restart the system. See sections 
3.3.1 Turn On Power on page 45 and 3.3.2 Logging In on page 45.
3. Put AIRO into Scan mode. See section 6.3.2 Choosing Scan Mode on page 73.
4. Repeat the scan set up sequence. See sections 6.8 Typical Scan Sequence: New Scan
and following starting on page 84.
5. After placing the Ring in SAB or STB orientation, verify that the orientation icons s are
green and show the correct orientation. See section 6.8.6 Confirming Scan Direction.
6. If either the Gimbal Rotation Sensor Error reappears or the scan direction icons do not
match the required direction, call technical support. See section 1.2.1 Contacting the
Company on page 2.

MI-42-0001 Rev. 22 269

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

• The system is raised on its casters. The drive mechanism failed. See section 12.5.2
• You are using the Pendant, but the
system will not move.
• The base is on the floor. The mechanism to raise the See section 12.5.3
• You cannot raise the system to base failed, or the system
move it. can’t transition from Scan
mode to Transport mode.

12.5.2 Base is Lifted but System Will Not Move

How to Move AIRO

When the Drive
Situation Solution
Wheel Fails
The system is on its casters and you are using the Put the main drive wheel into neutral
Pendant, but the system will not move. manually. Push from the normal position.

Never attempt to put the main drive wheel into neutral on an incline. There is a risk of
injury and equipment damage from uncontrolled movement.

s
d
Figure 183

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 TROUBLESHOOTING: Transport Failure

Figure 184

Steps
1. Lift a latch to release Gimbal. See Figure 183.
2. Rotate the Gimbal out of Transport position into Scan position s.
This reveals the drive mechanism in the base under the Gimbal d viewed from the end
opposite the system power cable.

See cautions about rotating the Ring in section

3.3.6 Rotating and Latching the Ring in Transport or Scan Position.
3. Reaching in under the Gimbal, grasp the left release lever as close to the slot as 
possible f. See Figure 184.

Do not use tools or extensions to move the release lever.

4. Carefully press the release lever down to the bottom of the slot.
This puts the main drive into neutral.
5. Repeat steps 3 and 4 if release lever re-engages.
6. Rotate the Gimbal into Transport position and lock.

See cautions about rotating the Ring in section

3.3.6 Rotating and Latching the Ring in Transport or Scan Position.
7. Push AIRO manually.
8. Mark the system as not for use and contact technical support.

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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
If possible, contact technical support before attempting to manually raise and transport the system.
Not Lift
See section 1.2.1 Contacting the Company.

Situation Solution
The system is lowered and will not Partially raise the base manually. Push from the normal
rise onto the casters. position.

Never attempt to raise the base on an incline. There is a risk of injury and equipment
damage from uncontrolled movement.

Equipment Needed: The emergency kit is stored under the panel covering the drive mechanism, which is located in the
Emergency Kit center of the Gimbal under the Ring. The kit consists of:
• 6 mm Allen wrench
• 12 mm ball screw
To access the kit, use:
• #2 Phillips head screwdriver
• Medium flat-tip screwdriver
• Small tape measure

Remove Cover

Figure 185

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 TROUBLESHOOTING: Transport Failure

Figure 186

Steps
1. Remove Tilt Stops. See Figure 135.
2. At the top of the Ring, tilt the Ring by pulling it firmly until the panel mounting screws can be
accessed a. See Figure 185. (This step may require two people.)
3. Remove the six remaining screws from the panel covering the drive mechanism.
4. With the flat-tip screwdriver, carefully pry up the panel.

Manually Raise the

System
Steps
1. For reference, measure the gap under the Gimbal from the bottom of the base to the floor.
2. Thread the screw from the emergency kit s into the center hole d ball end down. (See
Figure 186 on page 273.)
3. Using the Allen wrench, tighten the screw clockwise until you feel the resistance of the inner
lift plate and the AIRO system begins to lift.
4. Turn until the machine lifts about 1/2” off the ground (approximately nine full turns).
NOTE: Measure the gap from the bottom of the base to the floor just as you did in step 1,
and then use the two measurements to calculate how much the gap changed.
5. Ensure that the screw protrudes up from the center somewhere between:
• Flush with the center
• 8 mm (5/16 in.) above it

MI-42-0001 Rev. 22 273

TROUBLESHOOTING: Transport Failure

How to Manually
Transport

Figure 187

Steps
1. Rotate the Gimbal into the locked position.

See cautions about rotating the Ring in section

3.3.6 Rotating and Latching the Ring in Transport or Scan Position.
2. Lock the Gimbal in transport position.
3. Follow the steps in section 12.5.2 Base is Lifted but System Will Not Move to disengage the
Main Drive with the release lever.
4. Position a person at each end of the system. See Figure 187.
5. At the same time:
• Person on the end of the system opposite the Pendant/power cord:
Place hands on the Ring’s support bezel for the camera panel and push system to 
move it.

Do not push on the camera or camera panel.

• Person on the Pendant end of the system:
Help steer and guide AIRO to storage or service ___location.
NOTE: If necessary, ask for assistance in guiding system to a safe storage or service
___location.
6. When the system is in a ___location adequate for storage, use the Allen wrench to remove the
emergency kit bolt from the center hole s.
7. Place the emergency kit back onto the retention magnets.
8. Reinstall the panel removed to access the emergency kit.
9. Return the Ring to the upright position, and reinstall the Tilt Stops.
10. Label the system as not for use and contact technical support.

274 MI-42-0001 Rev. 22

 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.

MI-42-0001 Rev. 22 275

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.

276 MI-42-0001 Rev. 22

 TROUBLESHOOTING: Detachable Power Cable

12.8 Detachable Power Cable

12.8.1 Overview

Determining If Your Certain AIRO systems feature the Detachable Power Cord or the Detachable Power Cable Upgrade
AIRO Features the that allow users to replace damaged power cords in the field. Before replacing a power cord, verify
Detachable Power that your system includes the Detachable Power Cable.
Cable

Figure 188

Steps
Verify that the main power connectors are covered by a black silicone band connection
cover (silicone cover) a and appear in the cable just before the Power Adapter Cable
Assembly (Adapter) s.
NOTE: If the silicone cover shows damage or significant wear, replace the cover:
a. Power off the system and unplug it from the wall outlet.
1. b. Disconnect the Detachable Power Cord and discard the damaged silicone cover.
See subsection Disconnecting the Detachable Power Cord on page 278.
c. Locate a new MI-20-1220 silicone cover. If necessary, contact technical support.
See section 1.2.1 Contacting the Company.
d. Install the new silicone cover and re-connect the Detachable Power Cord. See
subsection Connecting the Detachable Power Cord on page 278.
Verify that the label on the Detachable Power Cord d shows a valid part number for your
region:
2.
• MI-32-0570 for North America (except in Mexico)
• MI-32-0573 for European Union (except in Italy, Switzerland, and Denmark)
3. Power off the system.
4. Unplug the system from the wall outlet.

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TROUBLESHOOTING: Detachable Power Cable

12.8.2 Maintaining the Detachable Power Cable

Disconnecting the After the power cord is disconnected from facility mains, either users or service personnel can
Detachable Power remove the power cord from the Adapter.
Cord
NOTE: Depending on the power-cable configuration (North America or international), the colors for
plugs and cords may differ.

s a

f
d

Figure 189

Steps
1. Ensure that AIRO is powered off and disconnected from facility mains.
2. Roll the silicone cover a on the main power connectors back until the red release 
latches s on the cord power connector are visible.
3. On the cord power connector, hold back the release latches s (one on each side).
4. Disconnect the cord power connector d from the Adapter power connector f.
5. Remove and discard the silicone cover.

Connecting the After disconnecting the Detachable Power Cord, users or service personnel can either re-connect
Detachable Power or replace it.
Cord

a
s

Figure 190

Figure 191

278 MI-42-0001 Rev. 22

 TROUBLESHOOTING: Detachable Power Cable

f
Figure 192

Figure 193

Figure 194

MI-42-0001 Rev. 22 279

TROUBLESHOOTING: Detachable Power Cable

Steps
1. Ensure that AIRO is powered off.
2. Verify that the label on the Detachable Power Cord shows a valid part number for your
region (see d in Figure 188):
• MI-32-0570 for North America (except in Mexico)
• MI-32-0573 for European Union (except in Italy, Switzerland, and Denmark)
3. Take a new silicone cover a, locate Adapter power connector s, and slide the cover over
the connector d.
NOTE: For new silicone covers, contact technical support. See section 1.2.1 Contacting the
Company.
4. Fold the silicone cover back f to access the Adapter power connector g.
NOTE: Make sure the silicone cover is clear of the Adapter power connector shield.
Pinching the cover between the Adapter and cord power connectors can damage the cover.
5. Plug the cord power connector h into the Adapter power connector until the latches click
into place.
6. Gently tug on the cord's power connector to verify that the connection does not disengage.
7. Roll the silicone cover over it to keep debris out of the cable connection j.
8. Tug on the covered connection to ensure that it is secure.
9. Reconnect the AIRO to facility mains.

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 TROUBLESHOOTING: Malfunctions and Return Instructions

12.9 Malfunctions and Return Instructions

12.9.1 Malfunctions

System Damage or Do not continue to use the system if:

Failure
• The power plug, cable, adapter, or strain relief is damaged (e.g., cable has been run over) or
frayed.
• The system does not operate normally when operating instructions are followed.

How to Respond to
Damage or Failure
Steps
1. Power down the system.
2. Unplug system from wall outlet.
3. Contact technical support.
4. Attach a notice such as “DO NOT USE” to equipment to prevent it from being used
inadvertently.

12.9.2 Return Instructions

Reporting Any defective components should be immediately reported to technical support.

Damaged
Equipment

Removing Only remove defective components if instructed to do so by technical support.

Components

How to Return Follow the instructions from technical support.

Components

How to Contact See section 1.2.1 Contacting the Company.

Technical Support

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TROUBLESHOOTING: Malfunctions and Return Instructions

This Page Intentionally Left Blank

282 MI-42-0001 Rev. 22

 DETACHABLE PENDANT: Chapter Overview

13 DETACHABLE PENDANT
13.1 Chapter Overview

13.1.1 Contents

Topics Covered
Section See
Detachable Pendant and Holster 13.2
Maintenance with Detachable Pendants 13.3
Technical Description for Detachable Pendants 13.4

MI-42-0001 Rev. 22 283

DETACHABLE PENDANT: Detachable Pendant and Holster

13.2 Detachable Pendant and Holster

13.2.1 Overview

Description

Figure 195

The Detachable Pendant, available for AIRO Mobile CT Systems running AIRO Software v2.1 or
higher, features a larger 25.4cm (10 in.) diagonal monitor with a 1280 x 800 pixel screen, an
ergonomic Pendant handle, and a cable that is detachable from the side of the system. In addition,
it provides a wider Holster that improves system handling when transporting the system from facility
storage to operating locations.

No. Component
a Detachable Pendant
s Holster
d Cable Strain Relief
f Latch and Connector Housing

While AIRO Software supports both Pendants, figures and examples in previous chapters show
screen-images from the 800 x 600 pixel hardwired Pendant.
Most operational procedures for AIRO systems with Detachable Pendants and Holsters are the
same as those for AIRO systems with hardwired Pendants and Holsters. However, because the
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 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.

284 MI-42-0001 Rev. 22

 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.

Figure 196

Figure 197

Figure 198

MI-42-0001 Rev. 22 285

DETACHABLE PENDANT: Maintenance with Detachable Pendants

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 196.
3. Note the position of the alignment mark a.
4. Locate the connector housing below the Ring’s latch. See Figure 25.
5. Holding the connector below the barrel ring, line up the alignment marks s.
6. Insert the connector into the socket until the barrel-ring clicks into place.
7. Loop the cable up along the latch housing with an approximately 15.24cm (6-in.) of cable
from the end of the connector cover to the strain relief d.
8. Secure the cable with the strain-relief and tighten the thumb screw f finger-tight.

Make sure the cable passes through the channel of the strain relief bracket.
Pinching it with the bracket or the alignment pin can puncture the cable insulation
and require Pendant replacement.
9. Power on the system. See section 3.3.1 Turn On Power.

13.3.2 Disconnecting Detachable Pendants

How to Disconnect 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.

Always power down AIRO before connecting or disconnecting the Detachable

Pendant. Connecting or disconnecting the pendant during scan workflows or while
the system is powered on can result in:
- Unused patient dose
- Delay of therapy
- Nonfunctional system

d
a

Figure 199

286 MI-42-0001 Rev. 22

 DETACHABLE PENDANT: Maintenance with Detachable Pendants

Figure 200

Steps
1. Power down the system. See section 3.4 Powering Down.
2. Locate the connector housing a below the Ring’s latch s. See Figure 25.
3. Loosen the thumb-screw on the cable strain relief d and release the cable.
4. Grasp the barrel-ring of the connector f and pull it down to disengage the “fingers” that
secure it.
5. Remove the connector from the socket in the connector housing.
6. Secure the strain relief with the Pendant and cable removed by positioning it to fill the
alignment hole and re-tightening the thumb-screw.
7. Reconnect a Detachable Pendant before restarting the system. See section 13.3.1.

MI-42-0001 Rev. 22 287

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 201

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
Touchscreen
13.5 cm (5.3 in.) x 21.6 cm (8.5 in.)
Storage None
Input Voltage 24 Vdc
Power Consumption 5W

288 MI-42-0001 Rev. 22

 DETACHABLE PENDANT: Technical Description for Detachable Pendants

AIRO Detachable
Pendant Holster
Specifications

Figure 202

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

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

MI-42-0001 Rev. 22 289

DETACHABLE PENDANT: Technical Description for Detachable Pendants

Immunity

IEC 60601 Test Level

Test Electromagnetic Environment - Guidance
and Compliance Level
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
Electrostatic relative humidity should be at least 30%.
discharge +/- 8 kV contact*
(ESD) IEC +/- 15 kV air* * The Detachable Pendant has reduced levels of 
61000-4-2 +/- 4 kV contact and +/- 8 kV for multiple successive
shocks. It passes the higher levels for a single
shock.

13.4.3 Location of Certification and Safety Labels

AIRO Certification NOTE: Systems with Detachable Pendants have labels as shown below.
Labels on Systems
with Detachable
Pendants
j a
s
d
f
g

h
k
l
;
Figure 203

No. Label in Location No. Label in Location

Columnless Warning (only on
a h X-Ray Unit Warning
columnless systems)
Support Contact (between Pendant
s Overbalancing Warning j
Holster and Ring)
d Backing Up System Warning k Laser Warning
System Name Plate with CE, ETL,
f Hand Position Warning l
and WEEE certifications
g Emergency Stop button on Pendant ; Ionizing Radiation Warning

290 MI-42-0001 Rev. 22

 INDEX

INDEX
Numerics Compatible equipment
Brainlab navigation systems ............................................ 258
3D Image Controls ............................................................ 121 Combining ...................................................................... 204
60601-9.2 Hazards Associated with Moving Parts................. 31 Commercially available ................................................... 259
Limits on medical software .............................................. 258
Limits on non-authorized combinations ............................ 258
A Stryker navigation systems.............................................. 259
Compliance
Accessories General electromagnetic immunity ................................... 227
Combining ...................................................................... 204
Standards ....................................................................... 227
List of ............................................................................. 258
Components
Marked and labeled ........................................................ 258 Overview ............................................................................ 8
Overview ........................................................................ 257
Parts lists (available on request) ...................................... 204
Add new phantom ............................................................. 144
System subassemblies ................................................... 206
AIRO Confirm the scan direction ................................................... 93
Medical purpose ................................................................. 5
Connectivity
Technical description ...................................................... 203
DICOM 3.1 ..................................................................... 221
Approved areas for use ..................................................... 217 Ethernet ......................................................................... 221
Areas of high occupancy ..................................................... 20
Contact data ......................................................................... 2
Assessing patient risk .......................................................... 27
Contraindications .................................................................. 5
Authorized EU representative ................................................ 2 Controls .............................................................................. 42
Axial scan described ......................................................... 206
Correcting patient information ............................................ 135
CPR table positions ............................................................. 17
CTDI
B Acronym ........................................................................... 21
See X-ray dose.
Backing up warning ............................................................. 35
Current
Battery charge, minimum for operation ....................... 219, 254
Statement ....................................................................... 218
Beam shape (X-ray) .......................................................... 220
Tube .............................................................................. 220
Before scanning .................................................................. 72
Brakes, system ................................................................... 56
Bypass 2D scan ........................................................ 105, 107
D
Daily inspections ............................................................... 173
C Detachable pendant
Connecting ..................................................................... 285
Cables, power and network ................................................. 44
Connector ___location .......................................................... 284
Calibration
Disconnecting ................................................................. 286
Daily gain calibration ....................................................... 156
Detachable power cable
Instructions (available on request) ................................... 204
Connecting and disconnecting ......................................... 278
Certification labels ............................................................. 237
Overview ........................................................................ 277
Changing patient information ............................................. 135
Securing for transport........................................................ 47
Circuit diagrams (available on request) .............................. 204
Specifications ................................................................. 215
Cleaning ................................................................... 168–171
Deviation from indications (maximum) ................................ 219
Collisions, risks when moving system................................... 32
Device description
Column
General .............................................................................. 4
Available User Manual supplements .................................. 65
Technical........................................................................ 205
Label for updated column .................................................. 66
Diagrams
Minimizing movement ....................................................... 33
Pendant display (detachable) .......................................... 288
Movement overview .......................................................... 32
Pendant display (hardwired) .............................................. 71
Movement variables .......................................................... 33
Sample OR setup ............................................................. 58
Rating plate label ............................................................ 234
System in scan mode .................................................... 9, 70
Specifications ................................................................. 215
System in transport mode ................................................... 8
Types ............................................................................... 65
With dimensions ..................................................... 209–212
Columnless system. See System without column.

MI-42-0001 Rev. 22 291

INDEX

DICOM FDA 21 CRF 1040.10 ....................................................... 227

Conformance statement ................................................... 10 Field of view ....................................................................... 78
Exports .......................................................................... 207 Fire safety
Direction keys (scan mode)................................................. 71 Effective type of fire extinguisher ...................................... 37
Disinfection .............................................................. 168–171 Recommended procedure ................................................ 37
Display. See Pendant. Focal spot size ................................................................. 220
Displayed scan parameters............................................... 111 Footprint
DLP, acronym .................................................................... 21 Diagrams with dimensions ...................................... 210, 212
Documentation Scan mode with column ................................................. 210
Available guides .............................................................. 12 Scan mode without column............................................. 212
Cautions format ................................................................. 3 Transport mode with column .......................................... 210
Intended audience ........................................................... 11 Transport mode without column ...................................... 212
Notes format ...................................................................... 3 FP-1000. See Tube.
Overview ......................................................................... 11 Frequency range .............................................................. 218
Requirements .................................................................. 11 Fuses
Warnings format ................................................................ 3 Required ....................................................................... 225
Dose check report .................................................... 144, 153 Specifications ........................................................ 218, 225
Driving the system .............................................................. 55

G
E Gain calibration .................................................................. 75
Editing patient information ................................................ 135 Gantry. See Ring.
Electrical Gigabit Ethernet ............................................................... 221
Safety warnings and cautions ........................................... 34 Gimbal
Terminal markings ......................................................... 218 Scan mode position ........................................................... 9
Electromagnetic immunity ......................................... 228, 289 Transport mode position ..................................................... 8
Emergency responses
For patient emergencies ................................................... 16
To stop motion. See Emergency Stop.
Emergency scan H
Icon ................................................................................. 80 Hand grips ......................................................................... 42
Performing..................................................................... 133 Hand position warning ........................................................ 56
Emergency Stop Helical scan described ...................................................... 205
Location of button ............................................................ 42 Helical scan pitch ............................................................. 221
Next steps ....................................................................... 16 Holster
Overview ......................................................................... 15 Detachable pendant ....................................................... 289
Releasing patients after.................................................... 16 Hardwired pendant..................................................... 42, 43
Reset .............................................................................. 15 Hospital network................................................................. 85
Symbol .......................................................................... 232 Hospital service ................................................................ 143
Test................................................................................. 75 Hospital worklist ................................................................. 89
With motion emergencies ................................................. 15 Humidity preconditioning. See Environmental requirements.
With patient emergencies ................................................. 16
EMI ................................................................................. 228
End position (scan)........................................................... 108
Environmental requirements I
Humidity preconditioning ................................................ 223 IEC
Least favorable working conditions ................................. 223 60601-1-6 classifications .................................................. 26
Operating ...................................................................... 223 61000 .................................................................... 228, 289
Preconditioning for use .................................................. 223 Performance standards .................................................. 227
Shipping ........................................................................ 223 Image
E-Stop test ......................................................................... 75 Assessing image quality ......................................... 161–167
Ethernet ........................................................................... 221 Changing views ............................................................. 123
EU, authorized representative ............................................... 2 Reconstruction matrix .................................................... 221
Exam region (scan) ............................................................ 98 Reconstruction time ....................................................... 221
Existing patients ................................................................. 85 Slice thickness ............................................................... 221
Existing scan images .......................................................... 80 Imaging performance
Export Mean CT (body) ............................................................. 248
Anonymized data ........................................................... 128 Mean CT (head) ............................................................ 248
Scan data ...................................................................... 127 Modulation transfer function ........................................... 249
To DICOM server........................................................... 128 Noise (body) .................................................................. 248
To USB ......................................................................... 128 Noise (head) .................................................................. 248
Troubleshooting ............................................................. 264 Results for standard kernel (typical) ................................ 249
Slice sensitivity profile .................................................... 250
Tomographic section thickness ....................................... 250
Uniformity (body) ........................................................... 248
F Uniformity (head) ........................................................... 248
FDA 21 CFR 1020.30 ....................................................... 227

292 MI-42-0001 Rev. 22

 INDEX

Implanted medical devices................................................... 28 MCS-1000. See Tube.

Incorrectly entered scan ...................................................... 29 Mechanical motion safety .................................................... 30
Indications for use ................................................................. 4 Medical devices and scanning ............................................. 28
Inspections Medical purpose (system) ...................................................... 5
Daily .............................................................................. 173 Menu
Semi-annual ................................................................... 174 Options in scan mode ....................................................... 80
Installation requirements.................................................... 217 Options in transport mode ................................................. 51
Instructions For Use. See Documentation. Metal objects....................................................................... 78
Intended use ......................................................................... 5 Mobius Imaging, LLC. contact information .............................. 2
Intended users ...................................................................... 5 Motion controls
Ionizing radiation warning .................................................... 20 Scan mode ....................................................................... 71
Transport mode ................................................................ 42

K
Key switch .......................................................................... 43
N
Navigation
Connector port .................................................................. 44
Connector port label........................................................ 235
L Connector port symbol .................................................... 232
Labels Service and calibration ............................................ 143, 154
Backing up warning ........................................................ 236 Systems ..................................................... 85, 91, 258, 259
By ___location (all systems).................................................. 237 Network connection ........................................................... 226
By ___location (systems with detachable pendants)............... 290 Network/data couplings ..................................................... 207
By ___location (systems with hardwired pendants) ................ 237 New patient......................................................................... 85
Certifications .................................................................. 237 New scan............................................................................ 80
Hand position warning..................................................... 236 Non-essential objects .......................................................... 78
High voltage ................................................................... 236
Input panel ..................................................................... 235
Ionizing radiation ............................................................ 235
Laser aperture ................................................................ 233
O
Laser warning ................................................................. 235 Oil coolant. See Tube.
Location of ..................................................................... 237 Operating principle ............................................................ 205
MI-43-0001 system rating plate ....................................... 233 Operating room
MI-43-0129 system rating plate ....................................... 234 Example diagram .............................................................. 58
Overbalancing warning ................................................... 235 Placing AIRO in ................................................................ 58
Protective earth terminal ................................................. 232 Operating table. See Table.
Safety ............................................................................ 237
Support contact .............................................................. 236
WEEE ............................................................................ 233
X-ray tube (oil cooled) ..................................................... 235 P
X-ray tube (water/glycol cooled) ...................................... 235 Parking ............................................................................... 62
X-ray unit warning ........................................................... 234 Patents ............................................................................... 10
Laser safety ........................................................................ 28 Patient
Legal information ................................................................ 10 CPR ................................................................................. 17
Load capacity Distance required to avoid skin burns ................................ 29
Patient weight ..................................................................... 5 Environment dimensions ................................................... 30
Table.................................................................................. 5 Group................................................................................. 5
Location for use .................................................................... 6 Laser safety...................................................................... 28
Logging in ........................................................................... 45 Maximum weight ................................................................. 5
Radiation risk.................................................................... 27
Reducing radiation dose.................................................... 27
Reducing radiation risk ...................................................... 27
M Patient environment
Maintenance Defined ............................................................................ 30
Overview ........................................................................ 141 Dimensions ...................................................................... 30
Preventative ................................................................... 174 Safety .............................................................................. 31
Scans ....................................................... 74, 148, 150, 151 Patient transfer
Maintenance personnel qualifications ................................. 174 For patient emergencies.................................................... 16
Malfunction ......................................................................... 37 For system motion emergencies ........................................ 16
Manual scan Patients
Control ........................................................................... 144 Excluded ............................................................................ 4
Performing ..................................................................... 150 Maximum weight ................................................................. 4
Manufacturer ........................................................................ 2 Pendant
Maximum deviation from indications ................................... 219 Cable strain relief ............................................................ 284
Maximum operating points ................................................. 219 Connecting detachable pendants..................................... 285
Maximum patient weight ........................................................ 5 Detachable ..................................................................... 284

MI-42-0001 Rev. 22 293

INDEX

Disconnecting detachable pendants ............................... 286 Protective clothing ........................................................... 26

Display (detachable) ...................................................... 284 Reducing dose................................................................. 27
Display (hardwired) .......................................................... 42 Reducing patient risk........................................................ 27
Display functions.......................................................... 8, 70 Reducing risk from incorrect scan ..................................... 29
Hardwired ........................................................................ 42 Safety.............................................................................. 20
Holster (detachable) ....................................................... 284 Radiological safeguards ..................................................... 14
Holster (hardwired) .................................................... 42, 43 Reconstruction time (image) ............................................. 221
Location of detachable pendant connector ...................... 284 Regulatory compliances ................................................... 226
Specifications (detachable) ............................................ 288 Replacing parts ................................................................ 225
Specifications (hardwired) .............................................. 213 Requirements
Using cable strain relief .................................................. 286 Documentation ................................................................ 11
Phantom .......................................................................... 178 Environmental................................................................ 223
Phase .............................................................................. 218 Installation ..................................................................... 217
Physical Characteristics .................................................... 208 Qualifications for operators/users ....................................... 5
Place of control (setting for use) ............................................ 6 Training ........................................................................... 11
Power Reset button ...................................................................... 42
Controls..................................................................... 42, 43 Responding to emergencies
Current statement .......................................................... 218 Patient ............................................................................. 16
Effects of battery failure.................................................... 39 System motion ................................................................. 15
Effects of power failure during scan .................................. 38 Restrictions on use (United States) ..................................... 10
Frequency range............................................................ 218 Ring
Functions available during power failure ........................... 38 Rotating and latching ....................................................... 53
Fuses ............................................................................ 218 Scan mode position ........................................................... 9
Interruption ...................................................................... 38 Transport mode position ..................................................... 8
Least favorable input conditions...................................... 218 Unlatching ....................................................................... 52
Maximum line current ..................................................... 218 Ring and base
On and standby key-switch positions ................................ 43 Diagrams with dimensions ...................................... 209, 211
Rated frequency range ................................................... 218 Scan mode with column ................................................. 209
Rated supply voltage...................................................... 218 Scan mode without column............................................. 211
Requirements ................................................................ 218 Transport mode with column .......................................... 209
Restoring a session ......................................................... 39 Transport mode without column ...................................... 211
Source .......................................................................... 218 Ring rotation time
Supply mains isolation ................................................... 218 Axial mode .................................................................... 221
Switch ............................................................................. 43 Helical mode.................................................................. 221
Terminal markings ......................................................... 218 Risk reduction .................................................................... 13
Tube voltage.................................................................. 218
Voltage statement .......................................................... 218
Power cable
Securing for transport....................................................... 47 S
Powering Safety
Down .............................................................................. 64 Backing up warning .......................................................... 35
On ................................................................................... 45 Effective type of fire extinguisher ...................................... 37
Preconditioning. See Environmental requirements. Fire ................................................................................. 37
Preventative maintenance ................................................ 174 Hand position warning ...................................................... 56
Profile of stray radiation ...................................................... 24 Hazard notices................................................................. 15
Protective barriers .............................................................. 26 Labels ........................................................................... 237
Protective clothing and devices ........................................... 26 Laser ............................................................................... 28
Mechanical motion ........................................................... 30
Patient environment ......................................................... 31
Transportation ................................................................. 35
Q Ventilation ....................................................................... 59
Q Guidance with Spine Guidance Software ....................... 259 Warnings and cautions ..................................................... 13
Qualifications Scan
Maintenance personnel .................................................. 174 Button ............................................................................. 42
Users ................................................................................ 5 Changing views for viewing ............................................ 123
Quality check scans Diagnostic viewing limit .................................................. 121
Control .......................................................................... 144 Direction in SAB orientation .............................................. 93
Performing..................................................................... 151 Direction in STB orientation .............................................. 93
Test object and software ................................................ 178 End position................................................................... 108
Exam region .................................................................... 98
Existing images for viewing .............................................. 80
Export ........................................................................... 131
R Export details ................................................................. 132
Radiation Export for assessing image quality .................................. 166
General warning .............................................................. 20 Exporting from image quality studies............................... 185
Patient risk ...................................................................... 27 Field of view .................................................................... 78
Profile of stray ................................................................. 24 Image reconstruction matrix ........................................... 221
Protective barriers ............................................................ 26 Image reconstruction time .............................................. 221

294 MI-42-0001 Rev. 22

 INDEX

In study .......................................................................... 131 Footprint diagrams .................................................. 210, 212

Pitch for helical ............................................................... 221 Fuses ..................................................................... 218, 225
Range of axial ................................................................ 221 Helical scans .................................................................. 221
Range of helical .............................................................. 221 Holster (detachable pendant) .......................................... 289
Recognizing metal artifacts ............................................. 268 Holster (hardwired pendant) ............................................ 214
Reconstruction time ........................................................ 221 Image reconstruction matrix ............................................ 221
Ring rotation time axial mode .......................................... 221 Image reconstruction time ............................................... 221
Ring rotation time helical mode........................................ 221 Maximum operating points .............................................. 219
SAB and STB directions for system without column ............ 93 Operating table ............................................................... 215
Selecting to view ............................................................. 131 Pendant (detachable) ...................................................... 288
Setting slice thickness of view ......................................... 126 Pendant (hardwired) ....................................................... 213
Slice position in............................................................... 126 Performance characteristics ............................................ 221
Slice thickness ................................................................ 221 Power cable (detachable) ................................................ 215
Start position .................................................................. 109 Ring and base diagrams ......................................... 209, 211
Stopping unintended ......................................................... 15 Scanned projection radiography ...................................... 221
Time of axial ................................................................... 221 System with column ................................................ 208–210
Time of helical ................................................................ 221 System without column ................................... 208, 211–212
View details .................................................................... 132 X-ray source assembly .................................................... 220
Window settings for viewing ............................................ 124 Standards, compliance ...................................................... 227
With medical devices ........................................................ 28 Start position (scan) .......................................................... 109
Scan mode Startup sequence ................................................................ 45
Choosing .......................................................................... 73 Stopping system in transport mode ...................................... 56
Diagram of ......................................................................... 9 Storage environmental requirements .................................. 223
Options menu in ............................................................... 80 Strain relief
Scanned Projection Radiography specification ................... 221 For pendant cables ......................................................... 284
Scanning Using on pendant cables ................................................. 286
Axial performance characteristics .................................... 221 Stray radiation
Helical performance characteristics ................................. 221 Horizontal profiles ............................................................. 25
Process .................................................................... 84–129 Technique factors ............................................................. 24
System setup.............................................................. 72–83 Vertical profiles ................................................................. 25
Scans Study
Helical described ............................................................ 205 Selecting to view ............................................................. 131
Sequential axial described............................................... 206 Setting description of ...................................................... 100
Scatter plot ......................................................................... 24 Subassemblies (system) .................................................... 206
Scout scan ........................................................................ 103 Supply mains isolation ....................................................... 218
Semi-annual inspections.................................................... 174 Supply voltage .................................................................. 218
Send data to server ........................................................... 127 Support................................................................................. 2
Separation distances Surgical setup ..................................................................... 58
For non-essential staff....................................................... 26 Symbols
For operator safety ........................................................... 26 On system and labels...................................................... 232
For RF communications equipment ................................. 231 Warnings and cautions in user manual ................................ 3
Series System
Also see Scan. Accessories .................................................................... 257
Diagnostic viewing limit ................................................... 121 Brakes.............................................................................. 56
Export ............................................................................ 131 Cleaning and disinfection ........................................ 168–171
Export details.................................................................. 132 Compatible equipment for use with .................................. 259
Export for assessing image quality .................................. 166 Improper use ...................................................................... 6
Exporting from image quality studies ............................... 185 Logging in ........................................................................ 45
In study .......................................................................... 131 Login security lock ...................................................... 51, 83
Selecting to view ............................................................. 131 Major subassemblies ...................................................... 206
Setting description .......................................................... 100 Medical purpose ................................................................. 5
Setting slice thickness of view ......................................... 126 MI-43-0001 rating plate label ........................................... 233
Slice position in............................................................... 126 MI-43-0129 rating plate label ........................................... 234
View details .................................................................... 132 Performance characteristics ............................................ 221
Viewing .................................................................. 121–127 Responding to motion emergencies ................................... 15
Service functions ......................................................... 80, 142 Responding to patient emergencies ................................... 16
Single shot scan ................................................................ 144 System without column
Skin burns, distance required to avoid .................................. 29 Available ............................................................................ 4
Skip 2D scan ............................................................ 105, 107 Avoiding collisions ............................................................ 32
Slice Compatible patient support................................ 32, 103, 138
Position in series or scan ................................................ 126 Patient environment .......................................................... 30
Setting thickness of view ................................................. 126 Patient position reference point ......................... 27, 103, 138
Thickness (image) .......................................................... 221 Phantom support requirement ......................................... 178
Slice sensitivity ................................................................. 250 Proper placement ............................................................. 31
Specifications Proton therapy .................................................................. 31
Axial scans ..................................................................... 221 SAB and STB scan directions ............................................ 93
Column .......................................................................... 215
Electrical ........................................................................ 218

MI-42-0001 Rev. 22 295

INDEX

T V
Table Ventilation .......................................................................... 59
And column movement. See Column, Movement overview. View station connector port ................................................. 44
Available User Manual supplements ................................. 67 Voltage
Positions for CPR ............................................................ 17 Statement ...................................................................... 218
Specifications ................................................................ 215 Supply line..................................................................... 218
Transferring ..................................................................... 67 Tube ............................................................................. 220
Troubleshooting ..................................................... 275, 276
Table remote
Charger specifications .................................................... 215
Description .................................................................... 207 W
Specifications ................................................................ 215 Warm-up scan.................................................................... 75
Task bar icons.................................................................... 76 Warning, general radiation .................................................. 20
Technical description ........................................................ 203 Water/glycol coolant. See Tube.
Technical support ................................................................. 2 WEEE........................................................................ 10, 176
Technique factors for maximum line current ...................... 218 Welcome screen ................................................................ 79
Tilt Stop Window level image settings ............................................. 124
Location ........................................................................ 170 Working conditions, least favorable ................................... 223
Removing ...................................................................... 170
Tomographic section thickness ......................................... 250
Training
Applications curriculum .................................................... 11 X
Materials ......................................................................... 11 X-ray
Required ......................................................................... 11 Beam shape .................................................................. 220
Requirements .................................................................. 11 Generator assembly specifications ................................. 220
Translate the ring ............................................................... 77 Source assembly specifications ...................................... 220
Transport Specifications ................................................................ 219
Process ..................................................................... 45–64 Tube housing type ......................................................... 220
Troubleshooting ............................................................. 270 Voltage and data values ................................................. 218
Transport mode X-ray dose
Backing up warning.......................................................... 35 Average CTDI ................................................................ 242
Diagram of......................................................................... 8 Body phantom profile ..................................................... 247
Hand position warning ...................................................... 56 Conditions of operation .................................................. 241
Maximum inclines ............................................................ 35 Controls and generators ................................................. 253
Maximum stopping distance ............................................. 36 CTDI 1cm below surface ................................................ 242
Maximum thresholds ........................................................ 35 CTDI around axis of rotation ........................................... 242
Overview ......................................................................... 41 CTDI at other angles ...................................................... 242
Safety.............................................................................. 35 CTDI free-in-air .............................................................. 244
Safety warnings ............................................................... 35 CTDI free-in-air profile .................................................... 245
Transporting equipment ...................................................... 41 CTDI locations ............................................................... 241
Troubleshooting CTDI per condition of operation ...................................... 243
Data will not export ........................................................ 264 CTDI per peak tube potential .......................................... 244
General ......................................................................... 262 Factors affecting ............................................................ 256
Table ..................................................................... 275, 276 Filter properties .............................................................. 255
Transport ....................................................................... 270 Geometric efficiency in Z ................................................ 246
Tube Half-value layers ............................................................ 255
Anode heating and cooling curves (FP-1000) .................. 251 Head phantom profile ..................................................... 246
Anode heating and cooling curves (MCS-1000) ............... 251 IEC 60601 requirements ................................................ 254
Current .......................................................................... 220 Information .................................................................... 241
Dose technical statement (FP-1000) ............................... 250 Managing levels ............................................................. 256
Dose technical statement (MCS-1000) ............................ 250 Maximum deviations ...................................................... 248
Housing heating and cooling curves (FP-1000) ............... 252 Nominal focal spot ......................................................... 254
Housing heating and cooling curves (MCS-1000) ............ 252 Notifications and alerts ..................................................... 21
Label for oil cooled unit .................................................. 235 Profile technique factors ................................................. 245
Label for water/glycol cooled unit .................................... 235 Protection against residual radiation ............................... 255
Oil cooled unit ................................................................ 220 Radiation detector effect ................................................ 254
Type .............................................................................. 220 Reducing risk ................................................................... 27
Voltage .......................................................................... 220 Technique factor definitions ............................................ 254
Water/glycol cooled unit ................................................. 220 Tube anode heating and cooling curves .......................... 251
Tube heat storage charts................................................ 253
Tube housing cooling curves .......................................... 252
Tube housing technical statements ................................. 250
U X-ray tube. See Tube.
USB port ............................................................................ 42
User Manual overview .......................................................... 3

296 MI-42-0001 Rev. 22

 INDEX

Z
Z-axis
And radiation dose reduction ............................................. 27
Continuous motion for helical scans ................................. 205
Illustrated ............................................................... 205, 206
Incremental motion for axial scans ................................... 206
Scan directions ........................................................... 53, 93
Translating along ........................................................ 52, 77
X-ray tube current modulation ................................... 27, 256

MI-42-0001 Rev. 22 297

INDEX

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298 MI-42-0001 Rev. 22