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Contents

Page iv

Contents

Chapter1. Introduction and Safety ...................................................................... 1-1

1.1. Overview .................................................................................................................................................................... 1-2

1.2. Owner Responsibilities ........................................................................................................................................ 1-2

1.2.1. System Compatibility ................................................................................................................................ 1-2

1.2.2. Operator Qualifications ........................................................................................................................... 1-2

1.2.3. Continued Compliance ............................................................................................................................ 1-2

1.2.4. Unauthorized Modifications .................................................................................................................. 1-3

1.3. Manufacturer's Responsibilities ...................................................................................................................... 1-4

1.3.1. X-Ray Equipment Certification ............................................................................................................. 1-4

1.3.2. After-sale Operating and Safety Practices..................................................................................... 1-4

1.3.3. Essential Performance ............................................................................................................................. 1-4

1.4. Communication Center Telephone Numbers .......................................................................................... 1-4

1.5. Safety Hazards ........................................................................................................................................................ 1-5

1.5.1. Safety Hazard Alerts ................................................................................................................................. 1-5

1.5.2. Explosion ......................................................................................................................................................... 1-5

1.5.3. Equipment Stability and Positioning ................................................................................................. 1-6

1.5.4. Motorized Mechanical Movement ...................................................................................................... 1-6

1.5.5. Improperly Attached Equipment ......................................................................................................... 1-6

1.5.6. Electrical Fire ................................................................................................................................................. 1-7

1.5.7. Ground Fault ................................................................................................................................................. 1-7

1.5.8. Improper Access ......................................................................................................................................... 1-7

1.6. Radiation Exposure ............................................................................................................................................... 1-8

1.6.1. General Protection ..................................................................................................................................... 1-8

1.6.2. Source-to-Skin Distance ......................................................................................................................... 1-8

1.6.3. Dose to Patient ............................................................................................................................................ 1-9

1.7. Ingress of Fluids .................................................................................................................................................... 1-16

1.8. Cooling Efficiency ................................................................................................................................................ 1-16

1.9. Burns .......................................................................................................................................................................... 1-16

1.10. Electromagnetic Compatibility Statement .............................................................................................. 1-17

1.11. Equipment Malfunction .................................................................................................................................... 1-24

1.12. Mains Isolation ...................................................................................................................................................... 1-24