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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