DX-D 100 Mobile X-ray Unit
User Manual
0188K EN 20201116 i
TABLE OF CONTENTS
Section Page
1 INTRODUCTION 1.........................................................
1.1 General Features 4...................................................
1.2 Product Identification 5................................................
1.3 Indications for Use 6..................................................
1.3.1 Intended Use 6................................................
1.3.2 Normal Use 6.................................................
1.3.3 Contraindications 6............................................
2 SAFETY AND REGULATORY INFORMATION 7..............................
2.1 General 7...........................................................
2.2 Responsibilities 10.....................................................
2.3 Maximum Permissible Dose (MPD) 11...................................
2.4 Radiation Protection 12.................................................
2.5 Monitoring of Personnel 14.............................................
2.6 Safety Symbols 15.....................................................
2.7 Regulatory Information 20..............................................
2.7.1 Certifications 20................................................
2.7.2 Environmental Statement on the Life Cycle of the Equipment
or System 20...................................................
2.7.3 Mode of Operation 20...........................................
2.7.4 Protection against Electric Shock Hazards 21.......................
2.7.5 Protection against Harmful Ingress of Water or Particulate Matter 21...
2.7.6 Protection against Hazards of Ignition of Flammable
Anaesthetic Mixtures 21.........................................
2.7.7 Protection against Hazards from Unwanted or Excessive Radiation 21.
2.7.8 Designated Significant Zones of Occupancy 22.....................
2.7.9 Distribution of Stray Radiation 24.................................
2.8 Electromagnetic Compatibility (EMC) 27..................................
2.9 Quantitative Information 35.............................................
2.9.1 Functional Tests Performed to Obtain the Quantitative Information 35..
2.10 Deterministic Effects 37................................................
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