Thales Pixium - Default Chapter; Table of Contents

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January 2024
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PIXIUM STATIC X-Ray Flat Panel Detectors - End User Manual
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Table Of Contents
1. Document History ................................................................................................................................ 4
2. Disclaimer............................................................................................................................................. 5
3. Symbols ................................................................................................................................................ 6
3.1.End User Symbols Definition............................................................................................................................ 6
3.2.Products Symbols definition ............................................................................................................................. 7
3.3.Labels And Packaging Symbols Definition....................................................................................................... 7
4. Glossary.............................................................................................................................................. 12
5. Device Information............................................................................................................................. 13
5.1.Product Scope................................................................................................................................................ 13
5.1.1.Medical Devices ..................................................................................................................................... 13
5.1.2.Accessories............................................................................................................................................ 13
5.1.3.Compatibility Matrix................................................................................................................................ 13
5.2.Medical Devices Applications......................................................................................................................... 13
5.3.IT networks characteristics............................................................................................................................. 14
5.3.1.PC HOST characteristics ....................................................................................................................... 14
5.4.IT Security ...................................................................................................................................................... 14
5.5.Product Legal Manufacturer and Manufacturing Site..................................................................................... 14
5.6.Intended User................................................................................................................................................. 14
5.7.Intended Purpose (For EU Countries Only) / Indication For Use (USA only)................................................. 15
5.8.Indications ...................................................................................................................................................... 15
5.9.Intended Patient Population ........................................................................................................................... 15
5.10.Contraindications.......................................................................................................................................... 15
5.11.Limitations .................................................................................................................................................... 15
5.12.Adverse effects / Undesirable side-effects ................................................................................................... 15
5.13.Acclimatization Time .................................................................................................................................... 15
5.13.1.Pixium Portable detector ......................................................................................................................16
5.14.Main Physical Characteristics ...................................................................................................................... 16
5.14.1.PIXIUM PORTABLE EZ-C HD Series.................................................................................................. 16
6. Safety And Precautions..................................................................................................................... 17
6.1.General Precautions....................................................................................................................................... 17
6.1.1.PIXIUM PORTABLE all series................................................................................................................ 17
6.2.Shocks............................................................................................................................................................ 18
6.2.1.PIXIUM PORTABLE EZ-C HD Series.................................................................................................... 18
6.3.Radio Frequency Protection........................................................................................................................... 19
6.4.Electro magnetic Compatibility (EMC) Compliance........................................................................................ 19
6.5.Applied Parts .................................................................................................................................................. 19
6.5.1.PIXIUM PORTABLE all SERIES............................................................................................................ 19
6.6.Biocompatibility .............................................................................................................................................. 19
6.6.1.PIXIUM PORTABLE all SERIES............................................................................................................ 19
6.7.Sterile ............................................................................................................................................................. 20
6.8.Pacemaker ..................................................................................................................................................... 20
6.8.1.PIXIUM PORTABLE EZ-C HD SERIES................................................................................................. 20
6.9.Degree Of Safety (Flammable Anesthetic Mixture)........................................................................................ 20
6.10.Disposal........................................................................................................................................................ 21