Operation Manual

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© Prognosys Medical Systems Private Limited│ X-Ray Products
Table of Content
Chapter 1 Introduction .......................................................................................................................... 6
1.1 Product Introduction ........................................................................................................... 7
1.2 Product Series ..................................................................................................................... 7
1.3 Product Intended Use ......................................................................................................... 7
1.4 Product Significant Performance Characteristics ............................................................... 8
1.5 Product Intended Patient Population................................................................................. 9
1.6 Product Intended Part of the body or type of tissue applied to or interacted with ........ 9
1.7 Product Intended user profile ............................................................................................ 9
1.8 Product Intended conditions of use ................................................................................. 10
1.9 Product Features ............................................................................................................... 11
1.10 Clinical Guide ..................................................................................................................... 11
Chapter 2 Safety and Regulatory ........................................................................................................ 12
2.1 Compliance Standards and Classification ............................................................................. 12
2.1.1 Compliance Standards ............................................................................................... 12
2.1.2 Classification ............................................................................................................... 13
2.2 Contraindications .................................................................................................................. 13
2.3 Power Supply Hazard ............................................................................................................ 13
2.4 Electric Shock Hazard ............................................................................................................ 14
2.5 Abnormalities Hazard ............................................................................................................ 16
2.6 Installation Precautions ........................................................................................................ 16
2.7 Connection Instructions ........................................................................................................ 18
2.8 External Network Connection ............................................................................................... 18
2.9 System Isolation Instructions ................................................................................................ 19
2.10 Software Precautions .......................................................................................................... 20
2.11 Disinfection Instructions ..................................................................................................... 20
2.12 Charging the Battery Pack ................................................................................................... 21
2.13 Battery Pack Instructions .................................................................................................... 22
2.14 Warnings for Pediatric Use.................................................................................................. 27
2.15 Other Precautions ............................................................................................................... 28
2.16 Disposal of Waste ................................................................................................................ 30
2.17 Product Labels ..................................................................................................................... 30
2.17.1 Identification Label .................................................................................................. 31
2.17.2 Battery Polarity Label ............................................................................................... 32
2.17.3 Battery Label ............................................................................................................ 33
2.17.4 Packing Carton Label ................................................................................................ 33
2.17.5 Adapter Specification Label ..................................................................................... 34