User Manual
3
© InnoCare Optoelectronics Corporaon │ X-Ray Products
Table of Content
Chapter 1 Introduction ............................................................................................. 6
1.1 Product Introduction ............................................................................ 7
1.2 Product Series ....................................................................................... 7
1.3 Product Indications for Use ............................................................... 7
1.4 Product Significant Performance Characteristics ....................... 7
1.5 Product Intended Patient Population .............................................. 8
1.6 Product Intended Part of the body or type of tissue applied to
or interacted with .............................................................................................. 8
1.7 Product Intended user profile ............................................................ 9
1.8 Product Intended conditions of use ................................................ 9
1.9 Product Features ................................................................................. 10
1.10 Clinical Guide ....................................................................................... 10
Chapter 2 Safety and Regulatory ........................................................................ 11
2.1 Compliance Standards and Classification ........................................ 11
2.1.1 Compliance Standards ................................................................ 11
2.1.2 Classification.................................................................................. 12
2.2 Contraindications ..................................................................................... 12
2.3 Power Supply Hazard .............................................................................. 12
2.4 Electric Shock Hazard ............................................................................. 12
2.5 Abnormalities Hazard .............................................................................. 14
2.6 Installation Precautions .......................................................................... 14
2.7 Connection Instructions ......................................................................... 15
2.8 External Network Connection ............................................................... 15
2.9 System Isolation Instructions ............................................................... 16
2.10 Software Precautions ............................................................................ 17
2.11 Disinfection Instructions ...................................................................... 17
2.12 Charging the Battery Pack ................................................................... 18
2.13 Battery Pack Instructions .................................................................... 19
2.14 Warnings for Pediatric Use.................................................................. 22
2.15 Other Precautions .................................................................................. 23
2.16 Disposal of Waste .................................................................................. 24
2.17 Product Labels ........................................................................................ 24
2.17.1 Identification Label ..................................................................... 25
2.17.2 Battery Polarity Label ................................................................ 26
2.17.3 Battery Label ................................................................................ 27
2.17.4 Packing Carton Label ................................................................ 27