User's Manual

Contents
8 iRay Technology Co., Ltd..
4.8 List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-NETWORK ........ 50
5. OPERATION ........................................................................................................................... 51
5.1 Main Operation ...................................................................................................................... 52
5.1.1 Steps for acquiring image ......................................................................................... 53
5.1.2 Software Mode ............................................................................................................ 54
5.1.3 After Use ................................................................................................................ 57
5.2 Correction and Calibration Template Generation.................................................................. 58
5.2.1 Pre-offset Template Generation ................................................................................. 58
5.2.2 Gain Calibration Template Generation ....................................................................... 58
5.2.3 Defect Correction Template Generation ..................................................................... 59
5.3 Local Image Check ............................................................................................................... 59
5.4 Firmware Upgrade ................................................................................................................. 61
6. REGULATORY INFORMATION ............................................................................................. 63
6.1 Medical equipment safety standards ..................................................................................... 64
6.2 Guidance and manufacture’s declaration for EMC .......................................................... 66
6.2.1 EMI Compliance Table ............................................................................................... 66
6.2.2 EMS Compliance Table .............................................................................................. 66
6.3 Radio Frequency Compliance Information ............................................................................ 69
6.3.1 FCC Compliance ................................................................................................... 69
6.4 Battery Safety Standards ...................................................................................................... 70
7. TROUBLE SHOOTING ........................................................................................................... 71
8. SERVICE INFORMATION ...................................................................................................... 73
8.1 Service Office Info ................................................................................................................. 74
8.2 Product Lifetime .................................................................................................................... 74
8.3 Regular Inspection and Maintenance .................................................................................... 74
8.4 Repair .................................................................................................................................... 74
8.5 Replacement Parts Support .................................................................................................. 75
9. APPENDIX .............................................................................................................................. 76
9.1 Appendix A Information of Manufactures .............................................................................. 77
9.2 Appendix B Information of Medical Device Directive European Representative .................. 77