User's Manual Part 1

Rev.1.5 Page 6 of 121 D-16-207
VIVIX-S 1417N User Manual
7. Regulatory Information ................................................................................................................ 99
7.1 Medical Equipment Safety Standards ............................................................................................. 100
7.1.1 Medical Equipment Classification ..................................................................................................................... 100
7.1.2 Product Safety Standard ........................................................................................................................................ 100
7.2 Radio Frequency Compliance Information ..................................................................................... 102
7.2.1 FCC Compliance ........................................................................................................................................................ 102
7.2.2 FCC SAR ........................................................................................................................................................................ 103
7.2.3 CE R&TTE SAR............................................................................................................................................................ 103
7.3 Labels and Symbols ............................................................................................................................ 105
7.3.1 Label................................................................................................................................................................................ 105
7.3.2 Product Serial Number........................................................................................................................................... 112
7.3.3 Product Symbols ....................................................................................................................................................... 113
7.4 Guidance and Manufacturer’s Declaration for EMC ..................................................................... 115
7.4.1 Electromagnetic Emissions ................................................................................................................................... 115
7.4.2 Electromagnetic Immunity .................................................................................................................................... 115
8. Information ................................................................................................................................... 118
8.1 Service Information ............................................................................................................................ 119
8.1.1 Product Lifetime ........................................................................................................................................................ 119
8.1.2 Regular Inspection and Maintenance.............................................................................................................. 119
8.1.3 Repair ............................................................................................................................................................................. 119
8.1.4 Replacement Parts Support ................................................................................................................................. 119
8.1.5 Consumables............................................................................................................................................................... 119
8.2 Warranty ............................................................................................................................................... 120
8.3 Revision History .................................................................................................................................. 121