User's Manual
Table Of Contents
- Instruction
- Product
- System Configuration
- Installation
- Setting
- Calibration
- Diagnosis, Inspection and Maintenance
- Troubleshooting
- Regulatory Information
- Medical Equipment Safety Standards
- Radio Frequency Compliance Information
- Labels and Symbols
- Guidance and Manufacturer’s Declaration for EMC
- Electromagnetic Emissions
- Electromagnetic Immunity
- Electrostatic Discharge (ESD) IEC 61000-4-2
- Electrical Fast Transient/Burst IEC 61000-4-4
- Surge IEC 61000-4-5
- Voltage Dips, Short Interruptions/Voltage Variations on Power Supply Input Lines IEC 61000-4-11
- Power Frequency (50/60 ㎐) Magnetic Field IEC 61000-4-8
- Conducted RF IEC 61000-4-6 / Radiated RF IEC 61000-4-3
- Information

Rev.1.0
Page 6 of 151 VW40-152-009
VIVIX-S 1012N User Manual
7.2.1 Daily Inspection ......................................................................................................................................................... 120
7.2.2 Performance Inspection ......................................................................................................................................... 120
7.3 Cleaning and Disinfection ................................................................................................................. 124
7.4 Product Initialization .......................................................................................................................... 125
7.4.1 SCU Initialization ....................................................................................................................................................... 125
7.4.2 Detector Initialization .............................................................................................................................................. 126
7.4.3 Wireless Initialization of Detector ..................................................................................................................... 127
7.5 Replacing the Fuse of SCU (SCU Basic only) ................................................................................. 128
8. Troubleshooting ........................................................................................................................... 129
8.1 Trobleshooting ..................................................................................................................................... 130
8.1.1 Failed to Turn the Detector On .......................................................................................................................... 130
8.1.2 The Power Switch of SCU or Status LED is not worked ......................................................................... 130
8.1.3 Communication Test is failed .............................................................................................................................. 131
8.1.4 The Active LED and Data LED of the Detector are blinking ................................................................ 131
8.1.5 Errors in Detector LED ............................................................................................................................................ 132
8.1.6 Rapid Consumption of Battery ........................................................................................................................... 132
8.1.7 Battery Pack or Installation Part of Battery is Getting Hot ................................................................... 132
9. Regulatory Information .............................................................................................................. 133
9.1 Medical Equipment Safety Standards ............................................................................................. 134
9.1.1 Medical Equipment Classification ..................................................................................................................... 134
9.1.2 Product Safety Standard ........................................................................................................................................ 134
9.2 Radio Frequency Compliance Information ..................................................................................... 136
9.2.1 FCC Compliance ........................................................................................................................................................ 136
9.2.2 FCC SAR ........................................................................................................................................................................ 137
9.2.3 CE R&TTE SAR............................................................................................................................................................ 137
9.3 Labels and Symbols ............................................................................................................................ 138
9
.3.1 Label ............................................................................................................................................................................... 138
9.3.2 Product Serial Number........................................................................................................................................... 143
9.3.3 Product Symbols ....................................................................................................................................................... 144
9.4 Guidance and Manufacturer’s Declaration for EMC ..................................................................... 145
9.4.1 Electromagnetic Emissions ................................................................................................................................... 145
9.4.2 Electromagnetic Immunity .................................................................................................................................... 145
10. Information ................................................................................................................................ 148
10.1 Service Information ........................................................................................................................ 149
10.1.1 Product Lifetime ........................................................................................................................................................ 149
10.1.2 Regular Inspection and Maintenance ............................................................................................................. 149