Table of Contents
1.0 General Warnings, Training and Safety Notices ā Read This First ................................. 1
1.1 Important Safety Conventions ................................................................................................................. 1
1.2 Symbol Definitions ................................................................................................................................... 6
1.3 Shipping, Unpacking, and Warranty Information ..................................................................................... 8
2.0 Product Description/Features/Intended Use ............................................................... 9
2.1 Product Description ................................................................................................................................. 9
2.2 Product Features .................................................................................................................................... 10
2.3 Intended Use .......................................................................................................................................... 14
3.0 Technical Specifications ............................................................................................ 15
3.1 NanoScope System ................................................................................................................................. 15
3.2 Ambient Conditions for Operation ......................................................................................................... 16
3.3 Ambient Conditions for Storage (in shipping packaging) ........................................................................ 16
3.4 NanoScope Handpiece ........................................................................................................................... 17
3.5 Safety, EMC, and Regulatory Requirements ........................................................................................... 18
4.0 Setup & Use ............................................................................................................. 20
4.1 Set up the NanoScope Console (Non-Sterile) .......................................................................................... 20
4.2 Prepare the NanoScope Handpiece Kit (Sterile) ..................................................................................... 22
4.3 Performing a NanoScope Procedure ...................................................................................................... 23
4.4 Ending a NanoScope Procedure ............................................................................................................. 25
5.0 Cleaning and Disinfecting ......................................................................................... 26
5.1 NanoScope Console................................................................................................................................ 26
6.0 Sterilization .............................................................................................................. 27
6.1 Transmissible Spongiform Encephalopathy Agents ................................................................................ 27
7.0 Maintenance ............................................................................................................ 28
7.1 Periodic Maintenance ............................................................................................................................ 28
7.2 Service Manual ...................................................................................................................................... 28
7.3 Annual Calibration ................................................................................................................................. 28
8.0 Technical Support ..................................................................................................... 29
9.0 Troubleshooting ....................................................................................................... 30
10.0 Repair Policy ............................................................................................................ 32
11.0 End of Life, Environmental Directives........................................................................ 33
12.0 Electromagnetic Emissions ....................................................................................... 34