User's Manual

User Manual
Manual No. AMSL/DMR/UM/FD 009
Rev. 00 Effective Date 12.07.2022 Page | 4
Contents
1. Manual Revision History ............................................................................................................... 7
2. Introduction .................................................................................................................................. 8
2.1 Product Introduction .......................................................................................................... 9
2.2 Product Series ..................................................................................................................... 9
2.3 Product Intended Use ......................................................................................................... 9
2.4 Product Significant Performance Characteristics ............................................................. 10
2.5 Product Intended Patient Population ............................................................................... 10
2.6 Product Intended Part of the body or type of tissue applied to or interacted with ........ 11
2.7 Product Intended user profile ........................................................................................... 11
2.8 Product Intended conditions of use ................................................................................. 11
2.9 Product Features ............................................................................................................... 12
2.10 Clinical Guide .................................................................................................................... 12
3. Safety and Regulatory ................................................................................................................. 13
3.1 Compliance Standards and Classification ......................................................................... 13
3.1.1. Compliance Standards ........................................................................................... 13
3.1.2. Classification .......................................................................................................... 14
3.2 Power Supply Hazard ........................................................................................................ 15
3.3 Electric Shock Hazard ........................................................................................................ 15
3.4 Abnormalities Hazard ....................................................................................................... 17
3.5 Installation Precautions .................................................................................................... 17
3.6 Connection Instructions .................................................................................................... 18
3.7 External Network Connection ........................................................................................... 19
3.8 System Isolation Instructions ............................................................................................ 19
3.9 Software Precautions ........................................................................................................ 20
3.10 Disinfection Instructions ................................................................................................... 20
3.11 Charging the Battery Pack ................................................................................................. 21
3.12 Battery Pack Instructions .................................................................................................. 22
3.13 Warnings for Pediatric Use ............................................................................................... 27
3.14 Other Precautions ............................................................................................................. 27
3.15 Disposal of Waste ............................................................................................................. 29
3.16 Product Labels................................................................................................................... 30
3.16.1. Identification Label ................................................................................................ 30
3.16.2. Battery Polarity Label ............................................................................................ 31
3.16.3. Battery Label .......................................................................................................... 31
3.16.4. Packing Carton Label ............................................................................................. 31
3.16.5. Adapter Specification Label ................................................................................... 32