Tabla De Contenido - AMATECH F-UPBLC Manual Del Usuario

INSTRUCTIONS FOR USE
Table of Contents
Universal Patient Braces (F-UPBLC, F-UPBLR, F-UPBL3S)
General Information ........................................................................................................... 6
1.1 Copyright Notice:........................................................................................................ 6
1.2 Trademarks: ............................................................................................................... 6
1.3 Contact Details: .......................................................................................................... 7
1.4 Safety Considerations: ............................................................................................... 7
1.4.1 Safety hazard symbol notice: ........................................................................... 7
1.4.2 Equipment misuse notice: ................................................................................ 7
1.4.3 Notice to users and/or patients: ........................................................................ 7
1.4.4 Safe disposal: .................................................................................................. 7
1.5 Operating the system: ................................................................................................ 8
1.5.1 Applicable Symbols: ......................................................................................... 8
1.5.2 Intended User and Patient Population: ............................................................. 9
1.5.3 Compliance with medical device regulations: ................................................... 9
1.6 EMC considerations: .................................................................................................10
1.7 EC authorized representative: ...................................................................................10
1.8 Manufacturing Information: ........................................................................................10
System .............................................................................................................................11
2.1 System components Identification: ............................................................................11
2.2 Product Code and Description:..................................................................................11
2.3 List of Accessories and Consumable Components Table: .........................................11
2.4 Indication for use: ......................................................................................................12
2.5 Intended use: ............................................................................................................12
2.6 Residual risk: ............................................................................................................12
Equipment Setup and Use: ...............................................................................................12
3.1 Prior to use: ...............................................................................................................12
3.2 Setup: .......................................................................................................................12
3.3 Device controls and indicators: ..................................................................................13
3.4 Storage, Handling and Removal Instructions: ............................................................13
3.4.1 Storage and Handling: ....................................................................................13
3.4.2 Removal Instruction: .......................................................................................13
3.5 Troubleshooting Guide: .............................................................................................13
Document Number: 80028299
Version: B
Page 4
Issue Date: 27 MAR 2020
Ref Blank Template: 80025118 Ver. E