AMATECH F-90001 Instrucciones De Uso página 4

INSTRUCTIONS FOR USE
Table of Contents
Lateral Brace (F-90001)
1 General Information ........................................................................................................... 6
Copyright Notice:........................................................................................................ 6
Trademarks: ............................................................................................................... 6
Contact Details: .......................................................................................................... 7
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
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
EMC considerations: .................................................................................................. 9
EC authorized representative: .................................................................................... 9
Manufacturing Information: ........................................................................................10
2 System .............................................................................................................................10
System components Identification: ............................................................................10
Product Code and Description:..................................................................................10
List of Accessories and Consumable Components Table: .........................................10
Indication for use: ......................................................................................................11
Intended use: ............................................................................................................11
3 Equipment Setup and Use: ...............................................................................................11
Prior to use: ...............................................................................................................11
Setup: .......................................................................................................................11
Device controls and indicators: ..................................................................................12
Storage, Handling and Removal Instructions: ............................................................12
3.4.1 Storage and Handling: ....................................................................................12
3.4.2 Removal Instruction: .......................................................................................12
Troubleshooting Guide: .............................................................................................12
Device Maintenance: .................................................................................................12
Document Number: 80028247
Version: B
Page 4
Issue Date: 30 MAR 2020
Ref Blank Template: 80025118 Ver. E