Tabla De Contenido - AMATECH F-70801 Instrucciones De Uso

INSTRUCTIONS FOR USE
Table of Contents
Radiolucent Spine Surgery Frame (F-70801)
1 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: .............................................................................................. 9
1.7 EC authorized representative: .............................................................................. 9
1.8 Manufacturing Information: .................................................................................. 9
2 System ......................................................................................................................... 10
2.1 System components Identification: .................................................................... 10
2.2 Product Code and Description:.......................................................................... 10
2.3 List of Accessories and Consumable Components Table: ................................ 11
2.4 Indication for use: ................................................................................................ 11
2.5 Intended use: ....................................................................................................... 11
2.6 Residual risk: ......................................................................................................... 11
3 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: .................................................... 18
3.4.1 Storage and Handling: .............................................................................. 18
3.4.2 Removal Instruction: .................................................................................. 18
Document Number: D-720640
Version: D
Page 4
Issue Date: 16 AUG 2021
Ref Blank Template: 80025118 Ver. E