Table Des Matières - AMATECH F-70100 Instructions D'utilisation

INSTRUCTIONS FOR USE
Table of Contents
Spine System (F-70100)
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:..................................................................................11
List of Accessories and Consumable Components Table: .........................................12
Indication for use: ......................................................................................................14
Intended use: ............................................................................................................14
Residual risk: ............................................................................................................14
3 Equipment Setup and Use: ............................................................................................... 15
Prior to use: ...............................................................................................................15
Setup: .......................................................................................................................16
Device controls and indicators: ..................................................................................20
Storage, Handling and Removal Instructions: ............................................................26
3.4.1 Storage and Handling: ....................................................................................26
3.4.2 Removal Instruction: .......................................................................................27
Troubleshooting Guide: .............................................................................................29
Document Number: 80028211
Version: A
Page 4
Issue Date: 25 MAR 2020
Ref Blank Template: 80025118 Ver. E