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INSTRUCTIONS FOR USE
Table of Contents
Radiolucent Spine Surgery Frame (F-70801)
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: ......................................................................................... 9
2
System ................................................................................................................................. 10
System components Identification: ............................................................................10
Product Code and Description:..................................................................................10
List of Accessories and Consumable Components Table: .........................................11
Indication for use: ......................................................................................................11
Intended use: ............................................................................................................11
Residual risk: ............................................................................................................11
3
Equipment Setup and Use: ............................................................................................... 12
Prior to use: ...............................................................................................................12
Setup: .......................................................................................................................12
Device controls and indicators: ..................................................................................13
Storage, Handling and Removal Instructions: ............................................................18
3.4.1 Storage and Handling: ....................................................................................18
3.4.2 Removal Instruction: .......................................................................................18
Troubleshooting Guide: .............................................................................................18
Document Number: 80028263
Version: B
All manuals and user guides at all-guides.com
Page 4
Issue Date: 25 MAR 2020
Ref Blank Template: 80025118 Ver. E
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