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INSTRUCTIONS FOR USE
Table of Contents
Hip Distractin System (AR-6529S)
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: .................................................................................................. 8
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: .... Error! Bookmark not defined.
1.6 EMC considerations: .................................................................................................. 9
1.7 EC authorized representative: .................................................................................... 9
1.8 Manufacturing Information: ........................................................................................10
2
System .............................................................................................................................11
2.1 System components Identification: ............................................................................11
2.2 Product Code and Description:..................................................................................13
2.3 List of Accessories and Consumable Components Table: .........................................13
2.4 Indication for use: ......................................................................................................14
2.5 Intended use: ............................................................................................................14
2.6 Residual risk: ............................................................................................................14
3
Equipment Setup and Use: ...............................................................................................15
3.1 Prior to use: ...............................................................................................................15
3.2 Setup: .......................................................................................................................15
3.3 Device controls and indicators: ..................................................................................26
3.4 Storage, Handling and Removal Instructions: ............................................................27
3.4.1 Storage and Handling: ....................................................................................27
3.4.2 Removal Instruction: .......................................................................................28
3.5 Troubleshooting Guide: .............................................................................................29
Document Number: 80028286
Version: C
Page 4
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E
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