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INSTRUCTIONS FOR USE
Table of Contents
Wrist Arthroscopy Tower System (R-734-10)
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: ...................................................................................................... 8
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: ........................................... 10
EMC considerations: .................................................................................................. 10
EC authorized representative: .................................................................................. 10
Manufacturing Information: ...................................................................................... 10
EU Importer Information: ............................................................................................ 10
Authorised Australian sponsor:.................................................................................. 10
2
System .................................................................................................................................. 11
System components Identification: ......................................................................... 11
Product Code and Description: ............................................................................... 11
List of Accessories and Consumable Components Table: ................................... 11
Indication for use: ....................................................................................................... 12
Intended use: .............................................................................................................. 13
Residual Risk: ............................................................................................................... 13
3
Equipment Setup and Use: ............................................................................................... 13
Prior to use: .................................................................................................................. 13
Setup: ........................................................................................................................... 13
Device controls and indicators: ............................................................................... 18
Storage, Handling and Removal Instructions: ........................................................ 18
Document Number: 80028155
Version D
Page 4
Issue Date: 27 MAR 2020
Ref Blank Template: 80025117 Ver. F.
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