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INSTRUCTIONS FOR USE
Table of Contents
Allen
®
Flex Frame System (A-70100)
1
General Information: .................................................................................................... 7
1.1 Copyright Notice: .................................................................................................. 7
1.2 Trademarks:............................................................................................................ 7
1.3 Contact Details:..................................................................................................... 8
1.4 Safety Considerations:........................................................................................... 8
1.4.1 Safety hazard symbol notice:...................................................................... 8
1.4.2 Equipment misuse notice: ........................................................................... 8
1.4.3 Notice to users and/or patients:.................................................................. 8
1.4.4 Safe disposal: ............................................................................................... 9
1.5 Operating the system: ........................................................................................... 9
1.5.1 Applicable Symbols: .................................................................................... 9
1.5.2 Intended User and Patient Population: .................................................... 10
1.5.3 Compliance with medical device regulations: ........................................ 11
1.6 EMC considerations: ............................................................................................ 11
1.7 EC authorized representative: ............................................................................ 11
1.8 Manufacturing Information: ................................................................................ 11
1.9 EU Importer Information:...................................................................................... 11
1.10Authorised Australian sponsor: ............................................................................ 11
2
System ......................................................................................................................... 12
2.1 System components Identification: .................................................................... 12
2.2 Product Code and Description:.......................................................................... 14
2.3 List of Accessories and Consumable Components Table: ................................ 15
2.4 Indication for use: ................................................................................................ 16
2.5 Intended use: ....................................................................................................... 16
2.6 Residual Risk: ........................................................................................................ 16
3
Equipment Setup and Use:......................................................................................... 17
3.1 Prior to use:........................................................................................................... 17
3.2 Setup: ................................................................................................................... 18
3.3 Device controls and indicators: .......................................................................... 22
Document Number: 80028177
Version E
Page 5
Issue Date: 26 MAR 2020
Ref Blank Template: 80025117 Ver. F
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