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INSTRUCTIONS FOR USE
Table of Contents
Allen
®
C-Flex Polar Head Positioner (A-70701)
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: .......................................... 9
1.6 EMC considerations: ............................................................................................ 10
1.7 EC authorized representative: ............................................................................ 10
1.8 Manufacturing Information: ................................................................................ 10
1.9 EU Importer Information:...................................................................................... 10
1.10Authorised Australian sponsor: ............................................................................ 10
2
System ......................................................................................................................... 11
2.1 System components Identification: .................................................................... 11
2.2 Product Code and Description:.......................................................................... 15
2.3 List of Accessories and Consumable Components Table: ................................ 15
2.3.1 Indication for use: ...................................................................................... 16
2.3.2 Intended use: ............................................................................................. 16
2.4 Residual Risk: ........................................................................................................ 16
3
Equipment Setup and Use:......................................................................................... 16
3.1 Prior to use:........................................................................................................... 16
3.2 Setup: ................................................................................................................... 17
3.3 Device controls and indicators: .......................................................................... 33
Document Number: 80028169
Version C
Page 4
Issue Date: 26 MAR 2020
Ref Blank Template: 80025117 Ver. F
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