INSTRUCTIONS FOR USE
Document Number: 80028171 Page 4 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
Table of Contents
Allen®AP- Vantage Table Adaptor (A-70115)
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
Australian sponsor Information:................................................................................ 10
2System ................................................................................................................................. 11
System components Identification:......................................................................... 11
Product Code and Description:............................................................................... 11
List of Accessories and Consumable Components Table:................................... 11
Indication for use: ...................................................................................................... 12
Intended use:.............................................................................................................. 12
3Equipment Setup and Use:............................................................................................... 12
Prior to use:.................................................................................................................. 12
Setup:........................................................................................................................... 12
Device controls and indicators:............................................................................... 15
Storage, Handling and Removal Instructions:........................................................ 15
3.4.1 Storage and Handling: ................................................................................... 15