Hillrom A-20500 Instructions D'utilisation page 4

INSTRUCTIONS FOR USE
Table of Contents
Arm Traction Device (A-20500)
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: ........................................... 10
1.6 EMC considerations: .................................................................................................. 10
1.7 EC authorized representative: .................................................................................. 10
1.8 Manufacturing Information: ...................................................................................... 10
1.9 EU Importer Information: ............................................................................................ 10
1.10 Authorised Australian sponsor: .................................................................................. 10
2 System ............................................................................................................................ 11
2.1 System components Identification: ......................................................................... 11
2.2 Product Code and Description: ............................................................................... 12
2.3 List of Accessories and Consumable Components Table: ................................... 12
2.4 Indication for use: ....................................................................................................... 13
2.5 Intended use: .............................................................................................................. 13
2.6 Residual Risk:................................................................................................................ 13
3 Equipment Setup and Use: ............................................................................................ 14
3.1 Prior to use: .................................................................................................................. 14
3.2 Setup: ........................................................................................................................... 14
3.3 Device controls and indicators: ............................................................................... 16
3.4 Storage, Handling and Removal Instructions: ........................................................ 16
Document Number: 80028152
Version D
Page 4
Issue Date: 27 MAR 2020
Ref Blank Template: 80025117 Ver. F