Hillrom A-90001 Instrucciones De Uso página 4

INSTRUCTIONS FOR USE
Table of Contents
Allen® Counter Traction Brace (90001)
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: ............................................................................... 11
2.3 List of Accessories and Consumable Components Table: ................................... 11
2.4 Indication for use: ....................................................................................................... 12
2.5 Intended use: .............................................................................................................. 12
3. Equipment Setup and Use: ............................................................................................... 12
3.1 Prior to use: .................................................................................................................. 12
3.2 Setup: ........................................................................................................................... 12
3.3 Device controls and indicators: ............................................................................... 12
3.4 Storage, Handling and Removal Instructions: ........................................................ 13
3.4.1 Storage and Handling: .................................................................................... 13
Document Number: 80028153
Version C
Page 4
Issue Date: 30 MAR 2020
Ref Blank Template: 80025117 Ver. F