Tabla De Contenido - Hillrom Allen Instrucciones De Uso

INSTRUCTIONS FOR USE
Table of Contents
Allen ® Traction Boot (A-93000)
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
2.6 Residual Risk: ............................................................................................................... 12
3 Equipment Setup and Use: ............................................................................................... 12
3.1 Prior to use: .................................................................................................................. 12
3.2 Setup: ........................................................................................................................... 13
3.3 Device controls and indicators: ............................................................................... 16
3.4 Storage, Handling and Removal Instructions: ........................................................ 16
Document Number: 80028186
Web Ver D
Page 4
Issue Date: 31 MAR 2020
Ref Blank Template: 80025117 Ver. F