Table Des Matières - Hillrom A-93005 Manuel D'instructions

INSTRUCTIONS FOR USE
Table of Contents
Allen ® Traction Boot Systems (A-93005, A-93006, A-93007)
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 Australian sponsor Information: .............................................................................. 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: ............................................................................................... 13
3.1 Prior to use: ................................................................................................................ 13
3.2 Setup: ......................................................................................................................... 17
3.3 Device controls and indicators: ............................................................................. 21
3.4 Storage, Handling and Removal Instructions: ...................................................... 22
Document Number: 80028199
Version: B
Page 4
Issue Date: 31 MAR 2020
Ref Blank Template: 80025117 Ver. F