Tabla De Contenido - AMATECH F-KCP Instrucciones De Uso

INSTRUCTIONS FOR USE
Table of Contents
Knee Crutch (F-KCP)
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: ................................................................................................................ 7
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: .................................................... 9
1.6 EMC considerations: .................................................................................................... 9
1.7 EC authorized representative: ................................................................................... 9
1.8 Manufacturing Information: ..................................................................................... 10
2 System ................................................................................................................................. 10
2.1 System components Identification: ......................................................................... 10
2.2 Product Code and Description:............................................................................... 10
2.3 List of Accessories and Consumable Components Table:................................... 11
2.4 Indication for use: ...................................................................................................... 11
2.5 Intended use: .............................................................................................................. 11
2.6 Residual risk: ................................................................................................................ 11
3 Equipment Setup and Use: ............................................................................................... 12
3.1 Prior to use: .................................................................................................................. 12
3.2 Setup: ........................................................................................................................... 12
3.3 Device controls and indicators: ............................................................................... 13
3.4 Storage, Handling and Removal Instructions: ........................................................ 13
3.4.1 Storage and Handling: ............................................................................................. 13
3.4.2 Removal Instruction: .................................................................................................. 13
Document Number: 80028231
Version: B
Page 4
Issue Date: 19 MAR 2020
Ref Blank Template: 80025118 Ver. E