Tabla De Contenido - AMATECH F-ABSL Manual Del Usuario

INSTRUCTIONS FOR USE
Table of Contents
Easy Armboard (I-ABSLFH)
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: ...................................................................................10
1.8 Manufacturing Information: ........................................................................................10
2 System ............................................................................................................................ 10
2.1 System components Identification: ............................................................................10
2.2 List of Accessories and Consumable Components Table: .........................................11
2.3 Indication for use: ......................................................................................................11
2.4 Intended use: ............................................................................................................11
2.5 Residual risk: ............................................................................................................11
3 Equipment Setup and Use: ........................................................................................... 11
3.1 Prior to use: ...............................................................................................................11
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
3.5 Troubleshooting Guide: .............................................................................................13
3.6 Device Maintenance: .................................................................................................13
Document Number: 80028226
Version: B
Page 4
Issue Date: 17 MAR 2020
Ref Blank Template: 80025118 Ver. E