Inhaltsverzeichnis - AMATECH F-10001-F Bedienungsanleitung

INSTRUCTIONS FOR USE
Table of Contents
Basic Stirrup (F-10001-F)
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: .................................................................................................10
1.7 EC authorized representative: ...................................................................................10
1.8 Manufacturing Information: ........................................................................................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: .........................................12
2.4 Indication for use: ......................................................................................................12
2.5 Intended use: ............................................................................................................12
2.6 Residual risk: ............................................................................................................13
3 Equipment Setup and Use: ...............................................................................................13
3.1 Prior to use: ...............................................................................................................13
3.2 Setup: .......................................................................................................................13
3.3 Device controls and indicators: ..................................................................................14
3.4 Storage, Handling and Removal Instructions: ............................................................14
3.4.1 Storage and Handling: ....................................................................................14
3.4.2 Removal Instruction: .......................................................................................14
3.5 Troubleshooting Guide: .............................................................................................14
Document Number: 80028249
Version: B
Page 4
Issue Date: 20 MAR 2020
Ref Blank Template: 80025118 Ver. E