Table Des Matières - AMATECH F-LHLEV3M Instructions D'utilisation

INSTRUCTIONS FOR USE
Table of Contents
Mizuho Levitator Stirrup (F-LHLEV3M)
1. General Information ........................................................................................................... 6
Copyright Notice:........................................................................................................ 6
Trademarks: ............................................................................................................... 6
Contact Details: .......................................................................................................... 7
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
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
EMC considerations: .................................................................................................. 9
EC authorized representative: ...................................................................................10
Manufacturing Information: ........................................................................................10
2 System .............................................................................................................................10
System components Identification: ............................................................................10
Product Code and Description:..................................................................................11
List of Accessories and Consumable Components Table: .........................................11
Indication for use: ......................................................................................................11
Intended use: ............................................................................................................12
Residual risk: ............................................................................................................12
3 Equipment Setup and Use: ...............................................................................................12
Prior to use: ...............................................................................................................12
Setup: .......................................................................................................................12
Device controls and indicators: ..................................................................................14
Storage, Handling and Removal Instructions: ............................................................15
3.4.1 Storage and Handling: ....................................................................................15
3.4.2 Removal Instruction: .......................................................................................15
Document Number: 80024541
Version: B
Page 4
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E