Tabla De Contenido - Hillrom Yellofin Elite Stirrup Instrucciones De Uso

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INSTRUCTIONS FOR USE
Table of Contents
Yellofin
Stirrups (O-YFASI, O-YFSI, O-YFES, O-YFESP)
®
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: ........................................................................................................... 8
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
EMC considerations: .................................................................................................. 10
EC authorized representative: ................................................................................. 10
Manufacturing Information: ..................................................................................... 10
EU Importer Information: ........................................................................................... 10
Australian sponsor Information: ................................................................................ 10
2
System ................................................................................................................................. 11
System components Identification: ......................................................................... 11
Product Code and Description:............................................................................... 11
List of Accessories and Consumable Components Table:................................... 12
Indication for use: ...................................................................................................... 13
Intended use: .............................................................................................................. 13
Residual Risk: ............................................................................................................... 13
3
Equipment Setup and Use: ............................................................................................... 14
Prior to use: .................................................................................................................. 14
Setup: ........................................................................................................................... 14
Device controls and indicators: ............................................................................... 17
Storage, Handling and Removal Instructions: ........................................................ 18
Document Number: D-720402
Version: D
Page 4
Issue Date: 18 MAR 2020
Ref Blank Template: 80025117 Ver. F

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