Tabla De Contenido - Hillrom Ultrafins Stirrups O-UFAS Instrucciones De Uso

INSTRUCTIONS FOR USE
Table of Contents
Ultrafins® Stirrups (O-UFAS)
1 General Information: ........................................................................................................... 7
1.1 Copyright Notice: ........................................................................................................ 7
1.2 Trademarks: ................................................................................................................... 7
1.3 Contact Details: ........................................................................................................... 7
1.4 Safety Considerations: ................................................................................................. 8
1.4.1 Safety hazard symbol notice: .......................................................................... 8
1.4.2 Equipment misuse notice: ................................................................................ 8
1.4.3 Notice to users and/or patients: ...................................................................... 8
1.4.4 Safe disposal: ..................................................................................................... 8
1.5 Operating the system: ................................................................................................. 9
1.5.1 Applicable Symbols:.......................................................................................... 9
1.5.2 Intended User and Patient Population: ........................................................ 10
1.5.3 Compliance with medical device regulations: .......................................... 10
1.6 EMC considerations: .................................................................................................. 11
1.7 EC authorized representative: ................................................................................. 11
1.8 Manufacturing Information: ..................................................................................... 11
1.9 EU Importer Information: ........................................................................................... 11
1.10 Australian sponsor Information: ................................................................................ 11
2 System ................................................................................................................................. 12
2.1 System components Identification: ......................................................................... 12
2.2 Product Code and Description:............................................................................... 12
2.3 List of Accessories and Consumable Components Table:................................... 13
2.4 Clinical Benefits: ......................................................................................................... 13
2.4.1 Indication for use: ............................................................................................ 13
2.4.2 Intended use: ................................................................................................... 14
2.5 Residual Risk: ............................................................................................................... 14
3 Equipment Setup and Use: ............................................................................................... 14
3.1 Prior to use: .................................................................................................................. 14
3.2 Setup: ........................................................................................................................... 14
3.3 Device controls and indicators: ............................................................................... 17
Document Number: 80028130
Version: B
Page 5
Issue Date: 06 MAR 2020
Ref Blank Template: Ver. F