Hillrom Ultrafins Stirrups O-UFAS Instrucciones De Uso página 4

INSTRUCTIONS FOR USE
Table of Contents
Ultrafins® Stirrups (O-UFAS)
1 General Information: ........................................................................................................... 6
1.1 Copyright Notice: ........................................................................................................ 6
1.2 Trademarks: ................................................................................................................... 6
1.3 Contact Details: ........................................................................................................... 6
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
1.9 EU Importer Information: ........................................................................................... 10
1.10 Authorised Australian sponsor: ................................................................................. 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 Clinical Benefits: ......................................................................................................... 13
2.4.1 Indication for use: ............................................................................................ 13
2.4.2 Intended use: ................................................................................................... 13
2.5 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: ............................................................................... 16
Document Number: 80024545
Version D
Page 4
Issue Date: 06 MAR 2020
Ref Blank Template: Ver. F