Tabla De Contenido - Hillrom O-FAS Manual Del Usuario

INSTRUCTIONS FOR USE
Table of Contents
Allen Flexible Anesthesia Screen (O-FAS)
®
1 General Information: ....................................................................................................... 6
Copyright Notice: ......................................................................................................... 6
Trademarks: ................................................................................................................... 6
Contact Details: ............................................................................................................ 6
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: .................................................................................................. 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: ................................... 11
Indication for use: ....................................................................................................... 12
Intended use: .............................................................................................................. 12
3 Equipment Setup and Use: ............................................................................................ 12
Prior to use: .................................................................................................................. 12
Setup: ........................................................................................................................... 12
Device controls and indicators: ............................................................................... 12
Storage, Handling and Removal Instructions: ........................................................ 13
Document Number: D-720088
Version: C
Page 4
Issue Date: 27 MAR 2020
Ref Blank Template: 80025117 Ver. F