Table Des Matières - Hillrom The Twister Instructions D'utilisation

INSTRUCTIONS FOR USE
Table of Contents
The Twister (O-LHPCCA)
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:................................... 11
Clinical Benefits: ......................................................................................................... 12
2.4.1 Indication for use: ............................................................................................ 12
2.4.2 Intended use: ................................................................................................... 12
Residual Risk: ............................................................................................................... 12
3 Equipment Setup and Use: ............................................................................................... 13
Prior to use: .................................................................................................................. 13
Setup: ........................................................................................................................... 13
Device controls and indicators: ............................................................................... 16
Document Number: 80028135
Version: C
Page 4
Issue Date: 06 MAR 2020
Ref Blank Template: 80025117 Ver. F