Hillrom A-30450-C Mode D'emploi page 5

INSTRUCTIONS FOR USE
Table of Contents
Carbon Lights Minor Procedures Table and Rectangular Table (A-30450-C, A-30410-C)
1. General Information: ........................................................................................................... 7
1.1 Copyright Notice: ....................................................................................................... 7
1.2 Trademarks: ................................................................................................................. 7
1.3 Contact Details: ......................................................................................................... 8
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: ...................................................................................................... 9
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: ................................. 12
2.4 Indication for use: ..................................................................................................... 13
2.5 Intended use: ............................................................................................................ 13
2.6 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: ............................................................................. 14
3.4 Storage, Handling and Removal Instructions: ...................................................... 14
Document Number: 80028143
Version D
Page 5
Issue Date: 26 MAR 2020
Ref Blank Template: 80025117 Ver. F