Hillrom A-20750 Instructions D'utilisation page 4

INSTRUCTIONS FOR USE
Table of Contents
Schlein Hand Positioner (A-20750)
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: ............................................................................. 13
List of Accessories and Consumable Components Table: ................................. 13
Indication for use: ..................................................................................................... 14
Intended use: ............................................................................................................ 14
3 Equipment Setup and Use: ............................................................................................... 14
Prior to use: ................................................................................................................ 14
Setup: ......................................................................................................................... 14
Device controls and indicators: ............................................................................. 15
Storage, Handling and Removal Instructions: ...................................................... 15
3.4.1 Storage and Handling: .................................................................................... 15
Document Number: 80028196
Version C
Page 4
Issue Date: 27 MAR 2020
Ref Blank Template: 80025117 Ver. F