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INSTRUCTIONS FOR USE
Table of Contents
Levitator III w/pad (F-LHLEV3)
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: ..................................................................................................... 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: .................................................................................................... 9
EC authorized representative: ................................................................................... 9
Manufacturing Information: ..................................................................................... 10
2
System ................................................................................................................................. 10
System components Identification: ......................................................................... 10
Product Code and Description:............................................................................... 10
List of Accessories and Consumable Components Table:................................... 11
Indication for use: ...................................................................................................... 11
Intended use: .............................................................................................................. 11
Residual risk: ................................................................................................................ 11
3
Equipment Setup and Use: ............................................................................................... 12
Prior to use: .................................................................................................................. 12
Setup: ........................................................................................................................... 12
Device controls and indicators: ............................................................................... 14
Storage, Handling and Removal Instructions: ........................................................ 15
3.4.1 Storage and Handling: ................................................................................... 15
3.4.2 Removal Instruction: ........................................................................................ 15
Document Number: 80028207
Version: A
Page 4
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E
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