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INSTRUCTIONS FOR USE
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PEDIATRIC POWER-LIFT STIRRUPS (PAIR) (BF854)
1
General Information ........................................................................................................... 6
1.1 Copyright Notice:........................................................................................................ 6
1.2 Trademarks: ............................................................................................................... 6
1.3 Contact Details: .......................................................................................................... 7
1.4 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
1.5 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
1.6 EMC considerations: .................................................................................................. 9
1.7 EC authorized representative: .................................................................................... 9
1.8 Manufacturing Information: ........................................................................................10
2
System .............................................................................................................................10
2.1 System components Identification: ............................................................................10
2.2 Product Code and Description:..................................................................................10
2.3 List of Accessories and Consumable Components Table: .........................................11
2.4 Indication for use: ......................................................................................................11
2.5 Intended use: ............................................................................................................11
2.6 Residual risk: ............................................................................................................11
3
Equipment Setup and Use: ...............................................................................................12
3.1 Prior to use: ...............................................................................................................12
3.2 Setup: .......................................................................................................................12
3.3 Device controls and indicators: ..................................................................................14
3.4 Storage, Handling and Removal Instructions: ............................................................14
3.4.1 Storage and Handling: ....................................................................................14
3.4.2 Removal Instruction: .......................................................................................14
3.5 Troubleshooting Guide: .............................................................................................14
Document Number: 80024522
Version: A
Page 4
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E

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