Tabla De Contenido - AMATECH F-LHPAOPT Instrucciones De Uso

INSTRUCTIONS FOR USE
Table of Contents
OPT PA LEG HOLDERS (F-LHPAOPT)
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: ................................................................................................................ 12
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: ........................................................ 15
3.4.1 Storage and Handling: ................................................................................... 15
3.4.2 Removal Instruction: ........................................................................................ 15
Document Number: D-720209
Version: C
Page 4
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E