Tabla De Contenido - AMATECH F-80200 Instrucciones De Uso

INSTRUCTIONS FOR USE
Table of Contents
Bariatric Armboard (F-80200)
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: ...................................................................................10
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: ..................................................................................13
Storage, Handling and Removal Instructions: ............................................................13
3.4.1 Storage and Handling: ....................................................................................13
3.4.2 Removal Instruction: .......................................................................................13
Remove Velcro® and patient's arm from the Armboard. ...........................................13
a.
Document Number: D-720576
Version: C
Page 4
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E