TRUE METRIX
®
PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Table of Contents
Table of Contents
Introduction ........................................ 1-5
• Introduction
• Intended Use Statement
• Safety
• System Specifications
• CLIA Requirements
System Components ..........................6-11
• System Components
• Meter Key Features
• Meter Design
• Meter Display Screen
• Test Strip Design
• Control Solution
Clinical Information .........................12-15
• Performance Characteristics
• Limitations of Use
• Interference Testing
Meter Setup &
Quality Control Testing ....................16-22
• Meter Setup
• Quality Control Testing
• Quality Control Testing Data Form
Blood Glucose Testing .....................23-24
• Blood Glucose Testing
Diabetes Data Management
Capabilities ......................................25-28
• Memory
• Diabetes Management Software
System Maintenance ........................ 29-33
• Troubleshooting
• Troubleshooting Display Messages
• Battery Replacement
• Cleaning and Disinfection
• System Storage
Training Program ............................. 34-42
• Training Program
• Training Checklist
• Training Post Test
References ............................................43
Appendix
• Appendix A – Clinical Studies
• Appendix B – Product Labeling
• Appendix C – Safety Data Sheets
• Appendix D – Forms
• Appendix E – Proficiency Testing Information