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
Summary of Contents for True Metrix Pro
Page 3: ...Introduction...
Page 9: ...System Components...
Page 16: ...Clinical Information...
Page 21: ...Meter Setup Quality Control Testing...
Page 29: ...Blood Glucose Testing...
Page 32: ...Diabetes Data Management Capabilities...
Page 37: ...System Maintenance...
Page 43: ...Training Program...
Page 53: ...References...
Page 55: ...Appendix A Clinical Studies Note Available for download at www niprodiagnostics com...
Page 57: ...Appendix C Safety Data Sheets...
Page 60: ...Appendix D Forms...
