TRUEresult
®
Quality Assurance / Quality Control Manual
4
Table of Contents
Safety Notice...........................................................................................................................................1-2
Introduction ...............................................................................................................................................3
Table of Contents ......................................................................................................................................4
Section 1: Using TRUEresult
®
in a Clinical Setting
Critical Safety Information/Important Information/Limitations/Expected Results ....................6-8
Regulatory Requirements - CLIA...................................................................................................9
Proficiency Testing Information ...................................................................................................10
Meter Specifications .....................................................................................................................11
Material Safety Data Sheets (MSDS)......................................................................................12-17
Section 2: Description of System
Meter........................................................................................................................................19-20
TRUEtest™ Test Strips ...........................................................................................................20-21
TRUEtest Glucose Control Solution.............................................................................................22
Section 3: Quality Control Testing
Automatic Self-Test ......................................................................................................................24
Control Test...................................................................................................................................24
How to Perform a Control Test ...............................................................................................25-26
Section 4: Blood Glucose Testing
Sample Information .................................................................................................................28-29
Obtaining a Blood Sample ............................................................................................................29
Tips for Fingertip Sampling....................................................................................................29
Tips for Forearm Sampling ...............................................................................................29-30
How to Perform a Blood Test..................................................................................................30-31
System Out of Range Warning Messages ....................................................................................31
Section 5: Set Up of Time, Date, Ketone Alert and Testing Reminders
Time/Date......................................................................................................................................33
Ketone Alert..................................................................................................................................34
Testing Reminders ...................................................................................................................34-35
Exit Set Up ....................................................................................................................................35
Section 6: Memory
Memory, Viewing Averages, Viewing Memory.....................................................................37-38
Section 7: Care and Storage of System
System (Meter and Test Strips) ....................................................................................................40
Meter .............................................................................................................................................40
TRUEtest Test Strips ....................................................................................................................40
TRUEtest Glucose Control Solution.............................................................................................40
Battery Replacement .....................................................................................................................41
Section 8: Troubleshooting
Display Messages..........................................................................................................................43
Display Messages..........................................................................................................................44
Section 9: Training Certification Program
Certificate Information ............................................................................................................46-47
Training Checklist ...................................................................................................................48-49
Training Written Test ..............................................................................................................50-54
Training Certificate (example)......................................................................................................55
Section 10: Forms
Quality Control Log.................................................................................................................57-58
At-Risk Patient Identification Notice ...........................................................................................59
Section 11: TRUEresult Lifetime Warranty
TRUEresult Lifetime Warranty ....................................................................................................61
Section 12: References
References .....................................................................................................................................63
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