Table of Contents
Introduction ................................................................................i
Section A
System Components
Assure
®
Prism multi Blood Glucose Meter
..........................................1
Meter Display Screen
......................................................................2
Assure
®
Prism multi Blood Glucose Test Strips
...................................3
Assure
®
Prism Control Solution
......................................................... 4
MeterSpecications
.......................................................................4
Section B Meter Operation and Set-up
Meter Set-up
..................................................................................5
Performing a Blood Glucose Test
......................................................7
Performing a Control Solution Test
...................................................9
Meter Memory
............................................................................. 12
Inserting or Replacing the Batteries
................................................ 13
Cleaning and Disinfecting the Meter
............................................... 14
Troubleshooting
............................................................................ 16
Assure
®
Prism multi Blood Glucose Test Strips Package Insert
........... 18
Assure
®
Prism Control Solution Package Insert
................................. 19
Section C Regulatory Review and Guidelines for QA/QC Protocols
Regulatory Review and Guidelines for QA/QC Protocols
................... 21
Accuracy and Precision Studies
......................................................22
Alternative Site Testing Evaluation
..................................................23
Section D Addendums
Product Ordering .................................................................................. 25
Warranty
..................................................................................... 25
Section E In-service Training
In-service Guide
........................................................................... 27
Competency Checklist
...................................................................28
Self-test
....................................................................................... 29
Nurse In-service Training Record
.................................................... 32
CertiedInstructorTrainingRecord
................................................33
Section F Quality Assurance/Quality Control Recording Forms
Meter Tracking Record
..................................................................34
Quality Control Record
..................................................................35
Field Inspection Report
.................................................................36