Qualigen FastPack IP System - Page 4

ii 65000159 Rev. 008 (06/17)
Sample Dilution - hCG ....................................................................................................................................... 29
When to Dilute a Test Sample ................................................................................................................... 29
What You Need .......................................................................................................................................... 29
Diluting a Sample ....................................................................................................................................... 30
Setting Dilution Mode ................................................................................................................................ 31
Dilution Mode ................................................................................................................................... 31
Enable Dilution Mode - hCG ................................................................................................................... 31
Disable Dilution Mode - hCG ................................................................................................................. 32
Testing with the FastPack
®
IP System in Dilution Mode .............................................................. 33
Testing a Neat Sample in Dilution Mode ............................................................................................... 33
Testing an hCG 1/100 Diluted Sample in Dilution Mode ..................................................................... 34
Testing an hCG 1/10000 Diluted Sample in Dilution Mode ................................................................ 35
WHO International Standard ............................................................................................................................ 37
WHO International Unit Mode ................................................................................................................. 37
Enable WHO Unit Mode – Total PSA ............................................................................................ 37
Disable WHO Unit Mode – Total PSA ........................................................................................... 38
Sample Collection and Delivery into the FastPack
®
IP .................................................................................... 39
What You Need .......................................................................................................................................... 39
Sample Collection and Delivery ................................................................................................................ 40
Sample Collection and Delivery into the FastPack
®
IP (Vitamin D Testing Only) ........................................ 43
What You Need .......................................................................................................................................... 43
Sample Collection and Delivery – Vitamin D Only .................................................................................. 44
Running Patient Samples ................................................................................................................................... 47
When to Run a FastPack
®
IP..................................................................................................................... 47
What You Need .......................................................................................................................................... 47
FastPack
®
IP System Procedure ............................................................................................................... 48
Cleaning the FastPack
®
IP System .................................................................................................................... 55
FastPack
®
IP System Cleaning Procedure ................................................................................................ 55
Troubleshooting ..................................................................................................................................................57
Troubleshooting the FastPack
®
IP System Analyzer ................................................................................57
Analyzer Software Upgrade ............................................................................................................................... 62
Analyzer Software Upgrade Using Smart Media Card ............................................................................. 63
Analyzer Software Upgrade Using USB .................................................................................................... 65
Calibration Reset ................................................................................................................................................ 67
Calibration Reset Procedure...................................................................................................................... 67
Downloading Data ..................................................................................................................................... 69
FastPack
®
IP System Product Specifications ............................................................................................ 71
Storage Conditions ..................................................................................................................................... 72
Statement of Compliance .......................................................................................................................... 72
Disposal ...................................................................................................................................................... 72
Principle of Operation ............................................................................................................................... 72
Limitation of Procedure ............................................................................................................................. 73