Qualigen FastPack IP System Reference guide

PROCEDURE
MANUAL

65000159 Rev. 008 (06/17) i
Table of Contents
FastSteps................................................................................................................................................................v
FastSteps for Vitamin D......................................................................................................................................vii
Welcome ................................................................................................................................................................ 1
What the FastPack®IP System Does........................................................................................................... 1
About This Manual ....................................................................................................................................... 1
Safety Features ......................................................................................................................................................2
Electrical........................................................................................................................................................2
Nemko Mark Label.............................................................................................................................2
Other Symbols...............................................................................................................................................2
Biomedical Label ................................................................................................................................2
Attention Label ...................................................................................................................................2
CE Mark Label ....................................................................................................................................2
IVD Label ............................................................................................................................................2
Setting Up the FastPack®IP System....................................................................................................................3
What is Included...........................................................................................................................................3
FastPack®IP System Set Up ........................................................................................................................3
Unpacking the FastPack®IP System .................................................................................................3
Getting Power to the FastPack®IP System .......................................................................................4
Turning ON the System Analyzer......................................................................................................4
Set Up Menu .......................................................................................................................................5
Language Units...................................................................................................................................5
Setting Date and Time........................................................................................................................6
Setting Analyzer for External Printer Use ........................................................................................7
Connecting the External Printer....................................................................................................... 8
Calibrating the FastPack®IP System................................................................................................................. 11
When to Calibrate ....................................................................................................................................... 11
What You Need ........................................................................................................................................... 11
Calibration Procedure ................................................................................................................................ 12
FastPack®IP Vitamin D Users ONLY! –Sample Pretreatment .................................................... 14
A Word about Calibration...................................................................................................................................19
Purpose........................................................................................................................................................19
General Procedure ......................................................................................................................................19
Preparing a FastPack®IP with a Calibrator Sample ......................................................................19
Preparing to Calibrate your Analyzer.............................................................................................. 19
Running the Calibrator FastPack®IP ............................................................................................. 19
When is Calibration Required?..................................................................................................................19
1. When Attempting to Use New Lots of FastPacks or Calibrators.........................................19
2. When it’s Time to Recalibrate ...............................................................................................19
FastPack®IP System Analyzer Calibration Process Tree ........................................................................ 20
Control Testing.................................................................................................................................................... 21
When to Control Test .................................................................................................................................21
What You Need ........................................................................................................................................... 21
Control Testing Procedure ........................................................................................................................ 22
FastPack®IP Vitamin D Users ONLY! –Sample Pretreatment ................................................... 23

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

65000159 Rev. 008 (06/17) iii
Warranty (For U.S. Only) ...........................................................................................................................73
Support / Services / Supplies.....................................................................................................................73
Manufactured By: .......................................................................................................................................74
Notes:...................................................................................................................................................................75

iv 65000159 Rev. 008 (06/17)

65000159 Rev. 008 (06/17) v
FastSteps

vi 65000159 Rev. 008 (06/17)

65000159 Rev. 008 (06/17) vii
FastSteps for Vitamin D

viii 65000159 Rev. 008 (06/17)