Qualigen FastPack IP System Referenzhandbuch

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