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)

65000159 Rev. 008 (06/17) 1
Welcome
The FastPack®IP System provides lab-quality immunoassay performance in a design ideal for the
physician’s office or small laboratory. The small system utilizes advanced technology to provide an
immediate result, yet it is very simple to use.
The FastPack®IP System includes the FastPack®IP Analyzer and External Printer. The FastPack®IP
System requires a disposable single-use FastPack®IP for each test. The operator simply loads the sample
into the FastPack®IP, places the FastPack®IP in the Analyzer, and presses the start button. When the test
is complete, the Analyzer displays the result.
The FastPack®IP System is for in vitro diagnostic use only.
This manual contains all of the information needed to operate and care for the FastPack®IP System.
Please read this entire manual before you begin operation.
For information on the performance of FastPack®IP tests, please refer to the current direction insert
posted on the Qualigen, Inc. website at www.qualigeninc.com.
If you have questions or concerns about the FastPack®IP System, please contact your local distributor or
call Qualigen, Inc. Toll Free: 1-877-770-6127.
What the FastPack®IP System Does
The FastPack®IP System performs immunoassays on serum and plasma samples. Refer to the Principle of
Operation for a detailed description.
Immunoassay tests help physicians diagnose and monitor a range of disease states.
About This Manual
Action
Instrument
Information
Illustration
This column represents
your action.
This column shows what
the analyzer displays.
This column provides
additional information
about the action.
Press the BLUE button.
“Ready”
This is the “Ready Mode”
of the instrument, i.e., the
analyzer is ready to
perform a test.

265000159 Rev. 008 (06/17)
Safety Features
Electrical
The FastPack® IP Analyzer must be connected to a properly grounded outlet.
Nemko Mark Label
The application of the Nemko mark denotes that the FastPack®IP System meets
all requirements for electrical safety and is approved for use in the field.
Other Symbols
All symbols discussed on this page can be found on the inside door plate of the FastPack®IP Analyzer.
Biomedical Label
This symbol indicates the area in the analyzer that may contain potentially
infectious human serum or blood products. Healthcare personnel should always
wear disposable gloves when handling blood products. Adhere to state and
federal infection control guidelines. All blood specimens should be handled at the
Biosafety Level 2 as recommended for any potentially infectious material in the
Centers for Disease Control/National Institutes of Health manual, “Biosafety in
Microbiological and Biomedical Laboratories,” 1988.
Attention Label
Attention: Important information that must be read is located both in the
Procedure Manual as well as in the directional inserts for all assays performed on
the FastPack®IP System.
CE Mark Label
This label signifies that the FastPack®
IP System conforms with all applicable health, safety and environmental
protection standards of the European Union.
IVD Label
The FastPack®IP System is an In vitro diagnostic medical device.

65000159 Rev. 008 (06/17) 3
Setting Up the FastPack®IP System
What is Included
1. FastPack®IP Analyzer
2. External Printer
3. AC Power Cords (2)
4. Desktop Power Supply (2)
5. Procedure Manual
QA Manual (US Only)
QA Log (US Only)
FastPack®IP System Set Up
Unpacking the FastPack®IP System
Action
Instrument
Information
Illustration
Remove all components of
the FastPack®IP System
from their boxes.
Keep shipping boxes and
internal packaging in case
units have to be returned.
Place analyzer on
countertop.
Analyzer is designed to be
set on a table top.
①
②
③
④
⑤

465000159 Rev. 008 (06/17)
FastPack®IP System Set Up
Getting Power to the FastPack®IP System
Action
Instrument
Information
Illustration
Plug Desktop Power Supply
into the analyzer.
Plug AC Power Cord into
Desktop Power Supply.
Turning ON the System Analyzer
Plug AC Power Cord into
the wall socket.
Turn analyzer on using
power button located on
back of unit.
Attention: Leave analyzer
on at all times.
Power Supply operates
with input voltage of 100
240±10% VAC and 50/60
Hz.
“Software vX.X”
The analyzer will beep
once and display the
internal software version
for 5 seconds. Analyzer will
now perform a self-
diagnostic check and it will
not function until
operating temperature is
reached. It takes 40- 60
minutes to reach operating
temperature. During this
time the display will show
two sets of temperature
readings. The analyzer will
beep twice and display
“Ready” when operating
temperature is reached.
“Ready”
“6/21/15”
Ready
6/21/15

65000159 Rev. 008 (06/17) 5
FastPack®IP System Set Up
Set Up Menu
Action
Instrument
Information
Illustration
Enter the Set Up Menu for
the analyzer by pressing
the RED button.
This mode is not accessible
when a test is in progress.
Language Units
Scroll to “Languages Units”
by pressing the RED
button.
“Languages
Units”
Press the BLUE button to
select the “Languages
Units” menu category.
Scroll through the
language options by
repeatedly pressing the
RED button.
English 1
English 2
Espanol
Portugues
Italiano
Deutsch
Francais
Nederlands
Swedish
The analyzer allows the
selection from nine
languages and units:
English 1
English 2
Spanish
Portuguese
Italian
German
French
Dutch
Swedish

665000159 Rev. 008 (06/17)
FastPack IP System Set Up
Action
Instrument
Information
Illustration
Select your language by
pressing the BLUE button.
Testosterone units will
display as “ng/dL” when
English 1 is selected.
Setting Date and Time
Scroll to “Date/Time” by
pressing the RED button.
“Date/Time”
Press the BLUE button to
select “Date/Time” menu
category.
If date is correct, press the
BLUE button to accept this
date.
“mm/dd/yy”
The analyzer has an
internal clock that allows it
to print the date for each
test result. To maintain
optimum quality control, it
is important this is set
correctly.

65000159 Rev. 008 (06/17) 7
FastPack IP System Set Up
Action
Instrument
Information
Illustration
If date is incorrect, press
RED button to change this
date.
Scroll to the correct date
and time digit with the RED
button.
“mm/dd/yy
hh:mm *M”
If English 2 or a European
language has been chosen,
date is in Day/Month/Year
format and time is in 24
hour format. If English 1 is
chosen, date is in
Month/Day/Year format
and time is in 12 hour
format.
See Troubleshooting if a
date or time error occurs.
or
Approve each date/time
digit and move ahead to
the next digit by pressing
the BLUE button.
“dd/mm/yy
hh:mm”
Setting Analyzer for External Printer Use
Scroll to “Set to Printer” by
pressing the RED button on
the analyzer.
“Set to Printer”
If the display shows “Set to
Computer” the system is
already configured for an
external printer. Selecting
this choice will change it to
be configured for output to
an external computer.

865000159 Rev. 008 (06/17)
FastPack®IP System Set Up
Action
Instrument
Information
Illustration
Press the BLUE button to
select the “Set to Printer”
menu option.
“Set to Printer”
Scroll to “Exit” by pressing
the RED button.
“Exit”
Select “EXIT” by pressing
the BLUE button.
Connecting the External Printer
Further instruction and
illustration can be found in
the External Printer User’s
Manual.
Serial
Interface
Cable

65000159 Rev. 008 (06/17) 9
FastPack®IP System Set Up
Action
Instrument
Information
Illustration
Connect the large end of
the Serial Printer Cable to
the rear of the external
printer with a screwdriver,
or tighten screws by hand.
Analyzer should be turned
on and in “Ready” position.
Connect the other end of
the Serial Printer Cable to
the analyzer at the port
labeled COM1.
Plug the Desktop Power
Supply into the back of the
External Printer.
Plug the AC Power Cord
into the Desktop Power
Supply.
Plug the AC Power Cord
into the wall socket.
External Printer operates
with input voltage of 100
240±10% VAC and 50/60
Hz.
Press the Printer’s ON
switch located on the left
side.

10 65000159 Rev. 008 (06/17)
FastPack®IP System Set Up
Action
Instrument
Information
Illustration
Remove the printer cover.
Unwrap and insert the
printer ribbon cartridge
into the printer.
Follow all instructions
found in the printer
manual.
You are now ready to
calibrate the analyzer! You
can only run a FastPack®IP
on the analyzer if it has
been calibrated for that
test.