QwikCheck Gold User manual

QwikCheck™ Sperm Quality Analyzer User Guide Version 1.00 I-Button WHO 5th _06_AUG_2012
1
QwikCheck™
S p e r m Q u a l i t y A n a l y z e r
U S E R G U I D E
W H O 5 t h V e r s i o n
V e r s i o n 1 . 0 0 I - B u t t o n
Catalog # F-A-00767-00
A U G U S T 6 , 201 2

QwikCheck™ Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012
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Table of
Contents
SECTION 1: System Overview
Front Panel 4
Key Pad Navigation 4
Measurement Capillary 4
Semen Parameters 5
Dynamic Range 5
SECTION 2: Technology
Concentration Measurement 6
Motility Measurement 6
SECTION 3: Getting Started / Set-Up
Power-On 7
Auto-Calibration and Self-Test 7
Set-Up System Defaults: Time, Date, Printing, WHO Morphology 7
Set-Up Controls 8 and 13
SECTION 4: Testing Semen Samples
Patient Information 9
Sample Data 9 Sample Type: Fresh, Washed, Frozen, Postvasectomy 14
Sample Testing: Fresh –Normal / Diluted / Low Volume Samples 10-11
Low Quality Test Results –Frozen / Washed 12
Printing 12
SECTION 5: Controls and QC
Control Set-Up and Testing 13
Set-Up: Assayed Control 13
Set-Up: Non Assayed Control 13
Running CONTROLS 14
Electronic Self-Test and Auto-Calibration 15
SECTION 6: I-Button Loading
Add I-button tests 16
SECTION 7: Service Menu
Service Data 17
Set-up 17 33
Service Personnel 17
Printing System Default Settings 17
SECTION 8: Error Messages and Warning Messages
Stabilization Failed 18 36
Self-Test Failed 18 36 33
Electronic Noise 19 36 33
Concentration Out of Range 19
APPENDIX 1: Filling the Testing Capillary with a Normal Volume Sample 20
APPENDIX 2: Filling the Testing Capillary with a Low Volume Sample 21
APPENDIX 3: Cleaning the Capillary Compartment 22
APPENDIX 4: Reference Values of Semen Variables 23
APPENDIX 5: Product Performance Data 24
APPENDIX 6: Measuring WBC's in Semen using QwikCheckTest Strips 27

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APPENDIX 7: Dilution Media: QwikCheckDilution 28
APPENDIX 8: Treating Viscous Samples: QwikCheck™ Liquefaction 29
APPENDIX 9: Assayed Control –QwikCheck-beads™ 30
APPENDIX 10: Service Report 31
APPENDIX 11: QwikCheck Report Printouts 33
APPENDIX 12: Counting Chambers (Concentration Standard Settings) 34

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SECTION 1: System Overview
The QwikCheck™ is a high performance, menu driven analytical medical device for
assessing human semen. The combination of technology in electro-optics and computer
algorithms results in a precise and accurate 75-second semen analysis. The system is
self-testing and self-calibrating and runs latex beads or stabilized sperm quality controls.
QwikCheck™
Keypad
QwikCheck™
Testing
Capillary
Keypad Navigation
Use NUMERIC keys to enter data; ARROW keys to move to the next field.
Press ENTER to select menu options, confirm data entries and to move to the
next screen or field.
Use the ESC button to return to the previous screen or field.
Testing Capillary
Disposable, designed to collect and test samples in a biologically safe manner.
Motility is measured in the 0.3 mm (thin) "Capillary Section." This section
requires 20 micro liters of semen.
Concentration is measured in the 10 mm (tall) "Cuvette Section." This section
requires 450 microliters of semen.
Automated
Measurement
compartment
Power
Indicator
Operational
display
I-Button
Keypad

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Semen Parameters Reported by the QwikCheck™
Automated
Test Results
Dynamic
Range
Semen Parameters with QwikCheck GOLD Abbreviation in Brackets
Sperm Concentration
(SPERM CONC.)
M/ml
Velocity
(VELOCITY)
mic
/sec
Total Motility
(TOTAL MOTILITY <PR+NP)
%
Sperm Motility Index
(SMI)
#
Progressive Motility
(PROG. MOTILITY <PR>)
%
Total Sperm Number / ejaculate
(SPERM #)
M
Non-progressive Motility
(NONPROG. MOTILITY <NP>)
%
Total Motile Sperm / ejaculate
(MOT. SPERM)
M
Immotility
(IMMOTILTIY <IM>)
%
Progressively Motile Sperm
Concentration (PMSC)
M/ml
Sperm Morphology (normal forms,
%)(MORPH. NORM. FORMS, WHO 5th)
%
Total Progressively Motile Sperm /
ejaculate (PROG. SPERM)
M
Motile Sperm Concentration
(MSC)
M/ml
Functional Sperm Concentration:
Progressively Motile Sperm without
Morphology (FSC)
M/ml
Total Morphologically Normal Sperm /
ejaculate (MORPH. NORM. SPERM)
M
Total Functional Sperm / ejaculate
(FUNC. SPERM)
M
Table of the Dynamic Range of the QwikCheck™
DYNAMIC RANGE OF THE SYSTEM Gold
SAMPLE
SPERM CONC in M/ml
MSC in M/ml
Motility %
FRESH
2-400 or < 2 M/ml
0.2-400 or <0.2 M/ml
0-100%
WASHED
2-200 or < 2 M/ml
0.2-200 or <0.2 M/ml
0-100%
FROZEN
Not reported
0.2-200 or <0.2 M/ml
Not reported

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SECTION 2: Technology
Technology
Step 1: The capillary is inserted into the measurement compartment.
Step 2: Concentration:
Millions of sperm cells are analyzed: A very specific wavelength of light
is absorbed by the sperm cells in the concentration chamber of the
testing capillary.
An detector measures the amount of light absorbed by the cells and
converts it to optical density (OD).
The “OD” reading is translated into sperm concentration by a
microprocessor based on proprietary algorithms.
Step 3: Motility:
Tens of thousands of sperm cells are analyzed in the thin section of the
testing capillary as they move through a light beam in the system,
causing light disturbances.
These light disturbances are converted into electronic signals with
“peaks and valleys.”
The electronic signal peaks are analyzed by microprocessor software
based on a proprietary MES algorithm and translated into motility
parameters.
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
0.8
Voltage [volts]
Time [sec]
Electronic Signal of Motile Sperm
QwikCheck™
Optical Block
Optical Block
LED
Conv
OD
Conv
Micro
Processor
M.E.S.
Proprietary
Algorithms
Semen
Parameters
LED
Density
Detector
Motility
Detector
Step 1
Step 2
Step 3

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SECTION 3: Getting Started / Set-Up
NOTE:
The QwikCheck GOLD
is loaded with a
minimal number of I-
Button tests in
memory. However, the
user must load tests
right away to insure
that testing will not be
interrupted. Please
refer to the I-Button
loading section of this
manual for instructions!
Power-On
Plug the system into a grounded electrical source.
Turn the system on by pressing the main switch located on the rear panel. The
Power indicator will illuminate and the following screen will be displayed.
Auto-Calibration and Self-Test
NOTE:
Do not use any of the
keyboard functions
during stabilization.
Press ON/OFF key on the keypad and auto-calibration will begin.
This process takes 5-7 minutes.
When the system stabilization and auto-calibration processes are complete, a
series of tests will be run.
Do not insert a capillary into the device or use any of the keyboard functions
until instructed to do so by the system.
The MAIN menu will appear when the self-test process is complete. The
system is now ready for use.
Set-up System Defaults
Before running a test for the first time, set up the system defaults by going to:
MAIN MENU > SERVICE > SET-UP
QwikCheck GOLD
SPERM QUALITY ANALYZER
VERSION 1.0
PRESS ON/OFF KEY
TO ACTIVATE THE UNIT
PRESS ON/OFF KEY
TO ACTIVATE THE UNIT
QwikCheck GOLD
SPERM QUALITY ANALYZER
PLEASE WAIT
SYSTEM STABILIZATION AND
AUTOCALIBRATION
MAIN MENU
TEST NEW PATIENT
RUN CONTROLS
ADD I-BUTTON TESTS
SERVICE
SERVICE MENU
SERVICE DATA
SET UP
SERVICE PERSONNEL
PRINT SELF-TEST DATA & SETTINGS

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Select either SYSTEM DEFAULTS or CONTROLS when the screen below appears:
SYSTEM DEFAULTS: Select the desired date/time formats, label printing
preference and concentration standard (see Appendix #12 for a table of counting
chambers: NEUBAUER vs. MAKLER type) when the screen below is displayed.
Press ENTER to accept.
CONTROLS: Follow the screen prompts and enter the appropriate information
from the control (Latex beads or Stabilized Sperm) product labeling.
Select the type of controls to be run (Latex Beads/Stabilized Sperm)
Select the LEVEL (1, 2, or NEGATIVE)
Enter the LOT #/ EXPIRATION DATE and TARGET VALUE from the product
labeling.
The QwikCheck™ is now ready to test samples and controls!
SERVICE: SET-UP
SELECT:
1. SYSTEM DEFAULTS
2. CONTROLS
SELECT AND PRESS ENTER
SYSTEM DEFAULT SETTINGS
DATE FORMAT: MM/DD/YY / DD/MM/YY
DATE/TIME SETTING: 01/04/05 08:15:45
AUTO PRINTING: YES/NO
# LABELS TO PRINT: 1 / 2
CONC. STD: 1 / 2
SERVICE: SET-UP CONTROLS
SELECT: LATEX BEADS/STABILIZED
SPERM
SELECT: LEVEL 1 / LEVEL 2 / NEGATIVE
PRESS ENTER TO CONTINUE
ESC TO RETURN TO SERVICE MENU
SET-UP: LATEX BEADS
LEVEL 1
LOT #: 0013122009
EXP DATE: 12/03/2010
TARGET VALUE: 46 +/- 6.4
PRESS ENTER

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Testing
Samples
SECTION 4: Test New Patient: FRESH, WASHED and FROZEN samples are all
run following similar screen instructions. Once the sample type is selected, the menu will
direct how to run the sample and what volume is required. If the sample is low quality,
the system will perform an additional 2 minute test.
From the MAIN MENU select TEST NEW PATIENT and the ENTER PATIENT/
SAMPLE DATA screen is displayed.
Enter the requested sample/patient information using the keypad:
PATIENT ID –patient identifying #(Maximum 20 numbers can be entered).
BIRTH DATE –Birth date of the patient.
ABSTINENCE - Number of days since the patient's last ejaculation.
SAMPLE/ACCESSION # - Up to 20 numbers identifying the sample
COLLECTED –Date and time the sample was collected.
RECEIVED –Date and time the sample was received.
Press ENTER to view the next screen:
Sample Data
Select: SAMPLE TYPE based on the following options:
FRESH –Sample not enriched, diluted or treated and is within 1 hour of
collection. Exception: Low volume samples diluted 1:1 with QwikCheck
dilution media can be used according to User Guide instructions.
WASHED –Sample enriched or prepared for artificial insemination using a
commercial media to replace seminal plasma. Frozen samples containing egg
yolk buffer are excluded.
FROZEN –Samples that have been frozen. Only motility parameters will be
reported (MSC, PMSC, SMI and VELOCITY).
Enter the remaining sample information:
VOLUME –Volume of the whole ejaculate in milliliters
WBC CONC. –select < 1 M/ml (normal) or >=1 M/ml (abnormal) leukocytes
(required entry). (QwickCheck Test Strips recommended).
PH –pH of the semen sample (QwickCheck Test Strips recommended).
Patient
Information
PLEASE NOTE:
The QwikCheck is
calibrated to run semen
specimens at room
temperature. It is not
necessary nor will the
user get accurate
motility results if the
sample is heated to
37ºC.
Sample
Information
PLEASE NOTE:
Refer to the appendix
section of this user
guide for information
on how to measure
semen WBC’s and pH
and how to handle
viscous samples.
ENTER SAMPLE DATA
SELECT FRESH / WASHED / FROZEN
VOLUME 2.5 ml
WBC CONC. SELECT < 1 M/ml / >= 1 M/ml
PH 7.0
ENTER PATIENT / SAMPLE DATA
PATIENT ID: 5788114
BIRTH DATE: 01/01/85
ABSTINENCE: 4 DAYS
SAMPLE / ACCESSION # 58888
COLLECTED: DD/MM/YY HH:MM
RECEIVED: DD/MM/YY HH:MM

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Normal
Volume
Samples
PLEASE
NOTE:
The QwikCheck will
begin testing when a
capillary is placed into
the testing chamber.
Sample Volume
After entering the patient and sample data, the screen above will be displayed.
SELECT: YES for NORMAL VOLUME samples ≥0.5 ml.
SELECT: NO for LOW VOLUME samples < 0.5 ml.
If YES: The sample is ≥0.5 ml the screen below provides instructions for
PREPARING a testing capillary. Do not touch the system at this time as it is
calibrating for the testing cycle.
Fill the testing capillary according to the instructions in the Appendix section of
this user guide: “Filling the SQA Capillary with a Normal Volume Sample”.
Insert the testing capillary into the measurement chamber of the QwikCheck
GOLD when instructed by the screen below:
Testing will begin automatically –do not touch the system or capillary during
testing.
Test results will be displayed when finished:
IS SAMPLE VOLUME SUFFICIENT FOR
COMPLETE TESTING >= .5 ml?
YES/NO
NORMAL VOLUME SPECIMEN
FILL, CLEAN & WIPE CAPILLARY
AUTOCALIBRATION-DO NOT TOUCH UNIT
NORMAL VOLUME SPECIMEN
FILL, CLEAN & WIPE CAPILLARY
INSERT IN CHAMBER
TESTING
DO NOT MOVE CAPILLARY OR
OPERATE DEVICE DURING TESTING
TEST RESULTS
SPERM CONC. 32.6 M/ml
TOTAL MOTILITY <PR+NP> 28.0 %
PROG. MOTILITY <PR> 5.2 %
NON PROG. MOTILITY <NP> 8.7 %
IMMOTILITY <IM> 72.0 %
MORPH.NORM.FORMS,WHO 5TH 20.6 %
TEST RESULTS
MSC 9.1 M/ml FSC 3.2 M/ml
PMSC 5.2 M/ml VELOCITY 20mic/sec
SMI 72
TOTALS PER VOLUME
SPERM # 65.2M MOT. SPERM 18.2M
PROG.SPERM 10.4M FUNC SPERM 6.4M
MORPH. NORM. SPERM 4.8M

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Low Volume
Samples
Diluted
Samples
Recommendation
for sample
dilution media:
Use QwikCheck™
Dilution Media for
best results and if
the sample is
viscous, FIRST treat
with QwikCheck-
Liquefaction kit,
then dilute.
20µl Low
Volume
Samples
If the sample is < 0.5 ml two options are available: DILUTE the sample 1:1 (QwikCheck
Dilution medial) to obtain a full report or run a LOW VOLUME sample (reports motility
parameters only).
To run a LOW VOLUME DILUTED sample, select option “1” when the screen below
is displayed:
Dilute the sample 1:1 with QwikCheck dilution media (see appendix section).
Follow the instructions in the appendix section of this User Guide: Filling the
Testing Capillary with a Normal Volume Sample.
The system will report accurate results only if the sample has been diluted 1:1
prcisely and the sample is adequate to fill the testing capillary after dilution.
To run a LOW VOLUME sample, select option “2” from the screen displayed below:
Aspirate only 20 µl of sample into the motility section of the capillary following
the instructions in the Appendix section of this User Guide: “Filling the SQA
Capillary with a Low Volume Samples”.
FRESH: LOW VOLUME SPECIMEN
PLEASE SELECT SAMPLE TESTING
OPTION:
1. DILUTE 1:1 WITH MEDIA
2. RUN 20 µl SAMPLE–LIMITED
REPORT
FRESH: LOW VOLUME SPECIMEN
PLEASE SELECT SAMPLE TESTING
OPTION:
1. DILUTE 1:1 WITH MEDIA
2. RUN 20µl SAMPLE-LIMITED
REPORT
SID TE4a: low volume sample
SID TE4a: Low volume sample query
LOW VOLUME SAMPLE
FILL CAPILLARY–20 MICROLITERS
CLEAN AND WIPE CAPILLARY
INSERT CAPILLARY INTO CHAMBER
TEST RESULTS
MOTILITY PARAMETERS ONLY
MSC 18.1 M/ml VELOCITY 3 mic/sec
PMSC 1.0 M/ml SMI 26
TOTALS PER VOLUME
MOT SPERM 18.5M PROG SPERM 6.7M
SID TE24: Test Results –Frozen Sample
20 μl

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Low Quality
Test Results
FROZEN,
WASHED
SAMPLE
TESTING
When a sample is LOW QUALITY, test results may be reported as < or > when
parameters fall below the dynamic range of the system. Only the following parameters
will be reported: Sperm Concentration, Motility, SMI and Motile Sperm Concentration due
to the limited number of cells, very low motility and/or poor morphology.
Examples of test results reported in this manner are seen in the screens below:
Run FROZEN and WASHED samples in the same manner by selecting SAMPLE TYPE:
FROZEN (or WASHED) from the MAIN MENU > TEST NEW PATIENT > ENTER SAMPLE
DATA screen. Follow the on-screen instructions.
FROZEN samples require only 20 microliters of sample and motility parameters
only are reported
WASHED sample can be run with a large or small volume sample (motility
parameters only will be report if using 20 microliters)
Printing
If the QwikCheck was set to automatically print test results on the label maker
they will now print.
If the default was not set, press the PRINT button on the keypad.
TEST RESULTS
SPERM CONC. <2.0 M/ml
TOTAL MOTILITY <PR+NP> < 22 %
PROG. MOTILITY <PR> %
NONPROG. MOTILITY <NP> %
IMMOTILITY <IM> %
MORPH. NORM. FORMS, WHO 5TH %
TEST RESULTS
MSC < 0.2 M/ml FSC M/ml
PMSC M/ml VELOCITY mic/sec
SMI 17
TOTALS PER EJACULATE
SPERM # N.A. MOTILE SPERM N.A.
PROG.SPERM N.A. FUNC SPERM N.A.
MORPH. NORM. SPERM N.A.
TESTING
LOW QUALITY SAMPLE
TESTING WILL TAKE 2 MORE MINUTES

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Control
Set-Up and
Testing
Set-Up
Please note:
When a new control lot
is used, the control
default settings must
be changed prior to
initiating a test.
Please note:
For the QwikCheck
GOLD to test
CONTROLS accurately,
the CONTROL defaults
must be set-up. If
some control
information is not
available, enter the
current date in the EXP
Date field and zeros in
all other fields.
SECTION 5: Controls
From the MAIN MENU select: RUN CONTROLS in order to run external quality control
samples (CONTROLS). Commercially available stabilized sperm can be run as non-
assayed controls. QwikCheck™ beads produced by Medical Electronic Systems are
assayed for the QwikCheck GOLD. It is recommended that controls be run daily or
based upon laboratory protocols.
Set-Up: Assayed Control: QwikCheck™Beads
For each new box of controls, system defaults need to be set-up/updated. To do this:
Go to: MAIN MENU > SERVICE > SET-UP > CONTROLS to view the screen
below:
Select the type of control (LATEX BEADS or STABILIZED SPERM)
Select the level of the control (LEVEL 1, LEVEL 2 or NEGATIVE)
PRESS: ENTER and the screen below will be displayed:
From the box/product labeling enter:
LOT#: number identifying the control media lot.
EXP. DATE: control expiration date (MM = month, YY = year).
TARGET VALUE and +/- Range: Manufacturer's labeled "Target Value
and +/- Range” for the level of the control being set-up.
PRESS ENTER to save the set-up information.
Continue to set-up each of the other levels of controls.
To run a non-assayed control, the Target Value and +/- range must be established by
the laboratory. Once this is determined, set-up the defaults and test the control in the
same way as QwikCheck Beads assayed control.
SERVICE: SET-UP CONTROLS
SELECT: LATEX BEADS / STABILIZED SPERM
SELECT: LEVEL 1/LEVEL 2/NEGATIVE
PRESS ENTER TO CONTINUE
ESC TO RETURN TO SET-UP MENU
SET-UP: LATEX BEADS LEVEL #1
LOT #: 112233445566778899
EXP DATE: 04/09 MM/YY
TARGET VALUE: 45 +/- 6.3
PRESS ENTER
SID IBT6: Add tests to counter: empty I button
inserted

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Testing will begin automatically.
Control test results will be displayed on the QwikCheck GOLD screen.
LOW, HIGH or NORM. will be displayed based on the testing outcome vs.
target value and +/- range.
Test results can be printed by pressing the PRINT button on the keypad.
Running
Controls on
the
QwikCheck
GOLD
Please note:
For the QwikCheck
GOLD to test
CONTROLS accurately,
the CONTROL defaults
must be set-up. Please
refer to the section
above to set-up the
controls.
Please note:
Insert the testing
capillary with the
control media ONLY
when prompted by the
screen.
CONTROL Testing
To run controls go to: MAIN MENU > RUN CONTROLS and press ENTER
When the screen below is displayed: Select the CONTROL LEVEL: #1, #2 or
NEGATIVE (LEVEL #3) that is being tested.
Press ENTER to continue.
Fill the testing capillary with the Control media as if you are running a normal
volume semen sample.
After a screen that asks you to PLEASE WAIT while the system auto-calibrates,
the screen below will be displayed:
CONTROL: LATEX BEADS, LEVEL #1
FILL, CLEAN AND WIPE CAPILLARY
INSERT IN CHAMBER
TESTING WILL BEGIN
AUTOMATICALLY
MAIN MENU
TEST NEW PATIENT
RUN CONTROLS
ADD I-BUTTON TESTS
SERVICE
RUN CONTROLS: LATEX BEADS
SELECT:
CONTROL LEVEL:
LEVEL #1/LEVEL #2/NEGATIVE CONTROL
PRESS ENTER TO CONTINUE
CONTROL TEST RESULTS
DATE 01/12/06 DD/MM/YY TIME 15:09:08
LEVEL #1 LOT# 11223344556677889900
EXP. DATE 04/09 MM/YY
TYPE: LATEX BEADS
TARGET VALUE: 45.0 +/- 6.3 M/ml
CONC. RESULTS: 45.4 M/ml NORM.
ACCEPTABLE RANGE: 38.7 –51.3 M/ml

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Electronic Self-Test and Auto Calibration
The QwikCheck automatically runs a series of tests to check calibration
settings and the internal operating system. Tests are run when the system is
turned on and prior to testing a sample.
Start-up:
Stabilization and auto calibration: Checks system stability and reference
ranges. The system sensors are analyzed for several minutes to insure that
the values are within a very narrow acceptable range. Once the system is
stable for 30 seconds it will pass stabilization and auto calibration. The system
will fail if it is not stable for at least 30 seconds and a warning message will be
displayed.
System noise: Measures the electronic noise level of the system to insure
effective measurement of electronic signals.
Self-test: The system produces electronic signals that simulate motility and
concentration measurements in order to check the performance of the system
and verify that the calibration settings are consistent with the factory
specifications. The QwikCheck will report failures (see section on error and
warning messages) and "freeze" the system if the system is not within the
established self-test ranges.
Prior to testing a sample:
Auto calibration verification: Reference values are read again. The
electronic parameters of the concentration and motility channels are measured
(without a testing capillary).
System noise: Measures the electronic noise level of the system to insure
effective measurement of electronic signals. Prior to running a test, the
QwikCheck will automatically adjust the noise level thresholds to insure
accurate readings.
Electronic spikes: Checks for any measurement points that are out of range
electronically. More than three such points will fault the system and a warning
message will be displayed.
Instructions for printing the QwikCheck GOLD Self Test parameters to
prepare for technical support:
How to print a copy of the SELF TEST DATA:
Remove the testing capillary from the system.
When a FAILED SELF TEST message appears select: MAIN MENU >
SERVICE> PRINT SELF TEST DATA AND SETTINGS > SELF TEST DATA.
Press ENTER after highlighting SELF TEST DATA to print a copy of the data.
How to view the system parameters FROM QwikCheck GOLD:
Go to: MAIN MENU > SERVICE > SERVICE DATA. All of the service screens
can be viewed by pressing ENTER.

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Customer Support/Troubleshooting: To quickly assess if the QwikCheck GOLD is
in good calibration, refer to the table and values below. The S/W Ver. 1.00 column
provides reference ranges for calibration. Enter information from the SELF TEST DATA
in the “QwikCheck Value" column to see if the system requires troubleshooting.
#
Parameter
S/W Ver. 1.00
QwikCheck
Value
Pass
Fail
1.
Ref 1
150 –350 mV
2.
LED Cur 1
5 –25 mA
3.
Amplitude
50 –100 mV
4.
Zero Level
500 - 525
5.
Ref 2
2500 –3500 mV
6.
LED Cur 2
10 –32 mA
7.
CONC. 1
0 –1 M/ml
8.
CONC. 2
50-150 M/ml
9.
CONC. 3
300-600 M/ml
10.
Count (Service
Data, Item #12)
26 - 36
I-Button
loading
SECTION 6: Add I-Button Tests
To add I-button tests, go to: MAIN MENU> ADD I-BUTTON TESTS and
press ENTER. The screen below will be displayed.
In each box of 50 testing capillaries, a new i-button is included that has 50
test credits loaded on the button.
Follow the on-screen instructions, holding the new i-button firmly against the
i-button port located on the side of the QwikCheck GOLD system.
The screen above will be displayed when the i-button is successfully loaded!
MAIN MENU
TEST NEW PATIENT
RUN CONTROLS
ADD I-BUTTON TESTS
SERVICE
TO ADD MORE TESTS
HOLD NEW I-BUTTON AGAINST PORT
AND PRESS ENTER
PRESS ESC TO EXIT
# TESTS ADDED: 50
# OF TESTS NOW REMAINING: 76
PRESS ESC TO EXIT

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SECTION 7: Service Menu
System set-up, maintenance and troubleshooting can be performed from the SERVICE
MENU. To activate this screen, press SERVICE in the MAIN MENU.
Service Data
Click on this option to view all the SELF TEST, ALGORITHM and
SERVICE DATA for the QwikCheck GOLD system.
Set-up
Click on the SET-UP option to set-up all the SYSTEM DEFAULTS
(date format; time/date; # labels to print; automatic printing;
morphology setting) or to set-up the CONTROL DEFAULTS.
Service
Personnel
A code is required to access SERVICE PERSONNEL. This option
allows a qualified service technician to access calibration and
maintenance settings.
Print system
Default Settings
The system SELF-TEST DATA and DEFAULT SETTINGS can be
printed to the label maker by selecting this option.
SERVICE MENU
SERVICE DATA
SET-UP
SERVICE PERSONNEL
PRINT SELF-TEST DATA & SETTINGS
SYSTEM DEFAULT SETTINGS
DATE FORMAT: MM/DD/YY / DD/MM/YY
DATE/TIME SETTING: 01/04/05 08:15:45
AUTO PRINTING: YES/NO
# LABELS TO PRINT: 1 / 2
SERVICE: SET-UP CONTROLS
SELECT: LATEX BEADS / STABILIZED SPERM
SELECT: LEVEL 1/LEVEL 2/NEGATIVE
PRESS ENTER TO CONTINUE
ESC TO RETURN TO SET-UP MENU
HIGHLIGHT OPTION
AND PRESS ENTER TO PRINT
1. SELF-TEST DATA
2. CONTROLS / TEST SETTINGS

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SECTION 8: Error Messages and Warning Messages
Stabilization Failed:
Ensure there is no testing capillary in the measurement compartment.
Remove the SYSTEM from sources of electronic noise (cell phones, etc.) and
vibrations (centrifuge).
Clean measurement compartment (refer to Appendix).
Reboot the QwikCheck system without a testing capillary in the chamber:
Turn system OFF then back ON at the main switch on the rear panel.
Press the front panel ON/OFF key to begin Auto-Calibration/Stabilization.
Call technical support if failure recurs.
Self-test Failed:
Ensure there is no testing capillary in the measurement compartment.
Remove the QwikCheck from sources of electronic noise (cell phones, etc.)
and vibrations (centrifuge).
Clean measurement compartment (refer to Appendix).
Reboot the QwikCheck system without a testing capillary in the chamber:
Turn the system OFF then back ON at the main switch on the rear panel.
Press the front panel ON/OFF key to begin Auto-Calibration and
Stabilization.
Call technical support if this message is displayed again. Prepare for technical
support by printing a copy of the SERVICE DATA:
Press the SERVICE key on the keypad to activate the SERVICE MENU
screen.
Select: PRINT SELF TEST DATA AND DEFAULT SETTINGS>SELF
TEST DATA.
Press ENTER

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Electronic Noise:
Ensure there is no testing capillary in the measurement compartment.
Remove the QwikCheck from sources of electronic noise (cell phones, etc.)
and vibrations (centrifuge).
Clean measurement compartment (refer to Appendix) and after cleaning:
Turn the system OFF then back ON at the main switch on the rear panel.
Press the front panel ON/OFF key to begin Auto-Calibration and
Stabilization.
From MAIN menu: Select TEST NEW PATIENT and rerun the test.
Call technical support if this message is displayed again. Prepare for technical
support by printing a copy of the SERVICE DATA:
Press the SERVICE key on the keypad to activate the SERVICE MENU
screen.
Select: PRINT SELF TEST DATA AND DEFAULT SETTINGS>SELF
TEST DATA.
Press: ENTER
Concentration Out of Range
Testing Semen Sample:
A message will appear indicating that the tests results for Sperm Conc and/or
MSC are beyond the upper limits of the dynamic range established by the
manufacturer for testing. This message will appear when:
SPERM CONC > 500 M/ml or
MSC > 450 M/ml
Review sample handling technique (see Appendix "Filling the SQA Capillary").
Re-test the sample using a new SQA capillary. If the message appears again,
reboot the system.
Call for technical assistance if problem persists.

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APPENDIX 1: Filling the Testing Capillary with a Normal Volume Sample
Sample size, collection container and preparation:
1. Sample volume should be at least .5 ml If sample volume is less than
.5 ml see Appendix 2.
2. The semen sample must be completely liquefied and well mixed
prior to aspiration. WARNING: Do not shake nor use a pipette to
aspirate and dispense specimen in order to mix, otherwise air bubbles
will form.
3. Carefully check that liquefied, fully mixed specimen is free of air
bubbles before aspirating a sample.
Filling the capillary:
1. Push the syringe piston in fully. Place only thin part of the capillary
into the bottom of the sample while angling the sample container at
about 45 degrees (Figure 1).
2. Place two fingers below the piston head and pull the piston back slowly
while keeping the tip of the capillary well below the sample level and
below any surface bubbles (Figure 1). Continue to aspirate the sample until it
appears in the Luer adaptor (figure 2).
3. Hold the capillary in a vertical position to confirm that the sample has
completely filled the thin section (without a meniscus) and the cuvette section
(Figure 2).
4. Tap on the syringe to make sure there are no air bubbles in the sample.
If, after tapping, some air bubbles appear below the Luer adaptor, dip the
capillary into the semen sample again and aspirate a small quantity of semen to
draw the air bubbles into the syringe.
5. Quickly (to avoid wicking) wipe the outer surface of the capillary - both top
and bottom with a wipe to prevent the QwikCheck optical chamber from
becoming clogged (Figure 3).
6. Slowly push-in the separating valve all the way (Figure 4). Insert the
capillary into the measurement compartment. Testing begins automatically.
Figure 1
Figure 2
Figure 3
Figure 4