V SPERM IIITM SQA GOLD 2.60 USER GUIDE WHO 5th 1 JUNE 17

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User Guide Version 2.60 I-Button

USER GUIDE

V e r s i o n 2 . 6 0 I - B u t t o n
W H O 5 t h

Catalog # V-A-00734-00

June 1, 2017

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User Guide Version 2.60 I-button WHO 5th

Table of SECTION 1: System Specifications and Requirements
Sperm Quality Analyzer SQA-V Version 2.60
Contents

4

SECTION 2: System Overview
Front Panel
Key Pad Navigation
Rear Panel
Measurement Capillary
Slide Adaptor
Semen Parameters
Reportable Range

7
7
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SECTION 3: Technology
Concentration Measurement
Motility Measurement

10
10

SECTION 4: Getting Started / Set-Up
Power-On
Auto-Calibration and Self-Test
Set-Up System Defaults: Time, Date, Printing, WHO, Chamber Standard
Set-Up Controls
12 and

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11
12
21

SECTION 5: Testing Semen Samples
Patient Information
Sample Information
Sample Type: Fresh, Washed, Frozen, Postvasectomy
Sample Volume: Low Volume, Diluted, Normal Volume
Testing
Test Results: Normal, Low Quality
Printing, Saving and Transferring Results to V-Sperm Gold
Postvasectomy Test

13
13
14
14-16
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SECTION 6: Controls and QC
Control Set-Up and Testing
Set-Up: Assayed Control
Set-Up: Non Assayed Control
Running CONTROLS on the Automated System
Electronic Self-Test and Auto-Calibration

21
21
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SECTION 7: Archive Functions
Transferring the SQA-V Archive to V-Sperm
Importing Single Test Results On-line
Importing Patient and Control Archives to V-Sperm

25
25
25

SECTION 8: Service Menu
Service Data
Service Personnel
Printing SQA-V Default Settings
Add I-Button Tests

26
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26

SECTION 9: Operating the Visualization System (Video Display)
Introduction
Operating Instructions
Standard Slide Preparation
Testing Capillary Preparation
Testing Process
Counting Cells Using the Visualization Screen

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SECTION 10: Error Messages and Warning Messages
Stabilization Failed
Self-Test Failed
Electronic Noise
Concentration Out of Range

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APPENDIX

1:

Filling the SQA-V Capillary with a Normal Volume Sample

31

APPENDIX

2:

Filling the SQA-V Capillary with a Low Volume Sample

33

APPENDIX

3:

Using Standard Slides in the Visualization System

34

APPENDIX

4:

Counting Cells Using the SQA-V Visualization System

35

APPENDIX

5:

Cleaning the Capillary/Slide Compartment

36

APPENDIX

6:

Reference Values of Semen Variables

37

APPENDIX

7:

Measuring WBC's in Semen using QwikCheck Test Strips

38

APPENDIX

8:

Dilution Media: QwikCheckDilution

39

APPENDIX

9:

Treating Viscous Samples: QwikCheck™ Liquefaction

40

APPENDIX

10:

Assayed Control – QwikCheck-beads™

41

APPENDIX

11:

Concentration Standard: Counting Chambers

42

APPENDIX

12:

Postvasectomy Protocol

43

APPENDIX

13:

Globozoospermic Samples

44

APPENDIX

14:

Service Report

45

APPENDIX

15:

SQA-V Test Report Printouts

47

APPENDIX

16:

Printer Ribbon/Paper Installation

48

APPENDIX

17:

Warranty

49

APPENDIX

18:

Product Performance Data

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SECTION 1: System Specifications and Requirements
Specifications Dimensions: 32 X 30 X 24 cm

Weight: 7 Kg
AC power supply: 100-240 VAC, 50-60 Hz, 20 VA

Version 2.60

Archive Capacity



500 test records / 750 QC records

Display(s)




Operational backlight LCD (16 lines x 40 characters)
Video backlight LCD (8 x 10 cm)

Factory Default Settings
SYSTEM:
Date format: DD/MM/YY
Time/Date: Manufacturer's local time/date
Morphology: WHO 5th
Chamber standard: 2
Printing Options: Automatic
CONTROLS:
Control Media: Latex Beads, Stabilized Sperm CAP or MES (Lot #, Target Values, +/- Ranges set up by user)

Front Panel





Displays: LCD video display and controls, LCD operational display.
Testing: Measurement compartment, Visualization compartment.
Other: Multi-button keypad, I-Button port, Focus knob, Built-in printer.

Keypad




Operational keys: ON/OFF, TEST, PRINT, SERVICE, ARCHIVE (now disabled),
DELETE, ENTER, four cursor buttons, ESC, ten numeric buttons (0-9).
Video control keys: ZOOM IN/OUT, ILLUMINATION HIGH/LOW, and
MONITOR ON/OFF.

Measurement Compartment




Sources of radiant energy - two LEDs for motility and spectrophotometry
channels.
Detector system - two photo detectors - Motility and Optical Density.

Operating System






Analysis Time: Normal Test–75 seconds; Low Quality–2 additional minutes;
Postvasectomy – 5 minutes.
Software: Resides on flash memory and drives all man-machine interface
functions, runs algorithms for test measurements, and operates visual and
automated screens. System can be upgraded from a PC CD-ROM.
Motility channel input signal: Analog, up to 5V.
Spectrophotometer channel input signal: Modulated(kHz)analog,up to 5V.

Printer




Built-in, Dot Matrix with ribbon cassette (Citizen).
Non-thermostatic narrow paper with 20 characters per line (Citizen).

Rear Panel


Revision 1_JUNE_2017

Power connector w/fuse-holder (fuse 250V,1A), Video connector,RS232 outlet.

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Visualization Compartment



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



White LED illumination system
CCD, 330 TV lines
Objective: Standard, x20
Signal Output: PAL standard
Zoom system for smooth magnification transition between x300 and x500
Focus regulator

Maintenance Schedule



Daily: Clean measurement compartment daily when running samples and
after every 10-15 tests and/or for ANY spillage. Follow manufacturer’s cleaning
instructions using manufacturer cleaning kit. (Refer to the appendix section
“Cleaning the Capillary/Slide Compartments” in this User Guide). ONLY use
the Manufacturers cleaning kit and cleaning brush or damage will
occur to the SQA-V film and the system will not operate!

Manufacturer Recommendations






Requirements



Operate the SQA-V away from devices that may cause electronic noise (cell
phones) or other devices causing vibrations such as centrifuges.
Turn system OFF at the rear-panel when not in use for extended period of
time.
When running Postvasectomy tests do not interrupt test cycle nor interfere
with system or testing capillary in any way – this test is highly sensitive to any
motion and requires complete stability of the system during the 5 minute
testing cycle.
Variations in ambient temperature can affect semen samples. It is essential
that semen samples are not heated for testing. The SQA-V is calibrated to
conduct tests at room temperature: 20-25ºC (68-77ºF).
Semen is considered a biologically hazardous material and is subject to
individual laboratory protocols for handling such materials and at a minimum:





Laboratory coat, mask and gloves for operating personnel protection.
Samples handling and waste disposal in specially marked hazardous waste
containers.
Only personnel trained to work with biologically hazardous materials such as semen
should be testing and handling semen.

Operating Temperature



Maximum operational humidity is 80% for temperatures of up to 31ºC with
decreasing linearly to 50% at 38ºC.



Operates in a wide range of ambient temperatures (15-38ºC) however the
system is calibrated to measure semen samples at room temperature:
20-25ºC (68-77ºF). Note: Extreme ambient temperature may impact the
accuracy of motility test results because of the known effect of temperature on
human semen.

Operational Environmental conditions:



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System is intended for indoor use at a maximum altitude of 2000m, mains
supply fluctuations ±10%, Overvoltage Category II, Pollution Degree II.

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PC / Hardware Requirements
Minimum requirements for V-Sperm software:

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



PC: Intel Core 15 M520 2.4GHz or equivalent
RAM: 4GB
Video card: 3D to support high resolutions 16:10 – 1440X900
Video color: At least 16 bit (65,535)
CD ROM drive
300GB free hard disk space for image capturing (approx. 3000 clips)
Monitor Screen: Color, Wide screen – should support resolution 16:10 or
16:9 (1440X900)
Operating system compatibility: Windows XP and 7; Excel/Word
(required for V-Sperm GOLD)
Communication Ports: Two FREE native RS232 ports (one for data transfer
and one for LIS); two USB ports
EXCEL and WORD required for export function and printing test
reports

Quality Control




Internal: Electronic Self-Test and Auto-Calibration. Runs automatically upon
start-up. Reference values are verified prior to each test.
External: Run daily prior to testing or per laboratory protocol. Runs assayed
latex bead control: "QwikCheck™-beads" (product of Medical Electronic
Systems) for concentration and negative control for motility/concentration OR
non-assayed: Latex beads or stabilized sperm CAP or MES for concentration.

Sample Testing






Sample Testing Temperature: Calibrated for room temperature only.
Motility results will be impacted by heating the specimen.
System calibrated to test Human semen and specified Control samples
only. Not for use with animal semen.
SQA-V measurement capillary: Disposable, plastic, testing capillary.
Requires 500 µl of sample for normal volume testing, 20 µl for low volume
testing, 300 µl for diluted mode. Use only manufacturers’ certified testing
capillaries in the automated and visualization system.
Slide adaptor: Supplied with the SQA-V. Must be used with a standard
laboratory slide and 22 x 22 mm cover-slip for accurate test results.

Software Required




Revision 1_JUNE_2017

V-Sperm Gold 3.60 (included with system): Required for setting SQA-V
system defaults, archive management/data transfer, capture and storage of
video images from the SQA-V and for displaying and printing self test data.
Excel/Word

(required for V-Sperm GOLD)

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SECTION 2: System Overview
The SQA-V is a high performance analytical medical device that combines technology in
electro-optics, computer algorithms and video microscopy. The system performs a 75second semen analysis and has the ability to print test results and archive up to 500
patient records. The system is self-testing and self-calibrating and runs latex beads or
stabilized sperm quality controls. Two systems: Automated and visualization allow
the user the flexibility to analyze all types of semen samples.

Visualization compartment:
Accommodates both a slide and
the SQA-V testing capillary

Printer and paper
Prpaper
Video display
and video controls

Focus knob:
Magnification X300 to x500

Operational
display
I-Button

Automated Measurement
compartment
Keypad

NOTE: The TEST

Zoom magnification X300 – X500

Keypad Navigation

button of the SQA-V
keypad is only active in
the CALIBRATION
mode.




The ARCHIVE button
on the keypad is
inactive because the
SQA-V archive is
managed through
V-Sperm GOLD.



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.

Rear Panel

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SQA-V Measurement Capillary
Components
Leur Adaptor

Syringe

Motility
Section

Cuvette
Section






Separating
Valve

Directing
Runner

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.
Both the measurement
accommodate the testing
Normal and Low Volume
instructions on how to use

and visualization chambers of the SQA-V will
capillary. Refer to: "Filling the SQA-V Capillary with
Samples" in the Appendix section of this guide for
the SQA-V testing capillary.

Slide Adaptor
NOTE:
In order to accurately
visualize the sample it
must be centered
approximately 12mm
from the end of the
glass slide.

Sample
location




Revision 1_JUNE_2017

Use with a standard laboratory slide 76 x 25.6 mm and 22 x 22 mm cover-slip
with a 10 µl sample placed approximately 12 mm from the end of the slide for
accurate results.
For use in the visualization compartment of the SQA-V.

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Semen Parameters Reported by the SQA-V
Automated
Test Results

Semen Parameters with SQA-V Abbreviation in Brackets
Sperm Concentration
(SPERM CONC.)

M/ml

Velocity
(VELOCITY)

mic
/sec

Total Motility
(TOTAL MOTILITY )

%

Sperm Motility Index
(SMI)

#

Progressive Motility
(PROG. MOTILITY )

%

Total Sperm Number / ejaculate
(SPERM #)

M

Non-progressive Motility
(NONPROG. MOTILITY )

%

Total Motile Sperm / ejaculate
(MOT. SPERM)

M

Immotility
(IMMOTILTIY )

%

Total Progressively Motile Sperm /
ejaculate (PROG. SPERM)

M

Sperm Morphology (normal forms, %)
(MORPH. NORM. FORMS, WHO 5th)

%

Total Functional Sperm / ejaculate
(FUNC. SPERM)

M

M/ml

Total Morphologically Normal Sperm /
ejaculate (MORPH. NORM. SPERM)

M

M/ml

Postvasectomy: Motile, Immotile and
Total Sperm/Scan
(#SPERM/SCAN: MOTILE, IMMOTILE
and TOTAL)

#

M/ml

Postvasectomy: Motile, Immotile and
Total Sperm/sample volume
(#SPERM/SAMPLE VOLUME: MOTILE,
IMMOTILE AND TOTAL)

M

Motile Sperm Concentration
(MSC)
Progressively Motile Sperm
Concentration (PMSC)

Functional Sperm Concentration:
Progressively Motile Sperm with Normal
Morphology (FSC)

Table of the Reportable Range of the SQA-V
Reportable
Range

REPORTABLE RANGE OF THE SQA-V 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

POSTVASECTOMY

Manual Input

0-30 Sperm/Scan

Not reported

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Technology SECTION 3: Technology
SQA-V Optical Block
Density Motility
Detector Detector

OD
Conv

Step 1

Micro
Processor

Conv
Step 2

M.E.S.
Proprietary
Algorithms

Semen
Parameters

Step 3
LED

LED

Step 1:

The capillary is inserted into the measurement compartment.

Step 2:

Concentration:

Step 3:



Millions of sperm cells are analyzed: A very specific wavelength of light
is absorbed by the sperm cells in the concentration chamber of the
SQA-V testing capillary.



An optical density 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 MES algorithms.

Motility:


Tens of thousands of sperm cells are analyzed in the thin section of the
SQA-V capillary as they move through a light beam in the SQA-V: The
movement of motile sperm cells causes 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.
0.8

0.6

Voltage [volts]

0.4

0.2

0

-0.2

-0.4

-0.6

0

0.2

0.4

0.6

0.8

1
Time [sec]

1.2

1.4

1.6

Electronic Signal of Motile Sperm

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Getting SECTION 4: Getting Started / Set-Up
Started
Power-On





Attach factory supplied electrical cable to the outlet on the rear panel.
Plug cable into a grounded electrical source.
Turn on SQA-V by pressing the main switch located on the rear panel. The
Power indicator will illuminate and the following screen will be displayed.

SQA-V VERSION 2.60
STANDBY POSITION
PRESS ON/OFF KEY
TO ACTIVATE THE UNIT

Auto-Calibration and Self-Test

SQA-V VERSION 2.60
PLEASE WAIT
SYSTEM STABILIZATION AND
AUTOCALIBRATION

NOTE:
Do not insert a
capillary/slide into the
device during the
stabilization process.
Do not use any of the
keyboard functions
during stabilization.



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

Press ON/OFF key on the keypad and system stabilization 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/slide 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
SQA-V is now ready for use.

MAIN MENU

TEST NEW PATIENT
RUN CONTROLS
SERVICE

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Set-up System Defaults
SQA-V system defaults are set-up through V-Sperm GOLD software. Therefore a
connection needs to be established between the SQA-V and the PC.



From the MAIN MENU, select SERVICE > SERVICE DATA.

SERVICE MENU
SERVICE DATA
SERVICE PERSONNEL
PRINT SELF-TEST DATA
ADD I-BUTTON TESTS

1.
2.
3.
4.
5.
6.
7.


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18
5
150
28
77.65
512
0.000

SERVICE DATA
8. 112
15.
9.
10
16.
10.
6
17.
11. 89
18.
12. 31
19.
13. 100
14. 100

The RS232 communication cable must be connected to the SQA-V and the PC.
Turn-on the PC and activate the V-Sperm GOLD version 3.60 software.
From the V-Sperm GOLD main navigation screen select SET-UP > SQA-V >
SQA-V Defaults. Then press the CONTINUE button.
V-Sperm GOLD will display the SQA-V system set-up screen:

SQA-V set-up
screen from
V-Sperm GOLD

CONTROL set-up
screen from
V-Sperm GOLD

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1.3
110
2
1000
1

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
NOTE: All Set-up fields
must have data in
order to transfer
information to the
SQA-V. If CONTROL
settings are not known,
enter “0” LOT #/
Target Value/+/Range. Enter current
date for the date field.



NOTE: The Set-up
data transfer may take
several minutes!
Please wait…..
NOTE: Factory default
settings are listed in
RED.




SQA-V System Default settings:

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Date Format (DD/MM/YY) or (MM/DD/YY)
Local date setting
Conc./Chamber Standard 1 or 2 (See appendix section for more information).
LES setting: Check with your distributor for set-up
Printing options: automatically print test results/self test report on start-up.
Control Set-up (from the manufacturer’s labeling):
Select type of control: Latex beads or Stabilized Sperm CAP.
Enter Lot Number for each control level (enter “0” if not known).
Enter +/- Range for each control level (enter “0” if not known).
Enter EXPIRATION date (use current date if the EXP date is unknown).
Press the Report button to view and print the selected default settings.
Press Apply to accept the default settings and transfer them to the SQA-V.

Testing SECTION 5: Testing Semen Samples
Information about the patient and sample is entered prior to the testing process. In
Samples

order to accurately "classify" the semen sample by type and volume and understand
the options for testing, refer to the information below.

Patient Entering Patient and Sample Information
Information

ENTER PATIENT / SAMPLE DATA
PATIENT ID:
5788114
BIRTH DATE:
01/01/85
ABSTINENCE:
4 DAYS
SAMPLE PROCESSING
SAMPLE / ACCESSION # 88
COLLECTED: DD/MM/YY
RECEIVED:
DD/MM/YY


PLEASE NOTE:
The SQA-V 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.

Revision 1_JUNE_2017



HH:MM
HH:MM

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 SQA-V keypad:



PATIENT ID – Unique number identifying the patient (Maximum of 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.

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Sample Press ENTER to view the next screen:
Information
SAMPLE TYPE
SELECT FRESH / WASHED / FROZEN / POSTVASECTOMY
VOLUME
WBC CONC.
PH
APPEARANCE
VISCOSITY
LIQUEFACTION
PLEASE NOTE:

2.5 ml
SELECT < 1 M/ml OR >= 1 M/ml
7.0
NORM./ABNORM.
NORM/ABNORM
NORM./ABNORM.

Sample Data



1:2 dilution means 1
part semen volume
plus 1 part diluent
volume, which results
in a 1:2 dilution. MES
has included (1+1) to
further define this
dilution in order to
prevent confusion.



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.



Select: SAMPLE TYPE (required entry) based on the following options:



FRESH – Sample not enriched, diluted or treated and is within 1 hour of
collection. Exception: Low volume samples diluted 1:2 (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) in order to quantify the impact of
freezing and thawing on the motility parameters of the specimen.



POSTVASECTOMY – Fresh samples designated as postvasectomy and
tested within an hour of collection.

Enter the remaining sample information using the SQA-V keypad:




VOLUME – Volume of the whole ejaculate in milliliters.





PH – pH of the semen sample (QwickCheck Test Strips recommended).

WBC CONC. – select < 1 M/ml (normal) OR >= 1 M/ml (abnormal)
leukocytes (required entry). (QwickCheck Test Strips recommended).
APPEARANCE – NORM/ABNORM visual assessment of the specimen.
VISCOSITY/LIQUEFACTION – NORM/ABNORM (WHO 5th guidelines for
NORM liquefaction is within 60 minutes of collection @ room temperature).

If POSTVASECTOMY SAMPLE TYPE was selected, please refer to the section
"Postvasectomy Test” in this user guide.

Sample Volume
IS SAMPLE VOLUME SUFFICIENT FOR
COMPLETE TESTING >= .5 ml?
YES/NO




Revision 1_JUNE_2017

After entering the patient and sample data, the screen above will be displayed.
Using the left and right arrow keys and then ENTER, select:




YES for NORMAL VOLUME samples ≥0.5 ml.
NO for LOW VOLUME samples < 0.5 ml.

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Low Volume
Samples




Please note:
Prior to each running a
test, the system will
perform autocalibration
(do not insert a
capillary until
instructed to do so on
the screen.)

If the sample is < 0.5 ml two options are available: Run as a low volume sample
and obtain just motility parameters or dilute the sample 1:2 (1+1) with
QwikCheck Dilution media and obtain a report of all parameters.
To run a low volume sample: 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-V Capillary with a Low Volume Samples”.
LOW VOLUME SPECIMEN
PLEASE SELECT SAMPLE TESTING OPTION:
DILUTE SEMEN 1:2 (1+1) WITH MEDIA
LOW VOLUME – 20 MICROLITERS ONLY
MOTILITY PARAMETERS ONLY
LOW VOLUME SAMPLE
SID TE4a: low volume sample
FILL CAPILLARY – 20 MICROLITERS
CLEAN
AND WIPE
CAPILLARY
SID TE4a: Low
volume
sample
query

INSERT CAPILLARY INTO CHAMBER

TEST RESULTS
MOTILITY PARAMETERS ONLY
MSC 18.5 M/ml
VELOCITY 5 mic/sec
PMSC 8.3 M/ml
SMI
26
TOTALS PER VOLUME
MOT SPERM 18.5M PROG SPERM 8.3M

Diluted
Samples



Please note:

Or the low volume sample can be diluted 1:2(1+1) with QwikCheck-Dilution
media:
LOW VOLUME SPECIMEN
PLEASE SELECT SAMPLE TESTING OPTION:

See the appendix

DILUTE SEMEN 1:2 (1+1) WITH MEDIA
LOW VOLUME – 20 MICROLITERS ONLY
MOTILITY PARAMETERS ONLY

section of this guide for
information about
dilution media.

LOW VOLUME SPECIMEN
SID TE4a: low volume sample
1. DILUTE SEMEN 1:2 (1+1) WITH MEDIA
2. TE4a:
MIX SAMPLE
THOROUGHLY
SID
Low volume
sample query
3. FILL, CLEAN AND WIPE CAPILLARY

INSERT CAPILLARY INTO CHAMBER



Revision 1_JUNE_2017

Follow the instructions in the appendix section of this User Guide: Filling the
SQA-V Capillary with a Normal Volume Sample.
The testing cycle and test results will be the same as a normal volume specimen
(see screens below).
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User Guide Version 2.60 I-button WHO 5th



Normal
Volume
Samples




The SQA-V algorithm compensates for the sample dilution as long as the sample
has been diluted accurately (If the total sample volume is 0.4 ml then 0.4 ml of a
clear media such as Earle’s buffer must be added).
Recommendation: If the LOW VOLUME sample is viscous, first treat with the
QwikCheck-Liquefaction kit and then dilute the sample for greater accuracy.
If the sample was > 0.5 ml. the screens below will be seen.
The system will first perform an FRESH
auto-calibration and check for electronic noise.
NORMAL
VOLUME
SPECIMEN
Do not insert a testing
capillary,
slide, nor
use ANY of the SQA-V keypad or
visualization functions
at
this
time.
1. MIX SAMPLE THOROUGHLY
2. FILL, CLEAN AND WIPE CAPILLARY
3. WAIT FOR AUTOCALIBRATION

AUTOCALIBRATION – DO NOT TOUCH UNIT



PLEASE NOTE:
The SQA-V will begin
testing when a capillary
is placed into the
testing chamber.

If the sample was ≥0.5 ml the screen above will provide instructions for preparing
a testing capillary.
Fill the SQA-V testing capillary according to the instructions in the Appendix
section of this user guide: “Filling the SQA-V Capillary with a Normal Volume
Sample”.
FRESH
NORMAL VOLUME SPECIMEN
1. MIX SAMPLE THOROUGHLY
2. FILL, CLEAN AND WIPE CAPILLARY
3. WAIT FOR AUTOCALIBRATION

INSERT CAPILLARY INTO CHAMBER



The screen above will be displayed when it is time to insert the filled testing
capillary in the measurement compartment, testing will begin automatically.

Testing A sample is tested in approximately 75 seconds. If the sample is low quality, the system
will perform an additional 2 minute test:

TESTING

DO NOT MOVE CAPILLARY OR
OPERATE DEVICE DURING TESTING

TESTING
LOW QUALITY SAMPLE
TESTING WILL TAKE 2 MORE MINUTES

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Test Results

TEST RESULTS
SPERM CONC.
TOTAL MOTILITY 
PROG. MOTILITY 
NONPROG. MOTILITY 
IMMOTILITY 
th
MORPH. NORM. FORMS, WHO 5

MSC
PMSC
SMI

32.6 M/ml
28 %
19 %
9
%
72 %
21 %

TEST RESULTS
9.1 M/ml
FSC
2.5 M/ml
6.3 M/ml
VELOCITY 9 mic/sec
34

TOTALS PER VOLUME
SPERM #
81.5 M MOT. SPERM 22.8 M
PROG. SPERM 15.8 M FUNC. SPERM 6.3 M
MORPH. NORM. SPERM 6.8 M

Low Quality
Test Results




Low quality test results may be reported as < or > when one or more of the
parameters falls below the SQA-V dynamic range. Only the following 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:
TEST RESULTS
SPERM CONC.
2.7 M/ml
TOTAL MOTILITY 
< 5 %
PROG. MOTILITY 
%
NONPROG. MOTILITY 
%
IMMOTILITY 
%
th
MORPH. NORM. FORMS, WHO 5
%

TEST RESULTS
MSC < 0.2 M/ml
FSC
M/ml
PMSC
M/ml
VELOCITY
mic/sec
SMI
0
TOTALS PER VOLUME
SPERM #
N.A.
MOT. SPERM N.A.
PROG. SPERM
N.A.
FUNC SPERM N.A.
MORPH. NORM. SPERM N.A.



Revision 1_JUNE_2017

The test results will be saved/printed automatically or an option to save and print
will be displayed depending on how the SQA-V was set-up.

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Printing
Saving and
Transferring
Test Results
to V-Sperm



If the SQA-V default was set to automatically print/save test results, the screen
below will now be activated.

DATA SAVED AND
NOW PRINTING





Immediately after saving/printing test results, an option to transfer the results of
the test just completed to V-Sperm is displayed on the SQA-V.
V-Sperm Gold must be activated and the PC must be connected via the RS232
cable to the SQA-V.
Following the screen directions, simply press the “Import Test” main menu
navigation button in V-Sperm and the test will automatically be transferred into
the V-Sperm data base.

TO TRANSFER TEST RESULTS TO V-SPERM:
PRESS: “IMPORT TEST” BUTTON
IN V-SPERM
PLEASE NOTE:
The SQA-V archive is
viewed from V-Sperm
only. The archive must
be transferred to the VSperm PC in order to
view, delete and edit
records.



The archive of the SQA-V can accommodate 500 Patient Test records. A warning
will appear when the archive is almost full. Data MUST be transferred to the PC
or it will be lost, overwritten or the SQA-V will no longer permit testing.
Warning QC Tests are not saved in the SQA-V (there is no QC Archive). Transfer
QC Tests to V-Sperm after performing each QC test by following the screen
instructions (above screen) after the test is run.



When the screen below is displayed, Patient Records must be transferred from
the SQA-V archive to the PC:
ARCHIVE ALMOST FULL
TO AVOID POSSIBLE LOSS OF DATA
DOWNLOAD THE ARCHIVE TO THE PC
PRESS ENTER TO CONTINUE

Revision 1_JUNE_2017




From the SQA-V, go to MAIN MENU > SERVICE > SERVICE DATA.




Turn-on the PC and activate the V-Sperm GOLD version 3.60 software.



After the records have been successfully transferred to V-Sperm, select YES
on the next screen to delete the SQA-V (Patient) archive from the SQA-V.

Make sure the RS232 communication cable is connected between the SQA-V
and the PC.
From the V-Sperm main navigation screen select IMPORT/EXPORT >
IMPORT DATA > select IMPORT ARCHIVE (PATIENT RECORDS). Press
CONTINUE and the records will automatically be transferred.

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Post Postvasectomy Test
Vasectomy
Testing The SQA-V runs a five minute POSTVASECTOMY test that can detect the presence of a
very small number of motile cells. Once the automated test has been performed, the
user is given the option to follow the POSTVASECTOMY protocol outlined below and
"scan" the testing capillary in the SQA-V visualization system (A POSTVACECTOMY
Protocol can also be found in the appendix section of this guide).

By scanning through the depth of the testing capillary, immotile and motile sperm cells
can be readily identified, easily counted and entered in the operational screen for visual
confirmation of the automated test results. Clinical studies positively demonstrated that
by incorporating both the SQA-V automated AND visualization system in the testing
protocol, a very high level of accuracy is obtained for identifying motile and non-motile
sperm cells in POSTVASECTOMY samples.
In order to obtain similar levels of accuracy it is imperative that the user strictly follow
the manufacturer's protocol outlined below. Additionally, once the testing cycle is
completed, test results can be documented by capturing and archiving a video clip of the
postvasectomy specimen using V-Sperm™ software.
Select POSTVASECTOMY as the SAMPLE TYPE from the ENTER PATIENT / SAMPLE
DATA screen.


Please note:
The POSTVASECTOMY
test takes
approximately 5
minutes to run and is
highly sensitive to
motion. Please do not
disturb the SQA-V or
the testing capillary
during the testing cycle
or the results may be
impacted.














Revision 1_JUNE_2017

Fill the SQA-V testing capillary following instructions in the appendix section of
this guide: "Filling the SQA-V Capillary with a Normal Volume Sample."
Insert the testing capillary into the SQAV lower chamber when instructed.
Testing will begin automatically.
Testing takes approximately 5 minutes.
Test results for motile sperm are
reported.
Select YES to when asked: “ENTER
VISUAL DATA PER USER GUIDE?” to
manually enter the number of
MOTILE/IMMOTILE sperm seen on the
visualization system.
Press ENTER to continue.

TESTING
DO NOT MOVE CAPILLARY OR
OPERATE DEVICE DURING TESTING
THIS TEST TAKES APPROX. 5 MINUTES
POSTVASECTOMY
# SPERM/SCAN: # SPERM/SAMPLE VOL.:
MOTILE

3

MOTILE

0.2 M

ENTER VISUAL DATA PER USER GUIDE?
YES/NO

Take the same testing capillary and
insert it into the visualization (upper)
compartment.
Set the magnification to x300 (Full zoom
out) and press ENTER to continue.
"Scan" the depth of the capillary by
slightly turning the visualization focus
knob (10 fields can be visualized) and
enter the total # MOTILE/IMMOTILE
SPERM cells visualized in all 10 fields.
The SQA-V will automatically report the
GREATER # of cells found by the
Automated or Visualization system.
Press ENTER and the test results screen
will be displayed.

19

PLEASE INSERT CAPILLARY
INTO VISUALIZATION SLOT
ADJUST MAGNIFICATION TO x300
PRESS ENTER

TURN FOCUS KNOB AND SCAN THROUGH
ENTIRE CAPILLARY DEPTH TO COUNT
MOTILE AND IMMOTILE SPERM
PLEASE ENTER:
# MOTILE SPERM
# IMMOTILE SPERM

3
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




Leave the testing capillary in the
visualization chamber and transfer the
test results to V-Sperm to capture and
attach a video clip of the sample in the
patient’s record.
If the SQA-V reports > 30 motile
spermatozoa, a screen will indicate that a
NORMAL TEST should be run instead of a
POSTVASECTOMY test.
> 30 motile spermatozoa is equivalent to
MSC > 2M/ml.

POSTVASECTOMY
# SPERM/SCAN:
MOTILE

PLEASE RE-RUN AS A NORMAL TEST
POSTVASECTOMY
# SPERM/SCAN:

20

# SPERM/SAMPLE VOL:

MOTILE

3

MOTILE

0.2 M

IMMOTILE

8

IMMOTILE

0.5 M

TOTAL

0.7 M

TOTAL

Revision 1_JUNE_2017

> 30

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Controls SECTION 6: Controls
Set-Up and
Testing External quality control samples (CONTROLS) are run on the RUN CONTROLS mode
Please note:
When a new control lot
is used, the control
default settings must
be changed prior to
initiating a test.
Refer to section(s):
Set-up: Assayed
Control and
Set-up: Non Assayed
material

from the MAIN MENU of the SQA-V. Commercially available latex beads or stabilized
sperm CAP can be run as non-assayed controls. QwikCheck™ beads produced by
Medical Electronic Systems are assayed for the SQA-V. It is recommended that
controls be run daily or based upon laboratory protocols.
The control media is aspirated into the testing capillary and run in the same manner
as a normal volume specimen in the testing compartment of the SQA-V.
For each new lot of controls, SQA-V system defaults need to be set-up/updated
through V-Sperm GOLD prior to running a test. To run an assayed control use the
information for Target Value and +/- Range provided on the product labeling. To run a
non-assayed control, the Target Value and +/- range must be established by the
laboratory or set 0 (zero) if not established. Follow instructions below to set-up an
assayed or non-assayed material. The testing process is the same.

Set-Up: Assayed Control
Each time a new lot of an assayed control is to be run, the user must set-up/update
the CONTROL settings through V-Sperm GOLD as described below. Previous settings
(defaults) will remain in place until updated.
Step 1:

From the SQA-V MAIN MENU select SERVICE > SERVICE DATA.

Step 2:

Make sure the SQA-V is connected to the PC via the RS232
communication cable.

Step 3:

Activate the V-Sperm on the PC and select: SET-UP > SQA-V and
press CONTINUE.

Step 4:

The set-up screen below will be activated in V-Sperm GOLD on the PC:

Step 5:

Select the type of control (Latex Beads or Stabilized Sperm)

Step 6:

Enter the following information from the box labeling:

Please note:
Level 1, 2, and
NEGATIVE control setup screen from
V-Sperm GOLD.
The NEGATIVE control
may also be labeled
Level 3 control on the
SQA-V.
For the SQA-V to work
properly the CONTROLS
must have set-up data
inserted. If control
material is not available
or non-assayed enter
current date in the EXP
Date field and zeros in
all other fields.

Step 7:

Revision 1_JUNE_2017



LOT# - number identifying the control media lot.



EXP. DATE – control expiration date (MM = month, YY = year).



TARGET VALUE and +/- Range –manufacturer's "Target Value
and +/- Range” for the SQA-V Automated System.



NEGATIVE control target values and +/- ranges are pre-set to 0.0.

To save settings: Press APPLY. The set-up may take two minutes.

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User Guide Version 2.60 I-button WHO 5th
Set-Up: Non-Assayed Material to Establish the target value and +/- range
This is also the set-up procedure for sperm concentration proficiency
challenge
Please note:
To run 10 replicates:
After each completed
test, remove the
capillary and initiate
the CONTROL test
again using the same
capillary.

Follow the same Steps 1-5 for “Set-up: Assayed Control” above.
Step 6:

Step 7:

Enter the following information from the product labeling


LOT# - number identifying the control media lot.



EXP. DATE – control media expiration date (MM=month, YY=year).

Enter the TARGET VALUE and +/- Range for Level 1 and Level 2:


Enter 00 for the target value.



Enter 0.0 for the +/- range.



NEGATIVE control target value and +/- range is pre-set to 0.0

Step 8:

Save settings: Press APPLY. The set-up takes about two minutes.

Step 9:

Establish the target value and +/- range for each level:


Fill a testing capillary and run 10 replicates following the instructions
below “Control Testing.”



Calculate the mean target value. Based on laboratory protocols
determine the +/- range (Example: 2SD).



Follow steps 1-7 of “Set-Up: Assayed Control” to update the target
value and +/- range for the control.

Running CONTROL Testing
Controls in
the SQA-V













Revision 1_JUNE_2017

MAIN MENU

Select RUN CONTROLS from the
MAIN MENU of the SQA-V.
The Control defaults have already
been set-up in V-Sperm.
Select the CONTROL LEVEL: #1, #2
or NEGATIVE (LEVEL #3) that is being
tested.

TEST NEW PATIENT
RUN CONTOLS
SERVICE

CONTROL LATEX BEADS
SELECT:
CONTROL LEVEL:
LEVEL #1/LEVEL #2/NEGATIVE CONTROL

Press ENTER to continue.
Controls are run in exactly the same
manner as a normal semen sample.

PRESS ENTER TO CONTINUE

Using control media, follow the same
procedure for filling an SQA-V testing
capillary with a NORMAL volume
sample.

CONTROL: LATEX BEADS, LEVEL #1

Testing will begin automatically.
Control test results will be displayed
on the SQA-V screen.
LOW, HIGH or NORM. will be displayed
based on the testing outcomes vs.
target value and +/- range (Disregard
this for non-assayed controls target
range set at “0”).
Test results will automatically be saved
and printed.

22

FILL, CLEAN AND WIPE CAPILLARY
INSERT IN CHAMBER
TESTING WILL BEGIN
AUTOMATICALLY
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

User Guide Version 2.60 I-button WHO 5th

Electronic Self-Test and Auto Calibration
The SQA-V 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 SQA-V 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 SQA-V
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 SQA-V system parameters to prepare for
technical support:
How to print a copy of the system parameters FROM THE SQA-V:





Remove the testing capillary from the system.
When a FAILED SELF TEST message appears select: MAIN MENU >
SERVICE>PRINT SELF-TEST DATA.
Press ENTER to generate a report.

How to view/print a copy of the system parameters FROM V-SPERM GOLD:






Revision 1_JUNE_2017

Verify that the SQA-V is connected to the PC and V-Sperm is activated.
From the SQA-V activate: MAIN MENU > SERVICE > SERVICE DATA.
Select the V-Sperm navigation buttons: UTILITIES>SELF-TEST DATA and
click CONTINUE.
Click on the PRINT button to view a Service Data Report.
Click PRINT in the upper left hand corner of the screen to print a report.

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User Guide Version 2.60 I-button WHO 5th



#
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

Revision 1_JUNE_2017

Refer to the table below. Enter numbers in the "SQA-V Value" column
that corresponds to the SQA-V system parameters printout. Compare
the values. If the value from the SQA-V is within range mark the
"Pass" column. If not, mark the "Fail" column.
Parameter
Ref 1
LED Cur 1
Amplitude
Zero Level
Ref 2
LED Cur 2
CONC. 1
CONC. 2
CONC. 3
Count (Service
Data, Item #12)

S/W Ver. 2.60

150 – 400 mV
5 – 25 mA
50 – 100 mV
500 - 525
2500 – 3500 mV
10 – 32 mA
0 – 1 M/ml
50-150 M/ml
300-600 M/ml
26 - 36

24

SQA-V Value

Pass

Fail

User Guide Version 2.60 I-button WHO 5th

Archive SECTION 7: Transferring the SQA-V Archive to V-Sperm
The SQA-V automatically prints PATIENT and CONTROL test results when a test is
completed. Only PATIENT TEST results (not CONTROL test results) are saved in the
SQA-V archive when the testing cycle is complete. To view, navigate, edit and
delete records, the test results have to be transferred to V-Sperm immediately
after running a test (on-line transfer) or imported to V-Sperm as a group (Patient
tests only). The SQA-V can store 500 patient records but does not store the control
records.
The screen below will be displayed when the PATIENT archive of the SQA-V is almost
full:

ARCHIVE ALMOST FULL
TO AVOID POSSIBLE LOSS OF DATA
DOWNLOAD ARCHIVE TO PC
PRESS ENTER TO CONTINUE

The following screen will appear after every CONTROL TEST is performed:
ATTENTION!
TO AVOID LOSS OF DATA
TRANSFER CONTROL RESULTS TO V-SPERM
PRESS: “IMPORT TEST” BUTTON
IN V-SPERM
To transfer data to V-Sperm, first connect the SQA-V to the PC and activate the
V-Sperm software. There are two options for transferring test results to V-Sperm:
IMPORT TEST RESULTS ON-LINE:




Immediately after saving/printing test results, an option to transfer the results
of the test just completed is displayed on the SQA-V.
Following the screen directions, simply select the “Import Test” main menu
navigation button in V-Sperm and the test will automatically be transferred
into the V-Sperm data base.
TO TRANSFER TEST RESULTS TO V-SPERM:
PRESS: “IMPORT TEST” BUTTON
IN V-SPERM

IMPORT PATIENT RECORDS FROM THE SQA-V TO V-SPERM:




Revision 1_JUNE_2017

Select the V-Sperm navigation button: IMPORT/EXPORT.
Select: IMPORT DATA > IMPORT ARCHIVE and press CONTINUE and the
tests will automatically be transferred.
Select: YES on the next screen to delete records from the SQA-V archive.

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Service SECTION 8: Service Menu
Menus

System set-up, maintenance and calibration can be performed from the SERVICE MENU.
To activate this screen, press SERVICE in the MAIN MENU.
SERVICE MENU
SERVICE DATA
SERVICE PERSONNEL
PRINT SELF-TEST DATA
ADD I-BUTTON TESTS
Service Data

Communication between the SQA-V and a PC via the RS232
interface is established through the SERVICE DATA screen.
System set-up and upgrades are also performed through
this screen.
The SQA-V archive can be transferred to a PC only when this
screen is activated.

Please note:
Go to the SQA-V to
load I-button tests
directly to the device.

Service
Personnel

A code is required to access SERVICE PERSONNEL. This option
allows a qualified service technician to access calibration and
maintenance settings.

Print SQA-V
SELF-TEST DATA

The system SELF-TEST DATA can be printed from this option.

Add I-Button
Tests

From the SQA-V MAIN MENU SELECT: SERVICE > ADD IBUTTON TESTS and follow the on screen instructions seen below:
TO LOAD I-BUTTON TESTS:
1. SLIDE I-BUTTON UNDER THE CLIP
2. PRESS DOWN FIRMLY
3. BUTTON MUST CONTACT PORT EDGES
PRESS ENTER
CONTINUE TO HOLD BUTTON
The I-Button loading screen below will appear:

PLEASE WAIT
I-BUTTON LOADING

The screen below will be displayed after successfully loading tests:

# OF TESTS ADDED:
# OF TESTS NOW REMAINING:
PRESS ESC TO EXIT

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Visualization SECTION 9: Operating the Visualization System (Video Display)
System

The SQA-V Visualization System with video display (upper screen) is used to view and
count sperm cells. The visualization system is a critical "link" to V-Sperm GOLD where
enhanced, real time video can be displayed on a PC monitor. The visualization system:





Accommodates both an SQA-V testing capillary to "scan" through a depth of
300 microns or a standard slide to view samples (20 micron depth).
Operates via control knobs to set focus, brightness, contrast and color, and via
the keypad zoom, illumination, and monitor on/off functions.
Magnification range: x300 to x500.

Operating Standard Slide Preparation:
Instructions





Use 10 µl of semen.

Standard slide, 22 mm x 22 mm cover-slip (to insure 20 micron depth).
Load the prepared, standard slide into the SQA-V slide adaptor.

Testing Capillary Preparation:



Fill the SQA-V testing capillary for either a normal or low volume specimen
(see Appendix).

Visualization Process:










The video display will automatically illuminate when the SQA-V is turned on.
Use monitor ON/OFF key on the keypad to independently operate the video
display.
Wait for the self-test to complete (system is disabled at this time).
To ensure that the visualization system is working properly prior to use:



Press the HIGH ILLUMINATION key multiple times to ensure a
maximum level setting.




To view cells: Press ZOOM IN to maximum magnification (x500).
To count cells: Press ZOOM OUT to minimum magnification (x300).

Insert semen sample (either capillary or slide) into the visualization chamber.
Adjust CONTRAST, COLOR, BRIGHTNESS, FOCUS and object
ILLUMINATION controls for optimal image quality.
Use ZOOM OUT (x300) / ZOOM IN (x500) to regulate magnification.

Counting Cells Using the Visualization Screen:
1. Follow the WHO Manual instructions for semen sample collection and
preparation. Thoroughly mix the sample before step #2.
2. Pipette 10uL of the semen sample onto a standard slide and cover with a
22x22 mm coverslip. Prepare a new slide if air bubbles or liquid spillage
occurs.
3. Load the slide into the slide adaptor and then insert the slide adaptor into the
SQA-V visualization chamber. (Refer to the SQA-V User Guide APPENDIX 3:
Using Standard Slides in the Visualization System for details).
4. Press the ZOOM-OUT button on the SQA-V keypad all the way to set the
magnification to x300.

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User Guide Version 2.60 I-button WHO 5th
Please note:
The visualization
screen grid of the
SQA-V is calibrated
to a CONC
STANDARD default
of “1” or
Makler/nondilutional chambers.
Please see the
Appendix Section
“Concentration
Standard –
Counting
Chamber” for
details.

5. Set the: BRIGHTNESS, CONTRAST & COLOR knobs of the video display:
a.

COLOR knob: Turn clockwise to the end (maximum color),

b.

CONTRAST: Turn counterclockwise to the end (maximum contrast),

c.

BRIGHTNESS knob: Turn clockwise from the darkest setting until the
background is light (not maximum!).

6. Adjust the focus knob to maximize the image: Turn clockwise all the way.
Then turn counterclockwise until a clear image appears on the screen.
7. Go to V-Sperm and click on the Real Time Video button. FREEZE the image.
8. The screen of both the SQA-V and the V-Sperm is divided into a grid
containing 20-distinct squares (see below).

9. Each spermatozoon seen on the ENTIRE 20-square grid is 1 Million/ml of
sperm concentration. FOR EXAMPLE: In the grid above, there are 7
spermatozoa in each cell of the grid. 7 (spermatozoa) X 20 (cells) = 140 M/ml
sperm concentration for this sample.
10. To count a minimum of 200 cells (per WHO), turn the silver knob of the slide
adaptor and a new field of view will be displayed in the grid.
11. When viewing multiple fields, divide the final count by the number of screens
(fields of view) counted. For example, if two of the screens above are counted
there would be a total number of 280 sperm cells so the sperm concentration
will be: 280 ÷ 2 = 140 M/ml.
12. Refer to table 2.2 of the WHO Manual 5th Edition to determine if the duplicate
counts are acceptable.

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Error and SECTION 10: Error Messages, Warning Messages and General
Warning
Messages Warning
General Warning:






The SQA-V equipment’s built-in protection for the operator and the
environment is ONLY operational if the SQA-V is operated properly following
the manufacturer’s specifications.
CAUTION: There is a risk of explosion or shorting if the SQA-V battery is
replaced by an incorrect type. Replacement batteries MUST be the same type
and manufacturer. Dispose of used batteries in accordance with the
manufacturer instructions.
Environmental condition for storage and transport: Recommended to store the
SQA-V at temperatures between 20°C -30°C.
Following the manufacturer’s recommended use, the expected life span of the
SQA-V is a minimum of 5 years. The life span can be extended when utilizing
the manufacturer’s annual preventative maintenance plan.

Stabilization Failed:






Ensure there is no testing capillary in the measurement compartment.
Remove the SQA-V from sources of electronic noise and vibrations.
Clean measurement compartment (refer to Appendix).
Reboot the SQA-V 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:





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Ensure there is no testing capillary in the measurement compartment.
Remove the SQA-V from sources of electronic noise and vibrations.
Clean measurement compartment (refer to Appendix).
Reboot the SQA-V without a testing capillary in the chamber:

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




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/Stabilization.

Call technical support if this message is displayed again. Prepare for technical
support by printing a copy of the SQA-V SERVICE DATA:



Press the SERVICE key on the SQA-V keypad to activate the SERVICE
MENU screen.




Select: PRINT SELF TEST DATA.
Press ENTER.

Electronic Noise:





Ensure there is no testing capillary in the measurement compartment.
Remove SQA-V from sources of electronic noise 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/Stabilization.

From the 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 SQA-V SERVICE DATA:



Press the SERVICE key on the SQA-V keypad to activate the SERVICE
MENU screen.




Select: PRINT 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 if the SQA-V reads:





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SPERM CONC > 500 M/ml or MSC > 450 M/ml

Review sample handling technique (Appendix "Filling the SQA-V Capillary").
Re-test the sample in a new SQA-V capillary. If the message appears again,

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reboot the system.


APPENDIX 1:

Call for technical assistance if problem persists.

Filling the SQA-V 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. Sample container should be wide-necked and deep enough to
facilitate inserting the capillary into the sample at the bottom of the
container.
3. The semen sample must be completely liquefied and well mixed
prior to aspiration. Gently rotate container to fully mix liquefied
specimen.
WARNING: Do not shake nor use a pipette to aspirate and dispense
specimen in order to mix, otherwise air bubbles will form.

Figure 1

4. Carefully check that liquefied, fully mixed specimen is free of air bubbles (or that there is
an adequate amount of sample below the air bubbles) before immersing the capillary into the
specimen, thus ensuring that no air bubbles will be aspirated into the capillary.

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. Placing two fingers below the piston head 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

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NOTE: Transferring the sample to a standard "tissue culture dish" (3 cm in diameter/1 cm deep)
will allow better visual control when filling the capillary as an intermediate step (see Figure 2).
3.

Holding the capillary in a vertical position (Figure 3), visually confirm
that the sample has completely filled the thin section (without a
meniscus) and the cuvette section and appears in the Luer adaptor. 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.

4. Quickly (to avoid wicking) and thoroughly wipe the outer surface of
the capillary - both top and bottom (Figure 4) with a delicate wipe
(Kimwipes, etc.). It is important to remove all semen from the exterior of
the capillary in order to prevent the SQA-V optical chamber from
becoming clogged. Visually confirm that the capillary chambers are still
full following the cleaning process. If some of the sample has been
depleted (meniscus formed in the thin part of the capillary) fill the
capillary part from the cuvette section by slightly pushing in the piston.

Figure 3

Figure 4

5. Slowly and carefully push-in the separating valve until it is level with
the plastic (Figure 5). The capillary is now ready to be inserted into one
of the SQA-V compartments for testing or viewing.

Figure 5

6. For automated testing push the
testing capillary into the lower
measurement compartment
with the blue stopper down.
Push it in as far as it will go to
ensure that the capillary is properly
seated in the compartment.
7. To visualize the specimen,
insert the capillary into the
visualization compartment with
the blue stopper up.

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APPENDIX 2: Filling the SQA-V Capillary with a Low Volume Sample
Sample size, collection container and preparation:
1. A sample as small as 20 micro liters can be tested for motility parameters by filling ONLY the thin
section of the testing capillary (Figure 1).
2. The semen sample must be completely liquefied and well mixed prior to
aspiration. Gently rotate the container to fully mix the liquefied specimen.
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 the liquefied, fully mixed specimen is free of air
bubbles (or that there is an adequate amount of sample below the air
bubbles) before immersing the capillary into the specimen, thus ensuring that
no air bubbles will be aspirated into the capillary.
4. It is recommended that the sample be withdrawn from a standard
"tissue culture dish" (3 cm in diameter/1 cm deep) to allow for better
visual control when filling the capillary.

Figure 1

Figure 2

Filling the capillary:
1. Push the syringe piston in fully. Place only the thin part of the capillary
into the bottom of the sample (Figure 1).
2. Pull the piston back slowly without withdrawing the capillary from the
sample. Fill only the (thin) capillary chamber with 20 micro liters of
semen (Figure 1). The exact quantity aspirated can be determined by the
gradations on the 1 ml syringe. Aspirate the sample until it just appears in
the cuvette part while keeping the tip of the capillary well below the sample
level and well below the level of any bubbles covering the liquid. Withdraw
the capillary tip from the semen sample and visually inspect the capillary to
ensure that the sample has completely filled the thin section (no meniscus).

Figure 3

Figure 4

3. Quickly (to avoid wicking) and thoroughly wipe the outer surface of the
capillary - both top and bottom with a delicate wipe (Kimwipes, etc.). It is
important to remove all semen from the exterior of the capillary in order to
prevent the SQA-V optical chamber from becoming clogged. Visually confirm
that the thin chamber of the capillary is still full of semen after completing
the cleaning process. If some of the sample has been depleted push-in the
piston slightly until the first drop appears on the capillary tip and then fill the
capillary again from the sample container.
4. The separating valve must now be removed. Detach the entire syringe from the hub (Figure 2) and
use the syringe tip to firmly push-out the separating valve from the underside of the capillary
(Figure 3). Completely detach the separating valve (Figure 4). The capillary is now ready to be
inserted into the SQA-V.
5. PLEASE NOTE: Test Low Volume samples as soon as the sample is aspirated into the
capillary.

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APPENDIX 3: Using Standard Slides in the Visualization System
Introduction
The SQA-V has a specially designed slide adaptor that enables the user to use standard slides to view
semen samples in the SQA-V visualization compartment. A slide is "seated" in a stable and secure manner
as described below and the slide adaptor is inserted into the SQA-V for testing.

User Instructions:
1. The slide adapter is designed for standard laboratory slides that are 76 mm long and 25.6 mm
wide. Thickness may vary from 1 mm to 2 mm. The viewing section of the slide must be completely
transparent.
2. Center a 10 micro-liter drop of semen at a distance of approximately 12 mm from the edge of the
slide and cover with a standard (22 mm x 22 mm) cover-slip. The droplet of semen should be
evenly spread across the entire surface area of the cover-slip automatically, without any additional
pressure applied to the cover-slip:

Sample location
3. Carefully place the prepared slide into the
slide adapter (with the non-loaded side
towards the slide holder):

6. Insert the fully loaded slide adapter into the
visualization chamber of the SQA-V:

4. Open the spring loaded slide holder by
pressing on its outer edge. Slip the slide into
the holder and release the spring:

5. Align the edge of the slide with the distal
edge of the slide adapter by turning the
silver slide position adjuster as seen below.
The slide will now be firmly in place in the
slide adapter:

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7. Optimize the video image in the usual
manner (please see the SECTION 9:
Operating the Visualization System) and
move to additional fields of view by turning
the silver knob of the slide adapter.

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APPENDIX 4: Counting Cells using the SQA-V Visualization System
1. Follow the WHO Manual instructions for semen sample collection and preparation. Thoroughly mix the
sample before step #2.
2. Pipette 10uL of the semen sample onto a standard slide and cover with a 22x22 mm cover slip. Prepare a
new slide if air bubbles or liquid spillage occurs.
3. Load the slide into the slide adaptor and then insert the slide adaptor into the SQA-V visualization
chamber. (Refer to the SQA-V User Guide APPENDIX 3: Using Standard Slides in the Visualization System
for details).
4. Press the ZOOM-OUT button on the SQA-V keypad all the way to set the magnification to x300.
5. Set the: BRIGHTNESS, CONTRAST & COLOR knobs of the video display:
a.

COLOR knob: Turn clockwise to the end (maximum color),

b.

CONTRAST: Turn counterclockwise to the end (maximum contrast),

c.

BRIGHTNESS knob: Turn clockwise from the darkest setting until the background is light (not
maximum!).

6. Adjust the focus knob to maximize the image: Turn clockwise all the way. Then turn counterclockwise
until a clear image appears on the screen.
7. Go to V-Sperm and click on the Real Time Video button. FREEZE the image.
8. The screen of both the SQA-V and the V-Sperm is divided into a grid containing 20-distinct squares (see
below).

9. Each spermatozoon seen on the ENTIRE 20-square grid is 1 Million/ml of sperm concentration. FOR
EXAMPLE: In the grid above, there are 7 spermatozoa in each cell of the grid. 7 (spermatozoa) X 20
(cells) = 140 M/ml sperm concentration for this sample.
10. To count a minimum of 200 cells (per WHO), turn the silver knob of the slide adaptor and a new field of
view will be displayed in the grid.
11. When viewing multiple fields, divide the final count by the number of screens (fields of view) counted. For
example, if two of the screens above are counted there would be a total number of 280 sperm cells so
the sperm concentration will be: 280 ÷ 2 = 140 M/ml.
12. Refer to table 2.2 of the WHO Manual 5th Edition to determine if the duplicate counts are acceptable.

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APPENDIX 5: Cleaning the Capillary Compartment

Fig. 1: Long cleaning brush

When to clean: DAILY (step 1), WEEKLY (step 2)
 Or if SELF-TEST or any other failure occurs
 Or if System becomes contaminated with semen
Cleaning kit components:
Long cleaning brush
Fibrous material cleaning paddles (single use)
Sponge-tipped drying paddles (single use)
Cleaning fluid (single drop dispenser)

Fig. 2: Cleaning lower chamber

PLEASE NOTE: Cleaning and drying Paddles are for
ONE TIME use only!

Fig. 3: “Dusting off”

CLEANING: STEP 1 (DAILY)
 Insert the long brush (bristle side down) into the
upper portion of the lower chamber of the SQA in
the same manner as a testing capillary (Fig 1 and 2).

Fig. 4: FIBROUS cleaning paddle

 Pull the brush out, applying downward pressure to
sweep or „dust off‟ the optics (you will feel a „shelf‟ in
the back/top section of the chamber) – (Fig 2 and 3)
 Monitor the system’s “REF. 2” parameter. It
should be between 2800 and 3200 mV if possible.

CLEANING: STEP 2 (WEEKLY)
1. Use a Fibrous material cleaning paddle (fig 4)
 Moisten with only ONE drop of cleaning fluid.
 Shake off excess fluid.
 Insert into the measurement compartment fibrous
material facing DOWN ONLY (fig 5)
 Move the cleaning capillary in and out three times.

Fig. 5: Insertion-Fibrous material facing DOWN

2. Use a sponge-tipped drying paddle into the testing
chamber and leave it for 10 – 15 seconds (fig 6).
NOTE: Do not move this drying paddle in and out.

Fig. 6: Insertion of drying Paddle

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APPENDIX 6: Reference Values of Semen Variables

SQA-V
TEST NAME

REFERENCE
RANGE*

SOURCE

SPERM CONC.

≥15 M/ml

WHO 5th manual*

Total Motility (PR+NP)

TOTAL MOTILITY


≥40 %

WHO 5th manual*

Progressive Motility (PR)

PROG. MOTILITY


≥32 %

WHO 5th manual*

NONPROG. MOTILITY


-

-

IMMOTILITY 

-

-

MORPH. NORM
FORMS, WHO 5th

≥4%

WHO 5th manual*

Motile Sperm Concentration

MSC

≥6 M/ml

MES*

Progressively Motile Sperm
Concentration

PMSC

≥5 M/ml

MES*

FSC

-

-

VELOCITY

≥5 mic./sec.

MES*

Sperm Motility Index

SMI

≥80

MES*

Total Sperm Number

SPERM #

≥39 M

WHO 5th manual*

MOT. SPERM

≥16 M

MES*

Total Progressively Motile Sperm

PROG. SPERM

≥12 M

MES*

Total Functional Sperm

FUNC. SPERM

-

-

MORPH. NORM.
SPERM

≥2 M

MES*

SEMEN PARAMETER
Sperm Concentration (Count)

Non-progressive Motility (NP)
Immotility (IM)
Sperm Morphology (normal forms, %)

Functional Sperm Concentration
Velocity (Average path velocity – VAP)

Total Motile Sperm

Total Morphologically Normal Sperm

The ranges established above are based on WHO 5th reference values or MES (for proprietary semen parameters).

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APPENDIX 7: Measuring WBC's in Semen
SQA-V Visualization System
Follow directions for preparing a standard slide with 10 µl of semen and refer to the "Using the Visualization
System" section of this guide. View up to 10 fields by turning the silver slide adaptor knob. Search for
leukocytes. If >1 M/ml are seen on the visualization system, select ABNORMAL (ABNORM) in the SAMPLE
DATA screen.

QwikCheckTest Strips for Semen
Place one drop of semen on the test patch for WBC's (leukocytes) and follow the instructions on the TEST
STRIP label/insert. Compare the patch to the color scale for WBC on the container. If the patch exceeds the
darkest lavender color on the scale it indicates that WBC concentration in the sample is abnormal or >1
Million/ml.
NOTE: Test strips are also supported for pH testing of semen.
Clinical Trial
The WBC patch of the test strip changes color due to a chemical reaction caused by the presence of esterase
in granulocytes. Esterases cleave to indoxyl ester, liberating the indoxyl which then reacts to diasonium salt to
produce a violet dye. This chemical reaction is not affected by bacteria, trichomonads or erythrocytes present
in the specimen.
QwikCheck test strips were evaluated by Medical Electronic Systems Ltd. (MES) for use as a qualitative
indicator (WBC's >1M/ml) of WBC's in human semen. To test this application WBC's were isolated from blood
and re-suspended in seminal plasma. Varying concentrations of WBC's in seminal plasma were tested using
the test strips. Test results were analyzed visually and by spectrophotometer readings.
Results and Conclusion
When the WBC concentration in semen is >1 Million/ml the WBC patch of the QwikCheck test strips exceeds
the darkest lavender color on the color chart after the testing time. (This reading corresponds to WBC
concentration > 1 Million/ml that is considered abnormal according to WHO 2010 5th edition, Pg. 107). A NEG
includes both the NEG color on the label AND any color of lavender LIGHTER than the >1M patch on the label.
References
WHO 2010 5TH edition laboratory manual for the examination of human semen, Pg. 16 (pH) and 107
(Leukocytes), Cambridge University Press.

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APPENDIX 8: Dilution Media

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APPENDIX 9: Treating Viscous Samples

PRODUCT INSERT
INTRODUCTION AND INTENDED USE
The QwikCheckTM Liquefaction Kit can be used to accelerate the liquefaction of viscous semen
samples that remain viscous thirty minutes after collection. High viscosity can impact the accurate
measurement of motility and concentration. Use QwikCheckTM Liquefaction to prepare viscous
semen samples for automated or manual semen analysis. For in-vitro use only.
KIT CONTENTS
 20 single dose, 5 mg vials of lyophilized α-Chymotrypsin and a product insert.
STABILITY AND STORAGE CONDITIONS



The product has a one year shelf life. Note the expiration date on the box and vials.
Vials can be stored at room temperature.

INSTRUCTIONS FOR USE
1. Select one vial of α-Chymotrypsin.
2. Tap the vial to move the contents to the bottom of the vial prior to opening.
3. Add the entire contents of one vial to a viscous semen sample.
4. Gently mix the sample to dissolve the powder.
5. Once the sample has liquefied (5-10 minutes), immediately perform automated testing or
neutralize the enzymatic activity (optional) by adding of Human Serum Albumin (HSA) (not
provided in this kit).
CLINICAL PERFORMANCE: Semen Samples Treated with QwikCheck Liquefaction:

Parameter:

Correlation Coefficients:
Semen samples Treated with
Chymotrypsin vs. Nontreated semen samples

Concentration

R = 0.98

Total Motility

R = 0.99

Progressive
Motility

R = 0.99

Morphology

R = 0.95

Conclusions:
 Test results demonstrated high
correlations for Concentration, Total
Motility, Progressive Motility and
Morphology between the treated
with chymotrypsin (QwikCheck
Liquefaction Kit) and non-treated
semen samples when run on the
SQA-V.
 No detrimental effect is seen when
treating semen samples with
QwikCheck™ Liquefaction kit
containing 5 mg chymotrypsin.

PRECAUTIONS AND WARNINGS
Each vial contains α-Chymotrypsin, a protease. This protease can cause irritation to eyes,
respiratory system or skin. In case of contact with eyes, rinse immediately with water and seek
medical attention. Observe the following preautions when handling the product:
 Wear suitable protective clothing: Mask, gloves and laboratory coat.
 Avoid dispersing material over the working area.
REFERENCES: WHO Laboratory Manual for the Examination of Human Semen and SpermCervical Mucus Interaction, 5th Edition, Cambridge University Press, 2012.

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APPENDIX 10: Assayed Control: QwikCheck™ Beads

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Appendix 11: Concentration Standard: Counting Chambers
A number of commercially available counting chambers are used in laboratories for manually counting sperm
cells. These chambers vary by depth and one type requires a diluted sample. It has been clinically established
that counts vary by approximately 30% depending on the chamber used.
The SQA-V permits the user to select the type of chamber the laboratory has implemented as a standard for
manual semen analysis. Once the concentration standard (CONC. STANDARD) has been selected the SQA-V will
automatically run semen samples based on that standard.

SQA-V Set-Up:





Select SERVICE > SERVICE DATA.
Log into V-Sperm and go to SET-UP > SQA-V > CONTINUE
Select a CONC. (concentration) STANDARD based on aligning the system with the options shown in
the table below:








CONC. STANDARD #1
CONC. STANDARD #2

Commercially available counting chambers are divided into two unique groups:
Standard #1: 10-20 micron depth and do not require sample dilution.
Standard #2: 100 micron depth (haemocytometers) that require sample dilution.

The table below classifies some commercially available chambers:

CHAMBER STANDARD #1

CHAMBER STANDARD #2

Makler

Beurker-Tuek

Micro-Cell

Buerker

Fixed Cover slip disposable chambers

Fuchs-Rosenthal
Fuchs-Rosenthal (modified)
Improved Neubauer
Neubauer
Malassez
Thoma
Thoma Modified

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Appendix 12: Post-vasectomy Protocol
The SQA-V runs a five minute POSTVASECTOMY test that can detect the presence of a very small number
of motile cells. Once the automated test has been performed the user is given the option to follow the
POSTVASECTOMY protocol outlined below (also refer to the Appendix section of this guide) and "scan" the
testing capillary in the SQA-V visualization system.
By scanning through the depth of the testing capillary the user is able to identify and readily count immotile
cells and visually confirm automated test results. Clinical studies positively demonstrated that by
incorporating both the SQA-V automated AND the visualization system in the testing protocol, a very high
level of accuracy is obtained for identifying motile and non-motile cells in POSTVASECTOMY samples.
In order to obtain similar levels of accuracy it is imperative that the user strictly follow the manufacturer’s
protocol outlined below. Additionally, once the testing cycle is complete, the user has an opportunity to
document test results by capturing and archiving a video clip of the postvasectomy specimen using
V-Sperm™ software.
This test is highly sensitive to any movement. The SQA-V and the testing capillary should not be disturbed
in any way during the 5 minute testing cycle.













Fill BOTH sections of the SQA-V testing capillary (for stability during the 5-minute test).
If the specimen volume is not adequate to fill both sections, dilute it with Earle's Buffer and
multiply results by the dilution factor.
Follow the user guide for instructions on running a POSTVASECTOMY sample.
Run the automated 5-minute test for motility parameters.
Remove the capillary and insert it into the visualization system and "scan" ten fields of the SQA-V
capillary following the user guide instructions.
Enter the number of motile and immotile sperm cells visualized.
The final test results will report the greater number of cells found in the automated or visualization
test.
Leave the testing capillary in the visualization system.
Save the test to the SQA-V archive and import it to the V-Sperm GOLD software.
Following the V-Sperm user guide instructions, import the test into the V-Sperm data base and
attach a live VIDEO clip to the patient’s test record for documentation purposes.
NOTE: If the SQA-V is reporting > 30 motile spermatozoa, a screen will indicate that a NORMAL
TEST should be run instead of POSTVASECTOMY > 30 motile spermatozoa is equivalent to
MSC > 2M/ml.

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APPENDIX 13: GLOBOZOOSPERMIC SAMPLES

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APPENDIX 14: SQA-V SERVICE SUPPORT REPORT

SQA-V SERVICE SUPPORT
Parameter Report
Device number: _______

SQA-V Software Version: ___________

Date: __________

Instruct the user to run a SERVICE report. For version 2.60 from the MAIN MENU select: SERVICE > PRINT
SELF TEST DATA.
Calibration parameters:
Fill-in the USER REPORT column with the calibration parameters found in the INTERNAL DATA SECTION of the
SERVICE DATA REPORT run on the “defective” SQA-V. Contact MES for the initial calibration parameters. These
parameters should not have changed.

Parameter

Service
Report
Item #

CONTR.REF1

#1

OD AMPLIF.

#13

MSC AMPLIF
OD VALUE
OD CORR
LB OD AMP
CONTR. Z.L*

#8
#15
#16
#18
#11

User Report

MES
Report

Comments

*CONTR. Z.L. can be adjusted in the field by a MES trained service technician.
Algorithm parameters:
Fill-in the User Report values for the following algorithm parameters found in the SERVICE DATA REPORT.
The SQA-V algorithm settings are defined and should not have changed.

Parameter

Service
Report
Item #

User
Report

MES
Settings

MIN.SP.HEIGHT

#2

5

MIN.SP.WIDTH

#9

10

MAX.SP.WIDTH

#3

150

NOISE THRESH

#10

6

SMI THRESH

#4

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Self Test Parameters:
Fill-in the SQA-V SELF TEST PARAMETERS from the SELF TEST printout in V-Sperm:



The SQA-V must be connected to the PC and V-Sperm activated.



From the SERVICE>SERVICE DATA screen of the SQA-V:


Go to the V-Sperm navigation buttons: UTILITIES>SELF TEST DATA



Select PRINT



Verify that the parameters listed below fall within the established range



Highlight the discrepancies and report to MES

Parameter

S/W Ver. 2.60
Criteria

Ref. 1

150 – 400 mV

LED Current 1

5 – 25 mA

Amplitude

50 – 100 mV

Count (#12)

26 – 36

Zero Level

500 – 525

Ref. 2

2500 – 3500

LED Current 2

10 – 32 mA

TSC 1 or CONC 1

0 – 1 M/ml

TSC 2 or CONC 2

50 – 150 M/ml

TSC 3 or CONC 3

300 – 600 M/ml

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SQA-V Self-Test
Parameters
Original
value

Original
value

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APPENDIX 15: SQA-V Reports
Semen Analysis Report

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Service Data Report

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APPENDIX 16: Printer Ribbon/Paper Installation

1.

Installing the Printer Ribbon:

Installing Printer Paper:

Turn off the power and open the Ribbon Cover –
remove old ribbon cassette

1. Open the front cover to expose the paper holder and roller

2.

Cut away any paper that is obstructing the ribbon
installation area

3.

Confirm that the new ribbon cassette is placed in the
correct way (see below)

2. Cut the edge of the paper as shown below

4.

Insert the new ribbon between the printing head and
the platen – press the cassette down from the knob
side

3. Insert the paper into the printer mechanism as shown
below. The paper will automatically advance OR press the
FEED SWITCH to advance the paper (advance one line at a
time by pressing once; press and hold to feed continuously)

5.

Remove the ribbon slack by turning the ribbon in the
correct direction to tighten it

4. Load the paper roll into the brackets – make sure the paper
roll is feeding paper in the correct direction – see example
below.

PLEASE NOTE:

Use only M.E.S. supplied ribbons

Do not print if there is no ribbon in the holder

Ribbons will dry out if sitting for a long time in the
printer

Replace ribbons when the print starts to become
lighter

PLEASE NOTE:






Load the paper in the direction shown above
Use only M.E.S. supplied paper – standard rolls are too
large for this printer and will damage it
Do not print when there is no paper or during loading
Do not pull on the paper in the reverse direction
Paper will jam if fed diagonally or incorrectly, in this case
turn the printer OFF and gently pull the paper in the right
direction

APPENDIX 17: Warranty
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Sperm Quality Analyzer
SQA, QwikCheck™ GOLD
Warranty
Medical Electronic Systems ("MES") warrants that the Sperm Quality Analyzer will be free from defects in
workmanship and materials for a period of twelve (12) months from date of purchase. During the warranty
period, if the device is shown to MES's reasonable satisfaction to be defective, MES shall, at its option, repair
such a device without charge for parts or labor. The foregoing remedy shall be purchaser's sole and exclusive
remedy under this warranty. In the event (i) purchaser makes any modifications or alterations to the SQA
/QwikCheck GOLD or (ii) the SQA/QwikCheck GOLD is used, operated, opened or serviced other than as
directed by MES or is damaged as a result of use, careless transportation (not in its original box, or within
the allowed temperature range, operation or servicing other than as directed by MES, the foregoing
warranties shall be void and of no further force or effect. EXCEPT FOR THE FOREGOING WARRANTIES, THE
PRODUCTS ARE SOLD AS-IS AND WITHOUT ANY OTHER WARRANTY OF ANY NATURE WHATSOEVER. MES
HAS NOT MADE AND DOES NOT MAKE ANY OTHER REPRESENTATION, WARRANTY, GUARANTY, OR
COVENANT, EXPRESS OR IMPLIED, WITH RESPECT TO THE DESIGN, CONDITION, DURABILITY,
SUITABILITY, FITNESS FOR USE, FITNESS FOR A PARTICULAR PURPOSE, OR MERCHANTABILITY OF THE
SQA IN ANY RESPECT. UNDER NO CIRCUMSTANCES AND IN NO EVENT, WHETHER AS A RESULT OF BREACH
OF CONTRACT OR WARRANTY, TORT (INCLUDING NEGLIGENCE AND STRICT LIABILITY) OR OTHERWISE,
INCLUDING BUT NOT LIMITED TO INACCURATE RESULTS OR OPERATOR ERROR, SHALL MES BE LIABLE FOR
ANY SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL MES'S LIABILITY WITH
RESPECT TO THE PRODUCT EXCEED THE PURCHASE PRICE FOR SUCH PRODUCT.
Extended service contracts are available for purchase.
Please contact the dealer or supplier for information.
Serial Number:_____________________ Date Purchased:___________________
Dealer:___________________________
Dealer Phone#: ___________________
Purchaser:_________________________ Purchaser Phone #:________________

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APPENDIX 18: Product Performance Data
Abbreviations:
TSC:
PMSC:
OD:

Sperm Concentration (Count)
Progressive Motile Sperm Concentration
Optical Density

MSC:
Motile Sperm Concentration
Morph Norm Forms: Morphologically Normal Forms
MV:
Millivolt

Performance Data Summary
The performance the SQA-V is summarized in the text, tables and graphs below. All values concerning sperm
concentration measurements are expressed as x106 sperm cells per milliliter (M/ml). Motility and Morphology values
are expressed as a percent (%). All testing was performed using human patient and donor semen samples.

Calibration:
Each SQA-V is biologically calibrated against two reference systems at Medical Electronic System's laboratory.

Dynamic Range:

Sample
Type

Test
Mode

Sperm
Conc.
M/ml

Motility
%

Morph
%

MSC
M/ml

PMSC
M/ml

#Sperm
Cells/field

Fresh

Normal

<2-400

0-100

2-30

<.2-400

0-400

-

Washed

Normal

<2-200+

0-100

2-30

<.2-200+

0-200+

-

Frozen

Normal

-

-

-

<.2-200+

0-200+

-

-

-

-

0-2

-

0-30

Accu-beads®

CV, %

Post-Vasectomy

Precision
SQA-V

Background: The precision and accuracy of the SQA-V was
compared to a known target value using latex beads (Accubeads®).
Latex beads are used as a quality control product to validate
the accuracy of sperm counting methods for two known levels
of concentration. In accordance with CLIA regulations such a
control is used to demonstrate operator proficiency using the
microscope and for validation of automated sperm counting
methods. The latex beads were run in the SQA-V in the same
manner semen samples are run on the system.
Limitations of method:
Latex beads cannot:

Measure sperm motility or morphology

Correct for inaccurate chamber depths or technician
errors
Method comparison:
A total of 320 latex bead samples were tested on ten SQA-V
systems (32 samples/SQA-V). SQA-V concentration readings
were compared to established target values +/- acceptable
range.

High 47± 7.0 M/ml

Interdevice
Variability

High 47± 7.0 M/ml

≤
0.01
≤
0.01
≤
2.00
≤
2.50

Low 24 ± 3.4 M/ml

Low 24 ± 3.4 M/ml

Accuracy: High Level Control
SQA-V QUALITY CONTROL TEST
(High level of Accu-beads, target range: 40-54 M/ml)

56
52
48
44
40
36
0

1

2

3

4

5

6

7

8

9

10

Number of SQA-V tested

Accuracy: Low Level Control
SQA-V QUALITY CONTROL TEST

30

millions per ml

Accu beads concentration in

(Low level of Accu-beads, target range: 20.6-27.4 M/ml)

Latex beads established target values +/- ranges
(Hemacytometer):

Vial #1: 47 +/- 7.0 M/ml

Vial #2: 24 +/- 3.4 M/ml

Revision 1_JUNE_2017

Intradevice
Variability

Accu beads concentration in
millions per ml

Precision and Accuracy Established Against a Known Target
(Latex beads)

28
26
24
22
20
18
0

1

2

3

4

5

6

Number of SQA-V tested

50

7

8

9

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Precision and accuracy established in clinical trials
using human semen samples

Table 1: Sensitivity/Specificity
SQA-V vs. Microscope

Clinical claims:

Sensitivity

Specificity

100%
97%

95%
85%

94%

75%

Concentration
Motility

94%
87%

90%
90%

Morph Norm Forms (WHO 4th )

69%

70%

Trial #1:

Specificity
 Concentration: 85%
 Motility: 80%
 Morph. Norm Forms (WHO 3rd): 65%
 Morph. Norm Forms (WHO 4th): 60%
 Morph. Norm Forms (WHO 5th): 90%
 Postvasectomy: 90% of motile cells detected
Sensitivity
 Concentration: 90%
 Motility: 85%
 Morph. Norm Forms (WHO 3rd): 85%
 Morph. Norm Forms (WHO 4th): 65%

Concentration
Motility
Morph Norm Forms (WHO 3rd )
Trial #2:

Trial #3: High Sensitivity (Postvasectomy - see table #5)

Correlation to Manual Method
 Concentration: 0.9
 Motility: 0.85
 Morph. Norm Forms (WHO 3rd): 0.65
 Morph. Norm Forms (WHO 4th): 0.45
 Morph. Norm Forms (WHO 5th): 0.45

Motile Sperm Cells

95%

95%

Immotile Sperm Cells

99%

100%

Trial #4 (ART laboratory, University Hospital
of Nantes, France):
Negative
SQA-V vs. Microscope
Predictive
Specificity
Value
Morph Norm Forms (WHO 5th )

92.5

Linearity
Linear Sperm Concentration throughout the SQA-V dynamic
range of 2M/ml to 400M/ml
 Squared regression coefficient of Dilution Curve R 2 ≥0.9.
 Averaged coefficient of variation CV of measured vs. expected
sperm concentration ≤ 20%.

Table #2: Correlation to Manual Method

Note: Claims are less than actual correlations noted (see tables 1
and 2).
Background: The SQA-V concentration, motility and morphology
readings were compared to standard microscopic results based
on WHO 3rd, 4th and 5th standards and MES protocols. Four
independent clinical trials were conducted at MES lab, Tel
Hashomer andrology dept and Ramat Marpe lab (Israel) and ART
laboratory, University Hospital of Nantes (France). A total of
>750 human semen samples were analyzed as described below
with approximately 350 samples of low quality and tested in the
Postvasectomy mode. Among them, 246 semen samples were
tested at University Hospital of Nantes.
#Samples

Fresh

Washed

Frozen

>750

>300

42

30

Trial #1

Trial #2

Sperm Concentration

0.93

0.94

Motility

0.86

0.87

0.66

-

Morphology WHO 4th / 5th

-

0.49*

MSC

-

0.79

Morphology WHO 3

rd

* Correlation is low due to narrow dynamic range of this
parameter per strict criteria and manual analysis subjectivity.

High
Sensitivity
>350

Limitations of clinical specificity:
 Highly viscous samples can only be read accurately with
liquefaction (QwikCheck™ Liquefaction Kit used).
 Sample size must be >0.7ml for fully automated tests.
 % Normal Morphology is a parameter derived from the
electronic signals of the system by a proprietary algorithm.
This is not a direct assessment of the stained smears.
 Results obtained from the use of the SQA-V visualization
system may be affected by the subjectivity of the operator.
Dynamic range limitation as stated above.

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Correlation Coefficients

Parameters

Analytical Specificity:
 To achieve analytical specificity a specific wave length of light
which is maximally absorbed by sperm cells and minimally
absorbed by other cells and seminal plasma is used.
 Low noise and high electronic resolution hardware
components and compensation circuits ensure that analytical
specificity is optimized.



97.9

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User Guide Version 2.60 I-button WHO 5th
Method comparison:
 SQA-V was compared to the microscope based on WHO 3rd
(Trial #1), 4th (Trial #2) and WHO 5th (Trial #4) guidelines.
 Sensitivity and Specificity were calculated using ROC
curves with the cutoffs based on the reference values of WHO
3rd, 4th and 5th guidelines (see Table #1).
 Correlation coefficients of the SQA-V results to the manual
method are presented in the Table #2.
 Precision: Inter-device (Tables #3) and intra-device (Table
#4) variations were compared to inter- and intra-operator
variability using Coefficients of Variation (CV, %). Duplicate
samples were assessed by two methods. The CVs
characterizing precision were calculated for multiple semen
parameters.
 The POSTVASECTOMY test (Trial #3) compared three
assessment methods:
o Microscope (standard slide: X400; 10 fields of view)
o SQA-V (SQA-V + SQA-V visualization)
o SQA-V visualization system (see table #2).
 Immotile cells were analyzed by use of the SQA-V
visualization system.
 218 semen specimens contained motile cells and were used
as the basis for the Post Vas visualization method comparison
(Table #5).
Table #3: Precision: Trial #1 and #2 (n=154)
Method
Parameter

Range

SQA-V
CV%
3.1
5.2
2.1
2.5
5.1
7.6
1.5
6.0

Entire Range
5-40
41-80
>80
Entire Range
10-50
51-55
>55

Sperm
Concentration

Motility

Microscope
CV%
6.1
5.9
5.5
3.2
7.2
10.3
3.4
4.1

Table #4: Mean Values and Precision: Trial #4 (n=246)
Semen
Parameter

Mean

CV, %

Op1

Op2

SQA-V

Manual

SQA-V

Sperm
Concentration

41.0

40.2

41.4

11.5

3.4

Total Motility

54.7

56.9

54.9

10.7

5.0

PR Motility

37.9

39.0

36.6

13.3

7.5

NP Motility

16.8

17.9

18.4

27.3

6.8

Morphology

7.6

7.6

11.5

27.4

6.5

Note: Op1 - operator 1; Op2 - operator 2

Limitations of method:
Samples were assessed by different operators using a microscope
and the SQA-V. Inter-operator subjectivity may have affected the
results of the study.

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Table #5: Percentage Motile Cells Detected: Trial #3
Postvasectomy mode
Method Comparison of
218 Samples with Motile
Cells

# Samples
Motile Sperm
Detected

% Samples
Motile Sperm
Detected

SQA-V Automated
System and Visualization
System

207

95%

Visualization System only

193

89%

Microscope only

161

74%

SQA-V Linearity
Clinical claims:
 Linear Sperm Concentration throughout the SQA-V dynamic
range of 2M/ml to 400M/ml:
 Squared regression coefficient of Dilution Curve R2 ≥0.9.
 Averaged coefficient of variation CV of measured vs.
expected sperm concentration ≤ 20%.
Goal: To demonstrate the ability of the SQA-V to accurately
report sperm concentration along the dynamic range of the
system using sequentially diluted human semen samples.

Results:
1. Squared regression coefficient R2 of Dilution Curve (trend line)
was found to be 0.992 (note: graph displaying results of four
SQA-V’s and DPBS and Hepes dilution media).
2. Averaged coefficient of variation CV of measured vs. expected
sperm concentration was 10%.

Methodology: 4 fresh human semen samples were pooled,
divided into two aliquots and centrifuged at 600g for 15 minutes.
The seminal plasma was decanted and the pellets were resuspended in washing media: DPBS & HepesHTF. Sequential
dilutions were run in 4 SQA-V systems.
Limitations of method:
 Dilution errors contribute to the accuracy of the
test results.



linearity

Sample handling errors such as the introduction of bubbles
into the testing capillary can cause inaccurate readings.

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