MES SQA-V Gold User manual
User Guide Version 2.60 I-Button
Revision 21_Sep_2015 1
U SE R G U I D E
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
September 21, 2015
User Guide Version 2.60 I-button WHO 5th
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Table of
Contents
SECTION 1: System Specifications and Requirements
Sperm Quality Analyzer SQA-V Version 2.60 4
SECTION 2: System Overview
Front Panel 7
Key Pad Navigation 7
Rear Panel 7
Measurement Capillary 8
Slide Adaptor 8
Semen Parameters 9
Reportable Range 9
SECTION 3: Technology
Concentration Measurement 10
Motility Measurement 10
SECTION 4: Getting Started / Set-Up
Power-On 11
Auto-Calibration and Self-Test 11
Set-Up System Defaults: Time, Date, Printing, WHO, Chamber Standard 12
Set-Up Controls 12 and 21
SECTION 5: Testing Semen Samples
Patient Information 13
Sample Information 13
Sample Type: Fresh, Washed, Frozen, Postvasectomy 14
Sample Volume: Low Volume, Diluted, Normal Volume 14-16
Testing 16
Test Results: Normal, Low Quality 17
Printing, Saving and Transferring Results to V-Sperm Gold 18
Postvasectomy Test 19
SECTION 6: Controls and QC
Control Set-Up and Testing 21
Set-Up: Assayed Control 21
Set-Up: Non Assayed Control 22
Running CONTROLS on the Automated System 22
Electronic Self-Test and Auto-Calibration 23
SECTION 7: Archive Functions
Transferring the SQA-V Archive to V-Sperm 25
Importing Single Test Results On-line 25
Importing Patient and Control Archives to V-Sperm 25
SECTION 8: Service Menu
Service Data 26
Service Personnel 26
Printing SQA-V Default Settings 26
Add I-Button Tests 26
SECTION 9: Operating the Visualization System (Video Display)
Introduction 27
Operating Instructions 27
Standard Slide Preparation 27
Testing Capillary Preparation 27
Testing Process 27
Counting Cells Using the Visualization Screen 28
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SECTION 10: Error Messages and Warning Messages
Stabilization Failed 29
Self-Test Failed 29
Electronic Noise 30
Concentration Out of Range 30
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: QwikCheckDilution 39
APPENDIX 9: Treatin
g
Viscous Sam
p
les: QwikCheck™ Li
q
uefaction 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 50
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Specifications
Version 2.60
SECTION 1: System Specifications and Requirements
Dimensions: 32 X 30 X 24 cm
Weight: 7 Kg
AC power supply: 100-240 VAC, 50-60 Hz, 20 VA
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
Power connector w/fuse-holder (fuse 250V,1A), Video connector,RS232 outlet.
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Requirements
Visualization Compartment
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
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:
Laboratorycoat,maskandglovesforoperatingpersonnelprotection.
Sampleshandlingandwastedisposalinspeciallymarkedhazardouswaste
containers.
Onlypersonneltrainedtoworkwithbiologicallyhazardousmaterialssuchassemen
shouldbetestingandhandlingsemen.
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:
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:
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
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 75-
second 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.
Printer and paper
Video display
and video controls
Operational
display
Visualization compartment:
Accommodates both a slide and
the SQA-V testing capillary
Focus knob:
Magnification X300 to x500
I-Button
Keypad
Automated Measurement
compartment
Zoom magnification X300 – X500
NOTE: The TEST
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.
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.
Rear Panel
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SQA-V
Components
Measurement 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.
Both the measurement and visualization chambers of the SQA-V will
accommodate the testing capillary. Refer to: "Filling the SQA-V Capillary with
Normal and Low Volume Samples" in the Appendix section of this guide for
instructions on how to use 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
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.
Motility
Section
Cuvette
Section Separating
Valve
Directing
Runner
Leur Adaptor Syringe
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Semen Parameters Reported by the SQA-V
Automated
Test Results
Table of the Reportable Range of the SQA-V
Reportable
Range
Semen Parameters with SQA-V 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>) % Total Progressively Motile Sperm /
ejaculate (PROG. SPERM) M
Sperm Morphology (normal forms, %)
(MORPH. NORM. FORMS, WHO 5th)
% Total Functional Sperm / ejaculate
(FUNC. SPERM)
M
Motile Sperm Concentration
(MSC)
M/ml Total Morphologically Normal Sperm /
ejaculate (MORPH. NORM. SPERM)
M
Progressively Motile Sperm
Concentration (PMSC)
M/ml
Postvasectomy: Motile, Immotile and
Total Sperm/Scan
(#SPERM/SCAN: MOTILE, IMMOTILE
and TOTAL)
#
Functional Sperm Concentration:
Progressively Motile Sperm with Normal
Morphology (FSC)
M/ml
Postvasectomy: Motile, Immotile and
Total Sperm/sample volume
(#SPERM/SAMPLE VOLUME: MOTILE,
IMMOTILE AND TOTAL)
M
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
Step 1
Detector Detector OD
Conv Micro
Processor
M.E.S.
Proprietary
Algorithms
Step 2 Step 3
Conv Semen
Parameters
LED LED
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
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.
Step 3: 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
0.4
0.2
0
-0.2
-0.4
-0.6
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2
Time [sec]
Electronic Signal of Motile Sperm
Voltage
[volts]
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Getting
Started SECTION 4: Getting Started / Set-Up
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.
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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SQA-V set-up
screen from
V-Sperm GOLD
CONTROL set-up
screen from
V-Sperm GOLD
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
SERVICE DATA
1. 18 8. 112 15. 1.3
2. 5 9. 10 16. 110
3. 150 10. 6 17. 2
4. 28 11. 89 18. 1000
5. 77.65 12. 31 19. 1
6. 512 13. 100
7. 0.000 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:
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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:
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
Samples
SECTION 5: Testing Semen Samples
Information about the patient and sample is entered prior to the testing process. In
order to accurately "classify" the semen sample by type and volume and understand
the options for testing, refer to the information below.
Patient
Information
Entering Patient and Sample 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 HH:MM
RECEIVED: DD/MM/YY 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.
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.
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"Postvasectomy Test” in this user guide.
Sample
Information
PLEASE NOTE:
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.
Press ENTER to view the next screen:
Sample Data
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.
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).
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
Sample Volume
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.
SAMPLE TYPE
SELECT FRESH / WASHED / FROZEN / POSTVASECTOMY
VOLUME 2.5 ml
WBC CONC. SELECT < 1 M/ml OR >= 1 M/ml
PH 7.0
APPEARANCE NORM./ABNORM.
VISCOSITY NORM/ABNORM
LIQUEFACTION NORM./ABNORM.
IS SAMPLE VOLUME SUFFICIENT
FOR COMPLETE TESTING >= .5 ml?
YES/NO
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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”.
Diluted
Samples
Please note:
See the appendix
section of this guide for
information about
dilution media.
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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Or the low volume sample can be diluted 1:2(1+1) with QwikCheck-Dilution
media:
FILL CAPILLARY – 20 MICROLITERS
CLEAN AND WIPE CAPILLARY
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
INSERT CAPILLARY INTO CHAMBER
TEST RESULTS
MOTILITY PARAMETERS ONLY
MSC 18.5 M/ml
PMSC 8.3 M/ml
VELOCITY 5 mic/sec
SMI 26
TOTALS PER VOLUME
MOT SPERM 18.5M PROG SPERM 8.3M
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 SPECIMEN
1. DILUTE SEMEN 1:2 (1+1) WITH MEDIA
2. MIX SAMPLE THOROUGHLY
3. FILL, CLEAN AND WIPE CAPILLARY
INSERT CAPILLARY INTO CHAMBER
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If the sample was > 0.5 ml. the screens below will be seen.
The system will first perform an auto-calibration and check for electronic noise.
Do not insert a testing capillary, slide, nor use ANY of the SQA-V keypad o
r
visualization functions at this time.
PLEA
The S
testing
is plac
testing
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.
Normal
Volume
Samples
SE NOTE:
Q
A-V will begin
when a capillary
e
d into the
chamber.
Testing
FRESH
NORMAL VOLUME SPECIMEN
1. MIX SAMPLE THOROUGHLY
2. FILL, CLEAN AND WIPE CAPILLARY
3. WAIT FOR AUTOCALIBRATION
AUTOCALIBRATION – DO NOT TOUCH UNIT
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.
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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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 <PR+NP> < 5 %
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 0
TOTALS PER VOLUME
SPERM # N.A. MOT. SPERM N.A.
PROG. SPERM N.A. FUNC SPERM N.A.
MORPH. NORM. SPERM N.A.
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.
Test Results
TEST RESULTS
SPERM CONC.
TOTAL MOTILITY <PR+NP>
PROG. MOTILITY <PR>
NONPROG. MOTILITY <NP>
IMMOTILITY <IM>
MORPH. NORM. FORMS, WHO 5th
32.6 M/ml
28
19
9
72
21
%
%
%
%
%
TEST RESULTS
MSC
PMSC
SMI
9.1 M/ml
6.3 M/ml
34
FSC 2.5 M/ml
VELOCITY 9 mic/sec
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
User Guide Version 2.60 I-Button
Revision 21_Sep_2015 18
Printing
Saving and
Transferring
Test Results
to V-Sperm
PLEASE NOTE:
The SQA-V archive is
viewed from V-Sperm
only. The archive must
be transferred to the V-
Sperm PC in order to
view, delete and edit
records.
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
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
From the SQA-V, go to MAIN MENU > SERVICE > SERVICE DATA.
Make sure the RS232 communication cable is connected between the SQA-V
and the PC.
Turn-on the PC and activate the V-Sperm GOLD version 3.60 software.
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.
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.
User Guide Version 2.60 I-button WHO 5th
Revision 21_Sep_2015 19
Post
Vasectomy
Testing
Postvasectomy Test
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.
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."
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.
Insert the testing capillary into the SQA- TESTING
V lower chamber when instructed.
Testing will begin automatically. DO NOT MOVE CAPILLARY OR
Testing takes approximately 5 minutes. OPERATE DEVICE DURING TESTING
Test results for motile sperm are
reported. THIS TEST TAKES APPROX. 5 MINUTES
Select YES to when asked: “ENTER
VISUAL DATA PER USER GUIDE?” to POSTVASECTOMY
manually enter the number of # SPERM/SCAN: # SPERM/SAMPLE VOL.:
MOTILE/IMMOTILE sperm seen on the MOTILE 3 MOTILE 0.2 M
visualization system.
Press ENTER to continue.
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 PLEASE INSERT CAPILLARY
out) and press ENTER to continue. INTO VISUALIZATION SLOT
ADJUST MAGNIFICATION TO x300
"Scan" the depth of the capillary by
slightly turning the visualization focus PRESS ENTER
knob (10 fields can be visualized) and
enter the total # MOTILE/IMMOTILE
SPERM cells visualized in all 10 fields. TURN FOCUS KNOB AND SCAN THROUGH
ENTIRE CAPILLARY DEPTH TO COUNT
The SQA-V will automatically report the MOTILE AND IMMOTILE SPERM
GREATER # of cells found by the PLEASE ENTER:
Automated or Visualization system. # MOTILE SPERM 3
Press ENTER and the test results screen # IMMOTILE SPERM 8
will be displayed.
User Guide Version 2.60 I-button WHO 5th
Revision 21_Sep_2015 20
POSTVASECTOMY
# SPERM/SCAN:
MOTILE > 30
PLEASE RE-RUN AS A NORMAL TEST
POSTVASECTOMY
# SPERM/SCAN: # SPERM/SAMPLE VOL:
MOTILE 3 MOTILE 0.2 M
IMMOTILE 8 IMMOTILE 0.5 M
TOTAL 11 TOTAL 0.7 M
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.
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