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USER GUIDE - Sklep Genos

1. _ _ IIIIIIII III Power connector and main switch assembly Revision 13 AUG 2007 7 SQA V Z User Guide Version 2 48 I Button SQA V Measurement Capillary Components Section 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 e 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 Sample must be centered location approximately 12mm from the end of the glass slide Use with a standard laboratory slide 76 x 25 6 mm and 22 x 22 mm cover slip with a 10 ul sample placed approximately 12 mm from the end of the slide for accurate results For use in the visualization compartment of the SQA V Revision 13 AUG 2007 8 SQA V 44 User Guide Version 2 48 I Button Semen Parameters Reported by the SQA V Automated Semen Parameters with SQA V Abbreviation in Brackets Test Results Sperm Concentration Motile Sperm Concentration M ml SPERM CONC MSC
2. Progressively Motile Sperm Conc a Motility MOTILITY lt a b c gt PMSC lt a gt M ml Rapid Progressive Motility a Progressively Motile Sperm Conc b M ml RAPID PROG MOTILITY lt a gt PMSC lt b gt Slow Progressive Motility b Functional Sperm Concentration Prog SLOW PROG MOTILITY lt b gt fs Sperm w Norm Morphology M ml Non Progressive Motility Total Number Sperm Ejaculate NON PROG MOTILITY lt c gt SPERM IMMOTILTIY lt d gt PROG SPERM ge s Bae a ate Total Motile Sperm Ejaculate 4th MOT SPERM Velocity mic Total Functional Sperm Ejaculate VELOCITY sec FUNC SPERM Sperm Motility Index SMI Postvasectomy Motile Immotile and Total Sperm Scan Postvasectomy Motile Immotile and Total Sperm sample volume SPERM SAMPLES VOLUME MOTILE M IMMOTILE AND TOTAL SPERM SCAN MOTILE IMMOTILE and TOTAL Table of the Dynamic Range of the SQA V DYNAMIC RANGE OF THE SQA V Gold Dynamic Range SAMPLE SPERM CONC in M ml MSC in M ml Motility o FRESH 2 400 or lt 2 M ml 0 2 400 or lt 0 2 M ml 0 100 WASHED 2 200 or lt 2 M ml 0 2 200 or lt 0 2 M ml 0 100 FROZEN Not reported 0 2 200 or lt 0 2 M ml Not reported POSTVASECTOMY Manual Input 0 30 Sperm Scan Not reported Revision 13_AUG_2007 9 SQA V Z User Guide Version 2 48 I Button Technology SQA V Optical Block i Density n Detector Detector D M E S Proprietary Algorithms I
3. SQA V VERSION 2 48 STANDBY POSITION PRESS ON OFF KEY TO ACTIVATE THE UNIT Auto Calibration and Self Test NOTE Do not insert a capillary slide into the device during the stabilization process Do not use any of the keyboard functions during stabilization Revision 13 AUG 2007 SQA V VERSION 2 48 PLEASE WAIT SYSTEM STABILIZATION AND AUTOCALIBRATION 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 TEST NEW PATIENT RUN CONTROLS SERVICE 11 SQA V Z User Guide Version 2 48 I button 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 gt SERVICE DATA SERVICE MENU SERVICE DATA SERVICE PERSONNEL PRINT SQA V DEFAULT SETTINGS ADD I BUTTON TESTS SERVICE DATA Patient Data System SQ A V set u p Choose date format rSQA w Date orph Criteria Europe DDMM Y Y O WHO 3rd screen from ea e ML Ee koq had EZ 12006 V Sperm GOLD O USA MM
4. I I I I I Step 1 ER I Semen Parameters Step 1 The capillary is inserted into the measurement compartment Step 2 Concentration e Milions 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 e An optical density detector measures the amount of light absorbed by the cells and converts it to optical density OD e The OD reading is translated into sperm concentration by a microprocessor based on proprietary MES algorithms Step 3 Motility e 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 e These light disturbances are converted into electronic signals with peaks and valleys e The electronic signal peaks are analyzed by microprocessor software based on a proprietary MES algorithm and translated into motility parameters Voltage volts Time sec Electronic Signal of Motile Sperm Revision 13 AUG 2007 10 SQA V Z User Guide Version 2 48 I Button 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
5. 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 The Sperm Quality Analyzer SQAV is a product of European Regulatory Authorized Representative Medical Electronic Systems Ltd Medes Limited P O Box 3017 P O Box 136 6 Beaumont Gate Caesarea Industrial Park 38900 IL Shenley Hill Radlett Herts WD7 7AR England Phone 972 4 6373981 Tel Fax 44 1923859810 Fax 972 4 6373984 Revision 13_AUG_07 50 SQA V Z User Guide Version 2 48 I button I FHlw w ws APPENDIX 17 Technical Bulletins and Product Updates Revision 13_AUG_07 51
6. do not insert a capillary until instructed to do so on the screen Diluted 5 Samples Please note See the appendix section of this guide for information about dilution media Revision 13_AUG_2007 If the sample is lt 0 5 ml two options are available Run as a low volume sample and obtain just motility parameters or dilute the sample 1 1 with QwikCheck Dilution media and obtain a report of all parameters To run a low volume sample Aspirate only 20 ul 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 1 WITH MEDIA LOW VOLUME 20 MICROLITERS ONLY MOTILITY PARAMETERS ONLY LOW VOLUME SAMPLE FILL CAPILLARY 20 MICROLITERS CLEAN AND WIPE CAPILLARY INSERT CAPILLARY INTO CHAMBER TEST RESULTS MOTILITY PARAMETERS ONLY PMSC lt a gt 1 1 M ml VELOCITY 5 mic sec PMSC lt b gt 7 2 M ml SMI 26 MSC 18 5 M ml TOTALS PER EJACULATE MOT SPERM 18 5M PROG SPERM 8 3M Or the low volume sample can be diluted 1 1 with QwikCheck Dilution media LOW VOLUME SPECIMEN PLEASE SELECT SAMPLE TESTING OPTION DILUTE SEMEN 1 1 WITH MEDIA LOW VOLUME 20 MICROLITERS ONLY MOTILITY PARAMETERS ONLY LOW VOLUME SPECIMEN 1 DILUTE SEMEN 1 1 WITH MEDIA 2 MIX SAMPLE THOROUGHLY 3 FILL CLEAN AND WIPE CAPILLARY INSERT CAPI
7. 5 Insert the fully loaded slide adapter Figure 3 into the visualization chamber of the SQA V 6 Optimize the video image in the usual manner and select the desired field of view using the slide position adjuster on the slide adapter Figure 4 Figure 4 Revision 13_AUG_07 34 SQA V Z User Guide Version 2 48 I button I H w jj ji APPENDIX 4 Cleaning the Capillary Slide Compartments EY Medical Electronic Systems Lt SQ A V Cleaning Instructions ONLY use the manufacturers cleaning kit and brushes to clean the SQA V or damage will occur to the film and the system will not function When to clean DAILY when running samples and After every 10 15 tests and or for ANY spillage If there is a Self test or any other failure If the SQA V becomes contaminated with semen Cleaning kit components CLEANING STEP 1 CLEANING STEP Il If the SQA V still does not pass self test use the cleaning brush 1 CLEANING THE VISUALIZATION COMPARTMENT 25 Blue Dot capillaries with fibrous material tips 25 sponge tipped drying capillaries 1 cleaning brush wooden handled Cleaning fluid TURN OFF SQA V and unplug it at main electrical outlet Select a BLUE DOT fibrous material capillary e Moisten with ONE drop of cleaning fluid shaking off l I excess fluid Fibrous Blue Dot cleaning capillary e Insert into the measurement compartment fibrous F E j gt material facing up and m
8. Guide Version 2 48 I button Please note The visualization screen grid of the SQA V is calibrated to a CONC STANDARD default of 1 or Makler non dilutional chambers Please see the Appendix Section Concentration Standard Counting Chamber for details Revision 13 AUG O07 Counting Cells Using the Visualization Screen Insert standard slide 10 ul sample 22X22 mm coverslip into the visualization compartment Press ZOOM OUT x300 all the way e Bring the image into focus The screen is divided into a 20 square grid in order to make counting easier for the user Each sperm cell seen on the ENTIRE screen represents 1 Million spermatozoa per ml 28 SQA V Z User Guide Version 2 48 I button EE Hww Revision 13_AUG_07 Stabilization Failed STABILIZATION FAILED TURN OFF MAIN SWITCH ON REAR PANEL REACTIVATE UNIT IF PROBLEM FERSISTS CALL FOR TECHNICAL SUPPORT Ensure there is no testing capillary in the measurement compartment Remove the SQA V from sources of electronic noise cell phones etc and vibrations centrifuge Clean measurement compartment refer to Appendix Reboot the SQA V without a testing capillary in the chamber e Turn system OFF then back ON at the main switch on the rear panel e Press the front panel ON OFF key to begin Auto Calibration Stabilization Call technical support if failure recurs Self test Failed FAILED SELF TEST
9. I Button Tests SERVICE MENU SERVICE DATA SERVICE PERSONNEL PRINT SQA V DEFAULT SETTINGS ADD I BUTTON TESTS 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 A code is required to access SERVICE PERSONNEL This option allows a qualified service technician to access calibration and maintenance settings The system default settings can be printed from this option Click this option to add I button tests Follow the instructions on the screen TO ADD I BUTTON TESTS 1 CONNECT THE SQA V TO THE PC 2 GO TO V SPERM SETUP SQA V NI BUTTON 3 FOLLOW THE V SPERM INSTRUCTIONS 26 SQA V Z User Guide Version 2 48 I button c a f FHww lt 1 Introduction Operating Instructions Revision 13_AUG_07 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 ill
10. TARGET VALUE and Range for Level 1 and Level 2 capillary Enter OO 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 MAIN MENU the SQA V a Select RUN CONTROLS from the MAIN MENU of the SQA V TEST NEW PATIENT RUN CONTOLS The Control defaults have already SERVICE been set up in V Sperm Select the CONTROL LEVEL 1 2 CONTROL LATEX BEADS or NEGATIVE LEVEL 3 that is being SELECT tested CONTROL LEVEL LEVEL 1 LEVEL 2 NEGATIVE CONTROL Press ENTER to continue Controls are run in exactly the same Pisa he Wet PO CONTASE manner as a normal semen sample Using control media follow the same CONTROL LATEX BEADS LEVEL 1 procedure for filling an SQA V testing capillary with a NORMAL volume FILL CLEAN AND WIPE CAPILLARY sample INSERT IN CHAMBER TESTING WILL BEGIN AUTOMATICALLY Testing will begin automatically e Control test results will be
11. TURAN OFF MAIN SWITCH ON REAR PANEL CLEAN OPTICAL CHAMBER REACTIVATE UNIT IF PROBLEM PERSISTS CALL FOR TECHNICAL SUPPORT Ensure there is no testing capillary in the measurement compartment Remove the SQA V from sources of electronic noise cell phones etc and vibrations centrifuge Clean measurement compartment refer to Appendix Reboot the SQA V without a testing capillary in the chamber e Turn the system OFF then back ON at the main switch on the rear panel e Press the front panel ON OFF key to begin Auto Calibration and Stabilization Call technical support if this message is displayed again Prepare for technical Support by printing a copy of the SQA V SERVICE DATA e Press the SERVICE key on the SQA V keypad to activate the SERVICE MENU screen e Select PRINT SQA V DEFAULT SETTINGS gt SELF TEST DATA e Press ENTER 29 SQA V Z User Guide Version 2 48 I button Revision 13_AUG_07 Electronic Noise ELECTRONIC MOISE TUAN OFF MAIN SWITH ON REAR PANEL EAC TIVATE UNIT IF PROBLEM PERSISTS CALL FOR TECHNICAL SUPPORT Ensure there is no testing capillary in the measurement compartment Remove SQA V from sources of electronic noise cell phones etc and vibrations centrifuge Clean measurement compartment refer to Appendix and after cleaning e Turn the system OFF then back ON at the main switch on the rear panel e Press the front panel ON OFF key to begin Auto Calibration and Stab
12. V Z User Guide Version 2 48 I Button 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 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 Visualization compartment Accommodates both a slide and the SQA V testing capillar Video display and controls Operational display I Button Focus knob Magnification X300 to x500 Automated Measurement compartment Zoom magnification X300 X500 Use NUMERIC keys to enter data ARROW keys to move to the next field Keypad Navigation 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 Rear panel assembly screws Video output connector RS 232 COM port Ventilation slots I li Instrument label m PP
13. be run instead of a POSTVASECTOMY test gt 30 motile spermatozoa is equivalent to MSC gt 2M ml 20 reste 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 21M ENTER VISUAL DATA PER USER GUIDE YES NO 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 3 IMMOTILE SPERM POSTVASECTOMY SPERM SCAN SPERM SAMPLE VOL MOTILE 3 MOTILE 0 21M IMMOTILE 8 IMMOTILE 0 53 M TOTAL 11 TOTAL 0 74 M POSTVASECTOMY SPERM SCAN MOTILE gt 30 PLEASE RE RUN AS A NORMAL TEST SQA V G1 User Guide Version 2 48 I Button lll Control SECTION 6 ntro 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 Please note Level 1 2 and NEGATIVE control set up 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 enter cur
14. 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 370C e 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 Morphology Criteria WHO 3 or WHO 4 Strict Printing options automatically print test results self test report on start up e Control Set up from the manufacturer s labeling Select type of control Latex beads or Stabilized Sperm 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 EXP date not know 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 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 Entering Patient and Sample Information ENTER PATIENT SAMPLE DATA PATIENT ID 5788114 BIRTH DATE 01 01 85 ABSTINENCE 4DAYS 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 DA
15. displayed on the SQA V screen CONTROL TEST RESULTS LOW HIGH or NORM will be displayed DATE 01 12 06 DD MM YY TIME 15 09 08 based on the testing outcomes vs LEVEL 1 LOT 11223344556677889900 target value and range EXP DATE 04 09 MM YY Test results will automatically be saved TYPE LATEX BEADS and printed TARGET VALUE 45 0 6 3 M ml CONC RESULTS 45 4 M ml NORM ACCEPTABLE RANGE 38 7 51 3 M ml Revision 13_AUG_07 22 SQA V Z User Guide Version 2 48 I button Revision 13_AUG_07 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 calib
16. gt 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 23 SQA V Z User Guide Version 2 48 I button Revision 13_AUG_07 e 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 2 Parameter S W Ver 2 48___ SQA V Value _ Pass_ Fail ___ 1 Refit t50 350mv_ o S 2 LED Curt 5 25mA 3 Amplitude 50 100mv_ o 4 Zero Level 500 525 J l o speet fao sow f L LED Cur 2 10 32 mA 7 CONC 1 O imM mi 8 CONC 2 50 150 M ml CONC 3 300 600 M mi J Count a 24 SQA V Z User Guide Version 2 48 I button CO SS 5saaasxaaKxs33s3s33 Archive The SQA V automatically saves and prints PATIENT and CONTROL test results 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 in a group The SQA V can store 500 patient records and 750 control records in two separate archives The screens below will be displayed when the PATIENT or CONTROL archive of the SQA V is almost full ARCHIVE ALMOST FULL TO AVOID POSSIBLE LOSS OF DA
17. of the SQA V visualization system e 218 of the 342 semen specimens contained motile cells and were used as the basis for the method comparison Table 4 Table 3 Precision Method CV CV 5 40 Motility 10 50 21 55 1 5 3 4 x 25 60 41 Table 4 Percentage Motile Cells Detected Parameter Range Sperm Concentration M ml Method Comparison of 218 Samples with Motile Cells SQA V Automated System and Samples Motile Sperm Detected Samples Motile Sperm Detected Visualization System Visualization System only Microscope only SQA V Linearity Clinical claims e Linear Sperm Concentration throughout the SQA V dynamic range of 2M ml to 400M mI Squared regression coefficient of Dilution Curve R 20 9 Averaged coefficient of variation CV of measured vs expected sperm concentration lt 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 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 re suspended in washing media DPBS amp HepesHTF Sequential dilutions were run in 4 SQA V systems Limitations of method e Dilution errors contribute to the accuracy of the linearity test results e Sample handling errors such as the
18. 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 e Variations in ambient temperature can affect semen samples It is essential that semen samples are not heated when testing The SQA V is calibrated to conduct tests at room temperature 22 260C 68 79 F Semen is considered a biologically hazardous material and is subject to individual laboratory protocols for handling such materials Revision 13_AUG_07 5 SQA V Z User Guide Version 2 48 I button HK Operating Temperature Operates in a wide range of ambient temperatures 15 38 C however the system is calibrated to measure semen samples at room temperature 22 26 C 68 79 F Note Extreme ambient temperature may impact the accuracy of motility test results because of the known effect of temperature on human semen System is fully operational at up to 80 humidity PC Hardware Requirements Minimum requirements for V Sperm software PC 1 GHz processor Pentium 3 RAM 256 MB AGP video display card with at least 16 MB of RAM memory Video color At least 16 bit 65 535 CD ROM drive 2 GB free hard disk space for image capturing approx 3000 clips Video resolution Minimum 640 x 480 Operating system compatibility Win
19. use of the SQA V visualization system may be affected by the subjectivity of the operator e Dynamic range limitation as stated above Revision 13 AUG O07 Table 1 Sensitivity Specificity SQA V vs a a Trial 1 Concentration Motility Morph Norm Forms WHO 94 75 3rd Trial 2 Motility 87 90 Morph Norm Forms WHO 69 70 ath Trial 3 High Sensitivity see table 4 Motile Sperm 95 95 Cells Immotile i P Table 2 Correlation to Manual Method Correlation Coefficients Parameters Trial 1 Trial 2 Sperm Concentration 0 93 0 94 M ml Motility 300 200 100 TSC SQA 0 50 100 150 200 25 TSC manual 2nd clinical trial TSC correlation 250 200 150 100 50 0 TSC SQA 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 38 SQA V Z User Guide Version 2 48 I button Method comparison e SQA V was compared to the microscope based on WHO 4TH guidelines e Sensitivity and specificity were calculated using ROC curves WHO 4TH guidelines were used to establish cutoffs for reference values see table 1 e The POSTVASECTOMY test 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 e Immotile cells were analyzed by use
20. year shelf life Note the expiration date on the box and bottle e Store bottle in the refrigerator upon receipt Bring to room temperature 22 26 C prior to use e Avoid prolonged exposure to light e Do not use if the solution contains precipitate or is cloudy INSTRUCTIONS FOR USE AUTOMATED SQA V 1 Measure the volume of the neat semen sample 2 If the volume is less than 0 5 ml dilute 1 1 3 Open the dilution kit bottle and pipette an amount of Earle s solution that is equal to the semen Sample volume measured in step 1 4 Add the Earle s solution to the neat semen sample and thoroughly mix the sample by rotating the container in a circular manner This will evenly distribute the spermatozoa throughout the sample without introducing bubbles 5 Fill the SQA V testing capillary immediately after the sample is mixed following the SQA V version 2 48 and 2 48 on screen instructions MANUAL e Follow laboratory sperm preparation protocols for diluting semen samples for testing PRECAUTIONS AND WARNINGS Exercise appropriate precautions to minimize direct contact with skin or eyes and prevent inhalation REFERENCES WHO 99 Laboratory Manual for the Examination of Human Semen and Sperm Cervical Mucus Interaction 4 Edition Cambridge University Press 1999 Reprinted 2000 Revision 13_AUG_07 41 SQA V Z User Guide Version 2 48 I button 1 TM Product Insert INTRODUCTION AND INTENDED USE The QwikCh
21. 0 9 e Averaged coefficient of variation CV of measured vs expected sperm concentration lt 20 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 readings using a Makler or Neubauer chamber based on WHO 4TH standards and MES protocols Three independent clinical trials were conducted at three sites A total of 539 human semen samples were analyzed as described below 342 samples were of low quality and were tested in the Postvasectomy mode ensitivity Precision Table 3 Duplicate samples were assessed using 2 SQA V s The coefficients of variation CV characterizing precision were calculated for Sperm Concentration and Motility and were below 6 Specificity e 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 e Low noise and high electronic resolution hardware components and compensation circuits ensure that analytical specificity is optimized Limitations of clinical specificity e Highly viscous samples cannot be read accurately e Sample size must be gt 0 7ml for fully automated tests e Normal Morphology is a parameter derived from the correlation between morphology and progressive motility This is not a direct measurement e Results obtained from the
22. 2 48 I button 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 13_AUG_07 Insert the testing capillary into the SQA V 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 Take the same testing capillary and insert it into the visualization upper compartment Set the magnification to x300 Full zoom out 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 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 gt 30 motile spermatozoa a screen will indicate that a NORMAL TEST should
23. ENU Select a CONC concentration STANDARD e CONC STANDARD 1 FACTORY DEFAULT e CONC STANDARD 2 Commercially available counting chambers are divided into two unique groups e Standard 1 10 20 micron depth and do not require sample dilution e e Standard 2 100 micron depth haemocytometers that require sample dilution The table below classifies some commercially available chambers STANDARD 1 STANDARD 2 CHAMBERS CHAMBERS Makler Beurker Tuerk Fixed cover slip disposable Buerker chambers i e Micro Cell Fuchs Rosenthal Fuchs Rosenthal modified Improved Neubauer Malassez Neubauer Thoma Thoma Modified Revision 13_AUG_07 44 SQA V Z User Guide Version 2 48 I button EE H w 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
24. ESULTS FSC M ml MSC lt 0 2 M ml PMSC lt a gt M ml VELOCITY mic sec PMSC lt b gt M ml SMI TOTALS vei EJACULATE MOT SPERM N A e 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 Revision 13_AUG_07 17 SQA V 4 User Guide Version 2 48 I Button 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 Revision 13 AUG 2007 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 and 750 QC tests A warning will appear when the archive is almost full Data MUST be transferred to the PC or it will be lost ove
25. IDDIYY WHO 4th rConc Chamber Standard Printing Options Import Export 1 Automatically print all test results O2 oO Automatically print Self Test Report on Start Up rContral CONTROL set up screen from V Sperm GOLD Revision 13 AUG O07 8 9 10 112 10 6 11 12 13 14 31 100 100 15 16 17 18 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 48 software From the V Sperm GOLD main navigation screen select SET UP gt SQA V gt SQA V Defaults Then press the CONTINUE button e e V Sperm GOLD will display the SQA V system set up screen V Sperm Management System y JZ Medical Electronic Systems Ltd ESCA GE ontrol Media Latex Beads Stabilized Sperm Utilities Log Off 080806001 Exp Date 91 06 01 06 080806003 Exp Date p1 06 v 12 SQA V Z User Guide Version 2 48 I Button NOTE All Set up fields must have data in order to transfer information to the SQA V If CONTROL settings are not known enter O 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 Testing Samples Patient Information PLEASE NOTE The SQA V is
26. LLARY INTO CHAMBER 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 The SQA V algorithm compensates for the sample dilution as long as the sample 15 SQA V Z User Guide Version 2 48 I button CC ST 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 vorme E Esss Samples FILL CLEAN AND WIPE CAPILLARY AUTOCALIBRATION DO NOT TOUCH UNIT If the sample was gt 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 PLEASE NOTE section of this user guide Filling the SQA V Capillary with a Normal Volume Sample The SQA V will begin testing when a capillary is placed into the testing chamber NORMAL VOLUME SPECIMEN FILL CLEAN AND WIPE CAPILLARY INSERT IN CHAMBER The screen above will be displayed when it is time to INSERT the filled testing capillary in the measurement compartment testing will begin a
27. SQA V Z User Guide Version 2 48 I Button o SQA V 4 USER GUIDE Version 2 48 lI Button Catalog 5139 August 2007 Revision 13 AUG 2007 1 SQA V Z User Guide Version 2 48 I button EE H _ii s Table of Contents Revision 13_AUG_07 SECTION 1 System Specifications and Requirements Sperm Quality Analyzer SQA V Version 2 48 SECTION 2 Svstem Overview Front Panel Key Pad Navigation Rear Panel Measurement Capillary Slide Adaptor Semen Parameters Dynamic Range SECTION 3 Technology Concentration Measurement Motility Measurement SECTION 4 Getting Started Set Up Power On Auto Calibration and Self Test Set Up System Defaults Time Date Printing WHO Chamber Standard 12 and 21 Set Up Controls SECTION 5 Testing Semen Samples Patient Information Sample Information Sample Volume Low Volume Diluted Normal Volume Testing Test Results Normal Low Quality Printing Saving and Transferring Results to V Sperm Gold Postvasectomy Test SECTION 6 Controls and OC 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 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 SECTION 8 Service Menu Service Data Service Personnel Printing SQA V Default Settings Add I Button Tests SECTION 9 Opera
28. TA DOWNLOAD ARCHIVE TO PC PRESS ENTER TO CONTINUE ATTENTION THE CONTROL ARCHIVE IS FULL NO NEW RECORDS CAN BE SAVED PLEASE TRANSFER THE ARCHIVE TO THE PC 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 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 IMPORT PATIENT AND CONTROL ARCHIVES TO V SPERM Select the V Sperm navigation button IMPORT EXPORT e Select IMPORT DATA gt IMPORT ARCHIVE or IMPORT CONTROLS and press CONTINUE and the tests will automatically be transferred e Select YES on the next screen to delete records from the SQA V archive Revision 13_AUG_07 25 SQA V Z User Guide Version 2 48 I button System set up maintenance and calibration can be performed from the SERVICE MENU To activate this screen press SERVICE in the MAIN MENU Please note I button tests are added through the V Sperm software Revision 13_AUG_07 Service Data Service Personnel Print SQA V Default Settings Add
29. TA screen is displayed Enter the requested sample patient information using the SQA V keypad e PATIENT ID Unique number identifying the patient Maximum of 20 numbers can be entered e BIRTH DATE Birth date of the patient e ABSTINENCE Number of days since the patient s last ejaculation e SAMPLE ACCESSION Up to 20 numbers identifying the sample e COLLECTED Date and time the sample was collected e RECEIVED Date and time the sample was received Revision 13 AUG _ 2007 13 SQA V Z User Guide Version 2 48 I button STO Press ENTER to view the next screen Sample SAMPLE TYPE Information SELECT FRESH WASHED FROZEN POSTVASECTOMY VOLUME 2 5 ml WBC CONC SELECT lt 1 M ml OR gt 1 M ml PH 7 0 APPEARANCE NORM ABNORM LIQUEFACTION NORM ABNORM VISCOSITY NORM ABNORM Sample Data Select SAMPLE TYPE required entry based on the following options e FRESH Sample not enriched diluted or treated and is within 1 hour of collection Exception Low volume samples diluted 1 1 with QwikCheck dilution media can be used according to User Guide instructions e WASHED Sample enriched or prepared for artificial insemination using a commercial media to replace seminal plasma Frozen samples containing egg yolk buffer are excluded e 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 t
30. as performed using human donor semen samples Calibration Each SQA V is biologically calibrated against two reference systems at Medical Electronic System s laboratory Sample Test Sperm m a MSC PMSC Sperm Type Mode Conc M ml M ml Cells field ce Dynamic Range Fresh Normal 2 x 2 400 0 100 100 z 2 400 0 400 400 Frozen Normal 2 200 cane Pe Eal C C c e L cem pes Vasectom Precision s s g CV Precision and Accuracy Established Against a SQA V Accu beads Known Target Latex beads High 47 7 0 lt Intra E device M ml 0 _ Background The precision and accuracy of the SQA V was Variabilit Low 24 3 4 compared to a known target value using latex beads Accu Y M ml beads 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 e Measure sperm motility or morphology e 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 valu
31. ation and a MSC motile cell concentration control The beads are run in the same manner the laboratory runs sperm counts on the SQA V manual counting chambers and the SQA V visualization system According to the CLIA 88 regulations for most moderately complex tests the general requirement is to analyze two levels of QC materials on each day of testing It is recommended that QwikCheck beads be run on the SQA V automated and visualization systems prior to each day of semen analysis testing For in vitro use only Each kit contains two known concentrations of QwikCheck beads in two 5 ml aliquots and one 5 ml negative concentration motile cell concentration control Store the beads at room temperature 20 25 C or 65 77 F The expiration date assumes that QwikCheck beads are stored at room temperature in their original containers and tightly capped to prevent evaporation Warning Contains 0 1 Sodium Azide as a preservative Other ingredients are not harmful due to their low concentration in the material For additional information please refer to the QwikCheck beads Material Safety Data Sheet QCB 001 Basic Instructions for using QwikCheck beads 1 Thoroughly mix or vortex the QwikCheck beads prior to use in order to distribute the beads evenly in the suspension It is imperative that the beads are evenly mixed in order to insure the accuracy of the target value The negative control material does not require extensi
32. 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 and the SQA V and the testing capillary should not be disturbed in any way during the 5 minute testing cycle e Typically there are minimal cells in a POSTVASECTOMY specimen Therefore in order to concentrate the cells the specimen must be centrifuged and the pellet re suspend prior to testing WHO 4TH recommends centrifuging specimens with counts lt 1 2 field in order to concentrate the specimen Centrifuge the specimen 600g for 15 minutes WHO 4TH Decant the supernatant and re suspend the pellet in 0 8 ml seminal plasma can be supplemented with Earl s Buffer Fill both sections of the SQA V testing capillary by filling BOTH sections for stability during the 9 minute test e If the specimen volume is not adequate to fill both sections add Earls Buffer Follow the user guide for instructions on running a POSTVASECTOMY sample e 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 th
33. dows XP and VISTA Excel Word required for V Sperm GOLD Ports One serial two USB ports Monitor 15 color 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 non assayed Latex beads or stabilized sperm for concentration and negative control for motility concentration Assayed control QwikCheck beads product of Medical Electronic Systems 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 ul of sample for normal volume testing 20 ul for low volume testing 300 ul 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 e V Sperm Gold included with system Required for setting SQA V system Revision 13 AUG O07 defaults archive management data transfer capture and storage of video images from the SQA V and for displaying and printing self test data SQA
34. e user guide instructions e Enter the number of motile and immotile sperm cells visualized e 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 e 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 e NOTE If the SQA V is reporting gt 30 motile spermatozoa a screen will indicate that a NORMAL TEST should be run instead of POSTVASECTOMY gt 30 motile spermatozoa is equivalent to MSC gt 2M ml Revision 13_AUG_07 A5 SQA V Z User Guide Version 2 48 I button L h sss SQA V SERVICE SUPPORT Parameter Report Device number SQA V Software Version Date Instruct the user to run a SERVICE report For version 2 48 from the MAIN MENU select SERVICE gt PRINT SQA V DEFAULT SETTINGS gt 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 Service Parameter Report Comments Item CONTR REF1 r x i x j S j CONTR Z L can be adjusted in the field b
35. eck Liquefaction Kit can be used to promote and accelerate the liquefaction of highly viscous semen samples that remain viscous thirty minutes after collection Since viscosity impacts the accurate measurement of motility concentration and antibody coating the QwikCheck Liquefaction Kit is used to prepare viscous semen samples for automated or manual semen analysis and is for in vitro use only KIT CONTENTS e 20 single dose 5 mg vials of lyophilized a Chymotrypsin e Product Insert STABILITY AND STORAGE CONDITIONS e The product has an eighteen month shelf life Note the expiration date on the box and vials e Store vials at 20 C Warm to room temperature 22 26 C prior to use INSTRUCTIONS FOR USE 1 Select one vial of a Chymotrypsin and bring to room temperature 2 3 minutes Tap the vial to move the contents to the bottom of the vial prior to opening Add the entire contents of one vial to a viscous semen sample Gently mix the sample to dissolve the powder Pe 2 N 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 PRECAUTIONS AND WARNINGS Each vial contains a Chymotrypsin a protease This protease may cause irritation to eyes respiratory system or skin In case of contact with eyes rinse immediately with plenty of water and seek medical attention Observe the followin
36. ersion 2 48 Revision 13 AUG O07 SECTION 1 System Specifications and Requirements Dimensions 40 x 30x 15cm Weight 4 kg AC power supply 100 to 250 VAC 50 60 Hz 20 VA Archive Capacity e 500 test records e 750 QC records Display s Operational backlight LCD 16 lines x 40 characters e 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 3rd Chamber standard 1 Printing Options Automatic CONTROLS Control Media Latex Beads Lot Target Values Ranges should be set up by the user before running controls Front Panel e Built in printer Visualization compartment LCD video display and controls Focus knob LCD operational display Measurement compartment Multi button keypad I Button port Keypad Operational keys ON OFF TEST PRINT SERVICE ARCHIVE now disabled DELETE ENTER four cursor buttons ESC ten numeric buttons 0 9 e Video control keys ZOOM IN OUT ILLUMINATION HIGH LOW and MONITOR ON OFF Measurement Compartment Sources of radiant energy two LEDs for motility and spectophotometry channels Detector system two photo detectors Motility and Optical Density Operating System e Analysis Time Normal Test 75 seconds Low Quality 2 minutes Postvasectomy 5 minutes SQA V Z User Guide Version 2 48 I button Hes lt saw lt s e Software Resides on flash memory and driv
37. ersion 2 48 I button EE H ww w s APPENDIX 3 Using Standard Slides in the Visualization System Introduction 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 introduced 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 3 Carefully place a standard 22 mm x 22 mm cover slip over the sample closely observing that the droplet of semen sample is evenly spread across the entire surface area of the cover slip The sample should spread evenly without using ANY additional pressure applied to the cover slip Figure 1 Figure 2 Figure 3 4 Carefully place the prepared slide on the slide adapter with the non loaded side towards the slide holder Open the spring loaded slide holder by pressing on its outer edge Figure 1 Slip the slide into the holder and release the spring Figure 2 This is most conveniently done with the slide position adjuster in a fully clockwise position The slide will now be firmly in place in the slide adapter
38. es acceptable range Latex beads established target values ranges Hemacytometer e Vial 1 47 7 0 M ml e Vial 2 24 3 4 M ml Revision 13_AUG_07 37 I High 47 7 0 lt Variability LOW 24 3 4 lt M ml 2 50 Accuracy High Level Control SQA V QUALITY CONTROL TEST High level of Accu beads target range 40 54 M ml ooopono BEBEBE Accu beads concentration in millions per mi Number of SQA V tested Accuracy Low Level Control SQA V QUALITY CONTROL TEST Low levelof Accu beads target range 20 6 27 4 M ml gmngnga iniga 20 4 S S 2 5 E E o 6 v S s 2 s oo oO lt Number of SQA Vtested SQA V Z User Guide Version 2 48 I button Precision and accuracy established in clinical trials using human semen samples Clinical claims Specificity e Concentration 85 Motility 80 Morph Norm Forms WHO 3 65 Morph Norm Forms WHO 4 60 Postvasectomy 95 of motile cells detected Sensitivity e Concentration 90 e Motility 85 e Morph Norm Forms WHO 3 85 e Morph Norm Forms WHO 4 65 Correlation to Manual Method e Concentration 0 9 e Motility 0 85 e Morph Norm Forms WHO 3 0 65 e Morph Norm Forms WHO 4 strict 0 45 Linearity Linear Sperm Concentration throughout the SQA V dynamic range of 2M ml to 400M ml e Squared regression coefficient of Dilution Curve R
39. es all man machine interface functions runs algorithms for test measurements according to WHO 4 guidelines 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 1 kHz analog up to 5V Printer e Built in Dot Matrix with ribbon cassette Citizen e Non thermostatic narrow paper with 20 characters per line Citizen Rear Panel Power connector with fuse holder fuse 250V 1A e Video connector e RS232 cable outlet 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 Requirements e 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
40. facilitate inserting the capillary into the sample at the bottom of the container 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 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 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 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 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 Revision 13_AUG_07 31 SQA V Z User Guide Version 2 48 I button CF H _ xs 3 Holding the capillary in a vertical position Figure 3 visually confirm that the sample has completely f
41. g precautions when handling the product e Wear suitable protective clothing Mask gloves and laboratory coat e Avoid dispersing material over the working area REFERENCES WHO 99 Laboratory Manual for the Examination of Human Semen and Sperm Cervical Mucus Interaction 4 Edition Cambridge University Press 1999 Reprinted 2000 Revision 13_AUG_07 42 SQA V Z User Guide Version 2 48 I button EE H wm s Medical Electronic Systems Ltd 20 Alon Hatavor Street Caesarea Industrial Park 38900 Israel AN Medical Electronic Systems Ltd E mail mes mes ltd com Website www mes ltd com badi Sa QwikCheck beads A QUALITY CONTROL MATERIAL FOR AUTOMATED AND MANUAL SPERM COUNTING SYSTEMS Introduction and Intended Use QwikCheck beads is an external quality control material for use in automated and manual sperm counting systems The material is for in vitro use only and is to be used as a tool to assess the accuracy and precision of the laboratory s sperm counting methods by providing a known target value and range Although the beads were developed for use on the SQA V automated and visualization system they can be used for manual proficiency testing on hemacytometers such as Neubauer counting chambers such as Makler and conventional fixed coverslips QwikCheck beads is supplied in a kit containing two vials of known concentrations of 4 micron latex beads suspended in an aqueous solvent and one vial of negative concentr
42. h WHO 4 Strict investigation wane Lus u Morphology Normal Forms WHO 4 Motile Sperm Concentration MSC Progressively Motile Sperm Concentration grade a PMSG lt a gt gt 10 M ml lt a b gt or gt 5 M ml lt a gt only MES Ltd Progressively Motile Sperm Concentration grade b oe s Functional Sperm Concentration FSC gt 7 M ml WHO 3 7 gt 3 M ml WHO 4 Velocity Average path velocity VAP VELOCITY MES Ltd MES Ltd Total Sperm Number SPERM gt 40 M ml WHO 4TH manual Total Progressively Motile Sperm PROG SPERM MES Ltd 214 M ml rd Total Functional Sperm FUNC SPERM MES Ltd gt 6 M mli WHO 4 Each laboratory should establish its own reference ranges for semen parameters The ranges established above are based on WHO 3 or 4 standards or MES Ltd for proprietary semen parameters Revision 13_AUG_07 36 SQA V Z User Guide Version 2 48 I button EE H ww wa Abbreviations TSC Sperm Concentration Count MSC Motile Sperm Concentration PMSC Progressive Motile Sperm Concentration Morph Norm Forms Morphologically Normal Forms OD Optical Density 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 10 sperm cells per milliliter M ml Motility and morphology values are expressed as a percent Unless otherwise noted all testing w
43. hawing on the motility parameters of the specimen e POSTVASECTOMY Fresh samples designated as postvasectomy and tested within an hour of collection PLEASE NOTE Enter the remaining sample information using the SQA V keypad Refer to the appendix e VOLUME Volume of the whole ejaculate in milliliters section of this user guide for information e WBC CONC select lt 1 M ml normal or gt 1 M ml abnormal on how to measure leukocytes required entry QwickCheck Test Strips recommended semen WBC s and pH and how to handle e PH pH of the semen sample QwickCheck Test Strips recommended viscous samples e APPEARANCE NORM ABNORM visual assessment of the specimen e LIQUEFACTION NORM ABNORM NORM liquefies within 60 minutes room temperature e VISCOSITY NORM ABNORM See WHO 4 guidelines e 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 gt 5 ml YES NO e After entering the patient and sample data the screen above will be displayed Using the left and right arrow keys and then ENTER select e YES for NORMAL VOLUME samples 20 5 ml e NO for LOW VOLUME samples lt 0 5 ml Revision 13_AUG_07 14 SQA V 44 User Guide Version 2 48 I Button Low Volume Samples Please note Prior to each running a test the system will perform autocalibration
44. he 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 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 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 PLEASE NOTE Test Low Volume samples as soon as the sample is aspirated into the capillary Revision 13_AUG_07 33 SQA V Z User Guide V
45. ilization From MAIN menu Select TEST NEW PATIENT and rerun the test Call technical support if this message is displayed again Prepare for technical Support by printing a copy of the SQA V SERVICE DATA e Press the SERVICE key on the SQA V keypad to activate the SERVICE MENU screen e Select PRINT SQA V DEFAULT SETTINGS gt SELF TEST DATA e Press ENTER Concentration Out of Range Testing Semen Sample TEST RESULTS OUT OF PHYSIOLOGICAL FLANGE RETEST SAMPLE YES ND 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 e SPERM CONC gt 500 M ml or e MSC gt 450 M ml Review sample handling technique see Appendix Filling the SQA V Capillary Re test the sample in a new SQA V capillary If the message appears again reboot the system Call for technical assistance if problem persists 30 SQA V Z User Guide Version 2 48 I button APPENDIX 1 Filling the SQA V Capillary with a Normal Volume Sample Cuvette Separating Syringe Section Valve Piston Capillary r Section Directing Syringe Runner Sample size collection container and preparation Filling the capillary 1 Sample volume should be at least 5 ml If sample volume is less than 5 ml see Appendix 2 Sample container should be wide necked and deep enough to
46. illed 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 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 j Figure 4 Figure 3 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 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 To visualize the specimen insert the capillary into the visualization compart
47. introduction of bubbles into the testing capillary can cause inaccurate readings Revision 13 AUG O07 1st clinical trial Motility correlation Motility SQA 0 20 40 60 80 Motility manual 100 2nd clinical trial Motility correlation R 0 87 100 0 10 20 30 40 50 60 70 80 90 Motility manual Motility SQA V am 100 2nd clinical trial MSC correlation 16 R 0 79 12 an o 8 wu 4 0 0 2 4 6 8 10 12 14 15 MSC manual SQA V DILUTION CURVE USING SEMEN DILUTED WITH DPBS amp HEPES SOLUTION ai s a m F w u W E S 0 20 40 60 80 100 120 Expected Sperm Concentration M ml Results 1 Squared regression coefficient R 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 39 SQA V 44 User Guide Version 2 48 I button a Flam SQA V Visualization System Follow directions for preparing a standard slide with 10 ul 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 gt 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 leukoc
48. l Imal Ta i HORM HORAM VISCOSITY HURN TEST RESULTS GS A mL CHC MOTILITY fr E PFROGRLCSSIVE MOTILITY Po Te lt a gt SLI y gt eee lt r TAROT di gt Ch AR id 4 49 Sor os oh MIRPH HORN PORES HHO Sri prsi PSC lt a gt Pre h gt Foc VEL OT SAHI 22 1x 40 im De SPL na 1 6 FP 1 a 1FR761 Ria r sc paa y TOTALS FER EJACULATE GFERH H HOTILE SPERA PE SFERH FUHC SPER Revision 13 AUG O07 H EZE BA HEF ti 14 571 fh wrt Report TaS DEFAULT SETTINGS REPORT i Sh ae PRIMT DATE 15 02 05 PRIHT TIAME ifray TIE DATE DATE PGRAAT DOAN TY TIME FRAT He Pe PATIEMT TESTING CONC GTAHDARD 1 MORPH WHO Gru CONTROL TESTING ai Se SAL ml TYPE LATEX READS ALT OPE TE D LEtEL HED CONTHUL LUT M EXP DATE 11705 TARGET VALUE Q eed 48 SERVICE DATA REPORT Sani SH 46 FRIHT DATE 15 02 05 PRINT TIME 17 59 SELF TEST DATA 3 427 31 W GORI HA 100 OF ml COHC 427 Shi ml H HORFH 20 1 VELOCITY 4mic sec KHLFBER SPIKE ii B0 a7 ha 2 1 SF1ml WIDTH 15476 SERVICE DATA 15 5 150 SQA V Z User Guide Version 2 48 I button APPENDIX 15 Printer Ribbon Paper Installation Front Cover Paper Lamp Setting Printing Paper Feed Switch Ribbon Cover 1 Open the front cover 2 Cut the edge of Printing Paper as the following drawing 3 Insert the paper into the paper insertion of the printer mechanism Mounti
49. ment with the blue stopper up Revision 13_AUG_07 32 SQA V Z User Guide Version 2 48 I button IE H w w w _ _ c x R APPENDIX 2 Filling the SQA V Capillary with a Low Volume Sample Sample size collection container and preparation 1 Filling the capillary 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 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 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 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 2 Push the syringe piston in fully Place only the thin part of the capillary into the bottom of the sample Figure 1 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 T
50. ng Bracke When auto loading function is specified paper is loaded automatically When auto loading function is not specified push the LF switch until the paper enters the printer mechanism By holding the paper holder in the arrowed direction insert paper roll and make sure paper holder hold the core Keep the paper winding direction correct While in replacing of paper do not send data from host terminal Do not pull the paper in reverse direction of paper feed This may cause ab normality of print head In case the paper is fed diagonally in paper supplying side or paper removing side paper jam may occur In this case turn OFF the power switch immedi ately and pull out the excessive paper slowly at straight direction Interface Connecto aper Holder Paper holder Roller Figure 1 Figure 2 Paper Feeding With the LF switch pressed once paper is fed by one line Paper is fed while it is continuously pressed To feed paper do not pull it forcibly Use the LF switch During pressing the LF switch the data can not be received Setting Ribbon Cassette 1 Open the ribbon cover Be sure to turn off power before opening it 2 In case the paper is out from front cover cut the paper or remove this paper 3 Confirming the correct direction of a new ribbon cassette insert ribbon be tween the printing head and the platen and press cassette down from the knob side 4 Turning the ribbon cassette knob in the arrowed di
51. onal 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 There are minimal to no cells present in a POSTVASECTOMY specimen Therefore the specimen needs to be centrifuged and the pellet re suspended in order to concentrate the specimen and increase the likelihood of finding cells The screen below will instruct CENTRIFUGE SAMPLE AND RESUSPEND PELLET PER USER GUIDE PRESS ENTER WHEN READY Centrifuge the specimen at 600g for 15 minutes Decant the supernatant and re suspend the pellet in 0 8 ml QwikCheck dilution media seminal plasma or other washing media 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 Revision 13 AUG 2007 19 SQA V Z User Guide Version
52. or the examination of human semen and sperm cervical mucus interaction 4 ed 1999 Cambridge University Press lt 1Wml gt 1M mi Hirer gt min TEST STRIPS a E val E E T E Reagent Strips iia for Semen Analysis Contents 100 strips For In Vitro Diagnostic Use Only Important Read package insert before use Store at room temperature below 30 C 86 F and away from direct sunlight and moisture Do not touch test areas Remove only the number of strips required for immediate testing Keep bottle tightly capped Lot XXXXXXX Expires MM YYYY Item 0700 MES Medical Electronic Systems Ltd www mes Itd com m Leukocytes m pH TESTS AND READING TIMES p Revision 13_AUG_07 40 SQA V Z User Guide Version 2 48 I button SESS SS PPENDIA 8 Dilution Medi iker DILUTION Product Insert INTRODUCTION AND INTENDED USE The QwikCheck Dilution Kit is to be used to dilute semen samples prior to automated manual testing and for semen sample preparation The dilution media is Earle s balanced salt solution which contains ingredients to support sperm motility and viability and is recommended by WHO for semen sample preparation WHO 99 4 ed manual p 104 The product is intended for in vitro use only KIT CONTENTS e 50 mli of sterile Earle s Balanced Salt solution e Product Insert STABILITY AND STORAGE CONDITIONS e The product has one
53. ormal sample of semen 5 Print and save Control test results SQA V Visualization System using a standard slide 1 Refer to the SQA V User Guide CONTROLS section for an explanation of how to set up the SQA V to test Manual Level 1 Level 2 QwikCheck beads or negative control Follow the instructions and screen prompts as outlined in the Controls section of the SQA V User Guide 2 Follow the basic instructions for mixing and preparing QwikCheck beads noted previously 3 Refer to the SQA V User Guide Operating the Visualization System to understand how to use a standard slide in the SQA V 4 Pipette 10 uL of QwikCheck beads or negative control onto a standard slide cover with a 22x22 mm coverslip to provide a 20 micron Revision 13_AUG_07 43 SQA V Z User Guide Version 2 48 I button L 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 gt SET UP gt PATIENT TESTING from the MAIN M
54. ove back and forth a few times Repeat with the material facing down Select a sponge material capillary and insert it in the same compartment in order to dry the chamber Insert the brush bristle side down fully into the upper portion of the lower chamber of the SQA V in same manner as a testing capillary Pull the brush out of the chamber while sweeping or dusting off the lens you will feel a step or shelf at the back and top of the chamber this is the top of the lens Switch SQA V unit ON and observe self test results The SQA V should now PASS the self test If not repeat cleaning procedure with the brush Open the visualization compartment door upper slot and swing the cover above the lens to the left Using Lens Paper or Kimwipes wipe the lens with 70 isopropyl alcohol not provided Revision 13_AUG_07 35 SQA V Z User Guide Version 2 48 I button L ss SQA V SEMEN PARAMETER TEST NAME REFERENCE RANGE SOURCE Sperm Concentration Count SPERM CONC gt 20 M mi WHO 4th manual RAPID PROG MOTILITY lt a gt gt 50 lt a b gt or SLOW PROG gt 25 lt a gt only MOTILITY lt b gt NONPROG Non Progressive Motility grade c MOTILITY lt c gt Rapid Progressive Motility grade a WHO 4TH manual Slow Progressive Motility grade b Immotility grade d IMMOTILITY lt d gt l rd MORPH NORM a Morphology Normal Forms WHO 3 FORMS WHO 3rd WHO 3rd manual MORPH NORM gt 15 Under t
55. ration 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 gt SERVICE gt PRINT SQA V DEFAULT SETTINGS gt SELF TEST DATA Press ENTER to generate a report How to view print a copy of the system parameters FROM V SPERM GOLD Verify that the SQA V is connected to the PC and V Sperm is activated From the SQA V activate MAIN MENU gt SERVICE gt SERVICE DATA Select the V Sperm navigation buttons UTILITIES
56. rection remove slack 5 On replacing a ribbon cassette pull it out as holding the PULL part In case the ribbon cassette is kept setting in printer so long time there may be the case to make a paper dirty And in case of continuous printing under low temperature light print may be occurred due to the characteristic of the ink Do not conduct printing with no nbbon cassette this may damage a pnnt head Replace ribbon cassette before wearing out completely Use exclusive ribbon cassette Revision 13_AUG_07 49 SQA V Z User Guide Version 2 48 I button SSS Sperm Quality Analyzer SQA V Warranty Medical Electronic Systems Ltd MES warrants that the Sperm Quality Analyzer the SQA 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 SQA is shown to MES s reasonable satisfaction to be defective MES shall at its option repair or replace such an SQA 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 or ii the SQA is used operated opened or serviced other than as directed by MES or is damaged as a result of use 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
57. rent date in the EXP Date field and zeros in all other fields from the MAIN MENU of the SQA V Commercially available latex beads or stabilized sperm 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 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 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 gt 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 GOLD on the PC and selec
58. rwritten or the SQA V will no longer permit testing ARCHIVE ALMOST FULL TO AVOID POSSIBLE LOSS OF DATA DOWNLOAD THE ARCHIVE TO THE PC PRESS ENTER TO CONTINUE To transfer the archives to the PC e From the SQA V go to MAIN MENU gt SERVICE gt SERVICE DATA e Make sure the RS232 communication cable is connected between the SQA V and the PC e Turn on the PC and activate the V Sperm GOLD version 3 48 software e From the V Sperm GOLD main navigation screen select IMPORT EXPORT gt IMPORT DATA gt select either IMPORT ARCHIVE PATIENT RECORDS or IMPORT CONTROLS CONTROL RECORDS e Press CONTINUE and the records will automatically be transferred e After all the records have been successfully transferred to V Sperm select YES on the next screen to delete the SQA V Patient or Control archive from the SQA V 18 SQA V Z User Guide Version 2 48 I Button 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 operati
59. t SET UP gt SQA V gt SQA V Defaults and press CONTINUE Step 4 The set up screen below will be activated in V Sperm GOLD on the PC O USA MMDDIYY i WHO 4th Conc Chamber Standard Printing Options 1 L Automatically print all test results ae O2 oO Automatically print Self Test Report on Start Up ie pea Media G Latex Beads Stabilized Sperm KEW ie sz R SE ce u ER Wc Vcc Go S aa ee Step 5 Select the type of control Latex Beads or Stabilized Sperm Step 6 Enter the following information from the box labeling 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 Step 7 To save settings Press APPLY The set up may take two minutes Revision 13 AUG 2007 21 SQA V Z User Guide Version 2 48 I button Hrwmm i s Set Up Non Assayed Material This is also the set up procedure for sperm concentration proficiency challenge Please note Follow the same Steps 1 5 for Set up Assayed Control above To run 10 replicates Step 6 Enter the following information from the product labeling After each completed LOT number identifying the control media lot test remove the capillary and initiate EXP DATE control media expiration date MM month YY year en uc ae Step 7 Enter the
60. ting the Visualization System Video Display Introduction Operating Instructions Standard Slide Preparation Testing Capillary Preparation Testing Process Counting Cells Using the Visualization Screen WWOONNN 10 10 11 11 12 SQA V Z User Guide Version 2 48 I button Revision 13_AUG_07 SECTION 10 Error Messages and Warning Messages Stabilization Failed Self Test Failed Electronic Noise Concentration Out of Range APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX APPENDIX O O N oo WwW A W N e e re e P PF PF N OD OF A wU N e O Filling the SQA V Capillary with a Normal Volume Sample Filling the SQA V Capillary with a Low Volume Sample Using Standard Slides in the Visualization System Cleaning the Capillary Slide Compartment Reference Values of Semen Variables Product Performance Data Measuring WBC s in Semen using QwikCheck Test Strips Dilution Media QwikCheck Dilution Treating Viscous Samples QwikCheck Liquefaction Assayed Control QwikCheck beads Concentration Standard Counting Chambers Postvasectomy Protocol Service Report SQA V Test Report Printouts Printer Ribbon Paper Installation Warranty Technical Bulletins and Product Updates 31 33 34 35 36 37 40 41 42 43 44 45 46 48 49 50 51 SQA V 4 User Guide Version 2 48 I button Specifications SQA V 4 7 V
61. umination and monitor on off functions e Magnification range x300 to x500 Slide Preparation e Use 10 ul of semen e Standard slide 22 mm x 22 mm cover slip to insure 20 micron depth e Load the prepared standard slide into the SQA V slide adaptor 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 e 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 e Press the HIGH ILLUMINATION key multiple times to ensure a maximum level setting e Turn BRIGHTNESS CONTRAST and COLOR buttons all the way counterclockwise e Turn FOCUS knob fully clockwise e To view cells Press ZOOM IN to maximum magnification x500 e To count cells Press ZOOM OUT to minimum magnification x300 Insert semen sample either capillary or slide into the visualization chamber Turn BRIGHTNESS knob clockwise until the video screen just begins to lighten up Turn FOCUS knob counterclockwise until image is focused e Adjust CONTRAST COLOR BRIGHTNESS FOCUS and object ILLUMINATION controls for optimal image quality Use ZOOM OUT x300 ZOOM IN x500 to regulate magnification 27 SQA V Z User
62. utomatically Testing A sample is tested in approximately 75 seconds If the sample is low quality the system will perform an additional 2 minute test DO NOT MOVE CAPILLARY OR OPERATE DEVICE DURING TESTING LOW QUALITY SAMPLE TESTING WILL TAKE 2 MORE MINUTES Revision 13_AUG_07 16 SQA V Z User Guide Version 2 48 I button CO STO Test Results TEST RESULTS SPERM CONC 32 6 M ml MOTILITY lt a b c gt 28 0 RAPID PROG MOTILITY lt a gt 5 2 SLOW PROG MOTILITY lt b gt 14 1 NON PROG MOTILITY lt c gt 8 7 IMMOTILITY lt d gt 72 0 MORPH NORM FORMS WHO 3 20 6 TEST RESULTS MSC 9 1 M ml FSC 2 5 M ml PMSC lt a gt 1 7 M ml VELOCITY 9 mic sec PMSC lt b gt 4 6 M ml SMI 34 TOTALS PER EJACULATE SPERM 81 5 M Pino SPERM 22 8 M PROG SPERM 15 8 M FUNC SPERM 6 3 M s ht Low quality sample semen parameters may be reported as lt or gt when one or es esurts more of the parameters falls below the SQA V dynamic range Only basic parameters can 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 MOTILITY lt a b c gt lt 5 RAPID PROG MOTILITY lt a gt SLOW PROG MOTILITY lt b gt NONPROG MOTILITY lt c gt IMMOTILITY lt d gt MORPH NORM FORMS WHO 3 TEST R
63. ve mixing Immediately withdraw a sample of the control material after opening the container Immediately and tightly close the container after withdrawing a sample to avoid evaporation or spillage Follow the same procedure normally used for manual or automated semen analysis see detailed instructions below al OS Target Value and Range SAMPLE TABLE follow Target values and Range on the box of QwikCheck beads Level 3 a Control Level 1 Million mL Level 2 Million mL Counting Method aac ee Target mange Target j seva ne sama a e Re oe oo rsi xn cautng chabert ns sim 2 ea Wr e NA neem s mores 2 s 95 e ma SQA V Automated System 1 Refer to the SQA V User Guide CONTROLS section for an explanation of how to set up the SQA V to test automated Level 1 Level 2 QwikCheck beads Follow the instructions and screen prompts in the Controls section of the SQA V User Guide 2 Follow the basic instructions for mixing and preparing QwikCheck beads noted previously 3 Aspirate a sample of the beads or negative control into the SQA V capillary in the same manner you would fill the capillary for a normal volume specimen Make sure that the cuvette section of the SQA V capillary is completely full of liquid and free of bubbles 4 Following the SQA V on screen instructions for Controls insert the SQA V capillary into the SQA V in the same manner you would test a n
64. y 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 Service Parameter Report MAX SP WIDTH 8 so fT Revision 13_AUG_07 46 SQA V Z User Guide Version 2 48 I button FE Self Test Parameters Fill in the SQA V SELF TEST PARAMETERS from the SELF TEST printout in V Sperm e The SQA V must be connected to the PC and V Sperm activated e From the SERVICE gt SERVICE DATA screen of the SQA V Go to the V Sperm navigation buttons UTILITIES gt 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 48 SQA V Self Test Criteria Parameters Amplitude 50 100 mV Count 12 26 36 TSC 1 or CONC 1 0 1M mI ee TSC 2 or CONC 2 50 150 M ml TSC 3 or CONC 3 300 600 M ml ww ss Revision 13_AUG_07 47 SQA V Z User Guide Version 2 48 I button EE H d lt a H s APPENDIX 14 SQA V Reports Semen Analysis Report SQA V Default Settings Service Data Report E EEEEEHEEREEFEEEEFEEEER ANALYS REPORT TEST BATE TEST TIME FRIAHT BATE PRIHT TIPE PATIEHT BATA if 012355456 fe BIRTH DATE 5 05 75 Airs T THERE 5 M5 SAMPLE DATA ACCESSIOH 1 DiD Ci FITWE R aie ES 1 eho RECETYED Chk ee DN 14 bo FRESH act Om
65. ytes Wait 120 seconds and 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 gt 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 gt 1 Million ml the WBC patch of the QwikCheck test strips exceed the darkest lavender color on the color chart after 120 seconds This reading corresponds to WBC concentration gt 1 Million ml that is considered abnormal according to WHO 99 4 edition Appendix 1A p 61 References e WHO 99 4 edition laboratory manual f

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