MES SQA-V Gold, User Manual

Page 1: ...User Guide Version 2 60 I Button Revision 21_Sep_2015 1 U S E 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...

Page 2: ...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...

Page 3: ...n 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 Dilut...

Page 4: ...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...

Page 5: ...itive 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 no...

Page 6: ...ex 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 co...

Page 7: ...e 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 Magni...

Page 8: ...odate 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 Sli...

Page 9: ...y 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...

Page 10: ...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...

Page 11: ...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 stabili...

Page 12: ...CE 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...

Page 13: ...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...

Page 14: ...rted 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 wit...

Page 15: ...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 Revision...

Page 16: ...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 scree...

Page 17: ...ROG 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...

Page 18: ...te 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 Q...

Page 19: ...ctions 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...

Page 20: ...MMOTILE 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...

Page 21: ...em 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 no...

Page 22: ...s 1 7 of Set Up Assayed Control to update the target value and range for the control Running Controls in the SQA V CONTROL Testing MAIN MENU Select RUN CONTROLS from the MAIN MENU of the SQA V TEST NE...

Page 23: ...actory 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 sam...

Page 24: ...tout Compare the values If the value from the SQA V is within range mark the Pass column If not mark the Fail column Parameter S W Ver 2 60 SQA V Value Pass Fail 1 Ref 1 150 400 mV 2 LED Cur 1 5 25 mA...

Page 25: ...ng screen will appear after every CONTROL TEST is performed ATTENTION TO AVOID LOSS OF DATA TRANSFER CONTROL RESULTS TO V SPERM PRESS IMPORT TEST BUTTON IN V SPERM To transfer data to V Sperm first co...

Page 26: ...vice Personnel A code is required to access SERVICE PERSONNEL This option allows a qualified service technician to access calibration and maintenance settings Print SQA V SELF TEST DATA The system SEL...

Page 27: ...A V is turned on Use monitor ON OFF key on the keypad to independently operate the video display Wait for the self test to complete system is disabled at this time To ensure that the visualization sys...

Page 28: ...Sperm and click on the Real Time Video button FREEZE the image 8 The screen of both the SQA V and the V Sperm is divided into a grid containing 20 distinct squares see below 9 Each spermatozoon seen o...

Page 29: ...emperatures between 20 C 30 C Stabilization Failed Ensure there is no testing capillary in the measurement compartment Remove the SQA V from sources of electronic noise and vibrations Clean measuremen...

Page 30: ...to Calibration Stabilization From the main menu Select TEST NEW PATIENT and rerun the test Call technical support if this message is displayed again Prepare for technical support by printing a copy of...

Page 31: ...ully 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...

Page 32: ...om 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...

Page 33: ...thin capillary chamber with 20 micro liters of semen Figure 1 The exact quantity aspirated can be determined by the gradations on the 1 ml syringe Aspirate the sample until it just appears in the cuv...

Page 34: ...slide and cover with a standard 22 mm x 22 mm cover slip The droplet of semen should be evenly spread across the entire surface area of the cover slip automatically without anyadditional pressure appl...

Page 35: ...the darkest setting until the background is light not maximum 6 Adjust the focus knob to maximize the image Turn clockwise all the way Then turn counterclockwise until a clear image appears on the scr...

Page 36: ...re to sweep or dust off the optics you will feel a shelf in the back top section of the chamber Fig 2 and 3 Monitor the system s REF 2 parameter It should be between 2800 and 3200 mV if possible CLEAN...

Page 37: ...Morphology normal forms MORPH NORM FORMS WHO 5th 4 WHO 5th manual Motile Sperm Concentration MSC 6 M ml MES Progressively Motile Sperm Concentration PMSC 5 M ml MES Functional Sperm Concentration FSC...

Page 38: ...ocytes 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 erythrocy...

Page 39: ...Revision 21_Sep_2015 39 User Guide Version 2 60 I button WHO 5th APPENDIX 8 Dilution Media...

Page 40: ...r neutralize the enzymatic activity optional by adding of Human Serum Albumin HSA not provided in this kit CLINICAL PERFORMANCE Semen Samples Treated with QwikCheck Liquefaction Parameter Correlation...

Page 41: ...Revision 21_Sep_2015 41 User Guide Version 2 60 I button WHO 5th APPENDIX 10 Assayed Control QwikCheck Beads...

Page 42: ...the SQA V will automatically run semen samples based on that standard SQA V Set Up Select SERVICE SERVICE DATA Log into V Sperm and go to SET UP SQA V CONTINUE Select a CONC concentration STANDARD ba...

Page 43: ...ostvasectomy specimen using V Sperm software This test is highly sensitive to any movement The SQA V and the testing capillary should not be disturbed in any way during the 5 minute testing cycle Fill...

Page 44: ...Revision 21_Sep_2015 44 User Guide Version 2 60 I button WHO 5th APPENDIX 13 GLOBOZOOSPERMIC SAMPLES...

Page 45: ...SQA V Contact MES for the initial calibration parameters These parameters should not have changed Parameter Service Report Item User Report MES Report Comments CONTR REF1 1 OD AMPLIF 13 MSC AMPLIF 8...

Page 46: ...Sperm navigation buttons UTILITIES SELF TEST DATA Select PRINT Verify that the parameters listed below fall within the established range Highlight the discrepancies and report to MES Parameter S W Ver...

Page 47: ...Revision 21_Sep_2015 47 User Guide Version 2 60 I button WHO 5th APPENDIX 15 SQA V Reports Semen Analysis Report Service Data Report...

Page 48: ...tting for a long time in the printer Installing Printer Paper 1 Open the front cover to expose the paper holder androller 2 Cut the edge of the paper as shown below 3 Insert the paper into the printer...

Page 49: ...or servicing other than as directed by MES the foregoing warranties shall be void and of no further force or effect EXCEPT FOR THE FOREGOING WARRANTIES THE PRODUCTS ARE SOLD AS IS AND WITHOUT ANY OTH...

Page 50: ...icroscope 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 M...

Page 51: ...of Nantes Samples Fresh Washed Frozen High Sensitivity 750 300 42 30 350 Analytical Specificity To achieve analytical specificity a specific wave length of light which is maximally absorbed by sperm c...

Page 52: ...le 2 Immotile cells were analyzed by use of the SQA V visualization system 218 semen specimens contained motile cells and were used as the basis for the Post Vas visualization methodcomparison Table 5...

Page 53: ...y 193 89 Microscope only 161 74 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 wer...

Page 54: ...Release 12_APR_2016 1 U S E R G U I D E V e r s i o n 3 6 0 I B u t t o n W H O 5 t h Catalog V A 00733 00 April 2016...

Page 55: ...Attach Images 7 Authorize Test Results 7 Search by Patient 7 Authorizing Test Results 7 Deleting Records 8 SECTION 5 Controls 8 SECTION 6 Video 9 SECTION 7 Importing Exporting Data from the SQA V 9 SE...

Page 56: ...m via person password security package includes the following User Guide Installation CD V Sperm Security device RCA video cable System Requirements SQA V with communication cable and power cable PC H...

Page 57: ...hrough the system click on one of the buttons When a navigation button is selected sub menu buttons appear across the top of the screen making it easy to access the features of the program A variety o...

Page 58: ...pply to save Attach Video Picture to a Test Record Insert a slide or testing capillary into the visualization system of the SQA V From the patient data screen select the record there could be multiple...

Page 59: ...indicate test results are out of range Click this icon to export the test report When test results are expressed as or a value low quality specimens only this icon indicates that test results possibl...

Page 60: ...the corresponding row Image Browser NOTE If there are no saved images in a patient s file the table will not appear NOTE Click the image to maximize it NOTE Click the image to GRID and FREEZE the imag...

Page 61: ...UN REPORT button to display a list of Control Test Results based on the selected parameters Click on the columns to sort data Tests that are out of range will be noted Select a corrective action for t...

Page 62: ...res and saves a video clip to an external file Save Picture Captures and saves a picture to an external file SECTION 7 Import Test Import Export from the SQA V NOTE If a message has been displayed on...

Page 63: ...Ports Auto Export SQA V SQA V Defaults V Sperm Set Up Set up Authorized Users Select SET UP V SPERM AUTHORIZED USERS and the screens below will be displayed Assign rights passwords and enter informati...

Page 64: ...lts of that test will not be reported on the patient s semen analysis report Test Parameters Set up V Sperm Report Test Parameters Select the information to be viewed on the V Sperm screens and report...

Page 65: ...ther language Click Apply to save the changes Set up Ports Select Set up V Sperm Ports to view Communication Port options Select the correct port for the PC and press Apply Set up Auto Export Select S...

Page 66: ...displayed Data must be entered in all fields of the table below or the SQA V will not accept the default settings SQA V System Default settings Date Format DD MM YY or MM DD YY Local date setting Conc...

Page 67: ...Click on the UTILITIES navigation button Select SELF TEST DATA Select PRINT or SAVE SECTION 10 Log Off LOG OFF V Sperm by clicking the navigation button and confirming with a click A new user can imm...

Page 68: ...to automatically begin installation Step 2 The screen will display Initializing Wise Installation Wizard Step 3 Close any programs that are open or running Step 4 Run the installation program and clic...

Page 69: ...e and subtype 640 x 480 Analog Video PAL B Step 4 Press Apply to save the changes Step 5 Place a slide sample in the SQA V and select the VIDEO function in V Sperm to test if the device is functioning...

Page 70: ...will be run routinely for proficiency testing other options can be selected just to run those samples Enter Lot Number for each control level enter 0 if not known Enter EXPIRATION date use current da...

Page 71: ...iate driver is automatically installed USB to RS232 Device Driver Installation 1 Close all open programs 2 Insert the USB to RS232 FTDI Drivers CD into the PC CD ROM 3 From the PC click START RUN and...