SQA IIC-P USER GUIDE Version 011_2008 Catalog # 7417 April 28,2008 Revision 11 1
Table of Contents SECTION 1: System Specifications and Requirements. SECTION 2: System Overview... Front Panel... Keypad Navigation... Rear Panel Measurement Capillary.. Semen Parameters. Dynamic Range SECTION 3: Device Technology SECTION 4: Getting Started Installation. Power-On.. Self-Test and Auto-Calibration.. SECTION 5: Testing Semen Samples.. Entering Patient and Sample Information Testing.. Test Results. High Sensitivity Test Important Notes Grading Test Results.. SECTION 6: Service Data SECTION 8: Troubleshooting. APPENDIX 1: Filling SQA II Capillary with Semen Sample. APPENDIX 2: Cleaning the Measurement Compartment. APPENDIX 3: Reference Values of Semen Variables.. APPENDIX 4: Product Performance Data... APPENDIX 5: Measuring WBC's in Semen using QwikCheck Test Strips. APPENDIX 6: Treating Viscous Samples APPENDIX 7: SQA IIC-P Report.. APPENDIX 8: Printer Specifications. APPENDIX 9: Printer Ribbon and Paper Installation. 3 5 5 5 6 6 7 7 7 8 8 8 8 8 8 9 9 10 10 10 11 11 12 13 14 15 17 18 19 20 21 Revision 11 2
Specifications SQA IIC-P Version XX SECTION 1: System Specifications and Requirements Dimensions: 14 x 36 x 22 cm Weight: 2.7 kg AC power supply: 100 to 250 VAC, 50/60 Hz, 20 VA Display Backlit LCD (4 lines x 40 characters) Front Panel Built-in printer LCD display Measurement compartment 23-button keypad Power indicator Parameter definition guide Rear Panel MES certification & serial # sticker Power socket with integrated fuseholder Ventilation slots Calibration control (set by the manufacturer - not to be adjusted or the calibration of the system will be compromised.) Keypad Operational keys: ON/OFF, TEST, PRINT, RECALL, DELETE, SERVICE, ENTER, four cursor keys, ten numeric keys (0-9), F1 and F2 keys. Measurement Compartment Source of radiant energy one tungsten lamp Detecting system - photo detector Operating System Analysis Time: Normal Test 45 seconds; High Sensitivity Test 420 seconds (7 minutes). Software: Resides on flash memory, drives all man-machine interface functions, and runs algorithms for test measurements. Measurement channel input signal: Analog, up to 5V. Printer Built-in, Dot Matrix with ribbon cassette (Citizen) Non-thermostatic narrow paper with 20 characters per line (Citizen) Maintenance Schedule Daily: Clean measurement compartment daily when running samples and after every 10-15 tests and/or for ANY spillage. ONLY use the Manufacturers cleaning kit or damage will occur to the SQA IIC-P measurement compartment and the system will not operate! Revision 11 3
Manufacturer Recommendations Operate the SQA IIC-P away from devices that may cause electronic noise (cell phones) or other devices causing vibrations such as centrifuges. Turn system OFF at the front panel and disconnect from the main electricity when not in use for extended period of time. When running High Sensitivity 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 7- minute testing cycle. Variations in ambient temperature can affect semen samples. It is essential that semen samples are not heated when testing. The SQA IIC-P is calibrated to conduct tests at room temperature: 22-26ºC (72-79ºF). Semen is considered a biologically hazardous material and is subject to individual laboratory protocols for handling such materials. Operating Temperature Operates in a wide range of ambient temperatures (15-38ºC), however the system is calibrated to measure semen samples at room temperature: 22-26ºC (72-79ºF). 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. 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 only. Not for use with animal semen. SQA IIC-P measurement capillary: Disposable, plastic testing capillary. Requires 20 µl of sample. Use only manufacturer s certified testing capillaries. Quality Assurance ISO-9002 manufacturing, lot control, traceability Certification FDA, CLIA Moderate, CE, Israeli, Russian, Chinese and Japanese Ministries of Health Revision 11 4
Basic features SECTION 2: System Overview The Sperm Quality Analyzer SQA IIC-P is an automated stand-alone medical device for semen analysis. The SQA IIC-P is a single-channel instrument combining technology of electro-optical detection and computer algorithms. The system performs a 45-second screening of human semen quality. Test results are displayed on a screen as well as printed. QC is performed by a built-in self-testing process. The system does not run external QC. The SQA-IIC-P has a limited application and is recommended for use as a screening device to determine normal vs. abnormal semen samples. The unit is based on normal semen references established by WHO (WHO 92, 3 rd ed. manual). The SQA-IIC-P is for human use only. Front Panel Keypad Navigation ON/OFF to turn on/off the device (1) NUMERIC to enter data (2) F2 to display the totals (semen variables per sample volume) after test completion or to start a new patient screen from the main menu (3) F1 for testing the sample at the high sensitivity mode (4) Revision 11 5
PRINT for printing results (5) RECALL to display the last report (6) DELETE to delete the character (7) SERVICE to display the service data after the self-test or test (8) TEST for activating the testing process (9) CURSOR to move to the next field (10) ENTER to confirm data entries and to move to the next screen or field (11) Rear Panel Ventilation slots Notes: 1. Calibration Control must not be touched by the user, otherwise the system calibration will be compromised. 2. Do not block the ventilation slots or system may malfunction due to overheating. Power socket with integrated fuseholder MES certification & serial # sticker Calibration control Measurement Capillary Rubber Cap Stoppers Capillary Section Disposable, designed to test samples in a biologically safe manner. 20 micro liters of semen required to fill the capillary for testing. Refer to Appendix 1: "Filling SQA II Capillary with Semen Sample" for instructions on how to use the testing capillary. Revision 11 6
Semen Parameters Automated test results Parameter Description SQA IIC-P syntax Units Sperm Concentration Total concentration of spermatozoa CONC M/ml Motility <a + b> Percent of spermatozoa with progressive motility MOTILITY % Normal Morphology (WHO 3rd) Percent of spermatozoa with normal morphology NORM MORPH % Functional Sperm Concentration Concentration of progressively motile spermatozoa with normal morphology FSC M/ml Motile Sperm Concentration Concentration of progressively motile spermatozoa MSC M/ml Sperm Motility Index Derived parameter reflecting both motile sperm concentration and average velocity SMI Total Number Sperm / Ejaculate Sperm Concentration multiplied by ejaculate volume ALL SPERM M Total Motile Sperm / Ejaculate MSC multiplied by ejaculate volume MOTILE SPERM M Total Functional Sperm / Ejaculate FSC multiplied by ejaculate volume FUNC. SPERM M Dynamic Range Sample Type Sperm Conc., M/ml Motility, % MSC, M/ml FRESH 5-200 10-100% 0.5-200 WASHED Not valid Not valid 0.5-200 FROZEN Not valid Not valid 0.5-200 SECTION 3: Device Technology Principles of testing The capillary is inserted into the SQA IIC-P measurement compartment. Tens of thousands of sperm cells are analyzed as they move through a light beam: The movement of motile sperm cells causes light disturbances. These light disturbances are detected and converted into analog electronic signals with peaks and valleys which are then analyzed by proprietary algorithms. Analog signal typical for fertile specimen Analog signal typical for subfertile specimen Revision 11 7
SECTION 4: Getting Started Installation Operate the SQA IIC-P away from devices that may cause electronic noise (cell phones) or other devices causing vibrations such as centrifuges. Before using the SQA IIC-P for the first time, check the available electrical supply (100-250 VAC, 50/60Hz). The power-input socket includes an integrated fuse holder at the bottom. 1-ampere fast-blow fuse is to be used. The SQA is insensitive to line variations in most environments. The system dissipates very little electrical power and has internal regulation of supply voltages. No special electrical supply, grounding, or filtering is required. Electrical surge protector recommended for areas where electricity fluctuates. Power-On Attach the factory supplied electrical cable to the outlet on the rear panel. Plug the cable into a grounded electrical source and the Power indicator will illuminate. Turn on SQA IIC-P by pressing the ON/OFF button. Self-Test / Autocalibration will be started each time the system is turned on. Self-Test and Auto-Calibration The SQA is equipped with an internal self-testing and self-calibrating system to ensure correct settings and measurements. Do not insert a capillary into the device or use any of the keypad functions until Self-Test is completed. The Self-Test process takes ~ 20 seconds. A Passed Self-Test message and Enter Patient Data screen will appear when the Self-Test process is complete. The SQA IIC-P is now ready for use. PASSED SELF-TEST ENTER PATIENT DATA: DATE 02/03/08 TIME 09:00 PATIENT ID 1234567890 A Failed Self-Test message will be displayed If the instrument does not meet the required performance. Clean the Measurement Compartment using an SQA II Cleaning Kit manufactured by MES Ltd. only (For details, please refer to the Section 6: Service Data & Appendix 2: Cleaning the Measurement Compartment). If Self-Test failure continues after cleaning, call for technical support. SECTION 5: Testing Semen Samples Entering Patient and Sample Information Enter the requested patient/sample information using the keypad and then pressing the Enter key: DATE & TIME first time entered by the user and then displayed automatically. PATIENT ID Unique number identifying the patient (Maximum of 10 numbers can be entered). ABSTINENCE - Number of days since the patient's last ejaculation. COLL./TEST TIME The elapsed time in minutes from semen collection to the beginning of the test. Revision 11 8
Semen assessment PLEASE NOTE: The SQA IIC-P is calibrated to run semen specimens at room temperature: 22 C to 26 C (68 F to 79 F). It is not necessary nor will the user get accurate motility results if the sample is heated to 37ºC. APPEARANCE NORM/ABNORM by visual assessment of the specimen VOLUME Volume of the entire ejaculate in milliliters. PH ph of the semen sample (QwickCheck Test Strips recommended). LIQUEFACTION NORM/ABNORM (NORM - liquefies within 60 minutes @ room temperature). VISCOSITY NORM/ABNORM (See WHO 99 4 th edition guidelines). WBC White Blood Cells (leukocytes) should be tested using QwickCheck Test Strips (recommended). Selection of NORM/ABNORM/N.A. entry is available. Testing After entering the patient/sample information, the screen below will be displayed: PASSED SELF-TEST INSTRUCTIONS FILL AND CLEAN CAPILLARY INSERT INTO OPTICAL CHAMBER PRESS TEST OR F1 BUTTON The screen above will be intermittently replaced with the following one: PASSED SELF-TEST INSTRUCTIONS FOR WHO PARAMETERS, USE ONLY FRESH UNTREATED SAMPLES See Appendix 1 for instructions on filling the SQA II testing capillary. The screen below will appear after pressing the Test button for Normal Test (45 second test time) or F1 button for High Sensitivity Test (about 7 minutes). TESTING TIME REMAINING: 45 Test Results The screen below will display the test results: Reported semen parameters TEST COMPLETED PRESS F2 FOR TOTALS WHO PARAMETERS CONC. 34M/ml MOTILITY 35% NORM MORPH 22% OTHER DATA FSC 4.1M/ml MSC 11.9M/ml SMI 91 Press the F2 button to view test results expressed in millions per ejaculate volume: TOTALS IN SAMPLE PRESS F2 TO RETURN ALL SPERM 170.0M MOTILE SPERM 59.50M FUNC. SPERM 20.50M Press the Print key to run a printout of the test results. Press the Enter or Test key for more options after testing is completed: TEST Retest same patient Revision 11 9
F1 Retest high sensitivity F2 New patient RECALL Last test results Press the Test or F1 key to retest the same sample without re-entering patient data. Press the F2 key to test a new patient. Press Recall to display the last test results. The last test results will remain in memory until a new test is run or the unit is switched off. If no key is activated for ~ 15 minutes, a printout of the last test will be run and then the unit will be turned off automatically. High Sensitivity Test Testing low quality samples A high sensitivity test can be performed as an initial test or as an additional test once a normal test performed. Press the F1 key to initiate this function. The main purpose of this test is to assess low quality or post-vasectomy samples for the presence of motile spermatozoa. This High Sensitivity test takes 7 minutes. Important Notes Test results are reported in two columns: - WHO Parameters and Other Data. For fresh non-treated samples analyzed within 1-2 hours of collection, all results are valid. For samples that do not meet the FRESH criteria, or for treated samples (frozen, enriched, diluted, washed, etc.), only the test results from the Other Data column will be availabe (this includes FSC, MSC and SMI). A low quality sample is defined as FSC < 0,5 million/ml. In these cases, the system will report WHO Parameters Unavailable. This is due to the fact that the system cannot accurately read such low concentrations of functional sperm. The only test results that will be reported are in the Other Data column. Polyspermia. In some rare cases (~ 2%) an extremely high concentration of sperm cells cannot be accurately measured by the SQA II. This can occur when the concentration is above 150 x 10 6 sperm cells/ml. The SQA IIC-P will correctly grade polyspermic samples as very fertile. Grading Test Results Quality Grade Sperm Conc. Motility Norm Morph. MSC FSC SMI Good >60 >50 >30 >26 >13 >160 Medium 20-60 30-50 20-30 10-26 3-13 80-160 Poor 0-20 0-30 0-20 0-10 0-3 <80 Revision 11 10
SECTION 6: Service Data Self-Test results Press the Service key to display the Self-Test parameters: DATA FROM SELF-TEST PRESS SER. TO RETURN COUNT 409 AMPLITUDE 15 LAMP VOLTAGE 2.92V REFERENCE 1.25V The Self-Test PASS criteria for acceptable ranges are presented below: Parameters Average Reading Acceptable Range COUNT 409 407-412 AMPLITUDE 20 10-30 LAMP VOLTAGE 3.20 V 2.50-4.50 V REFERENCE 1.50 V 1.00-3.00 V COUNT represents the frequency of the Self-Test analog signal. The very narrow acceptable range (±0.5%) reflects a high electronic precision of the instrument. AMPLITUDE represents the average spike amplitude. LAMP VOLTAGE proportional to the light intensity. REFERENCE reference voltage after detector. The Self-Test service data is valid only PRIOR to testing a sample. Once the semen sample has been tested, the service data is no longer valid until the unit is turned OFF and back ON. SECTION 7: Troubleshooting Fixing problems PROBLEM The power indicator is not lightening. SOLUTION The power indicator should be illuminated at all times when the instrument is plugged in, regardless of the power ON/OFF switch. If it is not: Check that the instrument is connected to a power source of appropriate voltage, and that the outlet is operational and energized. Replace the fuse(s). The unit fails Self-Test. Reboot the system: turn power OFF, wait five seconds, then turn it ON. Peer into the measurement compartment slot during the Self- Test. If no light is visible, call for technical support. If the light is visible inside the measurement compartment slot during Self-Test but the unit fails Self-Test again, the measurement compartment may be contaminated due to failure to wipe and clean the tip of the testing capillary when operating the system. Implement a cleaning procedure (see Appendix 2: Cleaning the Measurement Compartment). If Self-Test failure continues after cleaning, call for technical support. Revision 11 11
Appendix 1: Filling SQA II Capillary with Semen Sample Mix a liquefied semen sample without introducing air bubbles by gently rotating the sample. Select a testing capillary Forcefully squeeze the rubber cap of the capillary and dip approximately 5 mm deep into the sample. Fully release the pressure on the rubber cap while the capillary is still in the sample gently filling the capillary. Observe the capillary to ensure that sample has fully filled the testing area of the capillary and has risen to the wider area of the capillary. Quickly and thoroughly wipe the outer surfaces of the capillary (both top and bottom). Removing excess sample in order to prevent clogging of the SQA IIC-P optical chamber by semen. While handling the capillary filled with a specimen, make sure not to inadvertently squeeze the cap. Important: Insert the capillary flat side up marked with an arrow as far as it will go into the slot of SQA IIC-P optical chamber. When the capillary is inserted into the instrument measurement compartment, press the TEST button to initiate the sample reading. Note: The capillary should remain in the chamber for the duration of testing only. Long insertion may cause sample leakage. Revision 11 12
APPENDIX 2: Cleaning the Measurement Compartment SQA IIC-P Cleaning Instructions: ONLY use the manufacturer s SQA II Capillary Compartment Cleaning Kit or damage will occur 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 IIC-P becomes contaminated with semen Cleaning kit components: 25 capillaries with fibrous material tips 25 sponge-tipped drying capillaries Cleaning fluid Cleaning procedure: Switch the SQA IIC-P OFF and unplug electrical cable from the main power. Select a fibrous material capillary: Place ONE-TWO drops of cleaning solution on the fibrous material (do not make it wet just moist). Shake off excess liquid. Insert into the slot of the measurement compartment wet side up and move back and forth a few times. Select a sponge material capillary, insert it in the same compartment, and move back and forth a few times in order to dry a chamber. Turn the SQA IIC-P back ON. The system should pass Self-Test without a problem. If not, repeat the cleaning procedure. Revision 11 13
APPENDIX 3: Reference Values of Semen Variables SEMEN PARAMETER SQA IIC-P TEST NAME REFERENCE RANGE* Sperm Concentration (Count) CONC. 20 M/ml Motility (progressive grades a+b) MOTILITY 50% SOURCE WHO 3 rd & 4 th manuals* WHO 3 rd & 4 th manuals* Morphology (% Normal Forms: WHO 3 rd ) NORM MORPH 30% WHO 3 rd manual* Motile Sperm Concentration (progressive) MSC 10 M/ml MES Ltd.* Functional Sperm Concentration FSC 7 M/ml MES Ltd.* Sperm Motility Index SMI 80 MES Ltd.* Total Number Sperm / Ejaculate ALL SPERM 40 M/ml WHO 3 rd & 4 th manuals* Total Motile Sperm / Ejaculate MOTILE SPERM 20 M MES Ltd.* Total Functional Sperm / Ejaculate FUNC. SPERM 14 M/ml MES Ltd.* *Each laboratory should establish its own reference ranges for semen parameters. The ranges established above are based on WHO 3 rd or 4 th edition manual standards or MES Ltd. (for proprietary semen parameters). Revision 11 14
Appendix 4: Product Performance Data Abbreviations: Conc.: Sperm Concentration (Count); MSC:Motile Sperm Concentration CV: Coefficient of variation Performance Data Summary: The performance of the SQA IIC-P is summarized in the text, tables and graphs below. All values concerning sperm concentration measurements are expressed as x10 6 sperm cells per milliliter (M/ml). Motility and morphology values are expressed as a percent (%). Unless otherwise noted, all tests were performed using human patient and donor semen samples. Calibration: Each SQA IIC-P device is biologically calibrated against two reference systems at Medical Electronic Systems Ltd. laboratory. Dynamic Range: Sample Type WHO parameters Other Data Conc. 6-200 M/ml FSC 0-200 M/ml Fresh Motility 10-100% MSC 0-200 M/ml Norm. Morph. 15-100% SMI 0-500 Washed, FSC 0-200 M/ml Frozen, Not relevant MSC 0-200 M/ml Treated, etc. SMI 0-500 Linearity Correlation (r) claims: Sperm Concentration: r = 0.80 MSC: r = 0.85 Method: The SQA IIC-P linearity was established experimentally by testing sequentially diluted semen samples. The fresh semen samples were diluted using pooled seminal plasma and tested using two SQA IIC-P devices. The dilution curve trendlines were generated by plotting the experimental results vs. expected values (see attached graphs). Actual correlation coefficients of dilution curves: Measured Conc., M/ml 60 50 40 30 20 10 0 DILUTION CURVES OF TOTAL SPERM CONCENTRATION DETERMINED USING SQA IIC-P DEVICES R = 0.99 R = 0.99 0 10 20 30 40 50 60 Expected Conc., M/ml Unit #2255 Unit #2256 Linear (Unit #2255) Linear (Unit #2256) DILUTION CURVES OF MOTILE SPERM CONCENTRATION DETERMINED USING SQA IIC-P DEVICES Sperm Concentration: r = 0.99 MSC: r = 0.98 Measured MSC, M/ml 25 20 15 10 5 0 R = 0.98 R = 0.98 0 5 10 15 20 25 Expected MSC, M/ml Unit #2255 Unit #2256 Linear (Unit #2256) Linear (Unit #2255) Revision 11 15
Precision SQA IIC-P intra- and inter-device variability Precision claims: Intra-device variability: CV < 15% Inter-device variability: CV < 18% Parameter Semen variables CV, % Background: In order to establish the SQA IIC-P precision, an intra- and inter-device variability were assessed. Method: A total of 30 fresh semen samples were tested in duplicates using 2 SQA IIC-P references. The coefficients of variation (CV) characterizing the inter- and intra-device variability were found to be below 15% (see table). Intra-device variability Inter-device variability Conc., 10.6 Motility, % 6.6 Morphology, % 4.0 Conc., M/ml 12.5 Motility, % 7.9 Morphology, % 4.2 Accuracy Correlation to manual method claims: Sperm Concentration: r = 0.80 Motility: r = 0.75 MSC: r = 0.85 Background: The study was conducted based on WHO 99 4 th ed. manual guidelines. The SQA IIC-P sperm concentration, motility and MSC readings were compared to the microscope results using correlation analysis. Method: Fresh semen samples were analyzed by the SQA IIC-P and microscope in parallel. Sperm Concentration was assessed using the Makler chamber. Motility was tested using the standard slide. MSC was calculated based on Sperm Concentration and Motility results. Correlation coefficients (r) of the SQA IIC-P readings to the manual semen analysis results were established using MedCalc statistical program. Correlation to manual method Parameters Correlation coefficients (r) Sperm Concentration, M/ml 0.89 Motility, % 0.82 MSC, M/ml 0.93 Limitations of the system: The SQA IIC-P is a single-channel medical device that utilizes analog signals generated by the system when motile spermatozoa cross the light beam for statistical deriving the reported semen parameters. The SQA IIC-P is recommended for use as a general screening device for assessing semen quality. In order to get the valid WHO semen variables, only fresh samples can be run on the SQA IIC-P device. Motility is critical for accuracy in the SQA IIC-P, therefore samples must be run within 1 hour of collection. The SQA IIC-P should not be used for longevity testing. Revision 11 16
APPENDIX 5: Measuring WBC's in Semen Using QwikCheck Test Strips QwikCheck Test Strips for Semen Place one drop of semen on the test patch for WBC's (leukocytes). 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 >1 Million/ml. NOTE: Test strips are also supported for ph testing of semen. Clinical Trial The WBC patch of the test strip changes color due to a chemical reaction caused by the presence of esterase in granulocytes. Esterases cleave to indoxyl ester, liberating the indoxyl, which then reacts to diasonium salt to produce a violet dye. This chemical reaction is not affected by bacteria, trichomonads or erythrocytes present in the specimen. QwikCheck test strips were evaluated by Medical Electronic Systems Ltd. (MES) for use as a qualitative indicator (WBC's >1M/ml) of WBC's in human semen. To test this application, WBC's were isolated from blood and re-suspended in seminal plasma. Varying concentrations of WBC's in seminal plasma were tested using the test strips. Test results were analyzed visually and by spectrophotometer readings. Results and Conclusion When the WBC concentration in semen is >1 Million/ml the WBC patch of the QwikCheck test strips exceed the darkest lavender color on the color chart after 120 seconds. (This reading corresponds to WBC concentration >1 Million/ml that is considered abnormal according to WHO 99 4 th edition manual, Appendix 1A, p. 61). References WHO 99 4 th edition laboratory manual for the examination of human semen and sperm-cervical mucus interaction, 4 th ed., 1999, Cambridge University Press. 1M/ml >1M/ml 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. Keep bottle tightly capped. Lot # 010307001 Expires: 09/2008 Item #0700 Strip Handle Revision 11 17
APPENDIX 6: Treating Viscous Samples INTRODUCTION AND INTENDED USE Product Insert The QwikCheck TM 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 TM Liquefaction Kit is used to prepare viscous semen samples for automated or manual semen analysis and is for in-vitro use only. KIT CONTENTS 20 single dose, 5 mg vials of lyophilized α-chymotrypsin. Product Insert STABILITY AND STORAGE CONDITIONS The product has a one-year shelf life. Note the expiration date on the box and vials. Store vials at -20 C. Warm to room temperature (22-26 C) prior to use. INSTRUCTIONS FOR USE 1. Select one vial of α-chymotrypsin and bring to room temperature (2-3 minutes). 2. Tap the vial to move the contents to the bottom of the vial prior to opening. 3. Add the entire contents of one vial to a viscous semen sample. 4. Gently mix the sample to dissolve the powder. 5. Once the sample has liquefied (5-10 minutes), immediately perform automated testing, or neutralize the enzymatic activity (optional) by adding of Human Serum Albumin (HSA) (not provided in this kit). PRECAUTIONS AND WARNINGS Each vial contains α-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 following precautions when handling the product: Wear suitable protective clothing: Mask, gloves and laboratory coat. Avoid dispersing material over the working area. REFERENCES: WHO 99 Laboratory Manual for the Examination of Human Semen and Sperm- Cervical Mucus Interaction, 4 th Edition, Cambridge University Press, 1999, Reprinted 2000. Revision 11 18
Appendix 7: SQA IIC-P Report DATE 02/03/08 TIME 10:26 PAT. ID 12345 ABSTINENCE 3 d COLL./TEST TIME 60 m VOLUME 5.0 ml APPEARANCE NORM LIQUEFACTION NORM VISCOSITY NORM PH 7.5 WBC NORM WHO PARAMETERS: CONCENT. 34M/ml PROG. MOTIL. 35% NORM. MORPH. 22% OTHER DATA: MSC 11.9M/ml FSC 4.1M/ml SMI 91 TOTALS IN SAMPLE: ALL SPERM # 170.0M MOTILE SPERM 59.50M FUNC. SPERM 20.50M N.A. NON AVAILABLE MSC MOTILE SPERM CONCENTRATION FSC FUNCTIONAL SPERM CONCENTRATION SMI SPERM MOTILITY INDEX ALL SPERM CONCEN * VOLUME MOTILE SPERM MSC * VOLUME FUNC. SPERM FSC * VOLUME Revision 11 19
Appendix 8: Printer Specifications Revision 11 20
APPENDIX 9: Printer Ribbon/Paper Installation Revision 11 21