SQA IIC-P User Guide_28_APR_2008 SQA IIC-P USER GUIDE. Version 011_2008. Catalog # April 28,2008. Revision 11 1
|
|
- Benjamin Quinn
- 6 years ago
- Views:
Transcription
1 SQA IIC-P USER GUIDE Version 011_2008 Catalog # 7417 April 28,2008 Revision 11 1
2 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 Revision 11 2
3 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 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
4 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
5 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
6 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
7 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 % WASHED Not valid Not valid FROZEN Not valid Not valid 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
8 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 ( 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 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
9 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 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
10 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 Poor <80 Revision 11 10
11 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 AMPLITUDE LAMP VOLTAGE 3.20 V V REFERENCE 1.50 V 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
12 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
13 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 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
14 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
15 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 M/ml FSC M/ml Fresh Motility % MSC M/ml Norm. Morph % SMI Washed, FSC M/ml Frozen, Not relevant MSC M/ml Treated, etc. SMI 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 DILUTION CURVES OF TOTAL SPERM CONCENTRATION DETERMINED USING SQA IIC-P DEVICES R = 0.99 R = 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 R = 0.98 R = Expected MSC, M/ml Unit #2255 Unit #2256 Linear (Unit #2256) Linear (Unit #2255) Revision 11 15
16 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
17 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 # Expires: 09/2008 Item #0700 Strip Handle Revision 11 17
18 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 Revision 11 18
19 Appendix 7: SQA IIC-P Report DATE 02/03/08 TIME 10:26 PAT. ID 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
20 Appendix 8: Printer Specifications Revision 11 20
21 APPENDIX 9: Printer Ribbon/Paper Installation Revision 11 21
System overview Installation System Description System Default Settings and Loading I-Button Tests Components/Kits /Accessories Maintenance & Cleaning
SQA-VISION TRAINING Content of Presentation System overview Installation System Description System Default Settings and Loading I-Button Tests Components/Kits /Accessories Maintenance & Cleaning SQA-Vision
More informationSQA-V Gold Semiannual Validation/Proficiency/QC Recommendations
MEDICAL ELECTRONIC SYSTEMS 5757 W. Century Blvd. Suite 805 Los Angeles, CA. 90045 Remember, it ALL Started with a Sperm! www.mes global.com SQA-V Gold Semiannual Validation/Proficiency/QC Recommendations
More informationUser Guide Version 2.48 I-Button USER GUIDE. Version 2.48 I-Button. Catalog # 5139 AUGUST Revision 20_AUG_2009 1
User Guide Version 2.48 I-Button USER GUIDE Version 2.48 I-Button Catalog # 5139 AUGUST 2009 Revision 20_AUG_2009 1 Table of Contents SECTION 1: System Specifications and Requirements Sperm Quality Analyzer
More informationQwikCheck BULL. User Guide
QwikCheck BULL User Guide Version 1.00 Catalog #Fpe-A-00338-00 May 2010 QwikCheck Bull User Guide TABLE OF CONTENTS Section 1: Overview 3 Section 2: System Overview 3 Section 3: Operating the QwikCheck
More information2017 SPERM QUALITY ANALYZERS FOR VETERINARY / BREEDING MES CATALOGUE
2017 SPERM QUALITY ANALYZERS FOR VETERINARY / BREEDING MES CATALOGUE COMPANY PROFILE Dear Partners! West Medica company specializes in manufacturing and distribution of veterinary equipment. The company
More informationUse Tomorrow s Technology Today
Use Tomorrow s Technology Today Company Profile (MES) is a leading edge company specializing in rapid, automated semen analysis for both the human and the veterinary markets. The Company s comprehensive
More information2017 SPERM QUALITY ANALYSIS MES CATALOGUE
2017 SPERM QUALITY ANALYSIS MES CATALOGUE [ 2 ] CONTENTS Page Section 4 7 Sperm quality analyzers 8 9 Digital systems for sperm analysis 15 19 Additional information [ 3 ] SPERM ANALYSIS SQA-Vision Sperm
More informationLeadCare BLOOD LEAD ANALYZER. Quick Reference Guide
LeadCare II BLOOD LEAD ANALYZER Quick Reference Guide Precautions Precautions Caution The LeadCare II Blood Lead Analyzer is a CLIA-waived device. Facilities that perform tests with the LeadCare II System
More informationDear HighQ Check System Owner :
Dear HighQ Check System Owner : Thank you for purchasing the HighQ Check Blood Glucose Monitoring System. This manual provides important information to help you to use the system properly. Before using
More informationMedescan Nebuliser Med - S600A Instructions Manual
Medescan Nebuliser Med - S600A Instructions Manual Please read this guidebook carefully before operating this unit Your Nebuliser is intended for use in the treatment of asthma, COPD and other respiratory
More informationGlucCell TM SYSTEM USER S GUIDE Ver 2.1 CELL CULTURE GLUCOSE METER. Important Information. Intended Use. Caution. About the System
GlucCell TM SYSTEM USER S GUIDE Ver 2.1 Intended Use The GlucCell TM Glucose Monitoring System (The GlucCell TM System) is designed to quantitatively measure the concentration of glucose during cell culture.
More informationMouse C-Peptide ELISA Kit
Mouse C-Peptide ELISA Kit Cat.No: DEIA4507 Lot. No. (See product label) Size 96T Intended Use The Mouse C-Peptide ELISA kit is for the quantitative determination of c-peptide in mouse serum, plasma, and
More informationGlucose Meter. User Guide. Veterinary Monitoring System. For dog and cat use only
Glucose Meter User Guide Veterinary Monitoring System For dog and cat use only Gpet instruction Manual 31/5/09 18:06 Page 2 Gpet instruction Manual 31/5/09 18:06 Page 3 TABLE OF CONTENTS Your g-pet system
More informationBovine Insulin ELISA
Bovine Insulin ELISA For quantitative determination of insulin in bovine serum and plasma. For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: 80-INSBO-E01 Size: 96 wells Version:
More informationPorcine/Canine Insulin ELISA
Porcine/Canine Insulin ELISA For the quantitative determination of insulin in porcine or canine serum and plasma. Please read carefully due to Critical Changes, e.g., Calculation of Results. For Research
More informationRat Insulin ELISA. For the quantitative determination of insulin in rat serum and plasma. For Research Use Only. Not For Use In Diagnostic Procedures.
Rat Insulin ELISA For the quantitative determination of insulin in rat serum and plasma For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: Size: 80-INSRT-E01, E10 96 wells, 10
More informationGlucCell TM SYSTEM USER S GUIDE ver 2.3 CELL CULTURE GLUCOSE METER. Important Information. Intended Use. Caution. About the System
GlucCell TM SYSTEM USER S GUIDE ver 2.3 Intended Use The GlucCell TM Cell Culture Glucose Monitoring System (The GlucCell TM System) is designed to quantitatively measure the concentration of glucose during
More informationBlood Glucose Monitoring System. User Guide
Blood Glucose Monitoring System User Guide Table of Contents Introduction...2 Important Safety Instructions...2 About ipet PRO Blood Glucose Monitoring System...3 About ipet PRO Meter...4 About the ipet
More informationCoaguChek S System. Quick Reference Guide. This is a CLIA-waived System. Coagulation Testing with Fresh Whole Blood
CoaguChek S System This is a CLIA-waived System Quick Reference Guide Coagulation Testing with Fresh Whole Blood May not print or view at 100% All unmarked prints black. Coag Swoosh prints gradients of
More informationMouse Ultrasensitive Insulin ELISA
Mouse Ultrasensitive Insulin ELISA For the quantitative determination of insulin in mouse serum and plasma. Please read carefully due to Critical Changes, e.g., Calculation of Results. For Research Use
More informationMARSHALLTOWN MEDICAL & SURGICAL CENTER Marshalltown, Iowa
MARSHALLTOWN MEDICAL & SURGICAL CENTER Marshalltown, Iowa CARE OF PATIENT POLICY & PROCEDURE Policy Number: 4:10 Subject: Policy: Glucose Monitoring (Accuchek) Nursing department staff and laboratory staff
More informationMouse C-peptide ELISA
Mouse C-peptide ELISA For the quantitative determination of C-peptide in mouse serum. For Research Use Only. Not for use in Diagnostic Procedures. Please read carefully due to Critical Changes, e.g., Calculation
More informationCarnitine / Acylcarnitines Dried Blood Spots LC-MS/MS Analysis Kit User Manual
Page 1 / 14 Carnitine / Acylcarnitines Dried Blood Spots LC-MS/MS Analysis Kit User Manual ZV-3051-0200-15 200 Page 2 / 14 Table of Contents 1. INTENDED USE... 3 2. SUMMARY AND EXPLANATION... 3 3. TEST
More informationMouse C-peptide ELISA
Mouse C-peptide ELISA For the quantitative determination of C-peptide in mouse serum. For Research Use Only. Not for use in Diagnostic Procedures. Please read carefully due to Critical Changes, e.g., Preparation
More informationHIV-1 p24 ELISA Kit. Catalog Number KA assays Version: 06. Intended for research use only.
HIV-1 p24 ELISA Kit Catalog Number KA0452 96 assays Version: 06 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Principle of the Assay... 3 General Information... 4 Materials
More informationRat C-peptide ELISA. For the quantitative determination of C-peptide in rat serum. For Research Use Only. Not For Use In Diagnostic Procedures.
Rat C-peptide ELISA For the quantitative determination of C-peptide in rat serum. For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: Size: 80-CPTRT-E01 96 wells Version: May 26,
More informationRat C-peptide ELISA. For the quantitative determination of C-peptide in rat serum
Rat C-peptide ELISA For the quantitative determination of C-peptide in rat serum Please read carefully due to Critical Changes, e.g., see Calculation of Results. For Research Use Only. Not For Use In Diagnostic
More informationInsulin (Porcine/Canine) ELISA
Insulin (Porcine/Canine) ELISA For the quantitative measurement of insulin in Porcine/Canine serum and plasma (EDTA) For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: 80-INSPO-E01
More informationProtn-Latex. For Determination of Protein in Latex. (Cat. # Latex, Latex) think proteins! think G-Biosciences
415PR-02 G-Biosciences 1-800-628-7730 1-314-991-6034 technical@gbiosciences.com A Geno Technology, Inc. (USA) brand name Protn-Latex For Determination of Protein in Latex (Cat. # 786-20Latex, 786-21Latex)
More informationHuman HIV (1+2) antigen&antibody ELISA Kit
Human HIV (1+2) antigen&antibody ELISA Kit Catalog Number. CSB-E18042h For the qualitative determination of human HIV (1+2) antibody and P24 antigen concentrations in serum, plasma. This package insert
More informationItems in the package:
Intended Use: The EasyLife Hb Monitoring System is designed for in vitro diagnostic use only (external use only), and is suitable for self-testing. The system is for healthcare professionals and persons
More informationPROCEDURE. TITLE: Bedside Glucose Monitoring PC Laboratory. Issuing Department: Clinical Director Signature: Departments Involved:
PROCEDURE TITLE: Bedside Glucose Monitoring Issuing Department: Clinical Director Signature: Departments Involved: Laboratory Nursing Effective Date: 10/97 Review Dates: 09/01, 07/02, 05/13 Revision Dates:
More informationCompressor Nebulizer System
MedPro The Professional Choice Le choix des professionnels MedProTM MC Compressor Nebulizer System 705-445 Instruction Manual Index 1. Introduction...2 2. Product Identification...2 3. Important Safeguards...3
More informationBlood Glucose & Ketone Monitoring System
Blood Glucose & Ketone Monitoring System Self monitoring of blood glucose is an integral part of diabetes care, but the high cost of testing can make this impossible. At ACON, our goal is to provide high
More informationCompressor Nebulizer. Guidebook
NSTRU Compressor Nebulizer Guidebook MODEL: MQ6002 READ THIS INSTRUCTION MANUAL CAREFULLY BEFORE USE Compressor Nebulizer MODEL NO: MQ6002 INSTRUCTIONS INDEX 1. Introduction ----------------------------------------------------------------
More informationCentriVet GK Blood Glucose & Ketone Monitoring System
CentriVet GK Blood Glucose & Ketone Monitoring System FOR ANIMAL USE. NOT FOR HUMAN USE. Welcome and thank you for choosing the CentriVet GK Blood Glucose & Ketone Monitoring System. The CentriVet GK Blood
More informationBRS GM100 Glucose Monitoring System. User Instruction Manual Ver. 3.5
BRS GM100 Glucose Monitoring System User Instruction Manual Ver. 3.5 TABLE OF CONTENTS Introduction... 3 Intended Use... 3 Understanding the GM100 Glucose Monitoring System... 4 Explanation of the Full
More informationRat Hemoglobin A1c (HbA1c) Kit Instructions
V.3 Crystal Chem Rat Hemoglobin A1c (HbA1c) Kit Instructions For the quantitative determination of hemoglobin A1c (HbA1c) in rat whole blood Catalog #80300 96 Assays For research use only. Not for use
More informationMorinaga Mouse C-peptide ELISA Kit
Morinaga Mouse C-peptide ELISA Kit For the quantitative determination of C-peptide in mouse serum, plasma, and fluid 96wells For Laboratory Use Only, not for use in diagnostic procedure Please read full
More informationInsulin ELISA. For the quantitative determination of insulin in serum and plasma.
Insulin ELISA For the quantitative determination of insulin in serum and plasma. For In Vitro Diagnostic use within the United States of America. This product is for Research Use Only outside of the United
More informationH.Pylori IgG
DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com
More informationH.Pylori IgG Cat # 1503Z
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationBlood Glucose Monitoring System
Blood Glucose Monitoring System Contents Chapter 1 OMRON Blood Glucose Monitoring System HEA-232 1.1 Introduction 1.2 List of Kit Contents 1.3 Product and Meter Display Chapter 2 Installing and Setting
More informationInstruction Manual Aerogen, Inc. Part No. AG-AL1010 Rev. C
Instruction Manual 2004 Aerogen, Inc. Part No. AG-AL1010 Rev. C Table of Contents Introduction... 3 System description... 4 Warnings... 5 Cautions... 5 Electromagnetic Susceptibility... 5 Symbols... 6
More informationProcine sphingomyelin ELISA Kit
Procine sphingomyelin ELISA Kit For the quantitative in vitro determination of Procine sphingomyelin concentrations in serum - plasma - celiac fluid - tissue homogenate - body fluid FOR LABORATORY RESEARCH
More informationHIV-1 p24 ELISA Kit. Cat.No: DEIA10155 Lot. No. (See product label) Size. Storage. Principle Of The Test. Reagents And Materials Provided
HIV-1 p24 ELISA Kit Cat.No: DEIA10155 Lot. No. (See product label) Size 96T Storage All reagents should be stored at 2-8 C, and should not be used beyond the expiration date on the label. Once opened,
More informationIV2-113E Use by. Invitron Glargine ELISA Kit REF LOT IVD. Definitions. English. For in-vitro diagnostic use. Instructions for use.
Definitions Instructions for use REF Catalogue number IV2-113E Use by English Invitron Glargine ELISA Kit For in-vitro diagnostic use Σ 96 LOT IVD Lot/Batch Code Storage temperature limitations In vitro
More informationTips for Training New Customers
Tips for Training New Customers Good Habits: Test Strips Recap vial immediately and tightly after removing a single test strip. Never remove the desiccant from the vial. Do not lay test strips out ahead
More information25-Hydroxyvitamin D2-D3 Serum VD-200 UHPLC Analysis Kit User Manual
Page 1 / 12 25-Hydroxyvitamin D2-D3 Serum VD-200 UHPLC Analysis Kit User Manual ZV-4027-0500-10 500 2-8 C Page 2 / 12 Table of Contents 1. INTENDED USE... 3 2. SUMMARY AND EXPLANATION... 3 3. IVD SYMBOLS...
More informationChlamydia trachomatis (CHLa)Test Kit
Chlamydia trachomatis (CHLa)Test Kit Instructions For Use Format: Cassette Specimen: Urethral/Genital Swab Catalog Number: VEL-001-CHLa * Please read the instructions carefully before use INTENDED USE
More informationCompressor Nebulizer Instruction Manual Part No.: 5055
Compressor Nebulizer Instruction Manual Part No.: 5055 DISTRIBUTED BY: SAVE THESE INSTRUCTIONS. CAUTION - U.S. Federal Law restricts this device to sale by or on the order of a physician. 666002-6310 V1.3
More informationHuman TSH ELISA Kit. User Manual
Human TSH ELISA Kit User Manual Catalog number: GTX15585 GeneTex Table of Contents A. Product Description... 2 B. Kit Components... 3 C. Additional Required Materials (not included)... 3 D. Reagent Preparation...
More informationTo provide you with necessary knowledge and skills to accurately perform 3 HIV rapid tests and to determine HIV status.
Module 9 Performing HIV Rapid Tests Purpose To provide you with necessary knowledge and skills to accurately perform 3 HIV rapid tests and to determine HIV status. Pre-requisite Modules Module 3: Overview
More informationCoQ10(Coenzyme Q10) ELISA Kit
CoQ10(Coenzyme Q10) ELISA Kit Catalogue No.: EU0196 Size: 48T/96T Reactivity: Universal Detection Range: 0.781-50ng/ml Sensitivity:
More informationVedolizumab Drug Level ELISA
Vedolizumab Drug Level ELISA For the quantitative determination of free Entyvio concentration in human serum and EDTA plasma. Please read carefully due to Critical Changes, e.g., Updates to specificity
More informationInsulin ELISA. For the quantitative determination of insulin in serum and plasma
Insulin ELISA For the quantitative determination of insulin in serum and plasma For In Vitro Diagnostic use within the United States of America. This product is for Research Use Only outside of the United
More informationHBeAg and HBeAg Ab ELISA Kit
HBeAg and HBeAg Ab ELISA Kit Catalog Number KA0290 96 assays Version: 17 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Principle of the Assay... 3
More informationPLUS One. Blood Glucose Monitoring System. Owner s Manual
PLUS One Blood Glucose Monitoring System Owner s Manual Dear PLUS One System Owner: Thank you for purchasing the PLUS One Blood Glucose Monitoring System. This manual provides important information to
More informationCompressor Nebulizer. Guidebook
NSTRU Compressor Nebulizer Guidebook MODEL: CN02WS (MQ6003) READ ALL INSTRUCTION BEFORE USE Airial TM Compressor Nebulizer INSTRUCTIONS INDEX 1. Introduction ----------------------------------------------------------------
More informationH. pylori Antigen ELISA Kit
H. pylori Antigen ELISA Kit Catalog Number KA3142 96 assays Version: 04 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of
More informationAmantadine ELISA Test Kit
Amantadine ELISA Test Kit Catalog No. LSY-10052 1. Principle This test kit is based on the competitive enzyme immunoassay for the detection of Amantadine. The coupling antigen is pre-coated on the micro-well
More informationDear Prodigy System Owner:
User's Manual Dear Prodigy System Owner: You have chosen one of the best blood glucose monitoring systems available. This booklet has important information about the system. Please read it carefully. Your
More informationRotavirus Test Kit. Instructions For Use. Format: Cassette Specimen: Fecal Extract Catalog Number: VEL-001-ROTA
Rotavirus Test Kit Instructions For Use Format: Cassette Specimen: Fecal Extract Catalog Number: VEL-001-ROTA * Please read the instructions carefully before use INTENDED USE Velotest Rotavirus Test is
More informationHepatitis C Virus (HCV) Antibody Test
Hepatitis C Virus (HCV) Antibody Test Instructions For Use Format: Cassette For: Catalog Number: VEL-001-HCV Specimen: Serum/Plasma * Please read the instructions carefully before use INTENDED USE Hepatitis
More informationPORTABLE COMPRESSOR NEBULIZER Guidebook & Manual Reorder No. 5606
PORTABLE COMPRESSOR NEBULIZER Guidebook & Manual Reorder No. 5606 Please read this guidebook carefully before operating this unit. Your Nebulizer is intended for use in the treatment of asthma, COPD and
More informationQUICK REFERENCE INSTRUCTIONS. THYROCHEK TSH Cassette
QUICK REFERENCE INSTRUCTIONS THYROCHEK TSH Cassette A certificate of CLIA waiver is required to perform the testing in a waived setting. If the laboratory does not have a Certificate of Waiver, the Application
More informationInstructions for use. TSH rat ELISA. Please use only the valid version of the Instructions for Use provided with the kit AR E-8600
Instructions for use TSH rat ELISA AR E-8600 TSH rat ELISA 1. INTRODUCTION 1.1 Intended use The TSH rat ELISA is an enzyme immunoassay for the quantitative measurement of TSH in rat serum. For research
More informationManagement of Central Venous Access Devices. Blood Glucose Monitoring
Management of Central Venous Access Devices Blood Glucose Monitoring Purpose To provide education on the standard of care regarding the use and monitoring of the Accu- Chek Blood glucose machine, including
More informationBeneCheck BK6-12M. Plus Multi-Monitoring Meter and Strips
BeneCheck BK6-12M Plus Multi-Monitoring Meter and Strips The BeneCheck BK6-12M multi-monitoring system is an easy to use, handheld device which allows you to check your Total Cholesterol, as well as Blood
More informationPKU (Phenylketonuria) Serum HPLC Analysis Kit User Manual
Page 1 / 20 PKU (Phenylketonuria) Serum HPLC Analysis Kit User Manual ZV-4003-0200-10 200 2-8 C Page 2 / 20 Table of Contents 1. INTENDED USE... 3 2. SUMMARY AND EXPLANATION... 3 3. TEST PRINCIPLE... 3
More informationBlood Glucose Measurement. Omnitest 5 & Omnican Lance FAQ Frequently Asked Questions
Blood Glucose Measurement Omnitest 5 & Omnican Lance FAQ Frequently Asked Questions FAQ Omnitest 5 & Omnican Lance CONTENT Omnitest 5 Overview 3 Application Range 5 Target Groups 5 Test Strips 5 Settings
More informationRayBio Human Granzyme B ELISA Kit
RayBio Human Granzyme B ELISA Kit Catalog #: ELH-GZMB User Manual Last revised April 15, 2016 Caution: Extraordinarily useful information enclosed ISO 13485 Certified 3607 Parkway Lane, Suite 100 Norcross,
More informationInfluenza A IgG ELISA
Influenza A IgG ELISA For the qualitative determination of IgG-class antibodies against Influenza A virus in human serum or plasma (citrate, heparin). For Research Use Only. Not For Use In Diagnostic Procedures.
More informationSee external label 2 C-8 C 96 tests Chemiluminescence. CMV IgM. Cat # Diluted samples, controls & calibrator 100 µl 30 minutes
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationChymotrypsin ELISA Kit
Chymotrypsin ELISA Kit Cat. No.:DEIA10041 Pkg.Size:96T Intended use The Chymotrypsin ELISA Kit is a sandwich Enzyme Immuno Assay intended for the quantitative determination of Chymotrypsin in stool. General
More informationWorksheet. Worksheet. Worksheet. Worksheet. Student Performance Guide. Student Performance Guide
LESSON 6-3 Laboratory Reagent Preparation and Calculations Worksheet LESSON 6-4 Chemistry Instrumentation in the Physician Office Laboratory Worksheet LESSON 6-6 Measuring Blood Glucose Worksheet LESSON
More informationTJF-160F/VF Cleaning and Disinfection Checklist
TJF-160F/VF Cleaning and Disinfection Checklist TJF-160F/VF Cleaning and Disinfection Checklist This checklist is used to evaluate and confirm if cleaning and disinfection of the TJF-160F/VF has been performed
More informationSee external label 96 tests HSV 2 IgA. Cat #
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationDIAGNOSTIC AUTOMATION, INC.
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationUSER MANUAL Please read before use
USER MANUAL Please read before use A comfortable and relaxing micro current stimulation treatment designed to help alleviate pain and soreness associated with a variety of conditions IMPORTANT SAFETY INFORMATION
More informationA82-LIFE-Dog Nebulizer NBB02
A82-LIFE-Dog Nebulizer NBB02 פיית אוויר A82-LIFE-Dog Nebulizer NBB02 www.mfcl.co.il COMPRESSOR NEBULIZER USER S MANUAL A82-LIFE-Dog Nebulizer NBB02 ILLUSTRATION OF PARTS A. NEBULIZER COMPRESSOR
More informationRat Proinsulin ELISA
Rat Proinsulin ELISA For the quantitative determination of proinsulin in rat serum For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: 80-PINRT-E01 Size: 96 wells Version: June
More informationFinTest IgG4 Screen 20 ELISA KIT
FinTest IgG4 Screen 20 ELISA KIT Cat. No.:DEIA6196 Pkg.Size:96T Intended use Enzyme immunoassay (microtiter strips) for the detection and the quantitative determination of IgG4 antibodies against 20 Food
More informationUser s Manual Blood Glucose Meter
User s Manual Blood Glucose Meter Contents Introduction...3 Chapter 1: Your New System...5 Chapter 2: Blood Glucose Tests...13 Chapter 3: Control Tests...25 Chapter 4: Meter Settings...31 Chapter 5: Review
More informationHuman Cytomegalovirus Virus (CMV) IgG ELISA Kit
Human Cytomegalovirus Virus Catalog No: IRAPKT1410 (CMV) IgG ELISA Kit Lot No: SAMPLE INTENDED USE The CMV IgG ELISA is intended for use in evaluating a patient s serologic status to cytomegalovirus (CMV)
More informationSee external label 2 C-8 C 96 tests CHEMILUMINESCENCE. CMV IgG. Cat # Step (20-25 C Room temp.) Volume
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationHuman Alpha 1 microglobulin ELISA Kit
Human Alpha 1 microglobulin ELISA Kit Catalogue No.: EH4144 Size: 48T/96T Reactivity: Human Range:0.625-40ng/ml Sensitivity:
More informationPoint of Care Testing. Bedside Glucose Meter
Point of Care Testing Bedside Glucose Meter 11/2017 Regulatory Overview Bedside glucose is a point of care lab test and YOU are performing this lab test under the Lab s CLIA license. All lab tests are
More informationHuman Cytomegalovirus IgM ELISA Kit
Human Cytomegalovirus IgM Catalog No: IRAPKT2012 ELISA Kit Lot No: SAMPLE INTENDED USE The CMV IgM ELISA is intended for use in the detection of IgM antibodies to Cytomegalovirus (CMV) infection in human
More information02006B 1 vial 02006B 1 vial Store at -20 C. Lyophilized recombinant IL-2
For detection and measurement of human interleukin 2 Catalog #02006 Catalog #02007 2 Plates 10 Plates Product Description The Human Interleukin 2 (IL-2) ELISA Kit is designed for the quantitative detection
More informationTable of Contents Section 1 Introduction... 1 Section 2 System Components... 4 Section 4 Initial Setup... 9 Section 5 Meter Setup and Options...
Table of Contents Section 1 Introduction... 1 Intended Use... 1 About Prothrombin Time (PT) Testing... 2 About International Normalized Ratio (INR) Values... 2 Test Principle... 2 Section 2 System Components...
More informationCOMPRESSOR NEBULIZER MODEL: JB USER S MANUAL
COMPRESSOR NEBULIZER MODEL: JB0112-062 USER S MANUAL Read this manual before operating the nebulizer Save these instructions for future reference Caution: Federal law restricts this device to sale by or
More informationHerpes Simplex Virus 2 IgG HSV 2 IgG
DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and 116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com
More informationToxoplasma gondii IgM (Toxo IgM)
DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com
More informationH. pylori IgM. Cat # H. pylori IgM ELISA. ELISA: Enzyme Linked Immunosorbent Assay. ELISA - Indirect; Antigen Coated Plate
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com H. pylori
More informationStep-by-Step Instructions For OraQuick HCV Rapid Antibody Test
Step-by-Step Instructions For OraQuick HCV Rapid Antibody Test Complexity: WAIVED for fingerstick whole blood and venipuncture whole blood. A Certificate of CLIA Waiver is required to perform the test
More informationCYTOMEGALOVIRUS (CMV) IgM ELISA Kit Protocol
CYTOMEGALOVIRUS (CMV) IgM ELISA Kit Protocol (Cat. No.:EK-310-91) 330 Beach Road, Burlingame CA Tel: 650-558-8898 Fax: 650-558-1686 E-Mail: info@phoenixpeptide.com www.phoenixpeptide.com INTENDED USE The
More informationSERION ELISA classic CMV Avidity Reagent B109 AVID
SERION ELISA classic CMV Avidity Reagent B109 AVID SERION ELISA classic Avidity Reagents are complementary components which, in combination with the corresponding SERION ELISA classic, enables the avidity
More informationRubella virus IgG ELISA Kit
Rubella virus IgG ELISA Kit Catalog Number KA0223 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of
More informationPRIMA. Blood Glucose Monitoring System. Owner s Manual
PRIMA Blood Glucose Monitoring System Owner s Manual English Dear FORA Diamond PRIMA System Owner: Thank you for purchasing the FORA Diamond PRIMA Blood Glucose Monitoring System. This manual provides
More information