AYTU BioSience mioxsys User Manual

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MiOXSYS Analyzer

User Manual

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Summary of Contents for AYTU BioSience mioxsys

Page 1 MiOXSYS Analyzer User Manual...
Page 2 373 Inverness Parkway, Suite 206 Englewood, CO 80112 USA Made in USA www.aytubio.com ©2018 Aytu BioScience, Inc. Document No. 100230 REV 6...
Page 3: Table Of Contents
Summary and Explanation ................3 MiOXSYS System ..................3 MiOXSYS Testing Instructions ..............4 Calculation of Results ................... 6 MiOXSYS Data Review Instructions ............. 6 MiOXSYS Identification Instructions ............7 MiOXSYS Analyzer Other Settings .............. 7 MiOXSYS Power Supply ................8 MiOXSYS Power Off ..................
Page 4: Description
The MiOXSYS System is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. The MiOXSYS System is indicated for use in adult males aged 21-45 yrs old who are undergoing semen analysis.
Page 5: Summary And Explanation
MiOXSYS System. The MiOXSYS Test can be used as a complementary measure to standard semen analyses (ie. motility or sperm concentration). The MiOXSYS Test provides a quick and holistic measure of oxidative stress by measuring static oxidation-reduction potential (sORP).
Page 6: Mioxsys Testing Instructions
• USB drive with software for download of data MiOXSYS Testing Instructions Initial Setup • Place the MiOXSYS Analyzer on a flat, level surface. Specimen Collection and Handling • Semen sample should be collected in accordance with published guidelines for collection and liquefaction for semen analysis.
Page 7 • The sample should be applied using a pipette. • 30ul is required for each test. • Apply the sample to the Sample Application Port on the inserted MiOXSYS Sensor. Make sure that the entire port is covered. Precaution: Please use gloves when handling biological material, as per standard laboratory practice.
Page 8: Calculation Of Results
Discard the MiOXSYS Sensor observing the proper disposal of biological fluids guidelines. • Once the used MiOXSYS Sensor is removed, “Insert sensor” will appear on the display screen. Repeat the steps in the Sensor Insertion section if performing additional testing.
Page 9: Mioxsys Identification Instructions
MiOXSYS Identification Instructions To identify your MiOXSYS Analyzer: • When the MiOXSYS Analyzer displays the “Insert sensor” screen, press the Menu button. • Scroll down to the “Serial numbers” option using the down arrow key. • Press the Enter or right arrow key.
Page 10: Mioxsys Power Supply
External controls tests should be performed thereafter in accordance with appropriate Federal, State, and local guidelines. A separate sensor must be used for each external control test. 3. MiOXSYS System should not be used in patient testing if the external controls do not produce the correct results.
Page 11: To Check Calibration
The Calibration Verification Key (CVK) verifies that the instrument is still within calibration. 1. Press the power button on the MiOXSYS Analyzer. The green power LED on the power button will illuminate to indicate the unit is ON. If using AC power, the display screen will be backlit.
Page 12: Troubleshooting And Error Codes
“Remove Sensor” sensor socket, but was unable to determine the type of sensor connected. (i.e. the connected sensor is not a MiOXSYS Sensor and is not a CVK.) “Socket occupied” There is something in the Please turn off power and socket connector at boot up.
Page 13: Mioxsys Specifications
The MiOXSYS System should be transported in the original packaging (including foam and box) or in a designated shipping container supplied by Aytu BioScience. If the MiOXSYS equipment is to be removed from use for repair or disposal, all surfaces should be wiped down with an alcohol wipe or swab.
Page 14: Glossary Of Symbols
Glossary of Symbols Manufacturer CE Mark (product Catalog Number meets the requirements Consult Instructions Serial Number of EC directive 98/79 in for Use vitro diagnostic medical Biological Hazard device) In Vitro Diagnostic Authorized Medical Device Underwriters Representative in Laboratories Use Caution European Community Certification Mark Risk of personal injury...
Page 16 Aytu BioScience, Inc. 373 Inverness Parkway, Suite 206 Englewood, CO 80112 USA +1 (720) 437-6580 www.MiOXSYS.com European Authorized Representative Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands Australian Sponsor Emergo Australia 201 Sussex Street Darling Park, Tower II, Level 20...