AYTU BioSience mioxsys User manual

MiOXSYS Analyzer
User Manual

373 Inverness Parkway, Suite 206
Englewood, CO 80112 USA
Made in USA
www.aytubio.com
©2018 Aytu BioScience, Inc. Document No. 100230 REV 6

1
Table of Contents
Description ................................................................................................... 2
Intended Use................................................................................................ 2
Warnings and Precautions............................................................................ 2
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..................................................................................... 8
MiOXSYS Maintenance ................................................................................ 8
Quality Control............................................................................................. 8
To Check Calibration.................................................................................... 9
Troubleshooting and Error Codes.............................................................. 10
MiOXSYS Specifications............................................................................. 11
Shipping and Handling............................................................................... 11
References.................................................................................................. 11
Glossary of Symbols ................................................................................... 12
MiOXSYS Analyzer
User Manual
FOR EXPORT ONLY. NOT FOR SALE IN USA.

2
Description
The MiOXSYS System uses the Static Oxidation-Reduction Potential (sORP) Test to measure
oxidative stress in a biologic sample.
Intended Use
The MiOXSYS Test performed on the MiOXSYS Analyzer is a rapid in vitro diagnostic semen analysis
test utilizing an electrochemical technology for the qualitative measurement (millivolts mV) of static
Oxidation Reduction Potential (sORP) in human semen.
The MiOXSYS System is intended for professional use in conjunction with standard semen analysis
parameters (ejaculate volume, total sperm, sperm concentration, total motility, progressive motility,
and morphology) as an aid to assess semen quality. For in vitro diagnostic use only.
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.
Warnings and Precautions
It is essential that you read the following warnings and precautions in order to avoid risks to persons
and damage to the analyzer and other equipment. Aytu BioScience does not accept responsibility
for damage or injury resulting from a lack of observance of the instructions in this manual.
Follow the User Guide!
Each time the MiOXSYS Analyzer is used,
knowledge of and attention to these
operating instructions is required. Use the
Aytu BioScience MiOXSYS Analyzer only for
the purpose it is intended.
Check that the AC voltage and frequency
printed on the AC power adapter label
match your electrical socket and whether
the shape and configuration of the plug
contacts are compatible.
Keep the Analyzer Away From Liquids!
The Aytu BioScience MiOXSYS Analyzer
is not waterproof. Fluids entering the
instrument could damage the electrical
components in the analyzer. Cleaning and
disinfecting methods commonly used on
laboratory instruments may be used. Please
see the notes on care in the MiOXSYS
Maintenance section of these instructions.
Allow the Instrument to
Reach Room Temperature!
Particularly on moving from a cold into
a warm environment (ie, after storage or
transport), condensation can form inside
and on the outside of the instrument. Wait
an appropriate time (approximately 1 hour)
before connecting to the main power supply
or switching on the instrument.
Use Only the Original Equipment!
Do not attach equipment that is not
expressly approved for use with the
Aytu BioScience MiOXSYS Analyzer.
Aytu BioScience does not recommend or
guarantee the function of the instrument
with other equipment.
Never Open the Analyzer!
There are no serviceable parts inside.
Service to any component of this device is
to be performed only by Aytu BioScience.
Unauthorized repairs or modifications
will void the warranty and may violate
conformity of the MiOXSYS Analyzer
with the regulatory requirements of the
Regulation (EU) 2017/745 of the European
Parliament and of the Council of 5 April
2017 on Medical Devices. Further notes on
maintenance can be found in the MiOXSYS
Maintenance section of these instructions.
Be Aware of the Danger of
Fatal Electric Shock!
Under no circumstances should you open
the AC power adapter. There are no
elements inside that require servicing
or maintenance.
Never use a mechanically damaged AC
power adapter — live connections might
be exposed.
The AC power adapter is not waterproof.
Therefore, never let liquids come into
contact with it. A lightly dampened cloth,
however, can be used to clean it when
disconnected. Please see the notes on care
in the MiOXSYS Maintenance section of
these instructions.
Use the AC power adapter only in a socket
that has been properly installed.
Do Not Use in Areas Where There is
A Risk Of Explosion!
This instrument is not approved for use in
areas where there is a risk of explosion.

3
Summary and Explanation
Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species
and other oxidants with the biological system’s ability to detoxify them or to repair the resulting
damage. Disturbances in the normal redox (reduction-oxidation) state of cells can cause toxic effects
on cells, including protein oxidation, lipid peroxidation, and DNA fragmentation.
Static oxidation-reduction potential (sORP) has been described as an integrated measure of the
balance between total oxidant activity (i.e. reactive oxygen species (ROS), oxidized thiols, superoxide
radicals, hydroxyl radicals, hydrogen peroxide, nitric oxide, peroxynitrite, transition metal ion, etc)
to total reductant activity (i.e. free thiols, ascorbate, α-tocopherol, β-carotene, uric acid, etc).1
Therefore, the amount of oxidative or reductive stress (redox balance) present in a biological sample,
like semen, can be monitored with an sORP sensor using the 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). Studies to date have demonstrated an
inverse relationship between reactive oxygen species (ROS) and sperm concentration, motility, and
volume1-3; however, ROS is only one contributor to oxidative stress and can be difficult to measure.
Analysis of the seminal plasma proteome suggest that both changes in both antioxidants and
oxidants are present.4 The advantage of the MiOXSYS Test is that takes into account both oxidant
and antioxidant activity, providing a total measure of oxidative stress with no sample preparation.
MiOXSYS System
MiOXSYS Analyzer
TESTINGALERT
MENU
ENTER
Red Alert LED BlueTesting LED
Menu Button
Enter Button
Scrolling Key Pad
Sensor Socket
Sensor Module
Display Screen
Power Button
with Green LED

4
USB InterfaceAC Power Port
MiOXSYS System (continued)
Back of MiOXSYS Analyzer
Materials Provided
• AC Power Cord With Plug Adapters
• Instructions for Use
• Calibration Verification Key (CVK)
Materials or Equipment
Provided Separately
• MiOXSYS Sensors
• MiOXSYS External Control Solutions (low and
high solutions)
• USB cable
• USB drive with software for download of data
Other Components
Needed But Not Provided
• Disposable powder-free latex gloves
or equivalent
• Sterile sample collection containers,
capable of holding >100μL of sample
• Vortex mixer
• Micropipette and aerosol resistant pipette
tips capable of delivering 30uL volume
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. Samples should be tested within one (1) hour of liquefaction.
• Samples that will not be tested within this time should be flash frozen immediately after
liquefaction and stored at -80 C until tested. Specimens may be frozen and thawed once.
Socket
Insertion End
Sample
Application Port
Reference
Cell
MiOXSYS Sensor

5
MiOXSYS Testing Instructions (continued)
Test Procedure
Sample and MiOXSYS Analyzer Setup
• Prior to testing, semen sample should be brought to
room temperature 18-30°C (64-86°F)
• 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.
• “MiOXSYS” and the date and time will appear on the
display screen for 3 seconds.
• When the MiOXSYS Analyzer is ready, “Insert sensor”
will appear on the display screen (Figure 1).
Sensor Insertion
• Unwrap an individual MiOXSYS Sensor.
• Holding sensor at front side edges (Figure 2), insert the
MiOXSYS Sensor face-up and with the sensor electrodes
facing the MiOXSYS Analyzer. Align the socket insertion
end with the sensor socket on the MiOXSYS Analyzer.
Make sure the sensor is fully inserted before continuing
the test procedure.
• Once the MiOXSYS Sensor is inserted properly, “Waiting
for sample” will appear on the display screen, and a
2-minute sample detection countdown timer will begin.
Sample Application
• The sample used for analysis can be either fresh or frozen semen, but should be
at room temperature 18-30°C (64-86°F) when tested.
• 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.
Sample Run
• When the sample flow reaches the reference cell of the sensor, the testing automatically
begins. Proper execution of the test is also indicated by the blinking of the blue testing LED.
• Once the test is initiated, the display screen will show “Processing sample” and the
time remaining.
• Do not press any buttons or remove the sensor while testing is in progress.
• If an error does occur during testing, an error code will appear on the display screen and
the red alert LED will illuminate. Please make a note of the error reading for your records.
Follow the instructions on the screen to clear the error.
TESTINGALERT
MENU
ENTER
Figure 2
Figure 1

6
MiOXSYS Testing Instructions (continued)
Test Results
• Audible beeps will indicate the completion of the test.
• On the display screen, the test results will appear in the following order:
Date
Time
Static ORP (sORP) in millivolts (mV)
NOTE: Before removing the sensor, record the date, time, static ORP, in your records.
• Remove the MiOXSYS Sensor from the sensor socket immediately after the data
is recorded.
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.
NOTE: If the MiOXSYS Analyzer is “ON” but inactive, the MiOXSYS Analyzer will automatically turn
“OFF.” A 15-second timeout warning appears on the display screen with a warning beep emitted
every second. The timeout clock can be reset by pressing any button.
Calculation of Results
• The sORP measurement displayed reflects the average of the final ten (10) seconds (or twenty
[20] readings) of the run. The sample analysis is completed in approximately three (3) minutes.
sORP values above the normal range indicate a change in the balance between oxidants and
antioxidants in favor of the oxidants, and signify the presence of oxidative stress in the specimen.
NOTE: A typical example of calculating and norming sORP values to sperm concentration
is illustrated below:
MiOXSYS Data Review Instructions
• When testing is not in progress, the previous 50 collected results can be reviewed by pressing the
Menu button on the MiOXSYS Analyzer.
• When the MiOXSYS Analyzer displays the “Insert sensor” screen, press the Menu button.
• Scroll to “Results (XXX)” using the arrow keys. Press the Enter or right arrow key.
NOTE: The number after the word “Results” shows how many runs are stored in memory.
• The most recently collected result will be displayed first. All collected results can be reviewed by
pressing the up or down arrows on the MiOXSYS Analyzer.
• To return to the “Options” screen, press the Menu or left arrow key.
Number Sample Date Time sORP (mV)
1Patient A 5/29/2015 10:13 AM 76.8
Sperm Concentration = 62.6 x 10
6
/mL; Patient sORP = 76.8 mV;
Normed sORP = 76.8/62.6 x 10
6
mL = 1.22 mV/10
6
sperm mL

7
• To return to the “Insert sensor” screen, press the Menu or left arrow key.
• Data can also be reviewed on a PC connected with the USB cable by using the included
Data Transfer Utility 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.
• The following serial numbers will be displayed:
S: serial number of the MiOXSYS Analyzer
D: serial number of the digital board on the MiOXSYS Analyzer
A: serial number of the analog board on the MiOXSYS Analyzer
F: firmware version number of the MiOXSYS Analyzer
These serial numbers are important if the MiOXSYS Analyzer requires any updates or calibration.
MiOXSYS Analyzer Other Settings
To set the date and time:
• When the MiOXSYS Analyzer displays the “Insert sensor” screen, press the Menu button.
• Scroll down using the arrow buttons to “Set date/time” and press Enter.
• Set date/time by pressing up and down arrows and move the cursor by pressing the left
and right arrows.
• Press Enter to save date/time settings.
To set the date format:
• When the MiOXSYS Analyzer displays the “Insert sensor” screen, press the Menu button.
• Scroll down using the arrow buttons to “Set date format” and press Enter.
• Scroll to desired date format using up and down arrow buttons and press Enter.
To clear all data on the MiOXSYS Analyzer:
CLEARING ALL DATA CAN NOT BE UNDONE AND IS NOT RECOMMENDED!!!
• When the MiOXSYS Analyzer displays the “Insert sensor” screen, press the Menu button.
• Scroll down using the arrow buttons to “Clear all data,” press Enter.
To check the Display Screen and all LEDs:
• When the MiOXSYS Analyzer displays the “Insert sensor” screen, press the Menu button.
• Using the arrow buttons, scroll to “Display test” and press Enter.
• All lights should illuminate properly. If they do not, contact Aytu BioScience at
720.437.6580 or via email at www[email protected].
• To exit the “Display test” mode, wait 15 seconds or press any scrolling button.

8
MiOXSYS Analyzer Other Settings (continued)
To determine the total number of sensor insertions (important if
your MiOXSYS Analyzer requires any updates or calibration):
• When the MiOXSYS Analyzer displays the “Insert sensor” screen, press the Menu button.
• Using the arrow buttons, scroll to “Socket status” and press Enter.
• The unit’s serial number will be displayed as “S/N XXXXX,” and the number of sensor insertions
will be displayed as “Insertions: XX.”
• Press the left arrow cursor or Menu button to go back to the options screen.
To determine the version of software your MiOXSYS Analyzer is running
and the date it was installed (important if your MiOXSYS Analyzer requires
any updates or calibration):
• When the MiOXSYS Analyzer displays the “Insert sensor” screen, press the Menu button.
• Using the arrow buttons scroll to “About” and press Enter. The firmware version will be displayed
as “F/W Version X.XX.XX,” and the date/time of installation will appear below it.
• Press the left arrow key or Menu button to go back to the options screen.
MiOXSYS Power Supply
The MiOXSYS Analyzer should be used only with the supplied universal AC input adapter.
• The MiOXSYS Analyzer has a permanent rechargeable battery. The battery can be charged
by plugging the provided AC power cord into the AC power port of the MiOXSYS unit and
an AC power source. Alternatively, the battery will also be charged if connected to a computer
with a USB cable.
• The MiOXSYS Analyzer can be operated using battery, USB or AC power.
MiOXSYS Power Off
• To properly turn off your MiOXSYS Analyzer, press and hold the power button for 3 seconds.
• The MiOXSYS Analyzer can remain plugged in for proper battery charging if so desired.
MiOXSYS Maintenance
• All exterior surfaces may be disinfected using an alcohol wipe or swab, as necessary.
• The MiOXSYS Analyzer calibration should be performed by the user at installation and monthly
therafter to ensure accuracy of the results. Please refer to the calibration label on the bottom of
the analyzer for its calibration expiration date.
Quality Control
1. Good laboratory practice recommends the use of the control materials. Users should follow the
appropriate federal, state, and local guidelines concerning the running of external controls.
2. MiOXSYS sORP External Control Solutions are supplied separately (cat# 100279). It is
recommended that each new lot or shipment of MiOXSYS Sensors be verified upon receipt and
before use. 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.

9
To Check Calibration
Calibration Verification is performed by the user at installation and at monthly intervals thereafter.
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.
2. “MiOXSYS” and the date and time will appear on the display screen for 3 seconds.
3. Insert the CVK into the sensor slot with the A-side facing up. The MiOXSYS Analyzer will
indicate that a calibration check is being performed on the A-side.
4. When the verification is complete, the results will be displayed in the following order:
a. Side A: ORP = 100.3mV • ICell = -100.0 nA
NOTE: Before removing the CVK, record the date, time, results, and check them against the
acceptance ranges listed on the Calibration Verification Card.
5. Repeat the procedure for the B-side of the CVK.
6. If the MiOXSYS Analyzer is out of calibration, please discontinue use of the MiOXSYS Analyzer
and call Aytu BioScience – 720.292.5449.
MiOXSYS System Calibration Verification Key
Acceptance Limits
Minimum Maximum
A-Side
ORP (mV) 99.0 101.0
ICell (nA) -101.0 -99.0
B-Side
ORP (mV) 295.8 304.2
ICell (nA) -30.4 -29.6

10
Troubleshooting and Error Codes
Error Message Description Troubleshooting
Test Errors
“Faulty sensor” The sensor response was too
noisy. (Spike detected.)
Repeat test procedure with a
new sensor.
“Compliance error” The measured cell current
differs from the acceptable
current by more than 5%.
Repeat test procedure with a
new sensor.
“Sensor disappeared” The sensor disappeared
during processing.
Repeat test procedure with a
new sensor.
“Unknown Sensor” or
“Sensor Detect Error”
“Remove Sensor”
The system detected
something connected to the
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.)
Repeat test procedure with a
new sensor.
“Socket occupied” There is something in the
socket connector at boot up.
Please turn off power and
inspect the socket module
for any obstruction and
remove. If problem persists,
please call Aytu BioScience at
720.292.5449.
“LOW” Result is below the limit of
detection.
Repeat test procedure with a
new sensor. If error message
persists, repeat test with a new
patient sample.
"HI" Result is above the limit of
detection.
Repeat test procedure with a
new sensor. If error message
persists, repeat test with a new
patient sample.
Socket Module Errors
“Socket module will
expire soon Press enter”
The number of sensor
insertions has exceeded 9000.
Please contact Aytu BioScience
for technical service at
720.292.5449.
“Socket module has expired
Power down”
The number of sensor
insertions has exceeded 10000.
Please contact Aytu BioScience
for technical service at
720.292.5449.
System Errors
“Self-test error” An error occurred during
self test process
Please discontinue use and
contact Aytu BioScience at
720.292.5449.
“Analog Front End** failure” Insert and sudden removal of
sensor prior to test completion.
Power down analyzer
completely and repeat test
procedure with a new sensor.

11
MiOXSYS Specifications
Test sample: Fresh or Frozen Semen
Test result: Referenced to 1X PBS or ascorbate standard
Sample volume: 30 μL
Measuring range: .00 to 400mV
Measuring time: 120 seconds/two minutes
Memory: Stores 50 most recent test results
Battery type: Non-serviceable, 1.8 Ah rechargeable lithium ion battery, 3.0 to 4.2 V
Analyzer/Battery life: 5 years
Operating
temperature range:
64 to 86 (18 to 30 C)
Humidity: 10% to 90% RH
Dimensions: 8.13 in (L) x 7.13 in (W) x 4.13 in (H)
Weight: 33.2 oz (940 grams) – MiOXSYS Analyzer
<0.1 oz (0.9 grams) – MiOXSYS sORP Sensor
Sound: A beep sounds when the measurement is complete and a test result
appears on the screen. Fifteen beeps in 15 seconds will sound when the
MiOXSYS Analyzer times out.
NOTE: Electromagnetic emissions are low and are unlikely to interfere with other nearby electronic
equipment; nor are emissions from nearby electronic equipment likely to interfere with the analyzer.
Shipping and Handling
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.
References on File at Aytu BioScience, Inc.
1. Pons-Rejraji, H., et al., [Role of reactive oxygen species (ROS) on human spermatozoa
and male infertility]. Gynecol Obstet Fertil, 2009. 37(6): p. 529-35.
2. Agarwal, A., et al., Characterizing semen parameters and their association with reactive
oxygen species in infertile men. Reprod Biol Endocrinol, 2014. 12: p. 33.
3. Du Plessis, S.S., et al., Contemporary evidence on the physiological role of reactive oxygen
species in human sperm function. J Assist Reprod Genet, 2015. 32(4): p. 509-20.
4. Intasqui, P., et al., Differences in the seminal plasma proteome are associated with oxidative
stress levels in men with normal semen parameters. Fertil Steril, 2016.

12
Glossary of Symbols
Catalog Number
Serial Number
Biological Hazard
Authorized
Representative in
European Community
Do Not Throw In Trash
Mark Indicates
Compliance with
the WEEE (Waste
Electrical and Electronic
Equipment) Directive
CE Mark (product
meets the requirements
of EC directive 98/79 in
vitro diagnostic medical
device)
Underwriters
Laboratories
Certification Mark
Restriction of the Use
of Certain Hazardous
Substances ( RoHS ) in
Electrical and Electronic
Equipment ( EEE )
Directive (2011/65/ EU)
Manufacturer
Consult Instructions
for Use
In Vitro Diagnostic
Medical Device
Use Caution
Risk of personal injury
or threat to health

13

©2018 Aytu BioScience, Inc. 100230 REV 6
Aytu BioScience, Inc.
373 Inverness Parkway, Suite 206
Englewood, CO 80112 USA
[phone]
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
Sydney, NSW 2000
Australia