TRAK Trak Male Fertility Testing System User manual

OWNER’S GUIDE

Precautions and Warnings
Intended Use
How it Works
Before You Begin
Customer Service
What’s Included
Guidelines for Collecting a Sample
Running the Test
Check for Potential Errors
Understand Your Sperm Concentration Result
After Testing
Cleaning
Disinfection
Storage
Running a Control Test
Test Accuracy
Frequently Asked Questions
2
3
3
4
4
5
7
9
21
23
25
25
26
26
27
37
39
Table of Contents
© 2018 Sandstone Diagnostics, Inc.

Precautions and Warnings
• For in vitro diagnostic use. Not to be taken internally.
• Keep out of the reach of children.
• STORAGE: Store in a dry place between 36˚F–86˚F
(2˚C–30˚C). Do not freeze. Protect from sunlight.
• Do not use after the expiration date printed on system components.
• Certain types of urological infections or recent surgery may interfere with
the accuracy of test results.
• Poor vision and/or improper overhead lighting may affect interpretation
of test results.
• This system cannot be used to prove paternity.
• This system cannot be used to conrm the success of a vasectomy or as
a method of birth control.
• This system does not protect against sexually transmitted diseases.
• DO NOT RE-USE. Props, Volume Cups, droppers, and “seal before
spin” stickers are single use only.
• This testing system assesses sperm concentration and semen volume
only. It does not detect all male fertility factors.
WARNING: Do not use Trak®if you suspect that you may have
a sexually transmitted infection such as hepatitis, HIV, chlamydia,
gonorrhea, or other diseases classied as STDs.
After use, all components of the testing system are considered
biohazardous and can potentially transmit infectious diseases.
2

Intended Use
The Trak®Male Fertility Testing System is intended for semi-quantitative
assessment of sperm concentration at 15 million sperm per milliliter
(M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL.
The System also provides a qualitative assessment of semen volume.
Sperm concentration and semen volume are only two factors that
could impact a man's fertility status and time to pregnancy. For
complete assessment of male reproductive health, the user should
consult a physician. For in vitro, over the counter home use.
How it Works
The Trak sperm concentration test uses centrifugal force to isolate
sperm cells from a semen sample. Any sperm cells present form a white
column in the Prop channel. The height of the column correlates with
the concentration of the sperm cells in the sample. The Trak Volume Cup
accumulates semen into a dened space to indicate semen volume.
Semen Volume
Low (1.5 mL or below)
Normal (Above1.5 mL)
Sperm Concentration
Low (15 M/mL or below)
Moderate (Between 15 & 55 M/mL)
Optimal (Above 55 M/mL)
3

Before You Begin
• Read and understand these instructions.
• Check expiration dates for all system components.
• Install Engine batteries. New batteries will last approximately
15 tests. Use AA alkaline batteries only.
• A clock or timer is required, but not included.
• Consider running a control test prior to running a real test.
• Super Sani-Cloth®wipes are recommended to disinfect your
Engine after use and are available for purchase online.
• Please allow 45 minutes after collecting your sample to
complete a test.
Customer Service
For technical support or if you have any questions or concerns
about Trak, please visit our website or contact customer service
Monday–Friday, 8:00am–6:00pm PST.
trakfertility.com | 1.888.241.2476 | [e-mail]
4

What’s Included
1
ENGINE
4
PROP POUCHES
8
8DROPPERS
“SEAL BEFORE SPIN”
STICKERS
BOTTLE OF
CONTROL
SOLUTION A
4
SAMPLE VOLUME
CUPS WITH LIDS
If any components of the system are missing or damaged, contact customer service
Monday–Friday, 8:00am–6:00pm PST at 1.888.241.2476.
2AA BATTERIES
1
NOTE:
Control Solution B
is available through
customer service.
5

Engine & Prop Details
RED & YELLOW
LIGHT
ENGINE
GREEN
LIGHT
BASE
LID
INSTALL
BATTERIES
UNDERNEATH
METAL
ENGINE ROD
HUB
SIDE VIEW
PROP
CENTER HOLE
CHANNEL
6

Guidelines for Collecting a Sample
IF YOU GO WITHOUT
EJACULATING FOR 3 DAYS
BEFORE COLLECTING A
SAMPLE THE FIRST TIME, IT
IS BEST TO GO WITHOUT
EJACULATING FOR 3 DAYS
BEFORE COLLECTING A
SAMPLE THE NEXT TIME
AT LESS THAN 2 DAYS SPERM
CONCENTRATION MAY BE LOW
AT MORE THAN 7 DAYS SPERM
CONCENTRATION MAY BE
HIGH AND FULL OF DEAD CELLS
WHEN REPEAT TESTING
CONSISTENCY
IS KEY
IT’S RECOMMENDED TO GO
2
TO7 DAYS
WITHOUT EJACULATING
BEFORE COLLECTING A SAMPLE
1
5
2
6
3
7
4
8
7

HAVE YOUR SAMPLE
VOLUME CUP READY
AND WITHIN REACH
MOST SPERM LIVE IN THE
1ST DROPS
OF EJACULATE
NEITHER SHOULD
BE USED WHEN
COLLECTING A SAMPLE
COLLECTION VIA SEXUAL
INTERCOURSE IS ALSO
NOT RECOMMENDED
MATERIALS IN
CONDOMS &
LUBRICANTS
KILL SPERM
8

Running the Test
If you miss the cup
or have a very low
sample volume,
discard the Volume
Cup and try again in
2 to 7days.
Only use the
specially treated
cups included in
the kit.
01
Collect a semen
sample in the
provided sample
Volume Cup.
Place lid on cup.
Protective gloves are recommended
if performing the test for someone
else. Always wash your hands well
with soap and water before and after
handling the sample Volume Cup,
dropper, Prop, or Engine.
Review the guidelines on page 7
for collecting a semen sample to
ensure an accurate result.
If you have never completed a Trak test, consider
performing a control test (see page 27).
Be sure that batteries have been installed in the
Engine before running a test.
Note: A red light will ash briey to indicate
that new batteries have been installed correctly.
HELPFUL ICONS:
Situations that may indicate an error
and possibly inaccurate test result.
Tips or additional information.
9

02
Swirl the cup for at least 15 seconds.
15
SECS
Collect a Sample
10

Running the Test
Place the cup so that the top of the liquid is
even with your eyes. Look straight at the cup.
0403
You need to wait
30 minutes for the
sample to liquefy at
room temperature
before running the
test. The test can
be performed up
to 2 hours after
sample collection.
30
MINS
If the cup is tilted, the liquid level may look higher
or lower than it actually is.
11

05
Find the top of the liquid. Be sure to read the liquid level from the
center because it may curve up at the edges. Record your semen
volume result before testing sperm concentration.
Read and Record Semen Volume Result
Men with low semen volume (<1.5 mL) may be at risk of infertility and/or
urological conditions and should consult a physician.
Normal (Above 1.5 mL)
Low (1.5 mL or below)
12

Running the Test
After reading the volume result, swirl the sample Volume Cup again
for at least 15 seconds to evenly distribute the sperm cells. Remove
the lid from the sample Volume Cup.
06
15
SECS
13

07
Open the Prop pouch and remove
the Prop. Remove the foil seal from the
Prop. Discard pouch and foil seal into
the empty test bag.
08
Remove the contents
from one test bag.
Prep the Sample
An extra dropper and
sticker are included in
each test bag if needed. 14

Running the Test
09
Pick up the Volume Cup. Pick up the dropper.
Squeeze the top bulb of the dropper, and
then insert the open tip of the dropper into the
deepest part of the sample (to avoid loading
bubbles). Release the top bulb to ll. Make sure
the “stick” part of the dropper is completely full.
If a whole sample is collected, but
there isn’t enough to ll the dropper,
discard the cup and dropper and try
again in 2 to 7days.
If your sample is too thick to load, leave
the sample in the cup for at least 15
additional minutes, or up to 2 hours
after sample collection. Be sure to swirl
the cup for at least 15 seconds before
lling the dropper.
The bottom bulb is for overow and
should partially ll.
15

11
Seal the Prop with
a “seal before spin”
sticker.
10
Insert the open tip of
the dropper into the
center hole of the Prop.
Squeeze the top bulb
to empty the sample.
The bottom bulb of the
dropper will not empty.
Use one
dropper load
only. Discard
dropper into an
empty test bag.
Place lid on cup
and set aside.
Load the Sample
16

Running the Test
12
Place the Engine on a at, stable surface. Open the lid. Pick up the
Prop. Attach the Prop to the Engine by pressing it rmly onto the
metal Engine rod.
17

13
Close the lid. The test
will begin automatically.
Do not open while
the Prop is spinning.
The test will complete in
about 6 minutes.
No light: If there is no light at all, there probably aren’t any batteries in the Engine.
Slow blinking red light: The batteries are low.
Single red light ash: The Engine didn’t detect the Prop and will not start.
Try to push the Prop on more securely. If the Prop will not attach securely, you
may need to start over with a new Prop, dropper, sticker, and any remaining
sample in the Volume Cup.
A green light blinks twice to indicate that the batteries are good and the
Prop was properly detected. The following yellow light indicates the test is in
progress. Do not open the lid while the yellow light is on.
6
MINS
Spin the Prop
18

Running the Test
Red light: If the Prop is left in the Engine for longer than three minutes, the red light
will illuminate. This means the result is invalid, and you will need to run another test
with a new Prop, dropper, sticker, and any remaining sample in the Volume Cup.
Blinking red light: A blinking red light indicates an error (for example, the lid was
opened before the test was complete) and the test result is not valid. Repeat the test
with a new Prop, dropper, sticker, and any remaining sample in the Volume Cup.
You should read the Prop in a room with good overhead lighting.
14
When the Engine stops, a solid green light will indicate that the test
is complete. Open the lid, remove the Prop, and place it on a at
surface. The test result must be read within 3 minutes.
READ RESULT
WITHIN 3 MINS
19