TRAK Male Fertility Testing System Owner's Manual

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OWNER'S GUIDE

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Summary of Contents for TRAK Trak Male Fertility Testing System

Page 1 OWNER’S GUIDE...
Page 2: Table Of Contents
Table of Contents 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...
Page 3: Precautions And Warnings
• 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 classified as STDs.
Page 4: Intended Use
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 defined space to indicate semen volume.
Page 5: Before You Begin
• 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 | support@trakfertility.com...
Page 6: What's Included
What’s Included DROPPERS BOTTLE OF CONTROL SOLUTION A “SEAL BEFORE SPIN” N O T E : Control Solution B STICKERS is available through customer service. SAMPLE VOLUME CUPS WITH LIDS PROP POUCHES AA BATTERIES ENGINE 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.
Page 7 Engine & Prop Details S I D E V I E W METAL ENGINE ROD PROP BASE ENGINE CENTER HOLE INSTALL BATTERIES UNDERNEATH CHANNEL RED & YELLOW GREEN LIGHT LIGHT...
Page 8: Guidelines For Collecting A Sample
Guidelines for Collecting a Sample W H E N R E P E AT T E S T I N G IT’S RECOMMENDED TO GO 7 DAYS CONSISTENCY IS KEY WITHOUT EJACULATING BEFORE COLLECTING A SAMPLE IF YOU GO WITHOUT EJACULATING FOR 3 DAYS AT LESS THAN 2 DAYS SPERM BEFORE COLLECTING A...
Page 9 M A T E R I A L S I N MOST SPERM LIVE IN THE DROPS CONDOMS & LUBRICANTS O F E J A C U L A T E KILL SPERM HAVE YOUR SAMPLE VOLUME CUP READY AND WITHIN REACH NEITHER SHOULD BE USED WHEN COLLECTING A SAMPLE...
Page 10: Running The Test
Volume Cup, Volume Cup. dropper, Prop, or Engine. Place lid on cup. 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 Only use the Engine before running a test.
Page 11 Collect a Sample Swirl the cup for at least 15 seconds. SECS...
Page 12 Running the Test You need to wait Place the cup so that the top of the liquid is 30 minutes for the even with your eyes. Look straight at the cup. sample to liquefy at room temperature before running the test.
Page 13 Read and Record Semen Volume Result 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. Normal (Above 1.5 mL) Low (1.5 mL or below) Men with low semen volume (<1.5 mL) may be at risk of infertility and/or urological conditions and should consult a physician.
Page 14 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. SECS...
Page 15 Prep the Sample Remove the contents Open the Prop pouch and remove from one test bag. the Prop. Remove the foil seal from the Prop. Discard pouch and foil seal into the empty test bag. An extra dropper and sticker are included in each test bag if needed.
Page 16 Running the Test 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 fill. Make sure the “stick”...
Page 17 Load the Sample Insert the open tip of Seal the Prop with the dropper into the “seal before spin” center hole of the Prop. sticker. Squeeze the top bulb to empty the sample. The bottom bulb of the dropper will not empty. Use one dropper load only.
Page 18 Running the Test Place the Engine on a flat, stable surface. Open the lid. Pick up the Prop. Attach the Prop to the Engine by pressing it firmly onto the metal Engine rod.
Page 19 Spin the Prop Close the lid. The test MINS will begin automatically. Do not open while the Prop is spinning. The test will complete in about 6 minutes. A green light blinks twice to indicate that the batteries are good and the Prop was properly detected.
Page 20 Running the Test 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 flat surface. The test result must be read within 3 minutes. READ RESULT WITHIN 3 MINS You should read the Prop in a room with good overhead lighting.
Page 21 Read Your Sperm Concentration Result Read Your Test Result Look straight down at the Prop channel to See page 21 for read your result. information on possible errors in the test result. If there is no error, see page 23 for Looking at the Prop channel at an angle details on reading...
Page 22: Check For Potential Errors
Running the Test Check for Potential Errors Examine the Prop carefully to make sure you do not see any of the following errors. E X AM PL E O F A IR BUB B LE Make sure there are no air bubbles If you see one or more air bubbles, run the test again with a new Prop, dropper, sticker, and any remaining sample in the...
Page 23 E X AM P LE S OF CLOG S Make sure there are no clogs If you see a clog, run the test again with a new Prop, dropper, sticker, and any remaining sample in the Volume Cup. The main reason for clogs is not swirling the sample well.
Page 24: Understand Your Sperm Concentration Result
In the meantime, if you have not already done so, run a control test to ensure proper use of the Trak system. Refer to page 27. If there is no white column the second time you run a test, your...
Page 25 See next page for further explanation of results. Optimal (Above 55 M/mL) Sperm concentrations above 55 M/mL are linked to faster time to pregnancy. Moderate (Between 15 & 55 M/mL) Men with sperm concentrations 55 M/mL or below may take longer to conceive. Low (15 M/mL or below) Men with sperm concentrations 15 M/mL or below may be at risk for infertility, and...
Page 26: After Testing
Understanding Both Results Semen volume and sperm concentration are two different semen measurements. Each one may affect your fertility. If either one or both results are low, you may be at risk for infertility and should consult a physician. See the FAQs for a list of specific result combinations that indicate possible risk for infertility.
Page 27: Disinfection
Store your Engine, Prop pouches, and other unused system components in the Trak kit until the next use. You may leave the batteries in the Engine with the lid closed. The Engine will run approximately 15 tests before the batteries need to be replaced.
Page 28: Running A Control Test
Consider performing a control test if: Locate the control solution and • You have never completed a Trak test. remove contents of one test bag. • You think the system components may have been improperly handled or stored.
Page 29 Open the Prop pouch and remove the Prop. Remove the foil seal from the Prop. Discard the pouch and foil seal into the empty test bag.
Page 30 Running a Control Test Shake control solution bottle for at least Pick up the dropper. Squeeze the top bulb 5 seconds. Make sure the control solution is mixed well. A small steel ball in the bottle of the dropper, and will help with this.
Page 31 Prop. Squeeze the top bulb to empty the solution. The bottom bulb of the dropper will not empty. Use one dropper load only. Cap control solution bottle and place in Trak kit. Discard dropper into an empty test bag.
Page 32 Running a Control Test Seal the Prop Place the Engine on a flat, stable surface. with a Open the lid. Pick up the Prop. Attach the “seal before sticker. Prop to the Engine by pressing it firmly spin” onto the metal Engine rod.
Page 33 Close the lid. The test will MINS begin automatically. Do not open while the Prop is spinning. The test will complete in about 6 minutes. 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.
Page 34 Running a Control Test 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 flat surface. The test result must be read within 3 minutes. READ RESULT WITHIN 3 MINS You should read the Prop in a room with good overhead lighting.
Page 35 Read Your Control Test Result Look straight down at the Prop channel Control Test to read your result. complete! Looking at the Prop channel at an angle can cause the white column to appear taller or shorter than it actually is. See page 35 for more details on reading your...
Page 36 Running a Control Test Expected Control Test Result Locate the top of the white column in the Prop channel. WHITE COLUMN...
Page 37 If your control test result does not look like the expected result image a second time, do not use the Trak testing system. Call customer service at 1.888.241.2476. Note: A second control solution (Control Solution B, not included in this system) is available through customer service.
Page 38: Test Accuracy
In a study of subjects aged 18 – 68 years, the Volume Cup showed an accuracy of 96% compared to a standard laboratory test. In a separate clinical study of 239 subjects aged 20 – 49 years, the Trak sperm concentration test showed the following accuracy compared to a standard laboratory test: <15 M/mL (93.3%), 15 –...
Page 39 To ensure test accuracy, pay close attention to the guidelines for running the test. Truly abstain, make sure to collect a full sample, and swirl the sample properly in the Volume Cup. If you need more help, visit trakfertility.com or contact customer service at 1.888.241.2476 or support@trakfertility.com.
Page 40: Frequently Asked Questions
What if I don’t collect the whole sample? Do not complete a Trak test with this sample. Discard the Volume Cup and lid, and try to collect a sample again in 2 to 7 days with a new Volume Cup.
Page 41 If you have not already done so, you are also recommended to run a control test to ensure proper use of the Trak system. Refer to page 27 of this Owner's Guide. If you don't see a white column a second time, consult a physician.
Page 42 Frequently Asked Questions (continued) Does a result 15 M/mL or below indicate that I am infertile? Not necessarily. A low result indicates that your sperm concentration is lower than most fertile men. Sperm concentration can also vary day to day and may be affected by other health, wellness, and lifestyle habits.
Page 43 Does a semen volume of 1.5 mL or below indicate that I am infertile? Not necessarily. A low semen volume result indicates that your volume is lower than most fertile men. You are advised to consult a urologist specializing in male reproductive health for a medical evaluation and guidance.
Page 44 trakfertility.com | 1.888.241.2476 | support@trakfertility.com Manufactured by Sandstone Diagnostics 6111J Southfront Rd, Livermore, CA 94551 P A T E N T S P E N D I N G...