Trividia Health True Focus - Monitoring Blood Glucose System Manual

Fast test guide

1. INSERT TEST STRIP
   
2. APPLY BLOOD SAMPLE
   

For quick reference only, not intended as a substitute for complete instructions.
Please read entire Owner's Booklet and product Instructions for Use before testing. Expected Results for people without diabetes:

KNOW YOUR BLOOD GLUCOSE MONITORING SYSTEM

Meter

Front of Meter

1. " - " Button - Decreases numbers in Meter
   Set Up; marks/unmarks test result; scrolls Memory results backwards by date/time.
2. " S " Button - Turns meter on to see
   Memory results, average values, and to go to Meter Set Up; sets options in Meter Set Up.
3. " + " Button - Increases numbers in Meter Set Up; marks/unmarks test result; scrolls Memory results forward by date/time.
4. Display Screen - Shows results, messages, user prompts, information.
5. Test Port - Insert TRUE FOCUS Test Strip here, contact blocks facing up.
6. Strip Release Button - Push to release test strip after testing for disposal.

Back of Meter

1. Battery Door - Use one non-rechargeable 3V lithium battery (#CR2032), positive ("+") side up (see Changing Battery).
2. Meter Label - Contains serial number of meter.

Meter Full Display Screen

1. Test Result
2. Memory Result
3. Drop Symbol
4. Average Result
5. Date
6. Time
7. AM/PM
8. Units of Measure

• Factory set to mg/dL, cannot be changed by user.)

1. Low Battery Symbol
2. Control Symbol
3. Ketone Symbol
4. Marked Test Symbol

Test Strip

Insert test strip into meter before touching Sample Tip to top of blood or control solution drop. Allow drop to be drawn into the test strip until dashes appear in the Display.

• Do not apply sample to top of test strip.
• Do not smear or scrape drop with test strip.

• DO NOT insert Sample Tip into meter. This may damage meter.
• Do not apply more sample to the test strip after testing begins.

1. Contact End - Insert test strip into meter with contacts (blocks) facing up.
2. Sample Tip - Touch Tip to top of drop of sample after Drop Symbol appears in the meter Display.

Test Strip Vial Label

Test Strip Vial Label (example)
(Examples only and do not represent actual Control Test ranges)

1. Lot Number (LOT) - Use for identifi cation when calling for assistance.
2. Use By Date (EXP)
3. Date First Opened
4. Control Test Range - Range of numbers where Control Test result must fall to assure the system is working properly.

• Write date fi rst opened on vial label. Discard vial and unused test strips 90 days after opening or after printed Use By Date has passed, whichever comes fi rst. Use of test strips past the Use By Date (EXP) may give inaccurate test results. Discard out-of-date products and test with new products.
• Ranges printed on test strip vial label are for Control Test results only and are not suggested levels for your blood glucose. Do not drink control solution.

Control Solution

Control Solution Bottle Label (example)

1. Lot Number (LOT) - Use for identifi cation when calling for assistance.
2. Use By Date (EXP)
3. Date First Opened
4. Control Solution Level (1, 2 or 3)

• Write date fi rst opened on bottle label. Discard bottle and unused control solution 90 days after opening or after printed Use By Date has passed, whichever comes fi rst. Use of control solution past the Use By Date (EXP) may give inaccurate test results. Discard out-of-date products and test with new products.

• Call the number on the cover of this Booklet for information on how to obtain control solution.

GETTING STARTED

The meter comes with pre-set time and date. Before using the meter for the first time or after a battery change, check time and date and update as needed.

The meter turns on when:

• a test strip is inserted into the Test Port, or
• when "S" Button is pressed and released (see Memory and Meter Set Up).

Meter turns off when:

• the test strip is released from the meter,
• the "S" Button is pressed and held for 3 seconds, or
• after 2 minutes of non-use.

Testing Checklist:

Check meter for damage (cracked Display, missing button, etc.). If damage is seen, do not use meter. Call for assistance.

Check test strip vial for damage (cracked or broken vial). Discard damaged vial and contents (test strips). Use a new vial of test strips for testing.

Write date first opened on test strip vial. Check Use By Dates (EXP) (printed and written) before using any test strips from the vial. Do not use 90 days after opening or if printed Use By Date (EXP) has passed, whichever comes first.

For Control Test, make sure you have clean tissues available. A small piece of plastic wrap, aluminum foil or waxed paper may be used for control solution sample drop in the Control Test.

For Control Test, make sure you have clean tissues available. A small piece of plastic wrap, aluminum foil or waxed paper may be used for control solution sample drop in the Control Test.

Check control solution bottle for any leaks or broken cap. Discard damaged bottle and open a new one for testing.

Write date first opened on control solution bottle label. Check Use By Dates (EXP) (printed and written) before using control solution. Do not use 90 days after opening or if printed Use By Date (EXP) has passed,

Quality Control

To assure accurate and reliable results, TRUE FOCUS Blood Glucose Monitoring System offers two kinds of quality control tests, an Automatic Self-Test and a Control Test. These tests let you know that your blood glucose monitoring system is working properly and your testing technique is good.

Automatic Self-Test:

The Automatic Self-Test lets you know if the meter and the Display is working properly.
Automatic Self-Test does not take the place of running Control Tests.

1. Insert test strip for missing
   
2. Full Display
   
3. Drop Symbol begins to blink. Meter may be used for testing.
   
   If an error message appears, the meter will not perform a test. See Troubleshooting or call for assistance (see Booklet cover).
   

Control Test:
We recommend performing Control Tests:

• before using your meter for the first time
• for practice to ensure your testing technique is good,
• when opening a new vial of test strips,
• occasionally as a vial of test strips is used,
• if results seem unusually high or low,
• if the test strip vial has been left opened, exposed to extreme heat, cold, or humidity,
• whenever a check on the performance of the blood glucose monitoring system is needed,
• if meter damage is suspected (meter was dropped, crushed, wet, etc.)

Performing a Control Test with more than one level of control solution is recommended to ensure that the blood glucose monitoring system is working properly. Three levels of TRUE FOCUS Control Solution are available. Contact place of purchase or use the number on the cover of this Booklet for more information on how to obtain levels of control solution.

Use ONLY TRUE FOCUS Control Solution for Control Test.

• Ranges printed on test strip vial label being used are for Control Test results only and are not suggested levels for your blood glucose. Do not drink control solution.

How To Test Control Solution

1. Gather and check supplies.
   See Getting Started -Testing Checklist.
   Do not use test strips or control solution if either Use By Dates (written or printed) have passed. Discard and use new products.
   
   (Examples only and do not represent actual Control Test ranges)
2. Allow control solution, vial of test strips and meter to adjust to room temperature.
   
3. Wash hands. Dry thoroughly.
   
4. Gently swirl or invert control solution bottle to mix.
   DO NOT SHAKE.
   
5. Remove obe test strip from vial. Close vial immediately.
   Use test strip quickly after taking it out of the vial.
   
6. Insert test strip firmly into Test Port. Meter turns on.
   Keep test strip in meter until testing is fi nished. Do not add control solution to test strip before inserting into meter.
   
7. Remove cap from control solution bottle. Gently squeeze a drop onto a clean tissue. Wipe off bottle tip and discard tissue. Gently squeeze a drop onto a small piece of unused aluminum foil, clear plastic wrap, or waxed paper for testing.
   

8. With test strip still in meter, touch Sample Tip to top of drop. Allow drop to be drawn into test strip.
   
9. Remove test strip from drop when Display begins to count down from 4. Meter is testing.
   
10. After testing is fi nished, result appears in the meter Display with the Control Symbol.
    
    
    (Examples only and do not represent actual Control Test ranges)
11. Compare result to Control Test Range printed on the test strip vial label for the control solution you are testing. If result is in range, the blood glucose monitoring system can be used for testing blood.
    If result is not within range, perform Control Test again
12. After result is shown, hold meter with test strip pointing into an appropriate waste container. Press Strip Release Button to release and discard the test strip. Meter turns off. Recap control solution bottle tightly.
    

• If Control Test result is still outside range after a second Control Test, do not use the blood glucose monitoring system for testing blood. Call for assistance (see cover for phone number).

• If test strip has been out of the vial too long before testing, an error message appears upon insertion of the test strip into the meter. Discard old test strip and retest using a new test strip.
• If test strip is removed before testing is fi nished, an error message appears. Discard old test strip and retest using a new test strip.
• Do not put control solution drop on top of test strip.
• If meter does not begin testing soon after drawing up sample, discard test strip. Repeat with a new test strip. If problem persists, see Troubleshooting.
• Removing the test strip before result is displayed cancels the test.
  An error message appears and the result is not stored in Memory. Retest with a new test strip and do not remove before result is displayed.

TESTING BLOOD

Obtaining a Blood Sample

Refer to lancing device's Instructions for Use for more detailed instructions on using the lancing device.

Important Notes Regarding Forearm Testing

• Alternate site testing results cannot be used for continuous glucose meter calibration or for insulin dose calculations.
• Check with your doctor or healthcare professional to see if forearm testing is right for you.
• Results from forearm are not always the same as results from fingertip.
• Some lancing devices include a special end cap for alternate site (forearm) testing. Check lancing device Instructions for Use.
• Use fingertip instead of forearm for more accurate results:

• Within 2 hours of eating, exercise, or taking insulin,
• If your blood sugar may be rising or falling rapidly,
• If your routine results are often fluctuating,
• If you are ill or are under stress,
• If your forearm results do not match how you feel,
• If your blood sugar may be low or high,
• If you do not notice symptoms when blood sugar is low or high.

• Wash your hands thoroughly with soap and warm water before and after handling the meter, lancing device, lancets or test strips.
• If the meter is being operated by a second person who gives testing assistance, the meter and the lancing device should be cleaned and disinfected before use by another person.
• For instructions on how to clean and disinfect the meter and lancing device, see Meter Cleaning and Disinfecting and Lancing Device Cleaning and Disinfecting in this Owner' s Booklet.
• ALL parts of your blood glucose monitoring system could carry blood-borne pathogens after use, even after cleaning and disinfecting. Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all, blood-borne pathogens.
• DO NOT share your meter or lancing device with anyone, including family members.
• Do not reuse lancets. Reuse of devices labeled for single-use may result in product contamination and patient infection.
• Used test strips and lancets are considered biohazardous. Dispose used test strips and lancets into appropriate waste container.
• Do not use venous blood for testing.
• To help prevent false high results, wash hands before using the blood blucose monitoring system to test blood, especially after fruit has been handled.

1. Select area to be lanced. Wash with soap and warm water, rinse and dry thoroughly.
   
2. From Fingertip
   Place end of lancing device equipped with lancet against fingertip. Lance fingertip.
   
   From Forearm
   Rub area vigorously or apply a warm dry compress to increase blood flow.
   
3. Set lancing device aside. To help blood drop form, lower hand to waist level and gently massage from palm to fingertip.
   
   Place end of lancing device equipped with a lancet firmly against forearm. Press trigger button. Apply firm pressure on lancing device for 10 seconds.
   
   Allow blood drop to form before attempting to apply to the test strip.
4. After testing, recap and remove used lancet from lancing device. Discard used lancet into appropriate waste container.
   

• Used test strips and lancets are considered biohazardous. Dispose used test strips and lancets in an appropriate waste container.

How to Test Blood

1. Check supplies (see Getting Started - Testing Checklist).
   Do not use test strips if either Use By Dates (written or printed) have passed. Discard and use new products
   
   (Examples only and do not represent actual Control Test ranges)
2. Allow vial of test strips and meter to adjust to room temperature.
   
3. Wash hands (and forearm for alternate site testing) in warm, soapy water. Rinse well and dry thoroughly.
   
4. Remove one test strip from vial. Close test strip vial immediately.
   Use test strip quickly after taking it out of the vial.
   
5. Insert test strip firmly into Test Port. Meter turns on.
   
6. Wait until Drop Symbol appears in the Display.
   Keep test strip in meter until testing is finished. Do not add blood to test strip before inserting into meter.
   
7. Lance fingertip (or forearm). Allow blood drop to form (see Obtaining a Blood Sample).
   
   Fingertip Testing
   
   Forearm Testing
8. With test strip in Meter, touch Sample Tip to top of blood drop and allow blood to be drawn into the test strip. Meter is testing.
   
9. Remove test strip from drop when meter begins to count down from 4.
   
10. After testing is finished, result appears in the meter Display. Record result in log book.
    • If you wish to mark the result, press the "+" Button before the Strip Release Button is pressed or the meter turns off (30 seconds). To remove the mark, press the "-" Button.
    • Marked test results are not included in Averages.
      
11. Hold meter with test strip pointing into an appropriate waste container. Press Strip Release Button to discard test strip. Meter turns off. Result is stored in the Memory.
    

• Used test strips and lancets are considered biohazardous. Dispose used test strips and lancets in an appropriate waste container.

• If test strip is removed before testing is finished, an error message appears. Discard old test strip and retest using a new test strip.
• Do not place blood drop on top of test strip.
• Removing the test strip before result is displayed cancels the test. An error message appears. Result is not stored in Memory. Retest with a new test strip. Do not remove before result is displayed.

Troubleshooting

1. After inserting test strip, meter does not turn on.

2. After applying sample, test does not start / meter does not beep or begin testing.

For assistance, call toll free: 1-800-803-6025 or local: 1-954-677-4599.

Messages

Display	Reason	Action
	Operating Temperature Error	Meter is outside testing temperature range. Move meter and test strips to an area between 57°F and 104°F. Wait 10 minutes before testing.
	Sample Error	Incorrect application of blood or control solution to the test strip or test strip may be damaged. Discard test strip. Repeat with new test strip.
	Used/Damaged Test Strip Error	Discard old test strip. Repeat test with a new test strip
	System Hardware or Software Error	Call for assistance.
	Low or Dead Battery	Low: About 20 tests can be done before battery dies. Dead: Battery Symbol appears and meter turns off when inserting a test strip.
	Ketone Test Alert	Perform ketone test per your treatment plan.
	Out of Range - High Results > 600 mg/dL	Retest with new test strip. If result is still "Hi" (High) or "Lo" (Low) contact doctor immediately.
	Out of Range - Low Results < 20 mg/dL

If error message still appears, any other error message appears, or troubleshooting does not solve the problem, call for assistance toll free: 1-800-803-6025 or local: 1-954-677-4599.

Out of Range Warning Messages

Meter reads blood glucose levels from 20-600 mg/dL.

If blood test result is less than 20 mg/dL, "Lo" appears in meter Display.

If blood test result is greater than 600 mg/dL, "Hi appears in meter Display.

ALWAYS repeat test to confirm Low ("Lo") and High ("Hi") results. If results still display "Lo" or "Hi", call your doctor or healthcare professional immediately.

• "Lo" results are included in the Average as 20 mg/dL. "Hi" results are included in the Average as 600 mg/dL.

Ketone Test Alert

If blood glucose test result displayed is greater than 240 mg/dL, "CK" followed by "KE" with "ketone" in top of Display. Check ketones per treatment plan.

When a Ketone Test Alert is shown it does not mean that ketones have been detected in your blood.

TRUE FOCUS Blood Glucose Monitoring System and Laboratory Testing

When comparing results between TRUE FOCUS Blood Glucose Monitoring System and a laboratory system, TRUE FOCUS blood tests should be performed within 30 minutes of a laboratory test. If you have recently eaten, fingerstick results from the TRUE FOCUS Blood Glucose Monitoring System can be up to 70 mg/dL higher than venous laboratory results.⁵ Diabetes experts have suggested that glucose meters should agree within 15 mg/dL of a laboratory system when the glucose concentration is less than 75 mg/dL and within 20% of a laboratory system when the glucose concentration is 75 mg/dL or higher.⁶

METER SET UP

• If meter turns off at any time during Set Up, go back to Step #1 and begin again.

1. Start with the meter off. Press and hold the "S" Button until the full Display appears and begins to blink. Release "S" Button.
   
2. Meter is in Set Up option for time. Press "+" or "-" to change. Press "S" to set and move to the next Set Up option.
   
   After the time, date, marker and beep is set up, pressing the "S" Button allows you to scroll through the set items again. Wait 30 seconds or press and hold the "S" Button to turn the meter off.
   
   Set Up options are (in order):
   • hour with AM or PM
   • minute
   • year
   • month
   • day
   • Beep (on/off)
   • Test Mark (on/off).
3. Press "+" or "-" Button to change and "S" Button to set and move to next option.
4. When "END" appears in the Display, these are no more Set Up options.
   

METER MEMORY

View Averages (1-, 7-, 14-, 30-day)

Averages allows you to view the average of all blood glucose results within a 1-, 7-, 14-, or 30 day period.

1. With meter off, press and release "S" Button. The full Display is shown followed by the last test result.
   
2. Press "S" Button to scroll through the 1-, 7-, 14-, and 30-day Averages.
   
   If there are less than 2 results in Memory, the Display shows "000". If there are no average values, three dashes are displayed for 7-, 14-, and 30-day Averages.

View Memory

Memory stores 400 results which are displayed from most recent to oldest. When Memory is full, the oldest result is replaced with the newest result.

1. After meter displays the 30-day Average, press and release "S" Button again.
   
2. The most recent result is shown with the Memory Symbol.
   
3. Press "-" Button to scroll backwards through results or "+" to scroll forwards through results.
   
4. At the end of the test results, the screen displays "End Mem". Pressing the "+" or "-" Buttons continues to scroll through results.
   
   Marked test results display a check mark (see Step 10 under How to Test Blood). Marked test results are not included in Averages.
   
   Control Test results display the Control Symbol. If no Control Test has been done, Display shows dashes and the Control Symbol.
   

BLOOD GLUCOSE MONITORING SYSTEM CARE

• Store blood glucose monitoring system (meter, control solution, test strips) in carrying case to protect from liquids, dust and dirt.
• Store in a dry place at room temperature (59°F-86°F). DO NOT REFRIGERATE OR FREEZE.
• Do not share your meter with anyone, including family members.

TRUE FOCUS Control Solution Care

• Write date first opened on control solution bottle label. Discard if either 90 days after opening or after date printed next to EXP on label has passed, whichever comes first.
• After each use, wipe bottle tip clean and recap tightly.
• Store at room temperature (59°F-86°F). DO NOT REFRIGERATE OR FREEZE.

TRUE FOCUS Test Strip Care

• Store test strips in original vial only. Do not transfer test strips to new vial or store test strips outside of vial.
• Write date first opened on test strip vial label. Discard unused test strips from vial if either 90 day after opening or after date printed next to EXP on label has passed, whichever comes first. Use of test strips past either date may give incorrect results.
• Close vial immediately after removing test strip. Store in a dry place at room temperature (59°F-86°F) and relative humidity of 10% - 90%. DO NOT REFRIGERATE OR FREEZE.

Meter Care, Cleaning and Disinfecting

Cleaning removes blood and soil from the meter.
Disinfecting removes most, but not all possible infectious agents (bacteria or virus) from the meter, including blood-borne pathogens.

• Meter should be cleaned and disinfected at least once a week.
• If the meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be cleaned and disinfected prior to use by the second person.
• Do not clean the meter during a test.
• Cleaning step #2 must occur before disinfectant steps #3 and #4.
• Only use Super Sani-Cloths to disinfect the meter. Super Sani-Cloths may be purchased at the following places:

• Amazon.com
• Officedepot.com or visit your local Office Depot store for availablity
• Walmart.com

How to Clean and Disinfect the Meter

1. Wash hands thoroughly with soap and water.
   
2. Make sure that the meter is off and a test strip is not inserted. Wipe the outside of the meter thoroughly with a fresh Super Sani-Cloth Wipe (EPA reg. no. 9480-4). Discard wipe.
   
3. Using a new Super Sani-Cloth Wipe, rub the entire outside of the meter 3 times horizontally and 3 times vertically, taking care to go over the entire meter (front, back and sides).
   

1. Ensure that the meter surface stays wet for 2 minutes Allow to air dry before use for an additional 1 minute.
   
   • Make sure no liquids enter the Test Port or any other opening in the meter.
   • Do not spray meter with any cleaning agents.
2. Make sure that the system is working properly by performing an Automatic Self-Test. See Automaticthe Self-Test under Getting Started.
   
3. Wash hands thoroughly after cleaning/disinfecting meter.
   

• If Automatic Self-Test gives an error message, call for assistance.
• Other disinfectants have not been tested. The effect of other disinfectants used interchangeably has not been tested with the meter. Use of disinfectants other than Super Sani-Cloth Wipes may damage meter.

Do not use the meter and call Customer Care for assistance toll free: 1-800-803-6025 or local: 1-954-677- 4599 if:

• Meter Display appears cloudy or any display segments are missing,
• Markings on meter, including back meter label, are coming off or missing,
• "S", "+" or "-" Buttons are hard to push on meter or do not work (see Memory),
• Unable to insert test strip into Test Port.
• Automatic Self-Test gives an error message.

• Super Sani-Cloth Wipes have been tested on the meter for a total of 1095 cleaning and disinfecting cycles, which is equal to cleaning and disinfecting the meter once a day for a 3 year period.

Lancing Device Care, Cleaning and Disinfecting

Cleaning removes blood and soil from the lancing device.
Disinfecting removes most, but n ot all possible infectious agents (bacteria or virus) from the lancing device, including blood-borne pathogens.

• Lancing device should be cleaned and disinfected at least once a week.
• Remove lancet from lancing device before cleaning.
• Cleaning step #2 must occur before disinfecting steps #3 and #4.

1. Wash hands thoroughly with soap and water.
   
2. Using ONLY Super Sani-Cloth Wipes (EPA* reg. no. 9480-4), thoroughly wipe the entire outside surface of the lancing device. Discard the used wipe.
   
3. Remove another fresh Super Sani-Cloth wipe and thoroughly wipe the entire outside surface of the lancing device and end cap by wiping the surface 3 times vertically and 3 times horizontally.
   
4. Ensure the lancing device surface stays wet for 2 minutes and is allowed to air dry for an additional 1 minute. Discard the used wipe.
   
5. Wash hands thoroughly again after handling the lancing device.
   

• Other disinfectants have not been tested. The effect of other disinfectants used interchangeably has not been tested with the lancing device. Use of disinfectants other than Super Sani-Cloth Wipes may damage lancing device.

Do not use the lancing device and call Customer Care for assistance toll free: 1-800-803-6025 or local: 1-954-677-4599 if:

• Markings on lancing device are coming off or missing,
• Trigger Button is hard to push or does not work,
• End Cap does not go back on lancing device,
• Arming Barrel does not click when gently pulled back.

• Super Sani-Cloth Wipes have been tested on the lancing device for a total of 1095 cleaning and disinfecting cycles, which is equal to cleaning and disinfecting the lancing device once a day for a 3 year period.

Changing Battery

1. Turn meter over. Lift tab on Battery Door.
2. Turn meter over, tap gently on the palm of your other hand to loosen and remove the battery. Discard old battery into an appropriate container.
3. Insert a new battery, positive ("+") side facing up.
   ~ Use non-rechargeable 3V lithium battery, #CR2032.
4. Close Battery Door.
   
5. Meter comes on, displays software version, and goes to Meter Set Up. Check settings (see Meter Set Up).
   
   If meter does not turn on, open Battery Door and check that the battery was inserted "+" with the side facing up. Close Battery Door and repeat Step 5. If meter still does not turn on, call for assistance.

• Batteries may explode if mishandled. Do not dispose of battery in fire. Do not take apart or attempt to recharge battery. Dispose according to local regulations.

Blood Glucose Monitoring System Specifications

Operating Range (Meter & Test Strips)

Relative Humidity: 10-93% (Non-condensing)

Temperature: 57°F - 104°F

Hematocrit: 25-60%

• Use within specified environmental conditions only.

Chemical Composition

TRUE FOCUS Test Strips: Glucose dehydrogenase-FAD (Aspergillus sp.), mediators, buffers and stabilizers.
TRUE FOCUS Control Solution: Contents: D-glucose, preservative, red dye and viscosity-adjusting agent.

Call for assistance Monday - Friday, 8AM-8PM Eastern Standard Time English or Spanish 1-800-803-6025 www.trividiahealth.com

© 2021 Trividia Health, Inc. TRUE FOCUS ™ and the Trividia Health logo are trademarks of Trividia Health, Inc.