Trividia Health TRUEbalance - Monitoring Blood Glucose System Manual

Test

1. INSERT TEST STRIP
   
2. APPLY BLOOD SAMPLE
   

Know Your System

Top of Meter

Front of Meter

Right Side of Meter

Back of Meter

1. Button - Decrease numbers in Set Up; remove Control Symbol; move backward by time/date when viewing results in Memory.
2. Button - Select settings; view Morning Average values; view results in Memory.
3. Button - Increase numbers in Set Up; add Control Symbol; move forward by time/date when viewing results in Memory.
4. Display - Shows test results, messages, user prompts, and other information.
5. Test Port - Insert TRUEbalance Test Strip here.
6. Data Port - For data download to a computer using the usb cable. Contact Customer Care at the number located on cover for more information.
   
   Do not try to recharge battery by plugging usb cable into a power outlet. Meter will be destroyed.
7. Battery Compartment - Use one non-rechargeable 3V lithium battery (#CR2032), positive ("+") side up.
   Note: See Changing Battery for details.
8. Meter Label - Contains telephone number for assistance.
9. Serial Number Label - Identifies Meter when calling for assistance.

Display

1. Time, Date, 14/30 Day Average.
2. Result in Memory.
3. 14- or 30-Day Morning Average.
4. Test result.
5. Battery Symbol (see Display Messages).
6. Temperature Symbol (see Display Messages).
7. 7. Drop Symbol - Apply blood or Glucose Control.
8. Control Symbol (see Control Test).
9. Unit of Measure.
   Note: Factory Set. Cannot be changed by user.
10. Time is P.M.
    Note: "AM" does not appear. "PM" is not an option if factory set for 24-hour clock.

Test Strip

Front of Test Strip

1. Contact End - Insert into Meter with Contacts (metallic blocks) facing up before adding sample.
2. Sample Tip - Touch sample (blood or Glucose Control) to edge of Tip.

Placement of Sample to Test Strip

Correct

Incorrect

• Allow sample (blood or Glucose Control drop) to be drawn into Sample Tip.

Holding the Test Strip Sample Tip to theblood sample too long after the Meter begins testing may cause inaccurate results.

• Do not smear or scrape drop with Strip.
• Do not apply more sample to Strip after removing from drop.

Note: Do not apply blood or Glucose Control to top of Test Strip.
Do not insert Sample Tip with sample into Meter for testing.
May damage Meter.

Test Strip Vial Label

1. Lot Number (LOT) - Used for identification when calling for assistance.
2. Expiration Dates (EXP) - Write date first opened on vial label. Discard vial and unused Test Strips 120 days after written date or date printed next to EXP, whichever comes first.
3. Control Range - Range of numbers in which Control Test result must fall to assure System is working properly.

Use of Test Strips or Glucose Control past the Expiration Dates may give incorrect test results. Discard out-of date products and test with new products.

Glucose Control

Glucose Control Bottle Label

1. Lot Number (LOT) - Used for identification when calling for assistance.
2. Expiration Dates (EXP) - Write date first opened on bottle label. Discard bottle if either 3 months after opening or date printed next to EXP on bottle label has passed, whichever comes first.
3. Control Level (0, 1, or 2) - Three levels of TRUEcontrol Control are available. We recommend testing at least 2 levels of Control. Contact place of purchase or call for assistance to obtain Control.

Getting Started

The Meter turns on automatically when a Test Strip Contact End is inserted into the Test Port or when is pressed (see Set Up andMemory). The Meter turns off automatically after the Test Strip is removed from the Test Port or after 2 minutes of non-use.

Meter comes with pre-set time and date. Before using the Meter for the first time or after a battery change, check the time and date and update as needed (see Set Up).

The TRUEbalance is a no-coding system, which means that the Meter does not have to be coded to each lot of Test Strips.

Quality Control Testing

To assure you are getting accurate and reliable results, TRUEbalance offers two kinds of quality control tests. These tests let you know that your TRUEbalance System is working properly and your testing technique is good.

Automatic Self-Test

An Automatic Self-Test is performed by the Meter each time a TRUEbalance Test Strip is inserted correctly into the Test Port.

Insert a Strip into the Test Port. The Meter is working properly if:

• the full Display appears, then
• the time appears in the upper part of the Display, and then,
• the Drop Symbol begins to blink.

If an error message appears in the Display, the Meter will not perform a test. See Troubleshooting or call for assistance (see cover for phone number).

If any segments are missing in the Display when Meter is first turned on, do not use the Meter for testing. Call for assistance.

Control Test

We recommend performing Control Tests for practice before using your Meter for the first time to test your blood.

Control Tests should be performed:

• For practice to ensure your testing technique is good,
• Occasionally as you use the vial of Strips,
• When opening a new vial of Strips,
• If results seem unusually high or low,
• If a vial has been left opened or exposed to extreme heat or cold, or humidity,
• If Meter damage is suspected (Meter was dropped, crushed, wet, etc.)

Note: Three levels of TRUEcontrol Glucose Control Solution are available for Quality Control Testing. It is important to perform Control Tests with more than one level of Control to assure your System is working properly and your testing technique is good. Contact place of purchase or call for assistance to obtain Control.

Control 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 Glucose Control.

Only the most current Control Test result is stored in Memory.

How to Test Glucose Control

Use ONLY TRUEcontrol Glucose Control Solution with the TRUEbalance Meter.

1. Wash hands with soap and water, dry thoroughly. Allow Control, vial of Strips and Meter to adjust to room temperature (68-77ºF). Write date first opened on Control Label and/or Strip vial label.
2. Check dates on Control label and Strip vial label. Do not use Control if 3 months past written opened date or past date printed next to EXP, whichever comes first. Do not use Strips 120 days past written opened date or past date printed next to EXP, whichever comes first. Discard out-of-date products and use new products if either date has passed.
   
3. Swirl or invert bottle gently to mix Control. DO NOT SHAKE!
4. Remove Strip from vial. Recap vial immediately.
   Note: Use Strip quickly after removal from vial. Strips that have been left out of vial too long will give an error message. If error message appears in Display, discard old Strip and test with new Strip.
5. Insert Test Strip Contact End (Contacts facing up) into Test Port. Meter turns on. Keep Strip in Meter until testing is finished.
   
   Contacts Face Up
6. Press Control Symbol appears in Meter Display.
   Note: If you decide not to perform a Control Test, press to remove Control Symbol.
   
7. Turn Control bottle upside Symbol down. Squeeze one drop of Control onto a clean tissue.
   Wipe off bottle tip.
   
8. Gently squeeze a drop on a small piece of unused aluminum foil or clear plastic wrap. Dispose after use.
   
9. With Strip still in Meter, touch edge of Sample Tip to drop of Control and allow drop to be drawn into Strip. Remove Strip from drop when Meter beeps.
   
   Note: If Meter does not beep and begin countdown soon after placing Sample Tip to Control drop, discard Strip. Repeat test with new Strip. If problem persists, see Troubleshooting.
10. Compare result to Control range printed on Strip vial label.
    
    If result is in range, System can be used for testing blood. If result does not fall within range, repeat test using a new Strip.
    Note: Control Test result shows the Control Symbol in the Display.
    Note: When using the meter for the first time, check the unit of measure in the meter Display after performing a control or blood test. Result must display in the correct unit of measure (mg/dL). If the result does not display in the correct unit of measure, DO NOT use the meter and DO NOT use the meter result to determine treatment.

If Control Test result is outside range, test again. If result is still outside range, System should not be used for testing blood. Call for assistance (see cover for phone number).

11. Remove Strip from Meter and discard. Meter turns off. Recap Control bottle tightly.

How to Obtain a Blood Sample

Refer to Lancing Device "Instructions for Use" for detailed instructions.

The Lancing Device is for single patient use ONLY. For cleaning/disinfecting your Lancing Device see Lancing Device Care in the Lancing Device Instructions for Use. Wash your hands thoroughly with soap and warm water after handling the Meter, Lancing Device, or Test Strips. Contact with blood presents an infection risk.

• Never share lancets or lancing device.
• Lancets are for single use only. Do not re-use.

From Fingertip

1. Prepare fingertip by washing hands in warm, soapy water. Rinse well. Dry thoroughly.
2. Place end of Lancing Device against tip of finger. Lance fingertip.
3. Set Lancing Device aside. To help blood drop form, lower hand to waist level, gently massaging finger from palm to fingertip. Allow blood drop to form before attempting to apply to Test Strip.
   Always recap, remove and discard used Lancet in appropriate container when testing is complete.
   Note: Used Strips and lancets are considered biohazardous. Dispose used Strips and lancets in approved biohazard container.

For Forearm Testing

1. Select area to be lanced. Wash with soap and warm water, rinse and dry thoroughly.
2. Rub area vigorously or apply a warm compress to increase blood flow.
3. Place end of Lancing Device firmly against forearm. Press trigger button. Apply firm pressure on lancing device for 10 seconds.
   Note: Some lancing devices include a special end cap for alternate site testing. Check lancing device Instructions for Use.

Important Notes Regarding Forearm Testing

• Check with your Doctor or Diabetes Healthcare Professional to see if forearm testing is right for you.
• Results from forearm are not always the same as results from fingertip.
• 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 or your routine results are often fluctuating,
  • If you are ill or under stress,
  • If your forearm test 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.

How to Test Blood Glucose

Always check your supplies before using. Check Meter for damage (damaged or cracked Display, missing or damaged buttons). If any damage is seen, do not use Meter. Call for assistance. Check Strip vials for damage. Discard any vials that appear cracked or broken.

1. Check dates on Strip vial being used. Do not use if 120 days past written date or date printed next to EXP, whichever comes first.
2. Wash hands (and forearm for alternate site testing). Rinse well and dry thoroughly.
3. Remove Strip from vial. Recap vial immediately.
   Note: Use Strip quickly after removal from vial. Strips that have been left out of vial too long will give an error message when used. Discard old Strip and use new Strip for testing.
4. With Meter off, insert Test Strip Contact End (Contacts facing up) into Test Port. Meter turns on. Keep Strip in Meter until testing is finished.
   
   Contacts Face Up
5. Wait until Drop Symbol appears in Display.
6. Lance fingertip or forearm. Allow drop to form.
7. With Test Strip still in Meter, touch edge of Sample Tip to blood drop and allow blood to be drawn into Strip. Remove Test Strip Sample Tip from sample drop immediately after the Meter beeps and starts to countdown on Meter Display.
   

Holding the Test Strip Sample Tip to the blood sample too long after the Meter begins testing may cause inaccurate results.

Note: If Meter did not beep and begin countdown soon after touching blood drop to Sample Tip, discard Strip. Repeat test with new Strip and new blood drop. If problem persists, see Troubleshooting.

8. After countdown, result is displayed with date and time. Remove Strip and discard. Result is stored in Memory. Meter turns off.
   
   Note: When using the meter for the first time, check the unit of measure in the meter Display after performing a control or blood test. Result must display in the correct unit of measure (mg/dL). If the result does not display in the correct unit of measure, DO NOT use the meter and DO NOT use the meter result to determine treatment.
9. Record result in log book.
   Note: Used Strips and lancets are considered biohazardous. Dispose of used Strips and lancets in approved biohazard container.

System Out of Range Warning Messages

TRUEbalance measures blood glucose results from 20-600 mg/dL.

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

If blood glucose 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 Diabetes Healthcare Professional immediately.

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

Set Up (Time/Date)

1. Start with Meter off. Do not insert Test Strip. Press and hold Date/Time appears in display. Release after full Display appears and Meter beeps.
   

Set Time

2. The hour flashes.
   To change, press or on top of Meter to select the hour. Like many alarm clocks, to set "PM", scroll through hours until "PM" appears in Display.
   
   Note: "PM" does not display if Meter is factory set to 24-hour clock. Press to set.
3. The minutes flash.
   To change, pressor to select the minutes. Press to set.
   

Set Date

4. The month (number) flashes.
   To change, pressor to Day select the month. Press to set.
5. The day (number) flashes.
   To change, press or to select the day. Press to set.
6. The year flashes
   To change, press or to select the year. Press to set.
   

Exit Set-up

To review settings, press. Make changes as needed, per instructions above.

Press and hold until Display goes blank.
Options are saved. Meter turns off.

Memory

Morning Averages (14 and 30 Day)

For Morning Average values, only the earliest blood test result performed between 4:00 am - 9:59 am (according to Meter clock) is used. Meter clock must be set correctly (see Set Up) for accurate Morning Average values.

1. Start with Meter off. Press and release. Display shows 14 day Morning Average value and then 30 day Morning Average value.
   
2. Meter switches between 14 and 30 day Morning Average values for 2 minutes before turning off.
   
3. If there are no Morning Average values, 3 dashes are displayed.
   
4. Press and release to view results in Memory. Press and hold to turn Average Meter off, or Meter turns off after 2 minutes of inactivity.

Viewing Results in Memory

Memory stores 365 results, which are displayed from most recent to oldest. The oldest result is removed from Memory when Memory is full and a new result is added.

1. Start with Meter off. Press and release. Meter displays date and time followed by 14 and 30 Day Morning Averages. Press again to view most recent result in Memory.
   
2. Press and release to advance to the first blood glucose result in Memory.
3. Press and release again to view the latest Control Test result. The control test result shows the Control Symbol in Display. Only one Control Test result is stored in Memory.
   
4. Continue to press and release to advance through the blood glucose results. Holding scrolls through the results quickly. Press and release the to reverse through the results.
5. Press and hold to turn Meter off. Meter also turns off automatically after 2 minutes of inactivity.

Caring for TRUEbalance

• Store System (Meter, Glucose Control, Test Strips) in Carrying Case to protect from liquids, dust and dirt.
• Store System in a dry place at room temperature (36°-86°F). DO NOT REFRIGERATE OR FREEZE.
• Do not keep meter in an area where it may be crushed (i.e. back pocket, drawer, bottom of bag, etc.).

Meter Care, Cleaning/Disinfection

Cleaning removes blood and soil, disinfecting removes infectious agents.

To Clean the Meter (removing blood or soil):

• We suggest cleaning your Meter when visibly dirty. Never put Meter in liquids or allow any liquids to enter the Test Port.
• Wipe Meter with a clean, lint-free cloth dampened with 70% Isopropyl alcohol.
• Let Meter air dry thoroughly before using to test.
• Do not use bleach to clean the Meter.

For assistance contact Customer Care using the phone number on the cover of the Owner's Booklet. For Healthcare Professionals, please refer to the Quality Assurance/Quality Control Manual for instructions on Meter Care, Cleaning/Disinfection.

The QA/QC Manual is available on our website www.trividiahealth.com or call 1-800-803-6025 or 1-954-677-4599.

Glucose Control Care

• Write date opened on Control label. Discard 3 months after opening or after date printed next to EXP, whichever comes first.
• After use, wipe bottle tip clean and recap tightly.
• Store at room temperature (36°-86°F).

DO NOT REFRIGERATE OR FREEZE.

Test Strip Care

• Store Strips in original vial only. Do not transfer old Strips to new vial.
• Write date opened on vial. Discard unused Strips and vial 120 days after opening or after date printed next to EXP, whichever comes first. Use of Strips past either date may give incorrect results.
• Close vial immediately after removing Strip. Use Strip quickly after removal from vial. Never store Strips outside of vial. Store in a dry place at room temperature below 86°F. DO NOT REFRIGERATE OR FREEZE.
• Do not reuse Strip.
• Do not bend, cut or alter Strips in any way.

Changing Battery

Replace battery when Low or Dead Battery Symbol appears in Display or Meter does not turn on.

1. Lift tab on Battery Cover.
2. Turn Meter over, tap gently to loosen and remove battery.
3. Insert new battery, positive ("+") side up. Close cover.
   Note: Use non-rechargeable 3V lithium battery (#CR2032).
4. Discard old battery in appropriate container.
5. Turn Meter on. If Meter will not turn on, check that battery was installed properly. If not, reinsert battery and try again. Call for assistance if problem persists.
   
   Battery is not rechargeable. If you have a cable or a cradle for downloading results to a computer, DO NOT plug the usb cable end into an electrical outlet. Trying to recharge the battery or power the meter by plugging into an electrical outlet will cause meter to catch on fire or melt.
   Note: Replacing battery may affect date and time settings. Check date and time by going to Set Up and scrolling through the time/date settings by pressing.

Battery is not rechargeable. Battery might explode if mishandled or incorrectly replaced. Do not dispose of battery in fire. Do not disassemble or attempt to recharge battery. Dispose according to local/country specific regulations.

Note: Replacing battery may affect date and time settings. Check date and time by going to Set Up and scrolling through the time/date settings by pressing.

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 countdown.

Messages

Messages

Display	Reason	Action
	Temperature Error Temperature change too quick	Wait 10 minutes for Meter and Test Strips to reach room temperature before testing.
	Temperature Too Cold Meter temperature less than 50ºF	Move Meter and Test Strips to area between 50º-104ºF before testing.
	Temperature Too Hot Meter temperature greater than 104ºF	Move Meter and Test Strips to area between 50º-104ºF before testing.
	Sample Not Detected or Using Wrong Test Strip	Retest with new or correct Strip and larger sample.
	Used Test Strip or Test Strip outside of vial too long.	Repeat with new Strip. If error persists, call for assistance.
	Meter Error	Call for assistance.
	Test Strip Error, Very high blood glucose result (higher than 600 mg/dL)	Retest with new Strip. If error persists, call for assistance. If you have symptoms such as fatigue. excess urination, thrist, or blurry vision, follow your healthcare professional's advice for high blood glucose.
	Test Strip Removed During Test	Retest with new Strip. If error persists, call for assistance.
	Meter Error	Call for assistance.
	Meter Error	Call for assistance.
	Communication Error	Turn Meter off and on again. If error persists, call for assistance.
	Low Battery	About 50 tests can be done before battery must be replaced.
	Dead Battery	Replace battery.
	Out of range - Hi Result > 600 mg/dL	Retest with new Strip. If result is still "Hi" or "Lo" contact Doctor immediately.
	Out of range - Lo Result < 20 mg/dL

System Specifications

Result Range: 20-600 mg/dL

Sample Size: Minimum 1 microliter (1 µL)

Sample: Fresh capillary whole blood or Glucose Control

Test Time: 10 seconds

Result Value: Plasma values

Assay Method: Electrochemical

Reference Method: Yellow Springs Instrument (YSI)

Power Supply: One 3V lithium battery
#CR2032 (non-rechargable)

Battery Life: Approximately 1,100 tests or 1 year

Automatic shut-off: After two minutes of non-use

Weight: 1.66 ounces

Size: 3.52" x 2.15" x 0.67"

Memory Size: 365 blood glucose results,
1 Control Test result

Operating Range (Meter & Test Strips):

Relative Humidity: 10-90% (Non-condensing)

Temperature: 50°F-104°F

Hematocrit: 30-55%

Note: Use within specified environmental conditions only.

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