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OKRA 06 User Manual
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OKRA 06 User Manual

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06
User Manual
Blood Glucose
Monitoring System
1
OKRA

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  • Page 1 User Manual Blood Glucose Monitoring System OKRA...
  • Page 2 We understand that self-testing of blood glucose level provides a way to control your diabetes and may give you peace of mind by testing regularly. The OKRA Pro Blood Glucose Monitoring System has been developed to provide you with a fast and accurate reading by a convenient and simple process.
  • Page 3 WARNING: during steady–state times (when glucose is not changing rapidly). Do not change your medication based on the OKRA Pro meter test results without contacting your Physician or Healthcare Professional. The OKRA Pro Test Strips are for use with the OKRA Pro Meter to quantitatively measure glucose in fresh capillary whole blood.
  • Page 4 /www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html WARNING: 1. The OKRA Pro meter and the reusable lancing device are for single patient use only. Do not share them with anyone including other family members. Do not use on multiple patients. 2. All parts of the kit are considered bio-hazardous and can potentially transmit infectious diseas- es, even after you have performed cleaning and disinfection.
  • Page 5 1. For in vitro diagnostic use only. 15. Store the OKRA Pro test strip vials in a cool, dry place. Keep out of direct sunlight. Do not 2. The single-patient use system is for single-patient use only and should not be shared freeze.

  • Page 6: Table Of Contents

    Before your test Caring for your OKRA Pro meter system 16-24 46-53 Comparing your meter and lab results Cleaning and disinfecting OKRA Pro system Storage of your system Setting your meter Transferring your results Auto-coding function Bluetooth function Performing a control solution test...

  • Page 7: About Your New Okra Pro Blood Glucose Monitoring System

    There are two additional levels (Level 1 & Level 3) of control solutions that can be purchased separately. Quick Guide Manual User Manual Please call toll free (833-977-1339) or visit www.okra.care for purchase Blood Glucose Blood Glucose Monitoring System Monitoring System...
  • Page 8 OKRA Pro Meter OKRA Pro meter display 1. Test Strip port Insert the OKRA Pro Test Strip here. Low Battery Warning Symbol 2. Display Screen Alarm Symbol Displays your test results, symbols, Caution Symbol and messages. Average Test Result System 3.

  • Page 9: Okra Pro Meter Display

    If the meter is moved from one temperature to another, allow 30 minutes for the meter to adjust to the new temperature before testing. Make sure that the OKRA Pro meter and test strips have adjusted to the temperature 1. Target to Apply Blood Sample (.5ul) of the location from where you are testing.
  • Page 10 This method will help you and your Healthcare Professional compare your In order to make the most accurate comparison to your laboratory results, please meter results with laboratory test results. The OKRA Pro test results and laboratory follow a few basic guidelines: test results both are expressed in plasma-equivalent units.

  • Page 11: Setting Your Meter

    Setting Your Meter The OKRA Pro meter has a wide variety of functions. In the setup mode you have the ability to turn activity/meal flags on or off, set the date/time, designate the number of days for your glucose average calculation and set up to five daily alarms.
  • Page 12 After pressing and releasing either the or buttons to set 1. VERY IMPORTANT: Your OKRA Pro meter testing units arepre-set to mg/dL. If you discover that the meter is not set the alarm hour and minute, confirm by pressing .

  • Page 13: Auto-Coding Function

    The OKRA Pro control solutions contain a known amount of glucose that reacts OKRA Pro meter has an automatic code recognition with the OKRA Pro test strip. By comparing your control solution test results with the function. expected range printed on the test strip vial, you can verify that the meter and test strips are working properly, and you are performing the test correctly.
  • Page 14 The control solution bottle icon ( ) contains the letter ‘c’ so it will not to be confused with the medication bottle icon. This will allow you to differentiate between a control solution test and an actual blood test. OKRA OKRA...
  • Page 15 If you are using the level 2 control solution, according to this particular vial of test strips, your meter should show a number between 80 and 120. - Check the expiration dates on all the products you are using. Be sure you are using OKRA control solution. Expiry date Blood Glucose Control Solution...

  • Page 16: Performing Your Test

    WARNING strip code number and adjusts the meter a ccordingly. 1. OKRA Pro meter and reusable lancing device are for single patient use only. Do not share them with anyone including other family members. Do not use on multiple patients.
  • Page 17 If the blood smears or runs, do not use that sample. Dry the area and gently squeeze another drop or puncture a new site. Replace the lancing cap by twisting it back on tightly. To adjust the depth setting: Use 1-2 for soft skin, 3-4 for average skin, and 5-6 for thick or calloused skin. OKRA OKRA...
  • Page 18 5 seconds. It will begin counting down from 5 to 1 second on the LCD display OKRA Pro test meter only requires 0.5 uL sample volume. window. When finished, the - Place the edge of the test strip to the drop of blood.
  • Page 19 Push the needle into the protective cover. 2. Please contact your Healthcare Provider for instructions on disposing of your glucose test strips and lancets. Pull the lancet out. Be sure to contact your Healthcare Provider for instructions on disposing of your lancets. OKRA OKRA...

  • Page 20: Reviewing Your Results

    Reviewing your averages Reviewing your blood sugar The OKRA Pro meter stores up to 365 test results in its built-in memory, along with the average sugar level for the number of days, which you have preset the glucose test meter to calculate.

  • Page 21: Alternate Site Test

    The OKRA Pro meter stores up to 365 test results in its built-in memory, along with the You may find that obtaining a blood sample from an alternative site is less painful average sugar level for the number of days, which you have preset the glucose test than using a fingertip.
  • Page 22 To reduce the chances of getting infection: never share a lancet or a reusable lancing device clear cap down against a fleshy area on the alternative with anyone. site and press the release button. Do not lift up. OKRA OKRA...
  • Page 23 2. Testing with a fingertip sample may identify hypoglycemia or an insulin reaction sooner than testing with a forearm or palm sample. 8. Place the edge of the test strip to the drop of blood. The blood will be automatically drawn up. OKRA OKRA...

  • Page 24: Caring For Your Okra Pro Meter System

    Why should cleaning and disinfecting the meter and the reusable lancing device be performed? 2. Please call OKRA Pro Customer Service at (833-977-1339). If you have any questions regarding proper cleaning and disinfecting procedures and purchasing the materials needed. Blood glucose meters and reusable lancing devices are at the high Riskof becoming contaminated with bloodborne pathogens such as Hepatitis B Virus(HBV).
  • Page 25 4. Wipe the outside of the reusable lancing device carefully (3 passes horizontal and should remain visibly wet for 2 minutes right after disinfecting 3 passes vertical). treatment. * To clean the reusable lancing device, wipe it with a CaviWipes towelette. OKRA OKRA...
  • Page 26 - Control solution test falls out of range. Your OKRA Pro Blood Glucose Monitoring System has an expected life of 3 years and - Lancing device does not function. should withstand the cleaning and the disinfecting recommended in this Instructions Ex.
  • Page 27 Storage of your OKRA Pro System Control Solution Storage - Storage condition: Store in a cool dry place between 46~86°F or 8~30°C To avoid the meter and test strips getting dirt, dust or other contaminants, please (Temperature). wash and dry your hands thoroughly before use.

  • Page 28: Bluetooth Function

    Step 2 Go to your app store on your mobile device (you can find your app store at If you wish to transmit your results to your OKRA Pro app on your mobile device, open your google play or the apple app store), and search for the ‘OKRA Pro App’ . Down- OKRA Pro app and follow the instructions above.

  • Page 29: Battery Installation

    Contact customer support if the problem persists. Your OKRA Pro meter uses only one 3V coin battery (CR2032), which is included. When replacing the battery, only CR2032 or equivalent coin battery should be used.
  • Page 30 (10 ~ 40°C) for more than 10 minutes and test again. Blood sample is placed on the test strip before the symbol for blood blinks. Wait for the meter to display the blinking blood icon before applying your blood sample. OKRA OKRA...
  • Page 31 If you are certain the meter is functioning correctly and no errors were made during the test procedure and the blood glucose is still consistently measured as “Lo”, the result may indicate severe hypoglycemia (low blood glucose). You should inform your Healthcare Professional immediately. OKRA OKRA...

  • Page 32: Inconsistent Or Unexpected Test Results

    There may be a problem with the glucose test strips. The results are inconsistent. Please insert a new test strip and perform your test again. OKRA OKRA...

  • Page 33: Warranty

    2. OKRA Pro reserves the right to make changes in design without obligation to incor- porate such changes into previously manufactured devices. 3. OKRA Pro has no knowledge of the performance of the device when the test strip is altered or modified in any manner.

  • Page 34: Specifications

    Fresh capillary whole blood Sample Volume IMPORTANT Please read this information and your OKRA Pro Instructions for use before using the OKRA Pro Test Range 20 ~ 600 mg/dL test strips. Customer support is available Monday thru Friday, 9 to 5pm Eastern Time.
  • Page 35 • The single-patient use system is for single-patient use only and should not be shared. OKRA Pro test strips have the new bio-sensor technology, requiring only a tiny drop of blood. OKRA Pro meter can store 365 readings in memory with date & time. All your • Not for neonatal use results are easily downloadable to your computer.
  • Page 36 • Avoid getting dirt, food, and water on the color-coded label (back of test strip). - Materials provided: OKRA Pro Test strips - Materials required but not provided: OKRA Pro meter, Instructions for use, control solution Level 2, reusable lancing device and lancets.
  • Page 37 If the code numbers do not match, do not • OKRA Pro meter and reusable lancing device are for single patient use only. Do not share them use it and contact customer support immediately. Refer to Instructions for use.
  • Page 38 Blood sugars may be altered by your food, physical activity, and/or stress. meal, insulin doses, or physical exercise. • Testing performed within two hours after meals, insulin doses, or physical exercise or whenever you feel that your glucose levels may be changing rapidly should be done OKRA OKRA...
  • Page 39 One to two hours after meals < 140 mg/dL(7.8 mmol/L) Reference: American Diabetes Association, Clinical Practice Recommendations OKRA Pro glucose control solution can be used with the OKRA Pro meter and OKRA (2013) Diabetes Care, Vol. 36, Supplement 1, p S1 - S100 Pro test strips only.
  • Page 40 If the control solution test results continually fall outside the range printed on the vial, the OKRA Pro glucose monitoring system may not be functioning properly. DO NOT use the system to test - OKRA Pro test strips used above altitudes of 10,000 feet will have an effect on test your blood until you receive a control solution test result that falls within the correct range.
  • Page 41 The performance of the test strips has been evaluated in clinical trials. Measurement OKRA Pro test strip results can be used with hematocrit levels in the range of 20% to Range: The measurement range of the OKRA Pro glucose monitoring system is 20 to 65%.
  • Page 42 Regressions between OKRA Pro BGMS results and the YSI 2300 for the capillary whole Precision Results for control solutions. blood samples: Linear regression 95% CI Slope 95% CI Intercept Control Solution Level 45 mg/dL 111 mg/dL 307mg/dL y= 0.9886x - 0.3843 (0.978, 0.999)
  • Page 43 Patient VENTRAL PALM vs YSI 2300 Finger Linear regression 95% CI Slope 95% CI Intercept Linear regression 95% CI Slope 95% CI Intercept y = 0.9922x + 8.3679 (0.975, 1.009) (3.616, 13.120) 0.9891 y = 0.9834x + 4.4829 (0.966, 1.001) (-0.332, 9.298) 0.9885 OKRA OKRA...
  • Page 44 Patient FORE ARM vs YSI 2300 Finger Linear regression 95% CI Slope 95% CI Intercept Linear regression 95% CI Slope 95% CI Intercept y = 0.9819x + 4.7354 (0.967, 0.997) (0.449, 9.022) y = 0.9989x - 0.0575 (0.981, 1.017) (-5.167, 5.052) 0.9874 OKRA OKRA...
  • Page 45 Patient CALF vs YSI 2300 Finger Linear regression 95% CI Slope 95% CI Intercept Linear regression 95% CI Slope 95% CI Intercept y = 0.9827x + 1.3423 (0.965, 1.001) (-3.693, 6.377) 0.9875 y = 0.9907x + 5.6915 (0.974, 1.008) (0.878, 10.505) 0.9888 OKRA OKRA...
  • Page 46 Control Solution Manual IMPORTANT - Before using the OKRA Pro meter and test strips, read all of the operating instructions in the Intended Use Instructions for use. The OKRA Pro control solutions are for use with OKRA Pro meter and test strips to - Consult with your Healthcare Professionals on managing your diabetes daily with the OKRA Pro brand glucose monitoring system.
  • Page 47 9. A result will appear in 5 seconds. - Do not use if the expiration date has passed. 10. Compare the result to the range printed on the test strip vial, the result should fall within that range. OKRA OKRA...
  • Page 48 Do not Refrigerate. Discard 3 months after opening. DISTRIBUTED BY CGETC Inc. Made in Korea ISC02631 - The control solution is made for the OKRA Pro glucose monitoring system. Do not 3.5mL In-Vitro Diagnostic Use. Rev.2020-11-01 INFCL003SFA Do not Freeze.
  • Page 49 5. Failure to shake the control solution adequately. 6. A problem with the meter. 7. An error in the way you are doing the test. DISTRIBUTED BY CGETC Inc. CITY OF INDUSTRY, CALIFORNIA 91748 Quality Guarantee (833-977-1339) www.okra.care OKRA OKRA...
  • Page 50 Memo Memo OKRA OKRA...

  • Page 51: Okra

    DISTRIBUTED BY CGETC Inc. CITY OF INDUSTRY, CALIFORNIA 91748 Quality Guarantee www.okra.care Customer service is available Monday thru Friday, 9 to 5pm Eastern Time. TEL: (833-977-1339) E-MAIL: support@okra.care INFM001LF IMC01931 Rev. 2021-07-01 OKRA...

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