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OKRA

OKRA

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When the control solution is applied to the top edge of the test strip, you should
get results within theexpected range printed on the label of the test strip vial. If the
control solution test results fall outside the range, repeat the test. Results that fall
outside the range may be caused by:
- Error in performing the test.
- Failure to shake the control solution bottle well (must shake vigorously).
- Failure to discard the first drop of control solution.
- Expired or contaminated control solution.
- Test strip deterioration.
- Meter malfunction.
- Control solution that is too warm or cold.

IMPORTANT NOTE

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
your blood until you receive a control solution test result that falls within the correct range. If you
continue to have problems, contact your local representative immediately.

The OKRA Pro test strips provide accurate results when the following constraints
are observed: Inaccurate results may occur in severely hypotensive individuals or
patients in shock. Inaccurate low results may occur for individuals experiencing a
hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients
should not be tested with this meter.

- Use only the OKRA Pro test strips with the OKRA Pro meter.

- Use fresh capillary whole blood only.

- The test strips are for single use only. Do not reuse.

- Dehydration may cause higher test results.

- Inaccurate results may occur when in shock, hypotensive, hyperglycemic, or

hyperosmolar state and with or without ketosis.

- OKRA Pro test strips used above altitudes of 10,000 feet will have an effect on test

results.

Limitations of System

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Содержание 06

Страница 1: ...OKRA 1 Blood Glucose Monitoring System 06 User Manual ...

Страница 2: ... OKRA Pro Blood Glucose Monitoring System has been developed to provide you with a fast and accurate reading by a convenient and simple process Our goal with the OKRA Pro is to provide the best quality healthcare products coupled with superior customer service Always consult with your Healthcare Professional before making any changes to your diabetes management program The OKRA Pro Blood Glucose M...

Страница 3: ...e OKRA Pro Meter to quantitatively measure glucose in fresh capillary whole blood Fresh capillary whole blood samples may be drawn from the fingertips ventral palm dorsal hand upper arm forearm calf and thigh The OKRA Pro Control Solutions are for use with the OKRA Pro Meter and OKRA Pro Test Strips to check that the meter and test strips are working together properly and the test is performing co...

Страница 4: ...ngle 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 3 Always use a new sterile lancet Lancets are for single use only 4 Please refer to page 46 and 51 for cleaning and disinfectin...

Страница 5: ...p before testing 13 Dry your hands completely before testing 14 Avoid testing in direct sunlight to receive more accurate test results 15 Store the OKRA Pro test strip vials in a cool dry place Keep out of direct sunlight Do not freeze 16 Store the test strips in their original vial only Do not mix the test strips in new vials or in any other container 17 Immediately replace the vial cap and close...

Страница 6: ...ing your blood sugar Reviewing your averages 12 16 16 24 25 30 37 38 39 12 14 15 16 18 20 24 30 37 38 39 40 45 46 53 53 54 56 57 63 64 66 67 91 40 41 41 43 48 Alternate site test Performing a blood test with an alternate site Lancing and sampling from an alternate site area Ventral palm Dorsal hand The lancing device clear cap Caring for your OKRA Pro meter system Cleaning and disinfecting OKRA Pr...

Страница 7: ...e call toll free 833 977 1339 or visit www okra care for purchase OKRA Pro Starter Kit Contents 1 OKRA Pro Meter 2 150 OKRA Pro Test Strips 3 150 Lancets 4 Lancing Device 5 Level 2 OKRA Pro Control Solution 6 Carrying Case 7 User Manual 8 Logbook 9 Batteries Included 10 Quick Guide 2 3 4 6 8 9 5 1 06 User Manual Blood Glucose Monitoring System 07 Quick Guide Manual Blood Glucose Monitoring System ...

Страница 8: ... messages 3 Power Enter Button Power the meter on off prompts memory data and acts as an enter button during setup and after tests 4 Up Down Arrow Buttons Scroll up or down to adjust settings or to retrieve memory OKRA Pro Meter OKRA Pro meter display 7 5 6 Low Battery Warning Symbol Alarm Symbol Caution Symbol Average Test Result System Before Having a Meal After Having a Meal After Taking Medica...

Страница 9: ... 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 of the location from where you are testing Do not operate the OKRA Pro system under direct sunlight WARNING To reduce the chance of infection 1 The lancing device and sterile lancets should NOT be shared with others 2 Always use a new sterile lan...

Страница 10: ...ical Chemistry Philadelphia W B Saunders Company 1994 959 If you perform a blood sugar test with the system at temperature near the low end of the operating range it could result in a false high blood sugar Repeat the test in warmer environment with a new test strip as soon as possible For additional information on possible limitations for accuracy on precision please refer to your test strip inse...

Страница 11: ... releasing either the or buttons to turn the User Activity Option on off confirm by pressing Year After pressing and releasing either the or buttons to set the year confirm by pressing Date Time After pressing and releasing either the or buttons to set the date and time confirm both by pressing Number of days for average After pressing and releasing either the or buttons to set the number of days ...

Страница 12: ...ows You have three distinct options to set the number of days They are currently defaulted at7 14 and 21days CAUTION 1 VERY IMPORTANT Your OKRA Pro meter testing units arepre set to mg dL If you discover that the meter is not set to mg dL please contact us at 833 977 1339 immediately 2 The correct units of measure in the U S are mg dL 3 Without setting the date properly the average glucose level a...

Страница 13: ... correctly It is very im portant that you perform the control solution test routinely to make sure you receive accurate results The Glucose control solution should be used Whenever you suspect the blood glucose test meter or blood glucose test strip are not functioning properly If your blood glucose test results are not consistent with your symptoms If you have dropped the blood glucose test meter...

Страница 14: ...the arrow on the test strip arrow up Do not insert the glucose test strip upside down Discard the 1st drop of control solution this will eliminate any residue Place a drop of control solution on a clean dry surface e g the lid of the test strip vial Dip the test strip into the control solution Results will appear in 5 seconds Compare the result to the range printed on the test strip vial the resul...

Страница 15: ...mmediately after use Read Instructions Shake well Store between 46 86 F 8 30 C Do not Refrigerate Do not Freeze Discard 3 months after opening In Vitro Diagnostic Use DISTRIBUTED BY CGETC Inc CITY OF INDUSTRY CALIFORNIA 91748 www okra care Blood Glucose Control Solution Blood Glucose Control Solution Blood Glucose Control Solution Level 1 3 5mL ISC02629 INFCL003SFA Made in Korea Rev 2020 11 01 Lev...

Страница 16: ...cose test strip out of the port and re start the procedure from the beginning 2 If the code on the LCD display window and the one on the glucose test strip vial do not match try another new glucose test strip If the mismatch persists please contact our customer support 3 If you apply your blood sample before the blood symbol blinks an Er5 message will appear on the LCD Please refer to Page 58 Step...

Страница 17: ...t discard 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 forthick or calloused skin Pull the end of the lancet device back To prick your finger push the center button CAUTION If the blood smears or runs do not use that sample Dry the area and gently squeeze another drop or puncture a new site ...

Страница 18: ...st strip Discard the glucose test strip and re start testing 2 If you do not conduct the test within 3 minutes the glucose test meter will automatically power off to save battery life In this case the test procedure should start again from the beginning 3 You may get an inaccurate result if the blood sample is not completely filled Correct Completely Filled Incorrect Poorly filled After the beepin...

Страница 19: ...tective cover Used test strips may be considered bio hazardous waste in your area Be sure to contact your Healthcare Provider for instructions on disposing of your test strips Pull the lancet out Be sure to contact your Healthcare Provider for instructions on disposing of your lancets Removing and Disposing of Used Test Strip Disposing of your lancet Blo od Glu cos e Mo nito ring Sys tem Mode l IG...

Страница 20: ...od sugar result Press and release the button and your previous result will appear on the display Reviewing your blood sugar Reviewing Your Results The latest The Second latest The Third latest The average from 7 days worth of data from your recent test date The average from 14 days worth of data from your recent test date The average from 21 days worth of data from your recent test date Reviewing ...

Страница 21: ...7 3 5 6 4 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 Performing a blood test with an alternative site Alternative Site Test Sampling from your upperarm forearm dorsal hand ventral palm thigh or calf allows you to use your fingertips less often You may fin...

Страница 22: ...ia low blood glucose or if you are suffering from hypoglycemia unawareness WARNING To reduce the chances of getting infection never share a lancet or a reusable lancing device with anyone Lancing Using the Clear for an Alternate Site Area 1 Remove the lancing cap by twisting off 2 Insert a lancet and replace with the clear cap 3 To bring fresh blood to the surface of the test site rub the test sit...

Страница 23: ...site each time you test Repeated punctures in the same spot may cause soreness and calluses 3 If bruising occurs at an alternative site or you have difficulty getting a sample consider sam pling from a fingertip instead You may want to review the choice of sites with your Healthcare Professional 4 Do not share your reusable lancing device with anyone including other family members CAUTION Do not t...

Страница 24: ...is to kill the bloodborne pathogen stated above Cleaning and disinfecting can be completed by CaviWipes Disinfecting Towelettes The CaviWipes are pre moistened towelettes manufactured by Metrex and readily available through major medical distributors and online shopping websites ex www amazon com www staples com Please refer to the disinfectant labeling for additional instructions on the safe use ...

Страница 25: ... minutes right after disinfecting treatment 5 Dispose of the used wipes 6 Wash your hands thoroughly with soap and water The meter must be cleaned and disinfected a minimum of once per week 1 Wash your hands before performing cleaning and disinfecting procedures 2 Remove the wipe from the container 3 Make sure the used lancet is removed prior to cleaning 4 Wipe the outside of the reusable lancing ...

Страница 26: ...cycles which rep resents cleaning and disinfecting once per day for 3 years The meter can withstand cleaning and disinfecting 7 times per week over the 3 year life of the device CAUTION To achieve disinfection of the stated efficacy kill claim the reusable lancing device should remain visibly wet for 2 minutes right after the completion of disinfecting treatment NOTE 1 After cleaning and disinfect...

Страница 27: ...heir original vial only Do not store in other types of containers Store test strip packages in a cool dry place Keep away from direct sunlight and heat After removing a test strip from the vial immediately replace the vial cap and close it tightly Record the discard date It expires 6 months after first opening on the strip label Do not use if expiry date has passed Touch the test strip with clean ...

Страница 28: ...store at google play or the apple app store and search for the OKRA Pro App Down load and launch the OKRA Pro app and fill in all details required Step 3 Once your OKRA Pro app is ready to use select Connect Device on the OKRA Pro app on your mobile device From the drop down list shown on you mobile device select the meter that you are using Step 4 Ensure your meter is switched off then press the ...

Страница 29: ...nitoring System Model IGM 1003 Rating 3V 4mA MadeinKorea IMC01932 INFM001LF Rev 2020 10 01 REF Tel 833 977 1339 www okra care S N Blood Glucose Monitoring System Model IGM 1003 Rating 3V 4mA MadeinKorea IMC01932 INFM001LF Rev 2020 10 01 REF Tel 833 977 1339 www okra care S N Blood Glucose Monitoring System Model IGM 1003 Rating 3V 4mA MadeinKorea IMC01932 INFM001LF Rev 2020 10 01 REF Tel 833 977 1...

Страница 30: ...before the symbol for blood blinks Wait for the meter to display the blinking blood icon before applying your blood sample Color area of the test strip is dirty defective or there is too much sunlight Action required Please insert a new glucose test strip and perform your test again or if it blinks with sun avoid direct sunlight and retest Contact customer support if the problem persists The ambie...

Страница 31: ...is still consistently measured as Lo the result may indicate severe hypoglycemia low blood glucose You should inform your Healthcare Professional immediately There are no readings stored in the meter The test result is over 600mg dL If HI appears on the LCD screen for the Glucose result the measured concentration is above 600mg dL The test should be repeated to ensure that the test procedure was d...

Страница 32: ...re symptoms or make significant changes to your diabetes control program Inform your Healthcare Professional of symptoms and or concerns Self testing may help to monitor your blood glucose levels Consults with your physician to determine the best range of expected blood glucose values for you Range of Expected Values CAUTION 1 Low Glucose Results if your result is lower than 70mg dL it may mean hy...

Страница 33: ...n neglect misuse maintenance by someone other than OKRA Pro or failure to operate in accordance with the instructions 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 Manufacturer s Warranty...

Страница 34: ...ng System is intended to be used by a single patient and should not be shared The OKRA Pro Blood Glucose Monitoring System is intended for testing outside the body in vitro diagnostic use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control It should not be used for the diagnosis of or screening of diabetes and or for neonatal use Alternative site testing shou...

Страница 35: ...formation section For in vitro diagnostic use only The single patient use system is for single patient use only and should not be shared Not for neonatal use Do not use for diagnosis of or screening for diabetes mellitus Not for use on critically ill patients patients in shock dehydrated patients or hyper osmolar patients Alternative site testing AST should only be performed during periods of stea...

Страница 36: ...0 or above 90 Avoid getting dirt food and water on the color coded label back of test strip Note Different levels of reactions will occur depending on the amount of sugar in the blood sample Each OKRA Pro Test Strip contains Glucose Dehydrogenase Aspergillus sp 7 2 Mediator Hexaammineruthenium Chloride 42 8 Binder 2 2 Stabilizer 47 8 Materials provided OKRA Pro Test strips Materials required but n...

Страница 37: ...infectious diseases even after you have performed cleaning and disinfection Never share a lancet or a reusable lancing device with anyone Always use a new sterile lancet Lancets are for single use only Avoid getting hand lotions oils dirt or debris in or on the lancets and the reusable landing device Please refer to page 46 51 in the Instructions for use for cleaning and disinfecting OKRA Pro Bloo...

Страница 38: ...ed 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 Important Information about Using Alternative Sites Testing from the fingertip You should also use fingertip testing whenever you have a concern about hypogly cemia insulin reactions particularly if you suffer from hypoglycemic unawareness lack of ...

Страница 39: ... new test strip If the results are still inconsistent please consult your Healthcare Professional Control Solution is designed to ensure that the meter and the test strips are working together properly A new vial of test strips is opened Any suspicion that the meter or test strips are not working properly When your blood glucose test results are not consistent with your symptoms If you drop the me...

Страница 40: ...the system to test your blood until you receive a control solution test result that falls within the correct range If you continue to have problems contact your local representative immediately The OKRA Pro test strips provide accurate results when the following constraints are observed Inaccurate results may occur in severely hypotensive individuals or patients in shock Inaccurate low results may...

Страница 41: ... with caution Do not use during or soon after xylose absorption testing Xylose in the blood will cause interference Icodextrin does not interfere with OKRA Pro strips Please note the following interferences that may affect test results The performance of the test strips has been evaluated in clinical trials Measurement Range The measurement range of the OKRA Pro glucose monitoring system is 20 to ...

Страница 42: ... 1 63 2 04 2 16 3 33 3 47 5 18 5 42 8 53 8 87 pooled CV 300 3 7 2 6 2 7 2 5 2 6 Precision Results for control solutions Control Solution Level N 45 mg dL 111 mg dL 307mg dL grand mean 600 51 111 311 pooled variance 600 4 8 7 5 60 2 pooled SD 600 2 2 2 7 7 8 95 CI 600 2 18 2 22 2 26 2 73 7 67 7 93 pooled CV 600 4 3 2 4 2 5 Alternative Site Testing Accuracy The OKRA Pro glucose monitoring system was...

Страница 43: ...00 Linear regression 95 CI Slope 95 CI Intercept R2 N y 0 9922x 8 3679 0 975 1 009 3 616 13 120 0 9891 150 Table 3 Data analysis at VENTRAL PALM Table 4 Regressions analysis at VENTRAL PALM Patient VENTRAL PALM vs YSI 2300 Finger Patient VENTRAL PALM vs YSI 2300 Finger System accuracy results for glucose concentration 75 mg dL 4 2 mmol L System accuracy results for glucose concentration 75 mg dL 4...

Страница 44: ...46 146 100 Linear regression 95 CI Slope 95 CI Intercept R2 N y 0 9819x 4 7354 0 967 0 997 0 449 9 022 v 150 Table 7 Data analysis at FORE ARM Table 8 Regressions analysis at FORE ARM Patient FORE ARM vs YSI 2300 Finger Patient FORE ARM vs YSI 2300 Finger System accuracy results for glucose concentration 75 mg dL 4 2 mmol L System accuracy results for glucose concentration 75 mg dL 4 2 mmol L With...

Страница 45: ...6 100 Linear regression 95 CI Slope 95 CI Intercept R2 N y 0 9827x 1 3423 0 965 1 001 3 693 6 377 0 9875 150 Table 11 Data analysis at CALF Table 12 Regressions analysis at CALF Patient CALF vs YSI 2300 Finger Patient CALF vs YSI 2300 Finger System accuracy results for glucose concentration 75 mg dL 4 2 mmol L System accuracy results for glucose concentration 75 mg dL 4 2 mmol L Within 5mg dL with...

Страница 46: ...ons about using the products please contact OKRA Pro Customer Service at 833 977 1339 or visit www okra care Control Solution Manual The OKRA Pro control solutions are for use with OKRA Pro meter and test strips to check that the meter and test strips are working together properly and that the test as a quality control checks to verify the accuracy of blood glucose test results Acceptable performa...

Страница 47: ...pendent on following instructions carefully 1 It is recommended that the meter control solution and test strips are at room temperature 68 77 F before testing 2 Prior to use gently shake the bottle 3 Discard the first drop of control solution 4 Wipe the tip clean 5 Make sure the test strip is inserted fully into the test port of the meter 6 The meter will automatically turn on and display the code...

Страница 48: ...OT Expiry date Manufacture Date Discard date WARNING Close immediately after use Read Instructions Shake well Store between 46 86 F 8 30 C Do not Refrigerate Do not Freeze Discard 3 months after opening In Vitro Diagnostic Use DISTRIBUTED BY CGETC Inc CITY OF INDUSTRY CALIFORNIA 91748 www okra care Blood Glucose Control Solution Blood Glucose Control Solution Blood Glucose Control Solution Level 1...

Страница 49: ...n 3 Control solution is too warm or cold 4 Failure to discard the first drop of control solution and to wipe the bottle tip clean 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 Memo ...

Страница 50: ...OKRA OKRA 98 99 Memo Memo ...

Страница 51: ...IMC01931 INFM001LF REF 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 ...

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