OKRA 06 User manual

OKRA
1
Blood Glucose
Monitoring System
06 User Manual

OKRA OKRA
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Dear OKRA Pro Blood Glucose Monitoring System Owner,
Thank you for choosing OKRA Pro Blood Glucose Monitoring System. This manual
contains everything you need to know about your new glucose meter and how it
works. Please take a moment to read the instructions carefully.
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. 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 Monitoring
System is for in vitro diagnostic use only.
OKRA Pro Customer Support is available Monday thru Friday,9 to 5pm Eastern Time.
Please call toll free (833-977-1339)
Email [e-mail]
Website www.okra.care
Instuctions for Use

OKRA OKRA
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Intended Use
The OKRA Pro Blood Glucose Monitoring System is intended for the quantitative
measurement of glucose in fresh capillary whole blood from the ngertips, ventral
palm, dorsal hand, upper arm, forearm, calf and thigh. The OKRA Pro Blood Glucose
Monitoring 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 eectiveness of diabetes control. It should not be used for the diagnosis of or
screening of diabetes or for neonatal use. Alternative site testing should be done only
during steady–state times (when glucose is not changing rapidly).
The OKRA Pro Test Strips are for use with the OKRA Pro Meter to quantitatively
measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples
may be drawn from the ngertips, 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 correctly.
Important Information
The OKRA Pro Blood Glucose Monitoring System provides a quick and easy way for
patients with diabetes to measure their blood sugar levels.
It should only be used with fresh capillary whole blood samples. It is designed for
in-vitro diagnostics use only and should not be used for any purpose other than
monitoring blood sugar levels. It should not be used for the diagnosis of diabetes or
for the testing of newborns (neonates).
WARNING:
Do not change your medication based on the OKRA Pro meter test results without contacting your
Physician or Healthcare Professional.

OKRA OKRA
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Important Safety Instructions
The Centers for Disease Control and Prevention (CDC) and the US Food and Drug
Administration (FDA) have become increasingly concerned about the risks for
transmitting hepatitis B virus (HBV) and other bloodborne pathogens to people
undergoing nger stick procedures for blood sampling. For instance, people with
diabetes who require assistance monitoring their blood glucose levels.
Reports of HBV infection outbreaks linked to diabetes care have been increasing.
This notice serves as a reminder that nger stick devices should never be used for
more than one person.
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.
3. Always use a new, sterile lancet. Lancets are for single use only.
4. Please refer to page 46 and 51 for cleaning and disinfecting the OKRA Pro Blood Glucose
Monitoring System.
“FDA Public Health Notication: Use of Fingerstick Devices on More than One Person
Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication Update
11/29/2010”
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm 224025.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses
Risk for Transmitting Bloodborne
Pathogens”(2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

OKRA OKRA
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Cautions and Safety Information
1. For in vitro diagnostic use only.
2. The single-patient use system is for single-patient use only and should not be shared
3. Not for neonatal use.
4. Do not use for diagnosis of or screening for diabetes mellitus.
5. Not for use on critically ill patients, patients in shock, dehydrated patients or hyperosmolar
patients.
6. Alternative site testing (AST) should only be performed during periods of steady-state blood
glucose conditions (when glucose is not changing rapidly).
7. AST should not be used to calibrate continuous glucose monitors (CGMs).
8. AST should not be used for insulin dose calculations.
9. Avoid getting hand lotions, oil, dirt or debris in and/or on the lancets, reusable lancing device
and test strips.
10. Do not use OKRA Pro glucose meter in a dry environment.
11. Practice using the lancing device and become accustomed with its use.
12. Wash your hands with warm clean water and soap 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 tightly after removing any test strips from the vial.
18. Make a note of the discard date, which is three months from the date you rst open a new vial
of strips. Throw OKRA Pro test strips and vial away after the discard date.
19. Do not use the test strips after the expiration date printed on the package or vial since it may
cause inaccurate results.
20. OKRA Pro test strips are for single use only. DO NOT RE-USE.
21. Do not test at temperatures below 50°F(10°C) or above 104°F(40°C).
22. Do not test with humidity below 10% or above 90%.
23. Do not bend, cut, or alter the test strips.
24. Avoid getting dirt, food, and water on the color-coding label (backside of test strip).
25. Refer to additional information in the OKRA Pro test strip package.

OKRA OKRA
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Table of Contents
About your new OKRA Pro Blood Glucose Monitoring System
OKRA Pro Kit contents
OKRA Pro meter
OKRA Pro meter display
OKRA Pro test strip
Before your test
Comparing your meter and lab results
Setting your meter
Auto-coding function
Performing a control solution test
Performing your test
Performing a blood test with your ngertip
Disposing of your test strips and lancets
Reviewing your results
Reviewing 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
4 1
4 1
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 Pro system Storage of your system
Transferring your results
Bluetooth function
Battery installation
Troubleshooting
Inconsistent or Unexpected Test Results
Warranty
Specications
OKRA Pro Test Strip Manual
OKRA Pro Control Solution Manual

OKRA OKRA
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About your New OKRA Pro Blood Glucose Monitoring
OKRA Pro Starter Kit Contents
There are two additional levels (Level 1 & Level 3) of control solutions that can be
purchased separately.
Please 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
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06 User Manual
Blood Glucose
MonitoringSystem
07 Quick Guide Manual
Blood Glucose
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OKRA OKRA
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Blood Glucose Monitoring System
Model : IGM-1003 Rating : 3V ,4mA Made in Korea
IMC01932 INFM001LF Rev.2020-10-01
REF
Tel : [phone]) www.okra.care
S N
5. Test Strip Ejector
For hands-free disposal of used
test strips.
6. Serial Number
7. Battery Cover
1. Test Strip port
Insert the OKRA Pro Test Strip here.
2. Display Screen
Displays your test results, symbols,
and messages.
3. Power/Enter Button
Power the meter on/o, 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
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Low Battery Warning Symbol
Alarm Symbol
Caution Symbol
Average Test Result System
Before Having a Meal
After Having a Meal
After Taking Medication
After Sport Activity
Control Solution Symbol
Blood Drop Symbol for Test
Strip Code Symbol
Test Result Unit Symbol
Temperature / Date
Time / Test Result Amount
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OKRA OKRA
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OKRA Pro Test Strip
Before Your Test
1. Target to Apply Blood Sample (.5ul)
2. Contact Bar
Insert this End into Test Strip Port
Make sure to read this section and the test strip package insert found in the test strip
box carefully. You will need to have all of the necessary items to begin testing:
Necessary Items
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
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 lancet and a new blood glucose test strip.
3. Lancets and blood glucose test strips are for single use only.
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1. OKRA Pro meter
2. OKRA Pro test strip
3. Sterile lancet
4. Lancing device
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OKRA OKRA
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Comparing your meter and laboratory results
Test results with the OKRA Pro Blood Glucose Monitoring System are plasma-equiv-
alent. This method will help you and your Healthcare Professional compare your
meter results with laboratory test results. The OKRA Pro test results and laboratory
test results both are expressed in plasma-equivalent units. However, your glucose
monitor results may dier from your laboratory results due to normal variation. Your
glucose monitor results can be aected by factors and conditions that do not aect
laboratory results in the same way.
The following may aect the accuracy of your meter:
1. You are severely dehydrated.
2. You have eaten recently. The blood glucose level from blood obtained from a
ngertip can be up to 70mg/dL higher than blood drawn from a vein (venous
sample) used for a lab test.1
3. Your hematocrit is above 65% or below 20 %.
1 Sacks, D.B.: Carbohydrates.: “Carbohydrates.: Burits, C.A. and Ashwood, E.R. (ed.),
Tietz Textbook of Clinical 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 insert.
In order to make the most accurate comparison to your laboratory results, please
follow a few basic guidelines:
You may still experience a dierence from the laboratory test results because blood
sugars can change very rapidly over a short period of time. This can be for a variety
of reasons such as exercise, medication, stress or loss of body uids.
Before going to the lab
- Do not eat for at least two hours before you test your blood.
- Perform a control solution test to make sure that the meter is working properly.
- Take your meter with you to the lab.
While at the lab
- Follow all instructions in this Instructions for Use for performing a blood sugar test with your meter.
- Conduct your meter test within 30 minutes after lab test.
- Use only fresh capillary whole blood from the ngertip.