OK Biotech OKmeter Direct User Manual

Blood Glucose Monitoring System
Blood Glucose Monitoring System
User Guide
Before You Begin
PLEASE READ THIS BEFORE USING.
The following basic safety precautions should always be taken.
1. Close supervision is necessary when the device is used by, on, or near children,
handicapped persons or invalids.
2. Use the device only for the intended use described in this User Guide.
3. Do not use test strips and control solutions which are not supplied by the
manufacturer.
4. Do not use the device if it is not working properly, or if it has suffered any damage.
5. Before using any product to test your blood glucose, read all instructions
thoroughly and practice the test. Do all quality control checks as directed and
consult with a diabetes healthcare professional.
6. KEEP THIS USER GUIDE WITH YOU.
Intended Use
The system is intended for use outside the body (in vitro diagnostic use only).
It should be used only for testing blood glucose (blood sugar) and only with fresh
capillary whole blood samples. The system is intended for use in the home and in
clinical settings. It should not be used for the diagnosis of diabetes or for the testing of
newborns.
1.
Getting To Know Your System
The OKmeter Direct Blood Glucose Monitoring System.
The OKmeter Direct system uses the latest technology to provide you with easy and
comfortable testing. The system requires only a 0.7 μL of blood sample to complete
the testing in only 6 seconds.
The OKmeter Direct system consists of
1. OKmeter Direct Blood Glucose Meter
2. OKmeter Direct Blood Glucose Test Strips
STRIP SLOT :
SET BUTTON :
Insert the test strip here.
The meter will turn on
Located in the battery compartment; press button
automatically.
to enter meter setting. Refer to "SETTING YOUR
STRIP EJECTOR :
METER" section of this use guide for details.
Slide the ejector forward
to discard the test strip.
DISPLAY :
The large, easy
to read display
S
shows test results,
messages, test
results stored in
memory.
Model Name: OK-1N Made in Taiwan
Battery : 1.5 V AAA x 2
For self-testing.
OK1NJ005001
OK Biotech Co., Ltd.
www.okbiotech.com 10-62-6263-0103 V1-AUG13
M BUTTON :
Main button, press button to turn the
DATA PORT :
meter on or perform other functions
described in this manua l.
Allows you to transfer the information stored in the
meter to a computer to view, analyze and print.
Please contact us if you need detailed information.
Meter
TEST STRIP HANDLE :
Hold this part to insert the test strip
into the meter slot.
A B S O R B E N T
CHANNEL:
Apply a drop of
blood here.
CONFIRMATION WINDOW:
This is where we confirm if enough blood is applied for the
test. Ensure that it is fully covered with blood sample.
Test Strip
2
.
Prepare For Blood Sampling
Adjustable Lancing Device
Your lancing device and lancets are used for obtaining
capillary blood samples from the puncture site.
Depth Selectors
(Offer 6 levels of skin penetration)
Release Button
Lancing Device Cap
Arrow
Lancet Holder
Lancet Ejector
Lancet
Protective cap
For In vitro diagnostic use
Please consult instructions
for use
Do not reuse
Lot number
Caution, consult
accompanying document
Performance Characteristics:
ACCURACY: More than ninety-five percent (95 %) of the individual glucose results fell within ± 0.83 mmol/L (15 mg/dL) of the
results of the glucose analyzer YSI 2300 measurement procedure at glucose concentrations < 4.2 mmol/L (< 75 mg/dL) and
within ± 20 % at glucose concentrations ≧ 4.2 mmol/L ( ≧ 75 mg/dL).
PRECISION: CVs (%) of intermediate precision and repeatability were less than 5%.
OK Biotech Co., Ltd.
4F-1, No. 83, Sec. 2, Gongdao 5th Rd.,
Hsinchu City 30070, Taiwan
TEL: +886-3-5160258
FAX: +886-3-5160028
www.okbiotech.com
E-mail: service@okbiotech.com
Principle of Measurement
Blood glucose is measured by an electrical current that is produced when a blood
samples mixes with the reagent (special chemicals) of the test strip. The electrical
current changes with the amount of glucose in the blood sample. The OKmeter Direct
meter measures the strength of the electrical current, calculates your blood glucose
level and then displays your result in either milligrams of glucose per deciliter (mg/dL) or
millimoles of glucose per liter (mmol/L).
Caution
1. The user should not take any decision of medical relevance without first consulting
his or her medical practitioner.
2. Call your doctor immediately if you experience symptoms that are not consistent with
your blood glucose test results.
3. High altitudes above than 3,402 meter (11,161 ft) may affect the test results.
4. Temperatures outside the range of 10°C to 40°C (50°F to 104°F) may affect the test
results. Do not test beyond of temperature range.
IMPORTANT HEALTH-RELATED INFORMATION
1. Apply only capillary whole blood sample to test your blood glucose. Applying other
substances or plasma, serum will cause wrong results.
2. Severe dehydration and excessive water loss may cause false low results. If
you believe you are suffering from severe dehydration, consult your healthcare
professional immediately.
3. Test results below 60 mg/dL (3.3 mmol/L)*1 indicates low blood glucose
(hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L)*2 indicates high
blood glucose (hyperglycemia).If your results are below 60 mg/dL (3.3 mmol/L) or
above 240 mg/dL (13.3 mmol/L), repeat the test, and if the results are still below 60
1
Code
15
14
13
12
11 10
8. AVERAGE: Appears in the memory mode while recalling 7/14/21/28 day test
averages.
9. MEMORY SYMBOL: Appears when in the memory mode.
10. CTL SYMBOL: Appears when doing a control sloution test.
11. TIME : The meter is programmed for a 12 hour period format.
12. DATE: Display month and date.
13. AND LOW SIGN: Appears when test result is within the range of 20 to 70 mg/dL
(1.1 mmol/L to 3.9 mmol/L).
14. AND HIGH SIGN: Appears when test result is higher than 120 mg/dL (6.7 mmol/L).
15. THERMOMETER SYMBOL: Appears when ambient temperature is above or below
BATTERY
the acceptable range needed for testing.
COMPARTMENT :
Holds TWO 1.5V
REPLACING THE BATTERY
AAA alkaline
batteries.
The OKmeter Direct meter comes with TWO 1.5V AAA alkaline batteries.
Battery life will vary depending on usage, so always keep spare batteries on hand.
The battery should last about 1000 tests or 12 months when testing 3 times a day.
When the batteries symbol appears on the meter display, battery is getting low. You will
still be able to test with low battery, but you should replace them as soon as possible.
METER LABEL :
When battery symbol and E-b shows up in the meter display, the meter will no longer
Each meter has its unique
give results and you must replace the batteries immediately. Please always have spare
number on it. Do not alter
batteries with you to ensure that you can replace the battery anytime.
or tear the label off.
How to replace the battery
1. Make sure the meter is turned off. Let the front of the meter
2. Remove the old batteries and replace with two (2) new 1.5V
S
3. Close battery cover.
CONTACT BARS:
Insert this end into strip slot.
NOTE:
1. Replacing the battery does not affect the test result stored in memory. However the
time and date may need to re-set.
2. As with all small objects, the battery should be kept away from small children as a
safety precaution. If the battery is swallowed, seek medical assistance immediately.
3. Batteries might leak chemicals if not used for a long time. Remove the batteries if
you are not going to use the device for extended (i.e., 3 months or more ).
4. Please discard the product or the batteries properly according to the regulations
of your country.
Important Lancing Device and Lancets Information
1. Lancet is for single use only.
2. Keep lancing device and lancets clean.
3. Use caution when removing the used lancet from the device and when disposing the
used lancet.
The meter and lancing device are for single patient use.
IMPORTANT :
Do NOT share them with anyone including other family members !
Do NOT use on multiple patients !
Sliding Barrel
Temperature limitation / Store at
Use by /Expiry date
Manufacturer
EU representative
This product fulfils the requirements of
Directive 98/79/EC In vitro diagnostic
medical device.
MDSS GmbH
Schiffgraben 41, D-30175
Hannover, Germany
10-62-6219-0003 V1-AUG13
2
1. TEST STRIP SYMBOL: Appears when the
meter is turned on and waiting for inserting a
3
test strip.
2. VOICE SYMBOL
4 3. BATTERY SYMBOL: Appears when battery is
weak.
5
4. BLOOD DROP SYMBOL: Flashes when it is
ready to apply the blood sample.
6
5. MEASUREMENT UNIT: Appears with the test
7
result in mg/dL or mmol/L.
8
6. Ketone?: Appears when result is higher than
240 mg/dL (13.3 mmol/L).
9
7. : Appears when test result is within the range
of 70 to 120 mg/dL (3.9 mmol/L to 6.7 mmol/L).
rest in the palm of your hand. Slide battery cover open.
AAA size alkaline batteries.
A :
1 . Getting To Know Your System
SIDE
2. Prepare For Blood Sampling
B :
3. Performing Blood Test
SIDE
4. Understanding Your Test Result
5. Memory Recall
6. Control Solution Testing
7. System Specifications
8. Caring For Your Meter And Test Strip
9. Display Messages And Problem-Solving Guide
mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), consult your healthcare
professional immediately.
4. 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 blood glucose meters.
5. Abnormal red blood cell counts (hematocrit level below 20% or above 60%) may
cause false results. Please consult your healthcare professional if you do not know
your hematocrit level.
6. Interference: Reducing substances occurring in the blood naturally (uric acid,
bilirubin) or from therapeutic treatments (ascorbic acid, acetaminophen) will not
significantly affect OKmeter Direct test results. However, elevated concentrations
of these substances may affect test results. The compounds listed in the tables
were found to have no affect at the concentration indicated.
Compounds Highest concentrations Compounds
tested at which no
≦ 8.0 mg/dL (0.53 mmol/L)
interference occured
≦ 5.0 mg/dL (0.28 mmol/L)
Acetaminophen Gentisic Acid
≦ 60 mg/dL (3.33 mmol/L)
Ascorbic Acid Hydroxyurea
≦ 90 mg/dL (1.54 mmol/L)
Aspirin L-dopa
≦ 500 mg/dL (12.9 mmol/L) Methyldopa
Bilirubin Maltose
≦ 5.0 mg/dL (0.44 mmol/L)
Cholesterol
≦ 2.0 mg/dL (0.11 mmol/L)
Creatinine Tolbutamide
≦ 900 mg/dL (50 mmol/L)
Dopamine Triglycerides
Galactose Uric Acid
REFERENCE:
* 1: Kahn, R. and Weir, G.: Joslinis Diabetes Mellitus, 13thed Philadelphia : Lea and Febiger (1994), 489.
* 2: Krall, L.P. and Beaser, R. S.: Joslin Diabetes Manual. Philadelphia : Lea and Febiger(1989), 261-263.
SETTING TIME AND DATE
Please install battery first and set correct time and date before you begin to test.
STEP 1. Enter Setting Mode
Start with the meter off. Open the battery compartment, and press SET
BUTTON. The meter will turn on and enter the setting mode.
STEP 2. Set the Year
The year appears with the number flashing. Press and release the M
BUTTON to obtain the desired year. Press SET BUTTON to confirm
and move to next MONTH setting.
STEP 3. Set the Month
The month appears with the number flashing. Press and release the M
BUTTON to obtain the desired month. Press SET BUTTON to confirm
and move to next DATE setting.
STEP 4. Set the Date
The date appears with the number flashing. Press and release the M
BUTTON to obtain the desired date. Press SET BUTTON to confirm
and move to next HOUR setting.
STEP 5. Set the Hour
The hour appears with the number flashing. Press and release the M
BUTTON to obtain the desired hour. Press SET BUTTON to confirm
and move to next minutes setting.
STEP 6. Set the Minutes
The minute appears with the number flashing. Press and release the M
BUTTON to obtain the desired minute. Press SET BUTTON to confirm
and the meter will enter to next unit setting.
STEP 7. Set the Unit of Measurement
The existing unit (for example mg/dL) will appear and flash. You can
choose to reset measurement unit. If you do not want to change unit,
press SET BUTTON to skip this step. If you want to change unit, press
and hold the M BUTTON for 3 seconds to change the unit to mmol/L.
Press SET BUTTON to confirm and the meter will enter to next setting.
STEP 8. Set the Unit of Temperature
The existing unit (for example °C) will appear and flashing. Press the M
BUTTON to change the unit to °F. Press SET BUTTON to confirm and
the meter will enter to next delete all memory setting.
STEP 9. Delete Memory
When the dEL symbol and the flashing memory symbol appear on the
display, you can choose to clear the memory. If you do not want to clear
the memory, press the SET BUTTON again to skip this step. If you want
to clear ALL memory, press and hold M BUTTON for 3 seconds. The "--
-" image will appear on the LCD screen to indicate that all memory has
been deleted.
STEP 10. Complete Setting
After delete memory, the meter will display "OFF" before shut down.
The meter setting is now completed.
IMPORTANT :
1.The time, date and unit of measurement can ONLY be changed in the setting mode. Therefore,
when you perform a blood glucose testing, it is not possible to change those parameters.
2.Your meter displays test results in milligram per deciliter (mg/dL) or millimoles of glucose per
deciliter. Use of the wrong unit of measure may cause you to misinterpret your blood glucose
level, and may lead to incorrect treatment. Please always consult with your healthcare
professionals before you reset the unit of measure.
3.While the meter is in the setting mode, if no button is pressed for 1 minute, the meter will turn off
automatically.
Setting your Lancing Device
1. Screw off the cap of lancing device. Insert a
lancet into the lancet holder and push down until
it is fully seated.
2. Twist off the protective cap until it separates from
the lancet.
3. Replace the lancing device cap and set the
puncture depth to the desired number.
To select the best depth:
For delicate skin
For normal skin
For thick or callused skin
4. Pull back the Sliding Barrel until it makes a click,
and then release. If it does not click, the device
may have been cocked when the lancet was
inserted.
Highest concentrations tested
at which no interference
≦ 5.0 mg/dL (0.32 mmol/L)
occured
≦ 3.0 mg/dL (0.39 mmol/L)
≦ 10 mg/dL (0.51 mmol/L)
≦ 900 mg/dL (26.3 mmol/L)
≦ 3.0 mg/dL (0.13 mmol/L)
≦ 400 mg/dL (14.8 mmol/L)
≦ 2,000 mg/dL (22.6 mmol/L)
≦ 8.0 mg/dL (0.48 mmol/L)