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SIDE
Read instructions
before use.
OK-P
10-62-2965-0003 V1-FEB11
10-62-2965-0103 V1-FAB11
OKP010001
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 manual.
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.
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 self-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. The system should not be used for the diagnosis of diabetes or for
the testing of newborns.
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
Getting To Know Your System
The OKmeter Cameo Blood Glucose Monitoring System.
The OKmeter Cameo 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.
Important :
Use only OKmeter Cameo test strips and control solutions with your
OKmeter Cameo meter. Use other test strips and control solutions with this meter
can produce inaccurate results.
current changes with the amount of glucose in the blood sample. The OKmeter Cameo
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 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 Cameo test results. However, elevated concentrations
of these substances may affect test results. The compounds listed in the table
were found to have no affect at the concentration indicated.
Compounds
Highest concentrations
tested at which no
interference occured
Compounds
Highest concentrations tested
at which no interference
occured
Acetaminophen
≦
8.0 mg/dL (0.53 mmol/L)
Gentisic Acid
≦
5.0 mg/dL (0.32 mmol/L)
Ascorbic Acid
≦
5.0 mg/dL (0.28 mmol/L)
Hydroxyurea
≦
3.0 mg/dL (0.39 mmol/L)
Aspirin
≦
60 mg/dL (3.33 mmol/L)
L-dopa
≦
10 mg/dL (0.51 mmol/L)
Bilirubin
≦
90 mg/dL (1.54 mmol/L)
Maltose
≦
900 mg/dL (26.3 mmol/L)
Cholesterol
≦
500 mg/dL (12.9 mmol/L)
Methyldopa
≦
3.0 mg/dL (0.13 mmol/L)
Creatinine
≦
5.0 mg/dL (0.44 mmol/L)
Tolbutamide
≦
400 mg/dL (14.8 mmol/L)
Dopamine
≦
2.0 mg/dL (0.11 mmol/L)
Triglycerides
≦
2,000 mg/dL (22.6 mmol/L)
Galactose
≦
900 mg/dL (50 mmol/L)
Uric Acid
≦
8.0 mg/dL (0.48 mmol/L)
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.
1.
DATE:
Display month and date.
2. TIME:
The meter is programmed for a 12
hour period format.
3. AVERAGE:
Appears when the meter is
in the memory mode while recalling
7/14/28 day test averages.
4. MEMORY SYMBOL:
Appears when in
the memory mode.
5. THERMOMETER SYMBOL:
Appears
when ambient temperature is above or
below the acceptable range needed for
testing.
6.
CONTROL SOLUTION TEST SYMBOL:
Appears when you are in Control Solution
Mode. Your test result will not be stored in meter memory.
7.
UNIT OF MEASURE:
Appears with the test result either in mg/dL or mmol/L.
8. BATTERY SYMBOL:
Appears when battery is weak.
9. BLOOD DROP SYMBOL:
Flashes when sample should be applied.
10. STRIP SYMBOL
:
Appears when the meter is turned on and waiting for inserting a
test strip.
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 cover. Press SET BUTTON
located at the right side of battery compartment. 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 Minute
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 flashing. If you
do not want to change the unit, Press SET BUTTON to skip this step.
If you want to change the 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 delete all memory setting.
STEP 8. 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 9. Complete Setting
After deleting 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 7, 14 and 28-day averages which you can access from the
meter memory. These averages are calculated from your latest result obtained
during the last 7, 14 and 28 days.
3.Your meter can display test result in milligram per deciliter (mg/dL) or millimoles
per liter (mmol/L). Your meter has been preset at the factory with the standard
unit measurement used where you live (mg/dL) . When you turn off the meter or
replace the battery, the unit will not be changed.
4.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.
1.
A
1
. Getting To Know Your System
2. Prepare For Blood Sampling
3. Performing Blood Test
4. Memory Recall
5. Control Solution Testing
6. Caring For Your Meter And Test Strip
7. System Specifications
8. About Alternative Site Testing (AST)
9. Display Messages And Problem-Solving Guide
SIDE
A :
SIDE
B :
Meter
Test Strip
ABSORBENT
CHANNEL:
Apply a drop of
blood here.
CONTACT BARS:
Insert this end into strip slot.
TEST STRIP HANDLE :
Hold this part to insert the test strip
into the meter slot.
CONFIRMATION WINDOW:
This is where we confirm if enough blood is
applied for has been drawn into strip.
Prepare For Blood Sampling
Adjustable Lancing Device
Your lancing device and lancets are used for obtaining
blood samples from the puncture site.
Lancet
Protective cap
2
.
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.
IMPORTANT :
The meter and lancing device are for single patient use.
Do NOT share them with anyone including other family members !
Do NOT use on multiple patients !
REPLACING THE BATTERY
The meter comes with ONE Lithium batteries (battery type CR2032) Before you start,
please install battery with the plus(+) side up.
Battery life will vary depending on usage, so always keep a spare battery on hand.
The battery should last about 1000 tests or 12 months when testing 3 times a day.
When the battery symbol appears on the meter display, battery is getting low. You will
still be able to test with low battery, but you should replace it as soon as possible.
When battery symbol appears together with E-b on the display, the meter will no longer
give results and you must replace the battery immediately. Please always have one
spare battery with you to ensure that you can replace the battery anytime.
How to replace the battery
1. Make sure the meter is turned off. Let the front of the meter
rest in the palm of your hand. Press the buckle on the battery
cover and lift up to open the cover. Remove the battery.
2. With the plus (+) side up, place the battery (battery type
CR2032) in the compartment and slide it upwards until it is
locked into place. You should hear a beep to indicate the
battery installed correctly. If not, please replace the battery
correctly.
3. Close battery cover.
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 period(i.e., 3 months or more ).
4.
Please discard the product or the batteries properly according to the regulations
of your country.
For
in vitro diagnostic use.
Temperature limitation / Store at.
Please consult instructions
for use.
Use by / Expiry date.
Do not reuse.
Manufacturer.
Lot number.
EU representative.
Caution, consult
accompanying document.
This product fulfils the requirements
of Directive 98/79/EC
in vitro
diagnostic medical device.
Performance Characteristics:
Accuracy:
≧
95% of the individual glucose results fall within ± 15 mg/dL(0.83 mmol/L) at glucose concentration < 75 mg/
dL(or 4.2 mmol/L) and within ± 20% at glucose concentration
≧
75 mg/dL(or 4.2 mmol/L), compared with glucose analyzer
YSI 2300.
PRECISION: CVs (%) of intermediate precision and repeatability were less than 5%.
DISPLAY :
Shows test results
and messages.
METER LABEL :
Each meter has its
unique number on it.
Do not alter or tear
the label off.
SET BUTTON :
Located in the battery
compartment; press button to
enter meter setting. Refer to
"
SETTING TIME AND DATE
"
section for details.
BATTERY
COMPARTMENT :
Holds ONE 3V Lithium battery
(battery type CR2032).
STRIP SLOT :
Insert the test strip here.
The meter will turn on
automatically.
M BUTTON :
Main button, press
button to turn the
meter on or perform
other functions
described in User
Guide.
DATA PORT :
USB port, allows you to transfer the information stored
in the meter to a computer to view, analyze and print.
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Blood Glucose Monitoring System
It's time
to
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OK Biotech Co., Ltd.
No. 91, Sec. 2, Gong Dao 5th Road,
30070 Hsinchu City, TAIWAN
TEL: +886-3-5160258
FAX: +886-3-5160028
www.okbiotech.com
E-mail: [email protected]
MDSS GmbH
Schiffgraben 41,
30175 Hannover,
GERMANY
V2-DEC14
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.
NOTE: THE DEPTH SELECTOR OFFERS 5 LEVELS OF SKIN
1-2 : FOR SOFT OR THIN SKIN
3 : FOR AVERAGE SKIN
4-5 : FOR THICK OR CALLOUSED SKIN
4. Pull back the cocking control until it makes a
click, and then release. If it does not click, the
device may have been cocked when the lancet
was inserted.
Lancing Device Cap
Lancet Holder
Depth Selector
Release Button
Cocking Control