OK Biotech OKmeter Hitech User Manual

User GUIDE
Blood Glucose
Monitoring System
10-62-2310-0003 V1-JUL11
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.
6. KEEP THESE 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 Hitech Blood Glucose Monitoring System.
INCLUDED IN YOUR KIT:
a. One OKmeter Hitech Meter(battery included).
b. OKmeter Hitech Test Strips.
c. Lancing Device (if another type of lancing device was included, see the separate
instructions that come with that lancing device)
d. Sterile Lancet
AVAILABLE SEPERATELY:
e. OKmeter Control Solution(ask for control solution where you obtain your test
strips)
Keep the meter and testing supplies away from young children. Small
WARNING:
items as the battery cover, battery, test strips, lancets, and control solution vial cap
are choking hazards.
STRIP SLOT :
Insert the test strip here.
The meter will turn on
automatically.
DISPLAY :
STRIP BOTTLE HOLDER :
shows test results and This is the place that you
messages. can insert and hold the strip
bottle here.
Meter
METER LABEL :
Each meter has its unique
number on it. Do not alter
or tear the label off.
3
.
Performing Blood Test
1. Wash your hands in warm, soapy water. Rinse and dry
completely. Warm your fingers to increase blood flow.
2. Remove a new test strip from vial. Be sure to tightly
replace vial cap after removing test strips. Insert test
strip immediately into strip slot as illustrated. The
meter turns on automatically.
3. The meter will show your last test result for 2 seconds,
then the blink dot displayed, now the meter is ready for
test.
4. Hold the prepared lancing device firmly against the
side of your fingertip. Press release button.
(NOTE: If you want to do alternative site testing, please
refer to the "About Alternative Site Testing (AST)"
Section. Please consult your healthcare professional
before obtaining blood from site other than your
fingertip.)
m m
o l/ L
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 Hitech
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 5°C to 45°C (41°F to 113°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 (3.3mmol/L)*1 indicates low blood glucose
(hypoglycemia). Test results greater than 240 mg/dL (13.3mmol/L)*2 indicates high
blood glucose (hyperglycemia).If your results are below 60 mg/dL(3.3mmol/L) or
above 240 mg/dL(13.3mmol/L), repeat the test, and if the results are still below 60
ATTACH YOUR STRIP BOTTLE TO THE METER
The OKmeter Hitech meter is designed to attach together with your OKmeter
Hitech strip bottle. Before you begin to test, please follow below procedure to
attach the strip bottle first.
1.Take strip vial from box.
2.Attach the bottle to the holder of meter as illustration.
3.Push bottle down until the meter is located in the middle of bottle.
REPLACE BATTERY
The meter comes with ONE Lithium batteries (battery type CR2032)
ABSORBENT
(preinstalled when new purchasing). The battery should last about 3000 tests.
CHANNEL:
a p p l y a d r o p o f
blood here.
When you insert strip and found the meter blinks "E-b" for 5 time and then turn
off, the battery is dead.
CONFIRMATION
The meter will no longer give results. If you want to replace new battery,
WINDOW:
please follow below procedure.
this is where we
confirm if enough 1. Make sure the meter is turned off.
Pull out the battery component as
blood is applied for
has been drawn illustration.
into strip.
2. With the positive (+) side up, place
the battery (battery type CR2032) in
the compartment.
TEST STRIP
3. Push back the battery component to
HANDLE
the meter.
CONTACT BARS:
Insert this end into
strip slot.
IMPORTANT:
1.Your meter can display test result in milligram per deciliter (mg/dL) or
Test Strip
millimoles per liter (mmol/L). The mg/dL unit is standard in the United
States. The mmol/L unit is standard in Canada and European countries.
Your meter has been preset at the factory with the standard unit
measurement used where you live. When you replace the battery, the unit
of measurement will not be changed. If you want to change the unit of
measurement, please contact with us or local distributor for help.
2.Please discard the used or dead batteries properly according to the
regulations of your country.
Incorrect Correct
mmol/L
IMPORTANT:
The meter will store your latest test result. If you want to recall your last result,
please insert the strip into meter, and the result will be shown in the meter display
for 2 seconds before the blink dot displayed.
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
MDSS GmbH
Schiffgraben 41, D-30175 Hannover, Germany
5. Gently massage your finger or puncture site to obtain the
required blood volume. To perform the test, you need
only 0.7μL of blood sample. Do not smear the blood
sample. To obtain best accurate result, wipe off the first
drop of blood and gently squeeze another drop of blood.
6. Apply the blood sample to the test strip until the
confirmation window is fully covered with blood.
7. Then the meter begins to count down and shows up test
result in 5 seconds.
8. Turn the meter off by removing the test strip. Discard
the used strip and lancet safely in a puncture resistant
container.
A :
1
. Getting To Know Your System
SIDE
2. Prepare For Blood Sampling
3. Performing Blood Test
4. Understanding Your Test Result
B :
5. Control Solution Testing
SIDE
6. Caring For Your Meter And Test Strip
7. System Specifications
8. symbols Description
9. About Alternative Site Testing (AST)
10. Display Messages And Problem-Solving Guide
mg/dL(3.3mmol/L) or above 240 mg/dL(13.3mmol/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 Hitech 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 Lowest concentrations Compounds
≦ 8.0 mg/dL (0.53 mmol/L) tested at which no
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 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.
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 Selector
Release Button
Lancing Device Cap
Lancet Holder
Lancet Ejector
Lancet
Protective cap
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.
4. The lancing device and lancets are in conformity with MDD 93/42/EEC. Refer
to product labels for contact information of manufacturer and CE marking.
Important : The meter and lancing devic are for single patient use.
Do NOT share them with anyone including other family members !
Do NOT use on multiple patients !
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.
4
.
Understanding Your Test Result
The normal blood glucose range is 70 to 105 mg/dL (3.9 to 5.8 mmol/L) for a
fasting, non-diabetic adult, but less than 140 mg/dL (7.8 mmol/L) two hours after
meals. Consult your healthcare professional to find out your target blood glucose
value.
If your blood glucose result seems unusually high or low, or inconsistent with your
previous results, check the following:
1. Was the blood sample applied immediately to the test strip after removing it from
the vial?
2. Was the volume of the blood sample sufficient?
3. Was the test strip vial cap tightly sealed?
4. Was the test strip used before the expiration date?
5. Were the test strips stored away from extreme temperatures in very cold or hot
weather or from areas of high humidity?
Then run a control test with OKmeter control solution. If the control test result
is within the acceptable range, review testing procedure and repeat your blood
glucose test with a new test strip. If your blood glucose value is still inconsistent
with your previous results, glucose trend, or how you feel, contact your doctor
immediately for help.
Lowest concentrations tested
≦ 5.0 mg/dL (0.32 mmol/L) at which no interference
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)
Cocking Control