in4 care GlucoAlpha Enchance User Manual

GlucoAlpha
™
Blood Glucose Monitoring System
User Guide
About GlucoAlpha™ ENHANCE
INTENDED USE
The GlucoAlpha™ Enhance Blood Glucose Monitoring System
(The GlucoAlpha™ Enhance System) is designed to
quantitatively measure the concentration of glucose in
capillary whole blood by persons with diabetes for self-
testing or by healthcare professionals for monitoring glucose
in the home or in healthcare facilities. The device is
indicated for professional use and over-the-counter sale.
ABOUT THE SYSTEM
The GlucoAlpha™ Enhance System uses the latest technology
in blood glucose monitoring to provide you with easy and
comfortable testing. The system requires only a 1.5μL of
blood sample to complete the testing in only 15 seconds.
The GlucoAlpha™ Enhance System consists of
1) GlucoAlpha™ Enhance Blood Glucose Meter,
2) GlucoAlpha™ Blood Glucose Test Strips,
3) GlucoAlpha™ Check Strip
4) GlucoAlpha™ Control Solution.
These products are intended to be used together to get
accurate blood glucose test results. Do not use other test
strips or control solutions with your meter.
GlucoAlpha™
BLOOD GLUCOSE TEST STRIP
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1. Aperture: apply the blood from either side of strip.
2. Test Confirmation Window: make sure the part is filled
up with blood to ensure the correct result.
3. Gray Electrode End: insert this end of test strip into meter.
IMPORTANT TEST STRIP INFORMATION
1. GlucoAlpha™ Enhance System measures the amount of
glucose in capillary whole blood. Blood can be applied
both to the right or left side of the test strip's apertures
and is automatically drawn to the test confirmation
window where the reaction takes place.
2. GlucoAlpha™ Blood Glucose Strips are intended for in vitro
diagnostic use with capillary whole blood or GlucoAlpha™
Control Solution. Results will not be accurate if used with
plasma or serum samples.
PREPARE FOR BLOOD SAMPLING
Your lancing device and lancets are used for obtaining
capillary blood samples from the fingertip.
ADJUSTABLE LANCING DEVICE
1. Depth Adjustment Cap 2. Depth Selector
3. Lancet Holder 4. Cocking Control 5. Release Button
Important
n The lancing device is in conformity with MDD 93/42/EEC.
Refer to package insert for contact information of
manufacturer and CE marking.
LANCET
Protective cap
Important
n Lancets are for single use only.
n Keep lancing device and lancets clean.
n Use caution when removing the used lancet from the
device and when disposing the used lancet.
n The lancets are in conformity with MDD 93/42/EEC. Refer
to product labels for contact information of manufacturer
and CE marking.
ENHANCE
IN4 Care
By IN4 Technology
IMPORTANT INFORMATION
GlucoAlpha™ Enhance System is intended for in vitro
diagnostic use with capillary whole blood. The system should
not be used for diagnosis of diabetes or for testing newborn
infant (neonatal testing).
CAUTION
n The user should not take any decision of medical
relevance without first consulting his or her medical
practitioner.
n Call your doctor immediately if you experience symptoms
that are not consistent with your blood glucose test results.
n Severe dehydration or excessive water loss may cause
false, low results. Call your doctor right away if you
believe you are suffering from dehydration.
n A sample with large amount of reducing substances such as
ascorbic acid and uric acid may cause result slightly higher
than the actual glucose level.
n A red blood cell count (hematocrit) that is either very high
(over 55%) or very low (under 30%) can cause false result.
n High altitudes above than 2,750 meter (8,800 feet) may
affect the test results.
n Temperatures outside the range of 10°C to 40°C (50°F to
104°F) may affect the test results.
3. Do not use glucose strips beyond the expiration date
indicated on the strip vial label.
4. The discard date for glucose strips is 90 days after first
opening the vial. Record the discard date on the vial,
when you open a new vial of glucose strips.
5. GlucoAlpha™ Blood Glucose Strip can be damaged by heat
and light. Keep them sealed in the original vial.
+10˚C +40˚C
(50˚F) (104˚F)
6. Store the vial in a cool, dry place below to
40˚C/104˚F and above to 10˚C/50˚F. Do not refrigerate.
7. Do not use damaged glucose strips or glucose strips
changed in any way. Use glucose strip immediately after
removing it from the vial; replace the vial cap and close it
tightly.
8. Do not transfer glucose strips to a new vial. Always carry
glucose strips in their original vial.
9. Do not place in direct heat or sunlight.
10. Do not carry loose glucose strips in your carrying case.
11. Blood glucose test strips are for single use only.
12. Do not use fluoride or iodoacetic acid as a preservative
for blood specimens.
SET LANCING DEVICE
1. Remove the depth adjustment cap. Insert a lancet into the
lancet holder and push down until it is fully seated (FIG 1).
2. Twist off the protective cap until it separates from the
lancet (FIG 2).
3. Replace the depth adjustment cap and set the puncture
depth to the desired number (FIG 3).
NOTE: The Larger The Number Setting The Deeper The Puncture.
4. Pull back the cocking control until it makes a click, and
then release (FIG 4). If it does not click, the device may
have been cocked when the lancet was inserted.
GlucoAlpha™ ENHANCE BLOOD GLUCOSE METER
Study this diagram and become familiar with all parts of your
GlucoAlpha™ Enhance Blood Glucose Meter.
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1. DISPLAY: The large, easy to read display shows blood
glucose results, messages, glucose results stored in
memory, time and date.
2. S BUTTON: Press S button to enter code setting and when
you need to decrease values in setting mode.
3. M BUTTON: Press M button to enter memory recall mode
and to increase values in setting mode.
4. STRIP SLOT: Holds a GlucoAlpha™ Blood Glucose Test Strip
and Check Strip in place when you perform blood glucose
test or perform check test.
5. BATTERY COMPARTMENT: Holds ONE 3v Lithium battery
(CR2032). The battery is not yet installed into meter when
new purchasing. By using the meter, please install the
battery first. Refer to Section "TAKING CARE OF YOUR
METER" of the manual for more information.
GlucoAlpha™ CHECK STRIP
The GlucoAlpha™ Check Strip can be used in 2 ways:
1. To check that the meter is operating
properly. Use when performing
quality control check on your meter.
2. To change the measuring unit of
your meter.
HOW TO CHECK METER BY CHECK STRIP
Step 1: Insert the check strip into strip slot with label side
up as above.
Step 2: You should obtain an acceptable "OK" reading within
3 seconds, which mean your meter is working properly.
Step 3: Remove the check strip to exit. Meter will
automatically off.
NOTE: IF YOU DO NOT GET "OK" READING BUT APPEAR OTHER
ERROR MEEAGE, REMOVE CHECK STRIP TO TURN OFF THE METER
FIRST. THEN REPEAT THE TEST. IF THE SECOND RESULT PERSISTS,
PLEASE CONSULT YOUR LOCAL DISTRIBUTOR FOR HELP.
How To Change Measuring Unit
The meter has two measuring units to choose from, mg/dL
and mmol/L. The default unit is mg/dL if you do not change.
Consult your doctor for the proper unit in your country.
Step 1: Insert check strip into strip slot with label side up.
Step 2: After "OK" displayed, press S button for 3 seconds
until flashing mg/dL shows up.
CODING YOUR METER
Before you use your meter for the first time and every time
you open a new box of test strips, you need to set the meter
to "match" the strips. This is called coding.
1. Insert the test strip into the strip slot (FIG 1) to turn on
the meter. Then the last code number will appear on the
screen.
2. Compare the code number shown on the meter display
against the code number on the test strip vial (FIG 2). If
the two numbers match you may begin blood testing.
Otherwise continue to the next step.
3. Press S button to enter the code mode and the code value
flashes (FIG 3).
4. Press S or M button to obtain the code number indicated
on the new test strip vial (FIG 4).
5. Upon obtaining the right code, waiting new setting flash 4
times to validate the change. After screen shows the
proper code and a blinking blood symbol shows up (FIG 5),
your meter is ready to perform blood test.
NOTE: when the meter is OFF, you can also press and S button for 3 seconds to code the meter directly. The coding procedures
are the same as above step 4 and 5.
IN4 Technology Corporation
www.in4-technology.com
GlucoAlpha™ ENHANCE LCD WINDOW
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1. TEST RESULT
2. BATTERY SYMBOL: Appears when battery is weak.
3. THERMOMETER SYMBOL: Appears when ambient
temperature is above or below the acceptable range
needed for testing.
4. BLOOD SYMBOL: Appears when the test strip is inserted
and meter is ready for blood testing.
5. STRIP SYMBOL
6. M188: Memory capacity is 153 entries. The display shows
M188 to ensure that all digits are working properly.
7. mg/dL mmol/L: The meter has two units of measurement
to choose from.
8. DAY AVG: Appears when the meter is in Memory Mode. The
meter automatically calculates your 7/14/30 days before
meal (AC) and after meal (PC) test averages if you preset
correct time and date.
9. DATE: Month/date.
10.TIME: The meter is programmed for a 12 hours period format.
Step 3: Press S button to switch from mg/dL to mmol/L.
Wait the new setting flash 4 times to validate the
new setting. Meter will display "OK" before OFF, and
the unit is been changed successfully.
Step 4: Remove the check strip from the meter.
SETTING TIME AND DATE
Time and date should be set prior to testing if you plan to
review your 7/14/30 days test average in before meal (AC)
and after meal (PC) reading or if you want to download the
results into computer or to review your memory to check
when a test was done.
TO SET THE TIME AND DATE
1. Make sure the meter is turned off.
2. Let the front of the meter rest in the palm of your hand.
3. Slide battery compartment door open and you will find a
"RESET" hole above the battery.
4. Prink the "RESET" hole to enter time and date setting.
5. At the beep sound, the year will flash - for example for
the year 2006, number "06" will appear.
6. Press S or M BUTTON to obtain the desired year.
7. Wait the new setting flash 4 times to confirm and move to
next setting.
8. Repeat to set the month, day, hour and minute.
9. After minute is set, the meter displays OK and turn off
automatically.
P30-A311
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