in4 care GlucoAlpha Enchance User Manual

IN4 Care

By IN4 Technology

GlucoAlpha™ ENHANCE

Blood Glucose Monitoring System

User Guide

P30-A311

IN4 Technology Corporation

www.in4-technology.com

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 self­testing 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.

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.

GlucoAlpha™ ENHANCE BLOOD GLUCOSE METER

Study this diagram and become familiar with all parts of your
GlucoAlpha™ Enhance Blood Glucose Meter.

4

1

5

2

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.

3

GlucoAlpha™ ENHANCE LCD WINDOW

1. TEST RESULT

2. BATTERY SYMBOL: Appears when battery is weak.

3. THERMOMETER SYMBOL: Appears when ambient

4. BLOOD SYMBOL: Appears when the test strip is inserted

5. STRIP SYMBOL

6. M188: Memory capacity is 153 entries. The display shows

7. mg/dL mmol/L: The meter has two units of measurement

8. DAY AVG: Appears when the meter is in Memory Mode. The

9. DATE: Month/date.

10.TIME:

6

2

3

9 8

temperature is above or below the acceptable range
needed for testing.

and meter is ready for blood testing.

M188 to ensure that all digits are working properly.

to choose from.

meter automatically calculates your 7/14/30 days before
meal (AC) and after meal (PC) test averages if you preset
correct time and date.

The meter is programmed for a 12 hours period format.

5

7

1

4

10

GlucoAlpha™
BLOOD GLUCOSE TEST STRIP

1

2

1

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.

3

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)

6. Store the vial in a cool, dry place below to

7. Do not use damaged glucose strips or glucose strips

8. Do not transfer glucose strips to a new vial. Always carry

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

(104˚F)

40˚C/104˚F and above to 10˚C/50˚F. Do not refrigerate.

changed in any way. Use glucose strip immediately after
removing it from the vial; replace the vial cap and close it
tightly.

glucose strips in their original vial.

for blood specimens.

GlucoAlpha™ CHECK STRIP

The GlucoAlpha™ Check Strip can be used in 2 ways:

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.

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.

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.

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

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).

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.

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.

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.

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.

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.

PERFORM BLOOD TEST

1. Wash your hands in warm, soapy water. Rinse and dry com­pletely. Warm your fingers to increase blood flow (FIG. 1).

2. Remove 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 (FIG. 2).

PERFORM BLOOD TEST (continued)

6. Use the loaded lancing device to obtain a drop on the side of
your finger (FIG. 6). Hold the device firmly against the side of
your finger. Press the release button. Gently massage your
finger to obtain the required blood volume. To perform the test,
you need only 1.5μL of blood sample resting on your finger.

7. Apply the blood to the aperture of strip and make sure that the
blood drop has saturated the test confirmation window. When
blood is applied to the strip, the meter will be started
automatically. (FIG. 7)

3. Check that the code number in the meter matches the
code on the vial of test strips you are using (FIG 3).

4. When the blood symbol flashes, you are ready to perform
the blood glucose test (FIG. 4).

5. By applying blood sample to the aperture of the test strip,
you can press M button to set the test as BEFORE MEAL
TEST(AC), or AFTER MEAL TEST(PC)(test be done in 2
hours after meal), or a CONTROL SOLUTION TEST(qC). If
not setting, the default of the meter is (AC)(FIG. 5)

MEMORY RECALL

The GlucoAlpha™ Enhance Blood Glucose Meter automatically
stores 153 test results, letting you review them in order from
the most recent to the oldest. If you have set the AC/PC and
time/date feature, the AC/PC and time/date of the results
are also displayed. If the memory is full and a new result is
added, the meter deletes the oldest result.

The meter also calculates and displays your previous 7-, 14­and 30-day before meal (AC) and after meal (PC) test
averages if you preset correct time and date.

TO RECALL RESULTS STORED IN MEMORY

1. Turn meter on by press M button 3 seconds to turn on the
meter. The first result displayed on the screen is your
latest test result.

2. By pressing M button, you will see your test record from
the most recent to the oldest.

3. By pressing S button you will obtain your 7 days before
meal (AC) setting. You can press S button again to obtain
your 7 days after meal (PC) setting.

4. Following press S button to review your 14 days and 30
days before meal and after meal averages.

NOTE: ANYTIME IN MEMORY MODE, YOU CAN PRESS S
BUTTON TO EXIT AND TURN OFF THE METER.

AC PC qC

TO DELETE MEMORY

1. While in the memory mode, select the test result you wish
to delete and display it on the screen.

2. Press M button until you hear a beep sound. The blink

“dEL” symbol will appear on the meter.

3. Press M button again until the “OK” symbol appears which
confirms that the selected test result has been deleted
successfully.

4. The meter will return to memory mode and display next
result after deleting.

DATA DOWNLOAD

You may download test results to your computer. To transfer
test results to a computer, you need to download
GlucoAlpha™ Software from our web site or from the CD
provided by us. Use the interface cable provided with CD to
download your test results to computer.

8. Test result will show up in 15 seconds (FIG 8). Before removing
strip from the meter, check if the AC/PC/qC setting is correct,
if not, please press M button to correct the setting.

9. Remove the strip from meter (FIG 9), and discard the used strip
and lancet safely in a puncture resistant container.

10. Testing range of the meter is 20-600mg/dL (1.1-33.3 mmol/L).
If HI is displayed, your blood glucose result may be higher than

33.3 mmol/L or 600 mg/dL. If LO is displayed, your blood
glucose result may be lower than 1.1 mmol/L or 20 mg/dL (FIG

10). Refers to page19 for details.

UNUSUAL TEST RESULT

NORMAL BLOOD GLUCOSE RANGE

The normal blood glucose range is 70 to 105 mg/dL (3.8 to

5.8 mmol/L)1 for a fasting, non-diabetic adult, but less than

140 mg/dL (7.7 mmol/L)2 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. Does the code number on the strip vial match the code
number on the meter?

2. Was the blood sample applied immediately to the glucose
strip after removing it from the vial?

3. Was the size of the blood sample sufficient?

4. Was the test strip vial cap tightly sealed?

5. Was the test strip used before the expiration date?

6. Were the test strips stored away from extreme
temperatures in very cold or hot weather or from areas of
high humidity?

Then run a quality control check with your GlucoAlpha™
Control Solutions and a new test strip. (The information of
how to do the control test, please refer to your control
solution package insert for more information.) 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 for help immediately.

SYSTEM SPECIFICATIONS

1. Assay Method: Electrochemical biosensor

2. Test Sample: Capillary Whole Blood

3. Test Result: Plasma / Serum glucose

4. Sample Size: Less than 1.5 μL

5. Measuring Range: 20 - 600 mg/dL or 1.1 - 33.3 mmol/L

6. Measuring Time: Less than 15 seconds

7. Memory Capacity: 153 test results with time and date

8. Average Display: 7, 14, 30-days AC and PC test average

9. Result Setting: AC, PC and qC setting

10.Power Supply: One 3-volt Lithium Battery (CR2032)

11.Battery Life: Approximately 1000 tests

12.Operating Temp. Range: 10ºC to 40ºC (50ºF - 104ºF)

13.Hematocrit Limit: 30% to 55%

14.Operating Relative Humidity: 20% - 80% RH

15.Automatic shut-off: In 10 minutes

DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE

When any of the following messages appears, there is a problem with your GlucoAlpha™ Enhance Blood Glucose Meter or the
way in which you are performing a test. These messages will help you to identify certain problems. If error messages appear
that are not listed on the following pages, please contact us for help.

ACTION TO TAKEDESCRIPTIONDISPLAY

Display All

Blood glucose result
may be higher than 600
mg/dL (33.3 mmol/L)

Blood glucose result
may be lower than 20
mg/dL (1.1 mmol/L)

Temperature is above
or below the operating
range of test strips.

If some parts of the display are not working. Contact us or your local
distributor for help.

If the reading is “HI” and you do not experience any hi blood glucose
symptoms, review proper testing procedure (refers to page 13) and
perform a quality check (refers to page 7 and 8). Repeat test, if the
result persists, contact your medical professional for help.

If the reading is “LO” and you do not experience any low blood glucose
symptoms, review proper testing procedure (refers to page 13) and
perform a quality check (refers to page 7 and 8). Repeat test, if the
result persists, contact your medical professional for help.

The result you have obtained may not be accurate. Move to an area
with temperature within the test strip's operating range temperature
between 10ºC to 40ºC (50ºF - 104ºF). Do not artificially heat or cool the
meter.

Change battery soon.Battery is low.

ACTION TO TAKEDESCRIPTIONDISPLAY

Change battery now.Battery is dead.

damaged.

Test strip is used or test
was not performed
correctly.

No responses when
strip is inserted

No responses after
sample is applied

NOTE : If there is any error message displayed but not listed here, or your meter shut down for no reason, you can reset
the meter by following two ways:

1. Replace the battery. 2. Use a lancet to prink the “reset” hole (with a reset mark) beside the battery component.

1. Battery dead

2. Wrong strip inserted

3. Meter defective

1. Sample not sufficient

2. Meter defective

Perform the test with a new test strip only.Test strip may be

Perform the test with a new test strip only and follow the chapter of
perform blood glucose test.

1. Replace battery

2. Insert the test strip correctly

3. Contact us for help

1. Repeat test with sufficient sample

2. Perform Meter Quality Check

REFERENCE

1. Tietz N.W. textbook of Clinical Chemistry, P.2190 (1994)

2. American Diabetes Association Position Statement, Diabetes Care Vol. 19 (Suppl.1), p.S4 (1996)

PERFORMANCE EVALUATIONS

PRECISION

Tests were carried by trained technicians in the laboratory
setting. The venous whole blood from one subject was
adjusted to 3 different levels. Strips out of a single lot were
tested. The results are shown in the following table.

Level No. of tests Mean[mg/dL] Mean[mmol/L] WithinRun[C.V.(%)]

Low 20 43 2.4 3.4

Normal 20 109 6.0 3.6

High 20 324 18.0 2.4

ACCURACY

Tests were performed at hospital by healthcare professionals
and diabetic patients. Fresh capillary finger whole blood
samples were tested with the GlucoAlpha™ Enhance System;
plasma samples from the subjects were tested with YSI
Model 2300 Glucose Analyzer as reference. The results are
shown in the following table.

Slope 1.003

y-intercept -1.07 mg/dL ; -0.06 mmol/L

Correlation Coefficient (R) 0.991

Number of tests 150

Range tested 84 - 489 mg/dL ; 4.7 - 27.2 mmol/L

SYMBOLS CONVEY

Information Essential For Proper Use

For in vitro diagnostic use.

Lot number

Use by /Expiry date

Temperature limitation / Store at

Do not reuse

Please consult instructions for use

Caution, consult accompanying document

Manufacturer

EC representative

This product fulfils the requirements of Directive
98/79/EC in vitro diagnostic medical device.

TAKING CARE OF YOUR METER

REPLACING THE BATTERY

The GlucoAlpha™ Enhance Blood Glucose Meter comes with a
battery (pre-installed when new purchasing).

Battery life will vary depending on usage, so always keep a
spare on hand.

The battery should last about 12 months when testing 3
times a day. When the battery symbol (FIG. ) 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
flashing on the display, the meter will no longer give results
and you must replace the battery immediately.

TO REPLACE THE BATTERY

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.

4. Remove the old battery and insert the new 3¬ volt Lithium
battery (CR2032) into the battery compartment, being
sure to align the plus (+) and minus (-) signs correctly.

5. Slide battery compartment door closed. Check to see that
your meter is working. If it fails to turn on, the battery
may have been inserted incorrectly. Remove the battery
and reinsert it.

NOTE: EVERY TIME WHEN YOU REPLACE THE BATTERY, THE
METER WILL TURN ON AUTOMATICALLY AND ENTER TO THE
TIME/DATE SETTING. PLEASE SET CORRECT TIME AND DATE
BEFORE TESTING.

CLEANING

Clean the outside of the meter with a soft cloth, slightly
dampened with water. Do not get moisture into the strip slot
and data port.

STORAGE AND HANDLING

Keep your meter free of dust. Protect it from extreme
temperature and humidity.

CUSTOMER SERVICE

Distributed by

IN4 Technology Corporation

www.in4-technology.com

HMD BioMedical Inc.

No. 257, Sec. 1, Chunghwa Rd., Hsinchu 300,Taiwan

Zengqing Jian

Maire-Baum-Str.3, D-76137 Karlsruhe, Germany

3K-02-223031 (Sept.2007)