AC-803 Blood Glucose Meter
User Manual
INTRODUCTION
Thank you for choosing AC-308 Blood Glucose Meter. The Meter associated with the AC-308
Blood Glucose Test Strip is designed to quantitatively measure the concentration of glucose in
capillary whole blood by persons with diabetes or by healthcare professionals for monitoring
glucose at home or in healthcare facilities.
Please read this manual before using your AC-308 Blood Glucose Meter. If you have any
questions or requirements, please contact us or your local distributor.
Table of Contents
- ABOUT THE METER
3
- AC-308 BLOOD GLUCOSE METER AND LCD WINDOW
5
- AC-308 BLOOD GLUCOSE TEST STRIP
6
- SETTING METER PARAMETERS
7
- PREPARING FOR BLOOD SAMPLING
7
- CHECKING THE CODE
8
- PERFORMING A TEST WITH AC-308 BLOOD GLUCOSE TEST STRIP
9
- UNDERSTANDING YOUR TEST RESULT
11
- MEMORY RECALL
12
- CONTROL SOLUTION (OPTIONAL)
13
- METER SPECIFICATIONS
14
- TAKING CARE OF YOUR METER
15
- DISPOSING YOUR METER
19
- DISPLAYING MESSAGES AND TROUBLESHOOTING
20
ABOUT AC-308 METER
Intended Use
The AC-308 blood glucose meter is designed
to quantitatively measure the concentration of
glucose in capillary whole blood by people
with diabetes or by healthcare professionals
for monitoring blood glucose at home or in
healthcare facilities.
The device is an over-the-counter device
indicated for professional use and for home
use.
The meter is for quantitative blood glucose
testing with AC-308 blood glucose test strips.
About the Meter
The AC-308 blood glucose meter uses the
biosensor technology in blood glucose
monitoring to provide you with easy and
comfortable testing. It requires only 0.8μL
blood sample to complete the testing in just 5
seconds.
Important Information
The AC-308 blood glucose meter is
intended for in vitro diagnostic use with
capillary whole blood. The meter should not
be used for diagnosis of diabetes or for
testing newborn infant (neonatal testing).
- Caution
- The user should not take any decision of
medical relevance without first consulting
with his or her medical professionals.
- Call your doctor immediately if you
experience symptoms that are not
consistent with your blood glucose test
results.
- Severe dehydration or excessive water loss
may cause false results. Call your doctor
right away if you believe you are suffering
from dehydration.
- A red blood cell count (hematocrit) that is
either very high (over 65%) or very low
(under 25%) may cause false result
- Operating temperature outside the range
of 10°C to 40°C (50°F to 104°F) may affect
the test results.
- Interferences: Acetaminophen, Dopamine,
L-DOPA, Ibuprofen, Salicylate, Bilirubin,
Creatinine, Cholesterol, Triglycerides, Uric
acid, EDTA, Galactose, Gentisic acid,
Glutathione, Haemoglobin, Heparin,
Maltose, Methyl-DOPA, Tolbutamide,
Tolazamide, Xylose, Pralidoxime Iodide and
Icodextrin (when occuring in normal or
therapeutic concentrations) do not
significantly affect results. However,
abnormal high concentrations of
substances, such as Acetaminophen,
Salicylate, Uric acid, and other reducing
substances in blood may cause inaccurate
high results.
- Intravenous administration of ascorbic acid
which results in blood concentration of
ascorbic acid >3 mg/dL will cause
overestimation of blood glucose results.
- The diabetes who accept xylose absorption
test please do not use the YourPal series
Blood Glucose meter and test strips,
because xylose could lead to high test
results.
- The Package of the AC-308 Blood Glucose
Meter contains:
- AC-308 Blood Glucose Meter
- Lancing Device
- 3V Lithium Battery (CR2032)
- User Manual
- Carrying Case
NOTE: PLEASE MAKE SURE THAT ALL
PRODUCTS LISTED ON THE “CONTENTS” OF
THE BOX ARE CONTAINED IN THE PACKAGE
BEFORE USING THIS METER. IF YOU FIND
ANY IMPERFECTION IN OUR PRODUCTS,
PLEASE RETURN THE ENTIRE PACKAGE TO
THE PLACE OF PURCHASE.
AC-308 BLOOD GLUCOSE
METER AND LCD WINDOW
Study the meter by reading the diagram.
- DISPLAY : The large, easy to read display shows
blood glucose results, messages, glucose results
stored in memory, time and date.
- "M" BUTTON : Press to enter memory mode to recall
the information stored in meter's memory and to
increase values in the setting mode.
- STRIP SLOT : Holds a Test Strip or Check Strip in
place when you perform blood glucose test or
perform check tests
- ATTERY COMPARTMENT : Holds ONE 3V Lithium
battery. The battery is not installed into meter when
newly purchased. Please install the battery first
before use.
- Meter Label : Label of the Meter.
- TEST RESULT
- DATE: Month/Date
- DAY AVG Appears when the meter
is in the memory mode while
recalling 7/14/21/28 day test averages.
- TIME: 24 hour period format.
- BATTERY SYMBOL: Appears when battery is low
- SYMBOL: “Keto” symbol appears when the blood
glucose concentration is above 17.8 mmol/L (320 mg/dL). This
simply suggests that a ketone test is recommended. Consult
your healthcare professional about testing for ketones;
“Hypo” symbol appears when the blood glucose
concentration is below 3.9 mmol/L (70 mg/dL).
- mg/dL / mmol/L: Results are displayed as mg/dL or mmol/L
- SYMBOL: The test can be adjusted and stored into 3
types of test modes - BEFORE MEAL TEST (AC ), AFTER
MEAL TEST (PC ), and CONTROL SOLUTION TEST (QC ).
- This display shows to ensure that all digits are working
properly.
- appears when reading previous results
- CODE: Code appears to indicate code number when it's ready
to test.
- THERMOMETER SYMBOL: Appears when ambient temperature
is outside the acceptable range needed for testing.
- STRIP SYMBOL: Appears when the test strip is inserted and
meter is ready for blood testing. Recap the vial immediately
after removing test strips.
AC-308 BLOOD GLUCOSE TEST STRIP
- Sampling Port: apply the blood to either
side of strip.
- Detection Zone: make sure the part is
filled up with blood to ensure the correct
results.
- For example:
- Electrode End: insert the end of test strip
into meter.
- IMPORTANT INFORMATION
- Do not use damaged test strips or test strips
changed in any way. Use test strip immediately
after removing it from the vial. Recap the vial
immediately and close it tightly
- AC-308 Blood Glucose Test Strips are
intended for in vitro diagnostic use with
capillary whole blood or control solution.
Results will not be accurate if used with plasma
or serum samples.
- AC-308 Blood Glucose Test Strip can be
damaged by heat and light. Keep them sealed
in the original vial. Keep the vial in a cool, dry
place below to 30℃/86℉and above 5℃/41℉.
- Do not use test strips beyond the expiration
date indicated on the vial. The discard date for
test strips is three (3) months after first
opening the vial. Record the discard date on
the vial, when you open a new one.
- For single use only.
- Do not carry loose test strips in your carrying
case
SETTING METER PARAMETERS
Setting Date, Time
When the battery is installed the first time or
every time it's replaced, the meter will
automatically enter the setting mode. Please
set the current time and date before you begin
testing.
- To set the time and date
- Press "S" button for 2 seconds to turn on
the meter. The meter will enter the setting
mode automatically
- The year flashes at the sound of beep, for
example for the year of 2017, number "17"
will flash.
- Press "S" button to obtain the
desired year.
- Press”M”button to
confirm and shifts to the next setting.
- Repeat to set the month, date, hour and
minute.
- After minute is set, the meter will
display "OK" before turning off.
Prepare for Blood Sampling Adjustable
Lancing Device
- Used with lancet to obtain a blood sample.
- Depth adjustment Cap
- Depth Selector
- Lancet Holder
while disposing
- Cocking Control
- Release Button
- Exit Button
Lancet
Used with lancing device to obtain a blood
sample.
Protective cap
- Important Information
- Lancet is for single use only
- Keep lancing device and lancets clean.
- Use caution when removing the used lancet
from the device and disposing.
- The lancing device and lancets are in
conformity with MDD 93/42/EEC. Refer to
product labels for contact information of
- Release Button
- Exit Button
ADJUSTABLE LANCING DEVICE
CHECKING THE CODE
- Before you perform your first blood glucose test
or every time you open a new box of test strips,
you need to verify that the meter “matches” the
strips.
- Insert the test strip into the meter in the
direction of the arrows. The meter turns
on and beeps. The code number appears
briefly
- Make sure the code number on the
display matches the code number on the
test strip container.
PERFORMING A TEST WITH AC-308 BLOOD GLUCOSE TEST STRIP
Wash your hands in warm, soapy water. Rinse and dry
completely. Warm your fingers to increase blood flow. Remove
a new test strip from vial. Be sure to tightly re-cap the vial after
removing test strips. Insert test strip immediately into strip slot
as illustrated. The meter turns on automatically
. Check that the code number in the meter matches the code on the
vial of test strips you are using
When the symbol flashes, you are ready to perform a test
Use the lancet loaded in lancing device to obtain a drop on the side
of your finger. 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 0.8μL
of blood sample.
Apply the blood sample to the right or left edge of the test strip in a
way that is comfortable to you. Make sure that the blood drop has
saturated the test confirmation window. When blood is applied to the
strip, a line moves on the display until measurement is completed.
Your result will show up in 5 seconds, and it is automatically
recorded in the meter’s memory. You may also want to record the
result in your logbook.
7. If the test is being done within 2 hours after meal, press“S”button to
change the setting from AC to PC (9.2).If the test is a control
solution test, press“S”button again to change the setting from PC
to QC (9.1).
NOTE: IF A TEST IS SET AS “QC ”, THE RESULT WILL NOT BE
CALCULATED INTO AVERAGES.
After testing is complete , remove the test strip from the meter.
Discard the strip and lancet safely in a puncture resistant container.
The meter has risk indicator function. If is displayed, your
blood glucose result may be higher than 320 mg/dL (17.8mmol/L).
If is displayed, your blood glucose result may be lower than 70
mg/dL(3.9mmol/L). The testing range of the meter is from 20 to 600
mg/dL(1.1-33.3mmol/L). If HI is displayed, your blood glucose result
may be higher than 600 mg/dL(33.3mmol/L). If LO is displayed,
your blood glucose result may be lower than 20 mg/dL(1.1mmol/L)
- UNDERSTANDING YOUR TEST RESULT-NORMAL BLOOD
GLUCOSE RANGE
- The normal blood glucose range is 70 to 100 mg/dL (3.9 to 5.6 mmol/L) for fasting and
less than
140 mg/dL (7.8 mmol/L) for two hours after meals for a non-diabetic adult. Consult your
healthcare
professionals 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 followings:
- Does the code number on the test strip vial match the code number on the meter?
- Was the blood sample applied to the test strip immediately after removing it from the
vial?
- Was the size of the blood sample sufficient?
- Was the test strip vial cap tightly sealed?
- Were the test strips expired?
- 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 control solutions and a new test
strip. 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.
- REFERENCE
- Stedman, Thomas Lathrop. Stedman’s Medical Dictionary, 28th Edition, 2006, pg. 2082
- D'Orazio et al.: IFCC Recommendation on Reporting Blood Glucose Results; Clinical
- MEMORY RECALL
- The AC-308 Blood Glucose Meter can automatically store up to 180 results
and automatically calculate
your average results of 7-, 14-, 21-, 28- days on both AC and PC.
When recalling the results, each single result appears from the latest to the earliest with
corresponding
time and date.
To Recall Results Stored in Memory
- Turn meter on by pressing "M" button until you hear a beep sound.
The first result displayed on the screen is your latest test result .
12 represents the 12th record of the overall results on this meter
- By pressing "M" button, you will see your test record from the
most recent to the oldest.
- Press the "S" button to view the average results. "03" represents
within the past 7 days there were 3 AC test results. Press the "S"
button continuously to view the average results sequentially for
7, 14, 21 and 28 days
- Please press "M" button for 2 seconds to EXIT or put it aside
for 3 minutes for auto shutdown.
- CONTROL SOLUTION (OPTIONAL)
- Control Solution is used to check if AC-308
Blood Glucose Meter and AC-308 Blood
Glucose Test Strips are working together
properly as a system. Control Solution can be
used in two ways:
- To practice the test procedure.
- To make sure that the AC-308 Blood Glucose
Meter and AC-308 Blood Glucose Test Strips are
working together properly.
- IMPORTANT INFORMATION
- Do not use control solution beyond the
expiration date indicated on the bottle label.
- The discharge date for control solution is 90
days after first opening. Record the discard
date on the bottle, when you open a new
bottle of control solution.
- Store the control solution closed at
temperature range of 5ºC-30ºC (41ºF-86ºF).
METER SPECIFICATIONS
1
|
Assay
Method
|
Electrochemical biosensor
|
2 |
Sample Size
|
0.8μL
|
3 |
Operating
Temp. Range |
10℃ - 40℃
(50℉~104℉)
|
4 |
Operating
Relative Humidity |
20% - 80%
RH
|
5 |
Acceptable
Hematocrit Range |
25~65%
|
6 |
Measuring
Range |
20 - 600
mg/dL or 1.1 - 33.3 mmol/L
|
7 |
Measuring
Time |
5 seconds
|
8 |
Memory
Capacity |
180 test
results with time and date
|
9 |
Power
Supply |
One 3V
Lithium Battery(CR2032)
|
10 |
Battery
Life |
Approximately 1000 tests
|
11 |
Test Result
|
Plasma
glucose
|
12 |
Test Sample
|
Capillary
whole blood from adults only
|
13 |
Automatic
shut-off |
In 3
minutes
|
14 |
Meter storage conditions
|
Temperature:
Humidity:
-25ºC to 70ºC
20% - 80% RH
|
|
- Electromagnetic Compatibility
- It is the manufacturer's responsibility to provide
equipment electromagnetic compatibility
information to the customer or user.
- It is the user's responsibility to ensure that a
compatible electromagnetic environment for
the equipment can be maintained in order that
the device will perform as intended.
- This product complies with the emission and
immunity requirements of EN/IEC 61326-2-6
and EN/IEC 61326-1.
- This equipment has been designed and tested
to CISPR 11 Class A. In a domestic environment
it may cause radio interference, in which case,
you may need to take measures to mitigate the
interference.
- Before using the equipment, the electromagnetic environment should be
evaluated prior to
operation of it.
Do not use this equipment in close proximity to
sources of strong electromagnetic radiation(e.g. unshielded intentional RF sources), as
these can interfere with the proper operation
- TAKING CARE OF YOUR METER
- When the meter is dirty, please clean it by
wiping gently with a cotton swab or cloth.
Avoid use powder to clean meter.
- This instrument should not be subjected to
extremes in temperatures, humidity, direct
sunlight, shock or dust.
- REPLACING THE BATTERY
- The AC-308 blood glucose meter's battery
life will vary depending on usage, so always
keep a spare available.
- The battery can last about 18 months when
testing 2 times a day, total 1000 tests.
- When the battery symbol appears on the
meter display, it means battery is getting low.
(FIG. A)
- 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. (FIG. B)
- NOTE:
- ·EVERY TIME WHEN YOU REPLACE THE
BATTERY, THE METER WILL TURN ON
AUTOMATICALLY ENTERING THE TIME/ DATE
SETTING.
- PLEASE SET THE CURRENT TIME AND DATE
BEFORE TESTING.
- PLEASE REMOVE THE BATTERY IF YOU WILL
NOT USE THE METER OVER A LONG PERIOD
OF TIME.
TO REPLACE THE BATTERY
Make sure the meter is turned off. Let the front of the meter
rest in the palm of your hand. Slide battery compartment
door open.
Remove the old battery and insert the new 3V Lithium battery
into the battery compartment, with the "+" side facing up
Slide battery compartment door closed. Check to see if your
meter is working. If it fails to turn on, the battery may have
been inserted incorrectly. Remove the battery and reinsert
it as illustrated.
- CLEANING METER
- Caring for your AC-308 Blood Glucose Meter is easy - just keep it free of
dust. If you need to
clean it, please follow the guidelines below carefully to help you get the best performance :
- Do:
- Make sure the meter is turned off
- Gently wipe the meter surface with a soft cloth slightly dampened with 75% medical
alcohol.
- Make sure that you squeeze off excess liquid from the cloth before you wipe the meter's
surface
- Do Not:
- Get any moisture in the code chip slot or test strip slot
- Spray any cleaning solution directly onto the meter
- Put the meter under water or liquid
- Pour liquid into the meter
- STORAGE AND HANDLING
- Keep your meter free of dust. Protect it from extreme temperature and
humidity
- DISPOSING YOUR METER
- During blood glucose measurement the meter itself may come into contact
with blood. Used
meters may carry a risk of infection. Please dispose your used meter properly after removing
the battery according to the regulations applicable in your country. For information about
correct disposal please contact your local council and authority.
The meter falls outside the scope
of European Directive 2012/19/EU (Directive on waste
electrical and electronic equipment (WEEE)).
- DISPLAYING MESSAGES AND TROUBLESHOOTING
- As listed below are problems that may appear with your AC-308 Blood
Glucose Meter when performing a test. These messages will help you to identify certain problems. If you
have any concerns or see
any other error display, please contact us or the local distributor for help.
- NOTE:
If there is any error message
displayed but not listed here, or
your meter shuts down for no
reason, you can reset the meter
or replace the battery.
DISPLAY
|
DESCRIPTION
|
ACTION TO TAKE
|
|
Display
check
|
If some
parts of the display do not work Contact your local distributor for help
|
|
Blood
glucose result may be higher than 33.3 mmol/L or 600 mg/dL. |
If this is
not confirmed by the way you feel, review proper testing procedure and
perform a quality check with control solution. Repeat blood test, if “HI”
still appears, call your doctor’s immediately
|
|
Blood
glucose result may be
lower than 1.1 /L or 20 mg/dL |
If this is
not confirmed by the way you feel, review proper testing procedure
and perform a quality check with control solution. Repeat blood test. If
“LO”
still appears, call your doctor’s immediately
|
|
Temperature
is above or below the operating range of test strips |
The result
you have obtained may not be accurate. Move to an area with
temperature between 10ºC to 40ºC (50ºF - 104ºF). Do not artificially heat or
cool the meter
|
|
Battery is
dead. |
Change
battery now
|
|
Test strip
may be damaged or test was not performed correctly |
Perform the
test with new test strip and follow the test procedure correctly
|
|
Test strip
is used |
Perform the
test with a new test strip only
|
No
responses when strip is inserted into the meter |
PowerMaybe:
1. Battery is dead
2. Wrong strip is inserted
3. Meter is defective |
You have
to:
1.Replace battery
2.Insert the test strip correctly
3. Contact us for help
|
No responses when blood
sample is applied to the strip |
Maybe:
1.Blood sample is not sufficient
2.Meter is defective |
You have to:
1. Repeat test with sufficient sample
2. Perform Meter Quality Check by inserting check strip。
|
|
SYMBOLS CONVEY
For in vitro diagnostic
use
Temperature
limitation/Store at
Authorized
representative
Humidity limitation
/store at
Please consult instructions for use
Caution,consult accompanying
document
Discarded glucose meters and
batteries must be discarded in
containers labelled with WEEE.
Please comply with local regulations
and take appropriate protective
measures to dispose off all wastes