All Medicus metene AGM-513S User manual

This summary is intended only as a
quick reference and is not a substitute
for Blood Glucose Monitoring
System User Manual. Please read the
entire User Manual before you begin
the test.
TEST SUMMARY
Check the expiration date
printed on the strip vial
label.
Insert a test strip. The
meter will
automatically turn on.
The blood glucose
result will be displayed
on the meter in just
5 seconds.
Apply the blood drop to
the side edge of the
yellow window of the test
strip.
Wait for the blood drop to
completely ll the yellow
window of the test strip
and then the meter will
begin the countdown.
Remove the battery
cover and put the
battery with “+” sign
facing up.
Lot No.:
Exp. Date:

Test Principle
The Blood Glucose Monitoring System is based on measurement of electric currents caused by
the reaction of glucose with the reagents on the gold electrode of the test strip. The blood sample is
drawn into the test strip's reaction chamber through capillary action. Glucose in the sample reacts with
glucose dehydrogenase and mediator on the test strip. This reaction creates electric currents. The
consequent electric currents are proportional to the glucose concentration in the blood and converted
to the equivalent glucose concentration by the algorithm programmed in the Meter.
LIMITATION
- The Blood Glucose Monitoring System is only for use with capillary whole blood.
- Inaccurate results may occur when in shock, hypotensive, hyperglycemic, or hyperosmolar state and with
or without ketosis.
- The Blood Glucose Monitoring System should not be used in critically ill patients, patients in
shock, dehydrated patients or hyper-osmolar patients.
- The Blood Glucose Monitoring System should not be for diagnosis of or screening for diabetes
mellitus.
Blood Glucose Monitoring System is intended to be used for the quantitative measurement
of glucose (sugar) in fresh capillary whole blood from ngertip. Blood Glucose Monitoring
System is intended to be used by a single person and should not be shared. It is intended for self-testing
outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the
eectiveness of diabetes control.
Blood Glucose Monitoring System should not be used for the diagnosis of or screening for
diabetes. Blood Glucose Monitoring System is not for use in neonates.
Blood Glucose Test Strips are for use with Blood Glucose Meter to quantitatively
measure glucose (sugar) in fresh capillary whole blood samples drawn from the ngertips.
Control Solution is for use with Blood Glucose Meter and Test Strips to check that
the meter and test strips are working together properly.
Intended Use
PRECAUTIONS

- A hematocrit that is either very high (above 65%) or very low (below 20%) can cause false test results.
- Not for neonatal use.
- Dehydration may cause higher test results.
- The system has not been tested above 10,000ft.
- The Meter is designed for use only with Test Strips.
(manufactured by All Medicus Co., Ltd.)
- The Blood Glucose Monitoring System is calibrated to produce values equivalent to the
results on plasma specimens on a laboratory analyzer (YSI 2300 STAT Plus).
-The Blood Glucose Monitoring System should be used for 50~104℉(10~40℃).
- The Blood Glucose Monitoring System is for in vitro diagnostic use.
-Do not drop the meter.
-Do not disassemble, repair or remodel without consultation. The sensitive parts could be damaged
and the warranty will then become invalid.
- Handle all the reagents with care knowing that they are capable of transmitting infection.
- Used test strips, lancets and meter may be considered bio-hazardous waste in your area. Please contact
your health provider for instructions on how to discard them.
- The Blood Glucose Monitoring System are for single patient use only and for over the
counter use.
Carefully read and follow the instructions in the User Manual and package inserts for the test strips and
control solution and practice the testing procedures before using the Blood Glucose
Monitoring System. It is very important to follow the instructions in order to avoid an incorrect test
result that leads to improper therapy.
Take note of information and cautions throughout this User Manual.
This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician oces,
or long-term care facilities because it has not been cleared by FDA for use in these settings, including for
routine assisted testing or as part of glycemic control procedures.
Use of this device on multiple patients may lead to transmission of Human Immunodeciency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.
Precautions for Use

Safekeeping
- Store the Meter in a room temperature between 32~104ഘ(0~40ഒ).
- Store the Meter where relative humidity is between 15~85%.
- Keep the Meter in sanitary environment.
- Keep the meter away from direct sunlight for a long time.
- Keep the test port away from dirt, blood or water.
- Do not store your meter and test strips in the car, the bathroom, or the refrigerator.
(sensitive to temperature and humidity)
- Keep the meter, test strip vials and lancing materials away from children.
- The meter should be strictly kept away from contact with liquids, except for cleaning and disinfecting
the meter. Please refer to the section entitled “Caring for your Blood Glucose Monitoring
System”for additional information.
If the meter does not work properly and you have followed the storage and
handling instructions in this User Manual, contact your healthcare provider.
- Use the test strip immediately after removing it from the vial.
- Use all the test strips within 4 months after the rst opening.
- Store test strips only in their original vial and do not transfer them to a new bottle or any other container.
- Do not touch the test strip with wet hands.
- Do not use the test strip beyond the expiration date printed on the vial.
- Do not bend, cut, or damage the test strips.
Precautions for Test Strip
- Store test strip vials in the place with temperature between 36~86℉(2~30℃) and humidity of 15-85% RH.
- Avoid direct sunlight, heat and excessive humidity.
- Always close the vial cap immediately after removing a test strip from the vial. If the test strip vial is left
open for a long time, the test strips will become unusable.

Reports of Hepatitis B virus infection outbreaks linked to multiple people sharing glucose meters have
been increasing. This notice serves as a reminder that use of this device on multiple patients may lead to
transmission of Human Immunodeciency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV),
or other bloodborne pathogens.
“FDA Public Health Notication: Use of Fingerstick Devices on More than One Person Poses Risk for
Transmitting Bloodborne Pathogens: Initial communication Update 11/29/2010”
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm224025.htm
“CDC Clinical Remider: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens”(2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
For single patient - home use
1. Do not share the system with anyone.
2. All parts of the kit are considered bio-hazardous and can potentially
transmit infectious diseases, even after you have performed cleaning and
disinfecting.
3. Always use a new, sterile lancet. Lancets are for single use only.
4. Please refer to page 25-30 of this manual for cleaning and disinfecting
your Blood Glucose Monitoring System.
8"3/*/(
IMPORTANT SAFETY INSTRUCTIONS

• Getting Started
l 11
l 31
Installing Battery l 36
LinkDr. 2.0 l 38
• Before Testing
•
Performing the Blood Glucose Test with
• Using the Meter Memory Function
• Setting Meter
• Caring for Meter
• Data Transfer
Display Message Guide l 39
Troubleshooting Guide l 45
Specications l 46
Performance Characteristics l 47
• Additional Information
Entering the EVENT RECORD MODE l 18
Understanding Your Test Results l 20
Recalling the Previous Test Results l 22
Caring for your Blood Glucose Monitoring System l 25
Checking Your System with Control Solution l 06
Blood Glucose Monitoring System l 01
Meter l 02
Meter LCD Display l 04
Test Strip l 05
Table of Contents

- Test results, icons, symbols and simple messages appear here.
LCD Display
Power Button
- Turn the meter on/o.
- Enter into SET MODE while pressing the power button for more
than 3 seconds.
- Delete all the stored test results in the AVERAGE MODE.
- Delete each test results in the MEMORY MODE.
Test Port
- Insert the Test Strip for testing. Then the meter turns
on and BLOOD DROP ICON will blink.
</> Button
- Recall the stored test result in the MEMORY MODE.
- Select an event in the EVENT RECORD MODE.
- Change the date, time and options in the SET MODE.
Meter 2

Battery Cover
Micro USB Port
- Transfer your test results from the
meter to a computer.
Test Strip Eject Button
3

Meter LCD Display
4
BATTERY LIFE.
SET MODE.
AVERAGE MODE.
MEMORY MODE.
MEMORY NUMBER.
The meter displays the current memory order number in the MEMORY MODE.
STRIP ICON.
When the STRIP ICON blinks, insert a test strip to the meter.
BLOOD DROP ICON.
When the BLOOD DROP ICON blinks, apply blood sample.
TEMPERATURE ICON.
When the meter is not used at a recommended temperature range, "Er1" and TEMPERATURE ICON appear.
CURRENT TIME and TEST TIME in the MEMORY MODE.
CURRENT DATE and TEST DATE in the MEMORY MODE.
UNIT OF MESUREMENT.
EVENT ICON.
If you choose an event icon which correlates to test results, it helps to manage glucose level more eectively.
ALARM.
You can set up to four dierent alarms. Each alarm rings for 10 seconds.
HYPERGLYCEMIC, HYPOGLYCEMIC WARNING ICON.
CONTROL SOLUTION ICON.
The meter automatically recognizes the dierence between the control solution and blood.
M A

- Hold this part to insert a test strip.
Grip
- Conrm if enough blood entered the conrmation window.
Conrmation window (Reaction chamber)
- Insert this part into the meter’s test port.
Gold electrodes
- Apply blood sample here; blood is absorbed automatically.
Yellow Side-edge
Test Strip
5

Control solution test is to check the performance of your meter and test strips.
Control Solution contains a measured amount of glucose that reacts with the
Test Strips.
The control solution test conrms that your meter and test strips are working correctly.
Compare your control solution test results with the range printed on the test strip vial
label. It is very important that you do this simple test routinely to make sure you get
accurate test results.
Check your system with the Control Solution under the following
situations.
- When you want to check the performance of the meter and test strip.
- When you leave your test strip vial cap open for a long time.
- When you open a new vial of test strips.
- When you think that the test results are not accurate.
- When you drop the meter.
- When you suspect your meter or test strips are not working properly.
- When your blood glucose test results are not consistent.
- Use only the Control Solution for the test.
- Check the expiration date printed on the control solution vial. Do not use
when the expiration date is expired. Discard the control solution on the
expiration date printed on the vial or three months after rst opening
whichever comes rst. When you rst open a new vial of the control solution,
count three months forward and write the expected discarding date on the
label of the control solution vial for your convenience.
- When using the Control Solution to examine the system, the measurements
should be tested within a temperature range of 10℃~ 40℃(50℉~ 104℉)
Checking Your System with Control Solution
6

- Do not drink the control solution.
- Tightly close the cap of control solution vial and store at 1ഒ~ 32ഒ
(34ഘ~ 90ഘ) after the test.
Do not force the test strip into your meter. This may cause malfunction.
- If the BLOOD DROP ICON does not appear, remove the test strip and insert it
again.
- If the BLOOD DROP ICON still does not appear, contact the manufacturer.
Do not use the test strip beyond the expiration date.
Check the expiration date printed on the test strip vial.

Insert a test strip, with the printed side facing up, into the test port of the
meter. Gently push it all the way in until it goes no further.
The meter will turn on automatically and beep. Then the BLOOD DROP ICON
will appear.
Insert a Test Strip

Lot No.:
Exp. Date:
7

To ensure accurate test results
- Gently shake the control solution (vial) to ensure the control solution is mixed
well before each test.
Apply the Control Solution

Slowly let the side edge of the yellow window of the test
strip touch the drop of the control solution. Once the conrmation
window lls completely, your meter will begin the countdown.
Prepare the control solution

Remove the vial cap and place it on a at surface with the top of the cap
pointing up. Squeeze the vial to discard the rst drop.
Squeeze a drop into the small well on the top of the cap or onto another
clean, non-absorbent surface.
Checking Your System with Control Solution
Your meter will display countdown from“5” to “1”,
then the test result will appear.
Test Result Appears in 5 seconds

8

The Control Solution range printed on the test strip vial is for the
Control Solution only. It is used to check the performance of your meter and
test strips. It is NOT a recommended range for your blood glucose level.
CONTROL SOLUTION ICON
Check the CONTROL SOLUTION ICON ‘ ’ to appear. If
CONTROL SOLUTION ICON ‘ ’ is not displayed, repeat the
test with a new test strip.
If the ICON ‘ ’still does not appear, contact your healthcare
provider.
Compare the control solution test result to the control solution range printed
on the test strip vial. The test result should fall within this range. Each vial of
test strips may have a dierent control solution range. If the test result you get
is not within this range, the meter and test strips may not be working properly.
Repeat the control solution test. Refer to the Test Strip Instruction for
the use.
* The image is only an
example of the control
solution range.
Compare Control Solution Test Results

Clean the top of the control solution cap with a clean, damp tissue or cloth.
Cleaning

Control
Solution 1
Control
Solution 2
102~138
(5.7~7.6)
298~402
(16.6~22.3)
9

All the control solution test results are recorded with CONTROL SOLUTION ICON
‘ ’to distinguish them from those of actual blood glucose tests in the meter
memory. Recorded control solution test results will not be calculated in your
result averages.
If your control solution test results continue to fall outside the range printed
on the test strip vial, the Blood Glucose Monitoring System may
not be working properly.
- If this is the case, do not use the system to test your blood glucose levels.
- Contact your healthcare provider and the manufacturer.
Out-of-range test results may be caused by one or more of the followings:
- Expired or contaminated control solution,
- Expired or damaged test strip,
- Use of control solution or test strip past its discarding date,
- Error in performing the test,
- Failure to shake the control solution vial well,
- Meter, test strips or control solution are kept too warm or too cold,
- or Meter malfunction
10
Checking Your System with Control Solution

Performing the Blood Glucose Test with
Meter
Test Strip
Lancing Device
Lancets
11

- Before using the lancing device, wash your hands in warm water with soap.
Make sure to rinse and dry them thoroughly. Perspiration, dirt or water remaining
on your hands may cause incorrect test results.
- Avoid using hand lotion or any other oily products before using the lancing
device.
Turn the cap of the lancing device counter-clockwise to remove the cap.
Remove the cap
Insert the lancet rmly into the holder until it comes to a full stop. When the
lancet is placed in the lancing device, twist o the protective disk of the lancet.
Do not discard the protective disk of the lancet; it will be used to dispose the
lancet safely after its use.
Insert a Lancet into the Lancet Holder.
Turn the cap of lancing device clockwise until it ts.
Replace the cap



Getting a blood sample from the ngertip
Preparing the Lancing Device (For single patient – home use)
12
Performing the Blood Glucose Test with