All Medicus GlucoDr SuperSensor User manual

A212DA305
06/2015
AGM-2200
BLOOD
GLUCOSE
MONITORING
SYSTEM
User Manual
Blood Glucose Monitoring System
#7102~7107, #7402, #7403, #7406, 140,
Beolmal-ro, Dongan-gu, Anyang-si,
Gyeonggi-do 431-804 REPUBLIC OF KOREA
www.allmedicus.com
Manufactured by
All Medicus Co., Ltd.
EU Representative
MT Promedt Consulting GmbH
Altenhofstr. 80, D-66386 St. Ingbert, Germany
Tel.: +49 6894 - 58 10 20

This summary is intended only as a
quick reference and is not a substitute
for GlucoDr SuperSensor Blood Glucose
Monitoring System User Manual.
Please read the entire this User
Manual before you begin testing.

TEST SUMMARY
Check the code number.
Press the power button to
turn on the meter. Check
the code number. The code
number displayed on the
meter must match the one
on the test strip vial.
Insert a test strip.
The meter will
automatically turn on.
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, then the
meter will begin the
countdown.
The blood glucose
result will be
displayed on the
meter in just
10 seconds.
02


This User Manual will tell you all you need to know
about the system and how it works.
Please read this carefully before using the meter.
“Thank you for using
Blood Glucose Monitoring System”

Test Principle
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 in the test strip. This reaction creates electrical
currents. The electrical currents produced are proportional to the glucose concentration in the blood
and converted to the equivalent glucose concentration values calculated based on the algorithm
programmed in GlucoDr SuperSensor Meter.
- The GlucoDr SuperSensor Meter is designed for use with GlucoDr SuperSensor Test Strips
(manufactured by All Medicus Co., Ltd.) only.
- The GlucoDr SuperSensor Blood Glucose Monitoring System is calibrated to produce values equivalent to
results on plasma specimens obtained from a laboratory analyzer (YSI 2300 STAT Plus).
- The GlucoDr SuperSensor Blood Glucose Monitoring System should not be used for the diagnosis of diabetes .
Precautions for Use
For Self-testing: GlucoDr SuperSensor Blood Glucose Monitoring System is for quantitative blood glucose
testing
in fresh capillary whole blood drawn from the ngertips, palm, arm, thigh, and calf. The GlucoDr
SuperSensor Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The
GlucoDr SuperSensor Blood Glucose Monitoring System is intended for use by diabetic lay users for self testing
to improve management of their blood glucose level. The GlucoDr SuperSensor Blood Glucose Monitoring
System should not be used for the diagnosis of or screening of diabetes mellitus, or for neonatal use.
For professional use: GlucoDr SuperSensor Blood Glucose Monitoring System is for quantitative blood
glucose testing in venous, arterial whole blood and fresh capillary whole blood drawn from the ngertips,
palm, arm, thigh, and calf. The GlucoDr SuperSensor Blood Glucose Monitoring System is for testing outside
the body (in vitro diagnostic use). The GlucoDr SuperSensor Blood Glucose Monitoring System is intended
for use by healthcare professionals to improve management of patient’s blood glucose level. The GlucoDr
SuperSensor Blood Glucose Monitoring System should not be used for the diagnosis of or screening of
diabetes mellitus, or for neonatal use.
Intended Use

PRECAUTIONS

Precautions for Test Strip
- Store test strip vials in dry place with temperature ranging between 1~32℃(34~90℉).
- 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.
- Use the test strip immediately after removing it from the vial.
- Use all the test strips within 4 months after the rst opening.
- Store your test strips only in their original vial and do not transfer them to a new bottle or any other
container.
- Do not handle the test strip with wet hands.
- Do not use the test strip after the expiration date printed on the vial.
- Do not bend, cut, or alter the test strips.
- Do not insert the same test strip into the test port multiple times. It can lead to an improper operation.
Safekeeping
- Store the GlucoDr SuperSensor Meter at a temperature between 0~40℃(32~104℉).
- Store the GlucoDr SuperSensor Meter at a place where relative humidity is less than 85%.
- Keep the GlucoDr SuperSensor Meter in sanitary environment.
- Keep the meter away from direct sunlight.
- 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.
- Clean the outside of the meter using a moist (not wet) cloth or tissue with isopropyl alcohol or mild
detergent with water. Do not immerse the meter in water or other liquid.
-
Rapid change in temperature may cause inaccurate test results in reading. When taking the meter from
cold to warm area or from warm to cold area, let the meter sit for about 30 minutes to adjust to the
room temperature.
- 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.
- A hematocrit that is either very high (above 60%) or very low (below 20%) can cause false test results.

·
Getting Started
l 17
l 26
Installing Battery l 31
Display Message Guide l 33
Troubleshooting Guide l 38
Specications l 39
Performance Characteristics l 40
Explanation of Symbols l 41
·
Before Testing
·
Performing the Blood Glucose Test with GlucoDr SuperSensorTM
·
Using the Meter Memory Function
·
Setting the Meter
·
Caring for GlucoDr SuperSensorTM Meter
·
Additional Information
Table of Contents
Entering the EVENT RECORD MODE l 21
Understanding Your Test Results l 23
Recalling the Previous Test Results l 24
Checking the Code Number l 06
Checking Your System with GlucoDr SuperSensorTM Control Solution l 09
Preparing the Lancing Device l 14
GlucoDr SuperSensorTM Blood Glucose Monitoring System l 01
GlucoDr SuperSensorTM Meter l 02
GlucoDr SuperSensorTM Meter LCD Display l 04
GlucoDr SuperSensorTM Test Strip l 05

GlucoDr SuperSensorTM Blood Glucose Monitoring System

Carrying case
User Manual
GlucoDr SuperSensorTM Meter
GlucoDr SuperSensorTM Test Strips
Battery
Lancing Device
Lancets
Upon request of distributor, actual package may consist of all
or part of items described above.

GlucoDr SuperSensorTM Meter

- Test results, icons, symbols and simple messages appear here.
LCD Display
Side Buttons
Power Button
- Turn the meter on/o.
- Enters into dierent MODEs while pressing the power button.
(2 seconds : CODE MODE, 5 seconds : SET MODE)
- Delete all stored test results in the MEMORY MODE.
(UP Button ▲& DOWN Button ▼)
- Change the code number in the CODE MODE.
- Recall the stored test result in the MEMORY MODE.
- Select an event in the EVENT RECORD MODE.
- Change the date and time in the SET MODE.
Test Port
- Insert the GlucoDr SuperSensor Test Strip for testing. Then the
meter turns on and displays the code number automatically.

Battery Cover
Data Port
- Transfer your test results from the meter
to a computer.


GlucoDr SuperSensorTM Meter LCD Display

Battery life.
SET MODE.
AVERAGE MODE.
MEMORY MODE.
CODE MODE.
MEMORY and CODE NUMBER.
The meter displays the current memory order number in the MEMORY MODE.
The meter displays the current code number in the CODE 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.

GlucoDr SuperSensorTM Test Strip

- Hold this part to insert or remove test strip.
Grip
- Make sure the conrmation window lls completely.
Conrmation window (Reaction chamber)
- Insert into test port.
Gold electrodes
- Apply blood sample here; blood is absorbed automatically.
Yellow Side-edge

Code numbers are used to calibrate your meter with the test strips for accurate test results.
Whenever you test, you must check if the code number displayed on the meter matches
the one on the test strip vial.
Checking the Code Number

Press the power button to turn on the meter.
Then the code number, STRIP ICON and BLOOD DROP ICON will appear.
Turn on the Meter
Make sure that the code number displayed on the meter matches the one on
the test strip vial. If the code numbers match, you can begin the test.
If they do not match, follow the next step.
Check the Code Number





You can enter the CODE MODE by pressing the power button for one second.
Then the code number blinks on the meter display.
Enter the CODE MODE

Use SIDE(UP/DOWN button) button to adjust the same code number printed
on your test strip vial.
Change the Code Number.

- Check the code number on the test strip vial before inserting the test strip.
-
You can not change the code number after the test strip is inserted into the test port.
- If you do not release the power button when the code number blinks, your
meter will go to SET MODE.


When the code number is correctly adjusted, press and release the power button.
A new code number will be saved and appear on the meter display.
Save the Code Number

- To change the code number faster, press and hold any of SIDE(UP/DOWN button)
buttons.

Control solution test is to check the performance of your meter and test strips. GlucoDr
SuperSensor Control Solution contains a measured amount of glucose that reacts with
the GlucoDr SuperSensor 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.
Checking Your System with GlucoDr SuperSensorTM Control Solution
9
Check your system with the GlucoDr SuperSensor 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 GlucoDr SuperSensor Control Solution for the test.
- Check the expiration date printed on the control solution vial. Do not use if the
expiration date is past. 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.
- The control solution, meter, and test strips should be kept at a room temperature
prior to the use.

- Do not drink the control solution.
- Tightly close the cap of control solution vial and store at a room temperature
after the test.
Do not force the test strip into your meter.
This may cause malfunction.
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 code number and the
BLOOD DROP ICON will appear. Make sure that the code number displayed on
the meter matches the one on the test strip vial. If the code numbers match,
you can start the test. If the code number on the meter doesn't match the one
on the test strip vial, adjust the code number on your meter. (see page 6-8)
Insert a Test Strip


02

Shake the control solution vial well. Prepare a drop of the control solution on a
clean plate. Slowly let the side edge of the yellow window of the test strip
touch the drop of the control solution following the nger symbol. Once the
conrmation window lls completely, your meter will begin the countdown.
Apply Control Solution
Your meter will display countdown from“10” to “1”, then the test result will
appear.
Test Result Appears in 10 seconds
To ensure accurate test results
- Gently shake the control solution (vial) to ensure the control solution is mixed
well before each test.
- Squeeze the vial to discard the rst drop before the test.
Do not remove the test strip from your meter before you select the ATTENTION
ICON in the EVENT RECORD MODE. If you remove the test strip before making
the selection, you cannot save the test result marked as the control solution test.
See page 21-22 for more details.




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 GlucoDr SuperSensor
Test Strip Instruction for the use.
Compare Control Solution Test Results
The Control Solution range printed on the test strip vial is for the GlucoDr
SuperSensor 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.
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,
- Code number printed on the test strip vial does not match the one displayed on
the meter,
- Meter, test strips or control solution are kept too warm or too cold,
- or Meter malfunction


02

Record all the control solution test results with
ATTENTION 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.
To record the control solution test results, press any of SIDE(UP/DOWN button)
buttons of the meter to select ATTENTION ICON. Press and release the power
button if selection is completed. The control solution test results will be saved.
Record the Control Solution Test Results in the Meter
If your control solution test results continue to fall outside the range printed on
the test strip vial, the GlucoDr SuperSensor 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 local distributor.



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
- 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.
Preparing the Lancing Device



