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 Dear ElementTM
Test Principle
Blood Glucose Monitoring System Owner

Thank you for choosing the ElementTM Auto-coding Blood Glucose Monitoring The enzyme glucose oxidase on the blood glucose test strip reads specifically
System. This booklet has important information you must know about the Element with the blood glucose. The current generated is converted and displayed as
TM
Auto-coding Blood Glucose Monitoring System. Please read it carefully. blood glucose value.
The ElementTM Auto-coding Blood Glucose Monitoring System is plasma-
We understand that self-testing of blood glucose level provides a way to control calibrated to allow easy comparison of results with laboratory methods.
your diabetes and may give you peace of mind by testing regularly. As a result Blood glucose test meter which is calibrated against a whole blood method may
ElementTM Auto-coding was developed to provide you with a fast and accurate have different results in comparison to ElementTM Auto-coding.
reading with a convenient and simple process. Our goal at ElementTM Auto-coding The laboratory system used for calibration of the ElementTM Auto-coding Blood
is to provide the best quality healthcare products coupled with superior customer Glucose Monitoring System is YSI 2300 STAT plus which is equipped with a
service. glucuse oxidase system.
Always consult with your healthcare professional before making any changes to
your diabetes management. The ElementTM Auto-coding Blood Glucose Monitor-
ing System is for in vitro diagnostic use only. Note
< Maintaining the ElementTM Auto-coding blood glucose test meter >
Important information 1. Do not assemble or disassemble the blood glucose test meter.
2. It will have to keep in the place where the water does not reach.
The ElementTM Auto-coding Blood Glucose Monitoring System is intended for use 3. Avoid getting dirt and moisture.
outside the body (in vitro diagnostic use only). It should be used only for testing 4. It does not have to keep in storage place of the chemical chemicals or the
blood glucose and only with fresh capillary whole blood samples. It should not be place where gas etc occurs.
used for the diagnosis of diabetes. 5. Keep out of direct sunlight.

Consult your physician or diabetic healthcare professional about daily manage-

ment of your diabetes and proper use of the glucometer.

Please pay close attention when handling blood. Improper procedures may cause
serious hazards to your health.

The ElementTM Auto-coding Blood Glucose Monitoring System contains small

parts. Please keep your monitoring system out of reach of children.

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 Contents Intended use of ElementTM
Blood Glucose Test Meter

1. Learning the System The ElementTM Auto-coding Blood Glucose Monitoring System is intended for in
Intended use of ElementTM Auto-coding Blood Glucose Test Meter 7 vitro diagnostic use only. ElementTM Auto-coding Blood Glucose Monitoring System
ElementTM Auto-coding Blood Glucose Monitoring System Kit Contents 8 is for self-testing.
ElementTM Auto-coding Blood Glucose Test Meter 9 It should not be used for the diagnosis of diabetes or for the testing of newborns.
ElementTM Auto-coding Blood Glucose Test Meter Display 10 The ElementTM Auto-coding was designed to test a blood glucose (sugar) level and
ElementTM Auto-coding Blood Glucose Test Strip Information 11-12 can be used with a capillary whole blood sample.
Do not use the ElementTM Auto-coding Blood Glucose Monitoring System for any
2. Before Testing other than for blood glucose testing.
Setting your blood glucose test meter 13-14
Auto-Coding Function 15
Performing a Glucose control solution test 16-17

3. Testing Your Blood Glucose

Testing Your Blood-Preparation 18 CAUTION
Collecting a Drop of Blood 19-21 Before using any product, please read all instructions.
Testing Procedure 22-24 Consult your physician or diabetic healthcare professional about daily
Testing Your Blood - Case of Setting user Option 25 management of your diabetes and proper use of the glucometer.
Test Strip Ejector Funtion 26 If you have any questions about the ElementTM Auto-coding product, please
contact Neon Diagnostics Ltd. Freephone patient helpline 0800 009 3378.
4. Reviewing Your Results 27
5. Alternate Site Testing 28
6. Performing a Blood Test using and Alternate Site 29-30
7. ElementTM Auto-coding Blood Glucose Test Meter Software 31
8. Taking Care of Your Blood Glucose Test Meter
Cleaning Your Blood Glucose Test Meter and Maintenance 32
Replacing the Batteries 33
Dispose of meter and batteries 33
9. Troubleshooting 34-37
10. Specifications 38
11. Conversion table mmol/L mg/dL 39
12. Symbol reference 40
13. Warranty 41

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 ElementTM Blood Glucose ElementTM Blood Glucose Test Meter
Monitoring System KIT Contents

Test Strip Port:

Insert the ElementTM Auto-coding test strip here

Test Strip Ejector

Display Screen:
Displays your test results, symbols and messages.

Function Button:
Powers the meter on/off, prompts memory data and
acts as an enter button during setup and after tests.

Up/Down Arrow Buttons:

Adjusts setting, scrolls through memory

Serial Number

1. ElementTM Auto-coding Blood 6. Warranty Registration Card

Glucose Test Meter 7. Patient Logbook Battery Cover
2. ElementTM Auto-coding Blood 8. Carrying Case
Glucose Test Strips 9. Two 3V Li-CR2032 Batteries
3. Lancing Device 10. Control Solution (Normal)
4. Lancets
5. Operation Manual
CAUTION
1. Do not use ElementTM Auto-coding blood glucose test meter in a dry
environment,especially if synthetic materials are present. Synthetic clothes,
Your ElementTM Auto-coding Blood Glucose Monitoring System has beens arts carpets, etc., may cause damaging static discharges in a dry environment.
shown above. Please return the system to place of purchase or contact your
2. Do not use ElementTM Auto-coding blood glucose test meter near cellular or
nearest ElementTM Auto-coding representative if the container seals are cordless telephones, walkie talkies, garage door openers, radio transmitters, or
broken or parts are missing. other electronic or electrical equipment that are sources of electromagnetic
radiation, as these may interfere with the proper operation of the blood glucose
test meter.

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 ElementTM Blood Glucose ElementTM Blood Glucose
Test Meter Display Test Strip Information

Low Battery Warning Symbol Storage and Handling Caution

Strip Code Symbol 1. Keep out of direct sunlight.

2. Store the ElementTM Auto-coding Blood Glucose Test Strip vials in a cool, dry place
between 2-30? (36-86? ). Do not freeze.
Blood drop symbol for test
3. Make a notation of the discard date on the vial label when you first open it. Discard
remaining ElementTM Auto-coding blood glucose test strips 6 months after first
Alarm Symbol opening the vial.
4. Close the vial cap tightly immediately after removing a ElementTM Auto-coding blood
Before Having a Meal glucose test strip.
5. Do not use test strips after the expiration date printed on the package or vial since it
After Having a Meal may cause inaccurate results.
6. Avoid getting dirt, food or water on the blood glucose test strip. Do not bend, cut, or
After Sports Activity alter the ElementTM Auto-coding blood glucose test strip.
7. ElementTM Auto-coding blood glucose test strips are for single use only.
8. Keep the blood glucose test strip vial away from children.
After Taking Medication
9. Please refer to the user’s manual for ElementTM Auto-coding blood glucose test strip
for additional information.
Temperature / Date 10. Discard the used blood glucose test strip carefully to prevent any infection.

Time / Test Result Amount

Test Result Unit Symbol Use only ElementTM Auto-coding brand blood glucose test strip with your ElementTM
Auto-coding blood glucose test meter.
Control Solution Symbol
Apply Blood Target Contact Bar
AVR Average Test Result System
Confirmation Window
CHK Troubleshooting Symbol

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 ElementTM Blood Glucose Test Strip Information Setting Your Blood Glucose Test Meter

Limitations of System : The ElementTM Auto-coding Blood Glucose Test Meter has a variety of
ElementTM Auto-coding blood glucose test strips provide accurate results when the following
constraints are observed: excellent functional modes; beep sound to alert when function is set, date,
time, five daily alarms, ability to designate activities related to the test result,
• Use only the ElementTM Auto-coding blood glucose test strips with the ElementTM and the ability to designate three unique data averages.
Auto-coding blood glucose test meter.
• Use fresh capillary whole blood only. Do not use plasma or serum.
• Do not use neonate samples.
• The blood glucose test strips are for single use only. Do not reuse.
• Dehydration may lower test results. If you are severely dehydrated, contact your physician
immediately
• Inaccurate results may occur when in shock, hypotensive individuals, hyperglycemic, or
hyperosmolar state, with or without ketosis.
• ElementTM Auto-coding blood glucose test strips may be used at altitude up to 10,000 feet
without an effect on test results. Power On User Activity Option Year
Press for 3 seconds After pressing and releasing After pressing and releasing
Physicians - Please note the following interferences that may affect test results : at least. either or buttons to turn either or buttons to set
• Element™ test strip results can be used with hematocrit levels in the range of 20% to 60%. the user Activity option on/off, the year (from 2007 to 2099),
If the hematocrit range is out of the range(20~60%), then the test results may be lower or confirm with . confirm with .
higher than actual value.
• Interferences: Acetaminophen, uric acid, ascorbic acid(vitamin C), and other reducing
substances (when occurring in normal blood or normal therapeutic concentrations) do not
significantly affect results. However, abnormally high concentrations in blood may cause
inaccurately high results.
• Lipemic samples; Cholesterol up to 500 mg/dL or triglyceride up to 3000 mg/dL do not
significantly affect the results. Glucose values, however, in specimens beyond these levels
should be interpreted with caution.
• Blood samples that contain a high concentration of dissolved oxygen may lower the test
result.

Performance Characteristics :
The performance of ElementTM Auto-coding blood glucose test strips has been evaluated in Date / Time Temperature unit
laboratory and in clinical tests (Please refer to strip manual for more details). After pressing and releasing Press and release either
either or buttons to set or buttons to set ℉ or ℃.
the date and time, confirm Enter button.
Measurement Range: The measurement range of the Blood Glucose Monitoring System is
each with .
0.6 to 33.3 mmol/L.

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 Setting Your Blood Glucose Test Meter Auto-Coding Function

1. ElementTM Auto-coding has automatic

code recognition function.

Number of days for average Alarm on/off

After pressing and releasing After pressing and releasing either
either or buttons to set the or buttons to turn the alarm
number of days for average on/off, confirm with .
calculation (3 different possible),
confirm with .

2. It recognizes automatically the code

number. This is a very convenient
function preventing the inconvenience
C16 of setting the code number on the
blood glucose test meter every time.
Alarm time Alarm
After pressing and releasing After programming the number of
either or buttons to set the desired alarms (5 alarms possible),
alarm hour and minute, confirm confirm with .
with .

CAUTION CAUTION
1. **VERY IMPORTANT: Correct test unit. 1. Do not bend the blood glucose test strip to prevent the Automatic code
Your ElementTM Auto-coding blood glucose test meter is pre-set to mmol/L as test
recognition failure.
unit.
See also conversion table on page 39. 2. If the code recognition label is damaged, the code recognition may fail.
2. Without setting the date properly, the average glucose level and the results in Please check the code number on the LCD display window with the
memory will not show proper values. It is recommended to set the meter before code number on the blood glucose test strip vial.
use and when new batteries are installed.
3. Yon can’t test your blood glucose while in the setting mode.
4. To turn the meter off during setup, press for at least 3 seconds

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 Performing a Glucose Control Solution Test Performing a Glucose Control Solution Test

The glucose control solution should be used when there is suspicion that the blood
glucose test meter or the blood glucose test strips are not working properly. For example: Note: - ElementTM glucose control solution is sold separately.
if strips have been exposed to extreme conditions or if you drop the blood glucose test - It is recommended that glucose control solution is stored at room
meter. temperature 20~25℃(68Ũ77℉) before testing.

Check the expiration date before performing a glucose control solution test.
For example
Do not use if expired. Once opened, solution expires after 3 months.
If you use a normal glucose control solution, you must use the normal range printed
The Glucose control solution should be used on the side of the blood glucose test strip vial.
• Whenever you suspect the blood glucose test meter or blood glucose test strip is not
functioning properly.
• If your blood glucose test results are not consistent with your symptoms or if you think
they are not accurate.
• If you have dropped the blood glucose test meter.
• For quality control in the point of care usage. !
!
• For teaching or learning the system. !
1. Shake the glucose control solution before use.
2. Discard the 1st drop of glucose control solution, this will eliminate any residue.
3. Place a drop of glucose control solution on a clean dry surface (ex. The lid of the blood
glucose test strip vial). • Results that fall outside the expected range may indicate:
4. Insert a blood glucose test strip • Test not performed at room temperature.
into the port and press the up • An error in the way you are doing the test.
arrow. A glucose control • Expired or contaminated glucose control solution.
solution vial will appear on the • A problem with the blood glucose test meter.
bottom left hand side of the • Glucose control solution that is too warm or cold.
screen, above the date and • Failure to discard the first drop of glucose control solution and to wipe the
time. bottle tip clean.
This will allow you to differentiate between a glucose control solution test and an actual • Failure to shake the glucose control solution adequately.
blood test for future reference.
5. Dip the blood glucose test strip into the glucose control solution. CAUTION
6. Results appear in 3 seconds. • If your glucose control solution falls out of range, do not perform a
glucose test, please contact your local representative.
7. Compare the result to the range printed on the blood glucose test strip vial, the results • The Glucose Control Solution range is not the recommended range for
should fall within that range. your blood glucose level.
8. If your glucose control solution falls out of range, do not perform a glucose test, please
contact your local representative.
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 Testing Your Blood - Preparation Collecting a Drop of Blood

Before testing, be sure to read this section and blood glucose test strip The lancing device is a convenient medical tool for collecting capillary blood
package insert found in the blood glucose test strip box carefully. samples for glucose monitoring or other tests which require one or two drops of
Make sure you have all the necessary items to begin testing: blood. As a more advanced lancing device, it provides ultimate safety and comfort
for obtaining blood samples. An adjustable tip offers 5 levels of skin penetration for
individual user’s comfort and a lancet ejector enables the safe disposal of the used
lancet.

PRECAUTIONS
• Never use a lancet that has been used by someone else. This could lead to
contamination.
• ElementTM Auto-coding blood • If the lancing device is to be used by another person, the unit must be properly
glucose test meter disinfected and a new tip and lancet must be used.
• ElementTM Auto-coding blood • Do not leave the lancet in the device after use.
glucose test strip • A new lancet must only be placed into the lancing device directly before testing.
• Lancing Device • This device has many small parts and could be a choking hazard for children if
• Sterile Lancets swallowed.
• In the case of hospital use, hospitals need to consult their own infection control
protocols in order to avoid any contamination.
• Always dispose of the used lancet in a biohazard garbage container.
CAUTION
To reduce the chance of infection.
• The Lancing Device and sterile lancets should NOT be shared with COMPONENTS
others.
• Always use a new, sterile lancet and new blood glucose test strip. Clear Tip
• Lancets are for single use only. DO not reuse.
• Avoid getting hand lotion, oils, dirt, or debris in or on the Lancets and
the Lancing Device. Ejection System
• Dry your hands completely before testing. Sliding Barrel

Practice using the lancing device and become accustomed with its use.
Wash your hands with warm, clean water and soap. Dry your hands
completely before testing. Lancet Holder Release Button
Depth Indicator/
Adjustable Tip

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 Collecting a Drop of Blood Collecting a Drop of Blood

Disposing of your lancet

1. Unscrew the tip of the lancing 2. With two fingers, pull out the 3. While holding the lancet
device by turning it counter- lancet carrier and hold it in carrier, insert a new sterile
clockwise while holding the place. lancet into the bottom of 1. Push the needle into the protective cover. 2. Pull the lancet out and discard accordingly.
base firmly. lancet carrier.

RECOMMENDED AVAILABLE LANCETS

Some general sterilized lancets are BD-Ultra Fine, Cleanlet Fine, E-Z Ject, G-P Lite, Microlet, Monolet,
One Touch, Soft Touch, Therasense, Ultra TLC and Unilet GP.
Note: Some less known lancets may not work properly with the due to their dimensions. Please, contact
your supplier to make sure you are using proper lancets.

USING THE CLEAR TIP (AST)

1. Place the lancing device on the skin in the chosen area, press and hold it continuously for a few
seconds. Then, push the release button to take a sample.
2. Watch through the clear tip until a sufficient blood sample is taken. If there is not enough blood, gently
4. Twist the cap of the lancet off. 5. Put the tip of the lancing 6. Hold the tip firmly in one hand massage the area until a sufficient sample has been collected.
device back on and turn it then pull out the sliding barrel
clockwise. with the other hand. This will STORAGE
cock the lancing device. Products must be stored at room temperature protected from sunlight or moisture.

CLEANING AND DISINFECTION

Click Clean and wipe the outside of the lancing device a minimum of once a week with a soft cloth, dampened
with mild soap and water. Wash the adjustable tip and the clear tip once a week with mild soap. DO NOT
immerse the lancing device in liquid.

WARRANTY
Lancing device has a 2-year warranty from the date of purchase. A malfunctioning device should be
returned to the following address:

7. Place the lancing device in 8. Unscrew the tip of the 9. Push the lancet ejector GMMC
place. Hold it firmly against lancing device by turning it forward with the thumb Room No. 1112, Ace Tower 9th Bldg., 345-30, Kasan-Dong, Kumchon-Ku, Seoul, South Korea
the side of the finger, with counter-clockwise. and simultaneously pull Tel : +82 2 2104 0470
the cap resting on the finger. out the sliding barrel to Fax : +82 2 2104 0472
(The harder it is pressed the dispose of the used lancet
deeper the puncture.) Press in a proper biohazard GMMC, S.L.
the release button to take a container. C/Jordi de S. Jordi 13, 6-23 46022 Valencia SPAIN
sample. Tel : +34 963 691 484
Fax: +34 961 125 949

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 Testing Procedure Testing Procedure

Correct Applying Blood

Correct
Completely Filled
Incorrect
Step 1

• Firmly insert the blood glucose test strip into the blood glucose test meter
port with the “infopia” facing towards you.
• The blood glucose test meter automatically turns on displaying the code, Incorrect
ambient temperature and the date and time.
• The ElementTM Auto-coding will automatically recognize the blood glucose Poorly filled
test strip code number. sample size • ElementTM Auto-coding blood glucose test
• A blinking blood glucose test strip will appear at the top of the screen indicat- meter only requires 0.3㎕ sample volume.
ing the blood glucose test meter is ready for testing. • Apply your blood to the glucose test strip
and do not take off your finger until you get
Note : Inserting the test strip in the wrong direction will turn the meter on, but the beep sound.
you will be unable to test. The test will automatically start.
Step 2
• Place the top edge of the blood glucose test strip to the area you
prepared for testing.
• The blood will automatically be “drawn” into the blood glucose test strip
CAUTION channel.
1. If the code is not displayed after for a while, pull the blood glucose test • When the chamber has enough blood, your blood glucose test meter will
automatically count down.
strip out of the port, and re-start the procedure from the beginning.
2. If the code on the LCD display window and on the test vial does not CAUTION
match, try another new blood glucose test strip. If the mismatch 1. If the countdown does not start, do not add more blood to the blood
persists, please contact your local representative for help. glucose test strip! Discard the blood glucose test strip an restart
3. If the meter does not power on, pull the blood glucose test strip out of testing.
the port, and re-insert the blood glucose test strip. 2. If you do not conduct the test within 3 minutes, the blood glucose test
4. Avoid testing under direct sunlight, for a more accurate test result. meter will automatically power off to save battery life. In this case
5. If you apply your blood sample too early, ERROR5 message will appear you need to start the test procedure again from the beginning.
on LCD ( refer to p34). 3. You may get an inaccurate result if the blood sample is not
completely filled in a single action.

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 Testing Your Blood -
Testing Procedure
Case of Setting User Option

Step 4

• If you selected to use the User Activity option

during set up, press and button to select
the activity that correlates with your result (refer
to p10), then press .
• If you did not select to use user activity option
during set up, press to continue to step 4-2.

Step 3
• After beeping sound, the test will begin automatically and your results will
appear in 3 seconds. It should begin counting down from 3 to 1 second on
the LCD window. The LCD window will display the result of your blood
glucose level, including temperature and time.
• Record the result value in your ElementTM Auto-coding logbook. When you
pull out the blood glucose test strip, the meter turns off automatically.

CAUTION
1. If the test result is out of the test range, the Hi/Lo message will be CAUTION
shown on the LCD window. (refer to p35) 1. If you did not activate the User Activity option, Step4 procedure is not
2. Safely discard used blood glucose test strips and lancets. conducted.
2. Please refer to page 13, if you want to set the User Activity option.

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 Test Strip Ejector Function Reviewing Your Result

The ElementTM Auto-coding blood glucose test meter stores up to 500 test
results in its built-in memory, along with the average sugar level for the
number of days which you had preset the blood glucose test meter to
calculate. These values can be retrieved on the LCD display at any time.

• Press and release button.

• Check your previous result by pressing the arrow button.
• Check your average data by pressing the arrow button.

Press and Push forward Eject your blood glucose

test strip

The third latest The second latest The latest

1. Once the test is completed, slide the ejector button forward to remove the
blood glucose test strip from the blood glucose test meter.
2. Discard the used blood glucose test strip and lancet accordingly.

7day average 14 day average 21day average

from the test date from the test date from the test date

CAUTION
1. If you push the ejector button forward too much, it may cause the failure Average test result
of the part.
2. Do not give strong impact to blood glucose test meter. Test Unit
Test result amount
Average test result days

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 Funkcija izmeta lističa za
Alternate Site Testing Performing a Blood Test Using and Alternate Site
testiranje sladkorja v krvi

To ensure accurate results when lancing your

Upper Arm forearm, upper arm, hand, thigh, or calf, wash
Forearm
the test site with soap and water.
Dorsal Hand Ventral Palm Make sure there is no cream or lotion on the
test site.Thoroughly dry your hands and test
Thigh Fingertips site.
Calf

Important Information About Using Alternative Sites Testing :

• Alternate sites where you can test are dorsal hand, ventral palm, upper arm, forearm,
calf, and thigh.
• Under certain conditions, blood glucose test results obtained using samples taken
from your alternate sites may differ significantly from fingertip samples
• The conditions in which these differences are more likely to occur are when your blood
glucose is changing rapidly such as following a meal, as insulin dose, or associated
with physical exercise.
• When blood glucose is changing rapidly, fingertip samples show these changes more
quickly than alternate sites samples.
• When your blood glucose is falling, testing with a fingertip sample may identify a
hypoglycemic (low blood glucose) level sooner than a test with an alternate sites
sample.
• Use alternate sites samples only for testing prior to or more than two hours after meal,
insulin doses, or physical exercise.
• Testing performed within two hours after meals, insulin doses, or physical exercise or
whenever you feel that your glucose levels may be changing rapidly should be done
from the fingertip.
• You should also use fingertip testing whenever you have a concern about hypoglyce-
mia (insulin reactions) such as when driving a car, particularly if you suffer from
hypoglycemic unawareness (lack of symptom to indicate as insulin reaction), as
forearm testing may fail to detect hypoglycemia.
CAUTION
• To ensure accurate results when lancing your arm (Upper arm or
forearm), leg (calf or thigh) or palm (ventral palm or dorsal hand), wash
Important : your hand and test site with soap and water.
We recommend that you test on your fingertips if you are testing for hypoglycemia • To receive accurate test results, at least 0.3ָ minimum sample volume
(low blood glucose) or if you are suffering from hypoglycemia unawareness. is required.

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 Funkcija izmeta lističa za ElementTM Blood Glucose Test Meter Software
Performing a Blood Test Using and Alternate Site
testiranje sladkorja v krvi

To bring fresh blood to the surface of the test site, rub the test site vigorously You can transfer test results from the ElementTM Auto-coding blood glucose
for a few seconds until you feel it getting warm. test meter to a computer.
You can download the software from our web site.
(http://www.infopia21.com)
Lance the test site with the lancing device:
You can purchase the computer communication cable separately from a local
1. Hold the clear cap down against the top of representative.
your test site. Press the release button. Do
not lift up.

2. Continue to hold the lancing device and

gradually increase pressure for several [User] [PC]
seconds.

3. While holding the lancing device on your

test site, look through the clear cap; until a
drop of blood appears approximate size

4. Lift the lancing device straight up; be careful

not to smear the blood on your testing site.

5. Place the edge of the blood glucose test

strip to the drop of blood.
cable
6. The blood will automatically draw into the
channel of the blood glucose test strip.

You may get an inaccurate result if the

blood sample is not completely filled in a
single action.

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 Cleaning Your Meter and Maintenance Replacing the Batteries

Meter The low battery icon will appear in the upper left corner of the LCD screen to alert you
Your meter does not require special maintenance or cleaning. Avoid getting when the battery power is running low, indicating a new battery is needed.
dirt, dust, blood, glucose control solution, or liquids on the blood glucose test
meter, the test port, or data port. Your blood glucose test meter operation
temperature is 10℃~40℃(50℉~104℉).
It is recommended that you store the meter in its carrying case after each use.
A cloth dampened with water and mild detergent can be used to wipe down the
outside of the blood glucose test meter. Your ElementTM Auto-coding blood
glucose test meter is a precision instrument. Please handle it with care.
Your ElementTM Auto-coding blood glucose test meter uses only two 3V Lithium
Lancet Device: batteries (CR2032), which are included. When replacing the batteries, only CR2032 or
Clean the lancing device and caps with soap and tepid water. To disinfect the equivalent lithium battery should be used.
After changing the batteries, please be sure to recheck your meter settings.
lancing device, prepare a disinfectant solution of one part household bleach to
10 parts water. Dampen a cloth with this solution and wipe the lancing device <Follow-up Action>
thoroughly. Soak only the cap for at least 30 minutes in the disinfectant 1. Check your meter with the glucose control solution (p16-17)
solution. Do not soak the lancing device in liquid. Rinse the lancing device and 2. Perform your test again (p22 - 24)
cap with water and dry thoroughly. 3. If you are experiencing symptoms that are not consistent with your blood glucose
test results, call your healthcare professional.
• For detailed instructions concerning ElementTM Auto-coding blood glucose
test strips, refer to the test strip package insert found in the blood glucose Dispose of meter and batteries
test strip box.
Dispose of meter:
• Please store the ElementTM Auto-coding blood glucose monitoring system in The meter must be disposed of according to the local regulations concerning the
a cool, dry area, out of reach of children. Do not freeze. For a more accurate disposal of electrical and electronic equipment.
test result avoid testing under direct sunlight. The Waste Electrical and Electronic Equipment(WEEE) regulation implement
• Do not soak the blood glucose test meter or blood glucose test strips in water provisions of the European Parliament and Council Directive 2012/19/EU aimed to
or liquid. reducing the amount of EEE waste going for final disposal.
• Do not subject the blood glucose test meter or blood glucose test strips to The manufacturer, has specific instructions for the recovery of the meter.
excessive heat. Please contact your distributor.
• Use your blood glucose test meter according to the instructions in the Dispose of batteries :
manual. Please recycle or dispose of used batteries using your local battery collection systems
• If you need to purchase the lancing device, lancets or blood glucose test and in compliance with your local environmental laws and regulations.
strips, contact your local representative. Batteries contain chemicals that, if released, may affect the environment and human
• Discard the used Lancets carefully, to prevent any infection. health. The crossed-out wheeled-bin symbol indicates the need for the separate
collection for batteries.
CAUTION
Remove both batteries from the battery compartment and dispose of them according your
institution's guidelines.

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 Troubleshooting Troubleshooting
Odpravljanje težav

The following chart may help you identify certain problems, but may not solve all
problems that can occur. Please contact your local representative if the problem
Message Problem Action Required
persists. Please insert a new blood
glucose test strip and perform
Message Problem Action Required Problem with the your test again. If the problem
Auto-coding label persists, Please contact your
Problem with the Place the battery again, and set local representative if the
blood glucose test the blood glucose test meter. If problem persists.
meter the problem persists, Please
contact your local representa- Place the blood glucose test
tive if the problem persists. The ambient
meter within the operating
temperature is too
temperature range for 10
low
minutes or more and retest.
Caused by either Please insert a new blood
used or wet blood glucose test strip and perform
glucose test strip your test again Place the blood glucose test
The ambient meter within the operating
temperature is too temperature range for 10
high minutes or more and retest.
Caused by less Please insert a new glucose
blood test strip and apply the blood
sample. Check the accuracy of your
blood glucose test strip by
performing a glucose control
The test result is solution test. If the test results in
Please insert a new blood lower than a normal reading, re-test your
Blood glucose test 0.5 mmol/L blood sample two or three
strip is damaged glucose test strip and perform
your test again times. If "Lo" persists, consult
your doctor immediately.
Check the accuracy of your
blood glucose test strip by
User applied the The test result is performing a glucose control
blood sample Please wait for the LCD to higher than solution test. If the test results in
before the LCD display icon blinking before 33.3 mmol/L a normal reading, re-test your
display applying your blood sample blood sample two or three
was blinking times. If "Hi" persists, consult
your doctor immediately.

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 Troubleshooting Troubleshooting

Message Problem Action Required Message Problem Action Required

The blood glucose

Low battery Battery needs replacing.
Battery is dead or Change the battery and if the
test meter does not there is a problem problem persists, please contact For your free replacement
power on with the blood your local representative. batteries, please contact
glucose test meter Neon Diagnostics Ltd.
Low battery symbol Freephone Patient Helpline:
appears in the 0800 009 3378
Test does not start Poor blood sample Please insert a new blood glucose upper left corner of
after applying blood
test strip and perform your test the LCD screen
sample
again(refer to the P.23)
Low battery Low battery Battery needs replacing.
warning symbol For your free replacement
There may be a problem Please insert a new blood glucose and 3 digit code batteries, please contact
The result is
inconsistent with the blood glucose test strip and perform your test Neon Diagnostics Ltd.
test strip again Freephone Patient Helpline:
0800 009 3378

No readings in
memory to display

Not enough
readings in
memory to display
designated
averages

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 Specifications Conversion table mmol/L mg/dL

Sample type Capillary whole blood mmol/L 0,6 1,0 1,5 2,0 2,2 2,5 2,8 3,0

Sample volume 0.3

mg/dL 10 18 27 36 40 45 50 54
Test Range 0.55 ~ 33.3 mmol/L
mmol/L 3,3 3,9 4,0 4,4 4,7 5,0 5,5 6,0 6,1
Reading time 3 seconds
mg/dL 60 70 72 80 85 90 100 108 110
Calibration Plasma - Equivalent

Altitude ≤ 3048m (10,000 feet ) mmol/L 6,7 7,0 7,2 7,5 7,8 8,0 8,3 8,9
Operating Temperature 10-40? (50-104? )
mg/dL 120 126 130 135 140 145 150 160
Operating Humidity 10-90%
mmol/L 9,0 9,4 10,0 10,5 11,0 11,1 12,0 12,5 13,9
Strip storage temperature 2-30? (36-86? )

Display Type LCD mg/dL 162 170 180 190 196 200 216 225 250

Dimension 76 X 56 X 18 (mm) mmol/L 14,4 15,0 16,0 16,6 17,0 18,0 19,0 20,0
Weight 45g ( Including Battery)
mg/dL 260 270 288 300 306 325 342 360
Power rating 3 V Li Battery (CR2032) X 2
mmol/L 20,8 22,2 23,0 24,0 25,0 26,4 27,7 30,0 33,3
Battery Life One year after purchasing

PC communications port Communication available mg/dL 375 400 414 432 450 475 500 540 600

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 Symbol Reference Warranty

Three - Year Warranty

Symbol Description
Consult Instructions for use If, at any time during the first three years after purchase, the blood glucose
test meter does not work for any reason with the exception of obvious abuse,
Used By
misuse, or disastrous damage, infopia Co.,Ltd. will replace your Element
This prodect fulfills the requirements of Directive Auto-coding blood glucose test meter or equivalence free of charge.
98/79/EC on in vitro diagnostic medical devices
Caution, consult accompanying documents The Warranty Policy of infopia Co.,Ltd. only applies to the original purchaser
For In Vitro Diagnostic Use of the Meter and will not include the batteries supplied with the blood glucose
test meter set.
Batch code
Catalogue Number Please fill in the warranty card attached to the set.
Mail or fax it back to us.
Temperature limitation

SN Serial number The ElementTM Auto-coding blood glucose test meter has a full three-year
warranty from the original date of your purchase. For your convenience,
Date of Manufacture
please include your date and place of purchase.
Manufacturer

Keep away from sunlight

For Self-testing
Separate collection for waste electrical and electorinic
equipment
EC REP Authorisd representative in the European community
Biohazard

Waste batteries and accumulators

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 MEMO

infopia Co., Ltd.

891, Hogye-Dong, Dongan-Gu, Anyang,
Kyunggi, 431-080, Korea
www.infopia21.com

EC REP Obelis S.A.

Bd. General Wahis 53

1030 Brussels, Belgium
Tel : +(32) 2.732.59.54
Fax : +(32) 2.732.60.03
E-Mail : [email protected]

Lancing Device : GMMC

Room No. 1112, Ace Tower 9th Bldg.,
345-30, Kasan-Dong,
Kumchon-Ku,
Seoul, South Korea

Lancet : Sae Han Med Corp.

973-16, Sungsuk-Dong, Ilsandong-Gu,
Goyang-City,
Gyeonggi-Do, Korea

U.K. Distributor: Neon Diagnostics Ltd.

Units 7 & 8
Swanbridge Industrial Park
Black Croft Road
Witham
Essex
CM8 3YN

INFM21AGB

42 www.infopia21.com IMM20-516 Rev.2013-05-02

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