Infopia GlucoLab User manual

for self testing
infopia Co., Ltd.
132, Anyangcheondong-ro, Dongan-gu,Anyang-si,
Gyeonggi-do, Korea (431-836)
www.infopia21.com
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]
INFM08A
IMC00099 Rev.2014-06-02
Lancet : infopia Co.,Ltd.
Lancing Device : GMMC
Rm 1112, Ace Tower 9th Bldg., 130, Digital-ro,
Geumcheon-gu, Seoul, Korea
Instructions for use
Global Medical Market Corporation S.L.
Parc Industrial Ciutat de Carlet Mestral 20,
46240 Carlet, Valencia, Spain
Tel : [phone]
Fax : [phone]
E-mail : [email protected]

Blood Glucose Monitoring System for self testing
Quick and Smart
Blood Glucose Monitoring System for self testing

4
Dear System Owner
Thank you for choosing the Blood Glucose Monitoring
System.
This instructions for use contains everything you need to know about
your new Blood Glucose Monitoring System and how it works.
Please take a moment to read it carefully, before using your new
system.
In choosing the Blood Glucose Monitoring System, you
have selected one of the most convenient, easy to use and less
painful systems available. It gives you accurate results in just 5
seconds using only 1㎕blood sample from Forearm, Upper arm,
Palm, Fingertips, Thigh, as well as Calf. You will find that testing on
your arm or leg is less painful than testing on your fingertips, since
they have fewer nerve endings. What’s more, the stores
up to 250 blood glucose test results and can identify up to 100
different users (see ID function).
Checking your blood glucose levels on a regular basis can make a
big difference in how well you manage your diabetes. Our goal is to
help you make it as comfortable and convenient as possible.
Before you get started, it is important to complete the warranty
registration card included in your kit, and mail it back to Obelis S.A.
Doing this will help us serve your needs better.
Intended Purpose
The Blood Glucose Monitoring System is intended for use
outside the body only (in vitro diagnostic use) and self-testing. The
recorded results make it easier for your doctor to access your
metabolic control. However, the self-testing should not take the place
of overall diabetes management assessment from your doctor. It
should be used only for testing blood glucose(sugar) and only with
fresh capillary whole blood samples. The Blood Glucose
Monitoring System is intended for use in the home and in
professional setting to monitor blood glucose levels.
Test Principle
Glucose in the blood sample will react to the electrodes in the test strip,
generating an electrical current that will stimulate a chemical action.
This reaction is measured by the meter and displayed as
your blood glucose result. The Blood Glucose Monitoring
System is plasma-calibrated to allow easy comparison of results with
laboratory methods.
5
Caution : If the code on the LCD window and on the blood glucose
test vial does not match, follow the coding procedure for accurate
results.

The Table of Contents
About Your New System page
Blood Glucose Monitoring System KIT Contents 8
Blood Glucose Test Meter 9
Blood Glucose Test Meter Display 10
Blood Glucose Test Strip information 11-12
Before You Test
Setting up Your Monitor 13~14
Checking the Meter with the Check Strip 15
Seting the Code to Match Your Test Strip 16
Performing Your Test
Before you Test 17
Collecting a Drop of Blood 18~20
Test Your Blood - Preparation 21~22
Performing Your Test 23~24
Performing a Control Solution Test 25~27
Reviewing Your Results 28~29
Alternate Site Testing 30
Performing a Blood Test Using and Alternate Site 30~32
Downloading Your Glucose Readings 33
Caring for Your Glucolab Meter 34
Changing Your Battery 35
Disposal of meter and batteries 36
Trouble Shooting 37~40
Specifications 41
Warranty 42
Symbol Reference 43
7
6
Caution :
Before using any product, please read all instructions. Consult
your physician or diabetic healthcare professional about daily
management of your diabetes and proper use of the glucometer.
If you have any questions about the product, please
contact your local representative.
Intended use of
Blood Glucose Test Meter
The Blood Glucose Monitoring System is
intended for in vitro diagnostic use only.
Blood Glucose Monitoring System is for self-testing. It
should not be used for the diagnosis of diabetes or for the testing of
newborns.
The was designed to test a blood glucose (sugar)
level and can be used with a capillary whole blood sample.
Do not use the Blood Glucose Monitoring System
for any other than for blood glucose testing.

8
Test Strip Port :
Insert the Test Strip here.
Displays Screen :
Display 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 settings and scrolls through
memory to review prior results.
Battery Cover
Serial Number
Data Port :
Download your test results.
Blood Glucose Test Meter
Blood Glucose
Monitoring System KIT Contents
• Blood Glucose Test Meter
• Conrol solution
• Lancing Device
• infolet Sterile Lancets
• Check strip
• Instructions for Use
• Warranty Card
• Logbook
• Battery
• Carrying case
Your Blood Glucose Monitoring System has been
sealed and it should contain all of the parts shown above.
Please return the system to place of purchase or contact your
nearest representative if the container seals are broken
or parts are missing.
• Blood Glucose Test Strips
9
Caution :
1. Do not use bloodglucosetestmeterinadryenvironment,especially
if synthetic materials are present. Synthetic clothes, carpets, etc., may
cause damaging static discharges in a dry environment.
2. Do not use blood glucose test meter near cellular or cordless
telephones, walkie talkies, garage door openers, radio transmitters, or other
electrical or electrical equipment that are sources of electromagnetic
radiation, as these may interfere with the proper operation of the blood
glucose test meter.

10
[ Storage and Handling Caution]
1. Keep out of direct sunlight.
2. Store the Blood Glucose Test Strip vials in a cool and dry place between 2-
30°C(36-86°F). Do not freeze.
3. Make a notation of the discard date on the vial label when you first open it. Discard remaining
blood glucose test strips passed by 6 months after first opening the vial.
4. Close the vial cap tightly and immediately after removing a blood glucose test strip.
5. Do not use test strips after the expiry date printed on the package or vial since it may cause
inaccurate results.
6. Avoid getting dirt, food or water on the blood glucose test strip. Do not bend, cut, or alter
the blood glucose test strip.
7. blood glucose test strips are for single use only. DO NOT RE-USE
8. Keep the blood glucose test strip vial away from children.
9. Pleaserefertotheuser’s manual for blood glucosetest strip foradditional information.
10. Discard the used blood glucose test strip carefully, to prevent any infection.
Use bloodglucose test stripswith blood glucose testmeter.
Target to apply blood.
Apply blood to the tip to the test strip
Insert this end of your test strip
with the contact bars facing up
Check to make sure blood fills
is in the channel
Confirmation Window
Contact Bar
Blood Glucose Test Strip Information
Low Battery Warning Symbol
User ID Symbol
Strip Code Symbol
Blood Drop Symbol for Test
Alarm Symbol
Before Having a Meal
After Having a Meal
After Sports Activity
After Taking Medications
Control Solution Symbol
Temperature/Date
Test Result Unit
Beeping sound Symbol
Time / Test Result Amount
Indication for deleting records
Display Screen
Blood Glucose Test Meter Display
11

Before You Test
Turn on Beeping sound
User’s testing option
User’s ID
The Blood Glucose Monitoring System has a wide variety of
functions to choose from. There is a beeping sound to alert you when a function
is set; date, time, five daily alarms, unique user ID, ability to designate activities
related to the test result, and the ability to designate three unique data averages.
•Press power button
and hold for
about 3 seconds
•After pressing and
releasing either or
buttons to turn the
beeper on/off, enter
•After pressing and
releasing either or
buttons to turn the
user testing option
on/off, enter
•After pressing and
releasing either or
buttons to turn user ID
on/off, enter
Date/Time Test unit
• After pressing and releasing
either or buttons to set
the date and time, enter
• Afterpressing and
releasingeither or
buttonsto set the testunit
ofresult, enter
Blood Glucose
Test Strip Information
12
Limitations of Blood glucose measuring system :
The blood glucose test Strips provide accurate results when the following constraints are
observed :
- Use the blood glucose test strips with the blood glucose
test meter or 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
you physician immediately
- Inaccurate results may occur when in shock, hypotensive, hyperglycemic,
or hyperosmolar state, with or without ketosis.
- Blood glucose test strips used above altitudes of 9,840 feet will have an
effect on test results.
Doctors - Please note the following interferences that may affect test results :
- test strip results can be used with hematocrit levels in the range of 20%
to 60%. If the hematocrit range is out of the range(20%~60%), then the test results
may be lower or higher than actual value. If you do not know your hematocrit level,
consult your healthcare professionals.
- Interferences : Acetaminophen, Uric and, 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 may cause inaccurately high results.
- Lipemic samples; Cholesterol up to 500 mg/dL or triglyceride up to 2890 mg/dl
do not significantly affect the results. Values 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 the blood glucose test strips has been evaluated in
laboratory and in clinical tests.
Measurement Range : The measurement range of the Blood
glucose measuring system is 10 to 600 mg/dL (0.6~33.3mmol/L).
13

14
Before You Test
Check your meter with the check strip.
The “check strip” is to make sure that your meter is functioning properly.
Insert the check strip with the “ <<< “ facing up in the test strip port of your meter.
The check strip automatically checks your meter when it is inserted into the test port.
If the value displayed is between the ranges of 107 - 127, your meter is functioning
properly.
If the value displayed does not meet the proper range, the LCD will display an “Er 1”
message.
If after reinserting the check strip you receive the same error, please contact your
local representative.
It is important to check your meter system after purchasing.
To ensure proper test results, please check your system periodically.
Note : In order to perform the more accurate glucose control solution
test, you can use the control solution 3 different levels – low, normal
and high.
You can buy each Auto-coding control solution (low, normal
and high levels) separately, please consult your local distributor about
control solutions.
Before You Test
Setting the Temperature Unit
Setting testing averages
Setting the Alarm
• After pressing and releasing
either or buttons to set
℃or ℉, enter
• After pressing and releasing
either or buttons to set
the average of testing day,
enter
• After pressing and releasing
either or buttons to set
the alarm, enter
Complete all Setting Mode
• After completing the set up,
all of the symbols are
displayed briefly before the
meter automatically shuts off.
Setting the Alarm Time
• After pressing and releasing
either or buttons to set
the alarm time, enter
Setting the Alarm
• After programing the
number of desired alarms
enter
Caution
1. VERY IMPORTANT: Set the right test unit. Your GlucoLab Meter is pre-set to mg/dL
as test unit. A wrong test unit will lead to wrong test result display. Please consult
your healthcare professional if you’re not sure which test unit to use. Without setting
the date properly, the average glucose level and the results in memory will not show
proper values. It is recommended to set the glucose test meter before use and also
when new batteries are installed.
2. You cannot test your blood glucose in the setting mode.
3. To turn the meter off during the setup, press for at least 3 seconds.
◆User can set upto 5 daily alarms as well as designate 3 unique glucose averages
15

16
Before testing, be sure to read this section and test strip package insert
found in the test strip box carefully, make sure you have all the necessary
items to begin testing:
• Meter
• Test Strip
• Lancing Device
• Sterile Lancets
CAUTION !
To reduce the chance of infection :
• The Lancing Device and sterile lancets should NOT be shared with others.
• Always use a new, sterile lancet.
• Lancets are for single use only.
• Avoid getting hand lotion, oils, dirt, or debris on the Lancets or the Lancing Device.
• Dry your hands completely before testing.
• Sterile lancets are for single use only. Do not reuse.
• Sterile lancets is used with a spring-operated lancing device
• Sterile lancets sterilized using gamma irradiation. After opening, exposed parts
should not be touched or put on the floor to prevent contamination.
Performing Your TestBefore You Test
Insert the test strip to turn your meter on. Please
insert your test strip fully, but be careful not to bend. The code
number should appear in the LCD window for 3
seconds (example: C18). Compare the code number on the
meter’s LCD window with the code number on the test strip
vial. If the two code numbers match, you can start testing.
If the two code numbers do NOT match, you must code
your meter according to the test strip vial code number before
the LCD display ends(Within 3 Seconds). Press the or
button to select the correct code. The number increases or
decrease by one digit every time you press or button.
To move more quickly, press and hold or buttons.
Code numbers are used to calibrate the Meter with the
Test strips for accurate results. You must code the meter
before using it. Confirm the code number for the first test and then
every time you change to a new vial of test strips.
If any error message appears any time, please refer to
the Trouble Shooting section of the manual for more
information (please refer to page 37~39).
17
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.

18
1.Unscrew the tip of the lancing device
by turning it counter-clock- wise while
holding the base firmly.
2. With two fingers, pull out the lancet
carrier and hold it in place. 3.While holding the lancet carrier,
insert a new sterile lancet into the
bottom of lancet carrier.
4. Twist the cap of the lancet off.
5. Put the tip of the lancing device
back on and turn it clockwise.
6. Adjust clear tip to the highest setting.
Hold the clear tip down against a fleshy
area on the alternative site. Press the
release button. Do not lift up.
8. Place the lancing device in place. Hold
the firmly against the side of the finger,
with the cap resting on the finger. (The
harder it is pressed the deeper the
puncture.) Press the release button to
take a sample.
9. Unscrew the tip of the lancing device
by turning it counter-clockwise.
10. Push the lancet ejector forward with
the thumb and simultaneously pull
out the sliding barrel to dispose of
the used lancet in a proper
biohazard container.
7.Hold the tip firmly in one hand then
pull out the sliding barrel with the
other hand. This will cock the lancing
device.
1 2 3 4 5
Collecting a Drop of Blood
Collecting a Drop of Blood
19
The lancing device is a convenient medical tool for collecting capillary
blood samples for glucose monitoring or other tests which require one or two
drops of 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. As an added bonus, the also comes with a
transparent tip for AST (Alternative Site Testing).
PRECAUTIONS
• Never use a lancet that has been used by someone else. This could lead to
contamination.
• If the lancing device is to be used by another person, the unit must be properly
disinfected and a new tip and lancet must be used.
• Do not leave the lancet in the device after use.
• A new lancet must only be placed into the lancing device directly before testing.
• This device has many small parts and could be a choking hazard for children
if 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.
• Sterile lancets is used with a spring-operated lancing device.
COMPONENTS
Depth Indicator/Adjustable Tip Lancet Holder
Clear Tip
Ejection System Sliding Barrel
Release Button
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1.Protective Cap
2.Needle
3.Needle Body
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