Infopia GlucoLab Bedienungsanleitung

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 : +34 963 691 484

Fax : +34 963 691 484

E-mail : [email protected]

Blood Glucose Monitoring System for self testing

Quick and Smart

Blood Glucose Monitoring System for self testing

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.

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

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.

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

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.

[ 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

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

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).

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

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).

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.

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

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

ɋɍ

1 2 3

←

1.Protective Cap

2.Needle

3.Needle Body

< Lancet > < Lancing device >

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