Глюкометр med care lis bg 101 инструкция по применению

BLOOD GLUCOSE

MONITORING SYSTEM

USER GUIDE

Before You Begin

PLEASE READ THIS BEFORE USING.

The following basic safety precautions should always be taken.

1. Close supervision is necessary when the device is used by, on, or near children,

handicapped persons or invalids.

2. Use the device only for the intended use described in this User Guide.

3. Do not use test strips and control solutions which are not supplied by the

manufacturer.

4. Do not use the device if it is not working properly, or if it has suffered any damage.

5. Before using any product to test your blood glucose, read all instructions

thoroughly and practice the test. Do all quality control checks as directed and

consult with a diabetes healthcare professional.

6. KEEP THIS USER GUIDE WITH YOU.

Intended Use

The system is intended for use outside the body (in vitro diagnostic use only).

It should be used only for testing blood glucose (blood sugar) and only with fresh

capillary whole blood samples. The system is intended for use in the home and in

clinical settings. It should not be used for the diagnosis of diabetes or for the testing of

newborns.

Principle of Measurement

Blood glucose is measured by an electrical current that is produced when a blood

1.

Getting To Know Your System

The Medicare Blood Glucose Monitoring System-LiS

The Medicare System-LiS system uses the latest technology to provide you with

easy and comfortable testing. The system requires only a 0.3 μL of blood sample to

complete the testing in only 6 seconds.

STRIP SLOT :

METER LABEL:

Insert the test strip here. The meter will

turn on automatically.

Each meter has its unique number on it. It can be

used when you want to obtain warranty service.

Please do not alter or tear the label off.

DISPLAY :

The large, easy to

read display shows

test results, messages,

test results stored in

memory.

Model Name: BG-101

MC14EL005001

OK Biotech Co., Ltd.

Hsinchu, Taiwan

M BUTTON:

BATTERY COMPARTMENT :

Main button, press button to turn the meter on

Holds one 3V Lithium battery (CR2032).

or perform other functions described in this User

Guide.

Meter

TEST STRIP HANDLE :

Hold this part to insert the test strip

into the meter slot.

A B S O R B E N T

CHANNEL:

Apply a drop of

blood here.

CONFIRMATION WINDOW:

This is where we confirm if enough blood is applied for the

test. Ensure that it is fully covered with blood sample.

Test Strip

2

.

Prepare For Blood Sampling

Adjustable Lancing Device

Your lancing device and lancets are used for obtaining

capillary blood samples from the puncture site.

Depth Selector

Lancing

Release Button

Device Cap

Lancet Holder

Lancet Ejector

For In vitro diagnostic use

Please consult instructions for use

Do not reuse

BG — 101

Lot number

Keep dry

Humidity limitation

This product fulfils the requirements of Directive 98/79/EC in vitro diagnostic medical device.

Performance Characteristics:

Accuracy: ≧ 95% of the individual glucose results fell within ± 15 mg/dL(0.83 mmol/L) at glucose concentration <

75 mg/dL(or 4.2 mmol/L) and within ± 20% at glucose concentration ≧ 75 mg/dL(or 4.2 mmol/L), compared with

glucose analyzer YSI 2300.

PRECISION: CVs (%) of intermediate precision and repeatability were less than 5%.

L-Tac MediCare Pte Ltd

25 Mandai Estate #07-11

Innovation Place Tower 1

Singapore 729930

Tel: +65 6334 2273

Fax: +65- 6863 8190

www.medicare-l-tac.com.sg

samples mixes with the reagent (special chemicals) of the test strip. The electrical

current changes with the amount of glucose in the blood sample. The Medicare System-

LiS meter measures the strength of the electrical current, calculates your blood glucose

level and then displays your result in either milligrams of glucose per deciliter (mg/dL) or

millimoles of glucose per liter (mmol/L).

Caution

1. The user should not take any decision of medical relevance without first consulting

his or her medical practitioner.

2. Call your doctor immediately if you experience symptoms that are not consistent with

your blood glucose test results.

3. High altitudes above than 3,402 meter (11,161 ft) may affect the test results.

4. Temperatures outside the range of 5°C to 45°C (41°F to 113°F) may affect the test

results. Do not test beyond of temperature range.

IMPORTANT HEALTH-RELATED INFORMATION

1. Apply only capillary whole blood sample to test your blood glucose. Applying other

substances or plasma, serum will cause wrong results.

2. Severe dehydration and excessive water loss may cause false low results. If

you believe you are suffering from severe dehydration, consult your healthcare

professional immediately.

3. Test results below 60 mg/dL (3.3 mmol/L)*1 indicates low blood glucose

(hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L)*2 indicates high

blood glucose (hyperglycemia).If your results are below 60 mg/dL (3.3 mmol/L) or

above 240 mg/dL (13.3 mmol/L), repeat the test, and if the results are still below

60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), consult your healthcare

professional immediately.

2

10

9

8

7.

UNIT OF MEASURE: Appears with the test result either in mg/dL or mmol/L.

8.

BATTERY SYMBOL: Appears when battery is weak.

9.

BLOOD DROP SYMBOL: Flashes when sample should be applied.

10. STRIP SYMBOL: Appears when the meter is turned on and waiting for inserting a

test strip.

REPLACING THE BATTERY

SET BUTTON:

Located in

1.The meter comes with ONE Lithium battery (battery type CR2032).

the battery

2.Battery life will vary depending on usage, so always keep a spare battery on hand.

compartment; press

button to enter

The battery should last about 1000 tests or 12 months when testing 3 times a day.

10-62-3463-0003

V1-JUL11

meter setting. Refer

3.When the battery symbol appears on the meter display, battery is getting low. You will

to «SETTING YOUR

still be able to test with low battery, but you should replace it as soon as possible.

METER» section of

this user guide for

4.When battery symbol appears together with E-b on the display, the meter will no

details.

longer give results and you must replace the battery immediately. Please always have

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one spare battery with you to ensure that you can replace the battery anytime.

How to replace the battery

J7

J7

J7

CONTACT BARS:

Insert this end into strip slot.

NOTE:

1. Replacing the battery does not affect the test result stored in memory. However the

time and date may need to re-set.

2. As with all small objects, the battery should be kept away from small children as a

safety precaution. If the battery is swallowed, see medical assistance immediately.

3. Batteries might leak chemicals if not used for a long time. Remove the batteries if

you are not going to use the device for 3 months or more.

4.

Please discard the product or the batteries properly according to the regulations

of your country.

Lancet

Protective cap

Important Lancing Device and Lancets Information

1.

Lancet is for single use only.

2. Keep lancing device and lancets clean.

Sliding Barrel

3. Use caution when removing the used lancet from the device and when disposing the

used lancet.

The meter and lancing device are for single patient use.

IMPORTANT :

Do NOT share them with anyone including other family members !

Do NOT use on multiple patients !

Temperature limitation / Store at

Use by /Expiry date

Manufacturer

Caution, consult accompanying document

Keep away from sunlight

EU representative.

10-62-3412-0003 V2-JUL15

OK Biotech Co., Ltd.

No. 91, Sec. 2, Gongdao 5th Road,

30070 Hsinchu City, TAIWAN

www.okbiotech.com

MDSS GmbH

Schiffgraben 41, 30175 Hannover, GERMANY

1

1. DATE: Display year, month and date.

2. TIME: The meter is programmed for a 12

hour period format.

3. AVERAGE: Appears when the meter is in the

memory mode while recalling 7/14/28 day test

3

averages.

4

4. MEMORY SYMBOL: Appears when in the

memory mode.

5

5. THERMOMETER SYMBOL: Appears when

6

ambient temperature is above or below the

acceptable range needed for testing.

7

6. CONTROL SOLUTION TEST SYMBOL:

Appears when you are in Control Solution

Mode. Your test result will not be stored in

meter memory.

1. Make sure the meter is turned off. Let the front of the meter

rest in the palm of your hand. Press the buckle on the battery

cover and lift up to open the cover. Remove the battery.

2. With the plus (+) side up, place the battery (battery type

CR2032) in the compartment and slide it upwards until it is

locked into place. You should hear a beep to indicate the

battery installed correctly. If not, please replace the battery

correctly.

3. Close battery cover.

A :

1

. Getting To Know Your System

SIDE

2. Prepare For Blood Sampling

B :

3. Performing Blood Test

SIDE

4. Understanding Your Test Result

5. Memory Recall

6. Control Solution Testing

7. Caring For Your Meter And Test Strip

8. System Specifications

9. Display Messages And Problem-Solving Guide

4. Inaccurate results may occur in severely hypotensive individuals or patients

in shock. Inaccurate low results may occur for individuals experiencing a

hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients

should not be tested with blood glucose meters.

5. Abnormal red blood cell counts (hematocrit level below 20% or above 60%) may

cause false results. Please consult your healthcare professional if you do not know

your hematocrit level.

6. Interference: Reducing substances occurring in the blood naturally (uric acid,

bilirubin) or from therapeutic treatments (ascorbic acid, acetaminophen) will

not significantly affect Medicare System-LiS test results. However, elevated

concentrations of these substances may affect test results. The compounds listed

in the tables were found to have no affect at the concentration indicated.

Compounds

Highest concentrations

Compounds

tested at which no

≦ 8.0 mg/dL (0.53 mmol/L)

interference occured

≦ 5.0 mg/dL (0.28 mmol/L)

Acetaminophen

Gentisic Acid

≦ 60 mg/dL (3.33 mmol/L)

Ascorbic Acid

Hydroxyurea

≦ 90 mg/dL (1.54 mmol/L)

Aspirin

L-dopa

≦ 500 mg/dL (12.9 mmol/L) Methyldopa

Bilirubin

Maltose

≦ 5.0 mg/dL (0.44 mmol/L)

Cholesterol

≦ 2.0 mg/dL (0.11 mmol/L)

Creatinine

Tolbutamide

≦ 900 mg/dL (50 mmol/L)

Dopamine

Triglycerides

Galactose

Uric Acid

REFERENCE:

* 1: Kahn, R. and Weir, G.: Joslinis Diabetes Mellitus, 13thed Philadelphia : Lea and Febiger (1994), 489.

* 2: Krall, L.P. and Beaser, R. S.: Joslin Diabetes Manual. Philadelphia : Lea and Febiger(1989), 261-263.

SETTING YOUR METER

Please install battery first and set to correct settings before you begin to test.

STEP 1. Enter Setting Mode

Start with the meter off. Open the battery compartment, and press SET

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BUTTON. The meter will turn on and enter the setting mode.

STEP 2. Set the Year

The year appears with the number flashing. Press and release the M

BUTTON to obtain the desired year. Press SET BUTTON to confirm

and move to next MONTH setting.

STEP 3. Set the Month

The month appears with the number flashing. Press and release the M

BUTTON to obtain the desired month. Press SET BUTTON to confirm

and move to next DATE setting.

STEP 4. Set the Date

The date appears with the number flashing. Press and flash the M

BUTTON to obtain the desired date. Press SET BUTTON to confirm

and move to next HOUR setting.

STEP 5. Set the Hour

The hour appears with the number flashing. Press and release the M

BUTTON to obtain the desired hour. Press SET BUTTON to confirm

and move to next minutes setting.

STEP 6. Set the Minute

The minute appears with the number flashing. Press and release the M

BUTTON to obtain the desired minute. Press SET BUTTON to confirm

and the meter will enter to next unit setting.

STEP 7. Set the Unit of Measurement

The existing unit (for example mg/dL) will appear and flash. You can

choose to reset measurement unit. If you do not want to change unit,

press SET BUTTON to skip this step. If you want to change unit, press

and hold the M BUTTON for 3 seconds to change the unit to mmol/L.

Press SET BUTTON to confirm and the meter will enter to next setting.

STEP 8. Delete Memory

When the dEL symbol and the flashing memory symbol appear on the

display, you can choose to clear the memory. If you do not want to clear

the memory, press the SET BUTTON again to skip this step. If you want

to clear ALL memory, press and hold M BUTTON for 4 seconds. The «—

-» image will appear on the LCD screen to indicate that all memory has

been deleted.

STEP 9. Complete Setting

After delete memory, the meter will display «OFF» before shut down.

The meter setting is now completed

IMPORTANT :

1.

The time, date and unit of measurement can ONLY be changed in the setting mode.

Therefore, when you perform a blood glucose testing, it is not possible to change those

parameters.

2.

Your meter displays 7, 14 and 28-day averages which you can access from the meter

memory. These averages are calculated from your latest result obtained during the last 7,

14 and 28 days.

3.

Your meter can display test result in milligram per deciliter (mg/dL) or millimoles per liter

(mmol/L). The mg/dL unit is standard in the United States. The mmol/L unit is standard

in Canada and European countries. Your meter has been preset at the factory with the

standard unit measurement used where you live. When you turn off the meter or replace

the battery, the unit will not be changed.

4.

Use of the wrong unit of measure may cause you to misinterpret your blood glucose

level, and may lead to incorrect treatment. Please always consult with your healthcare

professionals before you reset the unit of measure.

Setting your Lancing Device

1. Screw off the cap of lancing device. Insert a

lancet into the lancet holder and push down until

it is fully seated.

2. Twist off the protective cap until it separates from

the lancet.

3 . Replace the lancing device cap and set the

puncture depth to the desired number.

NOTE: THE DEPTH SELECTOR OFFERS 5 LEVELS OF SKIN

PENETRATION:

1-2 FOR SOFT OR THIN SKIN

3 FOR AVERAGE SKIN

4-5 FOR THICK OR CALLOUSED SKIN

4. Pull back the sliding barrel until it makes a click,

and then release. If it does not click, the device

may have been cocked when the lancet was

inserted.

Highest concentrations tested

at which no interference

≦ 5.0 mg/dL (0.32 mmol/L)

occured

≦ 3.0 mg/dL (0.39 mmol/L)

≦ 10 mg/dL (0.51 mmol/L)

≦ 900 mg/dL (26.3 mmol/L)

≦ 3.0 mg/dL (0.13 mmol/L)

≦ 400 mg/dL (14.8 mmol/L)

≦ 2,000 mg/dL (22.6 mmol/L)

≦ 8.0 mg/dL (0.48 mmol/L)

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Информация производителя

Способ применения

Система измерения уровня глюкозы в крови Медикеа-Лис (Medicare — Lis) иепользует новейшие технологии, чтобы обеспечить Вам легкое и удобное измерение.
Для проведения измерения и получения результата требуется всего 0,3 мкл крови и 6 секунд времени.

Полоски для глюкометровЛанцеты для глюкометров

Способ применения и дозировкаОписаниеСоставФармакотерапевтическая группаПоказанияУсловия храненияСрок годностиХранятся в холодильникеСодержит спиртКодеинсодержащийНаркотический/Психотропный

Способ применения и дозировка

1. Вымойте руки и место для анализа: Вымойте руки теплой водой с мылом. Прополощите и высушите хорошо. Согрейте пальцы для прилива крови.

2. Вставьте тест-полоску: Извлеките новую тест-полоску из упаковки. Сразу же поместите полоску в разъем. Прибор включится автоматически. Когда символ крови начинает мигать, можно начать проведение теста.

3. Выбор и прокол места для анализа

    • Для кончика пальца:  Держите подготовленное прокалывающее устройство, направив строго на боковую поверхность кончика пальца. Нажмите кнопку спуска ланцета.
    • Для альтернативных мест (ладонь или предплечье): Проконсультируйтесь с врачом перед альтернативных мест для тестирования.

      4. Получите пробу крови:

      • Аккуратно помассируйте палец или место для анализа для получения достаточного количества крови.
      • Для проведения теста Вам понадобится всего 0.3 мкл крови. Не смазывайте образец крови.
      • Для получения точного результата сотрите первую каплю крови и аккуратно выдавите вторую каплю.

      5. Нанесите кровь на тест-полоску

      • Нанесите кровь на кончик впитывающего канала тест полоски пока окошко подтверждения полностью не заполнится кровью.
      • После этого прибор начинает обратный отсчет и показывает результат через 6 секунд.

      6. Посмотрите на результат

      • Прибор отобразит значение уровня содержания глюкозы в крови через 6 секунд.

      7. Извлеките тест-полоску из прибора для его выключения и утилизируйте

      • Результат Вашего теста автоматически записывается в память устройства.
      • Выключите прибор, вытащив тест-полоску.
      • Использованные тест-полоски следует утилизировать надлежащим образом.

      8. Защита использованного ланцета

      • Отсоедините колпачок прокалывающего устройства и наденьте на острый кончик ланцета защитный элемент.

      9. Утилизируйте использованный ланцет

      • Протолкните эжектор ланцета вперед и извлеките ланцет.
      • Закройте ланцет защитной крыщкой и поместите в контейнер для острых предметов для последующей утилизации.

      Описание

      Система измерения уровня глюкозы в крови Медикеа-Лис (Medicare — Lis):

      • Не нуждается в кодировании; это позволяет сократить время и избежать субъективной ошибки при кодировании.
      • Позволяет использовать альтернативное место для теста (ладонь, предплечье).
      • Оснащена памятью.

      Состав

      Комплектация:

      • Прибор для измерения уровня глюкозы в крови Медикеа-Лис (MediCare — Lis) модель BG-101 — 1шт.
      • Щелочная батарейка – 1 шт.
      • Прокалывающее устройство Медикеа (MediCare) — 1 шт.
      • Ланцеты одноразовые стерильные Медикеа (MediCare) 30G – 10 шт.
      • Сумочка для переноски — 1шт.
      • Руководство пользователя системой — 1 шт.
      • Краткое руководство пользователя — 1 шт.

      Фармакотерапевтическая группа

      Медицинские приборы

      Показания

      Система измерения уровня глюкозы в крови Медикеа-Лис (MediCare — Lis) предназначена для измерения уровня глюкозы в капиллярной крови вне организма (только для диагностики invitro) в домашних условиях людьми с сахарным диабетом или с подозрением на сахарный диабет, а также медицинскими специалистами в медучреждениях.

      Условия хранения

      При температуре 4°С~40°С (39°Р~104°Р) при относительной влажности воздуха 10-85% .

      Срок годности

      Срок службы 5 лет

      Хранятся в холодильнике

      Нет

      Содержит спирт

      Нет

      Кодеинсодержащий

      Нет

      Наркотический/Психотропный

      Нет

      Обращаем ваше внимание, что инструкция к товарам может меняться. Для уточнения актуальной информации обратитесь к оригинальной инструкции.

      Самовывоз в Арзамасе

      Низкие цены

      Арзамас, ул. Гостиный ряд, 25, пом.1

      Твоя экономия

      Арзамас, ул. Парковая, 5

      АптекаПлюс

      Арзамас, пр-кт Ленина, 137

      АптекаПлюс

      Арзамас, ул. Мира, 15

      АптекаПлюс

      Арзамас, ул. Мира, 14А, пом.1

      Аптеки в вашем городе 43 аптеки

      Все сети аптек в вашем городе

      Кратко о товаре Глюкометр Медикеа-ЛиС BG-101 в Арзамасе

      Купить Глюкометр Медикеа-ЛиС BG-101 в Арзамасе можно в удобной для вас аптеке, сделав заказ на Мегаптека.ру

      Цена на Глюкометр Медикеа-ЛиС BG-101 в Арзамасе – от 552,40 рублей

      Инструкция по применению для Глюкометр Медикеа-ЛиС BG-101

      Цены в других городах

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      Москва, Новосибирск, Екатеринбург, Казань, Нижний Новгород, Челябинск, Самара, Уфа, Ростов-на-Дону, Омск, Красноярск, Воронеж, Пермь, Волгоград, Краснодар, Тюмень, Саратов, Ижевск, Барнаул, Ульяновск, Иркутск, Ярославль, Саранск, Вологда, Брянск, Улан-Удэ, Абакан, Курск, Ставрополь, Белгород

      Цена зависит от выбранной аптеки и действительна только при заказе через сервис Мегаптека.ру

      SIDE

      1

      2

      Before You Begin

      PLEASE READ THIS BEFORE USING.

      The following basic safety precautions should always be taken.

      1.  Close supervision is necessary when the device is used by, on, or near children, 

      handicapped persons or invalids.

      2.  Use the device only for the intended use described in this User Guide.

      3.  Do not use test strips and control solutions which are not supplied by the 

      manufacturer.

      4.  Do not use the device if it is not working properly, or if it has suffered any damage.

      5.  Before using any product to test your blood glucose, read all instructions 

      thoroughly and practice the test. Do all quality control checks as directed and 

      consult with a diabetes healthcare professional.

      6.  KEEP THIS USER GUIDE WITH YOU.

      Intended Use

      The system is intended for use outside the body (

      in vitro

       diagnostic use only). 

      It should be used only for testing blood glucose (blood sugar) and only with fresh 

      capillary whole blood samples. The system is intended for use in the home and in 

      clinical settings. It should not be used for the diagnosis of diabetes or for the testing of 

      newborns.

      Principle of Measurement

      Blood glucose is measured by an electrical current that is produced when a blood 

           Getting To Know Your System

      The Medicare Blood Glucose Monitoring System-LiS

      The Medicare System-LiS system uses the latest technology to provide you with 

      easy and comfortable testing. The system requires only a 0.3 μL of blood sample to 

      complete the testing in only 6 seconds.

      samples mixes with the reagent (special chemicals) of the test strip. The electrical 

      current changes with the amount of glucose in the blood sample. The Medicare System-

      LiS meter measures the strength of the electrical current, calculates your blood glucose 

      level and then displays your result in either milligrams of glucose per deciliter (mg/dL) or 

      millimoles of glucose per liter (mmol/L). 

      Caution

      1.  The user should not take any decision of medical relevance without first consulting 

      his or her medical practitioner. 

      2.  Call your doctor immediately if you experience symptoms that are not consistent with 

      your blood glucose test results.

      3.  High altitudes above than 3,402 meter (11,161 ft) may affect the test results. 

      4.  Temperatures outside the range of 5°C to 45°C (41°F to 113°F) may affect the test 

      results. Do not test beyond of temperature range.

      IMPORTANT HEALTH-RELATED INFORMATION

      1.  Apply only capillary whole blood sample to test your blood glucose. Applying other 

      substances or plasma, serum will cause wrong results.

      2.  Severe dehydration and excessive water loss may cause false low results. If 

      you believe you are suffering from severe dehydration, consult your healthcare 

      professional immediately.

      3.  Test results below 60 mg/dL (3.3 mmol/L)*1 indicates low blood glucose 

      (hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L)*2 indicates high 

      blood glucose (hyperglycemia).If your results are below 60 mg/dL (3.3 mmol/L) or 

      above 240 mg/dL (13.3 mmol/L), repeat the test, and if the results are still below 

      60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), consult your healthcare 

      professional immediately.

      4.  Inaccurate results may occur in severely hypotensive individuals or patients 

      in shock. Inaccurate low results may occur for individuals experiencing a 

      hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients 

      should not be tested with blood glucose meters.

      5.  Abnormal red blood cell counts (hematocrit level below 20% or above 60%) may 

      cause false results. Please consult your healthcare professional if you do not know 

      your hematocrit level.

      6.  Interference: Reducing substances occurring in the blood naturally (uric acid, 

      bilirubin) or from therapeutic treatments (ascorbic acid, acetaminophen) will 

      not significantly affect Medicare System-LiS test results. However, elevated 

      concentrations of these substances may affect test results. The compounds listed 

      in the tables were found to have no affect at the concentration indicated.

      Compounds

      Highest concentrations 

      tested at which no 

      interference occured

      Compounds

      Highest concentrations tested 

      at which no interference 

      occured

      Acetaminophen

       8.0 mg/dL (0.53 mmol/L) Gentisic Acid

       5.0 mg/dL (0.32 mmol/L)

      Ascorbic Acid 

       5.0 mg/dL (0.28 mmol/L) Hydroxyurea

       3.0 mg/dL (0.39 mmol/L)

      Aspirin

       60 mg/dL (3.33 mmol/L)

      L-dopa

       10 mg/dL (0.51 mmol/L)

      Bilirubin

       90 mg/dL (1.54 mmol/L)

      Maltose

       900 mg/dL (26.3 mmol/L)

      Cholesterol

       500 mg/dL (12.9 mmol/L) Methyldopa

       3.0 mg/dL (0.13 mmol/L)

      Creatinine

       5.0 mg/dL (0.44 mmol/L) Tolbutamide

       400 mg/dL (14.8 mmol/L)

      Dopamine

       2.0 mg/dL (0.11 mmol/L) Triglycerides

       2,000 mg/dL (22.6 mmol/L)

      Galactose

       900 mg/dL (50 mmol/L)

      Uric Acid

       8.0 mg/dL (0.48 mmol/L)

      REFERENCE:

      * 1: Kahn, R. and Weir, G.: Joslinis Diabetes Mellitus, 13thed Philadelphia : Lea and Febiger (1994), 489.  

      * 2: Krall, L.P. and Beaser, R. S.: Joslin Diabetes Manual. Philadelphia : Lea and Febiger(1989), 261-263.

      1. 

      DATE:

       Display year, month and date.

      2. 

      TIME:

       The meter is programmed for a 12 

      hour period format.

      3. 

      AVERAGE:

       Appears when the meter is in the 

      memory mode while recalling 7/14/28 day test 

      averages.

      4. 

      MEMORY SYMBOL:

       Appears when in the 

      memory mode. 

      5. 

      THERMOMETER SYMBOL:

       Appears when 

      ambient temperature is above or below the 

      acceptable range needed for testing.

      6. 

      CONTROL SOLUTION TEST SYMBOL:

      Appears when you are in Control Solution 

      Mode. Your test result will not be stored in 

      meter memory.

      7. 

      UNIT OF MEASURE:

       Appears with the test result either in mg/dL or mmol/L.

      8. 

      BATTERY SYMBOL: 

      Appears when battery is weak.

      9. 

      BLOOD DROP SYMBOL: 

      Flashes when sample should be applied.

      10. 

      STRIP SYMBOL: 

      Appears when the meter is turned on and waiting for inserting a 

      test strip.

      1.

      A

      1

      . Getting To Know Your System

      2. Prepare For Blood Sampling

      3. Performing Blood Test

      4. Understanding Your Test Result

      5. Memory Recall

      6. Control Solution Testing

      7. Caring For Your Meter And Test Strip 

      8. System Specifications

      9. Display Messages And Problem-Solving Guide

      SIDE

      A  :

      SIDE

      B  :

      Test Strip

      ABSORBENT 

      CHANNEL:

      Apply a drop of 

      blood here.

      CONTACT BARS:

      Insert this end into strip slot.

      TEST STRIP HANDLE :

      Hold this part to insert the test strip 

      into the meter slot.

      CONFIRMATION WINDOW:

      This is where we confirm if enough blood is applied for the 

      test. Ensure that it is fully covered with blood sample.

      For 

      In vitro diagnostic use

      Temperature limitation / Store at

      Please consult instructions for use

      Use by /Expiry date

      Do not reuse

      Manufacturer

      Lot number

      Caution, consult accompanying document

      Keep dry

      Keep away from sunlight

      Humidity limitation

      EU representative.

      This product fulfils the requirements of Directive 98/79/EC in vitro diagnostic medical device.

      Performance Characteristics:

      Accuracy:

       95% of the individual glucose results fell within ± 15 mg/dL(0.83 mmol/L) at glucose concentration

      75 mg/dL(or 4.2 mmol/L) and within ± 20% at glucose concentration 

      75 mg/dL(or 4.2 mmol/L), compared with 

      glucose analyzer YSI 2300.

      PRECISION: CVs (%) of intermediate precision and repeatability were less than 5%.

      1

      2

      3

      4

      5

      6

      7

      9 8

      10

      REPLACING THE BATTERY

      1.The meter comes with ONE Lithium battery (battery type CR2032). 

      2.Battery life will vary depending on usage, so always keep a spare battery on hand. 

         The battery should last about 1000 tests or 12 months when testing 3 times a day. 

      3.When the battery symbol appears on the meter display, battery is getting low. You will 

      still be able to test with low battery, but you should replace it as soon as possible.

      4.When battery symbol appears together with E-b on the display, the meter will no 

      longer give results and you must replace the battery immediately. Please always have 

      one spare battery with you to ensure that you can replace the battery anytime.

      How to replace the battery

      J7

      1. Make sure the meter is turned off. Let the front of the meter 

      rest in the palm of your hand. Press the buckle on the battery 

      cover and lift up to open the cover. Remove the battery.

      J7

      2. With the plus (+) side up, place the battery (battery type 

      CR2032) in the compartment and slide it upwards until it is 

      locked into place. You should hear a beep to indicate the 

      battery installed correctly. If not, please replace the battery 

      correctly.

      J7

      3. Close battery cover.

      NOTE: 

      1. Replacing the battery does not affect the test result stored in memory. However the 

      time and date may need to re-set.

      2. As with all small objects, the battery should be kept away from small children as a 

      safety precaution. If the battery is swallowed, see medical assistance immediately.

      3. Batteries might leak chemicals if not used for a long time. Remove the batteries if 

      you are not going to use the device for 3 months or more.

      4. 

       Please discard the product or the batteries properly according to the regulations

                    of your country.

      SETTING YOUR METER

      Please install battery first and set to correct settings before you begin to test.

      J7

      STEP 1. Enter Setting Mode

      Start with the meter off. Open the battery compartment, and press SET 

      BUTTON. The meter will turn on and enter the setting mode. 

      STEP 2. Set the Year

      The year appears with the number flashing. Press and release the M 

      BUTTON to obtain the desired year. Press SET BUTTON to confirm 

      and move to next MONTH setting.

      STEP 3. Set the Month

      The month appears with the number flashing. Press and release the M 

      BUTTON to obtain the desired month. Press SET BUTTON to confirm 

      and move to next DATE setting.

      STEP 4. Set the Date

      The date appears with the number flashing. Press and flash the M 

      BUTTON to obtain the desired date. Press SET BUTTON to confirm 

      and move to next HOUR setting.

      STEP 5. Set the Hour

      The hour appears with the number flashing. Press and release the M 

      BUTTON to obtain the desired hour. Press SET BUTTON to confirm 

      and move to next minutes setting.

      STEP 6. Set the Minute

      The minute appears with the number flashing. Press and release the M 

      BUTTON to obtain the desired minute. Press SET BUTTON to confirm 

      and the meter will enter to next unit setting. 

      STEP 7. Set the Unit of Measurement

      The existing unit (for example mg/dL) will appear and flash. You can

      choose to reset measurement unit. If you do not want to change unit,

      press SET BUTTON to skip this step. If you want to change unit, press

      and hold the M BUTTON for 3 seconds to change the unit to mmol/L.

      Press SET BUTTON to confirm and the meter will enter to next setting.

      STEP 8. Delete Memory

      When the dEL symbol and the flashing memory symbol appear on the 

      display, you can choose to clear the memory. If you do not want to clear 

      the memory, press the SET BUTTON again to skip this step. If you want 

      to clear ALL memory, press and hold M BUTTON for 4 seconds. The “—

      -“ image will appear on the LCD screen to indicate that all memory has 

      been deleted.

      STEP 9. Complete Setting

      After delete memory, the meter will display “OFF” before shut down. 

      The meter setting is now completed

      IMPORTANT :

      1. The time, date and unit of measurement can ONLY be changed in the setting mode. 

      Therefore, when you perform a blood glucose testing, it is not possible to change those 

      parameters.

      2. Your meter displays 7, 14 and 28-day averages which you can access from the meter 

      memory. These averages are calculated from your latest result obtained during the last 7, 

      14 and 28 days. 

      3. Your meter can display test result in milligram per deciliter (mg/dL) or millimoles per liter 

      (mmol/L). The mg/dL unit is standard in the United States. The mmol/L unit is standard 

      in Canada and European countries. Your meter has been preset at the factory with the 

      standard unit measurement used where you live. When you turn off the meter or replace 

      the battery, the unit will not be changed. 

      4. Use of the wrong unit of measure may cause you to misinterpret your blood glucose 

      level, and may lead to incorrect treatment. Please always consult with your healthcare 

      professionals before you reset the unit of measure.

      BLOOD GLUCOSE 

      MONITORING SYSTEM

      BG — 101

      USER GUIDE

      J7

      MC14EL005001

      Model Name: BG-101

      OK Biotech Co., Ltd.

      Hsinchu, Taiwan

      10-62-3463-0003

      V1-JUL11

      Meter

      DISPLAY :

      The large, easy to 

      read display shows 

      test results, messages, 

      test results stored in 

      memory.

      STRIP SLOT :

      Insert the test strip here. The meter will 

      turn on automatically.

      METER LABEL:

      Each meter has its unique number on it. It can be 

      used when you want to obtain warranty service. 

      Please do not alter or tear the label off.

      M BUTTON:

      Main button, press button to turn the meter on 

      or perform other functions described in this User 

      Guide.

      SET BUTTON: 

      Located in 

      the battery 

      compartment; press 

      button to enter 

      meter setting. Refer 

      to “SETTING YOUR 

      METER” section of 

      this user guide for 

      details.

      BATTERY COMPARTMENT :

      Holds one 3V Lithium battery (CR2032).

      Protective cap

      Lancet

        Important Lancing Device and Lancets Information

      1.    Lancet is for single use only.

      2.  Keep lancing device and lancets clean.

      3.  Use caution when removing the used lancet from the device and when disposing the 

      used lancet.

      IMPORTANT : 

      The meter and lancing device are for single patient use.

                           Do NOT share them with anyone including other family members !

                           Do NOT use on multiple patients !

      Setting your Lancing Device

      1. Screw off the cap of lancing device. Insert a 

      lancet into the lancet holder and push down until 

      it is fully seated.

      2. Twist off the protective cap until it separates from 

      the lancet.

      4

      5

      3.Replace the lancing device cap and set the 

      puncture depth to the desired number.

      NOTE: THE DEPTH SELECTOR OFFERS 5 LEVELS OF SKIN 

      PENETRATION:

      1-2 FOR SOFT OR THIN SKIN

      3 FOR AVERAGE SKIN

      4-5 FOR THICK OR CALLOUSED SKIN

      1

      2

      4. Pull back the sliding barrel until it makes a click, 

      and then release. If it does not click, the device 

      may have been cocked when the lancet was 

      inserted.

           Prepare For Blood Sampling

      Adjustable Lancing Device

      Your lancing device and lancets are used for obtaining

      capillary blood samples from the puncture site.

      2

      .

      Lancet Holder

      Lancing

      Device Cap

      Depth Selector

      Release Button

      Lancet Ejector

      Sliding Barrel

      OK Biotech Co., Ltd.

      No. 91, Sec. 2, Gongdao 5th Road, 

      30070 Hsinchu City, TAIWAN

      www.okbiotech.com

      MDSS GmbH

      Schiffgraben 41, 30175 Hannover, GERMANY

      L-Tac MediCare Pte Ltd

      25 Mandai Estate #07-11

      Innovation Place Tower 1

      Singapore 729930

      Tel: +65 6334 2273

      Fax: +65- 6863 8190

      www.medicare-l-tac.com.sg

      10-62-3412-0003   V2-JUL15

      3

      .

      Performing Blood Test

      1. Wash Your Hands and the Puncture Site : Wash

      your hands in warm, soapy water. Rinse and dry

      completely. Warm your fingers to increase blood flow.

      2. Insert Test Strip : Remove a new test strip from vial.

      Be sure to tightly replace vial cap after removing test

      strips. Insert test strip immediately into strip slot as

      illustrated. The meter turns on automatically. When the

      blood symbol blinking, you are ready to perform a test.

      3. Select and Lance a Puncture Site

      *For Fingertip

      Hold the prepared lancing device firmly against the

      side of your fingertip. Press release button.

      *For AST

      Please refer to the «About Alternative Site Testing

      (AST)» Section. Please consult your healthcare

      professional before obtaining blood from site other

      than your fingertip.

      4. Obtain a Blood Sample : Gently massage your finger

      or puncture site to obtain the required blood volume.

      To perform the test, you need only 0.3 μL of blood

      sample. Do not smear the blood sample. To obtain

      best accurate result, wipe off the first drop of blood and

      gently squeeze another drop of blood.

      5. Apply Blood Sample : Apply the blood sample to the

      opening of absorbent channel of test strip until the

      confirmation window is fully covered with blood. Then

      the meter begins to count down.

      6. Read Your Result :

      The meter will display your blood glucose value after 6

      seconds.

      6

      .

      Control Solution Testing

      If your Medicare control solution did not come with an Medicare control solution

      Instruction, the following information shall take the place of the instruction.

      Medicare control solutions contain a pre-set amount of glucose that reacts with

      OKmeter test strips. By testing your control solution and comparing the test results

      with the expected range printed on the test strip vial label, you can make sure that the

      meter and the test strips are working properly together as a system and that you are

      performing the test correctly.

      Why perform a control solution test?

      1. To ensure that your meter and test strip are working properly together.

      2. To allow you to practice testing without using your own blood.

      When should the control solution test be performed?

      1. Whenever you suspect that the meter or test strips are not working properly.

      2. When your blood glucose test results are not consistent with how you feel, or

      when you think your results are not accurate.

      3. When test strips are exposed to extreme environmental conditions.

      4. If you drop the meter.

      5. After changing the battery.

      Important Control Solution Information

      1. Check the expiration date on the control solution bottle. Do not use if expired.

      2. Control solution, meter, and test strips should come to room temperature (68-

      77 ºF/20-25ºC) before testing.

      3. Shake the bottle before use, discard the first drop of control solution after

      squeezing, wipes off the dispenser tip to avoid contaminations. These steps

      ensure you will get a good sample and an accurate result.

      4. Record the discard date on the bottle when you open a new bottle of control

      solution.

      NOTE : 1. There are two levels of control solution (normal and high) available to purchase.

      Please contact with your local distributor when required.

      2. The control solution range printed on the test strip vial is for Medicare control solution

      only. It is used to test meter and strip performance. It is not recommended range for

      your blood glucose level.

      Composition:

      1. D-Glucose

      5. Disodium EDTA

      2. Polyvinyl acetate (aqueous emulsion)

      6. Food Pigment Red No.6

      3. Fumed silica

      7. Antifoaming agent

      4. Sodium Benzoate

      (Polyethylene Glycol 4000)

      9

      .

      Display Messages And Problem-Solving Guide

      The following is a summary of some display messages and symbols. These messages

      help to identify certain problems but do not appear in all cases when a problem has

      occurred.

      Improper use may cause an inaccurate result without producing an error message.

      In the event of a problem, refer to information under »action to take»

      DISPLAY

      DESCRIPTION

      If some parts of the display are not

      Display check

      working. Contact your local distributor

      for help.

      The meter is waiting for test strip to be

      Moving Strip

      inserted.

      The meter is ready for blood applying

      Blinking Blood

      into test strip.

      Deleting memory

      Deleting is complete.

      If this is not confirmed by the way you

      feel, review proper testing procedure

      Test result is higher than

      and perform a control test. Repeat blood

      600 mg/dL (33.3 mmol/L).

      test, if the display still appears, please

      call medical assistance immediately.

      If this is not confirmed by the way you

      feel, review proper testing procedure

      Test result is lower than

      and perform a control test. Repeat blood

      20 mg/dL (1.1 mmol/L).

      test, if the display still appears, please

      call medical assistance immediately.

      4

      .

      The normal blood glucose range is below 100 mg/dL (5.6 mmol/L) for a

      fasting, non-diabetic adult, but less than 140 mg/dL (7.8 mmol/L) two hours

      after meals.* Consult your healthcare professional to find out your target blood

      Incorrect

      Correct

      glucose value.

      If your blood glucose result seems unusually high or low, or inconsistent with

      your previous results, check the following:

      1. Was the blood sample applied immediately to the test strip after removing it

      from the vial?

      2. Was the volume of the blood sample sufficient?

      3. Was the test strip vial cap tightly sealed?

      90°

      4. Was the test strip used before the expiration date?

      5. Were the test strips stored away from extreme temperatures in very cold or

      hot weather or from areas of high humidity?

      Then run a control test with Medicare control solution. If the control test result

      is within the acceptable range, review testing procedure and repeat your blood

      glucose test with a new test strip. If your blood glucose value is still inconsistent

      with your previous results, glucose trend, or how you feel, contact your doctor

      immediately for help.

      REFERENCE:

      *American Diabetes Association (http://www.diabetes.org/diabetes-basics/prevention/pre-diabetes/diagnosis.html)

      How to Perform a Control Test

      NOTE :

      1. Be sure that you are in Control Solution Mode so that the test result will not be stored

      in themeter memory.

      2. DO NOT APPLY THE CONTROL SOLUTION DIRECTLY TO THE TEST STRIP!

      Overdosed solution may give inaccurate result.

      3. Repeat test if test result falls outside the control range stated on the test strip label. If

      subsequent test remains to produce unacceptable result, the meter or test strip may

      be faulty. DO NOT use the system. Contact us or your local distributor for help.

      DISPLAY

      Battery is weak.

      ACTION TO TAKE

      Battery is dead.

      Maybe:

      1. Used strip or

      2. Meter is defective.

      Temperature is out of the

      operating range.

      Maybe:

      No responses

      1. Battery is dead.

      when strip is

      2. Wrong strip be

      inserted into

      the meter

      3. Meter is defective.

      No responses

      Maybe:

      when blood

      1. Blood sample is not

      sample is

      applied to the

      2. Meter is defective.

      strip

      7. Remove Strip to Turn Meter Off :

      Your blood glucose result is automatically stored in the

      meter memory. Turn the meter off by removing the test

      strip.

      8. Secure the Used Lancet : Twist off the lancing device

      cap, and push the exposed tip of the lancet into its

      protective cap.

      9. Discard the Used Lancet : Slide the lancet ejector

      forward and dispose the lancet. Discard the lancet

      according to your safety regulations.

      * Do not reuse lancets.

      1. Insert Test Strip : Insert a new test strip into the strip slot,

      the meter will activate.

      2. Mark as a Control Solution Test : After the blood

      symbol( ) appears, press M BUTTON and a CONTROL

      SOLUTION TEST SYMBOL( ) shows up, now you are in

      the Control Solution Mode. The meter will not store your

      test result in the memory when you preset the test as a

      control solution test. If you decide not to perform a control

      solution test, press M BUTTON again and the CONTROL

      SOLUTION TEST SYMBOL ( ) will disappear.

      3. Squeeze a drop of Control Solution : Shake control

      solution bottle well. Remove the cap. Squeeze bottle,

      discard the first drop and wipe off the dispenser tip with

      a clean tissue paper or cotton swab. Squeeze a drop on

      clean bottle cap/fingertip /non-absorbent surface.

      4. Apply Control Solution : Apply the drop to the opening

      of the strip absorbent channel until the confirmation

      window is filled. The meter begins to count down.

      5. Check if the test result is in range: After the meter

      counts down, the test result shows up. Compare the test

      result with the range printed on the test strip vial. The

      result should fall within the printed range.

      DESCRIPTION

      ACTION TO TAKE

      Replace battery soon.

      Replace battery now.

      You have to:

      1. Repeat test with a new test strip.

      moistened strip is

      2. Contact your local distributor for

      inserted.

      help.

      The meter is not working. Move to an

      area with temperature between 10ºC to

      40ºC (50ºF — 104ºF) and wait at least 30

      minutes. Do not artificially heat or cool

      the meter.

      You have to:

      1. Replace battery.

      2. Insert the test strip correctly.

      inserted.

      3. Contact your local distributor for

      help.

      You have to:

      1. Repeat test with sufficient

      sample.

      sufficient.

      2. Contact your local distributor for

      help.

      5

      .

      Memory Recall

      The Medicare System-LiS automatically stores 120 test results, letting you review

      them in order from the most recent to the oldest. The meter also calculates and

      displays 7, 14 and 28-day averages. You can review the individual or average test

      result by entering the memory mode.

      STEP 1. Enter the Memory Mode

      While the meter is turned off, press M BUTTON to turn on the

      meter. When the strip symbol blinks in the display, press M

      BUTTON again to enter memory mode.

      STEP 2. Recalling Average Test Results

      When entering the memory mode, the 7-day average will

      appear. If you continue to press the M BUTTON, the 14-day

      and 28-day averages will appear in order.

      STEP 3. Recalling Individual Test Results

      After 28-day average, the most recent test result with date

      and time will be shown. Press M BUTTON once and the next

      most recent test result will appear. Each time you press and

      release the M BUTTON, the meter will recall up to your last

      120 test results in order. When the memory is full, the oldest

      result is dropped as the newest is added. After reaching the

      last set of result, the meter will turn off automatically.

      STEP 4. Exit the Memory Mode

      If you want to exit the memory mode before reaching the last

      result, press and hold M BUTTON for three (3) seconds to

      turn off the meter.

      NOTE :

      1.

      The control solution results are NOT stored in the memory if you preset the

      control test correctly. (Please refer to the «CONTROL SOLUTION TEST» Section

      for details). The list of past results and the result average are for blood glucose

      results only.

      2.

      When using the meter for the first time, »—-» is displayed. When you recall the

      test results or review the average result, it means that there is no test result in

      memory.

      3.

      The averages are calculated from your latest result obtained during the last 7, 14

      and 28 days.

      4.

      Anytime in memory mode, you can press M BUTTON for three (3) seconds to

      exit and turn off the meter.

      5.

      While in the memory mode, if you leave the meter alone without any action for

      one (1) minute, the meter will turn off automatically.

      7

      .

      Caring For Your Meter And

      To avoid the meter and test strips getting dirt, dust or other contaminants, please

      wash and dry your hands thoroughly before use.

      Cleaning

      Your meter does not require special maintenance. As long as no blood or control

      solution comes in direct contact with the meter, there is no special cleaning

      required.

      To clean the meter exterior, wipe with a cloth moistened with tap water or a mild

      cleaning agent, then dry the device with a soft and dry cloth. Do not flush with

      water.

      Do not use organic solvents to clean the meter. Your meter is a precision

      instrument. Please handle it with care.

      Storage

      1. Meter Storage

      * Storage condition: -20ºC~50ºC (-4ºF~122ºF), below 90% relative humidity.

      * Avoid dropping and strong impact.

      * Avoid direct sunlight and humidity.

      2. Strip Storage

      * Storage condition: 4°C~40°C (39°F~104°F), and 10~85% relative humidity. Do

      not freeze.

      * Store your test strips in their original vial only. Do not transfer to other

      container.

      * Store test strip packages in a cool and dry place. Keep away from direct

      sunlight and heat.

      * After removing a test strip from the vial, immediately replace the vial cap and

      close it tightly.

      * You may touch the test strip anywhere with clean, dry hands when removing it

      from the vial or inserting it into the meter.

      * Use each test strip immediately after removing it from the vial.

      * Do not bend, cut, or alter a test strip in any way.

      * Keep the strip vial away from children since the cap and the test strip can be

      a potential choking hazard. If swallowed, please seek medical assistance

      immediately.

      3. Control solution storage

      * Store the control solution in a cool, dry place between 4°C (39°F) and 30°C

      (86°F).

      8

      .

      System Specifications

      Model Name

      BG-101

      Assay Method

      Electrochemical biosensor

      Test Sample

      Capillary Whole Blood

      Test Result

      Referenced to plasma glucose value

      Alternative Site Testing

      YES (palm, forearm)

      Sample Size

      0.3 μL

      Measuring Time

      6 seconds

      Measuring Range

      20 – 600 mg/dL (1.1 – 33.3 mmol/L)

      Acceptable Hematocrit Range 20~60%

      Operating Condition

      10°C~40°C (50°F~104°F), between 10-85% R. H.

      Storage/Transportation Condition 4°C~40°C (39°F~104°F), between 10-85% R. H.

      Memory Capacity

      120 test results with time and date

      Average Calculation

      7, 14, and 28 days

      Power Supply

      One 3-volt Lithium Battery (battery type CR2032)

      Battery Life

      Approximately 1,000 tests

      Automatic shut-off

      In 2 minutes

      Dimensions

      80 mm(L)x 48 mm(W) x 15 mm(H)

      Weight

      37 g

      Test Strip

      SIDE

      1 2

      Before You Begin

      PLEASE READ THIS BEFORE USING.

      The following basic safety precautions should always be taken.

      1. Close supervision is necessary when the device is used by, on, or near children,

      handicapped persons or invalids.

      2. Use the device only for the intended use described in this User Guide.

      3. Do not use test strips and control solutions which are not supplied by the

      manufacturer.

      4. Do not use the device if it is not working properly, or if it has suffered any damage.

      5. Before using any product to test your blood glucose, read all instructions

      thoroughly and practice the test. Do all quality control checks as directed and

      consult with a diabetes healthcare professional.

      6. KEEP THIS USER GUIDE WITH YOU.

      Intended Use

      The system is intended for use outside the body (in vitro diagnostic use only).

      It should be used only for testing blood glucose (blood sugar) and only with fresh

      capillary whole blood samples. The system is intended for use in the home and in

      clinical settings. It should not be used for the diagnosis of diabetes or for the testing of

      newborns.

      Principle of Measurement

      Blood glucose is measured by an electrical current that is produced when a blood

      Getting To Know Your System

      The Medicare Blood Glucose Monitoring System-LiS

      The Medicare System-LiS system uses the latest technology to provide you with

      easy and comfortable testing. The system requires only a 0.3 μL of blood sample to

      complete the testing in only 6 seconds.

      samples mixes with the reagent (special chemicals) of the test strip. The electrical

      current changes with the amount of glucose in the blood sample. The Medicare System-

      LiS meter measures the strength of the electrical current, calculates your blood glucose

      level and then displays your result in either milligrams of glucose per deciliter (mg/dL) or

      millimoles of glucose per liter (mmol/L).

      Caution

      1. The user should not take any decision of medical relevance without rst consulting

      his or her medical practitioner.

      2. Call your doctor immediately if you experience symptoms that are not consistent with

      your blood glucose test results.

      3. High altitudes above than 3,402 meter (11,161 ft) may affect the test results.

      4. Temperatures outside the range of 5°C to 45°C (41°F to 113°F) may affect the test

      results. Do not test beyond of temperature range.

      IMPORTANT HEALTH-RELATED INFORMATION

      1. Apply only capillary whole blood sample to test your blood glucose. Applying other

      substances or plasma, serum will cause wrong results.

      2. Severe dehydration and excessive water loss may cause false low results. If

      you believe you are suffering from severe dehydration, consult your healthcare

      professional immediately.

      3. Test results below 60 mg/dL (3.3 mmol/L)*1 indicates low blood glucose

      (hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L)*2 indicates high

      blood glucose (hyperglycemia).If your results are below 60 mg/dL (3.3 mmol/L) or

      above 240 mg/dL (13.3 mmol/L), repeat the test, and if the results are still below

      60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), consult your healthcare

      professional immediately.

      4. Inaccurate results may occur in severely hypotensive individuals or patients

      in shock. Inaccurate low results may occur for individuals experiencing a

      hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients

      should not be tested with blood glucose meters.

      5. Abnormal red blood cell counts (hematocrit level below 20% or above 60%) may

      cause false results. Please consult your healthcare professional if you do not know

      your hematocrit level.

      6. Interference: Reducing substances occurring in the blood naturally (uric acid,

      bilirubin) or from therapeutic treatments (ascorbic acid, acetaminophen) will

      not significantly affect Medicare System-LiS test results. However, elevated

      concentrations of these substances may affect test results. The compounds listed

      in the tables were found to have no affect at the concentration indicated.

      Compounds Highest concentrations

      tested at which no

      interference occured

      Compounds Highest concentrations tested

      at which no interference

      occured

      Acetaminophen

      8.0 mg/dL (0.53 mmol/L) Gentisic Acid

      5.0 mg/dL (0.32 mmol/L)

      Ascorbic Acid

      5.0 mg/dL (0.28 mmol/L) Hydroxyurea

      3.0 mg/dL (0.39 mmol/L)

      Aspirin

      60 mg/dL (3.33 mmol/L) L-dopa

      10 mg/dL (0.51 mmol/L)

      Bilirubin

      90 mg/dL (1.54 mmol/L) Maltose

      900 mg/dL (26.3 mmol/L)

      Cholesterol

      500 mg/dL (12.9 mmol/L) Methyldopa

      3.0 mg/dL (0.13 mmol/L)

      Creatinine

      5.0 mg/dL (0.44 mmol/L) Tolbutamide

      400 mg/dL (14.8 mmol/L)

      Dopamine

      2.0 mg/dL (0.11 mmol/L) Triglycerides

      2,000 mg/dL (22.6 mmol/L)

      Galactose

      900 mg/dL (50 mmol/L) Uric Acid

      8.0 mg/dL (0.48 mmol/L)

      REFERENCE:

      * 1: Kahn, R. and Weir, G.: Joslinis Diabetes Mellitus, 13thed Philadelphia : Lea and Febiger (1994), 489.

      * 2: Krall, L.P. and Beaser, R. S.: Joslin Diabetes Manual. Philadelphia : Lea and Febiger(1989), 261-263.

      1. DATE: Display year, month and date.

      2. TIME: The meter is programmed for a 12

      hour period format.

      3. AVERAGE: Appears when the meter is in the

      memory mode while recalling 7/14/28 day test

      averages.

      4. MEMORY SYMBOL: Appears when in the

      memory mode.

      5. THERMOMETER SYMBOL: Appears when

      ambient temperature is above or below the

      acceptable range needed for testing.

      6. CONTROL SOLUTION TEST SYMBOL:

      Appears when you are in Control Solution

      Mode. Your test result will not be stored in

      meter memory.

      7. UNIT OF MEASURE: Appears with the test result either in mg/dL or mmol/L.

      8. BATTERY SYMBOL: Appears when battery is weak.

      9. BLOOD DROP SYMBOL: Flashes when sample should be applied.

      10. STRIP SYMBOL: Appears when the meter is turned on and waiting for inserting a

      test strip.

      1

      . Getting To Know Your System

      2. Prepare For Blood Sampling

      3. Performing Blood Test

      4. Understanding Your Test Result

      5. Memory Recall

      6. Control Solution Testing

      7. Caring For Your Meter And Test Strip

      8. System Specifications

      9. Display Messages And Problem-Solving Guide

      SIDE

      A :

      SIDE

      B :

      Test Strip

      ABSORBENT

      CHANNEL:

      Apply a drop of

      blood here.

      CONTACT BARS:

      Insert this end into strip slot.

      TEST STRIP HANDLE :

      Hold this part to insert the test strip

      into the meter slot.

      CONFIRMATION WINDOW:

      This is where we conrm if enough blood is applied for the

      test. Ensure that it is fully covered with blood sample.

      For

      In vitro

      diagnostic use Temperature limitation / Store at

      Please consult instructions for use

      Use by /Expiry date

      Do not reuse

      Manufacturer

      Lot number

      Caution, consult accompanying document

      Keep dry Keep away from sunlight

      Humidity limitation EU representative.

      This product fulls the requirements of Directive 98/79/EC in vitro diagnostic medical device.

      Performance Characteristics:

      Accuracy:

      95% of the individual glucose results fell within ± 15 mg/dL(0.83 mmol/L) at glucose concentration <

      75 mg/dL(or 4.2 mmol/L) and within ± 20% at glucose concentration

      75 mg/dL(or 4.2 mmol/L), compared with

      glucose analyzer YSI 2300.

      PRECISION: CVs (%) of intermediate precision and repeatability were less than 5%.

      REPLACING THE BATTERY

      1.The meter comes with ONE Lithium battery (battery type CR2032).

      2.Battery life will vary depending on usage, so always keep a spare battery on hand.

      The battery should last about 1000 tests or 12 months when testing 3 times a day.

      3.When the battery symbol appears on the meter display, battery is getting low. You will

      still be able to test with low battery, but you should replace it as soon as possible.

      4.When battery symbol appears together with E-b on the display, the meter will no

      longer give results and you must replace the battery immediately. Please always have

      one spare battery with you to ensure that you can replace the battery anytime.

      How to replace the battery

      1. Make sure the meter is turned off. Let the front of the meter

      rest in the palm of your hand. Press the buckle on the battery

      cover and lift up to open the cover. Remove the battery.

      2. With the plus (+) side up, place the battery (battery type

      CR2032) in the compartment and slide it upwards until it is

      locked into place. You should hear a beep to indicate the

      battery installed correctly. If not, please replace the battery

      correctly.

      3. Close battery cover.

      NOTE:

      1. Replacing the battery does not affect the test result stored in memory. However the

      time and date may need to re-set.

      2. As with all small objects, the battery should be kept away from small children as a

      safety precaution. If the battery is swallowed, see medical assistance immediately.

      3. Batteries might leak chemicals if not used for a long time. Remove the batteries if

      you are not going to use the device for 3 months or more.

      4.

      Please discard the product or the batteries properly according to the regulations

      of your country.

      SETTING YOUR METER

      Please install battery rst and set to correct settings before you begin to test.

      STEP 1. Enter Setting Mode

      Start with the meter off. Open the battery compartment, and press SET

      BUTTON. The meter will turn on and enter the setting mode.

      STEP 2. Set the Year

      The year appears with the number ashing. Press and release the M

      BUTTON to obtain the desired year. Press SET BUTTON to confirm

      and move to next MONTH setting.

      STEP 3. Set the Month

      The month appears with the number ashing. Press and release the M

      BUTTON to obtain the desired month. Press SET BUTTON to conrm

      and move to next DATE setting.

      STEP 4. Set the Date

      The date appears with the number flashing. Press and flash the M

      BUTTON to obtain the desired date. Press SET BUTTON to confirm

      and move to next HOUR setting.

      STEP 5. Set the Hour

      The hour appears with the number ashing. Press and release the M

      BUTTON to obtain the desired hour. Press SET BUTTON to confirm

      and move to next minutes setting.

      STEP 6. Set the Minute

      The minute appears with the number ashing. Press and release the M

      BUTTON to obtain the desired minute. Press SET BUTTON to conrm

      and the meter will enter to next unit setting.

      STEP 7. Set the Unit of Measurement

      The existing unit (for example mg/dL) will appear and ash. You can

      choose to reset measurement unit. If you do not want to change unit,

      press SET BUTTON to skip this step. If you want to change unit, press

      and hold the M BUTTON for 3 seconds to change the unit to mmol/L.

      Press SET BUTTON to conrm and the meter will enter to next setting.

      STEP 8. Delete Memory

      When the dEL symbol and the ashing memory symbol appear on the

      display, you can choose to clear the memory. If you do not want to clear

      the memory, press the SET BUTTON again to skip this step. If you want

      to clear ALL memory, press and hold M BUTTON for 4 seconds. The “—

      -“ image will appear on the LCD screen to indicate that all memory has

      been deleted.

      STEP 9. Complete Setting

      After delete memory, the meter will display “OFF” before shut down.

      The meter setting is now completed

      IMPORTANT :

      1.

      The time, date and unit of measurement can ONLY be changed in the setting mode.

      Therefore, when you perform a blood glucose testing, it is not possible to change those

      parameters.

      2.

      Your meter displays 7, 14 and 28-day averages which you can access from the meter

      memory. These averages are calculated from your latest result obtained during the last 7,

      14 and 28 days.

      3.

      Your meter can display test result in milligram per deciliter (mg/dL) or millimoles per liter

      (mmol/L). The mg/dL unit is standard in the United States. The mmol/L unit is standard

      in Canada and European countries. Your meter has been preset at the factory with the

      standard unit measurement used where you live. When you turn off the meter or replace

      the battery, the unit will not be changed.

      4.

      Use of the wrong unit of measure may cause you to misinterpret your blood glucose

      level, and may lead to incorrect treatment. Please always consult with your healthcare

      professionals before you reset the unit of measure.

      BLOOD GLUCOSE

      MONITORING SYSTEM

      BG — 101

      USER GUIDE

      J7

      MC14EL005001

      Model Name: BG-101

      OK Biotech Co., Ltd.

      Hsinchu, Taiwan

      10-62-3463-0003

      V1-JUL11

      Meter

      DISPLAY :

      The large, easy to

      read display shows

      test results, messages,

      test results stored in

      memory.

      STRIP SLOT :

      Insert the test strip here. The meter will

      turn on automatically.

      METER LABEL:

      Each meter has its unique number on it. It can be

      used when you want to obtain warranty service.

      Please do not alter or tear the label off.

      M BUTTON:

      Main button, press button to turn the meter on

      or perform other functions described in this User

      Guide.

      SET BUTTON:

      Located in

      the battery

      compartment; press

      button to enter

      meter setting. Refer

      to “SETTING YOUR

      METER” section of

      this user guide for

      details.

      BATTERY COMPARTMENT :

      Holds one 3V Lithium battery (CR2032).

      Protective cap

      Lancet

      Important Lancing Device and Lancets Information

      1. Lancet is for single use only.

      2. Keep lancing device and lancets clean.

      3. Use caution when removing the used lancet from the device and when disposing the

      used lancet.

      IMPORTANT :

      The meter and lancing device are for single patient use.

      Do NOT share them with anyone including other family members !

      Do NOT use on multiple patients !

      Setting your Lancing Device

      1. Screw off the cap of lancing device. Insert a

      lancet into the lancet holder and push down until

      it is fully seated.

      2. Twist off the protective cap until it separates from

      the lancet.

      3.Replace the lancing device cap and set the

      puncture depth to the desired number.

      NOTE: THE DEPTH SELECTOR OFFERS 5 LEVELS OF SKIN

      PENETRATION:

      1-2 FOR SOFT OR THIN SKIN

      3 FOR AVERAGE SKIN

      4-5 FOR THICK OR CALLOUSED SKIN

      4. Pull back the sliding barrel until it makes a click,

      and then release. If it does not click, the device

      may have been cocked when the lancet was

      inserted.

      Prepare For Blood Sampling

      Adjustable Lancing Device

      Your lancing device and lancets are used for obtaining

      capillary blood samples from the puncture site.

      Lancet Holder

      Lancing

      Device Cap

      Depth Selector

      Release Button

      Lancet Ejector

      Sliding Barrel

      OK Biotech Co., Ltd.

      No. 91, Sec. 2, Gongdao 5th Road,

      30070 Hsinchu City, TAIWAN

      www.okbiotech.com

      MDSS GmbH

      Schiffgraben 41, 30175 Hannover, GERMANY

      L-Tac MediCare Pte Ltd

      25 Mandai Estate #07-11

      Innovation Place Tower 1

      Singapore 729930

      Tel: +65 6334 2273

      Fax: +65- 6863 8190

      www.medicare-l-tac.com.sg

      10-62-3412-0003 V2-JUL15

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