Medcare bg 101 инструкция

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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

2

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