BeneCheck GLU User Manual

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TABLE OF CONTENTS

Chapter 1

BeneCheck Blood Glucose Monitoring System

1.1

Introduction

...........................................................................................................

1-2

1.2

Contents of the Kit

................................................................................................

1.3

Labelling and Informations

...............................................................................

1.4

System Components

Meter

..........................................................................................................................

5-6

Test Strips

....................................................................................................................

Code Strip

....................................................................................................................

Chapter 2

Setting-up the Meter

2.1

Installing/Replacing the Batteries

........................................................

9-10

2.2

Set the Year/Month/Day/Hour....

.......................................................

10-11

Set the Minute/Unit of Temperature

.......................................................

2.3

Coding the Meter

..........................................................................................

13-15

2.4

Control Test

......................................................................................................

15-19

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Chapter 1 BeneCheck Blood Glucose Monitoring System

1.1 Introduction

Thank you for choosing BeneCheck Blood Glucose Monitoring System. The BeneCheck Blood Glucose Monitoring System is designed by General Life Biotechnology Co., Ltd and marketed all over the world.

The BeneCheck Blood Glucose Monitoring System provides you with accurate, plasma-calibrated results based on electrochemical sensor technology and the superior capillary sampling. The BeneCheck Blood Glucose Monitoring System requires only a small amount of blood, the blood glucose level is precisely calculated and displayed in 10 seconds.

Intended Use :

The BeneCheck Blood Glucose Monitoring System is designed to measure the blood glucose levels in whole blood. The test strips are for testing outside the body ( in vitro diagnostic use ). It should be used only for testing blood glucose with fresh capillary whole blood samples. The system is suitable for diabetics to monitoring their blood glucose at home by themselves and also can be used at clinical sites by healthcare professionals to test the blood glucose levels of patients.

Chapter 3

How to Perform a Blood Glucose Test

3.1

Before Testing

.................................................................................................

20-22

3.2

Perform the Blood Glucose Test

.........................................................

23-24

3.3 Care after the Test

......................................................................................

24-25

Chapter 4

Meter Memory Function.............................................26-27

Chapter 5

How to Set the Blood Glucose Measurement Units.........28-29

Chapter 6

Storage and Handling of Meter and Strips.........................30

Chapter 7

Icon and Alert Tones......................................................31

Chapter 8

Error Message and Trouble Shooting............................32-34

Chapter 9

Specications...............................................................35

Chapter 10 Limitations...............................................................36-37

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1.2 Contents of the Kit

Please check the whole package for the BeneCheck Blood Glucose Monitoring System. The system includes the following items :

Item No. Description Quantity

PD-A016 BeneCheck Blood Glucose Meter 1 PD-A041 BeneCheck Blood Glucose Test Strip (vial) 1 PD-A020 Code Strip 1 PD-F004 BeneCheck Glucose Control Solution 1 PP-E003 BeneCheck Blood Glucose User’s Manual 1 PP-E006 BeneCheck Blood Glucose Test Strip Instruction 1 PD-A019 Kit Carrying Bag 1 PD-A015 Lancing Device 1 PD-A018

Lancets (pack) (Manufacturer : For detail information, please refer to inside package. )

Optional :

(

not included in the standard kit package, please contact your

local distiubutor for ordering. )

BeneCheck Blood Glucose

Test Strip BK-G-S001

The BeneCheck Blood Glucose Monitoring System is calibrated by J&J DT60 Analyzer (Kodak EKTACHEM DT60 Analyzer) using venous plasma. The DT60 Analyzer is calibrated by VITROS DT calibrators which were referenced to NIST SRM917b and AACC/CDC (Hexokinase/G6PDH).

Please read the entire USER’S MANUAL carefully before using the BeneCheck Blood Glucose Monitoring System to test your blood glucose levels. This USER’S MANUAL guides you through the operation procedures with illustrated directions

and help you nd the required informations.

WARNING : Please carefully read the instructions in this USER'S MANUAL and become familiar with the test procedures before using the system to test blood glucose level. User should do the quality check and consult with a diabetic healthcare professional before doing any important medical decision.

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1.4 System Components Meter ( Front Side )

GLU

Test Port : Where you insert the test strip for test.

LCD Screen : for display of operating infor m ation and t e st results.

Front Button : for on/off and memory mode operation.

1.3 Labelling and Informations

Caution, consult accompanying documents

Do not re-use

Keep dry

Operation temperature limitation

In-vitro diagnostic

Lot number

CE certication

Read instructions

Storage temperature limitation

Use by

EU Representative

Catalogue number (Product number)

Manufactured by

Keep away from sunlight

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Electronic Contact Bars :

Insert this end of the test strip into the Test Port of the meter to activate it.

Sample Inlet :

The inlet where the whole blood or control solution is drawn in. When a blood sample or control solution touches this end, the sample will be sucked into the reaction zone automatically.

Test Strip

TOSHIBA

Blood Glucose Meter

Model : PD-A016

General Life Biotechnology Co., Ltd.

No.53, Jung Jeng Rd., Shin Juang,

Taipei Hsien, Taiwan, 242

Battery : One CR2032

0197

BeneCheck

R 2 0

Battery Cover Lid :

Lift upward while replacing the battery.

Battery Cover :

For covering the battery.

Battery :

3V lithium battery(CR2032)

Reset Button : For setup and reset of the meter.

Tag :

Display information about the meter.

Meter ( Back Side )

Screw :

Fo r holding the meter together, do not open or disassemble the BeneCheck Blood Glucose meter.

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Chapter 2 Setting-up the Meter

2.1 Installing/Replacing the Batteries

A 3-volt lithium battery (CR2032) is included in the meter package. Use only 3V lithium batteries. Do not use or replace the battery with different types of batteries. Doing so will damage the electronics of the meter.

Instructions :

Blood Glucose Meter

Model : PD-A016 General Life Biotechnology Co., Ltd. No.53, Jung Jeng Rd., Shin Juang,

Taipei Hsien, Taiwan, 242 Battery : One CR2032

0197

BeneCheck

Hold the meter with one hand, slightly lift the back cover lid to open the back cover.

Insert a new battery in the meter with the “+” side facing up, you will hear a “beep” sound which indicates that meter is on.

Code Strip ( Front View )

Contact Bar :

Insert this end into the Test Port of the meter.

Code Number

Tset Mode

：

G - Glucose

Tset Mode

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Set the Year

Press the front button to advance one year until you get a correct year number.

After you set the desired year number, press the back setting button again then the meter enters into month setting.

Set the Month

Press and release the front button until the correct month appears.

Press the setting button and the day segment will start blinking.

Set the Day

Press and release the front button until the correct day appears.

Press the setting button and hour segment starts blinking.

Set the Hour

Press and release the front button until the correct hour appears.

Press the setting button and minute segment start blinking.

Please back the cover onto the meter.

2.2 Set the Year/Month/Day/Hour/Minute/Temperature unit

After a battery is installed in the meter for the rst time

(as described in 2.1),

the

meter goes into setting mode automatically.

The directions to setting mode.

Open the battery cover (on the back of the meter), press the setting button then a number such “08” will blink on screen, which means Year.

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Set the Minute

Press and release the front button until the correct minute appears.

Press the setting button and temperature unit (˚C or˚F) starts

blinking.

Set the Unit of Temperature

Press and release the front button to select the unit of

temperature, ˚C or ˚F.

2.P r ess th e s ett i ng but ton whe n t he des i red un it i s selected. The meter thus completes the setting and turns off automatically.

Note : Please refer to Chapter 5 for the blood glucose measurement units setting procedure.

2.3 Coding the Meter

The BeneCheck Blood Glucose Meter should be coded before testing with BeneCheck Glucose Test Strips for the first time, or every time a new box of BeneCheck Glucose Test Strips is used. Each vial of test strips has an assigned code number. The code strip is packaged with the test strip in order to calibrate/ code the meter. Every time a test strip is inserted, please be sure to check the code number appearing on the screen is the same as the code number marked on the test strip vial.

Directions :

Check the code number on the code strip is the same as the code number on the test strip vial.

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2. Insert code strip into the test port of the meter.

ode

Wait for the code number to appear on the screen.

Code

Make sure the code number on the screen is the same as the code number on the code strip. Remove the code strip. “

” should appear on the screen,

indicating that the meter has been coded.

Cautions :

If “E-C” appears on the screen after removing the code strip, there may be a problem with the code strip. Perform the coding again, and if “E-C” continues to appear, please contact the original dealer or supplier for service.

2.4 Control Test

A control solution is used to check the performance of the BeneCheck Blood Glucose Monitoring System, including BeneCheck Blood Glucose Meter, BeneCheck Blood Glucose Test Strip, and the user’s operating skill. The system performs adequately if the control test result falls within the indicated control range listed on the test strip vial.

The system should be checked

●

When you get the meter for the rst time or begin using a new vial of test strip.

●

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

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● Any time the blood glucose test results are not consistent with how you

feel, or any time you think your results are not accurate.

●

Any time you drop or bump the meter.

●

Upon the advice of the healthcare professional.

Directions :

Insert a test strip and immediately cover the vial to keep the other test strips in dry condition. The meter will turn on automatically.

After “CH” and “ ” appear on the screen, the ambient temperature and code number will follow. Be careful to make sure the code number is the same as the code number marked on test strip vial.

A blood drop symbol “ ” blinking on the screen means the system is ready for sample loading.

Please shake well and discard the rst three drops of control

solution, then drop some control solution onto a clean surface.

Touch the sample inlet of the test strip to the drop of control solution until the meter sounds a “beep”. The screen will display a countdown from 10 seconds.

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Note :

●

Do not reuse the test strips.

●

Newly opened vial of control solution and test strips must be marked with the opening date.

●

Close the test strip vial lid tightly after use.

●

Do not use BeneCheck Blood Glucose Monitoring System to do any test until you can get the control test result falls within the range listed on the test strip vial.

●

If the test results fall outside the control range, please refer to Chapter 8 for trouble shooting.

After 10 seconds the screen will display the control test results. Compare the results to the control range listed on the test strip vial.

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Chapter 3 How to perform a Blood Glucose Test

3.1 Before Testing

Please follow the step-by-step instructions to ensure accurate test results. Materials required to perform a blood glucose test include :

●

BeneCheck Blood Glucose Meter

●

BeneCheck Blood Glucose Test Strip

●

Lancing Device / Lancet

●

Tissue or cotton ball with 75% ethanol for wiping blood sampling area after test, or simply wash hands with soap and water thoroughly before and after test for disinfection.

Directions :

Take a test strip and immediately cover the vial to keep the other test strips in dry condition.

Fully insert the contact bar of the test strip into the test port of the meter. The meter will turn on automatically.

After “ CH ” and “ ” appear on the screen, the code number will follow.

Check the code number on the screen is the same as the one on the test strip vial. If not, remove the test strip and recode the meter.

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Note :

●

The blood glucose test must be performed within 3 minutes, otherwise the meter will be turned off automatically. If turned off, remove and re-insert the test strip to do the test again.

●

Test strips cannot be reused. If a used test strip is inserted, a warning message “ E-U ” will display on the screen. Always use new test strips.

●

If the wrong end of the test strip is inserted, or if the test Strip is inserted backwards the Meter will not activate.

Warning :

● Lancet cannot be reused.

● Please always use certied lancets to ensure safety.

3.2 Perform the Blood Glucose Test Directions :

Insert the BeneCheck Blood Glucose Test Strip and take a blood sample according to the instructions for lancing device in the system.

Touch the sample inlet of the test strip to the drop of blood sample until the meter sounds a “beep” that means the sample is drawn into the strip successfully.

The screen will display a countdown from 10 seconds. After 10 seconds the screen will display the glucose results.

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Note :

●

Please complete the test procedures within 3 minutes or the meter will automatically turn off.

● Do not apply the blood sample on the test strip anywhere other than the sample inlet.

●

Do not apply the blood sample to a same test strip twice, it will cause inaccurate test results.

3.3 Care after the Test Directions :

Follow the instructions for lancing device to treat and discard the used

disposable lancet into an appropriate sharps or biohazard container.

After performing a test, remove the test strip and meter will automatically

turned off.

3. Record the test result and date in your personal diabetes diary.

Note :

● Please check your system performance regularly or when you suspect your test result is inaccurate.

●

Dropping, bumping or other violent impact may damage the meter or cause malfunction.

●

Do not use the meter in an environment with possible magnetic, electromagnetic, and radioactive interferences.

Warning :

● Do not disassemble the meter for any reason.

●

Please follows local regulations to discard used test strips and

lancets.

●

Used test strips, lancets and any other materials which have

been in contact with blood should be treated as potential biohazards. If a user has an infectious disease, the used test strips and other materials could be sources of infection.

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Chapter 4 Meter Memory Function

The BeneCheck Meter automatically stores up to 180 records, both blood glucose test results and control test results, each time a test is performed. It also provides you with 7-, 14-, 21- and 28-day averages of the blood glucose test results. The memory counts up from M01 through M180. Please follow these directions to recall stored test results.

Directions :

Make sure that no test strip is inserted in the meter.

Press the “Front Button” once to turn the meter on. A full display will appear on screen after a short “beep” sound.

Press the “Front Button” once again before the code number appears. The 7-day

average ( 7 DAY.A ) will display on the screen.

Followed by 14-, 21- and 28-day average when press the “Front Button” repeatedly.

After the 28-average, the latest stored result M01 appears on the screen. The memory number increases progressively each time the button is pressed till M180.

To turn the meter off, press the “Front Button” for over 3 seconds and the meter

will make a long “beep” sound. The meter will also automaticallyshut down

after

3 minutes.

Note :

●

Please complete the test procedures within 3 minutes or the meter will automatically turn off.

●

Do not apply the blood sample on the test strip anywhere other than the sample inlet.

●

Do not apply the blood sample to a same test strip twice, it will cause inaccurate test results.

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Chapter 5 How to Set the Glucose Measurement Units

Directions :

Make sure that no test strip is inserted in the meter.

Open the battery cover of the meter, press “Setting Button” once then a blinking number “0x” will appear on Screen. (See Fig.1-3)

1 2 3

3. Press “Setting Button” repeatedly until the glucose unit “mg/dL” or “mmol/L” blinks on the Screen. Press “Front Button” will switch between “mg/dL” and “mmol/L”. (See Fig.4a&4b)

Press the setting button once will shift to temperature setting. Press

“Setting Button” again will nish the setting and turns off automatically.

Note :

●

The setting items of the meter is listed as follows. Please be careful to set the desired glucose unit.

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Chapter 6 Storage and Handling of Meter and Strips

Due to sensitive to heat and humidity, the performance of test strips may be affected by improper storage and handling. Please store the test strips and meter

carefully according to the specications listed in Chapter 9.

Note:

Store the meter, code strip, test strips and control solution at room

temperature. Do not expose them beyond the range described in Chapter 9.

Do not freeze or refrigerate the meter and strips.

Keep the meter clean by wiping the exterior of the meter with a tissue or lint-

free cloth.

Chapter 7 Icon and Alert Tones

7.1 lcon on the Screen

The vivid and clear information icons on the screen are helpful and convenient. In addition to providing accurate blood glucose test results, the icon design on the screen are easy to understand at a glance and will save you the effort of carrying the User’s Manual for reference.

7.2 Alert Tones

●

Normal Alert Sound : a short “beep”

●

Warning Alert Sound : 5 short “beeps”

●

Turning On/Off Alert Sound : a long “beep”

Code Number Icon

Strip Loading Icon

Result Area

Battery Icon

Temperature Icon

System Check Icon

Memory Number Icon

Blood Loading Icon

Average Icon

Unit Icon

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Chapter 8 Error Message and Trouble Shooting

Message Cause Solution

E-0 There may be a problem

with the meter or code strip.

Repeat the test with a new code strip. If the problem persists, please contact the dealer for service.

E-9 The test strip may be

removed after applying blood to the absorbent hole.

Review the instructions and try again with a new test strip. If the problem persists, please contact the dealer for service.

E-A There is a problem with

the meter.

Review the instructions and try again with a new test strip. If the problem persists,please contact the dealer for service.

E-b The power of the battery is

too low to run a test.

Replace the battery at once.

Message Cause Solution

E-C

Usage of the code strip was inserted improperly, damaged, or incorrect.

Check that the code number on the meter display matches the code number on the test strip vial. Code the meter or retest as necessary. If the error message appears again, please contact the dealer for service.

E-t & Tm Sign

Th e t em p er at u r e w a s below or above the system operating range.

Repeat the test after the meter and the test strip have reached the temperature within the operating range.

It could be caused by a used test strip or a temporary or permanent electronic problem.

Repeat the test with a new test strip. If the error message appears again, please contact the dealer for service.

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Chapter 9 Specications

System Accuracy

: ± 20% at glucose level > 75 mg/dL

Test Sample

: Capillary whole blood

Measuring Time

: Less than 10 seconds Measuring Range : 20 - 600 mg/dL (1.1 - 33.3 mmol/L) Sample Volume : About 1 - 1.5 µL Strip Storage Condition : 10 - 30˚C Operation Temperature

: 10 - 40˚C Relative Humidity

: Less than 95%

Memory

: 180 test results Battery Type

: One 3V (CR2032) lithium battery Battery Life

: Approximately 1,000 tests Dimensions

: 61*77*19 mm Weight

: About 47g (batteries not included)

Message Cause Solution

Hi 1.Blood glucose level is

higher than 600 mg/dL.

.Test strip has problem.

Review the instructions and try again with a new test strip.

2. Check the test strip vial to make sure that it is not marked beyond the expiration date.

Lo 1.Blood glucose level is

lower than 20 mg/dL.

2.Test strip has problem.

1. Review the instructions and try again with a new test strip.

Check the test strip vial to make sure

that it is not marked beyond the expiration date.

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Chapter 10 Limitations

Please observe the following limitations for obtaining accurate results of BeneCheck Blood Glucose Monitoring System :

For In-vitro diagnostic use only ( External use only ).

2. Do not dispose test strips in high humidity or direct sunlight. Don’t freeze the strips.

BeneCheck Blood Glucose Test Strip is for single use only, please do not reuse

the test strip.

Handle the strip with clean and dry hands; lancing site for the test should be cleaned and dried thoroughly.

Do not perform the test while a cell phone is used beside; prevent the electronic signal interference.

Oxygen concentration low in air may cause the test inaccurate; there is no effect from altitude up to 10,000 feet above sea level.

Medical therapy for intravenous injection, such as immunoglobulin preparations and p e ritoneal dialysis solutions, contai n ing sugar compounds may cause higher test results.

Hematocrit (Hct) range from 30-55% is acceptable. Hct less than 30% may cause elevated results. Hct above 55% may cause reduced glucose results versus a whole blood reference.

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BeneCheck GLU User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual