SuperCheck2 6277 User Manual

USER GUIDE

62 77 AP-M01A2

Blood Glucose Monitoring System

Model:6277

No Coding

Required

SuperCheck2

Rev.d at e:06/2011

Explanation of symbols:

Important Notice to Reader of this Manual

This manual is written for the Btm SuperCheck2 meter: model 6277 Voice Meter . The Btm SuperCheck2 Model 6277 contains a speaking function that provides audible messages to help the user for using the meter and hearing the test results. In the manual you will read many audible sentences, which is only for the model 6277. If you don't want to hear any sentences from meter, please refer the section 8: Settings, and you can adjust the meter to “Voice Off”.

Caution (refer to accompanying documents). Please refer to safety-related notes in the manual accompanying this instrument.

Consult instructions for use.

Keep away from sunlight.

O

86 F

O

30 C

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46 F

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8 C

Authorised representive in the european community.

Manufacturer

Do not reuse

Use by / Expiry date

Lot number

In vitro diagnostic medical device.

Temperature limitation

1. Contents

Section Topic Page

1. Table of Contents

2. Introduction

3. Appearance and Key Functions of the meter

4. Alternate Site Testing

5. Safety Information

6. Quick Testing Instructions

Date/Time/Alarm/ Memory Deletion /Voice volume) 9

Preparing for Testing

7. Installing the Battery

8. Settings (

.Running a Control Solution Test

Blood Testing

10.Running a Blood Glucose Test

11.Recalling the Memory and Viewing the Average

12.Expected Values

13.Transmitting Results

Maintenance

14.Maintenance of Your System

15.Troubleshooting

16.Customer Service

17.Limitations

Important Additional Information

18. Specifications

19. Ordering Supplies

20. Warranty Information

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12-16

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19-21 22-23

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26-27

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30 30 31

NOTE: For information about the name of the manufacturer of the lancing device and the lancets, please refer to the package inserts that came with your starter kits.

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2. Introduction to the System

Intended Use / Indications for Use

The Btm SuperCheck2 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use as an aid by either a healthcare professional or a patient diagnosed with diabetes mellitus for monitoring their blood glucose levels when self testing. The Btm SuperCheck2 Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.

The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.

Contents of the System

This User Guide has been prepared to describe the proper use of the Btm SuperCheck2 Blood Glucose Monitoring System. Please read this User Guide carefully including the package inserts before testing. The system is available as either a meter or as a complete starter kit. If you have a meter only you can purchase any additional spares from your system provider.

The Btm SuperCheck 2 Blood Glucose Monitoring System contains the following items:

1.SuperCheck2 Glucose Meter with 2 AAA batteries

2.User Guide

3.Log Book

4.Carrying Case

5.SuperCheck2 Glucose Test Strips

6.SuperCheck2 Control Solution (Medium)

7.Sterile Lancets

8.Lancing Device

9.Package Inserts for Test Strips, Control Solution, and Lancets/Lancing Device

"A single level control solution (Medium) is provided in the "Starter Kit,". You may purchase any control solutions that you need from your system provider."

The Btm SuperCheck2 Glucose Meter uses Btm SuperCheck2 Glucose Test Strips. Neither the meter nor the test strips will work when used with any other brand of glucose products.

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3. Appearance and Key functions of the meter

The principle of the method When glucose reacts with the reagents on the test strips, an electrical current is produced, which is proportional to the glucose concentration in the blood sample. The glucose concentration is calculated by the meter and based on the current measured.

1.Test strip slot - When the strip is inserted into the slot, the meter will automatically turn on.

2. LCD Display - Guide you through the test using symbols and simple messages.

3. M Key - Power ON/OFF, also for memory recalling mode, please refer to manual for detailed function description.

4. C Key - Setting mode, please refer to manual for detailed function description.

5. Speaker - Where voice comes out.

6. RS232 port - Cable connection and data transmitting.

7. Battery Compartment - Where batteries are located.

8. Ejector - Remove used strip.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

*If your meter has the back light feature, this will come on automatically during every operation to help user readability and to assist with the smooth operation of your meter .

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4. Alternate Site Testing (AST)

What is AST? AST is the sampling from anatomical sites (parts of the body) other than the fingertip (i.e. forearm) to check the blood glucose levels. This system allows you to test on the forearm with the equivalent results to fingertip testing.

There are important limitations to AST. Please consult your healthcare professional before you use AST.

What is the advantage ? Some patients may encounter discomfort when taking a blood sample from the fingertip as the finger tips have a high concentration of nerve endings. Other body sites do not have as many nerve endings, so you will not feel as much pain as at the fingertip.

When to use AST ? Medication, stress, illness, food and exercise can affect blood glucose levels. Capillary whole blood at the fingertip can reflect test changes faster than capillary blood at other sites of body. If you test your blood glucose level during or immediately after a meal, physical exercise or stressful events, take the other sites of the body blood sample from your fingertip instead of from other sites.

Use AST only:

1. 2 hours or more after taking insulin;

2. 2 hours or more after a meal;

3. 2 hours or more after exercise.

Do not use AST if you are pregnant, or if you are aware that your glucose level is not as stable as usual, or if you think you have hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).

Do not use AST if you think your blood glucose is low and if your AST results do not match the way you feel.

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1.Please unscrew the lancing device by turning the end cap counter clockwise. A clear cap will come with the package of a meter kit or a lancing device. The clear cap on the lancing device will make it easy for you to get a drop of blood for AST.

2.Insert a new lancet firmly into the lancet holder.

3.Twist off the protective top of the lancet.

4.Close the end cap of the lancing device and grasp the lancing device as shown. Slide into locking position. If necessary, please set the lancing device for a deeper puncture.

5.Select a soft, fleshy area on your forearm that is clean and dry, away from bone and free of visible veins and hair.

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Testing Procedure for AST

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6.Massage the selected area gently to increase blood flow to the puncture site. Clean the test location with an alcohol wipe or with soap and water .

7.Open the test strip vial. Take one test strip out of the vial and quickly cover the vial to keep air out.

8.Insert a test strip into the meter while the meter is off. The meter will turn on automatically, and you will hear: “Hello, the Meter is ready.” A blinking blood icon will be displayed on the screen. You will hear “Apply blood now.” If no action is taken in 2 minutes, the meter will turn off automatically. You will hear: “Goodbye.”

9.Press and hold the loaded lancing device against the forearm for a few seconds, then press and release the button.

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10. Wait for a few seconds until the blood drop forms. Make sure you have sufficient blood to fill the small window of the test strip. For individuals who experience difficulty in getting sufficient blood for a test, it may be helpful to rub the puncture site a little longer before using the lancing device.

11. Apply your blood to the front edge (the tip) of the test strip, and the meter will start counting down for 6 seconds then display the test results on the screen. You will hear:

“Testing in process.” and “The glucose level is number/unit. ”

12. Remove the used strip by hand or by pushing the ejector button. The meter will turn off automatically, and you will hear: “Goodbye”, and

the LCD screen will display “OFF”.

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5. Safety Information

Please use this device only for the intended use described in this user guide.

Before using this system to test your blood glucose please read the instructions carefully and practice the test when you first use this system. Do a quality check on the system following the instructions and consult with your healthcare professionals for questions or problems.

Be aware of the safety of young children or handicapped persons near you when you conduct a glucose test using this system.

Please keep the test strip vial away from children. The test strips and vial cap can present a choking hazard.

Please be cautious when removing the lancet. Take the lancet out carefully. Always place the protective cap back on the exposed tip or (if using a twist lancet) place the cap on a hard surface and push the exposed tip into the protective cap and discard of properly.

Never try to disassemble the meter in any circumstance. If your meter is not working properly, or if you need the Technical Support, please contact your local distributor for help.

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6. Quick Testing Instructions

1.With the meter turned off, insert a new test strip into the meter, and you will hear: “Hello, the Meter is ready.” A blinking blood icon will be displayed on the screen. You will hear “Apply blood now.”

2.Lance the finger and let a blood drop form.

3.Apply the blood drop to the front edge of the test strip when the blood drop icon is still blinking on the meter. Wait for 6 seconds, and the meter will display the test result. You will hear: “Testing in process.” and “The glucose level is

number/unit.”

4.Remove the used strips by hand or by pushing the ejector and the meter will power off with a display of “OFF” on the screen. You will hear:

“Goodbye.”

(For detailed instructions start on page 18 for Control Solutions and page for Blood Testing.)

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7. Installing the battery

1.Turn off the meter by pressing the “M” button and hold for 2 seconds before replacing the batteries. Slide down the battery cover on the back of the meter by pushing the cover in the direction of the arrow and put the cover aside.

2.Remove the two used batteries.

3.Insert 2 new batteries with

correct ＋/－ direction.

(Battery: AAA 1.5V 2 Alkaline 24A LR03)

4.Put the battery cover back in place by pushing the cover in the opposite direction of the arrow to close the cover into position.

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Note:

1.It is suggested that batteries need to be replaced when the battery icon appears empty. If you keep using the meter, the battery icon will start flashing and an error message E_3 will appear on the screen.

2.Note that replacing the battery will not reset the stored testing results.

3.You need to reset the time and date after the batteries are replaced.

4.If there is any unexpected symbol on the display, please follow the above procedure to replace the batteries again.

5.Please dispose of batteries according to your local ordinances.

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8.Settings ( Date / Time / Alarm /

Memory Deletion / Voice Volume)

1.Appears with the test result or in mmol/L.

2.Appears when you recall the memory.

3.Appears when you are in setting mode.

4.Appears for control solution test flag (c).

5.Indicates the meter is ready to take the blood sample when it flashes.

6.Indicates the battery status.

7.Indicates if audio function is on or off.

8.Indicates current displayed result is an average.

9.Appears when alarm is on.

10.Month

11.Day

12.Hour

13.Minute

(1)Measurement Units

(6)Battery Symbol

(3)Setting

(2)Memory

(10)Month

(11)Day

(12)Hour

(13)Minute

The LCD scr een will show as below:

(4)Test flag (5)Blood drop icon

(7)Voice Symbol (Speaker icon)

(8)Day Average

(9)Alarm Reminder

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The LCD screen for Power Off - When the meter is off, the date, time, measurement unit, battery icon and “OFF” will be still on the screen. If the voice is on or the alarm reminder is on, the speaker icon and the alarm icon will be displayed as well.

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Set the Year - Press C key to adjust the year until the desired year is displayed and then press the M key to confirm the year setting. When pressing the C key, the year will be adjusted in the range of 2009 to 2029. After the year setting is confirmed, you will see the month segment flashing on the screen. (Each time you press the C key to adjust the year, you will hear: “The year is 20xx.” If year 09 is selected, and you will hear: “The year is 2009.”) Set the Month - Press C key to adjust the month until the desired month is displayed and then press the M key to confirm the month setting. You will then see the day segment is flashing on the screen. (Each time you press the C key to adjust the Month, you will hear: “The month is xxx.” If December is selected, and you will hear: “The month is December.”) Set the Day - Press C key to adjust the day until the desired day appears and then press the M key to confirm the day setting. You will then see the hour segment is flashing on the LCD screen. (Each time you press the C key to adjust the day, you will hear: “The day is xxx.”

th

If 18 is selected, and you will hear: “The day is the eighteenth.”)

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:

1-01~01 01

AM

SETSET

:

12-01~0101

AM

SETSET

:

12-18~0101

AM

SETSET

Set the Hour - Press C key to adjust the hour until the desired hour appears on the screen and then press the M key to confirm the setting. You will then see the minute segment is flashing on the screen. (Each time you press the C key to adjust the Hour, you will hear: “The hour is xxx.” If 11 pm is selected, and you will hear: “The hour is eleven PM.”) Set the Minute - Press C key to adjust the minute until the desired minute appears on the screen and then press the M key to confirm the setting. You will then see an “AL” displayed on the screen center. (Each time you press the C key to adjust the Minute, and you will hear: “The minute is xxx.” If 25 minute is selected, and you will hear: “The minute is twenty five.”)

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Set the Alarm Reminder - Press C key to toggle between the alarm reminder setting or no-setting mode. (If setting alarm is selected, and you will hear: “Ready to set Alarm Reminder.”) If you see the LCD display a small flashing icon of alarm clock in the lower left corner with a time segment display, it means that you are in the alarm setting mode. If you see only AL without the icon of the small alarm clock, it means that you are not in the alarm setting mode. Press M key to confirm the alarm setting mode. If you select the alarm setting mode, alarm clock icon will stop flashing and the hour of the time segment will start flashing. You will hear: “Ready to set Alarm Reminder.” Press C key until the desired alarm hour appears and then press M key to confirm the hour setting. ( If 8 AM is selected, and you will hear: “The hour is eight AM.”) Then the minute segment will start flashing. Press C key until the desired minute appears on the screen and then press M key to confirm the minute setting. (If 25 minute is selected, and you will hear: “The minute is twenty five.”) You will see the measuring unit flashing on the upper left corner of the LCD display. (Each time you press C key to adjust the hour, and you will hear: “The hour is xx x.” Each time you press the C key to adjust the minute, and you will hear: “The minute is xx x.” At the end of this process, and you will hear: “Alarm Reminder Set.”)

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:

12-18~1101

PM

SETSET

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:

12-18~11

25

PM

SETSET

:

25

08

AM

SETSET

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4.

Delete Memory - Press C key to toggle between a flashing “dEL” for memory deletion or a non-flashing “dEL”. If you want to delete all memory, press M key while the “dEL” is flashing. If you do not want to delete all memory, press M key when the “dEL” is not flashing. Once the M key is pressed, the LCD display will move to the setting of voice volume setting mode. You will see the display of “VoL” in the center of screen. (When the “dEL” is flashing on the screen, and you will hear: “Ready to delete memory records.”)

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Set the Voice Volume - Press C key to toggle between the selection of speaking mode and non-speaking mode. If you want to turn off the speaker, press M key when the screen does not show the small speaker icon. You will hear: “Voice Off.” If you see a small speaker icon appears below the battery icon on the right side of LCD screen, you can press M key to turn on the speaker. Then you will see the existing voice volume level at the lower right corner of the screen. There are 7 levels of voice volume. You can press C key to adjust the voice level and then press the M key to confirm the setting. (There will be

a “beep” sound to indicate the level of voice volume adjusted.)

The meter will turn off automatically after 2 seconds with a display of “OFF”, and you will hear: “Goodbye.”

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Note:

1.When you change the date and time backward, you will not change the test results in the meter memory.

2.You need to move through the language, year, month, day, hour, minutes, alarm, measurement unit, dEL, and VoL to save the meter settings and turn off the meter.

3.The average readings in the meter memory are calculated from the results obtained during the 7, 14, 28, 60, and 90 calendar days preceding the current date and time settings.

Power off Screen- When the meter is off, the time, date, measurement unit, and battery icon will be still on the screen as Figure 11. If the alarm reminder has been set or the voice has been turned on, then the alarm or the speaker icon will appear on the power off screen as well. The LCD screen will display “OFF”.

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9.Running a Control Solution Test

IMPORTANT:

Always make sure you press C key for Control Solution test, otherwise the control solution test result will be stored in the memory, and affect your“AVG”results.

2.Press the C key, and the meter will display a letter “C” on the upper right corner of screen, indicating the control test mode. You will hear: “Apply Control Solution now.” The test result will not be stored in the memory.

3.Squeeze a small amount of Control Solution on a flat surface and apply to the front edge of the test strip, and you will hear: “Testing in process.”

4.Wait for 6 seconds, and the meter will display the result. You will hear: “The

glucose level is number/unit.”

5.Remove the used strips by hand or by pushing the ejector and the meter will power off with a display of “OFF” on the screen. You will hear: “Goodbye.”

1.Insert a strip into the meter, and you will hear: “Hello, the Meter is ready.” A blinking blood icon will be displayed on the screen. You will hear: “Apply

blood now.”

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IMPORTANT!!!

1.You must press the C key to distinguish the control solution test from the blood glucose test. Do not perform the blood test in Control Solution mode.(If you perform the blood test in Control Solution mode, the test result will not be stored in the memory. )

2. Use only Btm SuperCheck2 Control Solution with Btm SuperCheck2 Glucose Meter.

3.Btm SuperCheck2 Control Solutions are used to check that the meter and the test strips are working together as a system and that you are performing the test correctly.

4.Btm SuperCheck2 Control Solution contains a known amount of glucose that reacts with test strips. The Medium and High level Control Solution are intended to check the monitoring system in different measurement ranges.

5.Shake the vial, discard the first drop of control solution, and wipe off the dispenser tip to ensure a good sample and an accurate result.

6.Use only for 3 months after first opening. Record the open date on the Control Solution vial. Discard after 3 months.

7. Compare your Control Solution test results with the expected range printed on the test strip vial label. If your glucose control results fall outside the expected range; repeat the

test. Results that repeatedly fall outside the expected range may indicate:

(1 ) You may not be doing the test correctly; repeat the test, by shaking

the control solution vial well and carefully following instructions. Please make sure the test is done within the temperature range.

(2)The Control Solution is expired or contaminated. (3)The test strips are damaged or outdated. (4 ) You may have applied the Control Solution before the blood drop

appears on the screen. This will cause incorrect glucose measurement. (5)Meter malfunction.

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10. Running a Blood Glucose Test

1.Please unscrew the lancing device by turning the end cap counter clockwise.

2.Insert a new lancet firmly into the lancet holder.

3.Twist off the protective tip of the lancet.

4.Close the end cap of the lancing device as shown. Slide into locking position.

5.Wash your hands in warm, soapy water. Be sure to rinse and dry well.

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6.Open the test strip vial. Take one new test strip out of the vial and recap the vial quickly and firmly.

7.While the meter is off, insert a new test strip into the meter's strip slot with the contact bars facing upwards. The meter will turn on with a full screen display,and you will hear: “Hello, the meter is ready.” A blinking blood iconwill be displayed on the screen. You will hear: “Apply blood now.” If no action is taken in 2 minutes, the meter will turn off automatically. You will hear: “Goodbye.”

8.Use the adjustable lancing device or the disposable lancet to take a blood sample from the fingertip and let it form a small round blood drop. To avoid body fluid contamination, it is recommended that you do not use the first blood drop for glucose testing.

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9.Apply a small blood drop to the front edge of the test strip, and the blood should be pulled into the confirmation window before the meter begins to count down. Do not push your finger against the test strip or try to apply a smeared blood sample. You will hear:

“Testing in process.”

10.The meter will start counting down for 6 seconds and your test result will be displayed on the screen. Remove the used test strip by hand or by pushing the ejector button. The meter will turn off and the test result is stored automatically.You will hear: “The glucose level is

number/unit.” and “Goodbye.” when meter turns off.

Important:

1. Never reuse a test strip An “E_5” error message will be displayed in the center of screen if a used strip is inserted into the meter. (You will hear: “The strip is wet or used.”)

2. Discard the test strip and lancet immediately in a puncture-proof container with a lid after use .

or a lancet.

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11. Recalling the Memory and Viewing the Average

Your blood sample test result will be automatically stored in the meter's memory. The meter can store up to 500 of the most recent test results. You can also view the average of test results for various periods of 7, 14, 28, 60 and 90 days. The control solution test results will not be stored in the memory.

(Note: Please make sure that you press C key when you run a Control Solution test, so that the control test result will not be added to the memory.)

A. Using the Meter Memory

1.With meter off, press M key to turn on the meter. After a brief full screen display, and you will hear “Recalling the memory” the meter will display the total number of test data stored in memory. Then the screen will display “001” as the sequential number of the most recent test result in memory. The memorized test data will be displayed next. If there is no memorized result in the meter, “---” is displayed and you will hear: “Zero memory.” The meter will turn off after 60 seconds if no action is taken. (When the meter displays the first memorized data, you will hear: “The glucose level is number/unit.”)

2.The meter will audibly read out the last 10 stored test results with date. The screen will display each of the

memorized test data in sequence. Press M and C key to review your test results in the memory forwards and backwards.

3.To turn off the meter, press the M key for 2 seconds, or the

meter will turn off automatically after 60 seconds if no activity, and you will hear: “Goodbye.”

B. Recalling the Test Results from the Meter Memory

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1. To display the average (AVG) test result, please turn the meter off. Press C and M keys at the same time and hold for about 2 seconds, wait for the AVG to be displayed on the screen, then release the two buttons. The meter will be in the average mode with “AVG” font displayed.

2.When the “AVG” is flashing at the lower left corner of the screen, the number 7 will be displayed under AVG and the average of the last 7 days test results will be displayed in the center of the screen. The number of tests completed in the last 7 days

will also be displayed in the lower right hand corner of the screen.

If you want to see the average of 14, 28, 60 and 90 days, keep pressing the M key to move the LCD display forward from 7 day average to 90 day average. The average display will move from 90 days backward to 7 days if you continue to press C key. You will hear: “The average for 7 day is number/unit.”

3.Press the M key and hold for only 2 seconds to exit the recall mode and turn off the meter, or the meter will automatically power off after 60 seconds. You will hear: “Goodbye.”

4.When “---” is displayed, showing that there are no test results in the memory. You will hear: “Zero memory.”

Calculations:

The 7 days average is the average of the last 7 day test results. The 14 days average is the average of last 14 day test results. The 28 days average is the average of last 28 day test results. The 60 days average is the average of last 60 day test results. The 90 days average is the average of last 90 day test results.

Note:

1.HI/LO results are not stored in the memory.

2.Do not insert the strip into the meter when you want to recall the test results.

C. Viewing the Average (AVG) of Test Data in Memory

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13. Transmitting Results

1.With the meter off, hold the M and C keys down at the same time for 5 seconds until “PC” is displayed. You will hear:

“Ready to transmit data.”

2.Press the C key to start transmitting. The meter will display a flashing “PC” during the transmission process. When the “PC” on the screen stops flashing, it indicates the transmission is completed. The meter will be power off if no action is taken in 60 seconds or M key is pressed for 2 seconds. You will hear:

“Goodbye.”

12.Expected Values 1Reference

BTM SuperCheck2 meter gives plasma equivalent results.

Before eating < 5.6 mmol/L Two hours after meals < 7.8 mmol/L

Blood glucose levels normally will vary from time to time depending on food intake, medication dosages, health, stress or exercise. Consult your physician or healthcare professional for the target glucose value appropriate for you. Expected plasma blood glucose values for normal, nondiabetic adults are as follows.

Note:

"Btm SuperCheck2 Glucose Meter allows you to transfer the test results stored in its memory to your personal computer. However, you will need to order software and a Data Download Cable separately from your distributor." The software and its data download procedure will come as a CD in the download cable box. You can also check with your distributor for the software download option. The meter still keeps the results in the memory after transmitting.

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Please, treat this meter with proper care, and keep it in good condition.

1.Store your meter in the protective case, in a clean dry place at 46~86℉( 8~30℃).

2.Always clean your meter after use. Wipe and clean the surface of the meter with a soft cloth that has been slightly dampened with mild detergent.

3.Please handle with care and do not drop the meter.

4.If this meter is used by healthcare professional infection control policies should be strictly followed.

5.The meter has a shelf-life of 2 years.

14. Maintenance of your system

We suggest you should periodically compare the test system to another test system which is well maintained and monitored by a healthcare provider .

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15.Troubleshooting :

Error messages:

E_1:The temperature is too low.

E_2:The temperature is too high.

E_3: Battery Low.

E_4: Memory damaged.

E_5: The strip is wet or used.

E_6:Error in meter or strip.

E_7:The blood sample is not sufficient.

HI :The glucose level is too high.

LO:The glucose level is too low.

The following is a summary of all the Error Messages. 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 or a symbol.In the event of a problem,refer to the information in the table under Solution.

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Problem Possible Cause Solution

Repeat the test after the meter and strip are placed in a warmer environment and allow the meter to warm up for a while before retesting.

Test again following the user guide for correct glucose measurement process. If you see HI again, please call your medical doctor for advice

immediately.

Repeat the test after the meter and strip are placed in a cooler environment and allow the meter to cool down for a period before retesting.

Please replace the two AAA batteries.

Please check the test strip to see if it is damaged or used. In either case, please discard the strip and repeat the test using a new strip.

Repeat the test with a new test strip. If E_6 continues to show up on screen, please call a customer service representative.

The meter can perform the glucose measuring without storing the test results into the meter's memory. Please write down the test results into the data logger before you call a customer service representative.

Test again following the user guide for correct glucose measurement process. If you see LO again, please call your medical doctor for advice immediately.

The meter is operating in an ambient temperature below 10 ℃ or 50℉ which is the lowest range of operating temperature.

(1) The meter displays an E_1 error message.

(2) The meter displays an E_2 error message.

The test result is lower than the measuring range of 1.1 mmol/L.

(3) The meter displays an E_3 error message.

(5) The meter displays an E_5 error message.

(6) The meter displays an E_6 error message.

(8) The meter displays HI on screen.

(9) The meter displays LO on the screen.

The meter is operating in an ambient temperature above 40 ℃ or 104℉ which is the cap of operating temperature.

The battery is too low to operate the meter.

1.If you apply the sample before blood drop icon appears on the screen.

2.The inserted test strip has been wet or used.

The meter is not working properly, either because of a defective meter or a defective strip.

The memory chip of the meter could be damaged or malfunctioning.

The test result is higher than the measuring range of 33.3 mmol/L.

(4) The meter displays an E_4 error message.

Please re-test by inserting a new test strip ensuring an adequate amount of blood comes into contact with the test strip.

(7) The meter displays an E_7 error message.

The blood sample is not sufficient .

16.Customer Ser vice

If you need assistance with your Btm SuperCheck2 Glucose Monitoring System, please contact:

Distributed By Apollo Medical Technologies Ltd Tele:01636831201 Email:[email protected] Website:www.apollomedicaltechnologies.com

For questions related to your health condition, please call your doctor or healthcare professional.

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17.Limitations

1.No Neonatal use Do not use for neonatal blood glucose testing.

2.Hematocrit range Hematocrit in the range of 32~60% has been shown not to affect the glucose results. If you do not know your hematocrit level, consult your healthcare professional.

3.Hemoglobin range Hemoglobin levels of 0.078 mmol/L did not interfere with blood glucose test results.

4.Elevated Cholesterol and Triglycerides Cholesterol levels up to 12.9 mmol/L and Triglycerides up to 33.1 mmol/L has been shown not to affect glucose results.

5.Medications Interference was observed for therapeutic levels of L-DOPA. No interference was shown for uric acid, acetaminophen, ascorbic acid and ibuprofen in normal therapeutic levels. However, higher concentrations in blood may cause incorrect results: Uric acid: > 0.65 mmol/L; acetaminophen: >0.41mmol/L ; ascorbic acid: >0.26 mmol/L; ibuprofen: >1.82 mmol/L.

6.The test strips may be used at altitudes up to 5,280 feet (1,609 m ) without an effect on test results.

7.Persons suffering from severe dehydration should not be tested using a capillary whole blood sample.

8.Test results below 3.9 mmol/L indicate low blood glucose (hypoglycemia). Test results greater than 13.3 mmol/L indicate high blood glucose (hyperglycemia). If you get results below 3.9 mmol/L or above 13.3 mmol/L, repeat the test, and if the results are still below 3.9 mmol/L or above 13.3 mmol/L , please consult

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your healthcare professional immediately .

9.Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with a blood glucose meter.

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18.Specifications

Test: Glucose Sample: Whole Blood Principle of the test method: Amperometric, glucose oxidase Test sites: Fingertip, forearm Measurement time: 6 seconds Code required:No code device Measurement Range: 1.1~33.3mmol/L. Batteries: 2 x AAA 1.5 V Alkaline 24A LR03 Operating Temperature: 10~40℃(50-104℉) Humidity: 20~80% RH Width: 48 mm Length: 99 mm Thickness: 14 mm Weight: ~72g Memory: 500 measurement results with date and time Auto power off after 2 minutes without action when a strip is inserted, or 60 seconds if there is no strip inserted.

19.Ordering Supplies

To order supplies, please contact the Manufacturer :

Distributed By Apollo Medical Technologies Ltd Tele:01636831201 Email:[email protected] Website:www.apollomedicaltechnologies.com

Traceability of glucose monitoring system: The accuracy of

Btm SuperCheck2 Blood Glucose System was assessed by

comparing blood results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, which is calibrated by YSI calibrator solution, refer to NIST SRM (standard reference material) # 917A Clinical Dextrose. The device has certified to meet the following standard: 98/79/EC, EN60601-1 + EN 60601-1-1 ISO 15197

(P.S. Please refer to the package insert that came with your test strips, and you will also find information on how the system works and on the performance characteristic reference.)

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20.War ranty Information

Your Btm SuperCheck2 Glucose Meter is warranted to be free of defects in materials and workmanship for one year from the date of the original purchase. This warranty does not cover device failure due to owner misuse or negligence, or normal wear and tear.

If you have a question about your Btm SuperCheck2 Glucose Meter or this warranty, please contact:

Biotest Medical Corporation No.3-2, Chien-kuo Rd., TEPZ Tantzu, Taichung 427, Taiwan, R.O.C. E-mail: [email protected]

Reference:

1.American Diabetes Association: Diabetes Care, January 2007, volume 30 (Suppl. 1) S42-S47.

2.American Diabetes Association-Diabetes Forecast website information : http://www.forecast. diabetes.org/diabetes-101/hyperglycemia http://www.forecast.diabetes.org/diabetes-101/ hypoglycemia

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BiotesT Medical Corporation

No. 3-2,Chien-kuo Road,TEPZ Tantzu, 427 Taichung, Taiwan ROC.

Tel : 886-4-25326668 Fax: 886-4-25326528

0537

Obelis s.a.

Bd. Général Wahis, 53 1030 Brussels, Belgium Tel:+32.2.732.59.54 Fax:+32.2.732.60.03 E-mail: [email protected]