SD Biosensor SD GlucoNavii NFC User Instruction Manual

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Blood Glucose Mobile Monitoring System

Blood

User Instruction

Guide

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Dear SD GlucoNavii® NFC System Owner;

Thank you for choosing SD GlucoNavii® NFC Blood Glucose Monitoring System. Your new SD GlucoNavii® NFC Blood Glucose Monitoring System is an important tool that can help you better manage your diabetes. Important steps for using the System are inside this guide. Please read it carefully.

If you have questions, we are here to help. Please contact SD Biosensor, Inc. Tel : +82-31-300-0400 Fax : +82-31-300-0499 website : www.sdbiosensor.com

We oer assistance 24 hours a day, 365 days a year in many languages. You can also visit

www.sdbiosensor.com for diabetes management tools

and product demonstrations.

Please refer to the instructions with following symbols in this User Instruction Guide.

To identify conditions or practices that could result in damage to equipment or other property.

To provide an additional useful information.

Before using any product to test your blood glucose, read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes health care professional. These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators, the American Diabetes Association, the U.S. Food and Drug Administration, and the Advanced Medical Technology Association.

CAUTION

NOTE

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

TABLE OF CONTENTS

Chapter 1 : Understanding Your New System

1. Before You Start Testing

2. Special Information for Healthcare Providers and Caregivers

3. Indication for Use

4. Product Description and the Principle of the use

5. The Complete SD GlucoNavii® NFC Blood Glucose Monitoring System

6. SD GlucoNavii® NFC Meter

7. SD GlucoNavii® NFC Test Strips

8. SD GlucoNavii® NFC Accessories

9. Changing the Battery

10. Meter Set up

11. Using SD GlucoNavii® NFC Test Strips

Chapter 2 : Control Solution Test

1. Performing a Control Solution Test

2. Troubleshooting Control Solution Test

Chapter 3 : Testing Your Blood Glucose

1. Getting a Drop of Blood

2. Performing a Blood Glucose Test

3. Understanding Test Results

4 4

6 6 6

8 12 13 14 16 26

TABLE OF CONTENTS

28 29 32

34 34 36 38

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

TABLE OF CONTENTS

Chapter 4 : Using NFC function

1. Information on NFC function

2. Information on Caution for NFC

3. Using NFC function

4. How to use GlucoNaviiApp

5. How to use SD NFC Software for PC

Chapter 5 : Using the Meter Memory

1. Searching Test Results

2. Downloading results to a computer

Chapter 6 : Maintenance and Troubleshooting

1. Performing a SD Glucose check strip

2. Cleaning the meter

3. Maintenance, Testing and Transportation

4. Cleaning the Lancing Device

5. Screen Messages and Troubleshooting

6. Warnings, Precautions and Limitations

Chapter 7 : Product Technical Information

1. System Specications

Annex 1 : Information for Healthcare Professionals Annex 2 : Symbol Annex 3 : References

40 40 40 41 42 43

45 46 50

51 51 52 53 54 55 61

63 63

65 66 68

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

CHAPTER 1 : Understanding Your New System

The SD GlucoNavii® NFC Blood Glucose Monitoring System

1. Before You Start Testing

About the meter and test strips t Carefully read and follow the instructions in the User

Instruction Guide and Package Inserts for the test strips and SD GlucoNavii® control solution. It is very important to follow the instructions in order to prevent an incorrect result or improper treatment.

t The meter, test strips, and SD GlucoNavii® control solution

are only for use outside the body (in vitro).

t Your new meter is designed for testing fresh capillary

whole blood samples (for example, blood from your ngertip, palm, upper arm, or forearm) or fresh venous blood.

t Only use SD GlucoNavii® NFC test strips. Other test strips

will give inaccurate results or E-1 error message.

t Do not use the SD GlucoNavii® NFC blood glucose

monitoring system for testing of serum or plasma or arterial blood.

t Inspect the container of test strips before using them for

the rst time. If you see any damage to the container cap or if anything prevents the cap from closing properly, do not use the test strips. Contact SD Biosensor, Inc. Damaged test strips can cause inaccurate results, which could lead

to improper treatment. About your new meter t Set the beep, date, time, hypo warning, post-meal alarm

and alarm on your meter before you begin testing. t SD GlucoNavii® NFC system has been found to be accurate

at altitudes up to 11,549 feet. (3,520 meters)

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

t Keep the meter and testing supplies away

from small children.

t The battery door, test strips, lancets,

protective disks, and control solution cap are choking hazards.

t Do not eat the test strips. t Do not swallow or inject SD GlucoNavii®

control solution, or use control solutions for any purpose.

CAUTION

Important Information t Dehydration: Severe dehydration resulting from exces-

sive water loss may cause false low results. If you believe

you are suering from severe dehydration, consult a

healthcare professional immediately. t Low glucose results: If your test result is lower than 70

mg/dL or is shown as Lo, it may mean hypoglycemia(low

blood glucose). This may require immediate treatment

according to your healthcare professional’s recommenda-

tions. Although this result could be due to a test error, it is

safer to treat rst, and then repeat the test. t High glucose results: If your test result is greater than 180

mg/dL or is shown as HI, it may mean hyperglycemia(high

blood glucose). If you do not have symptoms, rst repeat

the test. Your healthcare professional can work with you

to decide what actions, if any, you should take if you

continue to get results higher than 180 mg/dL or if you

have symptoms. t Repeated unexpected results: If you continue to get

unexpected results, check your system with control

solution. See Checking the System with Control Solution

on pages 28 - 33. If you are experiencing symptoms that

are not consistent with your blood glucose results and

you have followed all instructions in this User Instruction

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

Guide, call your healthcare professional. Never ignore

symptoms or make signicant changes to your diabetes

control program without speaking to your healthcare

professional. t Consult your physician to determine if it is appropriate for

your child to be taught how to use the meter system or

any other medical products.

2. Special Information for Healthcare Providers and

Caregivers

t Do not use this device to measure blood glucose in

people who are experiencing cardiovascular collapse

(severe shock) or decreased peripheral blood ow. t Hematocrit: A hematocrit (percentage of your blood that

is red blood cells) that is higher than 70% can cause false

results.

3. Indication for use (Purpose of the devices)

Your new SD GlucoNavii® NFC meter and accessories work

together to measure the amount of glucose (sugar) in

your blood.

Your SD GlucoNavii® NFC blood glucose monitoring

system is indicated for monitoring glucose in fresh

capillary whole blood or fresh venous blood. Testing

is done outside the body. (in vitro diagnostic use) This

system is indicated for home (over-the-counter or OTC) by

person with diabetes, or in clinical settings by healthcare

professionals, as an aid to monitor the eectiveness of

diabetes control. This system should not be used for the

diagnosis of diabetes.

The SD GlucoNavii® NFC blood glucose monitoring system

is suitable for self-testing.

4. Product Description and the Principle of the use

SD GlucoNavii® NFC test strip is designed with an

electrode that measures glucose levels. Glucose in the

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

blood sample mixes with reagent on the test strip that

cause a small electric current. The amount of current that

is created depends on how much glucose is in the blood.

SD GlucoNavii® NFC meter measures the current that is

created and converts the measurement to the amount of

glucose that is in the blood.

The blood glucose result is displayed on the meter’s LCD

display.

By touching a drop of blood to the tip of the SD

GlucoNavii® NFC test strip, the strip’s reaction chamber

automatically draws the blood into the strip through

capillary action. When the chamber is full, SD GlucoNavii®

NFC meter start to measure the blood glucose level. It is

a simple and practical system for the daily monitoring of

your blood glucose level.

5. The Complete GlucoNavii® NFC BGMS

The system includes:

t SD GlucoNavii® NFC Meter t SD GlucoNavii® NFC Test strips t SD Glucose Check strip t 3V battery type CR2032 t User Instruction Guide t Quick Guide t Self-test Diary t Test Strip Package Insert t Carrying Case t Lancing device t Lancet

t SD GlucoNavii® control solution t SD GlucoNavii® control solution insert t SD GlucoNavii® NFC application for Android phone t SD NFC Software for PC t SD NFC Reader/Writer

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

Display

Shows blood glucose result, messages, and glucose result stored in memory.

NFC

6. SD GlucoNavii® NFC Meter

Arrow Buttons

Use for meter setup and review of memory moving to the right and left.

ON/OFF Button

Press to turn meter ON or OFF.

Test Strip Slot

Insert test strip here.

Battery Cover

Remove cover to change battery.

Location of NFC function

Tap a smartphone or SD NFC R/W for communication.

Data port

Cominucate test results with a personal computer. (If you have software)

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

Indicates Measurement time

Indicates during the meter setting

Indicates beep setting

Warns when the battery is low or must be replaced

Indicates if environmental temperature is exceeded during testing

Indicates post-meal or pre-meal

Testing date

Indicates a test result stored in memory

Unit of test result

Test result and nfc message

Display

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

Indicates the average result

Test strip

Tell you when to apply the sample and indicates if you select whole blood for blood reference type

Indicates a control solution test result

Indicates alarm setting

Indicates hypo warning

Indicates S/W communication

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

1) Strip Stand-by Display

After turning on the meter, the below will be displayed automatically to show the test strip icon ashing. In this Strip Stand-by Display, it’s able to enter setting mode of the meter or search the test results.

2) Blood Stand-by Display

If a test strip is inserted into the meter in either Strip Standby Display or turning o, the below will be displayed automatically to show the appropriate test result after applying blood sample. And if you pull o the test strip, it will return to Strip Stand-by Display. In this Blood Standby Display, the ON/OFF button doesn’t act. But if you need to check the meter or the test strip, you may use a control solution. Then the control solution icon in the left-side of test strip icon will be displayed by pressing left button during 3 seconds.

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

7. SD GlucoNavii® NFC Test Strip

SD GlucoNavii® NFC System measures the amount of glucose in whole blood. Blood is applied in the Yellow Window (TOP EDGE) of SD GlucoNavii® NFC Test Strip and is automatically drawn into the reaction cell where the reaction takes place.

(Top Edge)

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

SD GlucoNavii® control solution

SD NFC Reader/Writer

8. SD GlucoNavii® NFC Accessories

Lancing Device

Cap & Comfort dial with puncture depth

selection

Arming

Knob

Release

Button

Check

Strip

Lancet SD Glucose check strip

Electrode

Arming Knob

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

9. Changing the Battery

Inserting and replacing the Battery

Your meter is shipped with one 3V battery type CR2032 that needs to be inserted before testing. The battery that comes with your meter can be found in the mesh pocket of your carrying case. Battery life will vary depending on usage, so always keep a spare on hand. The meter saves battery power by automatically turning o after 1 minute without inserting a test strip or 3 minutes with a test strip, from non-use. If the meter does automatically shut o, all tests in memory are saved.

STEP-1: Push the recessed plastic tab of the battery compartment forward to ip and open the battery door.

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

STEP-2: Insert the 3V battery (type CR2032) into the

compartment with “+” side facing you.

STEP-3: Snap battery cover back in place.

STEP-4: Push the ON/OFF button or insert a strip to start testing.

After inserting or replacing the battery, conrm that the time and date are set correctly. If they are not, use the ON/OFF and left/right buttons to reset the meter before testing. See the “10 Meter Set up”.

NOTE

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

10. Meter Set up

STEP-1 : Setting the Audible Beep

1. In Strip Stand-by Display, if you press the ON/OFF button during 3 seconds, the display for setting the beep will appear, the rst step of the setting mode.

2. Set the beep mode on or o by pressing either the left or the right button and then selecting the preferred feature by pressing the ON/OFF button. If you select the beep on feature, a ‘beep’ sound is made at the same time; otherwise, if you select the beep o feature, no sound is made.

[ During 3 sec. ]

[ Left or right

button ]

[ ON/OFF

button ]

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

STEP-2: Setting the Hypo warning

1. After beep setting, the display for setting the hypo warning will appear, the second of setting mode.

2. Set the hypo warning mode ‘o’ or the result you want to select among 60, 70, 80 mg/dL(3.3, 3.9, 4.4 mmol/L) by pressing either the left or the right button and then selecting the preferred feature by pressing the ON/OFF button.

t You can set the meter to let you know when

your result indicates a possible low blood glucose (hypoglycemia). You can also select what blood glucose level you want this indicator to have 60, 70, 80 mg/dL(3.3, 3.9, 4.4 mmol/L).

t If your results are lower than selected hypo

result, the candy symbol will appear on LCD with a ‘beep’ sound. It is very important to manage your hypoglycemia.

NOTE

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

STEP3: Setting the date and time

[ Date Setting ]

1. The third step of setting mode is the Date & Time setting. After setting the hypo warning, the display for setting Date & Time will appear, the third step of the setting mode. Set the correct year by pressing either the left or the right button and then select the correct year by pressing the ON/OFF button.

Your new meter comes with a preset time and date. You may need to change the time to your time zone. Having the right time and date in your meter is important if you use the meter memory. It also helps your healthcare team interpret your results.

NOTE

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

[ Left or right

button ]

[ ON/OFF

button ]

2. Next will appear the setting display for month and day format. The meter can display the month and day in either a Month-Day (m-d) format or a Day-Month (dm) format. Set the preferred format on the display by pressing either the left or the right button and select by pressing the ON/OFF button.

3. Set the correct month or day on the display by pressing either the left or the right button and select by pressing the ON/OFF button.

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

[ Time Setting ]

1. Next will appear the display for setting the 12 or 24 Hour

clock format. The meter can display the time in either the 12h format or the 24h format. Set the preferred format on the display by pressing either the left or the right button and select by pressing the ON/OFF button.

2. Next will appear the setting display for time format. Set

the correct hour and minute on the display by pressing either the left or the right button and select the correct time by pressing the ON/OFF button.

[ Left or right

button ]

[ ON/OFF

button ]

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

STEP4: Post-meal alarm

You can use the meter’s post-meal alarm function to remind you to test your blood glucose after meal.

1. After day and time setting, the display for setting the post-meal alarm will appear, the fourth of setting mode.

2. Set the post-meal alarm mode ‘2h’ or ‘o’ by pressing either the left or the right button and then select the preferred feature by pressing the ON/OFF button.

[ Left or right

button ]

[ ON/OFF

button ]

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

t If you select the post-meal alarm ‘2h’ feature

and test with pre-meal mark, the ‘clock symbol’ will appear on result display and the ‘beep’ sound will be made in 2 hours to remind you to test your blood glucose after meal for 1mimute.

t If you perform the pre-meal test while the

post-meal alarm setting is on, then the postmeal mark will appear automatically on your LCD when you test within following period: from 30min to 130min after your pre-meal test.

t If you mark the new test result with a pre-

meal mark, the old alarm setting will be ignored and only the new setting will sound in 2 hours.

NOTE

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

STEP5: Setting the alarm

You can use the meter’s alarm function to remind you to test your blood glucose.

1. After Post-meal alarm setting the display for setting the alarm will appear, the fth of setting mode.

2. Set the rst alarm on or o by pressing either the left or the right button and then select the preferred feature by pressing the ON/OFF button.

[ Left or right

button ]

[ ON/OFF

button ]

t If you select the alarm o feature, next will

appear the Strip Stand-by Display.

t If you select the alarm on feature, you can set

the alarm up to four times a day at any time you want.

NOTE

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

3. If you select the alarm on feature in rst alarm mode, the clock will blink. Set the correct time and minute you want to set an alarm on the display by pressing either the left or the right button and then select the preferred feature by pressing the ON/OFF button.

4. If you nish setting the rst alarm, next will appear the second alarm setting mode. Set the alarm with the same way as above. [2, 3]

5. You can set the third and fourth alarm mode with the same way as above. [2, 3]

[ Left or right

button ]

[ ON/OFF

button ]

If you select the alarm o feature in rst (also second, third and fourth) alarm mode, next will appear the Strip Stand-by Display.

NOTE

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

STEP6: DATA REVIEW SETTING

This function is to review the latest test result when inserting the strip into the meter. You can check your latest test result before testing.

1. After alarm setting, display the Data review setting mode.

2. Set the data review function by pressing the left or right button for selecting the preferred feature.

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

3. If you nish data review setting mode, next appear at the strip-stand by display.

11. Using SD GlucoNavii® NFC Test Strips

[ Important Test Strip Information ]

t SD GlucoNavii® NFC blood glucose test strip should be

used with SD GlucoNavii® NFC meter. Using other glucose test strip can cause inaccurate the result or ‘E-1’ error message.

t After removing a test strip from the container, replace the

container cap immediately and close it tightly.

t Use the test strip within three minutes after you take it out

of the container.

t Store test strip containers in a cool, dry place at 2-32°C(36-

90°F). Keep away from direct sunlight and heat. Do not refrigerate test strips.

t Do not expose strips to heat, moisture or humidity.

Temperatures outside the required range, as well as moisture and humidity (e.g. bathroom, kitchen, laundry room, car, or garage) can damage your test strips and lead to inaccurate results.

t Store test strips in their original container only to avoid

damage or contamination. Do not transfer test strips to any other storage device, and do not store outside of their original container.

t Do not use test strips from any container that is damaged

or left open to air.

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

t Write the opening date on the container label when you

rst open it. Discard remaining SD GlucoNavii® NFC Test Strips after the discard date. (6 months after rst opening from the container)

t SD GlucoNavii® NFC Test Strips are for single use only.

Never reuse a test strip that has had either blood or control solution applied to it.

t Avoid getting dirt, food or liquids on the test strip. With

clean, dry hands, you may touch the test strip anywhere on its surface.

t Do not bend, cut, or alter SD GlucoNavii® NFC Test Strip

in any way.

Do not swallow test strips. The test strip container may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.

CAUTION

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Control Solution Test

CHAPTER 2 : Control Solution Test

Why you do control solution test ;

t SD GlucoNavii® control solution is used to check that the

meter and the test strips are working together as a system and that you are performing the test correctly.

t It is very important that you do this simple check routinely

to make sure you get an accurate result.

When you do control solution test ;

t You open a new box test strips. t You left the test strip container open or you think your test

strips have been damaged.

t Your test strips were stored in extreme temperatures and/

or humidity.

t You want to check the meter and test strips. t You dropped the meter. t Your test result does not agree with how you feel. t You want to check if you are testing correctly.

Before you begin ;

t Use only SD GlucoNavii® control solution. t Check the expiration date on the control solution

container. Record the opening date on the container label. Do Not use after expiration or discard date (date opened plus three months), whichever comes rst.

t Control solution, meter and test strips should be at room

temperature 18-30°C (64-86°F) before testing with control solution.

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Control Solution Test

t Shake the container, discard the rst drop of control

solution, and wipe o the tip to ensure a proper sample and an accurate result.

t Store SD GlucoNavii® control solution tightly closed

at temperatures between 8-30°C (46-86°F). Do Not refrigerate.

1. Performing Control Solution Test

You need the meter, a test strip, and control solution Level M or Level H. The control level is printed on the test strip label. For more information how to obtain SD GlucoNavii® control solution, call at +82-31-300-0400.

t Do not swallow SD GlucoNavii® control

solution; it is not for human consumption.

t Do not apply SD GlucoNavii® control solution

to the skin or eyes as it may cause irritation.

CAUTION

A set of Level M and H control solutions is available for purchase. To order control solutions, talk to your pharmacist or medical surgical supply dealers. Your meter is designed to recognize the dierence between SD Glucose Control Solution and blood. The meter automatically stores the test results using a control solution, letting your review them. But the meter does not include them in averages.

NOTE

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Control Solution Test

STEP-1:

1) Remove a new test strip from container. Be sure to

tightly replace container cap after removing test strip.

2) Insert a test strip (yellow window printed ‘ ’ facing

up) into test strip slot. The meter turns on automatically.

STEP-2:

1) Press the left button for 3 seconds to check the testing

system using a control solution in Blood Stand-by Display. If you don’t want a control solution test, press the left button again.

2) Shake the control solution container and discard the

rst drop of solution. Gently squeeze the container to form one small drop. Bring the drop to the edge of the strip, and allow the strip to automatically draw the control solution into the yellow window. When control solution is applied to the test strip, the meter counts down from 5 to 1 second on the display. Tightly replace the cap on control solution.

NFC

[ Left

button ]

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Control Solution Test

3) The control solution result appears on the screen in just 5 seconds.

4) Compare control solution result with the range printed on the test strip container.

If the results are not within the control range printed on

the test strip container, then the meter and strips may not be working properly. Repeat the control solution test.

5) Remove the used test strip for control solution from the meter and discard it.

mg/dL

mmol/L

NFC

NOTE

The control solution range printed on the

test strip

container is for SD

GlucoNavii®

Control

Solution only. It is not a recommended range for your blood glucose level.

[This is an example. Refer to the ranges on your test strip container.]

Control Range

Level M Level H

90-140 mg/dL 170-240 mg/dL

5.0-7.8 mmol/L 9.4-13.3 mmol/L

mg/dL

mmol/L

[Example]

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Control Solution Test

Check Action

Did you do the test in control solution mode? Did you see “control solution container icon” on the screen with the result?

If not, do the test again. Insert a test strip; Press the left button for 3 seconds in Blood Standby Display to display a control solution container icon.

Have the test strips and/or control solution expired?

Make sure that test strips and control solutions are not past expiration date. This date is shown the container/bottle. Make sure the expiration date of both a test strip and a control solution.(test strip : 6 months, control solution : 3months)

Were control solutions at room temperature (18-30°C, 64-86°F) when used?

If not, retest with new bottle of control solution, or warm up/cool down to room temperature. (18-30°C, 64-86°F)

2. Troubleshooting Control Solution Test

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Control Solution Test

Check Action

Did you insert test strip rmly into meter?

Make sure test strip is inserted into the test strip slot until it will go on further.

Did you follow the procedure correctly?

Read again “Chapter 2 : Control Solution Test” (pages 28-33) and retest.

Were test strips stored correctly? (at 2-32°C, 36-90°F) Was the bottle cap replaced immediately after removing a test strip?

If not, retest with a new container of test strips.

Is the meter damaged? Does it show an error message?

If yes, contact SD Biosensor, Inc. at +82-31-300-0400.

Is the control result outside the acceptable range(printed on your test strip container)?

Repeat the test. If you get the same results, do not use your meter and test strip until you solve the problem. If you still have problem, call SD Biosensor, Inc. at +82-31-300-0400.

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Testing Your Blood Sugar

CHAPTER 3 : Testing Your Blood Glucose

1. Getting a Drop of Blood

1) Wash your hands in warm, soapy water. Rinse well and dry completely. Warming ngers can increase blood ow.

2) Turn the lancet insert cap counterclockwise to remove it, insert the lancet into the lancing device holder and push down rmly until it is fully seated. Twist the lancet protective disk until it separates from the lancet.

3) Replace the cap and turn it clockwise, until it is snug. Adjust the puncture depth setting by turning the comfort dial. The dial has 1 to 5 steps, and the higher the step number, the stronger the blood sampling pressure on the puncture site.

The comport tip oers 5 dierent levels of skin

penetration.

t 1-2 : for soft or thin skin t 3 : for average skin t 4-5 : for thick or callused skin

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Testing Your Blood Sugar

4) After cocking the lancing device back, hold the lancing device rmly against the side of nger and then press the release button.

t A lancet should only be used once. Do not

share used lancets with another person. To prevent possible infection, a used lancet should not be touched by another person.

t Used lancets in the regular trash can be

dangerous. We recommend that you throw out the used lancets in sharps containers or test strip vials. Please be sure to save the cap so that the lancets cannot spill out of the container into the trash.

CAUTION

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Testing Your Blood Sugar

2. Performing a Blood Glucose Test

1) Remove a new test strip from container. Be sure to tightly replace container cap after removing test strip.

2) Make sure the meter turn o. And then, Insert the test strip into the meter.

3) When the blood drop symbol ashes (Blood Stand-by Display), you are ready to perform a test.

4) Let your arm hang down at your side to allow blood to ow to your ngertips. Grasp your nger just below the joint closest to the ngertip.

5) Obtain a drop of blood sample using the lancet and lancing device.

6) Hold your nger to the tip of the strip until the yellow window is completely lled with blood. Do not place the blood drop on top of the strip.

Always wash hands with warm, soapy water. Rinse and dry them before testing.

NOTE

NFC

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Testing Your Blood Sugar

7) The blood will be drawn into the strip automatically. If beeper is turned on, meter will beep to let you know the test is beginning.

8) When blood is applied to the strip, start the test. After 5 seconds, the test result appears on the screen.

9) You can set the pre-meal or post-meal test if you want. The symbol indicating pre-meal( ) or post-meal( ) appears on the screen. Choose what you want by pressing the left or right button. If you press the On/O button, no select any features.

10) When the test is done, pull out the used test strip and discard it.

t Remove the inserted lancet from the lancing

device and dispose the used lancet with care.

t Always use fresh capillary or venous whole blood

for tests.

t If you want to use NFC function, refer to ‘Chapter

4. Using the NFC function’ on page 40~44 .

NOTE

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Testing Your Blood Sugar

3. Understanding Test Results

Your test results

1. After 5 seconds testing time from applying a blood into strip, you will receive a normal result, 10mg/dL to 600mg/dL.

2. If your blood glucose is above 600 mg/dL, you will receive a “HI” and is below 10 mg/dL, you will receive “Lo”. In these cases, repeat the test with new test strip. If this message show again, contact your healthcare professional immediately.

3. If you set the pre-meal mark after the test, you will receive a result with pre-meal mark. ( )

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Testing Your Blood Sugar

4. If you set the post-meal mark after the test, you will receive a result with post-meal mark. ( )

Normal Blood Glucose Readings

The normal fasting blood glucose range for an adult without diabetes is 74 - 106 mg/dL.

Two hours after meals, the blood glucose range for an adult without diabetes is less than 140 mg/dL.

t 'BTUJOHUPNHE- t IPVSTBGUFSNFBMTNHE-

What This Means For You

Frequent blood glucose testing is the best means to track how well you are doing with your diabetes management. It helps you track the eects of medications, diet, exercise, and stress management. Blood glucose test results can also tell you if your diabetes is changing. This may alert you to adjust your treatment plan. Always consult your healthcare professional before making any adjustments.

Frequency of Testing

Work with your healthcare professional to decide when and how often to test. This will depend on such things as age, type of diabetes, and medications. It is important to make testing part of your daily routine.

If you perform the pre-meal test while the postmeal alarm setting is on, then the post-meal mark will appear automatically on your LCD when you test within following period: from 30min to 130min after your Pre-meal test.

CAUTION

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using NFC function

Chapter 4: Using NFC function

1. Information on NFC function

NFC(Near eld communication) is a set of standards for smartphones and similar devices to establish radio communication with each other by touching them together or bringing them into close proximit.

This function is comfortable for test results back-up at PC or smartphones. So, you can easily monitor your blood glucose results.

SD GlucoNavii® NFC follows “Felica” standard which include ISO/ IEC 18092.

2. Information on Caution for NFC

t Check your smatphone or PC OS version. For PC, It is available for Windows XP, Windows VISTA, Windows 7 and need to SD NFC reader writer purchased separately.

For Smartphone, It is available for only smartphones with

Android OS v.2.3.1 or higher. Check the list in http://www. nfcworld. com/nfc-data/android/.

t Before using this function, check the meter turn o. If turn

the meter on, you cannot use NFC function.

t Check the location of chip for NFC in your smartphone. It

is dierent by manufacturer. For more information, refer to manufacturer website of your smartphone.

t SD NFC software for PC is able to download at www.

sdbiosensor.com .

t If the distance between the meter and a smartphone(or

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using NFC function

SD NFC reader writer) is far(about over 2cm/0.06ft), NFC function is not operated.

3. Using NFC function?

1) After testing or you want to test result back-up, turn the meter o.

2) Check the location of NFC at your smartphone.

3) If you tap SD GlucoNavii® NFC to your Smart phone, two kinds of action are happened. First, start App. Seconds, Upload Data. (If App. is already running, please, wait a minute.)

4) After nishing the communication, check that the test results are transferred well in your smartphone or PC.

More information on App or software for PC, refer to each manual.

NOTE

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using NFC function

4. How to use GlucoNaviiApp

1) Download & Install

t Search ‘GlucoNavii’ in Google Play at your

celphone. You can search other keyword that are ‘SD Biosensor’ or ‘NFC glucose meter’.

t Install GlucoNavii App. in your phone.

t Check the NFC function at your smart-phone. If it

is the ‘O’ setting, turn NFC function ‘On’.

2) Communicate with SD GlucoNavii® NFC

t Please power o SD GlucoNavii® NFC meter. t If you tap SD GlucoNavii® NFC to your smart-

phone, two kinds of action will be happened. First, if App. is not turning it on, start App. Seconds, if App. is already running, please, wait a minute to upload test results.

3) Utilize GlucoNaviiApp

(1) Start App. (2) If you need to upload new data, just tap GlucoNaviiNFC to your Smart Phone.

Please remember the points of contact for both devices.

NOTE

NFC enabled smart-phone with Android OS v.2.3.1 or higher. Check the list in http://www.nfcworld.com/nfc-data/ android/.

NOTE

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using NFC function

5. How to use SD NFC Software for PC

1) Download the software at www.sdbiosensor.com. And then, start the software.

2) Turn the meter o. If not, you cannot start NFC function.

3) Tap the meter with SD NFC reader writer plugged with PC. And then, Start the communication.

4) After nishing the communication, you can look the log book(test results) or graph.

If you have any question or queries about SDGlucoNaviiApp, or SD NFC Software for PC , please email to (SD_Dev@sdbiosensor.com).

More information on App or software for PC, refer to each manual.

NOTE

European Union Directive Conformance Statement

Hereby, SD Biosensor declares that SD GlucoNavii(R) NFC blood glucose meter is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.

You can view your product’s Declaration of Conformity(DoC) to Derictives 1995/5/EC(R&TTE) Directive at www.sdbiosensor.com.

NOTE

WARNING: Changes or modications made to this equipment not expressly approved by SD Biosensor, Inc. for compliance could void the user’s authority to operate the equipment.

CAUTION

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using NFC function

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment o and on, the user is encouraged to try to correct the interference by one or more of the following measures:

t Reorient or relocate the receiving antenna. t Increase the separation between the equipment

and receiver.

t Connect the equipment into an outlet on a circuit

dierent.

t from that to which the receiver is connected. t Consult the dealer or an experienced radio/TV

technician for help.

NOTE

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using the Meter Memory

CHAPTER 5 : Using the Meter Memory

The meter automatically stores about 500 glucose results, letting your review them in order from the most recent to the oldest. If you have set the time/date feature, the time and date of the results are also displayed. If the memory is full and a new result is added, the meter deletes the oldest result. The meter also calculates three kinds of 7, 14 and 30-day averages of test results stored in memory, 1)normal, 2)premeal and 3)post-meal state averages. You do not need to set the time and date for the meter to give you average calculations. HI/Lo result (results outside of the meter’s reading range) and results with control solution symbol are not included in averages.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using the Meter Memory

1. Searching Test Results

1) In Strip Stand-by Display, press the left arrow button to review in sequence from the most recent test result to the last test results stored in memory.

[Normal result]

[Pre-meal result]

[Post-meal result]

[ Left button ]

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using the Meter Memory

[Control Solution result]

3) If there aren’t the stored test results, the following display appears for 1 second, and then the meter will display Strip Stand-by Display automatically.

2) After the result with date and time display for 1 second, the date will change into the appropriate memory number automatically.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using the Meter Memory

4) In Strip Stand-by Display, press the right arrow button to review three kinds of 7,14 and 30 day averages of test result stored in memory in sequence. (normal, pre-meal and post-meal state) You can also review the number of results at each average in the right bottom of the LCD window. If you press the right arrow button once more after displaying the 30 day average(with post-meal mark), the 7-day average result appear again.

[Post-meal average]

[ Normal average ]

[Pre-meal average]

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using the Meter Memory

5) If there aren’t any stored 7, 14 and 30-day average of test results, following display will appear on the LCD.

You cannot search the stored test results and average of results in the meter, if a test strip is inserted in the meter, Blood Stand-by Display. After removing the test strip from the meter, you can search the test results and average of results stored in memory by pressing the left or the right button.

NOTE

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Using the Meter Memory

2. Downloading results to a computer

You can use your meter with SD NFC Software to store your records and to help you spot patterns for planning meals, exercise, and medication. SD NFC Management Software puts information downloaded from the meter into charts, diagrams and graphs.

1) Obtain the SD NFC Software and SD NFC R/W.

2) Install the software on a personal computer.

Please

refer to Software Product Manual.

t While the meter is connected to the PC, it is

unable to perform a blood glucose test.

t For downloading SD NFC Software and Software

Product manual(both are free of charge), please visit www.sdbiosensor.com.

t For ordering SD NFC Reader/Writer

, please contact

our representative.

t For more information,please refer to Software

Product Manual. If the cable port got ESD while downloading data, time delay, a few seconds, may be happened. After a while, the meter retransmit data automatically.

NOTE

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

CHAPTER 6 : Maintenance and Troubleshooting

Performing Check strip Test

When you do the check strip test?

t When you want to easily check the performance of the

meter.

t Before using your meter for the rst time. t Whenever your result does not agree with the level

you feel.

t If you have repeated a test and the blood glucose

result is still lower or higher than expected.

How to Use the check strip

1. Insert SD Glucose Check strip (facing up ‘Check strip’ printed in arming knob) into test strip slot. The meter turns on automatically.

2. If the check strip is inserted properly, the meter will start the check.

Check Strip test does not replace Control Solution test.

CAUTION

Check

Strip

NFC

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

3. The check result appears on the screen in 5 seconds. ‘OK’ message appears on the screen if there isn’t any problem for the meter. If not, ‘EEE’ message appears on the screen.

2. Cleaning the meter

Caring for SD GlucoNavii® NFC meter is easy. Just keep it free of dust. If you need to clean it, follow these guideline carefully to help you get the best performance possible.

To prevent malfunction of the meter, keep the test strip port free of blood, moisture, dirt, or dust. Use a lint-free cloth dampened with water to clean meter. Thoroughly wring out cloth before use. Do not use an abrasive cloth or antiseptic solution, as these may damage the display screen.

[ ‘OK’

Message ]

[ ‘EEE’

Message ]

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

3. Maintenance, Testing and Transportation

The meter needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong. If you drop the meter or think it is not giving accurate results, make sure that your test strips and control solution haven’t expired, and then run a control solution test.

Precautions for Maintenance, Testing and Transportation

1) Meter

t Keep the test strip slot free of dust. t Protect the internal meter from humidity. t The carrying case is designed to let you store a variety

of supplies you may need and helps to protect your meter.

t If you keep the meter with the battery inserted, then

keep it in a low humidity environment.

t Do not modify the meter, such as resembling or

remodeling, NFC function is not operated well. If any function is not perated, please contact SD Biosensor, Inc.

2) Test strip

t The test strip is sensitive to humidity, keep it in a dry

and cool environment, and do not store in direct sunlight.

t After pulling out the test strip from its container, close

a container cap of the test strip immediately.

t The test strip container closes tightly and can protect

the test strips, so you should keep the unused test strips in the container in which they came.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

3) Lancet and Lancing device

t The needle of lancet is sharp, keep the lancet away from

children.

t Keep the lancet and lancing device dry and do not store

in direct sunlight, or high heat and humidity locations.

t A lancet should not use for the other intended use except

sampling blood.

t A lancet is for single use only. Do not reuse. t A lancet provided with SD GlucoNavii® NFC Blood glucose

meter is able to use every lancing devices manufactured by other company. But if at all possible, use the lancing device manufactured by SD Biosensor, Inc.

t Before using, check a packaging condition, if there is any

problem, you should not use it.

t If a lancet protective disk is loosed or needle of a lancet is

exposed, you should not use it.

t To reduce the chance of infection for the used lancet,

discard it.

4) Control solution

t Keep SD GlucoNavii® control solution in 8-30°C (46-

86°F) environment.

t Do not refrigerate or freeze. t Do not use SD GlucoNavii® control solution that has

passed the expiration date.

t SD GlucoNavii® control solution can be used for 3

months after opening the container. Write the opened date on the container when you rst opened.

t No reconstitution or dilution is necessary. t Wipe the container tip clean and reseal the container

tightly after each use.

4. Cleaning the Lancing Device

Clean the outside of SD lancing device regularly with 70% isopropyl (rubbing) alcohol. Do not place the entire device under water. Do not use bleach. At least once a week, disinfect the cap after cleaning by placing it in 70% rubbing alcohol for 10 minutes. Allow the cap to air-dry after disinfecting.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

5. Screen Messages and Troubleshooting

Message Description

t The meter turns on normally.

[Strip Stand-by Display]

t The meter is ready for you to

insert a test strip.

[Blood Stand-by Display]

t The meter is ready for a drop of

blood.

t The meter is ready for a drop of

blood with pre-meal mark.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

t The meter is ready for a drop of blood with post-meal mark.

t The meter shows the test result.

t The meter shows three kinds of average of results.

[Normal Results Average]

[Pre-meal Results Average]

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

t The meter shows the saved results of blood glucose.

t The meter is ready for a drop of control solution.

[Post-meal Results Average]

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

[Low battery]

t At this time, battery is getting low but you can still

perform about 50 tests. Replace the battery soon. See Chapter 1 “9. Changing the Battery”.

[Replace battery]

t Battery power is low. Replace the

battery immediately. See Chapter 1 “9. Changing the Battery”. If you press the ON/OFF button after discharging of the battery, the battery icon will ash and then after ten seconds the meter will turn o automatically.

[HI message]

t Blood glucose may be higher than

the measuring range of the system. See chapter 3 “4. Understanding Test Results”.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

[Lo message]

t Blood glucose may be lower than

the measuring range of the system. See chapter 3 “4. Understanding Test Results”.

[Internal Error Message for a meter]

t Turn o a meter. Then turn on

the meter again. If there is still error message, please contact SD Biosensor, Inc. TEL: +82-31-300-0400.

[Strip Error]

t Defective test strip or the test strip

is damaged or inserted improperly. Discard this test strip and test again using new test strip. See Chapter 3 “2. Performing a Blood Glucose Test”.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

[Blood Sample Error]

t An insucient amount of blood was

applied. Discard this test strip and test again using new test strip and a larger sample, making sure blood is placed to the narrow channel in the top edge of the test strip. See Chapter 3 “2. Performing a Blood Glucose Test”.

[Temperature Error]

t If the environmental temperature is

above or below the operating range of a meter, a thermometer icon will appear on the display. Move to an area between 8-45°C (46-113°F), wait for 30 minutes, and perform a test. Do not articially heat or cool the meter. See Chapter 6. “Product Technical Information”.

[Communication Error]

t The communication between meter

and computer is failed. Connect again between meter and PC.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

6. Warnings, Precautions and Limitations

t Never make signicant changes to your diabetes

control program or ignore physical symptom without consulting with your healthcare professional.

t Severe dehydration (excessive water loss) may cause

false low results. If you believe you are suering from dehydration, consult your healthcare professional right away.

t Extremes in hematocrit may aect test results.

Hematocrit levels greater than 70% may cause falsely low readings.

t 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.

t Normal endogenous (within body) natural levels

of uric acid, ascorbic acid (vitamin C), bilirubin, triglycerides, and hemoglobin do not interfere with your blood glucose results obtained.

t Interferences : The following compounds, elevated

levels of ascorbic acid, uric acid, acetaminophen, total bilirubin, triglycerides may aect results.

Compound Limitation

Ascorbic acid > 4 mg/dL

Uric acid

> 9 mg/dL

Acetaminophen

> 6 mg/dL

Total bilirubin

> 40 mg/dL

Triglycerides

> 1800 mg/dL

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Maintenance and Troubleshooting

t Do not use during or soon after xylose absorption

testing. Xylose in the blood will cause an interference.

t SD GlucoNavii® NFC System is not designed to be a

substitute for pathology laboratory equipment and should not be used for the diagnosis of diabetes.

t Do not use SD GlucoNavii® NFC meter to test neonates.

It has not been validated for neonatal use.

t Preservatives: When using the venous blood foe

sample, blood may be collected by healthcare professional into test tubes the anticoagulants(EDTA, lithium heparin or sodium heparin). Do not use other anticoagulants or preservatives.

t Peritoneal dialysis solution: Icodextrin does not

interfere with SD GlucoNavii® NFC test strip.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Product Technical Information

CHAPTER 7 : Product Technical Information

1. System Specications

Result Range

10 - 600 mg/dL, (0.6 - 33.3 mmol/L)

Calibration Plasma-equivalent

Sample Fresh capillary or venous whole blood

Sample Size 0.5 microliter

Test Time 5 seconds

Assay Method

Glucose Dehydrogenase Biosensor

ON/OFF Source

One replaceable 3 V Lithium Battery type CR2032

Battery Life Around 1,000 tests

Glucose Unit mg/dL , mmol/L

Display LCD (Customized)

Controls

3 Buttons

Size

48 mm × 90 mm × 15 mm

Weight

50g (with battery)

Automatic Shuto

t 1 minutes after last user action

without inserting test strip into the meter

t 3 minutes after last user action when

inserting test strip into the meter

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Product Technical Information

- Meter

- Test strip

Operation

Temperature 8 - 45°C (46 - 113°F)

Hematocrit 0 - 70%

Altitude

Up to 11,549 feet. (3,520 meters)

Storage

Temperature 2°C – 32°C (36°F – 90°F)

Memory

500 blood glucose tests

Function

- Hypo warning : 60, 70, 80 mg/dL(3.3, 3.9,

4.4 mmol/L)

- Pre-meal and post-meal mark

- Alarm setting (up to 4 times)

- Post-meal Alarm

- 7-, 14- and 30-day Averages of the following results

1)Normal Results

2)Pre-meal Results

3)Post-meal Results

- Automatic shuto

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Product Technical Information

Annex 1 : Information for Healthcare Professionals

Decisions about whether to recommend alternative site testing (AST) should take into account the motivation and knowledge level of the patient and his or her ability to understand the considerations relative to diabetes and AST. If you are considering recommending AST for your patients, you need to understand that there is a potential for a signicant dierence between ngertip and alternative site blood glucose test results. The dierence in capillary bed concentration and blood perfusion throughout the body can lead to sample site-to-site dierences in glucose results. These physiological eects vary between individuals and can vary within a single individual based upon his or her behavior and relative physical condition. Our studies involving AST of adults with diabetes show that most persons will nd their glucose level changes more quickly in the ngers’ blood than the alternative sites’ blood.

This is especially important when glucose levels are falling or rising rapidly. If your patient is used to making treatment decisions based upon ngertip readings, he or she should consider the delay or lag-time, aecting the reading obtained from an alternative site.

Healthcare professionals : Follow the infection control procedures appropriate for your facility

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Product Technical Information

Annex 2 : Symbol

The following list describes all symbols used on SD GlucoNavii® NFC Blood glucose monitoring (BGM) system.

Symbol Description

Caution, consult accompanying documents

Battery type used in this meter

Crossed out wheeled bin: To discard it separately from other household waste

Consult instructions for use

In-vitro diagnostic medical device:

This system is intended to use outside the body (in vitro diagnostic use).

Serial number for this meter.

Date of manufacture : To indicate the date of manufacture for this meter

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Product Technical Information

Symbol Description

Lot No. or Batch Code To indicate the lot number for this system

Expiry date: This system should be used by the given date.

To indicate the temperature limitations in which the transport package has to be kept and handled

Catalogue number: To indicate the catalogue number for this system

To indicate the manufacturer

$POUBJOT4VóDJFOUGPSO5FTUT

To use for 6 months after rst opening the container.

DO NOT REUSE: To warn the user of a piece of equipment that it is for single use only and that it must not therefore be used more than once

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Product Technical Information

Annex 3 : References

1. American Diabetes Association, Clinical Practice Recommendation Guidelines 2003, Diabetes care, Vol.

26. Supplement 1. p.22

2. Stedman, TL. Stedman’s Medical Dictionary, 27th Edition, 1999, p. 2082.

3. Ellen T. Chen, James H. Nichols, Show-Hong Duh, Glen Hortin, MD: Diabetes Technology & Therapeutics, Performance Evaluation of Blood Glucose Monitoring Devices, Oct 2003, Vol. 5, No. 5 : 749 -768

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Product Technical Information

Return

You must contact SD Biosensor Customer Service at +8231-300-0400 before returning your meter. You will be instructed how to return the meter to SD Biosensor, Inc. Returned meters without this authorization will not be accepted.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

707070

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Product Technical Information

Manufactured by

SD BIOSENSOR, Inc.

C-4th&5th Floor Digital Empire Building 980-3, Yeongtong-dong, Yeongtong-gu, Suwon-si, Kyonggi-do, Korea

EC-Representative

717171

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Product Technical Information

MEMO

727272

SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

Product Technical Information

MEMO

For further information on

please contact your

SD BIOSENSOR, Inc.

Representative

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01GM40/01GC40 series

FCC ID : RPJ01GM40

0168 0123

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TEL : +82-31-300-0400 F AX : +82-31-300-0499

C-4th&5th Floor Digital Empire Building 980-3, Yeongtong-dong

Yeongtong-gu, Suwon-si, Kyonggi-do, Korea

SD Biosensor SD GlucoNavii NFC User Instruction Manual

Specifications and Main Features

Frequently Asked Questions

User Manual