SD CodeFree Manual de usuario

L21CF1ENR2

Issue date : 2012.08

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

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

01GM11/01GC11 series

TEL : +82-31-300-0400 FAX : +82-31-300-0499

For further information on

please contact your

SD BIOSENSOR, Inc.

Representative

User Instruction

Guide

BLOOD GLUCOSE MONITORING SYSTEM

Coding

www.sdbiosensor.com

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM

Dear SD CodeFree™ System Owner;

Thank you for choosing the SD CodeFree™ Blood Glucose

Monitoring System. Your new SD CodeFree™ 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.

NOTE

CAUTION

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.

NOTE

SD CodeFree™ 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 CodeFree™ Blood

Glucose Monitoring System

6. The SD CodeFree™ Meter

7. The SD CodeFree™ Test Strip

8. SD CodeFree™ Accessories

9. Changing the Battery

10. Meter Set up

11. Using SD CodeFree™ 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. Alternative Site Testing (AST)

4. Understanding Test Results

TABLE OF CONTENTS

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM

TABLE OF CONTENTS

Chapter 4 : Using the Meter Memory

1. Searching Test Results

2. Downloading results to a computer

Chapter 5 : Maintenance and

Troubleshooting

1. Performing a SD Check Strip Test

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 6 : Product Technical

Information

1. System Specications

Annex 1 : Information for Healthcare

Professionals

Annex 2 : Symbol

Annex 3 : References

Annex 4 : Supplies and Accessories

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

CHAPTER 1 :

Understanding Your New System

The SD CodeFree™ Blood Glucose Monitoring

System

1. Before You Start Testing

About the meter and test strips

• Carefully read and follow the instructions

in the User Instruction Guide and Package

Inserts for the test strips and control solutions.

It is very important to follow the instructions

in order to prevent an incorrect result or

improper treatment.

• The meter, test strips, and control solutions are

only for use outside the body (in vitro).

• Your new meter is designed for testing fresh

capillary whole blood samples (for example,

blood from your ngertip, palm, upper arm,

or forearm). Only use SD CodeFree™ test strips.

Other test strips will give inaccurate results.

• Do not use the SD CodeFree™ blood glucose

monitoring system for testing of serum or

plasma or arterial, venous whole blood.

• 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 the SD Biosensor Customer

Care Service Center. Damaged test strips can

cause inaccurate results, which could lead to

improper treatment.

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

About your new meter

• Set the beep, date, time, hypo warning, post-

meal alarm and alarm on your meter before

you begin testing.

• Set the Pre-meal and Post-meal mark on your

meter, if you want to display it.

• This meter has a pre-set unit, mg/dL or

mmol/L, for your country.

• The SD CodeFree™ system has been found

to be accurate at altitudes up to 12,388 feet.

(3,776 meters)

Important Information

• Dehydration: Severe dehydration resulting

from excessive water loss may cause false low

results. If you believe you are suering from

severe dehydration, consult a healthcare pro-

fessional immediately.

• Low glucose results: If your test result is lower

than 70mg/dL(3.9 mmol/L) or is shown as ‘Lo’,

it may mean hypoglycemia. (low blood glu-

• Keep the meter and testing

supplies away from small children.

• The battery door, test strips,

lancets, protective disks, and

control solution cap are choking

hazards.

• Do not eat the test strips.

• Do not swallow or inject control

solutions, or use control solutions

for any purpose other than testing

the SD CodeFree™ system.

CAUTION

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

cose) This may require immediate treatment

according to your healthcare professional’s

recommendations. Although this result could

be due to a test error, it is safer to treat rst,

and then repeat the test.

• High glucose results: If your test result is

greaterthan180mg/dL(10mmol/L)orisshown

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(10 mmol/L) or

if you have symptoms.

• 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 31-

37. If you are experiencing symptoms that are

not consistent with your blood glucose results

and you have followed all instructions in this

User Instruction Guide, call your healthcare

professional. Never ignore symptoms or make

signicant changes to your diabetes control

program without speaking to your healthcare

professional.

• 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.

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

2. Special Information for Healthcare

Providers and Caregivers

• Do not use this device to measure blood

glucose in people who are experiencing

cardiovascular collapse (severe shock) or

decreased peripheral blood ow.

• Hematocrit: A hematocrit (percentage of your

blood that is red blood cells) that is either very

high (above 60%) or very low (below 20%) can

cause false results.

3. Indication for use (Purpose of the

device)

Your new SD CodeFree™ meter and accessories

work together to measure the amount of

glucose (sugar) in your blood.

Your SD CodeFree™ blood glucose monitoring

system is indicated for monitoring glucose in

fresh capillary whole blood samples drawn

from the ngertip, palm, forearm or upper

arm. Your SD CodeFree™ meter must be used

with only SD CodeFree™ blood glucose test

strip. 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 or for testing newborns. When

you put a drop of blood onto the test strip,

the meter displays a blood glucose result

in ve seconds. Testing your blood glucose

regularly can make a big dierence in how you

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

manage your diabetes every day. Discussing

your results with your doctors and following

their advice about medicine, exercise, and

food plans can help you better control your

diabetes.

The SD CodeFree™ blood glucose monitoring

system is suitable for self-testing.

4. Product Description and the Principle of

the use

SD CodeFree™ test strip is designed with

an electrode that measures glucose levels.

Glucose in the 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 CodeFree™ 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 CodeFree™ test strip, the strip’s reaction

chamber automatically draws the blood into

the strip through capillary action. When the

chamber is full, the SD CodeFree™ meter

starts to measure the blood glucose level. It

is a simple and practical system for the daily

monitoring of your blood glucose level.

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM

Understanding Your New System

5. The Complete SD CodeFree™ Blood

Glucose Monitoring System

The system includes:

• SD CodeFree™ Meter

• SD CodeFree™ Test strips

• SD Glucose Check strip

• 3V battery type CR2032

• User Instruction Guide

• Quick Guide

• Self-test Diary

• Strip Insert

• Carrying Case

• Lancing device (with a white cap for

ngertip testing and a clear cap for

Alternative Site Testing)

• Lancet

• SD Glucose Control Solution

• Control solution insert

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