SD CodeFree User manual

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 : [phone] FAX : [phone]
For further information on
please contact your
SD BIOSENSOR, Inc.
Representative
User Instruction
Guide
BLOOD GLUCOSE MONITORING SYSTEM
No
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 : [phone]
Fax : [phone]
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
2
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
4
4
7
7
8
9
10
15
16
17
19
29
TABLE OF CONTENTS
31
33
36
38
38
40
44
51

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
3
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
54
55
59
60
60
61
62
64
65
71
73
73
76
77
80
80

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
4
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
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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
6
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
7
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
8
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
9
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
<Option>
• SD Glucose Control Solution
• Control solution insert

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
10
Understanding Your New System
Display
Shows blood glucose
result, messages, and
glucose result stored in
memory.
6. The SD CodeFree™ Meter
Arrow Buttons
Used 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.
Data port
Download test
results to a personal
computer.(If you have
software)

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
11
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
Display

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
12
Understanding Your New System
Indicates the
average result Test strip
Tells 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 CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
13
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 Stand-by 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
Stand-by 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 CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
14
Understanding Your New System
Also for Blood Stand-by Display if you want to
display pre-meal or post-meal mark, its icon will
be displayed by pressing the right button one
or two times.
[Pre-meal] [Post-meal]
If you perform the pre-meal test while
the post-meal 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.
NOTE

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
15
Understanding Your New System
7. The SD CodeFree™ Test Strip
The SD CodeFree™ System measures the
amount of glucose in whole blood. Blood
is applied in the Yellow Window (TOP
EDGE) of the SD CodeFree™ Test Strip and is
automatically drawn into the reaction cell
where the reaction takes place.
(Top Edge)

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
16
Understanding Your New System
SD Glucose Control Solution
8. SD CodeFree™ Accessories
1
2
AST Cap
Cap & Comfort
dial with puncture
depth selection
1
2
Lancing Device
Cap & Comfort dial with puncture depth
selection
Arming
Knob
Release
Button
Lancet SD Glucose Check strip
Electrode
Hold
Here

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
17
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 CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
18
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 CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
19
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 ]