Code Free
Code Free
Code Free
NOTE
TABLE OF CONTENTS
TABLE OF CONTENTS
Chapter 1 : Understanding Your New
System
1. Before You Start Testing
2. Special Information for Healthcare
Providers and Carers
3. Indications for Use
4. Product Description and the Principle
of use
5. The Complete SD CodeFree Blood
Glucose Monitoring System
6. The SD CodeFree Meter
7. The SD CodeFree Test Strips
8. SD CodeFree Accessories
9. Inserting the Battery
10. Meter Set up
11. Using SD CodeFree Test Strips
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TABLE OF CONTENTS
CHAPTER 1 :
Understanding Your New System
The SD CodeFree Blood Glucose Monitoring
System
CAUTION
Important Information
Dehydration: Severe dehydration resulting
from excessive water loss may cause false low
results. If you believe you are suffering from
severe dehydration, consult a healthcare professional immediately.
Low glucose results: If your test result is
lower than 70 mg/dL (3.9 mmol/L) or is shown
4. P
roduct Description and the Principle
of use
<Option>
SD Control Solution
Control solution package insert
10
Indicates
Measurement
time
Displayed when in
setup mode
Indicates beep
setting
Indicates if
environmental
temperature
is exceeded
during testing
Testing date
Indicates a test
result stored in
memory
Unit of test
result
Test result
11
Display
Test strip
Indicates a
control
solution test
result
Indicates alarm
setting
Indicates hypo
warning
12
13
[Pre-meal]
NOTE
14
[Post-meal]
(Top Edge)
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SD Check strip
Electrode
Hold
Here
Lancing Device
Cap & Comfort dial with puncture depth
selection
AST Cap
Release
Button
Arming
Knob
16
17
NOTE
18
2.
[ Left or right
button ]
[ ON/OFF
button ]
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2.
NOTE
20
NOTE
[ Date Setting ]
1. After setting the hypo warning, the
setting will show the Year - press the
or left arrows to select the year and
press the ON/OFF switch to confirm
selection.
next
right
then
your
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[ Left or right
button ]
[ ON/OFF
button ]
2.
3.
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[ Left or right
button ]
2.
[ ON/OFF
button ]
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[ 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 confirm by pressing the
ON/OFF button.
2.
1.
[ Left or right
button ]
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[ ON/OFF
button ]
NOTE
25
2.
the display
Set the first alarm on or off by pressing either
the left or the right button and then confirm
you want to set the alarm by pressing the
ON/OFF button.
[ Left or right
button ]
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[ ON/OFF
button ]
3.
[ Left or right
button ]
NOTE
[ ON/OFF
button ]
27
NOTE
5.
6.
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CAUTION
30
CHAPTER 2 :
Control Solution Test
31
CAUTION
CAUTION
32
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NOTE
[ Left
button ]
2) Shake the control solution container and
discard the first 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
seconds on the display. Tightly replace the
cap on the control solution.
3) The control solution result appears on the
display in just 5 seconds.
34
mg
/dL
mm
ol/L
[Example]
Control Range
mg/dL
mmol/L
Level M
Level H
90-140 mg/dL
170-240 mg/dL
5.0-7.8 mmol/L
9.4-13.3 mmol/L
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NOTE
Action
Were control
solutions at room
temperature (1830C, 64-86F)
when used?
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Action
Make sure the test strip
is inserted into the test
strip slot until it will go no
further.
Is the meter
damaged? Does
it show an error
code?
Is the control
result outside
the acceptable
range (printed
on your test strip
container)?
37
Check
CHAPTER 3 :
Testing Your Blood Glucose
1. G
etting a Drop of Blood
1
2
1
1
1
2
2
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2
2
2
1
CAUTION
39
NOTE
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[Pre-meal]
41
CAUTION
[Post-meal]
NOTE
42
Dispose of all used test strips
in accordance with your local
guidelines.
Remove the inserted lancet from
the lancing device and dispose of
the used lancet according to local
guidelines.
Always use fresh capillary whole
blood on meter tests.
STEP 1
Line up the blood drop
with the yellow window
channel on the test strip.
STEP 2
NOTE
Narrow Channel
STEP 3
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Step-2
The meter turns on in two ways. The first way
is to press the ON/OFF button and the second
way is to just insert the test strip into the test
strip slot in power off mode, the meter turns on
automatically. Just inserting the test strip this
way means you dont need to press the ON/OFF
button.
3.
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2.
5.
1
1
Step-4
Pick up the meter and touch the end of
the test strip to the blood sample until the
reaction site is full. Immediately remove the
meter and test strip from the blood drop.
IMPORTANT:
Insert strip
vertically into the
blood sample; not
at an angle.
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2.
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4.
CAUTION
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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.
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CHAPTER 4 :
Using the Meter Memory
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[ Left button ]
[Normal result]
[Pre-meal result]
[Post-meal result]
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[ Normal average ]
[Pre-meal average]
[Post-meal average]
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NOTE
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NOTE
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CHAPTER 5 :
Maintenance and Troubleshooting
1. Performing an SD Check strip Test
CAUTION
60
[ OK
Message ]
[ EEE Error
Message ]
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accordance with local guidelines.
4) Control solution
If you are a medical professional or have the
control solution in your possession please note
the following.
Keep the SD Control Solution in a cool dry
environment 8-30C (46-86F) .
Do not refrigerate or freeze.
Do not use SD Control Solution that has
passed its expiration date.
The SD Control Solution can be used for 3
months after opening the container. Do
not use after this time. Write the opened
date on the SD Control Solution container
when first opened.
No reconstitution or dilution is necessary.
Wipe the container tip clean and reseal the
container tightly after each use.
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[Replace battery]
When the low battery
icon flashes you must
replace the battery
immediately. See
Chapter 9. Inserting the
Battery If you press the
ON/OFF button after
the battery is discharged, the battery
icon will flash and the meter will turn off
automatically after ten seconds.
[HI message]
Blood glucose may
be higher than the
measuring range of the
meter. See chapter 3
4. Understanding Test
Results
[Lo message]
Blood glucose may
be lower than the
measuring range of the
meter. See chapter 3
4. Understanding Test
Results
[Internal Error Message
for a meter]
Turn off the meter. Then
turn on the meter again.
If the error message
persists, please contact SD
Biosensor, Inc. TEL: +8231-300-0400 or the place
from where the unit was purchased.
[Strip Error]
The test strip is defective,
damaged or inserted
incorrectly. Discard this
test strip and test again
using new test strip. See
Chapter 3 2.Performing a
Blood Glucose Test
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Limitation
Ascorbic acid
> 4 mg/dL
Uric acid
> 9 mg/dL
Acetaminophen
> 6 mg/dL
Total bilirubin
> 40 mg/dL
Triglycerides
CHAPTER 6 :
Product Technical Information
1. System Specifications
Result Range
10 - 600 mg/dL,
(0.6 - 33.3 mmol/L)
Calibration
Plasma-equivalent
Sample
Sample Size
Test Time
5 seconds
Glucose Oxidase Biosensor
One replaceable 3 V Lithium
Battery type CR2032
Battery Life
Glucose Unit
mg/dL , mmol/L
Display
LCD (Customized)
Controls
3 Buttons
Size
47 mm 95 mm 17.5mm
Weight
Automatic
Shutoff
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Assay
Method
ON/OFF
Source
Function
- Meter
Operation
Temperature
Humidity
15% RH 90% RH
Hematocrit
20% - 60%
Altitude
Temperature
Humidity
15% RH 90% RH
- Test strip
Storage
Temperature
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Electromagnetic Compatibility
This meter meets the electromagnetic
immunity requirements as per EN ISO 15197
Annex A. The chosen basis for electrostatic
discharge immunity testing was basic standard
IEC 61000-4-2. In addition, the meter meets the
electro-magnetic emissions requirements as
per EN 61326. Electromagnetic emission from
the meter is thus low. Interference from other
electrically driven equipment is unlikely.
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Annex 2 : Symbol
77
Symbol
Description
Consult instructions for use
IN VITRO DIAGNOSTIC MEDICAL
DEVICE:
This system is intended for
use outside the body (in vitro
diagnostic use).
BATCH CODE:
To indicate the lot number for this
system.
DATE OF MANUFACTURE:
To indicate the date of
manufacture for this system.
USE BY:
This item should be used by the
given date.
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79
Symbol
Annex 3 : References
1.
2.
3.
ITEM
Cat No.
System
01GC110
SD CodeFree Blood Glucose meter /
SD CodeFree Blood Glucose test strip
(10T x 1vial) / Lancet(10ea) / Lancing device
01GC111
SD CodeFree Blood Glucose meter /
SD CodeFree Blood Glucose test strip
(10T x 1vial) / Lancet(10ea) / Lancing device/
SD Control Solution (Level M x 1vial)
01GC112
SD CodeFree Blood Glucose meter /
Lancet(10ea) / Lancing device
01GC113
SD CodeFree Blood Glucose meter /
Lancing device
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Cat No.
01GM11
Meter
Strip
Control
Solution
Lancet
Software
NOTE
01GS11
SD CodeFree Blood Glucose test strip
(25T x 2vial)
01GS11B
SD CodeFree Blood Glucose test strip
(25T x 1vial)
01GCS10
SD Control Solution
(2 vial : Level M and Level H)
01GL10
Lancets (100ea x 1 box)
01SCC10
SD Communication Cable
81
Return
You must contact the medical professional
or Company you purchased this meter from
to obtain authorisation before returning
your meter. Returned meters without this
authorization will not be accepted.
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SD BIOSENSOR, Inc.
C-4th&5th Floor Digital Empire Building 980-3,
Yeongtong-dong, Yeongtong-gu, Suwon-si,
Kyonggi-do, Korea
EC-Representative
83
MEMO
MEMO
L21CF1ENR1
Date issue : 2011. 07
01GM11/01GC11 series
User Instruction
Guide
No
Coding