SCAN G-427B User manual

SCAN Blood Glucose Meter
Model: G-427B
Distributed by CoachCare
97 3rd Avenue, New York, NY 10003 USA
Made in China
SCAN blood glucose
meter
User manual
Model Number: G-427B

important safety instructionS
The meter and lancing device are for single patient use.
Do not share them with anyone including other family
member! Do not use on multiple patients!
All parts of the kit are considered biohazardous and can
potentially transmit infectious diseases even after you
have performed cleaning and disinfection.
 Changes or modifications not expressly approved by the
party responsible for compliance could void the user’s
authority to operate the equipment.
read this before using
DANGER - Misuse of this electrical device can cause
electrocution, burns, fire and other HAZARDS.
Basic safety precautions should always be taken, including
all those listed below.
Close supervision is necessary when equipment is used by,
on, or near children, handicapped persons or disabled
persons.
The following basic safety notice should always be taken:
1. Do not place the device in liquid, nor put it where it could
fall into liquid.
2. The following basic safety notice should always be taken.
3. Use the device only for the intended use described in this
manual.
4. Do not use adjunct which are not supplied by the
producer.
5. Do not let the device come into contact with surfaces
which are too hot to touch.
6. Do not use the device where aerosol sprays are being
used.
7. Do not use the device if it is not working properly, or if it
has been damaged.
8. Read through the manual, practice the test, and then use
the product to test your blood glucose. Do all quality
control checks as directed and consult with a diabetes
expert.
KEEP THE INSTRUCTIONS IN A SAFE PLACE.
1 2

table of contents
BEFORE YOU BEGIN __________________________________ 5
INTRODUCTION TO THE SYSTEM ______________________ 6
About Your System _______________________________ 6
Test Principles ___________________________________ 8
CONTENTS OF THE KIT _______________________________ 9
Blood Glucose Meter ____________________________ 10
Meter Screen Display Message ___________________ 11
Test Strip_______________________________________ 12
SETTING THE METER AND DELETING THE MEMORY ____ 13
Setting the Date and Time________________________ 13
Setting the Unit (mg/dL or mmol/L)_______________ 14
Deleting the Memory ____________________________ 14
The Two Measuring Modes _______________________ 15
TESTING WITH BLOOD SAMPLE ______________________ 16
Overview of the Lancing Device___________________ 17
Performing a Blood Glucose Test__________________ 20
Control Solution Test ____________________________ 23
Viewing Results on the App and Meter_____________ 25
CARE AND STORAGE FOR YOUR SYSTEM ______________ 27
SPECIFICATIONS ____________________________________30
Display Messages _______________________________ 31
Problems ______________________________________ 32
Performance Characteristics______________________ 33
Electrical and Safety Standards ___________________ 36
FCC Requirements ______________________________36
LIMITATIONS OF USE
The SCAN G-427B Blood Glucose Monitoring System is
not intended for use on neonates.
The SCAN G-427B Blood Glucose Monitoring System is
not intended for use on artery blood, neonates’ serum and
plasma.
The system can be used up to an altitude of 10744 feet.
The following substances at levels greater than normal or
therapeutic levels may cause significant interference
(affect the result by greater than 10%) resulting in an
inaccurate result: ascorbic acid, uric acid, hemoglobin,
acetaminophen, Dopamine, L-dopa, L-dopa and
Tolbutamide etc. These sub- stances do not affect test
results in normal concentration but may affect test results
in high concentration. Do not use haemolysis sample,
icterus sample or high lipemia samples.
 Patients undergoing oxygen therapy may yield falsely
lower results.
Not for use for patients in a hyperglycemic-hyperosmolar
state, with or without ketosis.
Not for use on critically ill patients.
Not to be used for patients who are dehydrated,
hypertensive, hypotensive or in shock.
 Very low (less than 20%) or very high (more than 60%) red
blood cell count (hematocrit) can lead to incorrect test
results. If you do not know your hemarocrit level, please
consult your health care provider.
 High temperature (more than 104°F) and low temperature
(less than 50°F) may lead to incorrect test results.
 High humidity (more than 85%) and low humidity (less than
10%) may lead to incorrect test results.
3 4

before you begin
Installing the Battery
1. Open the battery cover on the back of your meter.
2. If replacing the batteries, please remove the used
batteries.
3. Insert 2 new (AAA) batteries with correct +/- direction.
4. Close the battery cover.
INTRODUCTION TO THE SYSTEM
ABOUT YOUR SYSTEM
Intended Use
The SCAN G-427B Blood Glucose Monitoring System is
comprised of SCAN G-427B Blood Glucose Meter and
SCAN G-427B Blood Glucose Test Strips.
The SCAN G-427B Blood Glucose Monitoring System is
intended to be used for the quantitative measurement of
glucose (sugar) in fresh capillary whole blood samples
drawn from the fingertip. The SCAN G-427B Blood Glucose
Monitoring System is intended to be used by a single
person and should not be shared. It is intended for
self-testing outside the body (in-vitro diagnostic use) by
people with diabetes at home as an aid to monitor the
effectiveness of diabetes control. The SCAN G-427B Blood
Glucose Monitoring System should not be used for the
diagnosis of or screening for diabetes. The SCAN G-427B
Blood Glucose Monitoring System is not for use for
neonates.
Environment Protection – Electrical products
should not be disposed of with household waste.
Please recycle where facilities exist. Check with
your local authority or retailer for recycling advice.
Operate via your Clinic's App with Bluetooth
Download your clinic’s app to your mobile device and follow
in-app instructions to set up your blood glucose meter.
Warnings
The system is intended for use outside the body (in-vitro
diagnostic use). It is for single-patient use. It should be
used only for testing glucose (sugar) and only with fresh
capillary whole blood samples taken from the finger. The
system is intended for use at home. It should not be used
for the diagnosis of diabetes or for the testing of neonates.
The System is intended for self-testing outside the body
(in-vitro diagnostic use) by people with diabetes at home
as an aid to monitor the effectiveness of diabetes control.
Alternative site testing should be done only during steady
state times (when glucose is not changing rapidly).
The G-427B blood glucose Test Strips are for use with the
Blood Glucose Meter to quantitatively measure glucose in
fresh capillary whole blood samples drawn from the
fingertips.
This device is not intended for use in healthcare or
assisted-use settings such as hospitals, physician’s offices,
or long-term care facilities because it has not been
determined to be safe and effective for use in these
settings, including for routine assisted testing or as part of
glycemic control procedures.
Use of this device on multiple patients may lead to
transmission of Human Immunodeficiency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other
bloodborne pathogens.
To prevent malware from damaging products or revealing
patient personal information, it is recommended to install
antivirus software on mobile devices.
 When the following phenomenon happens, the user
should stop using meter and contact customer service:
• The test result of control solution exceeds the range of
vial labeled.
• The meter failure to display relative information;
• The meter does not respond when insert Test Strips;
•The meter damaged severely (eg. Case broken, screen
chalkboard)
TEST PRINCIPLES
The System uses electrochemical methodologies. The
System quantitatively measures blood glucose levels using
an Amperometric method. The method involves detecting
the current produced from glucose oxidation. The strength
of the current produced by the reaction depends on the
amount of glucose in the blood sample.
The electrons generated during this reaction are transferred
from the blood to the electrodes. The magnitude of the
resultant current is proportional to the concentration of
glucose in the specimen.
The current level is converted into a readout displayed on
the Meter.
5 6

INTRODUCTION TO THE SYSTEM
ABOUT YOUR SYSTEM
Intended Use
The SCAN G-427B Blood Glucose Monitoring System is
comprised of SCAN G-427B Blood Glucose Meter and
SCAN G-427B Blood Glucose Test Strips.
The SCAN G-427B Blood Glucose Monitoring System is
intended to be used for the quantitative measurement of
glucose (sugar) in fresh capillary whole blood samples
drawn from the fingertip. The SCAN G-427B Blood Glucose
Monitoring System is intended to be used by a single
person and should not be shared. It is intended for
self-testing outside the body (in-vitro diagnostic use) by
people with diabetes at home as an aid to monitor the
effectiveness of diabetes control. The SCAN G-427B Blood
Glucose Monitoring System should not be used for the
diagnosis of or screening for diabetes. The SCAN G-427B
Blood Glucose Monitoring System is not for use for
neonates.
Warnings
The system is intended for use outside the body (in-vitro
diagnostic use). It is for single-patient use. It should be
used only for testing glucose (sugar) and only with fresh
capillary whole blood samples taken from the finger. The
system is intended for use at home. It should not be used
for the diagnosis of diabetes or for the testing of neonates.
The System is intended for self-testing outside the body
(in-vitro diagnostic use) by people with diabetes at home
as an aid to monitor the effectiveness of diabetes control.
Alternative site testing should be done only during steady
state times (when glucose is not changing rapidly).
The G-427B blood glucose Test Strips are for use with the
Blood Glucose Meter to quantitatively measure glucose in
fresh capillary whole blood samples drawn from the
fingertips.
This device is not intended for use in healthcare or
assisted-use settings such as hospitals, physician’s offices,
or long-term care facilities because it has not been
determined to be safe and effective for use in these
settings, including for routine assisted testing or as part of
glycemic control procedures.
Use of this device on multiple patients may lead to
transmission of Human Immunodeficiency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other
bloodborne pathogens.
To prevent malware from damaging products or revealing
patient personal information, it is recommended to install
antivirus software on mobile devices.
 When the following phenomenon happens, the user
should stop using meter and contact customer service:
• The test result of control solution exceeds the range of
vial labeled.
• The meter failure to display relative information;
• The meter does not respond when insert Test Strips;
•The meter damaged severely (eg. Case broken, screen
chalkboard)
TEST PRINCIPLES
The System uses electrochemical methodologies. The
System quantitatively measures blood glucose levels using
an Amperometric method. The method involves detecting
the current produced from glucose oxidation. The strength
of the current produced by the reaction depends on the
amount of glucose in the blood sample.
The electrons generated during this reaction are transferred
from the blood to the electrodes. The magnitude of the
resultant current is proportional to the concentration of
glucose in the specimen.
The current level is converted into a readout displayed on
the Meter.
7 8

CONTENTS OF THE KIT
A meter
 Test strips x 25 pcs
User manual
2 AAA alkaline batteries
 Lancing device
 Sterile lancets x 25 pcs
BLOOD GLUCOSE METER
1
2
3
4
5
1. Strip port
Where you insert the Test Strip into strip port, the Meter
will turn on automatically.
2. Strip ejector
Slide forward to eject the Test Strip after test.
3. LCD Display
It guides you through the test using symbols and simple
messages
4. "M" Button
It is used to turn on the Meter enter the memory mode
5 "S" Button
It is used to set up the Meter
NOTE:
The lancing device can be used several times
however the sterile lancet should be changed after
each use.
Control solution is not included in the standard kit.
There are three levels for the control solution: low,
normal and high. Please contact the place of
purchase for more information.
If any items are missing from your kit or opened prior to use,
please contact local customer services or place of purchase
for assistance.
9 10

TEST STRIP
Each strip can be used only once. The Test Strip consists of
the following parts:
Absorbent hole
Apply a drop of blood here. The blood will
be drawn in automatically.
Confirmation window
This is where you confirm if enough blood
has been applied to the absorbent hole of
the strip.
Test strip handle
Hold this part to insert the strip into the slot.
Contact bars
Insert this end of the Test Strip into the
meter. Push it in firmly until it will go no
further.
ATTENTION
Test results might be wrong if the
contact bar is not fully inserted into
the test slot.
The front side of the Test Strip should
face up when inserting the Test Strip.
METER SCREEN DISPLAY MESSAGE
2
4
6
8
10
1
3
5
9
7
12
11
1. Blood drop symbol
Flashes when it is
ready to apply the
blood sample.
2. Low battery symbol
Appears when the
battery power is low.
3. Test strip symbol
Appears when the
Meter is turned on.
4. Test result area
Displays glucose
results
5. Ketone display
6. Measurement unit
Appears with the test
result in mg/dL or
mmol/dL
7. Bluetooth symbol
8. CTL symbol
Appears when doing
a control test and
indicates that the
result won’t be stored
in the memory
9. Date
10. Memory symbol
Appears when you
review the memory
11. Time
12. Day average
Indicates that the
displayed test result
is an average value
11 12

SETTING THE METER AND DELETING THE MEMORY
SETTING THE DATE AND TIME
1. Setting the Year
Press and Hold “S” button for 3 seconds,
until the last two digits of the year flash on
the screen (for example, “14” equals 2014).
Press the “M” button until the correct year
appears. Press “S”.
2. Setting the month
With the month flashing, press “M” until the
correct month appears. Press “S”.
3. Setting the day
With the day flashing, Press “M” until the
correct day appears. Press “S”.
4. Setting the AM/PM
With the AM or PM flashing, Press “M” until
the correct one appears. Press “S”.
5. Setting the hour
With the hour flashing, Press “M” until the
correct hour appears. Press “S“.
6. Setting the minute
With the minute flashing, Press “M” until
the correct minute appears. Press “S”.
SETTING THE UNIT (MG/DL OR MMOL/L)
1. mg/dL → mmol/L
With the “mg/dL” displaying, press “M” button until the
“mmol/L” appears, press “S” button twice again until the
meter turn off.
2. mmol/L → mg/dL
With the “mmol/L” displaying, press “M” button until the
“mg/dL” appears, press “S” button twice again until the
meter turn off.
DELETING THE MEMORY
 Press “S” then “dEL” will display with flashing “M”
 Press “M” once to confirm delete, press “M”
button again to delete ALL memory. The meter
then displays “OK”, which means that the
memory is deleted. If you don’t
want to delete the memory, press
the S button to skip this step. The
meter will automatically turn “OFF”,
and the set up will be completed.
NOTE:
The date, time, unit and memory deletion can
ONLY be set in the setting mode.
 When the meter is in setting mode, if no button is
pressed within 3 minutes, the meter will turn off.
No set up necessary, meter is pre-set for Eastern
Standard Time (EST). Please refer to page 13 of
this manual for setup instructions.
13 14

THE TWO MEASURING MODES
The meter provides you with two modes for measuring,
General and CTL. The CTL mode should be used when a
control solution is being tested. See the table below.
MODES USE WHEN
General tests
(not display)
CTL testing with the control solution
any time of day regardless
of time since last meal
You can switch between each mode by:
1. Start with the meter turned off. Insert a Test
Strip to turn on the meter, the screen will
display a flashing blood drop and Bluetooth
symbol, time and date.
2. Press “M” to select General or CTL mode.
TESTING WITH BLOOD SAMPLE
CAUTION
To reduce the chances of infection:
Choose a clean, dry work surface.
Never share a lancing device and lancet with another
person.
 Always use a new and sterile lancet. Lancets are for single
use only.
Always use a new Test Strip. Test strip are for single use
only.
Avoid getting lotion, oils, dirt or debris in or on the lancet
and lancing device.
NOTE
Before testing, please read the following steps
thoroughly and carefully, please relax and do the test
step by step. Simplifying or changing the test
procedure may produce inaccurate results.
15 16

OVERVIEW OF THE LANCING DEVICE
A. Device cap
B. Handle
C. Needle cap
D. Needle holder
E. Device body
F. Connecting collar
G. Adjustable tip
H. Release button
I. Ejection button
J. Device control cap on the
lancets and the lancing device.
If your lancing device differs from the one shown here,
please refer to the manufacturer’s manual to ensure proper
usage.
Setting Up the Lancing Device
1. Screw the device cap off. 2. Put the needle into the
needle holder until the bottom.
3. Screw the needle cap and
put it in the recycling dustbin.
4. Cover the cap. 5. Adjust the proper level
(usually level 3).
6. Aiming at the sterilized part
for blood-taking, press the
blue release key to finish
blood-taking.
7. Screw the device cap. 8. Push the ejection button and
discard the used lancet in the
appropriate container.
9. Cover the device cap.
J
NOTE
To reduce the chance of infection:
Never share a lancet or the lancing device.
 Always use a new, sterile lancet. Lancets are for
single use only.
Avoid getting hand lotion, oils, dirt, or debris when
handling the lancets.
NOTE
The adjustable tip offers 5 levels of skin penetration.
Twist the adjustable tip to the proper level:
1-2 level for soft or thin skin
3 level for average skin
4-5 level for thick or calloused skin
17 18