Bioland Technology BGMB001 Blood Glucose Monitoring System User Manual G 427B x

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Bioland®
Blood Glucose Monitor
Model：G-427B
OWNER'S MANUAL
Dear Bioland Blood Glucose Monitoring System Owner:
Thank you for choosing this system!
This manual contains important information you must know about the system.
Please read it thoroughly and carefully.
The system provides No Code function which means that you don't need to calibrate your
metermaking it easier for the user to monitor blood glucose at home.
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!
AlI 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.
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.
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 off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:
‐‐ Reorient or relocate the receiving antenna.
‐‐ Increase the separation between the equipment and receiver.
‐‐ Connect the equipment into an outlet on a circuit different from that to which the receiver
is connected.
‐‐ Consult the dealer or an experienced radio/TV technician for help.
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,
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handicapped persons
or invalids.
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 make 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 all the manual, and 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 THESE INSTRUCTION IN A SAFE PLACE
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Table of Contents
BEFORE YOUR BEGIN ......................................................................................................................... 4
INTRODUCTION TO THE SYSTEM....................................................................................................... 4
Intended Use ............................................................................................................................. 4
ABOUT ALTERNATIVE SITE TESTING (AST) ......................................................................................... 5
CONTENTS OF THE KITS..................................................................................................................... 6
Blood Glucose Meter................................................................................................................. 7
Meter Screen Display Message ................................................................................................. 7
Test Strip.................................................................................................................................... 7
SETTING THE METER AND DELETING THE MEMORY ........................................................................ 8
THE TWO MEASURING MODES ....................................................................................................... 11
TESTING WITH BLOOD SAMPLE ...................................................................................................... 11
Overview of the Lancing Device .............................................................................................. 12
Setting Up the Lancing Device................................................................................................. 12
Preparing the puncture site .................................................................................................... 13
Performing a Blood Glucose Test ............................................................................................ 13
Comparing Meter and Laboratory Results .............................................................................. 15
CONTROL SOLUTION TEST ............................................................................................................... 15
VIEWING RESULTS ON THE METER ................................................................................................. 16
CARE AND STORAGE FOR YOUR SYSTEM ........................................................................................ 17
Cleaning and Disinfection........................................................................................................ 17
METER SPECIFICATION .................................................................................................................... 18
Limitations of use: ................................................................................................................... 18
DISPLAY MESSAGE ........................................................................................................................... 19
Problems ................................................................................................................................. 20
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BEFORE YOUR BEGIN
Installing the battery
1. Open the battery cover on the back of 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.
Environment Protection – Waste 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.
INTRODUCTION TO THE SYSTEM
Indications for Use
The 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 Blood Glucose Monitoring System is intended to be used by a single patient and
should not be shared.
The Blood Glucose Monitoring 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. The Blood Glucose Monitoring System is not to be used for the diagnosis of
or screening of diabetes, or for neonatal use.
The Test Strips are for use with the Blood Glucose Meter to quantitatively measure glucose
drawn from the fingertips.
Caution



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 and the alternative sites including
the palm, the forearm, the upper arm, the calf and the thigh. The system is intended for
use at home. It should not be used for the diagnosis of diabetes or for the testing of
newborns.
The System is to be used by a single person and should not be shared.
The System is intended for self‐testing outside the body (in vitro diagnostic use) by
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



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 “ Bioland ” Test Strips are for use with the Blood Glucose Meter to quantitatively
measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm,
forearm, upper arm, calf and thigh.
The Bioland control solutions is intended for use with the System, to check that the
glucose meter and test strips are working properly and that you are doing the test
correctly. These solutions contain a known range of glucose, as indicated on the strips
vial bottles.
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.
AST in this system can be used only during steady‐state blood glucose conditions described in
the section of “About AST”.
Test principle
The test is based on the measurement of electrical current generated by the reaction of
glucose with the reagent of the strip. The meter measures the current and displays the
corresponding blood glucose level. The strength of the current produced by the reaction
depends on the amount of glucose in the blood sample.
ABOUT ALTERNATIVE SITE TESTING
(AST)
Important. There are limitations for doing AST.
Please consult your healthcare professional before you do AST.
What is AST?
Alternative site testing (AST) means that people use parts of the
body other than the fingertips to check their blood glucose levels.
This system allows you to test on the palm, the forearm，the upper
arm, the calf，or the thigh with the equivalent results to fingertips
testing.
What’s the advantage?
Fingertips feel pain more readily because they are full of nerve endings (receptors). At other
body sites, since nerve endings are not so condensed, you will not feel as much pain as at the
fingertip.
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When to use AST?
Food , medication , illness, stress and exercise can affect blood glucose levels. Capillary blood
at fingertip reflects these changes faster than capillary blood at other sites. Therefore when
testing blood glucose during or immediately after meal, physical exercise, or any other event,
take a blood sample from your finger only. You do AST only in the following instances:
 In a pre‐meal or fasting state (more than 2 hours since the last meal).
 Two hours or more after taking insulin.
 Two hours or more after exercising.
NOTE:
 Alternative site testing(AST) should not be used to calibrate continuous glucose
monitoring systems (CGMs).
 Results from alternative site testing should not be used in insulin doses calculations.
Do NOT use AST if:
 You think your blood glucose is low.
 You are unaware of hypoglycemia.
 You are testing for hyperglycemia.
 Your AST results do not match the way you feel.
 Your routine glucose results are often fluctuating.
CONTENTS OF THE KITS








A Meter
Carry Case
Owner’s Manual
Two AAA Alkaline Batteries
Test Strips (Optional)
Lancing Device
Sterile Lancet (Optional)
Control Solution (Optional)
NOTE:
 The Lancing Device can be used for several times however the lancet should be changed
after each use.
 Sterile lancet and control solution are not included in the standard kit.
 There are three levels for the control solutions: low, normal and high available, 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.
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Blood Glucose Meter
1. STRIP PORT：Where you insert the test strip.
The meter will turn on automatically
2. DATA PORT：Located at the side is for cable
connection
3. STRIP EJECTOR： Slide forward to eject the
test strip after test
4. LCD DISPLAY：It guides you through the test
using symbols and simple messages
5. "M" BUTTON：It is used to turn on the meter
enter the memory mode
6. "S" BUTTON：It is used to set up the meter
Meter Screen Display Message
1)
BLOOD DROP SYMBOL: Flashes when it is ready
to apply the blood sample
2) TEST STRIPS SYMBOL: Appears when the meter is
turned on
3) LOW BATTERY SYMBOL: Appears when the
battery power is low
4) MEASUREMENT UNIT: Appears with the test
result in mg/Ml or mmol/L
5) CTL SYMBOL: Appears when doing a Control test
and indicates That the result won/t be Stored in
the memory
6) MEMORY SYMBOL: Appears when you review
the memory
7) TEST RESULT AREA: Displays glucose results
8) KETONE WARNING: Appears when your result ≧ 13.3mmol/L (240mg/dl)
9) BLUETOOTH SYMBOL: Appears when transmit data
10) DATE
11) DAY AVERAGE: Indicate that the displayed test result is an average value
12) TIME
Test Strip
Each strip can be used only once. The test strip consists of the
following parts:
1‐Absorbent hole
Apply a drop of blood here. The blood will be drawn in automatically.
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2‐Confirmation window
This is where you confirm if enough blood has been drawn into the absorbent hole of the
strip.
3‐Test strip handle
Hold this part to insert the test strip into the slot.
4‐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.
SETTING THE METER AND DELETING THE MEMORY
1. Setting the language and voice volume
1.1 Setting the language
Press and Hold “S” button for 3 seconds, until the ENG or
ESP is flashing. Press “M” button to select a language you
desire. Press “S”.
1.2 Setting the Volume
With the Volume level number flashing, Press “M” button to select level
between “0”~”7” (set “0” to turned off voice). Press “S”.
2. Setting the date and time
2.1 Setting the Year
Press and Hold “S” button for 3 seconds, until the last two digits of the
year will flash on the screen (for example, “14” equals 2014). Press “M”
button until the correct year appears. Press “S”.
2.2 Setting the month
With the month flashing, press “M” until the correct month appears.
Press “S”.
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2.3 Setting the day
With the day flashing, Press “M” until the correct day appears. Press “S”.
2.4 Setting the AM/PM
With the AM or PM flashing, Press “M” until the correct one appears.
Press “S”.
2.5 Setting the hour
With the hour flashing, Press “M” until the correct hour appears. Press S“.
2.6 Setting the minute
With the minute flashing, Press “M” until the correct minute appears.
Press “S”.
3. 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. Meter is pre‐set for Eastern Standard Time. Please
refer to page 13 of this manual for set up instruction.
4. Speaking Function
Clever Choice Voice HD meter “speaks” with step by step instructions to guide you through
the process of setting up your meter and blood glucose testing. The following table tells you
when and what the meter “speaks”/
When does the meter speak?
What does the meter speak?
Setting up the meter
Choosing the language
Setting mode, thank you for using this
9 / 19
product.
Setting the voice volume
Voice volume is (number)
Setting the year
The year is (number)
Setting the month
The month is (month)
Setting the date
The date is the (number)
Setting the AM/PM
AM/PM
Setting the hour
The hour is (number)
Setting the minutes
The minutes are (number)
Deleting the memory
1. Delete all record mode. Press “M” key to
delete all records.
2. Are you sure? Yes, to press “M” key again.
3. All memory record have been deleted.
At the end of the meter setting
1. Today’s date is (month) (day), (year)
2. The time is (hour minute)AM/PM
3. Thank you for using this product
Using the meter
Insert test strip
When the meter is ready to test.
1. Test strip inserted
2. Today’s date is (month) (day), (year)
3. The time is (hour minute)AM/PM
4. Please apply blood onto the test strip.
After sample is applied onto the test strip
Beep
When the test is completed (result appears
on display)
Your blood glucose is (number) milligrams
per deciliter
When the test result is＜20mg/dL
Your blood glucose is less than 20 milligrams
per deciliter
When the test result is ＞600mg/dL
Your blood glucose is over 600 milligrams per
deciliter
When selected CTL for control solution
testing
Control solution mode
Recall the stored test result (press M key to
turn on)
1. Today’s date is (month)(day),(year)
2. The time is (hour minute)AM/PM
3. Press M key for memory recall mode
4. Memory record for (month)(day),(year)
(hour minute)AM/PM
5. Your blood glucose was (number)
milligrams per deciliter
Recall the average of blood glucose results
The (number) day blood glucose average is
(number) milligrams per deciliter for
(number) records
If no results stored in memory
No memory record available
Downloading results from your meter onto
the computer
Connecting computer
When display E‐b
The battery is dead, please replace
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When inserted an used strip
Strip has been used
When room temperature is outside operating
range, which is 50℉~104℉(10℃~40℃)
Temperature is out of range
When error message appear
Unable to measure
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 test (not display)
Any time of day without regard to time since
last meal
CTL
Testing with the control solution
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.
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.
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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.
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 ge ng hand lo on, oils, dirt, or debris when handling the lancets.
Setting Up the Lancing Device
1. Screw the lancing device cap off. Insert a needle into the lancet
holder and push down firmly until it is fully in place.
2. Screw the needle cap and place it in appropriate location to use
again after finish blood‐taking.
3. Replace the lancing device cap. Turn the cap until it is snug but
not too tight. And then Adjust the adjustable tip to proper level.
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
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4. Pull the device control cap until it clicks. If not clicks, check the needle is installed
appropriately.
5. Aiming at the sterilized part for blood‐taking, press the release key
to finish blood‐taking.
6. Screw the device cap. Push the exposed needle into the needle cap,
and then push the ejection button to discard the used needle in
appropriate container. Cover the device cap at last.
Preparing the puncture site
Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a
significant influence on the glucose value obtained. Blood from a site that has not been
rubbed exhibits a measurably different glucose concentration than blood from the finger.
When the puncture site was rubbed prior to blood extraction, the difference was significantly
reduced.
Please follow the suggestions below before obtaining a drop of blood:
 Rub the puncture site for about 20 seconds before penetration.
 Select the puncture site either at the fingertips or another body part (please see
section “Alternative Site Testing” (AST) on how to select the appropriate sites).
 Clean the puncture site using cotton moistened with 70% alcohol and let it air dry.
Fingertip testing
Hold the lancing device firmly against the side of your finger. Press
the release key. You will hear a click, indicating that the puncture is
complete.
NOTE：
 Choose a different spot each time you test. Repeated punctures at the same spot may
cause soreness and calluses.
 Please consult your health care professional before you begin AST.
 It is recommended to discard the first drop of blood as it might contain tissue fluid,
which may affect the test result.
Performing a Blood Glucose Test
Step 1.
Wash hands with soap and warm water.
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Step 2.
Remove a test strip from its vial. With clean, dry hands, you may touch the test strip
anywhere on its surface. Do not bend, cut or modify the test strips in any way. Remove the
test strip from the vial and use it instantly.
Step 3.
Insert the test strip into the meter's test port and the meter is turned on. The time and date
appears on the screen.
NOTE: Be sure to use “Bioland” test strips, other test strips may not produce accurate results.
Step 4
When the blood drop symbol flashes on the screen, you may select the appropriate
measurement mode, for selecting the measurement mode of Control(CTL) or
General, please refer to the “THE TWO MEASURING MODES” section.
Step 5
Apply your blood to the absorbent hole of the test strip.
Step 6
As soon as enough blood has filled the confirmation window of the test strip, you
will hear a beep letting you know the test has begun. A countdown of 5 seconds
starts.
Note: make sure the confirmation window of the Test Strip is completely filled with your
blood sample.
Step 7
Your blood glucose level, along date and time appears on the display. Blood
glucose results are automatically stored in the memory. When bluetooth connected,
Bluetooth symbol flashing, and waiting for other device with Bluetooth to scan and connect,
then upload the test results data.
NOTE:
The results obtained from this meter are plasma‐calibrated. This helps you and your physician
or other qualified healthcare provider to compare your meter results with laboratory tests.
Reference to the instructions given by your physician or other qualified healthcare provider,
do not deviate from these instructions on the basis of the result without first consulting your
physician.
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Step 8
Eject the used test strip and remove the lancet. To eject the test strip,
point the strip at a disposal container for sharp objects. The meter will
switch itself off automatically after the test strip is ejected.
Please wash hands thoroughly with soap and water after handling the
meter, lancing device, or test strips.
Reference value:
Time of day
Before breakfast (fasting)
Two hours after meals
Normal plasma glucose rang for people without
<100 mg/dL
<140 mg/dL
Source: American Diabetes Association. Standards of Medical Care in Diabetes‐2012.Diabetes
Care 2012,35（Suppl.1)S11‐S63. Please work with your doctor to determine a target range
that works best for you.
Comparing Meter and Laboratory Results
The meter provides you with whole blood equivalent results. The result you obtain from your
meter may differ somewhat from your laboratory result due to normal variation. Meter
results can be affected by factors and conditions that do not affect laboratory results in the
same way. To make an accurate comparison between meter and laboratory results, follow the
guidelines below.
Before going to the lab:
■ Do a control solu on test to make sure that the meter is working properly.
■ Fast for at least eight hours and then do comparison tests, if possible.
■ Take your meter with you to the lab.
While staying at the lab:
Make sure that the samples for both tests are taken and tested within 15 minutes of each
other.
■ Wash your hands and then obtain a blood sample
■ Never use your meter with blood that has been collected in a gray top test tube.
■ Use fresh capillary blood only.
CONTROL SOLUTION TEST
Material needed:
● Glucose Meter
● Test strips
● Control solu on
When to do a control solution test:
◆ When you suspect that the meter or test strips are not working properly.
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◆ If your blood glucose test results are not consistent with how you feel.
◆ After the test strips are exposed to extreme conditions.
◆ After dropping the meter.
The control solution is to check that the meter and the test strips can work together as a
system and work correctly.
Step 1
Insert the test strip to turn on the meter. Insert the test strip into the meter.
Wait for the meter to display the drop symbol.
Step 2
You may press “M” button to select CTL mode, for selecting the CTL mode,
please refer to the “THE TWO MEASURING MODES” section.
Step 3
Apply the control solution
Shake the control solution vial thoroughly before use.
Squeeze out a drop and wipe it off, then squeeze another drop and place it on the tip of the
vial cap.
Hold the meter to move the absorbent hole of test strip so it touches the drop. Once the
confirmation window fills completely, the meter will begin counting down.
To avoid contaminating the control solution, do not directly apply control solution onto a
strip.
Step 4
The result of the control solutions test appears on the display. The result will not be stored
under CTL mode.
The result of the control solutions test should be within the range printed on the test strip vial
label. If the test results falls outside the specified range printed on test strip vial label, repeat
the test. Results falling outside the specified range may be caused by:
■ Error in performing the test
■ Expired or contaminated Control Solu on
■ Expired or contaminated Test Strip
■ Malfunc on of your Meter
If you continue to get control solution test results that fall outside of the range printed on the
vial, the system may not be working properly, Do not use the meter. Please contact your
customer support immediately
NOTE: Do not use the expired control solution.
VIEWING RESULTS ON THE METER
Your meter stores the 500 most recent blood glucose test results with dates and times. It also
provides 7‐, 14‐, 21‐, 28‐, 60‐ and 90‐day averages of your blood glucose test results.
Note: The control solution readings are not included in the average of your results.
Recalling the Stored Test Results
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1.Start with the meter off, press the “M” button to turn on the meter.
The “ ” symbol will flash with the time and date displayed on the
screen.
2.Press “M” again, the most recent test results with date and
time will display. Press “M” once more and the next most
recent test results will appear. Each time you press and release
“M”, the meter will recall up to your last 500 test results in
order. Press the “S” to turn off the meter. When the memory is
full, the oldest result is dropped and the newest result is
added.
Reading the Average of Blood Glucose Results
When the meter is off, press and hold the “M” button until the
DAY AVG flashing, release button then 7‐day average results
appear with “n024” (means 24 records to be averaged) on the
screen. Press the “M” button to review the 14‐, 21‐,28‐, 60‐ and
90‐day general averages. Press the “S” button to turn off the
meter. Note: The control solution readings are not included in the average of your results.
CARE AND STORAGE FOR YOUR SYSTEM
◆ Handle the meter with care. Dropping or throwing the meter may cause damage to the
◆
◆
◆
◆
device.
Don't expose the Blood Glucose Monitoring System, Test strip, and Control Solution, to
extreme conditions, such as high humidity, heat, freezing cold or dust. The storage
conditions for the test strips are 39℉~86℉, Humidity＜80%RH. Storage conditions for the
meter are ‐40℉~131℉, Humidity＜80%RH.
Always wash your hands with soap and water and rinse and dry completely before handling
the Blood Glucose Monitoring system and Test strip.
Use CaviWipes (see below) to clean the Blood Glucose Monit oring System.
Discard the used lancet into a container for sharp objects.
Cleaning and Disinfection
The cleaning and disinfection is absolutely necessary for the test procedure, because cleaning can
insure the meter works well (for example, display will be clear to see after cleaning); and
disinfection can avoid the infection to you or to the other people, and the cross‐infection. We
strongly warn that the device should be cleaned and disinfected following use on every patient.
And we suggest you use the following product: CaviWipes (EPA registration number：46781‐8）.
You can purchase this product according to the following information: visit the web site:
www.metrex.com or contact Metrex at 800‐841‐1428 for product or technical information.
CaviWipes are also available at www.amazon. com or via a Google search.
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The meter for single‐patient use and the lancing devices may be cleaned 5‐6 times per day (Test
5‐6 times every day), so the meter will be cleaned and disinfect about 11000 cycles that include
cleanings plus disinfections (1 cycle = 1 cleaning + 1 disinfection) during its 5 years life cycle.
1. Before the test, the user should clean and wash hands. If you are a caregiver, (not the patient),
please use disposable gloves.
2. After test, take one wipe to clean the meter’s housing, buttons, lens, mark, usb cover and
support block, including its front and back for 10 seconds for cleaning until there is no soil on
the surface. Then disinfect the meter’s housing, buttons, lens, mark, usb cover and support
block use another wipe for 2 min, keep the surface wet for 2 min.
3. Take off the glove; discard carefully according to your health‐ care provider’s instruction.
Note:
1. Each disinfection step requires a pre‐cleaning step.
2. If the meter is being operated by a second person who is providing testing assistance to the
user, the meter and lancing device shall be cleaned and disinfected first.
3. The users should wash hands thoroughly with soap and water after handling the meter, lancing
device, or test strips.
METER SPECIFICATION
Model
G‐427B (with “ Bioland ” test strip and control
solution)
Machine size
90mm (L)×54mm (W)×13mm(H)
Weight
50g (excluding batteries)
Measuring method
Amperometric technology using glucose oxidase
Measuring range
20 mg/dL ~600 mg/dL
Blood Source
Fresh capillary whole blood
Blood Volume
Around 1.8uL
Memory
448 blood glucose tests
Display
LCD display with backlight
Power source
DC 3V (AAA×2 alkaline batteries)
Battery Life
Approx. 500 normal tests
Operating conditions
50℉~104℉, Humidity:25%~80%RH
Storage Condition (system :meter and test
strips)
39.2℉~104℉and below 85% relative humidity
Storage Condition (meter)
‐40℉~131℉, Humidity＜80%RH,
700hPa~1060hPa
Use life
Five years
Limitations of use:
※ The blood Monitoring System is not intended for use on neonates.
※ The blood Monitoring System is not intended for use on artery blood, neonates’ serum and
plasma.
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※ The Blood Glucose Meter should be used with “ Bioland ” test strip.
※ The system can be used up to an al tude of 10744 feet.
※ The following substances at levels greater than normal or therapeu c 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.
※ The following compounds, when determined to in excess of their limitation, may produce
inaccurate results:
Compound
Ascorbic acid
Uric acid
Acetaminophen
Bilirubin
Dopamine
L‐dopa
Methyldopa
Tolbutamide
Triglycerides
Hemoglobin
Limitation
＞2mg/dL
＞10mg/dL
＞5mg/dL
＞15mg/dL
＞0.03mg/dL
＞0.45mg/dL
＞0.75mg/dL
＞24mg/dL
＞2000mg/dL
＞250mg/dL
※ Pa ents undergoing oxygen therapy may yield falsely lower results.
※ Not for use for pa ents in a hyperglycemic‐hyperosmolar state, with or without ketosis.
※ Not for use on critically ill patients.
※ Not to be used for pa ents 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.
DISPLAY MESSAGE
MESSAGE
WHAT IT MEANS
Blood glucose level is lower
than 20mg/dl (1.1mmol/L)
ACTION
The message indicates very low blood
sugar. You should consult with your
healthcare professional.
Blood glucose level is higher
than 600 mg/dl (33.3mmol/L)
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This indicates sever hyperglycemia
(high blood glucose).
You should seek imme‐ diate medical
assistance.
Meter is ready to test control
solution under the CTL state.
Battery power is low.
MESSAGE
Please place a drop of control solution
onto the test well of test strip.
Please change the battery.
WHAT IT MEANS
ACTION
Use a used test strip
Please use a new strip and re‐test
Error massage indicates that
you may remove the strip afeter
applying blood to the absorbent
hole
Try again with a new test strip
Problem with the meter
Re‐test with a new test strip. If the
problem is still unsolved, please call the
customer care line for help.
Environmental temperature is
lower than 50℉~104℉
Please test at an environmental
temperature within 50℉~104℉
operation range
Problems
Problems
Causes
Display remains 1. Battery may be installed
blank after the improperly.
test strip has 2. Battery power is too low for
been
inserted use.
into the Meter.
3. Too much time has passed
between inserting the Test Strip
and perfor‐ ming the test.
44. Test Strip has not been fully
inserted into the Meter.
Test results are 1. Not enough sample in the Test
incon sistent or Strip.
Control Solution 2. Test Strip or Control Solution
test results are has expired.
not within
3. Test Strip has been damaged
the
specified due to heat or humidity so that
range.
sample cannot be applied or the
speed of applying sample is too
slow.
44. System is not per‐ forming due
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Solutions
1.Install the Battery correctly.
2.Replace with new Battery.
3.Reinsert the Test Strip into the
Meter.
4. Reinsert the Test Strip into the
Meter.
1. Redo test with new test strip and
make sure that enough sample has
been added.
2. Redo test with new test strip.
3. Perform a Control Solution test using
a new Test Strip. If results are still out
of range, replace with new vial of Test
Strips.
4. Bring System to a room temperature
environment and
The Meter co‐
untdown did not
start.
to the environment being above wait approximately 30 minutes before
or below room temperature.
per‐ forming a new test.
Test Strip has not been inserted Use a new Test Strip and redo the test.
correctly.
Bioland Technology LTD.
No. A6B7 (Block G) ShangRong Industrial Zone No. 5 Baolong Road, Baolong Community Longgang
District 518116, Shenzhen, Guangdong PEOPLE’S REPUBLIC OF CHINA
Version: V1.0 @ 2016-01 by Bioland Technology LTD.
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