Owner’s Booklet
BG-203 Blood Glucose Monitoring System
Advanced Diabetes Management System
mmol/L
AM
Contents
Important Safety information
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Meter ···········································································································
Test Strip ···········································································································
Lancing Device ·································································································
Lancet ··············································································································
Included in your kit ···························································································
Setting the date and time ··············································································
Setting the measuring unit ··································································
Setting the test reminder ··········································································
Preparing the lancing device ······································································
Blood sampling
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Testing ·····································································································
Interpreting unexpected test results ·························································
When to perform a control test ·········································································
Performing a control test ········································································
Understanding out-of-range control test results ···································
Maintenance ·····························································································
Replacing the battery ····················································································
Meter maintenance ······················································································
Introduction ·····································································································
Getting to know your system ······································································
Setting up your meter·····················································································
Testing your blood glucose ············································································
Memory and averages ····················································································
Control solution testing ····························································································
01
02
06
06
07
08
09
09
10
10
11
12
13
13
16
18
21
24
26
26
27
29
31
31
32
Comparing Your Meter Result to a Laboratory Result·······························
23
Important Health-Related information ·····················································
03
Limitations ·································································································
05
Troubleshooting ·········································································································
Technical information ····································································································
Specifications ··············································································································
Disposing of the meter, test strips, lancets and batteries ····································
Warranty ····························································································································
Traceability ···························································································································
34
37
37
39
40
41
Performance Characteristics ·····························································································
42
Symbol Index ························································································································
44
Appendix ·································································································································
46
1
Thank you for choosing Sejoy BG-203 blood glucose monitoring
system. Before you start testing, carefully read this Owner’s Booklet.
Intended Use
Test Principle
Peel off the insulation film from battery compartment before first use.
*
Introduction
The strip measures glucose by using amperometric technology
employing a glucose oxidase reaction. When whole blood or
control solution is drawn into the tip of a test strip, glucose in
the sample reacts with chemicals and produces an electrical
current. The meter measures electrical current and calculates
amount of glucose. The glucose result is displayed as a calculated
plasma value.
• • Venous whole samples collection and preparation should be obtained
••
by healthcare professionals.
The Sejoy BS-102 Test Strips are used with the Sejoy BG-203 Blood Glucose
Meter to quantitative measure blood glucose with fresh capillary whole blood
or venous whole blood. The system is intended for in vitro diagnostic home-use
and by healthcare professional in a clinical setting as an aid to monitor the
effectiveness of diabetes control. This system is not for use in the diagnosis of
diabetes mellitus, screening nor for testing newborns.
Introduction
Important Safety information
Warning
• During normal testing, any blood glucose meter or lancing device may
come in contact with blood. All parts of the kit are considered
biohazardous and can potentially transmit infectious diseases from
blood-borne pathogens, even after you have performed cleaning and
disinfection.
• The meter and lancing device should never be used by more than one
person. Do not share the meter and lancing device with anyone, including
family members, due to the risk of infection from blood-borne pathogens.
• Cleaning and disinfecting the meter and lancing device destroys most,
but not necessarily all, blood-borne pathogens.
• If the meter is being operated by a second person who is providing testing
assistance to the user, the meter and lancing device should be cleaned
and disinfected prior to use by the second person.
• Disinfect the meter and lancing device before allowing anyone else
handle them. Do not allow anyone else to test with the meter or lancing
device.
For instructions on how to clean and disinfect the meter and lancing device,
see Chapter Maintenance.
• Wash hands thoroughly before and after handling the meter, lancing device,
or test strips.
• Choking hazard. Small parts included. Keep away from children.
• Strong electromagnetic fields may interfere with the proper operation of the
meter. Do not use this meter close to sources of strong electromagnetic
radiation.
• To avoid electrostatic discharge, do not use the meter in a very dry
environment, especially one in which synthetic materials are present.
2
3
or other material for safe handling and/or prior to disinfecting.
• It is important to keep the meter and lancing device clean and disinfected.
Clean and disinfect the lancing device once per week to remove visible dirt
Introduction
3
Important Health-Related information
·Patients undergoing oxygen therapy may receive inaccurate results.
·Some people with diabetes do not experience symptoms of low blood
sugar (hypoglycemia). Others, such as children or people who are
unconscious or have certain disabilities, may not be able to
communicate their symptoms to caregivers. For these reasons, do
not change any treatment without first talking to your doctor.
·Run a control test when you open a new box of test strips or if you think
that your test result is incorrect. Running a control test lets you know
that the meter and test strips are working properly.
·DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT
THAT DOES NOT MATCH HOW YOU FEEL OR IF YOU BELIEVE THAT
YOUR TEST RESULT COULD BE INCORRECT. If your blood glucose
result doesn’ t match how you feel and you have followed the instructions
in this manual, follow your doctor’s instructions, or call your doctor.
·Children should be taught how to use the meter and any other medical
products appropriately.
·If you have followed all the instructions in this booklet and still have
symptoms that don’t seem to match your test results – or if you have
questions – talk to your doctor.
·Being severely dehydrated or losing a lot of water may give you false
(low) test results. If you think you’re suffering from dehydration, call
your doctor right away.
Introduction
4
·The system is designed for using with fresh capillary whole blood , Do not use
arterial blood, serum or plasma.
·Do Not test on neonatal sample(new born).
·Inaccurate test results may be obtained at high altitude more than about 3048
meters above sea level.
·BS-102 blood glucose test strip: less than 30% or more than 55% of the
hematocrit ratio will affect the measurement results. Please contact your
doctor to determine your hematocrit ratio.
·Some substances may cause false results with enzymatic tests.
Introduction
5
Limitations
The interference listed below have been tested and shown no apparent
influence on results at the normal or higher therapy levels.
Acetaminophen
Ascorbic acid
Ibuprofen
2.0 mg/dL
2.0 mg/dL
4.2 mg/dL
Levodopa
Creatinine
Dopamine
No clear range of effective drug concentration
1.5 mg/dL
0.04 mg/dL
Tetracycline
0.5 mg/dL
Urate
8.0 mg/dL
Other interfering substances in EN ISO 15197 : 2015 Annex A are not
verified, it may also affect the test results.
Getting to know your system
a. Meter (battery included)
b. Test Strips
c. Lancing Device
d. Sterile Lancet
e. Control Solution
f. Carrying case
INCLUDED IN YOUR KIT
WARNING: Keep the meter and testing supplies away from
children. Small items such as the battery cover, batteries, test strips,
lancets, protective covers of the lancets, and control solution vial
cap are choking hazards.
6
b
c
e
f
d
CTRL
LOT：
Expiration date ：
Frist open date ：
9.3-14.0 mmol/L
168-252 mg/dl
BS-101
Control Solution
LOT:
Exp.Da te:
Date ope ned:
2.0ml
S
32
mmol/L
AM
a
In-door glucose measurement is recommended.
Manufacturer of Lancing Device and Sterile Lancet
EC
REP
Manufacturer of Lancing Device and Sterile LancetSha nd ong Lianfa
Medical Plastic Products Co.. Ltd.No.1
Shuangshan Sanjian Road, 250200, Zhangqi u Ci ty, Jinan, Shandong,
PEOPLE'SREPUBLIC OF CHINA
ShanghaiInternational Holding Corp. GmbH (Europe )E C| REPEiffestrasse 80,
20537 Hamburg Germany
Beijing Ruicheng Medical Suplies Co., Ltd.
No. 558 Zhangzikou, Yangsong Town, Hua ir ou District, 10400 Bejing, China
Lotus NL B.V.
EC REPKoningin Julinaplein 10, le Verd,2595 AA , The Hague, Netherlands.
CE:0123
for sterile lancet
CE:for lancing device;
CE:0197
for sterile lancet
CE:for lancing device;
EC
REP
Getting to know your system
a. Meter
Strip Port
LCD
“S” Button
“M” Button
Apply Blood Sample Reminder
Memory
Low Battery Reminder
Average
AVG
mg/dL
mmol/L
MEM
Measuring Unit
AM
PM
Alarm Clock Reminder
Time
Month
Date
Test Result
Temperature is out of range
Display
7
Battery
Compartment
Battery Cover
Eject button
Getting to know your system
b. Test Strip
Contact Bar: Insert it into strip port. Push it all the way until it goes no further.
Top Edge: Apply blood sample here.
Confirmation Window: Sample checking area.
Important: the meter should only be used with BS-102 test strips.
Using other Test strips with this meter can produce inaccurate results.
Important Test Strip Information
• The system has an operating range of 10℃~40℃ (50℉~104℉).
• Store the test strip package in a cool, dry place between 1℃~30℃
(33.8℉~86℉).
• Use test strips only within the system operating temperature range.
• Keep away from direct sunlight or heat.
• Store your test strips in their original vial only; never transfer them to
another vial or any other container.
• Never store individual test strips outside the vial.
• After removing a test strip from the vial, immediately close the vial cap
tightly.
• With clean, dry hands, you may touch the test strip anywhere when
removing it from the vial or inserting it into the meter.
• Do not use test strips beyond the expiration date. This may cause
inaccurate results.
• Do not bend, cut, or alter test strips.
Warning: The cap or vial contains drying agents that may be
harmful if inhaled or swallowed and may cause skin or eye
irritation.
8
Contact Bars
Top Edge
Confirmation Window
32
Getting to know your system
d. Lancet
c. Lancing Device
Protective Cap
Lancet Pin
Lancet Ejector
Trigger Button
Sliding Barrel
Lancet Carrier
Lancet Cap
Lancing Device Cover
Arrow
Adjustable Tip
9
Setting up your meter
When using the meter for the first time, please set the parameters of the
meter. With the meter off, long-press button “S” to enter setting mode.
Set the month
Press and release the button “M”
to advance one month until the correct
month appears.
After the month is set, press button “S”,
the date figure is flashing automatically.
Set the date
Press and release the button “M” to
date appears. After the date is set,
press button “S”, the hour figure is
flashing automatically.
①
②
advance one day until the correct
Set the hour
Press and release the button “M” to
hour appears. After the hour is set,
press button “S”, the minute figure
is flashing automatically.
③
advance one hour until the correct
10
S
Setting up your meter
Set the minute
Press and release the button “M” to
correct minute appears. After the
minute is set, press button “S”, the
time format figure will appear.
The meter can display the time
in either an AM/PM (12-hour) or
a 24:00 (24-hour) format. Press
and release button “M” to select
the format.
With the preferred time format
on the display, press button “S”,
the measuring unit figure will
appear.
OR
OR
④
Set the time format
⑤
advance one minute until the
mg/dL
mmol/L
11
Set the measuring unit
The meter can display test
results in either milligrams per
decilitre (mg/dL) or millimoles
per litre (mmol/L). Press and
hold button “S” and “M” for 5
format. With the preferred
measuring unit format on the
display, press button “S” to enter
the alarm clock setting.
⑥
seconds to select the preferred
Setting up your meter
OR
Set the alarm clock
The meter can set an alarm
clock to remind you of
the testing time.
Press button “M” to check
the alarm function.
If the alarm is on, press
button “S”, the time figure
is flashing. For time setting,
refer to step 3 and 4. After
setting, press button “S”
to exit the setting mode.
If there is no alarm function
requirement, press the “S” key
to exit the setting mode.
⑦
12
Testing your blood glucose
Preparing the lancing device
Warning
• During normal testing, any blood glucose meter or lancing device
may come in contact with blood. All parts of the kit are considered
biohazardous and can potentially transmit infectious diseases
from blood-borne pathogens, even after you have performed
cleaning and disinfection.
• The meter and lancing device should never be used by more than
one person. Do not share the meter and lancing device with
anyone, including family members, due to the risk of infection
from blood-borne pathogens.
• Cleaning and disinfecting the meter and lancing device destroys
most, but not necessarily all, blood-borne pathogens.
• If the meter is being operated by a second person who is
providing testing assistance to the user, the meter and lancing
device should be cleaned and disinfected prior to use by the
second person.
• Disinfect the meter and lancing device before allowing anyone
else to handle them. Do not allow anyone else to test with the
meter or lancing device.
• It is important to keep the meter and lancing device clean and
disinfected. For instructions on how to clean and disinfect the
meter and lancing device, see Chapter Maintenance.
• Wash hands thoroughly before and after handling the meter,
lancing device, or test strips.
• You must not insert the lancet cap into the lancing device and
simultaneously press the release button or hold the lancing
device with the release button resting on a surface such as on
the table. This could release the lancet and inadvertently cause
injury.
13
13
Testing your blood glucose
14
Preparing the lancing device
①
Screw off the lancing device cover.
② Insert a new lancet into the lancet carrier firmly.
③ Hold the lancet needle cover and gently twist
it off the lancet.
④ Put on the lancing device cap.
Avoid touching the trigger button.
⑤ Adjust the depth setting
The indication marks 5 levels of skin
penetration. Switch the lancing device cap
to the desired setting.
Note: To select the best depth:
1-2 for soft or thin skin, 3 for average skin.
4-5 for thick or calloused skin.
①
Testing your blood glucose
Preparing the lancing device
⑥
Hold the lancing device cover in one hand.
Using the other hand, slowly pull the sliding
barrel away from the lancing device cover.
You will hear a click, indicating that the lancet
carrier is locked into position. Release sliding
barrel to return it to its original position.
15
Testing your blood glucose
Blood Sampling
① Wash your hands and the puncture site
with an alcohol swab or soapy water.
Rinse and dry thoroughly.
② Position the end of the adjustable tip
against the side of the finger. Press the
trigger button, and then lift the lancing device
③ Gently squeeze your finger until you get a
round drop of blood. Discard the first drop.
Do not use, If the blood is smeared or running.
Wipe the area and gently squeeze
another drop of blood or puncture a new site.
Approximate size
away from the finger after the puncture is
complete. Place the lancing device aside and
wait a few seconds for a blood drop to form.
16
Testing your blood glucose
Blood Sampling
IMPORTANT:
• Use only Test Strips BS-102.
• Make sure your meter and test strips are about the same temperature
before you test.
• Testing must be done within the operating temperature range
10℃~40℃ (50℉~104℉).
For the most accurate results, test at room temperature
20℃~25℃ (68℉~77℉).
• Tightly close the cap on the vial immediately after use to avoid
contamination and damage.
• Store unused test strips only in their original vial.
• Do Not open the test strip vial until you are ready to remove a test strip
and perform a test. Use the test strip immediately after removing it from
the vial.
• Do Not return the used test strip to the vial after performing a test.
• Do Not re-use a test strip that had blood or control solution applied to it.
Test strips are for single use only.
• Write the first open date on the vial label when you first open it. Discard
the vial 3 months after first-open date.
13
17
Testing your blood glucose
AVG
mg/dL
mmol/L
MEM
AM
PM
AVG
mg/dL
mmol/L
MEM
AM
PM
18
Testing
② System check screen
Note:
•If appears, it indicates that the
Place the system in room temperature
for half hour. Then test again.
•If appears, it indicates that the
③ The blood drop symbol flashes on
operating temperature is out of range.
battery is almost empty. Replace the
ready to apply blood sample.
the display screen. Your meter is now
Note: If you do not start the test within
unused test strip and reinsert it into
Important: The meter should only be
test strips with this meter can produce
inaccurate results.
three minutes, the meter will turn off.
To restart your meter, take out the
the meter.
used with BS-102 test strips. Using other
① With meter off or in setting mode and memory mode,
insert a test strip to enter into testing mode.
3
2
The screen will briefly display all content
to confirm that the display is working
properly.
battery now.
Testing your blood glucose
Testing
⑥
the unit of measure, the date and time of the test.
Blood glucose results are automatically stored in the
meter’s memory.
Read your result on the meter
④ Apply the sample
Gently touch the channel to the edge of the blood drop.
Note:
• Do Not apply more blood to the test strip after you have
moved the drop of blood away.
• Do Not move the test strip in the meter during a test.
⑤ Wait for the confirmation window to fill completely
The blood drop will be drawn into the narrow channel
and the confirmation window should fill completely.
When the confirmation window is full, this means
you have applied enough blood. Now you can move
the test strip away from the blood drop and wait for
Full
Not full
mmol/L
19
• Discard the first drop of blood. Do Not smear or scrape
the drop of blood with the test strip.
the meter to count down from 5 to 1 with 1 beep-sound
indicating the end of test.
After the measurement is over, the meter will
display the blood glucose level along with
Testing your blood glucose
20
⑦ Delete the memory
If you don’t want to keep the test result,
⑧ Turn your meter off.
Push the eject button gently to automatically eject
the test strip from the meter, or remove the test
strip by hand, the meter will automatically shut
down. Please handle the used test strip carefully.
press the “S”button and “M” button at the
same time to delete it . After memory
cleared, the meter will display"dEL"and
then turn off automatically.
Testing your blood glucose
Interpreting unexpected test results
The meter can accurately measure blood glucose concentrations
between 2.2 to 33.3 mmol/L (40 to 600 mg/dL).
Expected Blood Glucose Level [1, 2, 3]
Normal Blood Glucose Range
3.9-5.8 mmol/L (70-105 mg/dL)
3.9-6.1 mmol/L 70-110 mg/dL
≤8.9 mmol/L （less than 160 mg/dL）
≤ 6.7 mmol/L less than 120 mg/dL
≤3.9 mmol/L Greater than 70 mg/dL
Before breakfast
Before lunch or supper
1 hour after meal
2 hour after meal
Between 2 am and 4 am
Time
Refer to the following cautions whenever your test results are lower or
higher than what you expect.
① Low glucose results
If your test result is lower than 2.2 mmol/L(40 mg/dL),
Lo will appear on the meter display screen. This
reading indicates severe hypoglycemia (low blood
glucose).
• Lo Reading with Symptoms
If you have a Lo reading and have symptoms such as weakness,
sweating, nervousness, headache or confusion, then follow your
doctor’s recommendation to treat hypoglycemia.
• Lo Reading without Symptoms
If you get a Lo reading, but have no symptoms of low blood glucose,
then retest with a new test strip on your fingers. If you still get a Lo
21
reading, follow your doctor’s recommendation to treat hypoglycemia.
mmol/L
Source:
1. Clin Chem 51,2005:1573-1576;
2. Stedmans Medical Dictionary,27th Edition,2000:2802;
3. American Diabetes Association: Standard of Medical Care in Diabetes
2019, Vol.39.
Testing your blood glucose
Interpreting unexpected test results
② High glucose results
If your test is above 33.3 mmol/L ( 600 mg/dL ), HI
will appear on the display screen. This indicates
severe hyperglycemia (high blood glucose).
• HI Reading with Symptoms
If you feel symptoms such as fatigue, thirst, excess urination, or blurry
vision, then follow your doctor’s recommendation to treat
hyperglycemia.
• HI Reading without Symptoms
If you get a HI reading, but have no symptoms of high blood glucose,
then retest with a new test strip. If you still get a HI reading, follow your
doctor’s recommendation to treat hyperglycemia.
③ Unusual hematocrit
Too high (above 55%) or too low (below 30%) hematocrit can cause
inaccurate results.
22
mmol/L
Please contact your doctor to determine your hematocrit ratio.
Comparing Your Meter result to a Laboratory result
Comparing your meter's results with laboratory results periodically.
The results of the Sejoy BG-203 meter are plasma equivalent. This method
• If your blood glucose is below 5.55mmol/L (100 mg/dL), your results generally
should fall within ±0.83mmol/L ( ±15 mg/dL) of the laboratory result.
• If your blood glucose is equal to or over 5.55 mmol/L (100 mg/dL), your
results generally should fall within ±15% of the laboratory result.
To maximize your chances of an accurate comparison between meter
and laboratory results, please follow a few basic guidelines:
Before going to the lab
• Perform a control solution test to make sure the meter is working properly.
• Do Not eat for at least eight hours before you test your blood glucose.
While at the lab
• Perform your meter test within 15 minutes from the lab test.
• Use only fresh capillary blood obtained from the fingertip.
• Follow all instructions in this Owner’s Booklet to perform a blood
glucose test by your meter.
will help you and your healthcare professional compare your meter results
with laboratory test results. The Sejoy BG-203 meter's test result and laboratory
test results both are expressed in plasma-equivalent units. However, your
blood glucose meter result may differ from your laboratory result due to normal
variation. Your blood glucose meter results can be affected by factors and
conditions that do not affect laboratory results in the same way.
23
Memory and averages
Storing Blood glucose and Control Test results
① Enter Memory Mode
Start with the meter off (no test strip inserted). Press and release the “M”
button to enter memory mode.
② View previous memory in order
Press and release “M” button to scroll forward to all
results. Your most recent result will display first.
Note: If there is no test result stored, the meter will
display “ ” for a few seconds then automatically
turn off.
The meter automatically stores up to 360 blood glucose test results with
the time and date of the test and any test markers. Results can be reviewed
at any time. Test results are stored from the newest to the oldest, so set
the time and date correctly in the meter. Setting the correct time and date
helps ensure appropriate interpretation of stored blood glucose results.
MEMMEMMEMMEM
mmol/L
MEM
mmol/L
MEM
24
Memory and averages
Exit
In memory mode, press and hold the “M” button for few seconds until the
meter turns off.
View 7-, 14-, 28-day average
Press and release “S” button to enter the
average value display.
The first memory display screen you see is your
7-day average.
This average includes all the readings from the
last period days.
n = indicates the number of results included in your average
Delete all memory
③
④
⑤
seconds. After memory cleared, the meter will
display"dEL"and then turn off automatically.
25
mmol/L
AVG
MEM
Long-press the “S” button approximately 3
Control solution testing
When to perform a control test
Control Solution contains a specific amount of glucose and is used to
check that the meter and the test strips are working properly.
Do a control solution test:
• Whenever you open a new vial of test strips.
• Whenever you want to check if you are testing correctly.
• If you suspect the meter and test strips are not working properly.
• If you have had repeated unexpected blood glucose results.
• If you drop or damage the meter.
• If you left the test strip container open or you think the test strips
have been damaged.
• If the test strips were stored in extreme temperatures and/or humidity.
• Your test result does not match how you feel.
NOTE:
• Only use the Sejoy CS-101 control solution.
• Close the control solution bottle tightly after use.
• Write the date you open the control solution bottle on the bottle label.
The control solution must be discarded 3 months after the
first open date or the expire date on the vial label, whichever comes
first.
• Do not use control solution that exceeds the expired date or discard date.
• Refer to the control solution label for control solution storage conditions.
• The control solution can stain fabric. Remove stains by washing with
soap and water.
CAUTION: Do Not swallow control solution. It is not for human
consumption. Do Not apply control solution to the skin or eyes
as it may cause irritation.
26
Control solution testing
Performing a control test
① Insert a test strip to turn the meter on
② System check screen
Each time the meter powers on, this screen
the display is working properly.
③ The blood drop symbol flashes on the
display screen. Your meter is now ready to
④ Shake the control solution vial before
vial to discard the first drop. Then wipe the
tip with a clean tissue or cloth. Hold the vial
upside down and gently squeeze a hanging
briefly appears so that you can make sure
apply blood sample.
each test. Remove the cap and squeeze the
drop.
AVG
mg/dL
mmol/L
MEM
AM
PM
AVG
mg/dL
mmol/L
MEM
AM
PM
AVG
mg/dL
mmol/L
MEM
AM
PM
AVG
mg/dL
mmol/L
MEM
AM
PM
27
3
2
Control solution testing
Performing a control test
⑤ Touch and hold the hanging drop of control
solution where the narrow channel meets the
TOP EDGE of the test strip. Make sure the
confirmation window fills completely. Control
solution should not be applied to the flat face of
the test strip.
CONFIRMATION
WINDOW
⑥ Read the result on the meter
When the confirmation window is full, the meter will
count down from 5 to 1. After the measurement is
over, the meter will display the blood glucose level
time of the test.
Results are automatically stored in the meter’s
memory.
TOP
EDGE
NARROW CHANNEL
Apply Drop Here
mmol/Lmmol/L
28
along with the unit of measurement, the date and
Control solution testing
Understanding out-of-range control test results
Compare the result displayed on the meter
to the control solution range printed on the
test strip vial. Each control solution have a
different control solution range.
Out-of-range results may be due to:
• not following the instructions detailed in steps 1–6
• expired or contaminated control solution
• expired or damaged test strip
• use of a test strip or control solution that passed its discard date
• a problem with the meter.
CAUTION: The control solution range printed on the test strip
vial is for Sejoy Control Solution only. It is not a recommended
range for your blood glucose level.
CAUTION: If you continue to get control solution test results
that fall outside the range printed on the test strip vial, Do Not use
the meter, the test strips, or the control solution. Contact the
vendor.
29
111–167
6.1–9.1
CTRL
LOT：
Expiration date ：
Frist open date ：
mmol/L
mg/dl
S
mmol/L
AM
Control solution testing
30
⑦ Delete the memory
If you don’t want to keep the test result, press
it. After memory cleared, the meter will
display"dEL"and then turn off automatically.
the “S” and “M” button to at the same time to delete
mmol/L
AVG
MEM
⑧ Turn your meter off
Push the eject button gently to automatically eject
the test strip from the meter, or remove the test
strip by hand, the meter will automatically shut
down. Please handle the used test strip carefully.
Maintenance
Replacing the battery
Your meter comes with one preinstalled, 3 volt, type 2032, button
battery. The battery provides enough power for the meter to perform
about 1000 tests. If your battery runs low, the battery symbol
appears on display screen until you change the battery.
Important: When this symbol appears, you should replace the battery
immediately.
① With the meter off,
(+) side facing up
② Remove the old batteries and place the new
ones in the battery compartment with the (+) side
facing up.
③ Put the battery cover back into position until it
locks into place.
④ Check your meter settings
Replacing the battery does not affect your stored
results. However, you may need to re-set your
meter settings. See Setting up your meter section.
Please dispose of the waste batteries according to the local
regulations
“
”
open the battery cover.
31
Maintenance
Avoid getting dirt, dust, blood, control solution, water, or any other liquid
in the meter’s test strip port.
Important: Never immerse the meter in water or any other liquid. This
may cause inaccurate reading or meter malfunction.
Storing your system
Store your meter, test strips, control solution and other items in your
carrying case after each use. Store each item in a cool, dry place.
Do Not refrigerate. Keep all items away from direct sunlight and heat.
Tightly close the cap on the test strip vial and/or control solution vial
immediately after use to avoid contamination or damage. Store test
strips only in their original vial.
Checking for expiration or damages to test strips and control
solution
Expiration dates for test strips and control solutions are printed on
their vial labels. When you first open a new vial of test strips or control
solution, record the discard date on the label. Refer to the test strip or
control solution vial for instructions on determining the discard date.
32
-20℃~55℃ (-4℉~131℉).
Cleaning and disinfection
Cleaning and disinfection are different, both should be performed.
Cleaning is a part of normal care and maintenance that should be
performed prior to disinfection, but cleaning does not kill germs.
Disinfection is a important way to reduce your exposure to disease.
Even though you are the only person using it,
Test strips and control solution should be stored between 1℃~30℃
(33.8℉~86℉). Meter and other items should be stored between
Meter maintenance
Maintenance
Cleaning your meter and lancing device
To clean your meter and lancing device, wipe the outside with a soft
cloth damped with water and mild detergent. Do not use alcohol
or another solvent. Do not get any liquids, dirt, dust, blood, or control
solution inside the meter through the strip port. Never spray cleaning
solution on the meter or immerse it in any liquid. Do not immerse the
lancing device in any liquid.
33
Disinfecting your meter and lancing device
The meter and lancing device should be disinfected periodically.
Clean your meter and lancing device prior to disinfecting.
To disinfect, prepare a solution of 1 part household bleach and 9 parts
water. Hold the meter with the strip port down. Use a soft
cloth damped with this solution to wipe the outside of the meter and
lancing device. Be sure to squeeze out any excess liquid first.
After wiping, cover the surface you are disinfecting with the soft cloth
damped with the bleach solution for 1 minute. Then wipe with a clean
soft cloth and wait until it dries.
Wash hands thoroughly with soap and water after handling the meter
and lancing device.
We recommend to disinfect periodically. When you assist others to
make blood glucose testing with the meter, please disinfect
it or wear gloves to protect yourself.
Troubleshooting
Message
Possible Cause
What to do
The test strip may be
used or damaged.
The sample was
applied before the
meter was ready. .
The system check
may be failed.
The test strip may be
moved during testing
The strip check
has problem.
Repeat with a new strip.
Remove the battery and
reinsert it after 30 seconds.
If it still doesn’t work,
please contact the vendor.
Retest with a new strip. Make
sure that the method of
applying sample is correct,
and test strip can not be
moved during testing.
Applying blood after the
symbol flashes on the
screen.
or sampling data is
unstable.
34
Make sure that the strip
model is correct and
retest with a new strip.
Make sure that the strip
model is correct and
retest with a new strip.
Troubleshooting
Battery power is low.
The meter is out of
operating temperature
range.
Replace the battery soon.
Place the system in
appropriate operating
environment for 30
minutes before retesting.
35
Contact the vendor.
Contact the vendor.
Meter does not enter the test mode after inserting a test strip.
Probable Cause
What to Do
Battery power is low.
Replace the battery (and reset the date and
time,if necessary.)
The battery is installed
incorrectly or there is no
battery in the meter.
Check that the battery is installed correctly.
Test strip inserted upside
down, or incompletely inserted
into the meter.
Check that the test strip is inserted correctly.
Defective meter or test strips.
Contact the vendor.
Blood or foreign objects put
into the test strip port.
Test does not start after applying the blood sample.
Probable Cause
What to Do
Defective test strip.
Repeat the test with a new test strip.
Sample applied after meter
times out and turns off.
Defective meter or test strips.
Troublheshooting
36
Remove the test strip, and repeat the test using
test strip symbols on the display screen before
you apply the blood sample.
a new test strip. Wait until you see the blood and
Technical information
Specifications
Product description
Assay method
Measurement range
Sample
Unit of measure
Memory
Size
BG-203 Blood Glucose Monitoring System
Glucose oxidase biosensor
2.2-33.3mmol/L (40~600mg/dL)
Fresh capillary whole blood
Approximate 1 microlitre
5 seconds
No coding
One 3.0V CR2032 button battery, replaceable
Approximately 1,000 tests
mmol/L or mg/dL; switchable
360 blood glucose results with date and time
109*29.7*18.9mm (L*W*H)
Sample size
Response time
Coding
Battery
Battery life
37
Calibration
Plasma equivalent glucose values
Shelf life
Three years
Technical information
Specifications
Weight
Operating environment
Meter storage environment
Hematocrit
Altitude
Automatic power off
Approximate 33g, battery not included
10℃~40℃ (50℉~104℉)
10 ~ 70% RH (non-condensing)
-20℃~55℃ (-4℉~131℉)
30%~55%
Up to 10,000 feet (3,048 meters)
above sea level
Approx. 3 minutes after last user action
38
10 ~ 70% RH (non-condensing)
43.7*17.6mm (L*H)
LCD size
Electromagnetic Compatibility
This meter meets the electromagnetic immunity requirements as standard
EN ISO 15197 : 2015. The chosen basis for electrostatic discharge immunity
testing was basic standard EN 61326 : 2013. It meets the electromagnetic
emissions requirements as standard EN 61326. Its electromagnetic
emission is thus low. Interference from the meter to other electrically-driven
equipment is not anticipated.
Disposing of the meter, test strips, lancets and batteries
Warning
• Any product coming in contact with blood is considered contaminated
(potentially infectious).
• During normal testing, any blood glucose meter may come in contact
with blood.
• Lancing devices may also be considered sharps. For disposal of sharps,
refer to local regulations.
Refer to any laws or ordinances relating to the disposal of sharps
and/or contaminated products. Contact your local health department
or other appropriate authorities for proper handling and disposal of
used meters, used test strips, used lancets, and used batteries.
Please consider the following points when disposing of used testing
materials:
• Consider recycling of the meters and batteries at an appropriate
facility. Be aware that the meter is potentially hazardous electronics
scrap (e-scrap) and should be disposed of accordingly. The batteries
are potentially hazardous also and should be disposed of accordingly.
• Disinfect the meter before recycling or disposing.
* 29 CFR 1910.1030 – Blood-borne pathogens
* Directive 2002/96/EC – Directive on waste electrical and electronic
equipment (WEEE)
39
Warranty
Limited 2-Year Warranty
The meter is guaranteed for 2-year from the date of purchase. If the
meter does not function properly due to defective components or poor
workmanship, we will repair or replace it freely. This warranty does not
cover damage due to improper handling in any way. Battery is not
included in the warranty.
40
Traceability
41
The traceability of the control solution is referenced to the EKF BIOSEN C
line-Clinic glucose analyzer. The EKF is the reference method used to
assess the accuracy with which glucose results are obtained using the system.
The value of the glucose is traceable to the National Institute of Standards and
Technology (NIST) Standard Reference Material (SRM) 917c (D-Glucose).
Concentration: 200 mg/dL
Performance Characteristics
42
The performance of the system has been evaluated both in laboratory and
in clinical tests.
Range: The display range of the meter is 2.2mmol/L to 33.3 mmol/L
(40mg/dL to 600 mg/dL). "HI" and "Lo" messages indicate results
outside of this range.
• Accuracy: The accuracy of the system was assessed by comparing
blood glucose results obtained using EKF Glucose Analyzer, a laboratory
instrument.
Table1. System accuracy results for glucose concentration < 5.55 mmol/L
(100 mg/dL)
Table2. System accuracy results for glucose concentration ≥ 5.55mmol/L
(100 mg/dL)
When the blood glucose is below 5.55mmol/L (100 mg/dL), 99.4% of
measured glucose results should fall within ±0.83mmol/L (±15 mg/dL)
of the laboratory result.
When the blood glucose is equal to or above 5.55mmol/L (100 mg/dL),
100% of measured glucose results should fall within ±15 % of the laboratory
result.
Within ±0.83mmol/L
(Within ±15mg/dL)
Within ±0.56mmol/L
(Within ±10mg/dL)
Within ±0.28mmol/L
(Within ±5mg/dL)
Within ±5%
Within ±10%
Within ±15%
36/174(20.7%)
156/174(89.7%)
173/174(99.4%)
345/426(81.0%)
419/426(98.4%)
426/426(100.0%)
Performance Characteristics
43
To maximize your chances of an accurate comparison between meter
and laboratory results, follow a few basic guidelines:
Before going to the lab
·Perform a control solution test to make sure the meter is working properly.
·Do Not eat for at least eight hours before you test your blood.
·Take your meter with you to the lab.
While at the lab
·Conduct your meter test within 15 minutes of the lab test.
·Use fresh capillary blood obtained from the fingertip.
·Follow all instructions in this Owners Booklet for performing a blood
glucose test with your meter.
Blood av 4.1mmol/L CV=4.9%
Blood av 6.7mmol/L CV=3.0%
Blood av 10.3mmol/L CV=3.1%
Blood av 18.2mmol/L CV=3.0%
Precision:
Control Solution av 2.6mmol/L SD=0.16mmol/L
Intermediate Precision
Control Solution av 18.9mmol/L CV=3.8%
Blood av 2.5mmol/L SD=0.14mmol/L
Repeatability
Table3. System accuracy results for glucose between 2.2 mmol/L (40 mg/dL)
and 33.3 mmol/L (600 mg/dL)
This study shows that the system compares well with a laboratory method
and meets the minimum acceptable performance criteria defined in EN ISO
15197 : 2015.
599/600(99.8%)
Within ± 0.83 mmol/L or Within ±15%
Control Solution av 6.9mmol/L CV=3.5%
Symbol Index
SN
∑
Consult instructions for use
In vitro diagnostic medical device
Serial number
Batch code
Manufacturer
Sterilized using ethylene oxide
Contain sufficient for < n > tests
Caution
Do not reuse
Storage temperature limitation
Use by
2
44
STERILE EO
Symbol Index
xxxx
The product conforms to the requirements of the EC
Directive IVDD ( 98/79/EC ) on in vitro diagnostic medical
devices “xxxx" is the identification number of notify body
Keep dry
Direct Current
45
European Authorized Representative
EC
REP
Please dispose of the waste according to the
local regulations
Appendix
1. Use of Fingerstick Devices on More Than One Person Poses Risk for
Transmitting Blood-borne Pathogens: Initial Communication, (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
Accessed June 8, 2011
2. CDC Clinical Reminder: "Use of Fingerstick Devices on More than One Person
Poses Risk for Transmitting Blood-borne Pathogens, (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
Accessed June 8,2011
3. Healthcare Infection Control Pratices Advisory Committee (HICPAC),
William A. Rutala, Ph.D.,M.P.H., and David J. Weber,M.D.,M.P.H. Centers for
Disease Control and Prevention, 2008."Guideline for Disinfection and
Sterilization in Healthcare Facilities, Atlanta."
46
Hangzhou Sejoy Electronics & Instruments Co., Ltd.
Area C, Building 2, No.365, Wuzhou Road, Yuhang Economic
Development Zone, Hangzhou City, 311100 Zhejiang P.R. China
EC
REP
Document No.: DBG-0304-007
Version: F
Date of Issue: 2022. 03
Shanghai International Holding Corp.Gmbh (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
0197
