PharmEvo Evocheck GO ELI-00055 User manual
Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd,
2595AA, The Hague, Netherlands.
Plot # A-29, North Western Industrial Zone,
Port Qasim, Karachi-75020, Pakistan.
Establishment License No.: ELI-00055
MicroTech Medical (Hangzhou) Co., Ltd.
No.108 Liuze St., Cangqian,Yuhang District,
Hangzhou 311121, Zhejiang, P.R. China
http://www.microtechmd.com
Document: 1017-FMTL-0200401
Revision: V03
Issued: 2021/03/22
Blood
Glucose
Monitoring
System
INSTRUCTION
MANUAL
i
Dear User:
Thank you for choosing the Blood Glucose Monitoring System.
Monitoring your blood glucose level is an integral part of treating diabetes.
PharmEvo is committed to help you control your condition so you can live a
healthy and active life.
Please read this user manual to help master the simple functions of your
Blood Glucose Meter. If used properly, the blood glucose meter
will give you accurate results.
The blood glucose monitoring system will give you accurate
readings from fresh capillary or venous whole blood. Capillary samples may be
drawn from the fingertip and in the case of neonates, the heel. This product is
for professional use in medical institutes or for self-testing by diabetics. Test
results serve only as helpful information, not as proof for clinical diagnoses.
You may consult your healthcare professional for instructions on how to
use the system correctly. Our customer support staff is available to assist
you as well.
Please forward your warranty card to your local authorized PharmEvo
distributor to activate your warranty coverage.
The Blood Glucose Monitoring System is manufactured and
supported by Microtech Medical (Hangzhou) Co., Ltd. If you have any
questions or concerns, please contact your local authorized PharmEvo
Important safety instructions before use:
Do not drop the meter or get it wet.
Only use the meter as directed by this instruction manual.
Only use blood glucose testing strips (hereafter
referred to as “test strips”).
Do not use the meter if is not working properly or has been damaged.
Do not place anything on top of the meter.
Unless specifically instructed in this Instruction Manual, do not let
anything get inside of the meter openings.
This meter can only be used to determine blood glucose levels using
whole blood samples. Do not use serum or plasma samples.
Patients who are severely ill, suffering from severe dehydration, or are
in a hyperosmolar state should not use the Blood
Glucose Monitoring system.
Remove the battery if the device is not to be used for an extended
period of time.
Do not use test strips or control solution past the expiration date.
Avoid using the meter near devices emitting electromagnetic radiation
such as televisions, mobile phones, microwaves, and X-ray machines.
Avoid static electricity, especially in very dry environments.
SpecificationIndex
1ii
Note:
Specification
Product Components
Component Descriptions
Blood Glucose Meter
Display
Blood Glucose
Test Strips
Control Solution
Meter Setup Before Use
Battery Installation
Setting Up Your Meter
Quality Control Tests
Testing Your Blood
Blood Sampling
Lancet Removal
Testing Blood Glucose
Understanding Test Results
Suggested Test Times and Target Goals
“HI” and “LO” Messages
“HYPO” and “HYPER” Messages
Meter Memory
Memory Mode
Clearing the Memory
Memory Data Transfer
Comparing Meter and Laboratory Results
Maintenance
Storage
Replacing the Battery
Cleaning
Troubleshooting
Warranty
Symbol Index
Product Name: Blood Glucose Monitoring System
Size: 83.5 mm (L) × 54 mm (W) × 19 mm (Thickness)
Glucose Test Range: 1.1-33.3 mmol/L (20-600 mg/dL)
Results Display: plasma equivalent
Minimum Sample Volume: 0.5µL
Test Time: 5 seconds
Battery: CR 2032 3.0V coin cell battery
Battery life: >1,000 readings(wireless functions disabled)
Glucose Concentration Units: mmol/L or mg/dL depending on the
standard of your country
Memory Storage: 500 test results with date and time stamp
Auto Shutdown: Automatic shutdown after 2 minutes
Display Size: 40mm × 42mm
Weight: about 50 grams (including battery)
Operating Temperature: 5-45°C (41-113°F)
Operating Humidity: 20-90% (non-condensing)
Hematocrit Range: 10-70%
Blood containing high levels of vitamin C or other reducing
agents can lead to inaccurate test results. Triglycerides
above 3,000 mg/dL and cholesterol above 500 mg/dL will lead to
inaccurate test results.
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Component Descriptions
32
Batteries
Blood Glucose Meter
Lancing Device
Carrying Case
Product Components
Test Strip Port
Display
">" Button
"M" Button
"<" Button
Data Port
Test Strip
Ejector
Label
Battery Cover
Blood Glucose Meter
Your Blood Glucose Monitoring System consists of several
items. Please identify each item, learn its name and how it is used.
Below are the items included in your Blood Glucose
Monitoring System:
1. Instruction Manual (includes Log Book, Warranty Card, Emergency Card)
2. Blood Glucose Test Strip Guide
3. Blood Glucose Meter (with 2 pcs of CR2032 batteries included)
4. Blood Glucose Test Strips (10 pcs)
5. Lancing Device
6. Disposable Sterile Lancets (10 pcs)
7. Carrying case
The meter reads the test strips and displays the blood glucose
concentration. Use this diagram to become familiar with all of the
parts of your meter.
Test Strip Port: Test strips are inserted into this area to perform a test.
Display: Shows test results, settings, and other information.
“<” Button: When the meter is off, holding the “<” button will turn the
meter on and enter the system settings menu.
“M” Button: When the meter is off, holding the “M” button will enter
memory mode. This button also is used to select/confirm.
“>” Button: When the meter is off, holding the “>” button will enter the test
reminder alarm mode.
Battery Cover: Remove the battery cover to install CR 2032 coin cell
battery.
Label: Contains product information.
Test Strip Ejector: Slide the ejector forward to discard a used test strip.
Data Port: When used with a data cable, you can transfer the data stored
in the meter to your personal computer, analyze, and print it. (Requires
data cable, please contact customer service)
Each test strip package is marked with a batch number (LOT),
expiration date ( ) and a control solution range (CTRL1 and
CTRL2). Please use Blood Glucose Test Strips with the
Blood Glucose Meter. The use of non-approved test
strips will result in the meter not turning on or an error.
Display
54
Date Time
Apply Blood
Icon AM/PM
Day Average
Pound Sign (#)
Memory
Control Solution
Hypo Icon
Readings Icon
Low Battery Icon
Mute
Test Reminder Alarm
Check Ketone Alert
Hyper Icon
Test Result
Display Area
Blood Glucose
Measurement Units
Before Meal
Icon
After Meal
Icon
Blood Glucose Test Strips
Fingerhold Area Use this area to grip the strip
Sample Area
Apply blood or
control solution here
Contacts
Insert this side into
the test strip port
IMPORTANT:
Storage and Handling
Correct Incorrect
BlueTooth Icon
blood glucose test strips contain chemical reagents. After
the test strip is placed into the test strip port and a blood sample is
applied, the blood automatically wicks into the test window. A
transient electrical current is generated, and this current is measured
to determine the correct blood glucose level reading.
Test Window Check to confirm an
adequate sample has been applied
Make sure that the blood sample is applied at the edge of the
test strip, never on the top surface. Applying blood to the top
surface of the strip will lead to inaccurate results.
Apply blood samples to the edge of the strip until the test window is
full. The blood glucose meter will begin to count down when there is
adequate blood. If the test window is not full, you may add additional
blood within three seconds. If not enough blood has been applied, an
error E-3 will be displayed. Please discard and use a new test strip.
If you see that the test window is not full, but the countdown begins
anyway, please discard and use a new test strip.
Please read and follow the storage and handling conditions
below:
Store test strips in a clean, dry environment at 2-35°C (36-95°F).
Do not store test strips in heat or direct sunlight.
76
Special Instructions for Test Strips Sold in a Vial
Test Strip Precautions
Control Solution
Storage and Handling
Control Solution Precautions
Do not refrigerate or freeze test strips.
Do not store or use strips in a humid environment, such as a bathroom.
Do not store the meter, test strips, or control solution near bleach or
cleaning agents that contain bleach.
Close the cap on the vial immediately after removing a test strip.
Use the test strip immediately after removing it from the package.
Do not use expired test strips. Doing so may lead to inaccurate results.
• If the Blood Glucose Meter and Test Strips are exposed
to a temperature outrange environment, please wait 30 minutes before
testing.
• For detailed information, please refer to the Blood Glucose
Test Strip Insert.
Tip: The test strip label contains the expiration date in year-month format. For
example, 2017-01 indicates that the test strips are valid until January 2017.
Test strips should be stored in the tightly capped vial provided.
Do not store test strips outside of the provided vial. Test strips must be
stored inside the original vial with the lid tightly sealed closed.
Do not transfer test strips from the provided vial into another container.
Close the cap on the vial immediately after removing a test strip.
A new vial of test strips may be used for 6 months after first being
opened. Please take note of the date that the vial was first opened,
and discard after 6 months.
For in vitro diagnostic use.
Use the test strip immediately after removing it from the package,
otherwise the test results may not be accurate.
Do not use test strips that are torn, bent, or damaged in any way.
Do not reuse test strips.
Keep the test strip packaging away from children and pets.
Consult your physician or healthcare professional before making any
changes in your treatment plan based on your blood glucose test
results.
Please refer to the test strip instructions for more detailed information.
Control solution is a glucose solution of known concentration that is used
to confirm that your meter and test strips are working properly. It is
important to run a quality control test regularly to make sure that you are
getting accurate results.
When should a Quality Control test be performed?
When you suspect that the meter or test strips
are not working properly.
When you suspect that your test results are
inaccurate, or inconsistent with how you feel.
When you suspect that your meter has been
damaged, dropped or exposed to liquids.
After cleaning your meter.
To confirm you are following the correct testing procedure.
To check the test strip when you open a new vial of strips.
Refer to page 12 for instructions on how to perform a quality control test.
Please review the following storage and handling instructions:
Store the control solution in the temperature range
5-30°C (41-86°F).
Do not refrigerate or freeze the control solution.
If the control solution is cold, do not use until it has warmed to room
temperature.
Do not use expired control solution.
Keep control solution bottles out of reach of children.
Tip: The control solution label contains the expiration date in year-month format.
For example, 2017-01 indicates that the test strips are valid until January 2017.
Control solution may be used for 6 months after the bottle is opened for
the first time. Please take note of the date that the bottle was first opened,
and discard after 6 months. Do not use beyond the expiration date.
For in vitro diagnostic use. The control solution is for testing only
outside of the body. Do not swallow or inject.
Control solution should be shaken before use.
Quality control tests should be carried out at 15-30°C.
Do not let the control solution bottle touch the test strip.
Use only the control solution that is recommended for your meter.
The control ranges shown on the test strip package are not
recommended ranges for your blood glucose level. Your personal
glucose range should be determined by your healthcare professional.
Meter Setup Before Use
98
Battery Installation
Month Day Year Month Day Time
or
Audio Settings
When the sound is on, the meter will provide a beep when:
a. The meter is powered on
b. The blood sample is adequate
c. The test results are displayed
d. An error occurs
e. A test reminder alarm is activated
or
Setting Up Your Meter
Follow the steps below to set up your meter:
System Settings
Date and Time Settings
1. Turn the meter to the back side, press to open the battery cover as
shown in the picture.
2. Insert the battery. Make sure that the positive side (+) is facing up.
3. Replace the battery cover, making sure that it is closed tightly.
Before using your meter for the first time, make sure all system settings
are correct. For example, setting the correct time is essential for the
history function to work properly.
Press the “<” button for 2 seconds to enter the system settings menu.
1. The display will show the month, day, and year. In the upper right
portion of the screen, the year will flash. Press the “<” or “>” buttons to
change the year, and then the “M” button to save your choice.
2. The display will now show the month and day in the top left corner.
Change the month and day by pressing the “<” or “>” buttons. Press
“M” to save.
3. Next, set the correct time. By default, the meter will show the time
in 24 hour display mode. Press “M” to save the correct time. The meter
will now allow you to change to either 24 hour or 12 hour display mode
by pressing “<” or “>”. Press “M” to save and continue to the next step.
You can turn your meter’s sound on and off in the audio settings menu.
Press “<” or “>” to turn the sound on or off. Press the “M” button to save
this setting.
You will hear a one beep warning sound when the meter is powered on,
if the blood sample is adequately applied, and when the test results are
displayed. You will hear 2 short beep warning sounds if an error occurs.
Please refer to the error code table included in this instruction manual.
After you have chosen the audio setting, the meter will enter the high and
low blood glucose alarm settings.
CAUTION: Please follow the local regulation to properly discard a used battery.
Your Blood Glucose Meter requires the CR 2032 3.0V coin
cell battery. You can find two in the carrying case. Please follow the steps
below for installation:
1110
or
or
or
High and Low Blood Glucose Alarm Settings
Ketone Test Warning Settings
Meal Marker Settings
Test Reminder Alarm Settings
or
The meter has high (Hyper) and low (Hypo) blood sugar warning alerts.
You should set these high and low alerts according to your health care
professional’s advice. When your test result is lower than the Hypo alert
value (the meter can be set to a maximum Hypo value of 5.6 mmol/L (100
mg/dL)), the symbol “HYPO” will be displayed. When your test result is
higher than the Hyper alert value (the meter can be set to a minimum
Hyper value of 6.7 mmol/L (120 mg/dL)), the symbol “HYPER” will be
displayed.
The Hyper and Hypo settings are OFF by default.
To change the Hypo limit alert value (or turn off), press the “<” or “>”
buttons and then the “M” button to save. Next, change the Hyper limit alert
value (or turn off) by pressing the “<”or“>” buttons and then the “M” button
to save. The meter will enter the ketone test warning setting.
To turn the blood ketone test warning on or off, press the “<” or “>” buttons
and then the “M” button to save. When the blood ketone test warning
function is on, the “KETONE?” symbol will show in the upper right section
of the display if your test result is higher than 16.7 mmol/L (300 mg/dL).
After choosing the ketone test warning setting, the system will enter the
meal marker setting.
The meter has a meal marker function that allows you to mark your test
result as before or after a meal. To turn the meal marker function on or off,
press the “<” or “>” buttons and then the “M” button to save. The meter will
power off after this setting is chosen.
You can preset up to 10 different test reminder alarms that can remind you
to regularly perform blood glucose tests. You can also turn any of the
reminder alarms on or off.
When the meter is off, long press the “>” button to enter the test reminder
alarm settings menu.
Press the “<” or “>” button to select the alarm number that you would like
to edit, and then press the “M” button to confirm your choice. Now you can
edit the time (hour/minute) that you would like the alarm to sound by
pressing the “<” or “>” button, and “M” to confirm/save. After saving the
time, the meter will turn off.
1312
Quality Control Tests
The test reminder alarms sound for 1 minute, and
then repeat at an interval of 5 minutes. The alarm
is cancelled by inserting a test strip or by pressing
any key.
When a test reminder alarm is on, the alarm clock
symbol will be displayed on the screen. An
example is shown in the figure:
When the test reminder alarm sounds, the display
shows:
Note: If you hold the “<” or “>” button, the numbers will decrease or
increase more quickly.
Tip: After you replace the battery, you will only need to reset the
time. Other settings are stored in the meter memory.
Quality control testing is done to verify that the blood glucose meter and
test strips are working correctly, and to ensure the accuracy of the test
results. Please conduct quality control tests in the following situations:
When you suspect that the meter or test strips are not working
properly.
When you suspect that your test results are inaccurate, or if they are
inconsistent with the way you feel.
When you suspect the meter is damaged.
1. Insert the test strip all of the way into the test strip port, and the
meter will turn on automatically. If the audio is on, you will hear a
“beep” sound, and all of the icons on the display will turn on at the
same time.
2. The screen will now display the date, time, and the apply blood icon
flashing. Test strip icon and flashing blood drop icon shows that the
test strip has been inserted correctly.
Tip: If the test strip is not inserted correctly, the meter will not
power on.
3. Shake the control solution bottle, gently squeeze out the control
solution, discard the first drop, and drop the second drop onto a clean
nonabsorbent surface. Now touch the second drop to the sample
area of the test strip. Do not let the bottle come into contact with the
test strip. If the audio is on, the meter will beep, telling you that
enough control solution has been applied.
Tips:
If a big bubble forms, wipe with clean cotton paper, and then do
the following steps.
If one drop of control solution does not fill the test window, please
add another drop within 3 seconds. Otherwise discard the test strip,
and try again.
4. After applying enough control solution, the display will count down 5
seconds and the control solution test result will be displayed on the
screen. If the control solution
test result falls within the
control range that is printed
on the package (CTRL 1 on
test strip vial), this indicates
that the meter is working
normally, and the system is
functioning properly.
When “ ” and “#” are displayed simultaneously, the result is from a
control solution test, and it will not be included in the 7, 14, 30, 60, or 90
day average. When you access your test history, the control solution
results are not displayed.
If the control solution results are outside of the reference range:
Confirm you are matching the correct range. Control Solution 1
results should be matched to the CTRL1 range printed on the test
strip vial.
Check the expiration date of the test strip and control solution.
Make sure that the packages have not been opened for more than
6 months. Discard any expired test strips and control solution.
Confirm that you are testing within the correct temperature range
(15-30°C).
Make sure that the test strip vial and control solution bottle have been
tightly closed.
Make sure that you are using the correct brand of control solution.
Make sure you are following the user guide instructions properly.
After checking all of the conditions above, repeat the quality control test
with a new test strip. If the quality control test results are still outside of
the range printed on the test vial, there may be a problem with your
meter. Please seek help and contact your local authorized PharmEvo
distributor.
Two levels of control solution are available labeled Control Solution 1 and
Control Solution 2. Control Solution 1 is sufficient for most self testing
needs. If you think your meter or strips may not be working correctly, you
may also want to do a level 2 test. The ranges for both (CTRL 1 and CTRL
2) are displayed on the test strip vial. Simply repeat Steps 4 through 6,
using Control Solution 2. For confirmation of results, Control Solution 1
tests should fall within the CTRL1 range, and Control Solution 2 tests
should fall within the CTRL2 range. If the control solution test results do
not fall within the respective ranges, DO NOT use the system to test
blood, as the system may not be working properly. If you cannot fix the
problem, contact your local authorized PharmEvo distributor for help.
Please contact your dealer to purchase control solution. Each box of
control solution contains both Control Solution 1 and Control Solution 2.
1514
5. After the test has been completed, slide the test strip ejector to pop out
the test strip, and the glucose meter will automatically turn off.
1716
Blood Sampling
IMPORTANT:
Lancet Release Button
Safety Cap
Lancing
Device Cap
Depth Adjustor Holder with
Carrier
Cocking Barrel
Fingertip Testing:
Depth Adjustment:
1 and 2:
3:
4 and 5:
for delicate skin
for normal skin
for thick or calloused
skin
Testing Your Blood
The following steps show how to use the meter, test strips, code chip,
lancing device and sterile lancets together to measure your blood glucose
concentration. The main steps are as follows:
Step 1: Insert the test strip face up into the test strip port. The meter will
automatically turn on and display the code chip number and
flashing “Apply Blood” icon.
Step 2: You can choose the blood collection site. Usually a tiny amount
of blood is collected from the fingers, hands. Touch the blood
drop lightly to the edge of the sample area. Complete the test
within two minutes, or the meter will automatically power off.
Step 3: After the meter detects that there is an adequate amount of
blood, the meter will count down 5 seconds and display the
glucose test results. The test result will be stored in the history
automatically. Slide the test strip ejector to eject the test strip,
and the meter shuts off automatically.
Before testing, first become familiar with how to collect blood and then
choose a clean and dry place to conduct the test.
Prior to testing, use with either alcohol or soapy water to
disinfect the sampling site. Use warm water to increase
blood flow if necessary. Dry your hands and the sampling
site, ensuring that there is no soap residue remaining.
Adjust the depth penetration to reduce the discomfort. You do not
need the clear cap for fingertip sampling.
1. Remove the lancing device
cap. Insert the lancet into the
lancet carrier until it comes to a
complete stop.
3. Carefully install the lancing
device cap onto the lancing
device, avoid touching the
lancet needle tip.
2. Twist off the safety cap from
the lancet, save the safety cap
for lancet disposal.
4. Adjust the puncture depth by
rotating the depth adjustor (the
lancing device has 5 puncture
depth settings). To reduce
discomfort, choose the lowest
setting that still produces an
adequate blood sample.
Note: Greater pressure
between the lancing device
against the finger will also
increase the puncture depth.
1918
Lancet Removal
Lancet Precautions:
Reminder:
5. Pull back the plunger until you
hear a click sound. Now the
lancing device is loaded and
ready to draw blood. 1. Unscrew the lancing device
cap. Firmly push the needle
into the safety cap.
2. Pull out the lancet from the
lancet carrier. Please dispose
of the used lancet properly.
6. Before taking a blood sample,
wash your hands or use an
alcohol swab to clean the
area. Washing your hands in
hot water increases blood
circulation. You can also
massage from wrist to finger
to promote better blood
circulation.
7. Holding the lancing device
against the side of the finger to
be lanced, press the release
button and then put down the
lancing device. Massage
forward slowly from the base
of your finger to the tip to
increase the sample size.
Wipe away the first drop of
blood and use the second drop
for the test strip.
Tip: To reduce pain, prick on
the sides of the fingertips,
where there are less nerve
endings. Rotate finger
locations as much as
possible to accelerate
wound healing and
decrease callouses.
Do not use a lancet if the safety cap is loose or missing.
Do not use a lancet if the needle is bent.
Use caution whenever a lancet needle is exposed.
Do not share lancets with other people.
To avoid cross contamination, always use a new sterilized
lancet. Do not reuse lancets.
Avoid contaminating lancets with hand lotion, detergents, oil,
and other debris.
Lancing devices and lancets should not be shared. Each person
should have his own lancing device and lancets.
Clean your lancing device before and after use with alcohol or a
disinfectant wipe. Be sure to clean the part of the device that
touches the finger. Do not immerse the lancing device in water.
Control excess bleeding and disinfect your wound after use.
2120
Testing Blood Glucose
When you insert the test strip, the meter will automatically turn on.
1. Insert the test strip into the test strip port, and the meter will turn on
automatically. If the audio is on, you will hear a “beep” sound, and
all of the icons on the display will turn on at the same time. If the strip
is inserted upside down, the meter will not turn on.
2. The test strip has been inserted correctly when you see the “Apply
Blood” icon and drop icon flashing. If the test strip is not correctly
inserted, the meter will not turn on – repeat the steps above.
3. Apply blood to the sample area of the test strip. If the audio is on, the
meter will beep, telling you that enough blood has been applied and
the meter will start to measure.
DO NOT:
Apply blood to the front or back of the test strip.
Smear the blood drop onto the test strip.
Press your finger against the test strip.
4. The display will count down 5 seconds during
the measurement process. If the audio is on, the
test will end with a beep. If you applied a blood
sample but the meter does not begin a
countdown, you may reapply a second drop of
blood within 3 seconds.
If you press the “>” button, the test results will be marked with the “#”
icon. Results marked with “#” symbol will not be used in the 7, 14, 30,
60 or 90 day average calculations. If you accidentally mark your result
with the “#” icon, simply press the “>” button again to cancel the mark.
After marking a result with “#”, please test again with a new strip.
If the before/after meal marker setting is on, you can press the “<”
button to tag the reading before or after meal, as shown in the figure:
Press the “M” button to confirm.
If an error code is displayed, please check the troubleshoot-
ing instructions (page 32). If “HI” or “LO” symbol is displayed, refer
to the “HI” and “LO” Messages section (page 25).
2322
Understanding Test Results
Suggested Test Times and Target Goals
When you wake up (before eating)
Before breakfast
1-2 hours after breakfast
Before lunch
1-2 hours after lunch
Before and after exercises
Time Target Range (mg/dL) Target Range (mmol/L)
Empty stomach 70-100 3.9-5.6
2 hours after a meal <140 <7.8
(Note: 1 mmol/L = 18 mg/dL)
How many times per day should I test?
Diabetes Type Number of Tests With Empty Stomach
Type 1 At least 3 times per day
Type 2 Test frequently to achieve your target range
Prenatal Diabetes At least twice per day
5. Record valid results in your logbook with the date and time, and
compare them to the target goals set by your healthcare professional.
(Refer to Suggested Testing Times and Target Goals on page 23)
6. After the test has been completed, slide the test strip ejector to pop
out the test strip, and the glucose meter will automatically turn off. Tracking your glucose concentrations with regular blood glucose testing
is an important part of managing diabetes. Your healthcare professional
will help you decide the normal target range for you glucose levels and
how often you should test according to your situation. Suggested times to
test include:
Before dinner
1-2 hours after dinner
After a snack
Before bedtime
2-3 o'clock in the morning
(if taking insulin)
More frequent tests may be required when:
You adjust your medication dosage.
You think your glucose levels may be too high or too low.
You feel ill.
Normal blood glucose target ranges (from ADA Clinical Practice
Recommendations, 2011).
Research indicates that measuring your blood glucose at least three
times per day will help you control you glucose level. Please discuss the
number of tests and test times with your healthcare professional.
Record your blood sugar levels and other relevant information in your log
book. Bring your records when you visit your healthcare professional.
It will help them understand your condition, and help them modify your
treatment plan.
2524
“HI” and “LO” Messages
“ “HYPO” and “HYPER” Messages
Meter Memory
Your meter can accurately measure blood glucose concentrations
between 1.1-33.3 mmol/L (20-600 mg/dL). “HI” and “LO” messages
indicate that the test measurement was outside of this range.
If “HI” is displayed, it indicates the test result is above 33.3 mmol/L (600
mg/dL). You should test again to ensure that no mistake was made in the
procedure. If you are sure your glucose meter is functioning properly, no
mistakes were made, and the test results still show “HI”, then you may be
in a state of severe hyperglycemia, please contact your healthcare
professional immediately.
If “LO” is displayed, it indicates the test result is below 1.1 mmol/L (20
mg/dL). You should test again to ensure that no mistake was made in the
procedure. If you are sure your glucose meter is functioning properly, no
mistakes were made, and the test results still show “LO”, then you may be
in a state of severe hypoglycemia, please contact your healthcare
professional immediately.
If “HYPO” is displayed, it indicates the test result is below the
hypoglycemia limit that you entered in the settings.
If “HYPER” is displayed, it indicates the test result is above the
hyperglycemia limit that you entered in the settings.
Blood Ketone Test Reminder: if “KETONE?” is
displayed, this indicates a blood ketone test is
necessary because your blood glucose test results
are higher than 16.7mmol/L (300 mg/dL).
Please contact your healthcare provider.
The glucose meter can store up to 500 test results with the corresponding
time and date. If 500 test results already exist, a new result will overwrite
the oldest one. The glucose meter is also capable of calculating 7, 14, 30,
60 and 90 day averages from the stored results.
Notes:
This meter sytem is only for in vitro diagnostic use, and can only be
used with Blood Glucose Test Strips. Use of other test
strips can lead to wrong test results.
This meter can only be used to determine blood glucose levels with
whole blood samples. Do not use serum or plasma samples.
This meter can be used within a hematocrit (HCT) range of 10% ~
70%. Please do not use this product for testing if your hematocrit
value is out of this range.
Ascorbic acid >3 mg/dL and Xylose >9 mg/dL will cause over
estimation of blood glucose results.
Fatty substances, such as triglycerides less than 3,000 mg/dL or
cholesterol less than 500 mg/dL, have no major effect on blood
glucose test results.
Patients who are severely ill, suffer from severe dehydration, or are in
a hyperosmolar state (with or without ketosis) should not use the
Blood Glucose Monitoring system.
This product is only suitable for clinical screening tests or family
self-monitoring. The test results can’t be referred to as confirmed
cases. In order to ensure the accuracy of the results, the test results
can be further confirmed by other methods, such as biochemical
methods.
As with all diagnostic reagents, test results must be linked with a
professional doctor’s diagnosis from the other clinical symptoms.
Carefully process waste caused by blood glucose tests according to
the relevant local laws and regulations, because blood samples are
considered a biohazard.
If the blood glucose meter is used for the first
time, “---” and “ ” will be displayed. The date
will not be shown for the first test.
1. Press the “M” button to enter memory mode.
The “ ” icon and latest test result will be
displayed.
2726
Memory Mode
Memory Data Transfer
Clearing the Memory
2. The stored test result along with the associated time and date are
displayed at the same time. Test results marked with “#” icon will not
be included in the 7, 14, 30, 60 and 90 day averages.
3. Press the “<” or “>” button to review all stored test results.
4. Press button “M” again to enter the data average screen. The number
of days (“DAY AVG”) and number of readings (“READINGS”) used in
the average calculation will be displayed. If no data has been
recorded, then the meter will turn off.
5. Press the “M” button again, and then use the “<” or “>” buttons to scroll
through the 7, 14, 30, 60, and 90 day averages. Press the “M” button
to see the before meal and after meal marker averages. The meter will
calculate the historical averages according to the parameters that you
choose and the meter will show how many records are used to
calculate the average.
6. If the meter has not been used for the amount of time indicated as the
“day average”, the meter will not show an average.
7. Finally, press “M” one last time to turn off the meter.
Note: Test results marked as quality control test or with the “#” symbol
will not be used in the calculated average.
Please be careful when using the clear memory function because the
action is irreversible. Once the memory is deleted, it cannot be restored.
The clear memory function will erase all test records.
1. While in the memory mode, press the “<” and “>”
buttons at the same time to enter the clear
memory mode.
2. Press “M” to confirm that you would like all
records to be erased. The “ ” and “---” icons will
display at the same time, and the meter will turn
off automatically after a few seconds.
3. If you want to abort the memory delete function,
you can cancel by pressing the “<” and “>”
button instead of the “M” button. The memory
will not be erased.
Blood Glucose meters are capable of transferring memory
data to a personal computer. Please refer to the software instructions for
correct usage and the proper equipment to connect to your computer.
The meter uses a CR 2032 3.0V coin cell battery. When the meter displays
the battery symbol ( ), this indicates that the battery is low and you should
replace the battery as soon as possible. The “E-6” error code means that the
battery is empty and you cannot use the meter until the battery is replaced.
How to replace the battery:
1. Make sure the meter is off.
2. Open the battery cover on the back of the meter.
3. Remove the old batteries and replace with a new CR 2032 3.0V coin
cell battery, making sure that the positive (+) electrodes are in the
correct orientation.
4. Replace the battery cover.
5. After replacing the battery, you may need to re-enter some settings in
the settings menu (for more information, see page 8).
Cleaning
Glucose Meter
Lancing Device
2928
Comparing Meter and Laboratory
Results
Proper maintenance of your meter is recommended for the best results.
Storage
Replacing the Battery
Maintenance
Your blood glucose meter and laboratory equipment both report
glucose concentrations in the serum or plasma component of your
blood. However variations between the two are normal, and your meter
results and laboratory results may be slightly different. Glucose
concentration results can be affected by a number of factors and
conditions, but these factors and conditions will not affect the test
results of biochemical analyzers.
Under normal conditions, the difference between measurements with
your meter and laboratory results are within the range allowed by
national standards.
To ensure a reasonable comparison between your meter and laboratory
results, please follow these guidelines:
1. Make sure your meter is working properly.
2. Comparisons will be more accurate if you do not eat for at least four
hours (preferably eight hours) before testing.
3. Bring your blood glucose meter, test strips, and control solution to
the lab.
4. Ensure that the time between tests with your meter and the laboratory
is within 15 minutes.
5. Wash and dry your hands before obtaining a blood sample.
6. Make sure you closely follow the instructions in this manual.
Test results may show small deviations, this may due to the following
reasons:
Blood oxygen and red blood cell count vary from person to person, and
even within the same person. Blood Glucose Meters test
blood glucose concentrations for the widest range of people possible. If
the user’s blood indexes fall within the middle of the range, the result will
be ideal. Otherwise, there will be some small deviations. (The deviations
should be within the range allowed by local government.)
Keep the test strip port area clean.
Keep the meter dry. Do not allow liquids to enter the housings. Avoid
extreme temperatures and humidity.
Do not leave the meter in your car.
Avoid dropping the meter. If you accidentally drop it, perform a quality
control test (see page 12) to verify the system is working properly.
Keep the meter and components away from children and pets.
Do not disassemble the meter. Disassembly will void the warranty.
Please follow the local regulations to dispose of the meter and battery
properly.
Under normal circumstances, no special cleaning is required. If cleaning
is needed, wear gloves before applying a mild detergent and water with a
soft damp cloth. Be careful not to allow water, dirt, blood, or control
solution inside of the meter. If your meter’s test strip port is stained with
blood, control solution or any liquid, please use a dry tissue or alcohol
swab to clean it immediately. Do not use anything wet to clean it. Perform
a quality control test to ensure that the meter is working properly.We
recommend that you store the meter in the carrying case after use.
Your blood glucose meter is a precision instrument. Please be careful.
As needed, use a soft damp cloth moistened with soap and hot water to
wipe the surface. Do not immerse the lancing device in water.
3130
Warranty
Symbol Index
Troubleshooting
Display Causes Solution
Meter
does not
turn on Meter is too cold
Strip error
Meter self test error
Insufficient sample
Strip testing error
Replace the battery.
Consult instructions for use
Use by
Manufacturer
Code Number
Serial Number
1 Time Use
Storage Temperature Range
For in vitro diagnostic use
Lot Number
DC Power
Control Range
Do not dispose with
household waste
Biohazard
Date of Purchase:
The meter has built-in messages to alert you of problems. When error
messages appear, note the error number, turn off the meter, and then
follow these instructions.
Battery may be damaged
or not have enough charge
Test strip is wet,
contaminated, or used
Sample applied to the
test strip too soon
Test strip was removed
during the test
Temperature exceeds the
normal operating range
(5°C ~ 45°C)
The battery is low, but may
be used for another 20 tests
The battery has been fully
discharged - no more tests
are possible
The meter has recorded a
level that is higher than the
meter test range
The meter has recorded a
level that is lower than the
meter test range
Allow the meter to warm to
room temperature for 30
minutes, then use.
Please be sure to use
Blood Glucose Test Strips and
repeat test with a new test strip.
Make sure that the strip has not
expired, is not damp, or used. If
the test strip is ok, remove the
battery for 30 seconds, and
retest with a new strip. If the
problem persists, contact
customer service.
Retest with a new strip. Make
sure there is enough blood to fill
the test window.
Repeat the test and ensure test
strip remains in place.
Move to a place within the
normal operating temperature
range and repeat the test.
The next 20 results will still be
accurate, but replace the battery
as soon as possible.
Replace the battery and
repeat the test.
Repeat test. Please make sure
fresh blood sample with intended
hematocrit level is used. Please
make sure blood sample is not
contaminated. If problem
persists, please contact local
authorized PharmEvo distributor.
Repeat test. If you see HI again,
contact your doctor immediately.
Repeat test. If you see LO again,
contact your doctor immediately.
1. Microtech Medical (Hangzhou) Co. Ltd. warrants that this product will
be free from defects in materials and workmanship for 5 years from
date of purchase.
2. Please complete the warranty card that came with this product and
mail it to your local authorized PharmEvo distributor to register your
purchase. Please keep your sales receipt and other related purchase
documents. If the meter fails for any reason other than obvious abuse
within the warranty period, we will repair or replace it free of charge.
Please note the date of purchase.
Note: The warranty covers only the blood glucose meter and does not
include the battery
Table of contents
