microlife GlucoTeq Blood Glucose Monitoring System Instruction Manual
- June 6, 2024
- microlife
Table of Contents
GlucoTeq Blood Glucose Monitoring System
GlucoTeq
Blood Glucose Monitoring System
EN Instruction Manual
Model No: BGM 200
GlucoTeq – BGM 200
IB BGM 200_mg EN 5120 – Revision Date: 2020-12-11
Explanation of Symbols For In vitro diagnostic use
Please consult instructions for use
Do not reuse
Temperature limitation Use by / Expiry date Manufacturer
LOT Lot number Keep dry
Caution, consult accompanying document Keep away from sunlight
Humidity limitation
EU representative
This product fulfils the requirements of Directive 98/79/EC in vitro diagnostic medical
0123 device.
Do not use if package is damaged
Serial number
Wholecare Biomedical Corporation 8F, 443, RuiGang Road, NeiHu Taipei, 11492, Taiwan
Medical Device Safety Service GmbH (MDSS GmbH) Schiffgraben 41 30175 Hannover / Germany
0123
Overview 1.Before you begin 2.Getting to know your system 3.Prepare for blood sampling 4.Performing blood test 5.Alternative site testing 6.Control solution testing 7.Memory recall 8.Caring for your meter and test strip 9.Specifications 10.System Troubleshooting 11.Performance Characteristics 12.Guarantee
1. Before you begin
Please read this before using.
The following basic safety precautions should always be taken. 1.Close
supervision is necessary when the device is used by, on, or near children or
people with disabilities. 2.Use the device only for the intended use described
in this user guide. 3.Do not use test strips and control solutions which are
not supplied by the manufacturer. 4.Do not use the device if it is not working
properly, or if it has suffered any damage. 5.Before using any product to test
your blood glucose, read all instructions thoroughly and practice the test. Do
all quality control checks as directed and consult with a diabetes healthcare
professional.
Keep this user guide with you.
Intended use: The system is intended for use outside the body (in vitro
diagnostic use only). It should be used only for self-testing blood glucose
(blood sugar) and only with fresh capillary whole blood samples. The system is
intended for use in the home and in clinical settings. The system should not
be used for the diagnosis of diabetes or for the testing of newborns.
Principle of Measurement Blood glucose is measured by an electrical current
that is produced when a blood sample mixes with the reagent (special
chemicals) of the test strip. The electrical current changes with the amount
of glucose in the blood sample. The Microlife GlucoTeq meter measures the
strength of the electrical current, calculates your blood glucose level and
then displays your result in either milligrams of glucose per deciliter
(mg/dL) or millimoles of glucose per liter (mmol/L).
Caution
1.The user should not take any decision of medical relevance without first
consulting his or her medical practitioner.
2.Call your doctor immediately if you experience symptoms that are not
consistent with your blood glucose test results.
3.High altitudes above 3,402 meter (11,161 ft) may affect the test results.
4.Temperatures outside the range of 10°C to 40°C (50°F to 104°F) may affect
the test results. Do not test outside of these temperature ranges.
5.Do not perform servicing and maintenance while the meter is in use.
6.Modification of this equipment is not allowed. If the equipment is used in a
manner not specified by the manufacturer, the protection provided by the
equipment may be impaired.
7.Do not use this meter near cellular or cordless telephones in a call,
walkie-talkies, garage door openers, radio transmitters, or other electrical
or electronic equipment that are sources of electromagnetic radiation, as
these may interfere with the proper operation of the meter.
Important Health-Related Information
1.Apply only capillary whole blood sample to test your blood glucose. Applying
other substances or plasma, serum will cause wrong results.
2.Severe dehydration and excessive water loss may cause false low results. If
you believe you are suffering from severe dehydration, consult your healthcare
professional immediately.
3.Test results below 60 mg/dL (3.3 mmol/L)1 indicates low blood glucose
(hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L)2 indicates
high blood glucose (hyperglycemia).If your results are below 60 mg/dL (3.3
mmol/L) or above 240 mg/dL (13.3 mmol/L), repeat the test, and if the results
are still below 60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L),
consult your healthcare professional immediately.
4.Inaccurate results may occur in severely hypotensive individuals or patients
in shock. Inaccurate low results may occur for individuals experiencing a
hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill
patients should not be tested with blood glucose meters.
5.Abnormal red blood cell counts may cause false results. Please consult your
healthcare professional if you do not know your hematocrit level.
6.Interference: Reducing substances occurring in the blood naturally (uric
acid, bilirubin) or from therapeutic treatments (ascorbic acid, acetaminophen)
will not significantly affect Microlife GlucoTeq test results. However,
elevated concentrations of these substances may affect test results. The
compounds listed in the table were found to have no affect at the
concentration indicated.
Compounds
Acetaminophen Ascorbic Acid Aspirin Bilirubin Cholesterol Creatinine Dopamine
EDTA Galactose Gentisic Acid Glutathione Haemoglobin Heparin Hydroxyurea
Ibuprofen Icodextrin L-dopa Maltose Methyldopa Pralidoxime Iodide Salicylate
Tolazamide Tolbutamide Triglycerides Uric Acid Xylose
Concentrations higher than the following values may cause inaccurate results 8.0 mg/dL (0.53 mmol/L) 5.0 mg/dL (0.28 mmol/L) 60 mg/dL (3.33 mmol/L) 90 mg/dL (1.54 mmol/L) 500 mg/dL (12.9 mmol/L) 5.0 mg/dL (0.44 mmol/L) 2.0 mg/dL (0.11 mmol/L) 360 mg/dL (12.3 mmol/L) 900 mg/dL (50 mmol/L) 5.0 mg/dL (0.32 mmol/L) 53 mg/dL (1.72 mmol/L) 500 mg/dL (0.08 mmol/L) 8,000 U/dL 3.0 mg/dL (0.39 mmol/L) 50 mg/dL (2.42 mmol/L) 13 mg/dL (0.01 mmol/L) 10 mg/dL (0.51 mmol/L) 900 mg/dL (26.3 mmol/L) 3.0 mg/dL (0.13 mmol/L) 25 mg/dL (0.94 mmol/L) 60 mg/dL (4.34 mmol/L) 100 mg/dL (3.21 mmol/L) 400 mg/dL (14.8 mmol/L) 2,000 mg/dL (22.6 mmol/L) 8.0 mg/dL (0.48 mmol/L) 100 mg/dL (6.66 mmol/L)
REFERENCE: Kahn, R. and Weir, G.: Joslinis Diabetes Mellitus, 13thed Philadelphia: Lea and Febiger (1994), 489. 1 Krall, L.P. and Beaser, R. S.: Joslin Diabetes Manual. Philadelphia: Lea and Febiger (1989), 261-263. 2
2. Getting to know your System
The Microlife GlucoTeq Glucose Monitoring System The Microlife GlucoTeq system
uses the latest technology to provide you with easy and comfortable testing.
The system requires only 0.5uL blood sample to complete the testing in only 5
seconds. Please review the contents of your purchase to confirm that all the
components are included as listed on the side of your meter box.
1 Illuminated Test Strip Slot
Insert the test strip here. The meter will turn on auto-
matically and the slot LED light will illuminate.
1
To track the position of test strip slot without strip
inserting, press main button
2
and the slot LED light will be flashing.
2 LCD Display
Guides you through the test using symbols and
simple messages.
3 Main Button
3
Turns the meter on or performs other functions
described in this user guide.
4
4 Data Port
Allows you to transfer the information stored in the
meter to a computer to view, analyze and print.
5 Set Button
Located on the back of the meter, inside the battery
compartment; used to set up the meter.
6 Battery Compartment
Holds ONE 3V Lithium battery (battery type
CR2032). Please install battery into meter before
you start testing.
7 Meter Label
Each meter has its unique number on it. Do not alter
or tear the label off.
5
vcc GND
6
7
8 Contact Bars Insert this end of the test strip into the meter. Push
9
it in firmly until it will not go any further.
8
9 Test Strip Handle
Hold this part to insert the test strip into the test strip
slot on the meter.
AT AK
AT Confirmation Window Shows whether enough blood has been drawn into the test strip’s absorbent channel.
AK Absorbent Channel Apply a drop of blood and it will be drawn in automatically.
AL Test Result Area Displays test results.
BP BO
AS Unit of Measure Indicates what unit of measure
the test result is displayed in.
AM Appears when test result is
BN BT Temperature Symbol
lower than 70 mg/dL (3.9 mmol/L) or higher than 180 AL mg/dL (10 mmol/L).
Appears when test result is AM within the range of 70 to 120 AN
BM BL BK BT
AS BK
AR
Appears when temperature is outside of operating range.
Control Solution Test Symbol
mg/dL (3.9 mmol/L to 6.7
AO AP AQ
Shows that you are in control
mmol/L).
solution mode.
AN Ketone Symbol Appears when test result is higher than 240 mg/dL (13.32
mmol/L).
AO Alarm Symbol Appears when you are setting alarms.
AP Test Strip Symbol Appears when the meter is in testing mode.
BL Memory Symbol Appears when you review the memory.
BM After Meal Indicates that your test is an After Meal test.
BN Before Meal Indicates that your test is a Before Meal test.
AQ Blood Drop Symbol Flashes when sample should be applied.
BO Date
AR Low Battery Symbol Appears when the battery
power is low.
BP Time
If any part of the display is not working, contact your local distributor for help.
Battery Microlife GlucoTeq meters come with one (1) CR2032 lithium battery.
The battery is manufactured in a charged state and not designed for
recharging. Recharging the battery can cause battery leakage, or in some
cases, high pressure rupture.
Warning: Batteries can explode or leak and cause burns if installed backwards,
disassembled,
charged or exposed to water, fire or high temperatures.
Low Battery
The meter will alert you when the power is getting low by displaying two
different messages: When the battery symbol AR appears alone on the display,
the meter is functional and the results remain accurate, but you should change
the battery as soon as possible. When the battery symbol AR appears together
with the «E-b» symbol on the display, the battery does not have enough power
for a test. You must change the battery before using the meter.
STEP 1: With the meter off, press
STEP 3: Replace with a new
the mark on the battery cover
battery. Be sure to align the
and slide up to open the cover.
vcc GND
battery properly with the positive
vcc GND
(+) side up.
STEP 2: Remove the old battery
by pressing on the buckle beside
vcc GND
the battery and gently pulling it at
STEP 4: Close the battery cover. If the meter does not power on and enter setting mode after you
the same time.
have replaced the battery, check
that the battery is correctly installed.
Replacing the battery does not affect the meter’s memory (previous test
results stored in
memory). However, the date, time and unit settings may need to be updated; update the settings
by following the steps in «Setting Time and Date».
As with all small objects, the battery should be kept away from small children. If the battery is swal-
lowed, seek medical assistance immediately.
Remove the battery if you are not going to use the device for a long period of time (i.e. 3 months or more), or the battery might leak chemicals.
Please discard the product or the batteries properly according to the regulations of your country.
Setting Mode
Please install battery first and complete the setting before you begin to test.
STEP 1: Enter Setting Mode
STEP 4: Set the Date
If your meter is off, press the SET
Press and release the main button
button 5 located in the battery
3 to advance the date. With the
vcc GND
compartment. The meter is now
correct date on the display, press
in the setting mode.
the SET button 5 and the time
will appear on the display with the
hour segment flashing.
STEP 2: Set the Year
STEP 5: Set the Hour
Press and release the main button
Press and release the main
3 to advance the year. With the
button 3 to advance the hour.
correct year on the display, press
With the correct hour on the
the SET button 5 and the date
display, press the SET button 5
will appear on the display with the
and the minutes segment will
month segment flashing.
start flashing.
STEP 3: Set the Month
STEP 6: Set the Minutes
Press and release the main button
Press and release the main
3 to advance the month. With the
button3 to advance the minutes.
correct month on the display,
With the correct minutes on the
press the SET button 5 and the
display, press the SET button 5
date segment will start flashing.
and the «OFF» will start flashing.
Fig. A STEP 7: Set the Alarm The meter allows you to set 4 different alarms with an order from 1 to 4. will be displayed during the alarm setting.
Fig. B 1 – Press the main button3 to turn the alarm ON (Fig.A) or OFF (Fig.B). 2 – Press SET button 5 to move to hour setting for alarm. (Fig.C) Use the main button 3 to set your desired hour. Press SET button5 again to set the minute. (Fig.D).
Fig. C 3 – Press SET button to set the next alarm. 4 – Repeat step 1-3 to set the second, third and fourth alarm. After completing fourth alarm, the AC/PC will start flashing.
Fig. D
STEP 8: Set AC/PC Press and release the main button 3 to select ON/OFF. With
the correct setting, press the SET button 5 for confirmation.
STEP 9: Delete Memory If you do not want to clear the memory, press the SET
button again to skip this step. If you want to clear ALL memory, press the
main button for five (5) seconds. The «- – -» will appear to indicate all
memory has been deleted and the meter will turn off.
STEP 10: Complete Setting Setup is now complete. «OFF» is displayed and the
meter will turn off.
3. Prepare for blood sampling
If your lancing device did not come with a lancing device insert, the
following information shall take the place of the insert.
Microlife LD-100 Lancing Device
Your lancing device and lancets are used for obtaining blood samples from the puncture site.
1 A stylish, slim and ergonomic design is very
12
convenient and user friendly.
2 Big window to show the penetration depth with
3
numeric display which is easy for the user to
read.
3 Big release button, comfortable and easy to
5
4
operate.
4 Patented feature of lancet ejection by one
thumb pushing with only one hand operation.
5 Patented safety switch design:
when the cap is closed, it allows only load but
lock the function of lancet ejection. When cap
is open, it allows lancet ejection but release the
trigger automatically to prevent accidental
pricking.
6 Depth adjustable cap
6
7
8
7 Release button
8 Plunger
9 Hub AT Clear cap (optional)
9 AT
AK Disposable lancet (optional)
AK
Special Features Intended Use: The lancing device is intended for use by a
single person with the lancet puncturing through the skin for collecting blood
sample. Safety Switch design: when the depth adjustable cap is open, the
trigger will be relieved automatically which prevents users from being pricked
if you are not intended to start the test. You can eject the used disposable
lancet on one hand operation by pushing the plunger with your thumb at this
status. When the cap is closed, it will lock the lancet eject function and
prevent the lancet from being removed when you are intended to start the test.
Stable and sophisticated structure design ensures almost no vibration, so that
the lancet pricking is steadier with almost no pain. It lowers the
psychological pressure of users very much and let people
recover the test frequencies which recommended by HCPs. A stylish, slim and
ergonomic design is very convenient and user friendly. Clear indication for
depth penetration (numeric display): easy to read and adjust for users.
Important Lancing Device and Lancets Information
1.Lancet is for single use only. 2.Keep lancing device and lancets clean.
3.Use caution when removing the used lancet from the device and when disposing
the used lancet.
The meter and lancing device are for single patient use.
Do NOT share them with anyone including family members.
Do NOT use on multiple patients.
Setting your Lancing Device
1
1. Hold the depth adjustable 5
cap in one hand and hold
hub in the other hand, twist
off the depth adjustable
cap.
2
2. Insert a new disposable 6
lancet firmly into the lancet
holder.
3
4
3. Twist off and set aside the protective cover of the disposable lancet.
5. Select a depth of penetration by rotating the top portion of the depth
adjustable cap until the number matched to the window. Settings are based on
skin type.«1,2» are for soft or thin skin. «3,4» are for average skin. «5,6»
are for thick or calloused skin.
6. Hold the hub in one hand and push on the plunger in the other hand. The
device will be cocked. Release the plunger; it will go back to its original
position near the hub.
The Lancing device is made by MEDIFUN CORPORATION No.8, Shuyi Rd., South
Dist., Taichung City, 40241, Taiwan (R.O.C.)
4. Replace the depth adjustable cap.
4. Performing a Blood Test
1. Wash Your Hands and the Puncture Site: Wash your hands in warm, soapy
water. Rinse and dry completely. Warm your fingers to increase blood flow.
AM
Incorrect
Correct
2. Insert Test Strip: Remove a new test strip from vial. Be sure to tightly
replace vial cap after removing test strips. Insert a test strip with the
contact bar end entering into the test strip slot first. Push the test strip
as far as it will go without bending it. The meter turns on automatically.
*To track the position of test strip slot, press main button and the slot LED light will flashing.
3. Select and Lance a Puncture Site: Hold the prepared lancing device firmly
against the side of your fingertip. Press the release button. NOTE: If you
want to do alternative site testing, please refer to the «About Alternative
Site Testing (AST)» section. Please consult your healthcare professional
before obtaining blood from site other than your fingertip.
4. Obtain a Blood Sample: Gently massage your finger or puncture site to
obtain the required blood volume. To perform the test, you need only 0.5 L of
blood sample. Do not smear the blood sample. To obtain best accurate result,
wipe off the first drop of blood and gently squeeze another drop of blood.
5. Apply Blood Sample: When the meter shows the «» symbol, apply blood to the
opening of the absorbent channel of the test strip where it meets the narrow
channel. Blood will be drawn into the test strip. If the test strip
confirmation window is full, you will hear a beep.
6. Read Your Result: After the meter counts down from 5 to 1, your blood
glucose test result appears along with the unit of measure, date and time.
7. Turn Off the Meter: This blood glucose result is automatically stored in
the meter memory. Turn the meter off by removing the test strip. Discard the
used test strip carefully to avoid contamination.
8. Remove the Adjustable Comfort Tip: After use, put the Protective Cap back
onto the exposed needle of the lancet.
9. Dispose the used lancet correctly: Slide the Lancet Ejector forward and dispose the used lancet in an approved container. Dispose the used lancet according to your country’s safety regulations. Replace the Lancing Device Cap.
5. Alternative Site Testing (AST)
There are important limitations for doing AST. Please consult your healthcare
professional before you perform AST. What is AST? Alternative Site Testing
(AST) means you can use parts of the body other than your fingertips to check
your blood glucose levels. The system allows you to test from the palm,
forearm, upper arm, calf or thigh, with equivalent results to fingertip
testing. What is the advantage? Fingertips feel pain more readily because they
are full of nerve endings (receptors). At other body sites, nerve endings are
not so numerous and you will not feel as much pain as you will experience at
the fingertip. 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, if you are
testing blood glucose level during or immediately after meal, physical
exercise or stressful event, take the blood sample from your fingertip only.
Use AST only: 1.In a pre-meal or fasting state (more than 2 hours since the
last meal).
2.Two hours or more after taking insulin.
3.Two hours or more after exercise.
4.During steady state blood glucose conditions.
Do NOT use AST if: 1.You have reason to believe you have hypoglycemia or
hyperglycemia.
2.Your routine glucose results are often fluctuating.
3.The test result is to be used to calibrate continuous glucose monitors
(CGMs).
4.The test result is to be used for insulin dose calculations.
How to increase the blood volume? Increase the blood flow by rubbing the
puncture site for more than 20 seconds before extracting blood. This helps to
reduce the risk of insufficient blood sample for a blood glucose test.
6. Control Solution Testing
If your Microlife control solution did not come with Microlife Control
Solution instructions, the following information shall take the place of the
instructions.
Microlife Control Solution contains a known amount of glucose that reacts with
Microlife GlucoTeq Blood Glucose Test Strips. By testing your control solution
and comparing the test results with the expected range printed on the test
strip vial label, you can make sure that the meter and the test strips are
working properly together as a system and that you are performing the test
correctly. It is very important that you do this simple check routinely to
make sure you get accurate results.
The standard GlucoTeq Blood Glucose Monitoring System DOES NOT contain the
control solution. To purchase Microlife Control Solution, please contact your
local distributor.
Important Information:
Use only Microlife Control Solution with your Microlife GlucoTeq meter. Check
the expiration date on the bottle. Do not use if expired. Use within a period
of 90 days from the date that you first open it. Record the discard date on
the control solution bottle when you first open it to serve as a reminder to
discard after 90 days. The control solution ranges are printed on the label of
the Microlife Blood Glucose Test Strip vial. They are not recommended target
ranges for your blood glucose. For in vitro diagnostic use. Do not add any
liquid to the Microlife Control Solution. Do not take internally or inject.
Why Perform a Control Solution Test: To ensure that your meter and test strips
are working properly together. To allow you to practice testing without using
your own blood.
When to Use: Whenever you suspect that the meter or test strips are not
working properly. When your blood glucose test results are not consistent with
how you feel, or when you think your results are not accurate. When test
strips have been exposed to extreme environmental conditions. If you drop the
meter.
Performing a Control Solution Test Start with the meter off.
STEP 1: Wash your Hands. Wash your hands with mild soap and water before
performing any test. Be sure to dry them thoroughly.
STEP 2: Insert Test Strip Insert a test strip with the contact bar end
entering into the test strip slot first. Push the test strip as far as it will
go without bending it. The meter turns on automatically.
STEP 3: Mark as a Control Solution Test After the «» symbol appears on the
display, press and hold the main button for 5 seconds and a symbol appears on
the display. With the
symbol on the display, the meter will not store your test result in the
memory. If you decide not to perform a control solution test, press and hold
the main button for 5 seconds again and the symbol will disappear.
STEP 4: Apply Control Solution 1.Check the expiration and discard dates on
your control solution and
test strip vials.
2.Shake the control solution bottle well, then remove cap.
3.Squeeze the bottle and discard the first drop then wipe the
dispenser tip with clean tissue paper or cotton.
4.Squeeze the bottle again to get a second drop onto a clean, non-
absorbent surface or on your clean fingertip.
5.Bring the tip of the test strip to touch the drop of solution until the
meter beeps.
Caution
To avoid contaminating the control solution with the content of the test
strip, DO NOT DIRECTLY APPLY CONTROL SOLUTION ONTO THE TEST STRIP.
Correct Incorrect
STEP 5: Check if the Test Result is in Range. After five (5) seconds, the
control solution test result appears on the display. Compare the test result
with the range printed on the test strip vial. Each vial of Microlife GlucoTeq
Blood Glucose Test Strips may have a different control solution range. The
result should fall within the printed range on the test strip vial.
Caution
Do not use test strips or control solution that have exceeded the discard
date, are expired or have been damaged. Your results may be inaccurate.
Low 30 – 50 mg/dL High 280 – 420 mg/dL
7. Memory Recall
The Microlife GlucoTeq meter stores a maximum of the 500 most recent blood glucose test results with date and time in its memory. It also provides you with 7, 14, 28, 60 and 90-day averages of your blood glucose test results. You can review the individual or average test results by entering the memory mode.
Recall the memory
STEP 1: Enter the Memory Mode While the meter is turned off, press and hold
the main button to turn the meter on. Press the main button again to enter
memory mode. The 7-day average will appear, indicating that you are in the
memory mode.
When using the meter for the first time or when the memory has been deleted,
«- – -» appears, indicating there are no test results in the meter memory.
STEP 2: Recalling Average Test Results If you continue to press the main
button, the 7, 14, 28, 60 and 90-day averages will appear in order. You can
then review the last 500 individual test results in memory. The 7day average
is calculated from the blood glucose results obtained during the last 7 days.
It also indicates how many blood glucose tests have been performed within this
period, e.g., 21 (21 tests in the last 7 days).
The 14-day average is calculated from the blood glucose test results obtained
during the last 14 days. It also indicates how many blood glucose tests have
been performed, e.g., 41 (41 tests in the last 14 days). The 28, 60, 90-day
averages show the same information.
STEP 3: Recalling Individual Test Results After the 90-day average, the most
recent test result with date and time will be shown. Press the main button
once and the next most recent test result will appear. Each time you press and
release the main button, the meter will recall up to your last 500 test
results in order. When the memory is full, the oldest test result is deleted
as the newest is added. After reaching the last individual result, press the
main button and the meter turns off.
STEP 4: Exit the Memory Mode Press and hold the main button for three (3)
seconds to exit memory mode at any point.
If you do not press any buttons for one (1) minute, the meter will display
«OFF» and turn off automatically
«Hi» and «Lo» test results are not included in the averages.
8. Caring For Your Meter And Test Strip
To avoid the meter and test strips getting dirt, dust or other contaminants,
please wash and dry your hands thoroughly before use.
Cleaning Your meter does not require special maintenance. As long as no blood
or control solution comes in direct contact with the meter, there is no
special cleaning required. To clean the meter exterior, wipe with a cloth
moistened with tap water or a mild cleaning agent, then dry the device with a
soft and dry cloth. Do not flush with water.
Do not use organic solvents to clean the meter. Your meter is a precision
instrument. Please handle it with care.
Storage 1. Meter Storage Storage condition: -20 °C~50 °C (-4 °F~122 °F), below
90 % relative humidity. Avoid dropping and strong impact. Avoid direct
sunlight and humidity.
2. Strip Storage Storage condition: 4 °C~40 °C (39 °F~104 °F), and 10~85 %
relative humidity. Do not freeze. Store your test strips in their original
vial only. Do not transfer to other container. Store test strip packages in a
cool and dry place. Keep away from direct sunlight and heat. After removing a
test strip from the vial, immediately replace the vial cap and close it
tightly. You may touch the test strip anywhere with clean, dry hands when
removing it from the vial or inserting
it into the meter. Use each test strip immediately after removing it from the
vial. Do not bend, cut, or alter a test strip in any way. Keep the strip vial
away from children since the cap and the test strip can be a potential choking
hazard. If swallowed, please seek medical assistance immediately.
3. Control solution storage Storage condition: Store the control solution
tightly closed at temperatures between 4 °C (39 °F) and 30 °C (86 °F). Do not
freeze.
9. Technical Specifications
Model Name: Assay Method: Test Sample: Test Result: Alternative Site Testing: Sample Size: Measuring Time: Measurement range: Acceptable Hematocrit Range: Operating conditions: Storage/Transportation Condition: Memory Capacity: Average Calculation: Power Supply: Battery lifetime: Automatic shut-off: Dimensions: Weight:
GlucoTeq Electrochemical biosensor Capillary whole Blood Referenced to plasma
glucose value YES (palm, forearm, upper arm, calf, or thigh) 0.5 L 5 seconds
20~600 mg/dL
20~60 % 10 °C~40 °C (50 °F~104 °F), between 10 – 85 % R. H.
Meter: -20 °C~50 °C (-4 °F~122 °F), below 90 % R. H. Strip: 4 °C~40 °C (39
°F~104 °F), between 10~85% R. H. 500 test results with time and date 7, 14,
28, 60, and 90 days 1 CR2032 lithium battery Approximately 1000 tests In 3
minutes 98 x 54 x 16.4 mm approximately 49 g (including battery)
10.System Troubleshooting
Special messages and error messages help to identify certain problems but do
not appear in all cases when a problem has occurred. Improper use may cause an
inaccurate result without producing an error message. In the event of a
problem, refer to the information under «Actions» in the «Error Messages»
section. If you continue to have a problem, please refer to the
«Troubleshooting Guide» section. If you follow the actions recommended but the
problem is not resolved, please contact your local distributor for assistance.
Message What it means
«Lo» appears when your result is below the measurement limit, which is less
than 20 mg/ dL (1.1 mmol/L). «Lo» indicates hypoglycemia (low blood glucose).
You should immediately consult your healthcare professional.
«HI» appears when your result is above the measurement limit, which is higher
than 600 mg/dL (33.3 mmol/L). You should immediately consult your healthcare
professional.
Error Message
Description
What it means: Appears when the batteries cannot provide enough power for a
test. Action: Replace the battery immediately. What it means: Appears when
inserting a used test strip. Action: Test with a new test strip. If the
problem persists, please contact your local distributor. What it means:
Appears when the temperature is out of the system operating range (10 °C~40 °C
(50 °F~104 °F)). Action: Repeat the test after the meter and test strip are
within the operating temperature range.
Only the most common error messages are listed. If your meter displays an error message that is not listed, please contact your local distributor.
Troubleshooting Guide The meter does not display a message after inserting a test strip
Probable Cause
Actions
Battery exhausted
Replace the battery.
Battery incorrectly installed or Check that the battery is correctly installed. absent
Test strip inserted upside down Insert the test strip correctly with the bar end entering into the test strip
or incompletely
slot first.
Defective meter
Please contact your local distributor for assistance.
The test does not start after applying the sample
Probable Cause
Actions
Insufficient blood sample
Repeat the test using a new test strip with a larger blood sample.
Defective test strip
Repeat the test with a new test strip.
Sample applied after automatic Repeat the test with a new test strip. Apply sample only when the «»
shut-off
symbol appears on the display.
(3 minutes after user action)
Defective meter
Please contact your local distributor for assistance.
The control solution test is out of range
Probable Cause
Actions
Error in performing the test Read the instructions thoroughly and repeat the test again.
Control solution bottle not shaken well
Shake the control solution bottle vigorously and repeat the test again.
Expired or contaminated control Check the expiration date and the discard date of the control solution. solution
Control solution that is too warm Control solution should come to room temperature
or too cold
(between 4 °C (39 °F) and 30 °C (86 °F)) before testing.
Test strip deterioration
Please repeat the test with a new test strip.
Meter malfunction
Please contact your local distributor for assistance.
11.Performance Characteristics
Precision Standard deviation (SD) for each glucose concentration < 100 mg/dL (5.55 mmol/L) and coefficient of variation (CV) for each glucose concentration 100 mg/dL (5.55 mmol/L) is 5.0 mg/dL (0.278 mmol/L) and 5.0%, respectively.
Intermediate precision
Control Solution Level Low 30-50 mg/dL (1.6~2.7 mmol/L)
mg/dL
mmol/L
Pooled Mean
44.6
2.48
SD
3.0
CV (%)
6.7%
Normal 96~144 mg/dL (5.3~8.0mmol/L)
mg/dL
mmol/L
100.0
5.55
2.9
2.9%
High 280~420 mg/dL (15.5~23.3mmol/L)
mg/dL
mmol/L
351.8
19.52
8.1
2.3%
Repeatability
Blood Glucose mg/dL
Pooled Mean SD CV (%)
30-50 mg/dL (1.6~2.7mmol/L) mg/dL mmol/L 44.7 2.48
3.2 7.1%
51-110 mg/dL (2.8-6.1 mmol/L) mg/dL mmol/L 101.1 5.61
3.2 3.2%
111-150 mg/dL (6.1-8.3 mmol/L) mg/dL mmol/L 132 7.33
3.8 2.9%
151-250 mg/dL (8.3-13.8 mmol/L) mg/dL mmol/L 221.4 12.29
6.8 3.1%
251-400 mg/dL (13.8-22.2 mmol/L) mg/dL mmol/L 349.1 19.38
9.8 2.8%
System Accuracy
For glucose concentration <100 mg/dL (5.55 mmol/L)
Within±5 mg/dL (Within±0.28mmol/L) Within±10 mg/dL (Within±0.56mmol/L) Within±15 mg/dL (Within±0.83mmol/L)
105/180 (58.3%)
164/180 (91.1%)
180/180 (100%)
Within±5% 262/420 (62.4%)
For glucose concentration 100 mg/dL (5.55 mmol/L)
Within±10%
Within±15%
391/420 (93.1%)
417/420 (99.3%)
Within±20% 420/420 (100%)
For glucose concentrations between 45.1 mg/dL (2.50 mmol/L) and 479 mg/dL (26.58 mmol/L) Within ±15 mg/dL (0.83 mmol/L) or ±15% 597/600 (99.5%)
The Microlife GlucoTeq Blood Glucose Monitoring System meets the requirements for System Accuracy as stated in ISO 15197:2013.
User Performance A study evaluating glucose values from fingertip, palm, forearm, upper arm, calf, and thigh capillary blood samples obtained by 100 lay persons showed the following results: 100% within ± 15 mg/dL (± 0.83 mmol/L) of the medical laboratory values at glucose concentrations below 100 mg/dL (5.55 mmol/L), and 95% within ±15% of the medical laboratory values at glucose concentrations at or above 100 mg/dL (5.55 mmol/L).
12.Guarantee
This device is covered by a 5 year guarantee from the date of purchase. During
this guarantee period, at our discretion, Microlife will repair or replace the
defective product free of charge. The above warranty will be valid when
following conditions are completed: The complete device is returned to
authorized after-sale center. The original purchase invoice is returned with
the returned device.
The following shall be excluded from or not covered by the warranty:
1.Accessories (lancing device, pouch) and consumables (batteries, test strips,
lancets). 2.Parts that are subjected to wear and tear, including without
limitation to LCD screen, flip cover, etc). 3.Packaging materials and wearing
parts. 4.Regular check and maintenance (calibration). 5.Damage caused by
incorrect application or non-compliance with the instructions for use
(including but not limited to improper storage). 6.Damage caused by accident
or negligence (including but not limited to battery leakage). 7.Damage cause
by force majeure. 8.The device has been unauthorized modified, altered or
disassembled. 9.The serial number on meter is removed/ made illegible or
tampered.
EXCEPT AS THE ABOVE LIMITED WARRANTY, NO OTHER WARRANTIES, EXPRESS OR IMPLIED,
ARE MADE. THE INDEMNITY OR COMPENSATION ARISING OUT OF OR IN CONNECTION WITH
THE WARRANTY SHALL BE ONLY LIMITED TO THE VALUE OF THE DEVICE.
These terms shall be without prejudice to the rights of the consumer in
accordance with applicable national law.
NOTE: Should guarantee service be required, please contact the dealer from
where the product was purchased, or your local Microlife service. You may
contact your local Microlife service through our website:
www.microlife.com/support
Repair or replacement will not prolong or renew the original warranty period
of the device.