Microlife GlucoTeq Instruction Manual

GlucoTeq
Blood Glucose Monitoring System
Instruction Manual
Model No: BGM 200

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 disabil-
ities.
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 electromag-
netic 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 thera-
peutic 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 Concentrations higher than the following values may cause
inaccurate results
Acetaminophen 8.0 mg/dL (0.53 mmol/L)
Ascorbic Acid 5.0 mg/dL (0.28 mmol/L)
Aspirin 60 mg/dL (3.33 mmol/L)
Bilirubin 90 mg/dL (1.54 mmol/L)
Cholesterol 500 mg/dL (12.9 mmol/L)
Creatinine 5.0 mg/dL (0.44 mmol/L)
Dopamine 2.0 mg/dL (0.11 mmol/L)
EDTA 360 mg/dL (12.3 mmol/L)
Galactose 900 mg/dL (50 mmol/L)
Gentisic Acid 5.0 mg/dL (0.32 mmol/L)
Glutathione 53 mg/dL (1.72 mmol/L)
Haemoglobin 500 mg/dL (0.08 mmol/L)
Heparin 8,000 U/dL
Hydroxyurea 3.0 mg/dL (0.39 mmol/L)
Ibuprofen 50 mg/dL (2.42 mmol/L)
Icodextrin 13 mg/dL (0.01 mmol/L)
L-dopa 10 mg/dL (0.51 mmol/L)
Maltose 900 mg/dL (26.3 mmol/L)
Methyldopa 3.0 mg/dL (0.13 mmol/L)
Pralidoxime Iodide 25 mg/dL (0.94 mmol/L)
Salicylate 60 mg/dL (4.34 mmol/L)
Tolazamide 100 mg/dL (3.21 mmol/L)
Tolbutamide 400 mg/dL (14.8 mmol/L)
Triglycerides 2,000 mg/dL (22.6 mmol/L)
Uric Acid 8.0 mg/dL (0.48 mmol/L)
Xylose 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.
To track the position of test strip slot without strip
inserting, press main button
and the slot LED light will be flashing.
2 LCD Display
Guides you through the test using symbols and
simple messages.
3 Main Button
Turns the meter on or performs other functions
described in this user guide.
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.
GlucoTeq - BGM 200
IB BGM 200 EN 2620 - Revision Date: 2020-07-02
Explanation of Symbols
For In vitro diagnostic use
Please consult instructions for use
Do not reuse
Lot number
LOT
Keep dry
Humidity limitation
0123
Do not use if package is damaged
Distributor
Microlife AG
Espenstrasse 139
9443 Widnau
Switzerland
www.microlife.com
8 Contact Bars
Insert this end of the test strip into the meter. Push
it in firmly until it will not go any further.
9 Test Strip Handle
Hold this part to insert the test strip into the test strip
slot on the meter.
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 auto-
matically.
Test Result Area
AL
Displays test results.
Appears when test result is
AM
lower than 70 mg/dL (3.9
mmol/L) or higher than 180
mg/dL (10 mmol/L).
Appears when test result is
within the range of 70 to 120
mg/dL (3.9 mmol/L to 6.7
mmol/L).
Ketone Symbol
AN
Appears when test result is
higher than 240 mg/dL (13.32
mmol/L).
Alarm Symbol
AO
Appears when you are
setting alarms.
Test Strip Symbol
AP
Appears when the meter is in
testing mode.
Blood Drop Symbol
AQ
Flashes when sample should
be applied.
Low Battery Symbol
AR
Appears when the battery
power is low.
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.
vcc
GND
vcc
GND

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.
vcc
GND
5
1
2
vcc 6
GND
3 3
4
7
Temperature limitation
Use by / Expiry date
Manufacturer
Caution, consult accompanying document
Keep away from sunlight
EU representative
This product fulfils the requirements of Directive 98/79/EC in vitro diagnostic
medical device.
Serial number
Wholecare Medical Device Safety Service GmbH
Biomedical Corporation (MDSS GmbH)
8F, 443, RuiGang Road, NeiHu Schiffgraben 41
Taipei, 11492, Taiwan 30175 Hannover / Germany
9
8
Unit of Measure
AS
BP BO
Indicates what unit of measure
the test result is displayed in.
BN Temperature Symbol
BT
BM
Appears when temperature is
BL
outside of operating range.
AL
BK
BT
Control Solution Test
BK
AM
AS
Symbol
AN AR
Shows that you are in control
AO AP AQ
solution mode.
Memory Symbol
BL
Appears when you review the
memory.
After Meal
BM
Indicates that your test is an
After Meal test.
Before Meal
BN
Indicates that your test is a
Before Meal test.
Date
BO
Time
BP
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. battery properly with the positive
vcc
GND
(+) side up.
STEP 2: Remove the old battery STEP 4: Close the battery cover.
by pressing on the buckle beside If the meter does not power on
the battery and gently pulling it at and enter setting mode after you
the same time. have replaced the battery, check
that the battery is correctly
installed.
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
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.
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
0123

3. Prepare for blood sampling

AT

AK 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
convenient and user friendly.
2 Big window to show the penetration depth with
numeric display which is easy for the user to
read.
3 Big release button, comfortable and easy to
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
7 Release button
8 Plunger
9 Hub
AT Clear cap (optional)
AK Disposable lancet (optional)
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. Hold the depth adjustable
1
cap in one hand and hold
hub in the other hand, twist
off the depth adjustable
cap.
2. Insert a new disposable
2
lancet firmly into the lancet
holder.
3. Twist off and set aside
3 4
the protective cover of the
disposable lancet.
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.
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
AM
PM
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 Alter-
native 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 μL 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 absor-
bent 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 regula-
tions. Replace the Lancing Device Cap.
1 2
3
4
5
6 7 8
9
AT
AK
5. Select a depth of pene-
5
tration by rotating the top
portion of the depth adjust-
able 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
6
and push on the plunger in
the other hand. The device
will be cocked.
Release the plunger; it will
go back to its original posi-
tion near the hub.
The Lancing device is made by
MEDIFUN CORPORATION
No.8, Shuyi Rd., South Dist., Taichung
City, 40241, Taiwan (R.O.C.)