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User Manual
D10421-08-01-02_R1_24/02/2011
HMM Diagnostics GmbH
D-69221 Dossenheim, Germany
www.hmm.info
Self-Monitoring Blood Glucose Meter
Please read this manual thoroughly before
first using this device
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Contents
I. Introduction
Measuring principle 6
Intended use 6
Important information 7
II. Ihr smartLAB®mini
Display & functions 9
Specifications 9
The smartLAB®pro test strips 10
Explanation of symbols 11
III. Setup & Operating procedures
Installing batteries 13
Function check 14
Notes on using smartLAB®pro blood glucose test strips 15
Note on smartLAB
®
„NO CODE“-test strips 16
Running a blood glucose test 17
Alternate Site Testing (AST) with the transparent cap 19
Reading stored test results from memory 20
Understanding your test results 20
Control solution testing 23
IV. Miscellaneous
Maintenance 27
Troubleshooting 28
Limitations of the measurement procedure 31
Warranty 33
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I. Introduction
Thank you for using the smartLAB®mini Self-Monitoring Blood Glucose System. This system was produced in close association with diabetes health care professionals, hospitals and, most importantly,
people with diabetes. The measuring results can help you determine
the effects of food, exercise and diabetes medications.
Your smartLAB®mini glucose meter was designed to be dependable,
easy-to use, compact, lightweight and portable to assist you in
monitoring your blood glucose on a regular basis. Please read this
manual thoroughly before you begin testing. It provides you and
your diabetes care team with important information and step-bystep direction to use meter correctly. Although your smartLAB®mini
system is easy to use, you should consult your healthcare professional (this may be your doctor, diabetes nurse educator or pharmacist) for instructions on how to use the system. The only way to
obtain accurate results from any system is to make sure you correctly use it. If you have any concerns, please call your authorized
distributor in your country during business hours.
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Measuring principle
The smartLAB®mini Self-Monitoring Blood Glucose System is designed to allow rapid measurement of blood glucose by using an
electrochemical biosensor technology. This system employs a disposable dry reagent strip technology, based on the glucose oxidase
method for glucose determination.
Each test strip features an electrode containing the glucose oxidase
from aspergillus niger. A capillary blood sample is applied to the
collecting area of the strip, and is automatically drawn into the
reaction zone, where the glucose oxidase catalyzes the oxidation of
glucose to produce glyconic acid. During the reaction, a mediator
transfers electrons to the electrode surface and generates a current. The amount of the current is proportional to the amount of
glucose present in the blood sample. The glucose concentration
is measured by your smartLAB®mini meter and displayed on the
screen after 5 seconds.
Intended use
This blood glucose meter is a self-test IVD medical equipment and
intended for both home testing and for professional use to monitor
the blood glucose (B-D-glucose) value from capillary whole blood.
It is used outside the body only (In-vitro diagnostic use). The meter
should be used only smartLAB®pro blood glucose test strips. Testing
is not valid on neonatal blood specimen.
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Important information
• Severe impact may cause the meter to malfunction. Do not disassemble the meter as it may damage components inside and cause
an incorrect reading. The warranty will be void if the meter has been
disassembled.
• Incorrect results may occur when performing the test. If you believe you are not feeling well, please contact your healthcare professional immediately.
• Always keep the meter clean and store it in a safe place. Protect
from direct sunlight to ensure a longer lifespan.
• The strip slot should be kept free from dirt, dust, blood stains,
and water stains.
• Do not store the meter and test strips in a car, a bathroom or
a refrigerator. And the meter, strips and lancing device should be
kept away from children or pets.
• Please refer to the limitations of the procedure before testing.
• Remove batteries if the meter will not be used for one month or
more.
• Store the kits in a dry place with temperature range is 2 to 30°C
(35.6 to 86 °F). Keep away from direct sunlight and heat.
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• Store your test strips in their original vial only. Do not transfer
them to a new vial or any other container.
• Indicate the date you open the vial.
Discard all unused strips
immediately after 90 days from open date. The strips are for single
use only.
• Warning for potential biohazard: Healthcare professionals using
this system on multiple patients should be aware that all products
or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting viral disease.
Do not touch the test strip with wet hands
Do not use expired test strips
(see expiration date on the strip vial)
Do not bend, cut or twist the strip
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II. Ihr smartLAB®mini
Display & functions
Test result
M ea s u r i n g
unit
Battery power
Thermometer
Error code
Code number
Apply
blood or control solution to
the test strip
Specifications
1. Type: smartLAB®mini
2. Measuring range: 20~630 mg/dL
(1.1~35.0 mmol/L)
3. Measuring duration: 5 seconds
4. Memory: 20 values
5. Operating temperature: 10°C~40°C
(50°F~104°F)
6. Relative humidity: RH ≤90%
7. Blood sample: ≥ 0,6 µL capillary
whole blood
8. Calibration: Plasma equivalent
9. Hematocrit (Hct): 30-55%
10. Battery type: 2 CR 3V Lithium bat-
teries
11. Battery life: over 3000 measurements
12. Display-size: 30 x 30 mm
13. Meter dimensions: 80 x 50 x 5 mm
14. Weight: 22g (without batteries)
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The smartLAB®pro test strips
Note: You can find the test strip expira-
tion date on the vial label next to the
symbol.
Expiration date
Vial opening date (please
note)
Electrode
Insert direction
Grip zone
Reaction zone
Aperture
Application zone
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Explanation of symbols
+
Please refer to the manual
This product meets the requirements of Directive
98/79/CE for in vitro diagnostic medical devices.
Lot number
Expiration date
For in vitro diagnostic use only
Use Lithium battery CR 2032 3V
Single use only
Storage temperature
Manufacturer
Before use, read manual first
Catalogue number
Serial number
Control solution
Opening date of test strip vial
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Set contents
1 smartLAB®mini blood glucose meter
1 User manual
1 smartLAB® plastic box
2 CR 2032 3V batteries
1 smartLAB® lancing device
1 smartLAB® Check Strip
1 smartLAB® Quick Start instruction
10 smartLAB® lancets
10 smartLAB®pro blood glucose test strips
Optional:
1 smartLAB® control solution
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III. Setup & Operating procedures
Installing batteries
The meter uses two CR 2032 3V Lithium
batteries. Batteries will normally last for
aprox. 3000 tests. Other types of CR 3V
lithium batteries are also acceptable, yet
the capacity of test times may differ. Install the batteries when you first use the meter or replace with new
batteries when the “LP” message and the low battery symbol appear
on the LCD display. Open the battery lid on the back side of the
smartLAB®mini meter and insert batteries with plus sign to top.
First insert the battery on the right side and then press the left side
down until it clicks. Close the battery lid.
Note:
1. Remove the batteries when you will not be using the meter for
one month or longer.
2. Values won’t be deleted when the batteries are replaced.
Meter, batteries, lancets, test strips etc. must be disposed of
according to local regulations at the end of their usage.
Low battery symbol
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Function check
You can carry out a function check with the Check Strip which is
included in your meter set. You do not have to do the function
check before every measurement. It helps you to control if your
smartLAB® meter works properly, from time to time, though.
1. Insert check strip into the meter:
Make sure your check strip is inserted with writing to top. The meter
will turn on automatically and the display will show „CHK“.
2. Check message in LCD display:
The function check will take approx. 3 seconds. The check can produce the following messages on the display:
• „OK” - your meter works properly
• „FAL“- change batteries and check again. If the message still appears, please refer to your local supplier.
3. Remove check strip:
The meter will turn off automatically after removing the test strip.
Please keep the check strip in the soft case of the meter.
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Notes on using smartLAB®pro blood glucose test strips
• Use only with smartLAB® blood glucose self-monitoring systems.
• Keep the test strips in their original vial.
• Close the vial tightly right after you take out a test strip. This
keeps the test strips dry.
• Use the test strip within three minutes after you have taken it
out of the vial.
• The strip is for single use only. Do not reuse it.
• Record the date you first open the test strip vial. Be sure to check
the “Expiration Date” on the test strip vial. The test strip is
good for three months from the date the vial is opened or until
the “Expiration Date” on the vial, whichever comes first.
• Store the test strip vial and your meter in a cool dry place
• Store the test strips below 30°C (86°F). Do not freeze.
• Do not apply blood or control solution to the test strip before you
insert it into the meter.
• Do not touch the test strip with wet hands. Do not bend, cut, or
twist the test strips.
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Note on smartLAB
®
„NO CODE“-test strips
The smartLAB®pro blood glucose test strips compatible with
smartLAB® glucose meters need not to be coded, any more. Thus,
when inserting a test strip, the display will read „Code 888“. That
is because all test strip charges only use this code. This will make
it easier for you to use your smartLAB® product free from errors.
(Avoidance of coding errors)
If „Code 888“ DOES NOT appear while inserting a test strip, your
meter either needs to be recoded or your glucose meter is not compatible with these smartLAB
®
pro blood glucose test strips. In either
case, please contact your distributor.
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Running a blood glucose test
1. Preparations
Before running a blood glucose test, make
yourself acquaint with the test strips and
the lancing device. Keep all required materials ready for use: your smartLAB®mini
meter, the smartLAB®pro test strips and
the smartLAB® lancing device including lancets.
Wash your hands thoroughly with warm water before colleting the
blood sample. Rinse your hands thoroughly.
2. Switch on the meter
Take a strip out of the vial and immediately close it. Insert the strip
into the meter in the direction of the arrow on the strip. The meter
turns on automatically. „Code 888“ appears on the display and afterwards the symbol for applying blood.
In case „Code 888“, DOES NOT appear on the display,
please contact your supplier (see chapter „Note on
smartLAB® „NO CODE“ test strips“)
3. Collecting a blood sample
When the blood drop flashes on the display,
gently massage the part of your finger tip
which you obtain a drop of blood from using the lancing device. Place the lancing device against the pad of
your finger. Press the trigger button to activate the lancing device.
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4. Blood glucose measurement
Hold the application zone of the test strip vertically onto the blood
sample. The blood is automatically sucked in the reaction zone of
the test strip. Be sure to get enough blood on the strip’s reaction
zone, otherwise, an inaccurate reading may result. The signal tone
indicates that enough blood entered the reaction zone. The meter
will now start with the measurement which will last 5 seconds. The
LCD display shows the remaining time of measurement in seconds.
Afterwards the note „OK“ indicates a correct measurement. The
measurement is finished with another signal beep and the measured value is shown on the display.
5. Storing memories
The displayed result is automatically stored in the memory of the
meter. If more than 20 results are reached, the oldest one is deleted.
6. Discarding used test strips and lancets
Write down the measured result in your personal diabetic log book
and take the test strip off the strip slot. The meter turns off. If you
don’t take off the test strip, the meter will turn off automatically
after 5 minutes.
In order to discard lancets from the smartLAB® lancing device, remove the end cap and carefully pull the used lancet out of the holder. Dispose of the lancet of according to local regulations.
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Alternate Site Testing (AST) with the transparent cap
You can also gain the blood
sample from other parts of the
body than the finger tip. If you
want to use Alternate Site Testing, please use the transparent
cap for your lancing device. Carry out the following steps:
• Gently massage the desired
punctuation site on your arm or
hand for a few seconds. This will
improve the blood circulation.
• Push the lancing device with
the transparent cap against the desired blood collection site and
push the trigger button to gain a sample.
• Exercise a constant pressure until you see through the transparent cap, that enough blood is gained. After that you can carry out
the blood glucose test, as usual.
Alternate Blood Collection Sites
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Reading stored test results from memory
You can read the last 20 test results on the internal memory of your
smartLAB®mini meter by inserting the check strip. The results will
be shown chronologically on the display.
Understanding your test results
The smartLAB®pro blood glucose test strips are whole-blood referenced. Your meter is plasma-calibrated for easier comparison to
lab results. The unit of blood glucose test results displayed on the
screen is either mg/dL or mmol/L, depending on which unit of
measurement you have selected. The mmol/L results will always include a decimal point; mg/dL results do not include a decimal point.
If „LO“ appears on the display, the monitor has determined that
your blood glucose level is lower than 1.1 mmol/L or 20 mg/dL. If
„HI“ appears on the display, the monitor has determined that your
blood glucose level is higher than 35 mmol/L or 630 mg/dL. Please
refer to the User Manual for instructions on warning messages.
Expected results for non-diabetic adults:
The normal fasting glucose range is 70 to 100 mg/dL (3.9 to 6.1
mmol/L). Two hours after meals, normal glucose values should be
less than 120 mg/dL (6.7 mmol/L).
Unusual test results:
If your blood glucose result doesn‘t match the way you feel, follow
these steps, and then repeat the test:
1. Check if the strips are within the expiration date.
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2. Be sure that the drop of blood completely filled the reaction zone
of the test strip
3. Do a function control test with the smartLAB® check strip
4. Optional: Check meter and test strip performance with the
smartLAB® control solution. When test results are still questionable
or inconsistent, consult your healthcare professional before making
any changes to your diabetes medication program.
Note:
1. Extremely high humidity may affect the test results. A relative
humidity greater than 90% may cause inaccurate results.
2. A red blood cell count (Hematocrit) that is either very high (above
55%) or very low (below 30%) may not provide accurate results.
3. Some studies have shown that electromagnetic fields may affect
results. Do not test near an operating microwave oven.
Symptoms of high or low blood glucose:
Being aware of the symptoms of high or low blood glucose can help
you understand your test results and decide what to do if they seem
unusual. Here are the most common symptoms:
High blood glucose (hyperglycemia): fatigue, increased appetite or
thirst, frequent urination, blurred vision, headache, general aching, or vomiting.
Low blood glucose (hypoglycemia): sweating, trembling, blurred
vision, rapid heartbeat, tingling, or numbness around mouth or
fingertips.
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If you are experiencing any of these symptoms, test your blood glucose. If your blood glucose result is displayed as LO or HI and you
have symptoms of low or high blood glucose, contact your doctor
immediately. If your blood glucose result does not match how you
feel, follow the steps under „Unusual Test Results.“
Comparing your meter‘s result to a lab result:
In order to compare the results of your smartLAB®mini meter
with a laboratory meter, it must be guaranteed that both use
the same measuring method (whole blood measurement). Your
smartLAB®mini is a plasma calibrated meter. This makes it easier to
compare its results to lab devices.
Your blood glucose can change quickly, especially after eating, taking medication, or exercising. If you test yourself in the morning,
then go to the doctor‘s office for a blood glucose test, the results
will probably not match, even if you are fasting. This is typically not
a problem with your meter, it just means that time has elapsed and
your blood glucose has changed.
If you want to compare your meter result to the lab result, you must
be fasting. Take your meter to the doctor‘s office, and test yourself
by fingertip within five minutes of having blood drawn from your
arm by a healthcare professional. Keep in mind that the lab uses
different technology than the meter, and that blood glucose meters
for self testing generally read somewhat lower or higher than the
lab result.
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Control solution testing
Running a control test lets you know that your meter and test strips
are working properly to give reliable results. You should run a control test when:
• You use the smartLAB®mini blood glucose meter for the first time.
• You open a new vial of test strips.
• You think the meter or test strips might be working incorrectly.
• You drop the meter.
• You have repeated a test and the test results are still lower or
higher than expected.
• You are practicing the test procedure.
Note: Professional users are instructed to follow federal, state, and
local guidelines concerning QC practices.
About the smartLAB® control solution
• smartLAB® control solution is for in vitro diagnostic use only.
• smartLAB® control solution is not intended for human consumption or injection.
• use only with smartLAB®pro test strips.
• Shake the smartLAB® control solution well before each use.
• Write the date you first opened the bottle on the bottle label.
• The smartLAB® control solution is durable for three months from
the date the vial is opened or until the „Expiration Date“ on the
bottle, whichever comes first.
• Do not use smartLAB® control solution that is past the Expiration
Date
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• The smartLAB® control solution can stain clothing. If you spill
it, wash your clothes with soap and water.
• Close the bottle tightly after use.
• Left over control solution should not be added back into the
control bottle.
• Store the bottle of smartLAB® control solution at room
temperature, below 30°C (86°F). Do not freeze nor refrigerate.
Running a smartLAB® control solution test
Please make sure you have all necessary items at hand when running a control solution test. You need the smartLAB®mini meter, a
smartLAB®pro test strip, and smartLAB® control solution.
1. Switch on the meter
Take a strip out of the vial and immediately close it. Insert the strip
into the meter in the direction of the arrow on the strip. The meter
turns on automatically. „Code 888“ appears on the display and afterwards the symbol for applying blood.
In case „Code 888“, DOES NOT appear on the display,
please contact your supplier (see chapter „Note on
smartLAB® „NO CODE“ test strips“)
2. Running the control solution test
When the symbol for applying blood appears, shortly shake the bottle with the smartLAB® control solution. Open the bottle and wipe
the tip of the bottle with a tissue. Squeeze a little drop of control
solution on a clean, not adsorbing surface (plastic, glass, etc.) and
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close the bottle immediately. Hold the application/reaction zone of
the test strip vertically onto the drop of control solution. The control solution is automatically sucked in the reaction zone of the test
strip. The signal tone indicates that enough blood entered the reaction zone. The meter will now start with the measurement which
will last 5 seconds. The LCD display shows the remaining time of
measurement in seconds. Afterwards the note „OK“ indicates a correct measurement. The measurement is finished with another signal
beep and the measured value is shown on the display. Leave the
test strip in its slot.
3. Comparing the results / acceptable range
Compare the result with the acceptable range indicated on the test
strip vial.( )The acceptable range is indicated in both units
(mg/dL and mmol/L). Please pay attention on comparing the results with corresponding units.
4. Understanding control test results
The label on your test strip vial shows the acceptable ranges for the
smartLAB® control solutions. The result you get should be inside
this range. Make sure you compare the result to the correct level
of control. When the control result is inside the range on the test
strip vial, your test strips and your meter are working properly. If
your control result is not inside the acceptable range (printed on
your test strip vial), here are some things you can do to solve the
problem:
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Problem Solution
Was the test strip exposed to open air for
a long period of time?
Repeat the control test with properly
stored strips.
Was the test strip vial capped tightly? This will humidify strips inside.
Replace the test strips.
Does the meter work properly? You can use the check strip to verify
the meter’s functions.
Is the control solution expired or contaminated?
Replace with new control solution
to check the performance of your glucose meter.
Were test strips and control solution
stored in a cool and dry place?
Repeat the control test with properly
stored strips or control solutions.
Did you follow the testing steps properly?
Read Chapter “Control Solution
Testing” again and retest.
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IV. Miscellaneous
Maintenance
Your smartLAB®mini blood glucose meter does not require any special cleaning. Just keep the meter free of dirt, dust, blood- and
water stains. Following these guidelines carefully will help you getting the best performance possible: Gently wipe the meter‘s surface
with a soft cloth Do not get any moisture in the test strip slot.
To clean the lancing device, use a mild dishwashing liquid and a soft
cloth. DO NOT place the entire device under water.
Please make sure that no liquids enter the meter‘s
apertures.
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Troubleshooting
Note: If you are not sure how to react on error codes, please con-
tact your local supplier.
Battery empty
Display: „LP“ & „Battery symbol “
Solution: Replace with new batteries.
System error
Display: „001 Error “
Solution: Replace batteries first. If the error
still occurs, please contact your local supplier.
System error
Display: „FAL“
Solution: Re-insert the ceheck strip (with writ-
ing to top). If „FAL“ still occurs, please contact
your local supplier.
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Memory error
Display: „005 Error“
Solution: Replace batteries first. If “Err”still oc-
curs, please contact your local supplier.
Test strip already used or wet
Display: „Err“ & „Test strip symbol“
Solution: Use a new test strip.
Temperature too high
Display: „Ht“ & „Thermometer symbol“
The operating temperature is too high (above
the required temperature range from 10°C 40°C (50°F - 104°F)). The error is a warning
that a continuation under these conditions
might lead to wrong blood glucose readings.
Solution: Take the meter to a location with
appropriate working temperature and wait for
the next measurement until the error does not
occur again.
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Temperature too low
Display: „Lt“ & „Thermometer symbol“
The operating temperature is too low (below the
required temperature range from 10°C - 40°C
(50°F - 104°F)). The error is a warning that a
continuation under these conditions might lead
to wrong blood glucose readings.
Solution: Take the meter to a location with appropriate working temperature and wait for the
next measurement until the error does not occur again.
Test result is higher than 630 mg/dL (35.0
mmol/L)
Display: „HI“
Solution: Test again. If the result is still too
high, please contact your doctor immediately.
Test result is under 20 mg/dL (1.1 mmol/L)
Display: „LO“
Solution: Test again. If the result is still too
low, please contact your doctor immediately.
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Limitations of the measurement procedure
1. DO NOT use serum or plasma sample.
2. DO NOT use neonate blood sample.
3. Extreme humidity may affect the results. A relative humidity
greater than 90% may cause incorrect results.
4. The System is designed to be used at temperatures between 10°C
and 35°C (50°F and 95°F). Outside this range, the system may yield
erroneous results.
5. DO NOT reuse the test strips. The test strips are intended for
single use only.
6. DO NOT use iodoacetic acid, fluoride or sodium fluoride/oxalate
as a preservative for blood specimens.
7. Hematocrit:
Test strip results are not significantly affected by hematocrits in
range of 30% to 55%. Hematocrit levels less than 30% may
cause incorrect high readings and hematocrit levels greater than
55% may cause incorrect low readings. If you do not know your
hematocrit level, consult your healthcare professional.
8. Interfering substances depend on the concentration. The sub-
stances below may affect the test results:
• Acetaminophen > 15 mg/dL or 1.0 mmol/L
• Geneticist Acid > 8 mg/dL or 0.5 mmol/L
• Levodopa > 10 mg/dL or 0.5 mmol/L
• Dopamine > 13 mg/dL or 0.7 mmol/L
• Methyldopa > 2.5 mg/dL or 0.12 mmoll/L
• Uric Acid >14 mg/dL or 0.4 mmol/L
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9. Patients undergoing oxygen therapy may have inaccurate results.
10. Altitude up to 3050 meters above sea level has no effect on
readings.
11. Test results may be false if the patient is severely dehydrated or
severely hypertensive, in shock, or in hypoglycemic-hyperosmo-
lar state (with or without ketosis). Critically ill patients should
not be tested with home-use blood glucose meter.
12. Elevated cholesterol and triglyceride levels may interfere with
the way light is reflected producing erroneous meter results.
13. Recent studies have shown that EMI can cause electronic medi-
cal device performance degradation and could lead to inappropriate therapy.
14. Grossly lipemic (fatty) samples may interfere with some meth-
odologies. To be aware of such interferences, patients under the
supervision of their physician should have baseline glucose values established by a clinical laboratory method prior to starting home glucose monitoring. These baseline values should be
checked periodically thereafter.
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Warranty
HMM Diagnostics GmbH products need to fulfill high quality requirements.
Because of this reason, HMM Diagnostics GmbH gives a 2-year warranty by purchasing this smartLAB® product. You can even extend
the warranty from 2 to 5 years without extra pay when you register
your product. Please use the warranty card included in your product
set.
Wear parts, batteries etc. are excluded from warranty.
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HMM Diagnostics GmbH
Friedrichstr. 89
D-69221 Dossenheim, Germany
mail: [email protected]
www.hmm.info
Manufacturer:
Weitere Informationen zu den smartLAB® Produkten /
More information on our smartLAB® products:
www.smartlab.org
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