Smart Lab mini nG User manual

31
ENGLISH
User Manual
Self-Monitoring Blood Glucose Meter
Please read this manual thoroughly befo-
re rst using this device
HMM Diagnostics GmbH
Friedrichstraße 89, D-69221
Dossenheim, Germany
www.hmm.info

32

33
ENGLISH
Contents
I. Introduction 35
Measuring principle 36
Intended use 36
Important information 37
Note on smartLAB®nG „NO CODE“-test strips 39
II. Your smartLAB®mini nG 40
Display & functions 40
Specifications 40
The smartLAB®nG test strips 41
Explanation of symbols 42
Set Contents 42
III. Setup & Operating procedures 43
Installing batteries 43
Function check 44
Notes on using smartLAB®nG blood glucose test strips 45
Running a blood glucose test 46
Alternate Site Testing (AST) with the transparent cap 48
Reading stored test results from memory 49
Understanding your test results 49
IV. Miscellaneous 52
Maintenance 52
Troubleshooting 53
Limitations of the measurement procedure 56
Regularity and Safety Notice 59
Warranty 59

34

35
ENGLISH
I. Introduction
Thank you for using the smartLAB®mini nG Self-Monitoring Blood
Glucose System (SMBG). This system was designed to be depend-
able, easy-to-use, compact, lightweight and portable to help you
monitor your blood glucose on a regular basis.
Please read this manual thoroughly before you begin testing. It pro-
vides you and your diabetes care team with important information
and step-by-step direction to use meter correctly. Although your
smartLAB®mini nG 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.

36
Measuring principle
The smartLAB®mini nG Self-Monitoring Blood Glucose System is de-
signed to allow rapid measurement of blood glucose by using an
electrochemical biosensor technology. This system employs a dis-
posable dry reagent strip technology, based on the FAD-binding
glucose dehydrogenase.
Each test strip features an electrode containing FAD-binding glu-
cose dehydrogenase. A capillary blood sample is applied to the col-
lecting area of the strip, and is automatically drawn into the reac-
tion zone, where the FAD-binding glucose dehydrogenase catalyzes
the glucose dehydrogenation. It will produce gluconolactone.
During the reaction, a mediator transfers electrons to the electrode
surface and generates a current. The amount of the current is pro-
portional to the amount of glucose present in the blood sample.
After 5 seconds, the smartLAB®mini nG will show glucose concen-
tration on the screen.
Intended use
The smartLAB®mini nG is intended for the quantitative measure-
ment of glucose in venous whole blood or fresh capillary whole
blood from fingertips, palm and forearm. Testing is done outside
the body (In Vitro diagnostic use). It is indicated for self-testing
(over the counter [OTC]) by persons with diabetes, or in clinical
settings by healthcare professionals, as an aid to monitor the ef-
fectiveness of diabetes control. The meter should be used only with
smartLAB®nG blood glucose test strips.

37
ENGLISH
Important information
• The smartLAB®mini nG blood glucose meter is designed and
approved for testing venous whole blood or fresh capillary
whole blood samples from your fingertips, palm and forearm.
The meter is for in vitro diagnostic use ONLY (for testing out-
side the body). It should not be used to diagnose diabetes.
• The smartLAB®mini nG blood glucose meter can only be used
with smartLAB®nG Blood Glucose Test Strips. Other test strips
will give inaccurate results.
• Severe impact may cause the meter to malfunction. Do not di-
sassemble the meter as it may damage components inside and
cause an incorrect reading. The warranty will be void if the
meter has been disassembled.
• Testing is not valid for neonatal blood specimens.
• 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. Pro-
tect 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

38
a refrigerator. And the meter, strips and lancing device should
be kept away from children or pets.
• 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.
• 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.
• You should not test critically ill patients with home-use blood
glucose meters.
• 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 trans-
mitting a viral disease.
• Please dispose device according to the local rule of the dispo-
sition of electronic device /accessory waste.
• If the equipment is used in a manner not specified by the ma-
nufacturer, the protection provided by the equipment may be

39
ENGLISH
impaired.
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
Consult with your healthcare professional before testing
on your palm or forearm.
Altitude up to 3,048 meters above sea level has no effect
on readings.
Health-Related Information
• If you are experiencing dehydration, frequent urination, low
blood pressure, shock or hyperosmolar hyperglycemic nonke-
totic coma (HHNKC), you may get a test result that is lower
than what your blood glucose really is. If you think you are
dehydrated, call your healthcare professional right away.
• If you have followed the steps in the user’s manual, but still
have symptoms that do not seem to match your test results, or
if you have questions, please contact your healthcare profes-
sional.
• Please read your test strip instructions carefully for additional
health-related information
Note on smartLAB®nG „NO CODE“-test strips
The smartLAB®nG blood glucose test strips compatible with
smartLAB®nG glucose systems need not to be coded, any more.

40
II. Your smartLAB®mini nG
Display & functions
Test result
Measuring
unit
Battery power
Thermometer
Error code
Code number
Apply
blood to the
test strip
Specications
1. Type: smartLAB®mini nG
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. Storage Temperature: -20°C ~50°C
(-4°F~122°F)
8. Blood sample: ≥ 0,6 µL capillary or
venous whole blood
9. Calibration: Plasma equivalent
10. Hematocrit (Hct): 30-55%
11. Battery type: 2 CR 3V Lithium bat-
teries
12. Battery life: over 3000
measurements
13. Display-size: 30 x 30 mm
14. Meter dimensions: 80 x 50 x 5 mm
15. Weight: 20g (without batteries)
16. Transportation temperature: -20°C
~50°C (-4°F~122°F)
17. Transportation humidity: RH ≤90%

41
ENGLISH
The smartLAB®nG test strips
Note: You can nd the test strip expi-
ration date on the vial label next to the
symbol.
Expiration date
Vial opening date (ple-
ase note)
Electrode
Insert direction
Grip zone
Reaction zone
Aperture Application zone

42
Explanation of symbols
+
Caution
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 rst
Catalogue number
Serial number
Opening date of test strip vial
Set contents
1 smartLAB®mini nG blood glucose meter
1 User manual
1 Wallet for safe transportation
2 CR 2032 3V batteries
1 smartLAB® lancing device
1 smartLAB® Check Strip
1 smartLAB® Quick Start instruction
10 smartLAB® lancets
10 smartLAB®nG blood glucose test strips

43
ENGLISH
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 accept-
able, yet the capacity of test times may
differ. Install the batteries when you rst use the meter by remv-
ing the battery protection or replace with new batteries when the
“LP” message and the low battery symbol appear on the LCD dis-
play. Open the battery lid on the back side of the smartLAB®mini
nG 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. The display will light up for
one second. Afterwards the device will turn off automatically.
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

44
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®nG 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.

45
ENGLISH
Notes on using smartLAB®nG blood glucose test strips
• Use only with smartLAB®nG Blood Glucose Meters.
• Run a control solution test every time you open a new box of
test strips
• Keep the test strips in their original bottle.
• After you take a test strip out of the bottle, tightly close the
bottle immediately. This keeps the test strips dry.
• Use the test strip within three minutes after taking it out of
the bottle.
• The strip is for single use only. Do not reuse it.
• Record the date you open the test strip bottle. Be sure to check
the expiration date on the test strip bottle. The test strip is
good for 6 months from the date the bottle is opened or until
the expiration date on the bottle, whichever comes first.
• Store the test strip bottle and your meter in a cool dry place.
• Store the test strips between 2°C ~30°C (36°F - 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.

46
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 ma-
terials ready for use: your smartLAB®mini
nG meter, the smartLAB®nG test strips
and the smartLAB®lancing device includ-
ing 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.
3. Collecting a blood sample
When the blood drop ashes on the display, gently massage the
part of your nger tip which you obtain a drop of blood from us-
ing the lancing device. Place the lancing device against the pad
of your nger. Press the trigger button to activate the lancing
device.

47
ENGLISH
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 nished 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.

48
Alternate Site Testing (AST) with the transparent cap
You can also gain the blood
sample from other parts of the
body than the nger tip. If
you want to use Alternate Site
Testing, please use the trans-
parent 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 circula-
tion.
• 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 trans-
parent cap, that enough blood is gained. After that you can carry
out the blood glucose test, as usual.
Alternate Blood Collection Sites

49
ENGLISH
Reading stored test results from memory
You can read the last 20 test results on the internal memory of
your smartLAB®mini nG meter by inserting the check strip. The
results will be shown chronologically on the display.
Understanding your test results
The smartLAB®nG blood glucose test strips are plasma referenced
and 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.
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).
Expected results for diabetic adults:
The normal fasting blood glucose range for an adult with diabetes is
70-130 mg/dL (3.9~7.2 mmol/L)*. Two hours after meals, the blood
glucose range for an adult with diabetes is less than 180 mg/dL
(10.0 mmol/L). For further queries about diabetes: please consult
your healthcare professional for the blood glucose range
appropriate for you.
Unusual test results:
If your blood glucose result doesn‘t match the way you feel, follow

50
these steps, and then repeat the test:
1. Check if the strips are within the expiration date.
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. Repeat the Measurement:
If the values of the repeated measurements are however questiona-
ble and do not match the way you feel, please contact your health
care professional before you change your medication.
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) below 30% may cause higher
results. Hematocrit above 55% may cause lower 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. A high blood glucose would be greater than 240 mg/dL
(13.33 mmol/L). A low blood glucose would be below 60 mg/dL
(3.33 mmol/L). Here are the most common symptoms:
High blood glucose (hyperglycemia): fatigue, increased appetite or
thirst, frequent urination, blurred vision, headache, general ach-
ing, or vomiting.