HMM Diagnostics smart LAB mini User Manual

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.

6

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