HMM SmartLAB User Manual

User Manual

HMM Diagnostics GmbH
Friedrichstraße 89
D-69221 Dossenheim, Germany
www.hmm.info

Self-Monitoring Blood Glucose System with wireless data transfer

Please read this manual thoroughly before first
using this device

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Contents

I. Introduction 43

Measuring principle 44
Intended use 44
Important information 45
Note on smartLAB®nG „NO CODE“ test strips 47

II. Your smartLAB®global W nG 48

Display & functions 48
Specifications 48
The smartLAB®nG test strips 49
Explanation of symbols 50
Set content 50

III. Setup & Operating procedures 51

Installing batteries 51
Function check 52
Wireless Data transfer 53
Notes on using smartLAB®nG blood glucose test strips 55
Running a blood glucose test 56
Alternate Site Testing (AST) with the transparent cap 59
Understanding your test results 60

Optional: Control Solution Testing 63

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IV. Miscellaneous 67

Maintenance 67
Troubleshooting 68
Limitations of the measurement procedure 72
Regularity and Safety Notice 74
Warranty 75

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I. Introduction

Thank you for using the smartLAB®global W nG 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®global W nG glucose system 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-by-step direction to use meter correctly. Although your
smartLAB®global W 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.

The smartLAB®global W nG System is an ANT+ and Bluetooth® Smart
device. It supports the ANT+ device profile (V. 2.1) and is kompatible
with receiving devices (such as PC and Smartphones) that support
the ANT+ weight scale device profile. With the integrated Bluetooth®
Smart the smartLAB®global W nG System can also sent data via BLE
to a corresponding receiver. You can then transmitt your values
wireless to these receiving devices.

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Measuring principle

The smartLAB®global W nG 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 FAD-binding
glucose dehydrogenase.

Each test strip features an electrode containing FAD-binding glu­cose dehydrogenase. A capillary blood sample is applied to the col­lecting area of the strip, and is automatically drawn into the reac­tion 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 pro­portional to the amount of glucose present in the blood sample.
After 5 seconds, the smartLAB® global W nG will show glucose con­centration on the screen

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 value from capillary whole blood and venous
whole blood. It is used outside the body only (In-vitro diagnostic
use). The meter should be used only with smartLAB®nG blood glu­cose test strips.

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Important information

• The smartLAB® global W 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 outside the body). It should not
be used to diagnose diabetes.

• The smartLAB® global W nG blood glucose meter can only be used with
smartLAB®nG Blood Glucose Test Strips. Other test strips will give in-

accurate results.

• 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.

• 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. 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.

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• 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 transmitting a viral disease.

• Please dispose device according to the local rule of the disposition of
electronic device/ accessory waste.

• If the equipment is used in a manner not specified by the manufactu­rer, the protection provided by the equipment may be 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

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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 nonketotic 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 professional.

• Please read your test strip instructions carefully for additional health­related 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.

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II. Your smartLAB®global W nG

Display & functions

M e as ur in g
result

M e as ur in g
unit

Apply
blood or con­trol solution to
the test strip

Battery power

Thermometer
Wireless

Specifications

1. Type: smartLAB®global W nG

2. Measuring range: 20~630 mg/dL

(1.1~35.0 mmol/L)

3. Measuring duration: 5 seconds

4. Time mode: AM/PM - 24 hours

5. Memory: 480 values

6. Operating temperature: 10°C~40°C

(50°F~104°F)

7. Storage Temperature: -20°C ~50°C

(-4°F~122°F)

8. Relative humidity: RH ≤90%

9. Blood sample: ≥ 0,6 µL capillary

whole blood

10. Calibration: Plasma equivalent

11. Hematocrit (Hct): 30-55%

12. Battery type: 2 CR 3V Lithium

batteries

13. Battery life: approx. 500 measure­ments

14. Display-size: 30 x 30 mm

15. Meter dimensions: 80 x 50 x 5 mm

16. Weight: 30g (without batteries)

17. Data transfer: wireless through
integrated ANT and BLE module

18. Transportation temperature: -20°C
~50°C (-4°F~122°F)

19. Transportation humidity: RH ≤90%

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The smartLAB®nG 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

+

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 first

Catalogue number

Serial number

Control solution

Opening date of test strip vial

Set contents

1 smartLAB®global W nG blood glucose meter
1 User manual
1 hard box
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
1 smartLAB®nG blood glucose test strip instruction