HNM Diagnostics smartLAB Sprint User Manual

User Manual
D10539-08-01-02_R2_24/02/2011
HMM Diagnostics GmbH D-69221 Dossenheim, Germany www.hmm.info
Self-Monitoring Blood Glucose System
Please read this manual thoroughly before first using this device
Content
I. Introduction
Measuring principle 6 Intended use 6 Important information 7 Note on smartLAB
®
„NO CODE“-test strips 9
II. Your smartLAB®sprint
Display & functions 10 Specifications 10 The smartLAB®pro test strips 12 Explanation of symbols 13
III. Setup & functions
Insert batteries 15 Turning the meter on/off 16 Function check 19 Control solution testing 20 Running a blood glucose test 24 Alternate Site Testing (AST) with the transparent cap 27 Understanding your test results 28 Displaying stored results 32 Displaying average values 33 Additional device settings 34
IV. Miscellaneous
Maintenance 38 Frequently Asked Questions 38 Troubleshooting 42 Limitations of the measurement procedure 45 Warranty 47
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I. Introduction
Thank you for using the smartLAB®sprint 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®sprint 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®sprint 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®sprint 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®sprint 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.
• You can download the test results from the meter memory to a computer for more in-depth analysis. (Requires according soft­ware and a Bluetooth interface)
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
9
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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II. Your smartLAB®sprint
Display & functions
test results
Code number
Measuring unit
Battery power
Thermometer
Test result transfer to computer
Error Code
Apply blood or control solution to the test strip
Specifications
1. Type: smartLAB®sprint
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: 450 values
6. Operating temperature: 10°C~40°C
(50°F~104°F)
7. Relative humidity: RH ≤90%
8. Blood sample: ≥ 0,6 µL capillary
whole blood
9. Calibration: Plasma equivalent
10. Hematocrit (Hct): 30-55%
11. Battery type: 2 1,5 V AAA Lithium
batteries
12. Battery life: over 1000 measure­ments
11. Display-size: 40 x 32 mm
12. Meter dimensions: 82 x 51 x 19 mm
13. Weight: 45,5 g (without batteries)
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RS-232 DOWNLOAD PORT
In combination with the required USB cable, you can download values to your PC with this port
S-Button (right side)
Turn on the meter or enter setting mode. In setting mode: memory but­ton
M-Button (left side)
Displays stored values. In setting mode: selection key
TEST STRIP INSERTION SLOT
Insert the test- or check strip here
12
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
13
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®sprint blood glucose meter 1 User manual 1 carrying bag 2 AAA 1,5V Alkali batteries 1 smartLAB® lancing device 1 smartLAB® Check Strip 1 smartLAB® Quick Start instruction 10 smartLAB® lancets 10 smartLAB®pro blood glucose test strips 1 smartLAB® control solution 1 smartLAB® warranty card
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III. Setup & functions
Insert batteries
The meter uses 2 1,5V AAA Alkali batteries. Batteries will normally last for aprox. 1000 tests. 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®sprint meter and insert the batteries, pay­ing attention to the polarity. 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.
To change batteries, open lid in arrow direction
Low battery display symbols
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