background image

GlucoMen

®

 LX  -  38973 - 09/07

UK

GlucoMen

®

 LX  -  38973 - 09/07

appendix

limitations

The GlucoMen

®

 LX Sensor test strips give accurate results when the following limitations are observed:

•  The test strips should not be used to diagnose diabetes or to test newborns.
•  Each test strip is for single use only. Do not reuse. Use a new sterile GlucoMen

®

 LX Sensor Test Strip each 

  time you test.
•  Your test strips are for personal use only. 

dO nOT

 share with others.

•  Use only fresh capillary whole blood. 

dO nOT US�e S�erUM Or plaS�Ma

.

•  There is no effect on blood glucose values for altitudes up to 3000 meters (10000 feet ) above sea level.
•  Refer to the User Manual for operating temperature range for the meter.
•  Extremes in humidity (higher than 90% and lower than 10%) may affect results.
•  The GlucoMen

®

 LX Sensor test strips are calibrated against plasma.

•  The anticoagulant sodium heparin may be used. EDTA is not recommended for use with GlucoMen

®

 LX 

  Sensor test strips.
•  Interferences from elevated levels of Acetaminophen, Tolazamide, Uric Acid, Bilirubin, Ephedrine, and 
  Methyldopa may affect results.
•  Test results may be falsely low if the patient is severely dehydrated.
•  Critically ill patients should not be tested with home blood glucose meters.

appendix

S�pecifications

Test Measured  

Blood Glucose

Glucose Methodology  

Glucose oxidase biosensor

Glucose Test Results  

mmol/L (Plasma values)

Sample type  

Fresh Capillary Whole Blood

Glucose Test range  

1.1 to 33.3 mmol/L

Length of Test  

4 seconds

Test Strip volumes  

0.3 μL

Battery Life (nominal)  

1000 Tests 

Low Battery Life  

About 20 Tests

Data Output Port  

Serial, USB 

Operating Ranges: Temperature 

5° to 45°C (41° to 113°F)

Operating Ranges: Humidity  

10% to 90% relative humidity

Weight  

75 g

Size  

96 x 51 x 20 mm

Meter data storage  

400 Results 

Chemistry Measurement 

Glucose test imprecision  

Refer to GlucoMen

®

 LX Sensor insert

Summary of Contents for GLUCOMEN LX

Page 1: ......

Page 2: ...orks Please read it carefully before us ing your new meter The GlucoMen LX blood glucose meter is designed to be conve nient and easy to use It gives accurate results in just 4 seconds using a very sm...

Page 3: ...American Diabetes Association ADA the US Food and Drug Administration FDA and the Advanced Medical Technology Association AdvMed Notes Cautions and Warnings NOTES Provide helpful operating informatio...

Page 4: ...itical to your care Since any meter may fail break or be misplaced you should always have a backup meter This product may become infectious in the course of use Discard the product in accordance with...

Page 5: ...tive 98 79 EC on in vitro diagnostic medical devices SN Serial number In Vitro Diagnostic Medical Device Direct Current Voltage In vitro device for self testing Catalogue number Blood glucose meter Bl...

Page 6: ...process provides a blood glucose result Test results are available in 4 seconds There is memory for one user s set of test results 400 The meter is powered by a battery that can perform approximately...

Page 7: ...0 non condensing INTRODUCTION Before Testing Before testing and to ensure accurate glucose results wash your hands and the testing site then thoroughly dry these areas The GlucoMen LX blood glucose me...

Page 8: ...frigerate or freeze Do not store near heat or moisture Store the test strips in their original vial only After removing a test strip from the vial immediately replace the vial cap and close tightly Do...

Page 9: ...ou have completed a blood glucose or control solution test the last result will appear the next time your meter is turned on The date and time displayed is the date and time of your previous blood sug...

Page 10: ...onsistent with how you feel To check the performance of the meter and test strips RUNNING CONTROL SOLUTION Important Information for Control Solution Use only the GlucoMen LX Control solution for the...

Page 11: ...solution vial Discard a drop before use Squeeze a drop of control solution onto a clean hard dry surface e g control cap 4 Pick up the meter with test strip inserted and touch the test strip to the co...

Page 12: ...range is ei ther higher or lower your meter or test strip may not be working properly Repeat the process using a new test strip Do not use the meter until test results fall within the appropriate rang...

Page 13: ...mol L the screen displays LO test result cannot be stored TESTING A BLOOD SAMPLE NOTE The meter will time out after 2 minutes of non use or if the strip is removed The keys are disabled until a strip...

Page 14: ...may cause the blood drop to smear 1b Select the Palm Heel or Palm Side test site in the highlighted areas as shown 2 Attach the clear cap to the lanc ing device Press and hold the lancing device FIRML...

Page 15: ...forearm and palm testing TESTING A BLOOD SAMPLE 4 Continue to hold the device pressing FIRMLY until a proper blood drop forms The clear cap allows you to see the blood drop 5 Apply blood drop to the...

Page 16: ...lthcare professional and or contact your healthcare professional immediately If you receive an Error Message see page 38 of this user manual displays meaning actions TESTING A BLOOD SAMPLE Do not use...

Page 17: ...s 2 Press the Left Right button to view all the data in memory The Left arrow goes back in time and the Right arrow goes forward in time All results including control results marked results and unmark...

Page 18: ...will turn off automatically after 30 seconds NOTE When the meter memory is full 400 test results each new test result stored in memory will remove the oldest test result stored in memory DATA MANAGEM...

Page 19: ...e the battery icon in the upper right corner of the screen and the blood drop at the lower left corner of the screen the meter has sufficient charge for 20 more tests Continue with testing as usual th...

Page 20: ...er is ready to ac cept blood Apply a blood sample to the test strip Refer to how to run a blood sample Countdown screen 4 second countdown as meter calculates the blood glucose test result No action r...

Page 21: ...TIONS Display What it Means What to Do Your blood glucose reading is higher than 33 3 mmol L You may have high blood sugar Retest your blood glucose immediately If your reading is still HI you should...

Page 22: ...the required testing temperature range of 5 to 45 C 41 to 113 F Move the meter to a warmer or cooler area as appropriate and wait a few minutes DISPLAYS MEANINGS ACTIONS Display What it Means What to...

Page 23: ...new strip Blood Sample Error Incorrectapplicationofbloodsampleorcontrol solution onto the test strip or the test strip may be damaged Review your sampling technique The blood sample quantity may be in...

Page 24: ...st plasma The anticoagulant sodium heparin may be used EDTA is not recommended for use with GlucoMen LX Sensor test strips Interferences from elevated levels of Acetaminophen Tolaza mide Uric Acid Bil...

Page 25: ...not return to Data review mode 3 Battery low icon is displayed in every mode except setup 4 Once battery level goes below the threshold that triggers the low battery warning it continues to give the w...

Page 26: ...ns 3 We have no knowledge of the performance of the GlucoMen LX blood glucose meter when used with test strips other than GlucoMen LX Sensor test strips Therefore we make no warranty as to the perform...

Page 27: ......

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