Vertex Diagnostics UltraTRAK Pro Manual do Proprietário

BLOOD GLUCOSEMONITORING SYSTEMOWNER’S MANUALVersion 1.0 Octorber, 2008311-4255100-001

10Contents of the System These products included in the kit have been designed, tested, and proven to work together as a system to

www.vertexdiagnostics.comvertexdiagnostics11Appearance and Key Function of the Meter 1. TEST SLOT Is where you insert the test strip. The meter will

12LCD Display TimeDay AverageAlarm Funtion IndicatorLow Battery SymbolTest Strip SymbolTest Result AreaKetone WarningBlood Drop SymbolMeasurement Uni

www.vertexdiagnostics.comvertexdiagnostics13Appearance of the Test Strip This system measures the amount of sugar (glucose) in whole blood.

14 PREPARATION BEFORE USEBattery Replacement Your meter comes with two 1.5V AAA alkaline batteries. The meter will alert you when the power i

www.vertexdiagnostics.comvertexdiagnostics15To replace the battery, make sure that the meter is turned off.STEP1 Press the buckle on bat

16Setting the Meter and Deleting the Memory Your meter comes with the time, date, unit of measurement, memory deletion and alarm function setting. I

www.vertexdiagnostics.comvertexdiagnostics17STEP 2 Set the Month Press and release the main button until you see the correct month. To move faster

18If you select 24h, format of time will be from 00:00 to 23:59 without AM and PM. An example is shown below.After nishing setting 12h or 24h, press

www.vertexdiagnostics.comvertexdiagnostics19STEP 6 Set the Minutes Press and release the main button to advance one minute. To move faster, keep

2Dear UltraTRAK PRO System Owner:This manual contains important information you must know about the system. Please read it thoroughly and carefully.Ul

20STEP 8 Delete Memory“dEL” and ashing yes/no is displayed on the screen. If you do NOT want to delete memory, press the main button to select “no” a

www.vertexdiagnostics.comvertexdiagnostics21STEP 9 Select and Set Alarm FunctionThe meter provides four alarms. You are able to set four different ala

22Alarm 2 settingIf you press the main button to select “OFF”, then press the set button to go to set Alarm 2.If you press the main button to select “

www.vertexdiagnostics.comvertexdiagnostics23Alarm 3 settingIf you press the main button to select “OFF”, then press the set button to go to set Alarm

24Alarm 4 settingIf you press the main button to select “OFF”, press the set button to turn off the meter.If you press the main button to select “On”,

www.vertexdiagnostics.comvertexdiagnostics25Alarm FunctionThe meter provides for alarms. The alarm function alerts you to perform your blood glucose r

26An example if Alarm 1 at 10:00AM and Alarm 2 at 2:00PM. The meter automatically turns on at 10:00 AM rst and next turns on at 2:00 PM. You can dire

www.vertexdiagnostics.comvertexdiagnostics27►Or you can leave the meter without pressing any button for two minutes. The meter will turn off automatic

28Checking with UltraTRAK PRO Glucose Control Solution UltraTRAK PRO glucose control solutions contain a known amount of glucose that reacts w

www.vertexdiagnostics.comvertexdiagnostics29When your test strips are exposed to extreme environmental • conditions (See Storage section of this manua

www.vertexdiagnostics.comvertexdiagnostics3IMPORTANT SAFETY INSTRUCTIONS READ THIS BEFORE USINGThe following basic safety precautions should always be

30Important Control Solution Information Use only UltraTRAK PRO control solutions.• Check the expiration date on the control solution vial. • Do not

www.vertexdiagnostics.comvertexdiagnostics31Doing a Control Solution Test STEP 2. Press the main buttonWhile the “ ” symbol is ashing, press the m

32WARNINGContact bars must be inserted all the way into the meter or you • may get an inaccurate test result.Every time you perform a control

www.vertexdiagnostics.comvertexdiagnostics33STEP 3 Obtain Control Solution. Shake the control solution vial well. Remove the cap from the control sol

34STEP 5 . Read and Compare the Result After counting to 0, the test result of control solution is shown on the screen.Compare this re

www.vertexdiagnostics.comvertexdiagnostics35 TESTING YOUR BLOODBe sure to read this section and the test strip package insert found in the test strip

36Testing Procedure Wash and dry your hands rst before starting.STEP 1 Set the Lancing Device.Screw off the cap of lancing device. Insert a l

www.vertexdiagnostics.comvertexdiagnostics37The lancing device is now ready for use. Set aside for later use.Slide the ejection/cocking control back u

38STEP 2 Insert Test StripSTEP 3 Get a Drop of BloodInsert a test strip with contact bars end rst and facing up into the test slot. The meter turns o

www.vertexdiagnostics.comvertexdiagnostics39Sites other than ngertip ¾Please refer to the section of “About AST” for available punctured sites.After

4TABLE OF CONTENTSIMPORTANT INFORMATION 06ABOUT ALTERNATIVE SITE TESTING (AST) 07GETTING STARTED 09 Intended Use 09 Principle of Measureme

40STEP 4 Apply Blood into the Test StripSTEP 5 Obtain an Accurate Result in 7 SecondsWhen “ “ is ashing on the screen, apply your blood to the

www.vertexdiagnostics.comvertexdiagnostics41Do not push your nger (with blood on it) against the test strip or • try to apply a smeared sample on the

42STEP 7 Remove the Lancet WARNINGThe used lancet and the used test strip may be potentially biohazard. Please discard it carefully according to your

www.vertexdiagnostics.comvertexdiagnostics43Expected Test Results Blood glucose monitoring plays an important role in diabetes control. A long-term

44 COMPARING METER AND LABORATORY RESULTSThe meter provides you with whole blood equivalent results.The result you obtain from your meter may

www.vertexdiagnostics.comvertexdiagnostics45You may still have a variation from the result because blood glucose levels can change signi

46 USING THE METER MEMORYView Results on the Meter Your meter stores the latest 450 results of control solution and your blood glucose with date and

www.vertexdiagnostics.comvertexdiagnostics47STEP 3. After the last test result, press the M button again and the meter will be turned off.STEP 1. When

48The 7- day average is calculated from the blood glucose results obtained during the last 7 days.STEP 2. Press the main button once by once to review

www.vertexdiagnostics.comvertexdiagnostics49STEP 3. Exit The Memory ModeAfter the 90-day average, press the main button again to turn off the meter.PL

www.vertexdiagnostics.comvertexdiagnostics5TESTING YOUR BLOOD 35 Test Procedure 36 Expected Test Results

502. When using the meter for the rst time, “---“ is displayed when you recall the test results or review the average result. It means that there is

www.vertexdiagnostics.comvertexdiagnostics51 VIEWING RESULTS ON A PERSONAL COMPUTERResults in memory can be transmitted to the personal c

52Step 3 Transmit DataFollow the instructions provided in the software to transmit data. Results transmitted will include date and time. Remove the ca

www.vertexdiagnostics.comvertexdiagnostics53 TAKE CARE OF YOUR METER AND STRIPTo avoid the meter and test strips getting dirt, dust or other contamina

542. Strip StorageStorage condition: 40°F to ¾140°F (4°C to 40°C), below 85% relative humidity. Do not freeze.Store your test strips in their ¾origi

www.vertexdiagnostics.comvertexdiagnostics55Use each test strip immediately ¾after removing it from the vial.Write the discard date (the ¾date opene

56The “Error Messages” you will probably encounter when using this meter are listed as followings. If you get any problem in performing test with thi

www.vertexdiagnostics.comvertexdiagnostics57Special Message Special symbols and messages appear together with your test result.Message What it means

58Error Message Message What it means ActionAppear when the battery can not provide enough power for a test.Replace the battery immediately.A

www.vertexdiagnostics.comvertexdiagnostics59 Problem in operation 1. If the meter does not display a message after inserting a test strip:2. If t

6 IMPORTANT INFORMATION Severe dehydration and excessive water loss may ¾cause false low results. If you believe you are suffering from severe

603. If the control solution test result is out of rangePROBABLE CAUSE WHAT TO DOError in performing the test.Read the instruction thor-oughly and

www.vertexdiagnostics.comvertexdiagnostics61 SPECIFICATIONSDimension & Weight: 61.7mm(L) x 92.7mm(W) x 23.2mm(H),

62 SUMMARY OF OPERATIONThis summary is intended only for quick reference and not as a substitute for the owner’s manual. Please read the enti

www.vertexdiagnostics.comvertexdiagnostics63STEP4. STEP4. Obtain a resultThe meter starts to count down. Never try to add any blood into the absorbent

64Distributed by:Vertex Diagnostics958 Church St.Baldwin, NY 11510USACustomer Care Line: 1.888.90.VERTEX Customer Service Line is available for 24

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www.vertexdiagnostics.comvertexdiagnostics7 ABOUT ALTERNATIVE SITE TESTING (AST)Important: There’re limitations for doing AST. Please consult your

8We strongly recommend you do AST in the following intervals:In a pre-meal or fasting state (more than 2 hours since ¾the last meal). Two hours or mo

www.vertexdiagnostics.comvertexdiagnostics9 GETTING STARTEDIntended Use The system is intended for use outside the body (in vitro diagnostic use). I