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Vertex Diagnostics UltraTRAK Owner's Manual

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UltraTRAK
TM
UltraTRAK
TM
Ver 1.0
2007 10

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Summary of Contents for Vertex Diagnostics UltraTRAK

  • Page 1 UltraTRAK UltraTRAK Ver 1.0 2007 10...
  • Page 2 UltraTRAK Dear System Owner: This manual contains important information that you must know about your system. Please read it carefully and keep it for future reference. For other questions regarding this system, please contact your local customer service. At all other times, you should contact your health care...

  • Page 3: Important Safety Instructions

    vertex diagnostics IMPORTANT SAFETY INSTRUCTIONS READ THIS BEFORE USING The following basic safety precautions should always be taken. 1. Close supervision is necessary when the device is used by, on, or near children, handicapped persons or invalids. 2. Use the device only for the intended use described in this manual. .

  • Page 4: Table Of Contents

    UltraTRAK TABLE OF CONTENTS IMPORTANT SAFETY INSTRUCTIONS IMPORTANT INFORMATION ABOUT ATERNATIVE SITE TESTING (AST) INTRODUCTION OF THE SYSTEM Intended Use Principle of Measurement Contents of the System Appearance and Key Function of the Meter Meter Display Segments Appearance of the Test Strip...
  • Page 5 vertex diagnostics Viewing Results on the Meter Viewing Results on a Personal Computer CARING FOR YOUR METER AND STRIP Cleaning Storage PROBLEM-SOLVING GUIDE Error Message Problem in Operation SPECIFICATIONS SUMMARY OF OPERATION...

  • Page 6: Important Information

    UltraTRAK IMPORTANT INFORMATION Severe dehydration and excessive water loss may cause false low re- sults. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately. Test results below 60 mg/dL* (. mmol/L) mean low blood glucose (hy- poglycemia).

  • Page 7: About Aternative Site Testing (Ast)

    vertex diagnostics ABOUT ALTERNATIVE SITE TESTING (AST) Important: There are limitations for doing AST. Please consult your healthcare professional before you do AST. What is AST? Alternative site testing (AST) means that people use parts of the body oth- er than fingertips to check their blood glucose levels.
  • Page 8 UltraTRAK Do NOT use AST if: You think your blood glucose is low. You are unawareness of hypoglycemia. Your AST results do not match the way you feel. You are testing for hyperglycemia. Your routine glucose results are often fluctuating.

  • Page 9: Introduction Of The System

    vertex diagnostics INTRODUCTION OF THE SYSTEM Intended Use The system is intended for use outside the body (in vitro diagnostic use). It should be used only for testing glucose (sugar) and only with fresh capil- lary whole blood samples taken from the finger and the alternative sites including the palm, the forearm, the upper arm, the calf and the thigh.

  • Page 10: Contents Of The System

    UltraTRAK Contents of the System The system consists of three main products: the blood glucose meter, test strips, and two levels of control solution. These products have been de- signed, tested, and proven to work together as a system to produce ac- curate blood glucose test results.

  • Page 11: Appearance And Key Function Of The Meter

    vertex diagnostics Appearance and Key Function of the Meter SETTING BUTTON (in the back) Setting the date, time and unit, located in the battery compartment. TEST PORT The test port is where you insert he test strip for testing. The meter will turn on automatically when you insert a test strip.

  • Page 12: Meter Display Segments

    UltraTRAK Meter Display Segments TEST RESULT AREA Test results are displayed here. (A decimal point appears when the unit of measurement is millimoles per litre.) MEASUREMENT UNIT BLOOD DROP SYMBOL Appears with the test result This symbol tells you when either in mg/dL or in mmol/L.

  • Page 13: Appearance Of The Test Strip

    vertex diagnostics Appearance of the Test Strip Your system measures the amount of sugar (glucose) in whole blood. Blood is applied to the absorbent hole of the test strip and is automatically drawn into the reaction cell where the reaction takes place. The test strip consists of the following parts: Contact Bars Insert this end of the test strip into the meter.

  • Page 14: Preparation Before Use

    UltraTRAK PREPARATION BEFORE USE Battery Replacement Your meter comes with one .0 V (CR202) lithium battery that is already installed. The meter will alert you when the power is getting low by displaying two different messages: 1. The symbol appears with “CHK” and...
  • Page 15 vertex diagnostics To replace the battery, make sure that the meter is turned off. 1. Press the buckle on battery cover and lift up to remove cover. 2. Remove the old battery and replace with one new .0 V (CR202) lithium battery.

  • Page 16: Setting The Meter And Deleting The Memory

    UltraTRAK Setting the Meter and Deleting the Memory Your meter comes with the time, date, unit of measurement and unit of temperature preset. But if you replace the battery, you may need to reset the meter. Start with the meter off. Then press the set button located in the battery com- partment.
  • Page 17 vertex diagnostics STEP 4 Set the Hour Press and release the Main button to ad- vance one hour. To move faster, hold the Main button down. With the correct hour on the display, press the Set button and then the minute segment flashes. STEP 5 Set the Minutes Press and release the Main button to ad- vance one minute.
  • Page 18 UltraTRAK STEP 8 Delete Memory and Exit the Setting Mode With “dEL” and flashing “mem” symbol on the dis- play: Press the Main button again to delete all of the memory, following the meter will display “---“ and “OK” to show that the memory is deleted. Then press the Set button to turn off the meter.
  • Page 19 vertex diagnostics PLEASE NOTE The time, date, unit of measurement and unit of temperature can ONLY be changed in the setting mode. Therefore, when you perform a glucose testing, those parameters are not possible to be changed. Your meter displays 7-, 14-, 21-, 28-, 60- and 90-day averages which you can access from the meter memory.

  • Page 20: Before Testing

    UltraTRAK BEFORE TESTING Checking the Display Each time you insert a test strip into the meter to turn the meter on, the meter will display ”CHK” and This tells you that the system is performing several self-checks. CAUTION If the code number displayed on the meter does not match the number printed on the vial, test results may be inaccurate.
  • Page 21 vertex diagnostics STEP 3 Code the Meter With the meter off, insert the code strip and the code number will appear on the display. Then remove the code strip and “OK” will appear. This tells you that coding is complete. You can start testing now. 1510...

  • Page 22: Checking The System With Control Solutions

    UltraTRAK Checking the System with Control Solutions control solutions contain a known amount of glucose that reacts with test strips. By comparing your control solution test results with the expected range printed on the test strip vial label, it is able to check that the meter and the test strips are working together as a system and that you are performing the test correctly.

  • Page 23: Important Control Solution Information

    vertex diagnostics Important Control Solution Information Use only control solutions. Check the expiration date on the control solution vial. Do not use if ex- pired. Control solution, meter, and test strips should come to room temperature (68~77ºF/20~25ºC) before testing. Shake the vial, discard the first drop of control solution, and wipe off the dispenser tip to ensure a good sample and an accurate result.

  • Page 24: Doing A Control Solution Test

    UltraTRAK Doing a Control Solution Test STEP 1 Insert the Test Strip Insert a test strip with contact bars end first and facing up, into the test slot. The meter turns on automatically and displays“CHK” and “ ” . Next, the ambient temperature and then the code number will appear.
  • Page 25 vertex diagnostics WARNING Contact bars must be inserted all the way into the meter or you may get an inaccurate test result. Every time you perform a control solution test, you must enter into the “CTL” test mode so that the test result will not be stored in the meter memory.
  • Page 26 UltraTRAK STEP 5 Read and Compare the Result After counting to 0, the test result of control solution is shown on the screen. Compare this result with the range printed on the test strip vial. It should fall within this range.

  • Page 27: Testing Your Blood

    vertex diagnostics TESTING YOUR BLOOD Be sure to read this section and the test strip package insert found in the test strip box carefully before testing. Make sure you have all items needed to test: A.Blood Glucose Meter B.Test Strip C.Lancing Device D.Sterile Lancet E.Clear Cap (For AST use)

  • Page 28: Testing Procedure

    UltraTRAK Testing Procedure WASH AND DRY YOUR HANDS FIRST BEFORE STARTING. STEP 1 Set the Lancing Device Screw off the cap of lancing device. Insert a lancet into the lancet holder and push down firmly until it is fully seated.
  • Page 29 vertex diagnostics Slide the ejection/cocking control back until it clicks. If it does not click the device may have been cocked when the lancet was inserted. Blood from sites other than the fingertip A clear cap, together with the kit, makes it easier to get a drop of blood for AST.
  • Page 30 UltraTRAK STEP 2 Insert Test Strip Insert a test strip with contact bars end first and facing up into the test slot. The meter will turn on automatically. “CHK” and will appear briefly on this display. Next, the ambient temperature and then the symbol with the code number will appear.
  • Page 31 vertex diagnostics STEP 3 Get a drop of blood Select the puncture site either in finger or in other parts (AST). Clean the puncture site with 70% alcohol cotton and let it air-dry. Fingertip Hold the lancing device firmly against the side of your finger.
  • Page 32 UltraTRAK STEP 4 Apply blood into the test strip When “ “ is flashing on the screen, apply your blood to the absorbent hole of the test strip until the confirmation window is fully covered with blood. The meter then begins to count down automatically.
  • Page 33 vertex diagnostics STEP 6 Remove the Lancet Always use caution when removing the lancet. Take the lancet out carefully. Place the disk on a hard surface and push the exposed tip into the pro- tective disk. WARNING The used lancet and the used test strip may be potentially biohazard.

  • Page 34: Expected Test Results 4

    UltraTRAK Expected Test Results Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that keeping blood glucose levels close to nor- mal can reduce the risk of diabetes complications by up to 60%* . The...

  • Page 35: Special Messages 5

    vertex diagnostics Special Messages meter displays results between 20 to 600 mg/dL (1.1 to . mmol/L). If your test result is lower than 20 mg/dL (1.1 mmol/L), “Lo” will appear on the meter display. This indicates severe hypoglycemia (low blood glucose). You should immediately treat hypoglycemia as recommended by your healthcare profes- sional.

  • Page 36: Comparing Meter And Laboratory Results 6

    UltraTRAK COMPARING METER AND LABORATORY RSULTS The result you obtain from your meter may differ somewhat from your labo- ratory result due to normal variation. Meter results can be affected by fac- tors and conditions that do not affect laboratory results in the same way.
  • Page 37 vertex diagnostics References *5: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 49-51. *6: Sacks, D.B.: “Carbohydrates. “ Burtis, C.A., and Ashwood, E.R.( ed.), Tietz Text book of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959.

  • Page 38: Using The Meter Memory 8

    UltraTRAK USING THE METER MEMORY View Results on the Meter Your meter stores the 450 most recent blood glucose test results with date and time in its memory. It also provides you with 7-, 14-, 21-, 28-, 60-, and 90-day averages of your blood glucose test results. You can review the test results in memory with these easy steps.
  • Page 39 vertex diagnostics STEP 2 Recall Test Results After 90-day average, the most recent test result with date and time ap- pears. Press the Main button to review your last 450 test results in or- der. When the memory is full, the oldest result is dropped as the latest is added.

  • Page 40: Viewing Results On A Personal Computer

    UltraTRAK Viewing Results on a Personal Computer Results in memory can be transmitted to the personal Interface Cable are required before installation. The software can be downloaded from www.vertexdiagnostics.com. The interface cable is an optional accessory. To learn more about Health Care System Software or to obtain an Interface Cable separately, please contact your local customer service.

  • Page 41: Caring For Your Meter And Strip

    vertex diagnostics CARING FOR YOUR METER AND STRIP To avoid the meter and test strips getting dirt, dust or other contami- nants, please wash and dry your hands thoroughly before use. Cleaning Your meter does not require special maintenance. As no blood or control solution comes in contact with the meter, there is no special cleaning re- quired.

  • Page 42: Strip Storage

    UltraTRAK 2.Strip Storage Storage condition: 9.2°F~104°F (4°C~ 40°C), below 85% relative humidity. Store your test strips in their original vial only. Do not transfer to other container. Store test strip packages in a cool and dry place. Keep away from direct sunlight and heat.

  • Page 43: Control Solution Storage

    vertex diagnostics 3.Control solution storage Storage condition: Store the control solution tightly closed at temperatures below 86°F(0°C). Do NOT refriger- ate. Record the discard date (date opened plus 90 days) on the control solution vial. Discard after 90 days.

  • Page 44: Problem-Solving Guide

    UltraTRAK PROBLEM-SOLVING GUIDE Following is a summary of some display messages and symbols. These messages help to identify certain problems but do not appear in all cases when a problem has occurred. Improper use may cause an inaccurate result without producing an error message or a symbol. In the event of a problem, refer to the information under action.

  • Page 45: Error Message

    vertex diagnostics Error Message Message Meaning Action Replace the battery at once. symbol appears with this message on the display by itself. This means that the battery will not provide enough power for a test. Error message could be caused Repeat the test with a new test by a used test strip, or a temporary strip.

  • Page 46: Problem In Operation

    UltraTRAK Problem in Operation 1. If the meter does not display a message after inserting a test strip: PROBABLE CAUSE WHAT TO DO a.Battery exhausted. Replace the Battery. b.Battery incorrectly Check that the battery is correctly installed or absent. .
  • Page 47 vertex diagnostics 3. If the control solution test result is out of range. POSSIBLE CAUSE WHAT TO DO Error in performing the test Read the instruction thoroughly and repeat the test again. Check if the code number on the Improper code number. display matches the code number on the test strip vial.

  • Page 48: Specifications

    UltraTRAK SPECIFICATIONS Dimension: 78mm*48mm*15mm Weight: 40.17g Power source: one CR202 V lithium coin battery Display: LCD Memory: 450 measurement results with date and time External output: RS22 PC interface Auto electrode inserting detection Auto sample loading detection Auto reaction time count-down...

  • Page 49: Summary Of Operation

    vertex diagnostics SUMMARY OF OPERATION This summary is intended only for quick reference and can not be taken as the substitute for the Owner’s Manual. Please read the entire manual before you begin doing test. STEP 1 Insert Test Strip The meter is automatically turned on and displayed room temperature and the code number.
  • Page 50 UltraTRAK STEP 2 Apply Sample Hold the drop of blood and make it fully contact to the absorbent hole of test strip until the confirmation window is complete- ly filled. STEP 3 Obtain a Result The meter starts to count down. Never try...

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