Vertex Diagnostics UltraTRAK, Owner'S Manual

Page 1: ...Ver 1 0 2007 10 UltraTRAKTM UltraTRAKTM ...

Page 2: ...mation 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 professional for assistance ...

Page 3: ... device only for the intended use described in this manual 3 Do not use strips and control solutions which are not supplied by the manufacturer 4 Do not use the device if it is not working properly or if it has suffered any damage 5 Before using any product to test your blood glucose read all instructions thoroughly and practice the test Do all quality control checks as directed and consult with a...

Page 4: ...play Segments 12 Appearance of the Test Strip 13 PREPARATION BEFORE USE 14 Battery Replacement 14 Setting the Meter and Deleting the Memory 16 BEFORE TESTING 20 Checking the Display 20 Coding the Meter 20 Checking the System with Control Solutions 22 Important Control Solution Information 23 Doing a Control Solution Test 24 TESTING YOUR BLOOD 27 Testing Procedure 28 Expected Test Results 34 Specia...

Page 5: ...esults on the Meter 38 Viewing Results on a Personal Computer 40 CARING FOR YOUR METER AND STRIP 41 Cleaning 41 Storage 41 PROBLEM SOLVING GUIDE 44 Error Message 45 Problem in Operation 46 SPECIFICATIONS 48 SUMMARY OF OPERATION 49 ...

Page 6: ...ood sample to the absorbent hole Applying other substances to the absorbent hole will cause inaccurate results If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in this owner s manual call your healthcare professional Inaccurate results may occur in severely hypotensive individuals or pa tients in shock In...

Page 7: ...e cause they are full of nerve endings receptors At other body sites since nerve endings were not so condensed you will not feel as much pain as at the fingertip When to use AST Food medication illness stress and exercise can affect blood glucose levels Capillary blood at fingertip reflects these changes faster than capil lary blood at other sites Therefore when testing blood glucose during or imm...

Page 8: ... the puncture site prior to blood ex traction has a significant influence on the glucose value obtained Blood from the site without rubbing exhibits a measurably different glucose con centration than blood from the finger When the puncture site was rubbed prior to blood extraction the difference was significantly reduced Please follow suggestions below before getting a drop of blood Rub the punctu...

Page 9: ... in the home and in clinical settings It should not be used for the diagnosis of diabetes or for the testing of newborns AST in this system can be used only during steady state blood glucose conditions described in the section of About AST Principle of Measurement The test is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip The meter...

Page 10: ... Card kCarrying Case Daily Logbook lExtra 3V Lithium Battery Warranty card Owner s Manaul Check your system to be sure that it is unopened prior to use and that it contains all parts listed above If either of these conditions occurred please return your system to the place of purchase There are 3 levels for control solutions low normal and high Please note that these three levels of control solu t...

Page 11: ...our test results are displayed here The large easy to read display guides you through the test using symbols and simple messages SETTING BUTTON in the back Setting the date time and unit located in the battery compartment MAIN BUTTON The main button in front of the meter is used to set up the meter enter the memory mode change the value of data time unit setting memory deleting and turn the meter ...

Page 12: ...result is above 240mg dL 1 mmol L this symbol will appear with sign on the display TEST RESULT AREA Test results are displayed here A decimal point appears when the unit of measurement is millimoles per litre BLOOD DROP SYMBOL This symbol tells you when to apply the sample DATE TIME MEM Indicates a test result stored in memory CTL SYMBOL Appears when in control solution test Its result won t be st...

Page 13: ... consists of the following parts Contact Bars Insert this end of the test strip into the meter Push it in firmly until it will go no further Test Strip Handle Hold this part to insert the test strip into the slot Confirmation Window This is where you confirm if enough blood Has been applied to the absorbent hole of the strip Absorbent Hole Apply a drop of blood here The blood will be sucked automa...

Page 14: ...ry However the time and date settings may need to be updated Batteries might leak chemicals if not used for a long time Re move the battery if you are not going to use the device for an extended period i e 3 months or more PLEASE NOTE 1 The symbol appears with CHK and test strip symbol the meter is func tional and the result remains accurate but it is time to change the battery 2 The symbol appear...

Page 15: ...tery and replace with one new 3 0 V CR2032 lithium battery Make sure that the positive side is facing up 3 Close the battery cover If the battery is inserted correctly you will hear a beep As with all small batteries the batteries should be kept away from small children who still put things in their mouths If they are swal lowed promptly see a doctor for help WARNING ...

Page 16: ...nd release the Main button to advance one year To move faster keep pressing the Main button until the de sired number appears With the correct year on the display press the Set button and then the month segment flashes STEP 2 Set the Month Press and release the Main button until the correct month appears To move faster hold the Main button down With the correct month on the display press the Set b...

Page 17: ...f measurement starts flashing STEP 6 Select mg dL or mmol L Press and release the Main button to se lect the unit of measurement you want to use Press the Set button and then the cur rent unit of temperature flashes The milligram per deciliter mg dL is the standard unit in the United States The mmol L is the standard unit in Canada Use of the wrong unit of measure may cause you to misinterpret you...

Page 18: ...tton 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 If you do not want to delete the memory press the Set button to skip this step and then the meter will be turned off Congratulations You have finished all settings now ...

Page 19: ...ter displays 7 14 21 28 60 and 90 day averages which you can access from the meter memory These averages are cal culated from results obtained during the 7 14 21 28 60 and 90 day preceding the current date and time settings When the date and time are changed the 7 14 21 28 60 and 90 day averages may change While the meter is in the Setting mode it will turn off automatically without any action in ...

Page 20: ...ch the number printed on the vial test results may be inaccurate CAUTION Coding the Meter STEP 1 Enter the Code Mode Start with the meter turned off Insert a test strip to turn on the meter CHK and will appear Next the ambient temperature and then the code number will appear STEP 2 Match the Code Numbers Compare the code number on the meter display with the code number on the test strip vial If th...

Page 21: ...TEP 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: ...use this system to test your blood for the first time practice the procedure using control solution When you can do three tests in a row that are within the expected range you are ready to test your blood For routinely check the meter and test strips perform a single test for each level of control solution at least once a week When the control solution test should be performed Whenever you suspect...

Page 23: ...ion and wipe off the dispenser tip to ensure a good sample and an accurate result Use only for 90 days after first opening Record the discard date date opened plus 90 days on the control solution vial Discard after 90 days Store the control solution tightly closed at temperatures below 86ºF 30ºC Do not refrigerate The control solution range printed on the test strip vial is for control solution on...

Page 24: ...de number on the display is the same as the code number on the test strip vial If the code numbers do not match please see Coding the Meter section of this manual STEP 2 Press the Main Button While the symbol appears on the display press the Main button and then CTL will appear on the display With the CTL sign on the display the meter will not store your test result in memory If you decide not to ...

Page 25: ...cap Squeeze the vial discard the first drop and wipe off the dispenser tip to prevent contamination Squeeze the vial again to get another drop and place the drop on your fingertip first STEP 4 Apply Control Solution Move your finger with control solution on it to meet the absorbent hole of the test strip and the drop will be automatically drawn into the test strip Remove your fin ger until the con...

Page 26: ...p vial It should fall within this range Out of range results If test results fall outside the range printed on the test strip vial check the section of Problem in Operation in troubleshooting guide and repeat the test If you continue to get out of range results it means that the system may not be working properly Do NOT test your blood Please call your local agent for help Normal 109 165 ...

Page 27: ...all items needed to test A Blood Glucose Meter B Test Strip C Lancing Device D Sterile Lancet E Clear Cap For AST use To reduce the chance of infection Never share a lancet or the lancing device with others Always use a new sterile lancet Lancets are for single use only Avoid getting hand lotion oils dirt or debris in or on the lancets and the lancing device WARNING A B C D E ...

Page 28: ... down firmly until it is fully seated Twist the protective disk until it separates from the lancet Replace the lancet device cap Turn the cap until it is snug but not too tight Twist the adjustable tip in either direction until the number lines up with the Arrow The adjustable tip offers 5 levels of skin penetration 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin ...

Page 29: ...he fingertip A clear cap together with the kit makes it easier to get a drop of blood for AST When you want to obtain blood from sites other than the finger replace the lancet de vice cap with the clear cap Turn the clear cap until it is snug but not too tight and then Slide the ejec tion cocking control back until it clicks The lancing device is now ready for use Set aside for later use ...

Page 30: ...ically CHK and will appear briefly on this display Next the ambient temperature and then the symbol with the code number will appear Make sure the code number showed on the screen is the same as the code number printed in the test strip vial If the code numbers are different please refer to section of Coding the Meter for the procedure of coding 1510 ...

Page 31: ...lable punctured sites After penetration discard the first drop of blood with a clean tissue paper or cotton Then gently squeeze the punctured area to obtain blood But be attention NOT to smear the blood sample The volume of blood sample must be at least 0 7 microliter actual size Choose a different spot each time you test Repeated punc tures in the same spot may cause soreness and calluses Before ...

Page 32: ...od on it against the test strip or try to apply a smeared sample on the test strip If you do not apply a blood sample to the test strip within 3 min utes the meter will automatically turn off You must remove and reinsert the test strip to restart the test procedure The blood should be completely filled the confirmation window before the meter begins to count down If you find that the confirmation ...

Page 33: ...emoving the lancet Take the lancet out carefully Place the disk on a hard surface and push the exposed tip into the pro tective disk The used lancet and the used test strip may be potentially biohazard Please discard it carefully according to your local regulations WARNING ...

Page 34: ...monitor and adjust your treatment plan to gain better control of your diabetes Time of day Plasma glucose range mg dL for people without diabetes Your target range mg dL mmol L Fasting and before meal Less than 110 2 hours after meals Less than 140 Bedtime Not specified Between 2 AM and 4AM Not specified Source ADA Clinical Practice Recommendations 2003 Please work with your doctor to determine a ...

Page 35: ...ur healthcare profes sional If your blood glucose test result is above 600 mg dL 33 3 mmol L Hi will appear on the meter display This indicates se vere hyperglycemia high blood glucose You should seek immediate medical assistance If you blood glucose test result is above 240 mg dL 13 3 mmol L KETONE and will appear on the meter display This indicates high blood glucose 4 and you should seek immedi...

Page 36: ...samples for both tests the meter test and the lab test are taken and tested within 15 minutes of each other Wash your hands before obtaining a blood sample Never use your meter with blood that has been collected in a gray top test tube Use fresh capillary blood only You may still have a variation from the result because blood glucose levels can change significantly over short periods especially if...

Page 37: ...stics 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: ... STEP 1 Enter the Memory Mode With the meter turned off press the Main button twice The 7 day average will appear indicating that you are in the memory mode If you continue to press the Main button the 14 21 28 60 and 90 day average will appear You can then review the last 450 tests in the memory The 7 day average is calculated from the blood glucose results obtained during the last 7 days The exa...

Page 39: ...for information The list of past results and the result average are for blood glucose results only When using the meter for the first time will appear show ing that there are no test results in memory If no button is pressed for 2 minutes the meter will show OFF and turn off automatically PLEASE NOTE After viewing the oldest test result push down the Main button again to resume to the 7 day averag...

Page 40: ...on your computer by following the in structions provided on Vertex s website www vertexdiagnostics com Step 2 Connect to Personal Computer Connect the interface cable to the serial port in your computer With the meter turned off connect the Interface Cable to the Data Port of the me ter PC will appear on the display indicating that the meter is ready to transmit data Step 3 Transmit Data Follow th...

Page 41: ...ith the meter there is no special cleaning re quired 1 To clean the meter exterior wipe with a cloth moistened with tap water or a mild cleaning agent then dry the device with a soft and dry cloth Do not flush with water 2 Do not use organic solvents to clean the meter Storage 1 Meter Storage Storage condition 68 F 140 F 20 C 60 C below 95 relative humidity Always store or transport the meter in i...

Page 42: ...e the vial cap and close it tightly Touch the test strip with clean and dry hands Use each test strip immediately after removing it from the vial Write the discard date the date opened plus 90 days on the vial label when you first open it Discard remain ing test strips 90 days after first open ing date Do not bend cut or alter a test strip in any way Keep the strip vial away from children since th...

Page 43: ...ol solution storage Storage condition Store the control solution tightly closed at temperatures below 86 F 30 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: ...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 Never try to disassemble the meter in any circumstances If you en counter any error messages not listed below or if you have followed the actions recommended below but the problem keeps unsolved please call the local agent for support ...

Page 45: ...with a new test strip If the error message appears again please call your local agent for help Repeat the test after the meter and test strip have reached a temperature within the operation range Error message indicates that there Error message indicates that there may by a problem with the meter or code strip Repeat the test with a new code strip If the problem persists please call the Customer C...

Page 46: ...when appears on the display Please call your local customer service for help b Defective test strip c Sample applied after automatic shutoff three minutes after last user action d Defective meter PROBABLE CAUSE WHAT TO DO a Battery exhausted Replace the Battery Check that the battery is correctly installed with the positive side up Insert the test strip correctly with the contact bars end first an...

Page 47: ...control solution vial very well Shake the control solution vigorously and repeat the test again Expired or contaminated control solution Check the expiry date or the discarded date of the control solution Control solution that is too warm or too cold Control solution meter and test strips should come to room temperature 68 77 F 20 25 C before testing Test strip deterioration Repeat the test with a...

Page 48: ...n Auto turn off after 3 minutes without action Temperature warning Operating condition 50 F 104 F 10 C 40 C below 85 R H noncondensing Storage Transportation condition 68 F 140 F 20 C 60 C below 95 R H Measurement Units Either mg dL or mmol L Measurement Range 20 600 mg dL 1 1 33 3 mmol L The specifications may be changed without prior notice The device has been certified to meet the electrical an...

Page 49: ...aken 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 Match the code Check if LCD displayed code number is same as the number on the strip vial 1510 ...

Page 50: ...firmation window is complete ly filled STEP 3 Obtain a Result The meter starts to count down Never try to add any blood into the absorbent hole even if you find that the confirmation win dow is not fulfilled Discard the strip and retest with a new strip STEP 4 Discard the used strip and the lancet according to your local regulations ...