OneTouch VERIOPRO +, Operator'S Manual

Page 1: ...1 Meter Operator s Guide Blood glucose monitoring system Yellow 5mm margin Red 7mm margin Yellow 5mm margin Red 7mm margin AW05948101B_OT_VerioPro _OB_Insides_R1 indd 1 4 3 12 3 07 PM...

Page 2: ...mplete explanation of how to use the new meter and testing supplies and reviews the do s and don ts of testing blood glucose levels Clear instructions and visuals will help you get comfortable using t...

Page 3: ...came with the system for safety related information Direct current Consult instructions for use Battery low Number Insert additional local symbols as required Yellow 5mm margin Red 7mm margin Yellow 5...

Page 4: ...orming a control solution test 22 4 Performing a blood glucose test 40 5 Reviewing past results 58 6 Performing a linearity test 62 7 Care and maintenance 77 Yellow 5mm margin Red 7mm margin Yellow 5m...

Page 5: ...es 80 9 Troubleshooting 83 10 Detailed information about the system 94 11 Index 104 Yellow 5mm margin Red 7mm margin Yellow 5mm margin Red 7mm margin AW05948101B_OT_VerioPro _OB_Insides_R1 indd 5 4 3...

Page 6: ...he fingertips Arterial and venous whole blood samples may be used as well The OneTouch Verio Pro Blood Glucose Monitoring System is intended for testing outside the body in vitro diagnostic use by hea...

Page 7: ...eter measures the current calculates the patient s blood glucose level displays the blood glucose result and stores it in its memory Standard precautions When testing multiple patients it is important...

Page 8: ...oring System The OneTouch Verio Pro System Kit A OneTouch Verio Pro Meter batteries included B Meter Storage Case A B Yellow 5mm margin Red 7mm margin Yellow 5mm margin Red 7mm margin AW05948101B_OT_V...

Page 9: ...est Strips The OneTouch Verio Control Solutions and Test Strips are available separately Follow your institution s procedure for obtaining additional test strips and control solutions Use only OneTouc...

Page 10: ...er and testing supplies away from young children Small items such as the test strips and control and linearity solution vial caps are choking hazards Do Not allow patients to ingest or swallow any ite...

Page 11: ...s time to change batteries Mini USB data port Connect to download to computer Up and down buttons Highlight change information or values Display mmol L is the pre set unit of measure and cannot be cha...

Page 12: ...ront Channel to apply sample Silver prongs Silver prongs should face you when you insert test strip into test strip port Yellow 5mm margin Red 7mm margin Yellow 5mm margin Red 7mm margin AW05948101B_O...

Page 13: ...and date see pages 16 18 m CAUTION If there are any missing pixels within the start up screen there may be a problem with the meter Contact Customer Service and or LifeScan sales representative After...

Page 14: ...ngs highlighted A bar highlights the current selection on the Main Menu NOTE When History is highlighted the result from the most recent blood glucose test appears at the bottom of the Main Menu When...

Page 15: ...advance to the Apply Blood screen Audible cues and warnings The meter will beep to provide prompts or confirmations and to notify of possible problems related to the meter test procedure test result...

Page 16: ...se a language In the Set Language screen press or to highlight the language you want and press Pressing after making your selection confirms each setting and takes you to the next screen When setting...

Page 17: ...set the hour and press Repeat this step to set the minutes 3 Set the date In the Set Date screen press or to change the date and press Repeat these steps to set the month then the year Set Time 12 12...

Page 18: ...rrect setting and press to return to that setting screen After making the correction press to return to the Settings screen When finished highlight Done and press to save the settings and return to th...

Page 19: ...n to the Main Menu Adjusting settings after setting up the meter for the first time Adjust the settings in the meter as needed Highlight Settings on the Main Menu screen and press Settings History mmo...

Page 20: ...stored in the meter and can be viewed at any time Highlight Meter Care on the Settings screen and press Meter Care Settings Time 10 05 Date 10 Dec 2011 Language English Meter Info Meter Care Control...

Page 21: ...nd hold to return to the Main Menu Meter Care Meter Info Serial BCXFF2HK So ware XX YY ZZ AA Units mmol L Last PC Transfer 03 Mar 2011 Yellow 5mm margin Red 7mm margin Yellow 5mm margin Red 7mm margin...

Page 22: ...control solution vial label when tagging control solution test results to be sure the result is tagged correctly see page 29 Follow your institution s policy and procedure guidelines for when to perf...

Page 23: ...o the test strips Do Not test if there is condensation water build up on the meter Move the meter and test strips to a cool dry spot and wait for the meter surface to dry before testing Store unused t...

Page 24: ...cut or modify the test strip in any way m CAUTION Do Not apply control solution to the skin or eyes as it may cause irritation Do Not use control solution after the expiration date printed on the via...

Page 25: ...batch or lot of test strips If you suspect that the meter or test strips are not working properly If the meter has had repeated unexpected blood glucose results If the meter has been dropped or damag...

Page 26: ...er is required NOTE Do Not press or the eject button during a test Wait for the Apply Blood screen to appear on the display NOTE The same Apply Blood screen that appears during a blood glucose test al...

Page 27: ...uce the risk of contamination which may lead to inaccurate control solution results 2 Prepare the control solution Remove the vial cap and place it on a flat surface with the top of the cap pointing u...

Page 28: ...f control solution Keep the meter pointed down to prevent control solution from entering the test strip port Touch the channel on the side of the test strip to the control solution Wait for the channe...

Page 29: ...of control solution Press the or to choose the level of control solution used for this test and press NOTE The level of control solution will be printed on the vial and also indicated by the color of...

Page 30: ...solution OR You have selected the wrong control solution level for the level that you used Select Change Level and then choose the level that you used Change Level Confirm Please verify Check selected...

Page 31: ...ive Low 30 Apr 19 00 mmol L 14 6 Remove the used test strip After viewing the control solution test hold the meter pointed down Press the eject button and the test strip will come out Used test strips...

Page 32: ...ct Settings and press 2 Next press or to choose Meter Care and press Settings History mmol L 01 Apr Serial BCXFF2HK 12 45 Meter Care Settings Time 12 45 Date 01 Apr 2011 Language English Yellow 5mm ma...

Page 33: ...esults at a time starting with the most recent Press to view older results or to view newer results To move more quickly press and hold or To return to previous screen press Press and hold to return t...

Page 34: ...eting a control solution test if the meter times out or the meter is turned off before a level is selected the result will be shown without a control solution level Control Results mmol L Mon 29 Apr 3...

Page 35: ...feature on or off 1 Highlight Meter Care on the Settings screen and press 2 Next select Control Reminder and press Meter Care Settings Time 10 05 Date 10 Dec 2011 Language English Meter Info Meter Car...

Page 36: ...nder Reminder Off Reminder Settings No of Days 4 Press or to select On or Off and press Reminder Off Turn On to set and receive Control Solution Test reminders On Yellow 5mm margin Red 7mm margin Yell...

Page 37: ...policy for control solution testing frequency when setting the reminder 1 Highlight No of Days on the Control Reminder screen and press 2 Press or to select the number of days and press Control Remind...

Page 38: ...the hour and press When finished press to return to the Control Reminder screen Check to be sure the settings are correct Press to return to the Meter Care screen or press and hold to return to the Ma...

Page 39: ...on and it is time for a control solution test to be performed this Reminder screen will appear within an 8 hour window of the reminder settings Press to continue OK Reminder Perform a control solutio...

Page 40: ...Strips Unlike some blood glucose meters no separate step to code the OneTouch Verio Pro Meter is required Make sure the meter and test strips are at about the same temperature before testing The OneT...

Page 41: ...ip and perform a test Use the test strip immediately after removing it from the vial especially in high humidity environments A test strip left out of the vial in excess of two minutes before testing...

Page 42: ...ants Whole blood samples with the following anti coagulants are suitable for use Heparin Citrate and EDTA Samples with Fluoride and Oxalate as anti coagulants are not suitable Interfering Substances D...

Page 43: ...ing venous and arterial whole blood samples Personal Protective Equipment Health care professionals should follow their institution s policy and procedure guidelines for hand hygiene In addition follo...

Page 44: ...ter must be disinfected after each patient as specified on pages 77 79 whether or not blood or body fluid contamination is suspected Test Strips OneTouch Verio Test Strips are intended for single use...

Page 45: ...used for one patient and must be reused for another patient the device must be disinfected in between patients or before use on another patient 1 Wear gloves when performing a fingerstick for glucose...

Page 46: ...discard gloves in appropriate biohazard waste receptacles after every procedure that involves potential exposure to blood or body fluids including fingerstick whole blood sampling 1 Perform hand hygie...

Page 47: ...able standards but some mobile phones may interfere with the proper operation of the meter if next to the meter during testing Other hospital equipment that emits electromagnetic radiation may cause i...

Page 48: ...Insert a test strip into the test strip port with the gold side of the test strip and the two silver prongs facing you Unlike some blood glucose meters no separate step to code the OneTouch Verio Pro...

Page 49: ...at capillary whole blood is obtained by puncturing the finger using a disposable single use lancing device Gently squeeze the finger until a round drop of whole blood appears Be sure to apply the samp...

Page 50: ...llection Use only fresh whole blood when performing a blood glucose test using an arterial or venous blood sample If testing with a fresh sample is not possible store the blood for no longer than 30 m...

Page 51: ...sample the test strip wicks blood into the channel Channel NOTE When applying a whole blood sample from the finger syringe or pipette keep the meter pointed down to prevent blood from entering the tes...

Page 52: ...ispense the blood from the syringe into a test tube then apply blood to the test strip using a narrow bore pipette m CAUTION Do Not use a syringe with a metal needle attached to the end Pipette Touch...

Page 53: ...mple with the test strip Do Not press the test strip too firmly against the puncture site or the channel may be blocked from filling properly Do Not apply more blood to the test strip after you have m...

Page 54: ...blood glucose result contact Customer Service and or LifeScan sales representative m CAUTION If the words Control solution appear and you are asked to select a level as per screen on page 29 when test...

Page 55: ...er to treat first and then do another test Follow your institution s policy regarding treatment of hypoglycemia If the blood glucose result is shown as EXTREME LOW GLUCOSE it means the result is below...

Page 56: ...result is over 33 3 mmol L Repeated unexpected blood glucose results If you get repeated unexpected results check the meter with control solution See Performing a control solution test pages 22 39 Als...

Page 57: ...hold to go to the Main Menu Or Press and hold for several seconds to turn the meter off Removing disposing of the used test strip After getting a result hold the meter pointed down Press the eject bu...

Page 58: ...screen is displayed release The Insert Strip to Test screen is displayed Press to go to the Main Menu History From the Main Menu highlight History and press to view all blood glucose results stored i...

Page 59: ...meter can display up to 5 results at a time starting with the most recent Press to view older results and to view newer results To move more quickly press and hold or Highlight any result to view the...

Page 60: ...nnect only to a computer certified to UL 60950 1 Use a standard USB cable i e off the shelf NOTE The Mini USB data port is located under the rubber port cover at the bottom of the meter Do Not connect...

Page 61: ...meter is in communication mode Do Not perform a test while the meter is connected to a computer If you insert a test strip a Warning screen will prompt you to disconnect the meter before testing Be a...

Page 62: ...rocedure guidelines for when to perform a linearity test Make sure the meter test strips and linearity solutions are at about the same temperature before testing Perform evaluation of system linearity...

Page 63: ...ly after use to avoid contamination or damage Tightly close the cap on the test strip vial immediately after use to avoid contamination and damage to the test strips Do Not test if there is condensati...

Page 64: ...test strip to the vial after performing a test Do Not use a test strip with bent or broken silver prongs Do Not re use a test strip that had blood control or linearity solution applied to it Test stri...

Page 65: ...Not use but discard test strips after the expiration date printed on the vial or the discard date date opened plus 6 months whichever comes first or test results may be inaccurate 1 From the Main Menu...

Page 66: ...Reminder Control Results Linearity Test Linearity Results 2 Next press or to choose Meter Care and press Meter Care Settings Time 12 45 Date 01 Apr 2011 Language English Yellow 5mm margin Red 7mm marg...

Page 67: ...r Operator s Guide for color codes Wait for the Insert Strip screen to appear Linearity Test Level 1 Level 2 Level 3 Level 4 Level 5 of tests 5 Insert a test strip Insert a test strip into the test st...

Page 68: ...on during a test 6 Prepare the linearity solution Remove the vial cap and place it on a flat surface with the top of the cap pointing up Squeeze the vial to discard the first drop Example Linearity So...

Page 69: ...hese steps are performed to reduce the risk of contamination which may lead to inaccurate linearity solution results Squeeze a drop into the small well on the top of the cap or onto another clean non...

Page 70: ...e test strip to the linearity solution Wait for the channel to fill completely Do Not apply more linearity solution to the test strip after you have moved the test strip away Do Not move the test stri...

Page 71: ...you selected for this test the screen will prompt you to retest using the same solution level or press and the result will be tagged with the solution that was selected If blood is applied to the tes...

Page 72: ...est strips may be considered biohazardous waste in your area Follow your institution s regulations for proper disposal After the test strip is ejected a number appears on the Linearity Test screen to...

Page 73: ...67 NOTE If the linearity test is complete press and hold to return to the Main Menu 11 Cleaning Place the vial cap back on the vial and clean the top of each linearity solution cap with a clean damp...

Page 74: ...ate 01 Apr 2011 Language English Viewing linearity solution test results 1 From the Main Menu press or to select Settings and press Settings History mmol L 01 Apr Serial BCXFF2HK 12 45 Yellow 5mm marg...

Page 75: ...solution are displayed To view this information for the previous day press repeatedly When pressing with Level 5 highlighted the previous day s number of tests for each level of solution will be displ...

Page 76: ...rity Results screen and press Results are displayed in order starting with the most recent To return to previous screen press Press and hold to return to the Main Menu Level 1 Results mmol L Tue 30 Ap...

Page 77: ...es contaminated it must be disinfected following the instructions for the meter If a single meter is used to test more than one patient the meter must be disinfected after each patient whether or not...

Page 78: ...es representative before using an alternative to the recommended disinfectant above as other chemicals may damage the meter Disinfection Instructions m CAUTION Do Not allow liquids dirt dust blood lin...

Page 79: ...ufacturer s instructions If you have questions about disinfecting the meter contact Customer Service and or LifeScan sales representative Hold the meter with the test strip port pointed down Use eithe...

Page 80: ...Use of an incorrect battery type may result in the meter providing fewer tests than normal from when the battery icon or the LOW BATTERY screen first appears m WARNING Batteries that are leaking can d...

Page 81: ...the cover to remove m WARNING To avoid a possible shock Do Not change the batteries while the meter is connected to a computer Lift the cover to open the battery compartment Remove the batteries from...

Page 82: ...ter batteries check that the batteries are correctly installed If the meter still does not power on contact Customer Service and or LifeScan sales representative 3 Check the meter settings Removing th...

Page 83: ...ood and Control Solution Testing Meter is too hot above 44 C to work correctly What to do for Blood and Control Solution Testing Move the meter and test strips to a cooler area Insert a new test strip...

Page 84: ...a cooler area Insert a new test strip when the meter and test strips are within the operating temperature range 18 C 28 C If you do not get another Temperature too high message you can proceed with te...

Page 85: ...nd test strips are within the operating temperature range 6 C 44 C If you do not get another Temperature too low message you can proceed with testing If the error message continues to appear contact C...

Page 86: ...n the operating temperature range 18 C 28 C If you do not get another Temperature too low message you can proceed with testing If the error message continues to appear 30 minutes after moving to a war...

Page 87: ...t with a new test strip see linearity testing pages 62 73 If this message continues to appear contact Customer Service and or LifeScan sales representative Warning Incorrect Sample Detected Retest wit...

Page 88: ...1 1 mmol L 30 Apr 19 00 View Previous What it means The blood glucose level may be very high severe hyperglycemia above 33 3 mmol L What to do Re test the blood glucose level If the result is EXTREME...

Page 89: ...est strip or a problem with the meter What to do Repeat the test with a new test strip see blood application pages 50 54 control solution testing pages 22 31 or linearity testing pages 62 73 If this m...

Page 90: ...ol or linearity solution only after Apply Blood or Apply Solution appears on the display If this message continues to appear contact Customer Service and or LifeScan sales representative ERROR 3 Meter...

Page 91: ...pplied There may be a problem with the meter What to do Repeat the test with a new test strip see blood application pages 50 54 control solution testing pages 22 31 or linearity testing pages 62 73 If...

Page 92: ...r LifeScan sales representative ERROR 5 Strip problem Retest with a new strip What it means Meter battery is low but still has enough power to perform a test What to do Once the Low Battery message is...

Page 93: ...replace the batteries as soon as possible Low Battery Replace soon OK What it means There is not enough battery power to perform a test What to do Replace the meter batteries Warning Battery Empty Re...

Page 94: ...t time 5 seconds Assay method GDH FAD glucose dehydrogenase Unit of measure mmol L Memory 980 blood glucose test results 200 control solution test results 50 linearity solution test results Automatic...

Page 95: ...midity non condensing 10 90 Altitude up to 3048 meters Hematocrit 20 60 Battery type Two replaceable AA alkaline batteries Battery ratings 2 x 1 5V d c 2 x AA alkaline batteries Direct current Technic...

Page 96: ...l L or higher Samples from 100 patients were tested using both the OneTouch Verio Pro System and the YSI 2300 glucose analyzer laboratory instrument System Accuracy Results for Glucose Concentrations...

Page 97: ...475 480 99 8 479 480 System Accuracy Results across the entire Glucose Range Percent and number of meter results that match the laboratory test Within 0 83 mmol L or 20 99 7 598 600 Therefore 99 7 of...

Page 98: ...ouch Verio Pro System compares well with a laboratory method of Subjects of Tests Slope Intercept mmol L 100 600 0 981 0 127 95 CI Slope 95 CI Intercept mmol L Std Error Sy x mmol L R2 0 974 to 0 988...

Page 99: ...l L Coefficient of Variation 2 2 2 4 0 06 2 55 5 6 5 4 0 10 1 88 7 2 7 1 0 14 1 90 11 1 10 8 0 22 2 01 19 4 19 0 0 42 2 18 Results show that the greatest variability observed between test strips when...

Page 100: ...Level Ranges mmol L Mean Glucose mmol L Standard Deviation mmol L Coefficient of Variation Low 1 4 2 7 2 11 0 04 2 11 Mid 5 7 7 7 6 50 0 10 1 53 High 16 5 22 4 18 81 0 33 1 75 Yellow 5mm margin Red 7...

Page 101: ...15 Within 20 59 7 108 181 92 3 167 181 99 4 180 181 100 181 181 Fingertip Results for Glucose Concentrations 4 2 mmol L Percent and number of meter results that match the laboratory test Within 0 28 m...

Page 102: ...the laboratory test Within 0 83 mmol L or 20 100 177 177 Arterial Results across the entire Glucose Range Percent and number of meter results that match the laboratory test Within 0 83 mmol L or 20 99...

Page 103: ...y used are low and not likely to cause interference in nearby electronic equipment The meter has been tested for immunity to Level 3 electrostatic discharge as specified in IEC 61000 4 2 This meter ha...

Page 104: ...lution testing reminder 35 Control solution testing 22 Control solution test results viewing 32 Dehydration 55 Date setting 17 Disinfecting the meter 77 Display check 13 58 Disposal test strips 31 57...

Page 105: ...Lancing device 40 43 Language setting 16 Linearity solution discard and expiration dates 63 65 Linearity solution testing 62 Linearity solution test results viewing 74 Low battery message 93 Main Menu...

Page 106: ...tart up screen 13 58 Storing the system 77 Symbols 3 Technical specifications 94 Temperature 22 40 62 83 84 85 86 95 Test strip applying drop of blood 50 Test strip discard and expiration dates 23 24...

Page 107: ...13 26 48 58 Unexpected blood glucose results 55 56 Unit of measure 11 31 54 71 94 Unusual red blood cell count hematocrit 56 Yellow 5mm margin Red 7mm margin Yellow 5mm margin Red 7mm margin AW0594810...

Page 108: ...108 Notes Yellow 5mm margin Red 7mm margin Yellow 5mm margin Red 7mm margin AW05948101B_OT_VerioPro _OB_Insides_R1 indd 108 4 3 12 3 08 PM...

Page 109: ...o GC Document Number Round Number Other Production Specifications Template OneTouch Lion Owner s Booklet AW 05948101B GC 059481 ADS 03 LCB 03 4 3 12 Marcello Centofanti x4839 LSGSUR4 Covers 5 colors I...