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Owner’s Booklet

Blood Glucose Monitoring System

Summary of Contents for VERIO SYNC

Page 1: ...Blood Glucose Monitoring System Owner s Booklet Instructions for use For use with the App on iPhone iPod touch and iPad...

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Page 3: ...1 Owner s Booklet Blood Glucose Monitoring System...

Page 4: ...e app lets you review and graph your results and helps identify patterns This Owner s Booklet offers a complete explanation of how to use your new meter and testing supplies It reviews the do s and do...

Page 5: ...A compatible Apple device with iOS 4 3 and 5 1 1 Made for iPod touch 3rd and 4th generation iPhone 4S iPhone 4 iPhone 3GS iPad 3rd generation iPad 2 and iPad Visit www OneTouch com for updates on comp...

Page 6: ...information Direct current Consult instructions for use Low battery Empty battery Low battery charging Empty battery charging Last blood glucose result Apply blood Do not apply blood Do not test Bluet...

Page 7: ...device 18 Initial syncing of the meter and app 23 Syncing to send results wirelessly to the app 26 2 Taking a test Testing your blood glucose 30 Testing with control solution 55 3 Viewing your results...

Page 8: ...one and Made for iPad mean that an electronic accessory has been designed to connect specifically to iPod touch iPhone or iPad respectively and has been certified by the developer to meet Apple perfor...

Page 9: ...iseases even after you have performed cleaning and disinfection For more information see FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting B...

Page 10: ...o Sync BGMS is not to be used for the diagnosis of or screening of diabetes or for neonatal use The OneTouch Verio Sync BGMS is also not for use on critically ill patients patients in shock dehydrated...

Page 11: ...ays the blood glucose result and stores it in the meter memory About Bluetooth Bluetooth is a type of wireless RF communication Cell phones use Bluetooth technology as do many other devices Your OneTo...

Page 12: ...tronic devices should not affect the use of your meter With the exception of your iPhone other electronic wireless devices that are in use nearby such as a cell phone or a wireless network may prevent...

Page 13: ...re cell phone use is not permitted such as hospitals some healthcare professional offices and airplanes you should set the meter to Airplane mode Bluetooth off See Step 1 on page 20 for more informati...

Page 14: ...12 The OneTouch Verio Sync Blood Glucose Monitoring System Included with your kit The following item is sold separately A B H G D E C F I...

Page 15: ...rio Level 4 Control Solution You can use either OneTouch Verio Level 3 Control Solution or OneTouch Verio Level 4 Control Solution with your OneTouch Verio Sync Meter For availability of test strips a...

Page 16: ...rn meter on Data Battery charging port Connect to recharge meter battery For downloading results to computer Display Meter button Turns meter on off Dims backlight and turns test strip port light on o...

Page 17: ...15 1 Setting up your system Test strip Channel to apply sample either side Silver prongs Insert into test strip port...

Page 18: ...r Contact Customer Service at 1 888 567 3003 available 7 days a week 8 a m 10 p m Eastern Time Next the Last Result screen appears The arrow indicates that this is the Last Result screen The three das...

Page 19: ...ip will turn them both back on The test strip port light provides additional light that may help you complete a test Five seconds after applying blood or control solution the test strip port light wil...

Page 20: ...ices must be within 10 feet of each other to pair and sync Download the OneTouch Reveal app from the App Store before pairing your meter and Apple device Multiple OneTouch Verio Sync Meters can be pai...

Page 21: ...be paired with one Apple device at a time For example you can pair your meter with an iPod touch iPhone or iPad but not more than one at the same time see Figure 2 m WARNING Do Not pair another person...

Page 22: ...meter button twice quickly 2 To turn on Bluetooth on your Apple device tap the Settings icon on the home screen 3 Then select General NOTE Test result data sent to the app from multiple meters will be...

Page 23: ...and set Bluetooth to ON Your devices are now searching for each other 5 Look for a device named OneTouch followed by the beginning of the Serial Number on the back of your meter This is your meter 6 T...

Page 24: ...22 Setting up your system 1 7 Enter your meter PIN number using the keypad The PIN number can be found on the back of your meter in the box PIN xxxxxx SN V3CHP01 PIN Number 8 Tap Pair...

Page 25: ...nitially sync the meter and app before you start testing your blood glucose The first time you sync the Apple device will set the clock in the meter However you will not see the date and time on the m...

Page 26: ...app to notify you that the meter is communicating with the app NOTE It is important to sync the meter and app before testing for the first time This will ensure that the correct date and time are att...

Page 27: ...l not be set Any glucose results from tests taken before the meter clock is set will not be assigned a date or time and will never be sent to the app With your meter off repeat steps 2 4 on page 24 to...

Page 28: ...cing with the app you are ready to begin testing see pages 30 54 Sync often to send test results wirelessly to the app 1 Open the app on your Apple device 2 Turn your meter on and make sure the Blueto...

Page 29: ...1 4 Syncing Data will appear on the Apple device to let you know the meter is sending results to the app 5 After the Sync the app will display a list of any new blood glucose results sent from the me...

Page 30: ...ime will appear with results unless you have downloaded the app paired your meter with your Apple device and initially synced your meter with the app see pages 18 25 IMPORTANT NOTE If you plan to sync...

Page 31: ...ow these steps 1 Be sure all meters are turned off 2 Open the app on the Apple device 3 Turn the first meter on and be sure Bluetooth is on 4 Wait for the meter to transmit its results 5 Turn the mete...

Page 32: ...erio Test Strips Unlike some blood glucose meters no separate step to code your OneTouch Verio Sync System is required Make sure your meter and test strips are about the same temperature before you te...

Page 33: ...strips are for single use only With clean dry hands you may touch the test strip anywhere on its surface Do Not bend cut or modify the test strip in any way When you first open a vial of test strips r...

Page 34: ...u cannot test due to a problem with your testing supplies contact your healthcare professional Failure to test could delay treatment decisions and lead to a serious medical condition This meter meets...

Page 35: ...p sampling Depth Wheel Cupped Side of Protective Cover Protective Cover OneTouch Delica Lancing Device NOTE The OneTouch Delica Lancing Device uses ONLY OneTouch Delica Lancets If the lancing device s...

Page 36: ...elica Lancing System should not be used to test on the forearm or palm with the OneTouch Verio Sync Blood Glucose Monitoring System m CAUTION To reduce the chance of infection and disease spread by bl...

Page 37: ...h time you test Repeated punctures in the same spot may cause soreness and calluses Before testing wash your hands thoroughly with warm soapy water Rinse and dry completely 1 Remove the lancing device...

Page 38: ...here so that the lancet fits into the lancet holder Push the lancet into the device until it snaps into place and is fully seated in the holder Twist the protective cover one full turn until it separ...

Page 39: ...37 Taking a test 2 3 Replace the lancing device cap Place the cap back onto the device turn clockwise to secure the cap Do Not overtighten...

Page 40: ...umbers are for a deeper puncture Shallower punctures work for children and most adults Deeper punctures work well for people with thick or callused skin Turn the depth wheel to choose the setting NOTE...

Page 41: ...st strip into the test strip port with the gold side of the test strip and the two silver prongs facing you No separate step to code the meter is required Silver prongs Test strip port NOTE When testi...

Page 42: ...ol blinks on the display you can apply your blood sample to either side of the test strip 7 Puncture your finger Hold the lancing device firmly against the side of your finger Press the release button...

Page 43: ...od Gently squeeze and or massage your fingertip until a round drop of blood forms on your fingertip If the blood smears or runs Do Not use that sample Dry the area and gently squeeze another drop of b...

Page 44: ...sample to the test strip You can apply blood to either side of the test strip Apply your sample to the opening of the channel Be sure to apply your sample immediately after you get a drop of blood App...

Page 45: ...gle guide the channel to the blood drop When it touches your sample the test strip wicks blood into the channel NOTE When you apply your blood sample the test strip port light turns off to indicate th...

Page 46: ...strip Do Not smear or scrape the sample with the test strip Do Not press the test strip too firmly against the sample site or the channel may be blocked from filling properly Do Not apply more blood t...

Page 47: ...e results from tests taken before your initial Sync will not be assigned a date and time and will never be sent to the app If mg dL does not appear with the blood glucose result contact Customer Servi...

Page 48: ...ed A list of your synced results will be displayed If Bluetooth on the meter is turned on the Sync symbol will blink next to the Bluetooth symbol on the meter result screen This means that the meter i...

Page 49: ...s correctly paired with your Apple device and initially synced with the app Bluetooth on both devices is turned on indicated by The Apple device and meter are both turned on The app is opened either b...

Page 50: ...the current time in the Apple device If the time difference is greater than 15 minutes you can set the app to prompt you to match the meter time with the time in the Apple device See Chapter 2 Using t...

Page 51: ...lancing device cap Remove the cap by turning it counterclockwise and then pulling it straight off of the device After getting a blood glucose result If left alone the meter will turn off automaticall...

Page 52: ...sh the lancet tip into the cupped side of the cover 3 Eject the lancet Slide the ejection control forward until the lancet comes out of the lancing device Return the ejection control to its back posit...

Page 53: ...lancing device cap Place the cap back onto the device turn clockwise to secure the cap It is important to use a new lancet each time you obtain a blood sample This will help prevent infection and sore...

Page 54: ...after handling the meter test strips lancing device and cap Interpreting unexpected test results Refer to the following cautions when your blood glucose results are higher or lower than what you expec...

Page 55: ...dL it may mean hyperglycemia high blood glucose and you should consider re testing Talk to your healthcare professional if you are concerned about hyperglycemia HI blood glucose results HI is displaye...

Page 56: ...nsistent with your blood glucose results and you have followed all instructions in this Owner s Booklet call your healthcare professional Never ignore symptoms or make significant changes to your diab...

Page 57: ...on OneTouch Verio Level 3 or OneTouch Verio Level 4 with your OneTouch Verio Sync Meter Either level can be used to check your system When you first open a new vial of control solution record the disc...

Page 58: ...ve had repeated unexpected blood glucose results If you drop or damage the meter m CAUTION Do Not swallow or ingest control solution Do Not apply control solution to the skin or eyes as it may cause i...

Page 59: ...est 1 Insert a test strip to turn the meter on Wait for the Apply Blood symbol to blink on the display NOTE The same Apply Blood symbol that blinks during a blood glucose test also appears during a co...

Page 60: ...cap and place it on a flat surface with the top of the cap pointing up Squeeze the vial to discard the first drop Wipe both the tip of the control solution vial and the top of the cap with a clean dam...

Page 61: ...o another clean non absorbent surface 3 Apply the control solution Hold the meter so that the side edge of the test strip is at a slight angle to the drop of control solution Touch the channel on the...

Page 62: ...pear on the display after about 3 seconds Control solution test results are stored in the meter but are not sent to the Apple device Example NOTE If Bluetooth on the meter is turned on the meter will...

Page 63: ...the result is in range Each vial of test strips has both OneTouch Verio Level 3 and OneTouch Verio Level 4 Control Solution ranges printed on its label Compare the result displayed on the meter to ei...

Page 64: ...use the meter test strips or control solution Contact Customer Service at 1 888 567 3003 available 7 days a week 8 a m 10 p m Eastern Time The control solution ranges printed on the test strip vial a...

Page 65: ...63 Taking a test 2 This page left blank intentionally...

Page 66: ...the meter with the app see pages 26 27 Download to a computer to review all results stored in the meter Downloading results to a computer OneTouch Diabetes Management Software DMS can store all of you...

Page 67: ...also used to recharge the meter battery See pages 72 79 for more information Once the command to download is sent from the computer to the meter the meter displays PC This means the meter is in commun...

Page 68: ...ion Cleaning and disinfection are different Both should be performed at least once per week Cleaning is part of your normal care and maintenance but does not kill germs You should clean your meter lan...

Page 69: ...e information on purchase options visit www onetouch com disinfection or contact Customer Service at 1 888 567 3003 Other products such as Clorox Disinfecting Wipes have not been tested and should not...

Page 70: ...ned when they are visibly dirty and before disinfection Clean your meter at least once per week 1 Use a Clorox Germicidal Wipe to wipe the outside of the meter and lancing device To clean your meter h...

Page 71: ...First clean your meter lancing device and cap prior to disinfecting Follow step 1 on the previous page 2 Use a new Clorox Germicidal Wipe to wipe the outside of the meter lancing device and cap until...

Page 72: ...g device and cap Do Not use alcohol or any other solvent Do Not allow liquids dirt dust blood or control solution to enter the test strip port or the data port Do Not squeeze the germicidal wipe into...

Page 73: ...g illegible depth setting numbers and lancing device malfunction such as failure to load cock or release Do Not use your meter or lancing device if you see evidence of such damage If you have question...

Page 74: ...eeded depending on use Using the meter button to turn the meter off will preserve battery power NOTE When the battery can no longer hold a charge the meter needs to be replaced Contact Customer Servic...

Page 75: ...m a test The symbol will appear by itself on the start up screen and blink for several seconds Then the symbol will continue to blink on all screens until the battery is recharged When the Empty Batte...

Page 76: ...io Sync Meter If you misplace the mini USB cable or AC adapter contact Customer Service at 1 888 567 3003 available 7 days a week 8 a m 10 p m Eastern Time Do Not charge meter outdoors or in a wet are...

Page 77: ...meter Start with the meter turned off Insert the mini USB cable into the data battery charging port located on the right side of your meter Verify that the wall outlet voltage matches the AC adapter...

Page 78: ...g the AC adapter into the wall outlet When traveling outside of the United States you may need an adapter to plug the AC charger into a local power outlet A voltage converter is not needed when travel...

Page 79: ...B port on your computer To optimize battery life it is best to recharge the battery when the Low Battery symbol appears see page 90 3 Charge the battery When the meter is connected to a computer or wh...

Page 80: ...your blood glucose After testing reconnect your meter and complete the charge NOTE When the meter is connected to a computer or wall outlet the test strip port light will turn off This indicates that...

Page 81: ...eck that the cable is plugged in correctly If this does not solve the problem contact Customer Service at 1 888 567 3003 available 7 days a week 8 a m 10 p m Eastern Time Even when battery power is ex...

Page 82: ...meter and Apple device is on see pages 20 21 The meter and Apple device are within 10 feet of each other The app is open on the Apple device NOTE Any interruption in transmission will cancel the trans...

Page 83: ...the meter or when your glucose levels are above 600 mg dL or below 20 mg dL Improper use may cause an inaccurate result without producing an error message NOTE If the meter is on but does not operate...

Page 84: ...ose level severe hypoglycemia below 20 mg dL What to do This may require immediate treatment Although this message could be due to a test error it is safer to treat first and then do another test Alwa...

Page 85: ...ans You may have a very high blood glucose level severe hyperglycemia above 600 mg dL What to do Re test your blood glucose level If the result is HI again obtain and follow instructions from your hea...

Page 86: ...at it means One of the following may apply Testing with used test strip Testing with a moist test strip or wet hands Problem with the meter What to do Repeat the test with a new dry test strip see blo...

Page 87: ...ready What to do Repeat the test with a new test strip Apply a blood or control solution sample only after Apply Blood symbol appears on the display If this message continues to appear contact Custom...

Page 88: ...t strip may have been damaged or moved during testing The sample was improperly applied There may be a problem with the meter What to do Repeat the test with a new test strip see blood application pag...

Page 89: ...is test strip damage What to do Repeat the test with a new test strip see blood application pages 42 44 or control solution testing pages 55 62 If the error message appears again contact Customer Ser...

Page 90: ...F to work correctly What to do Move the meter and test strips to a cooler area Insert a new test strip when the meter and test strips are within the operating range 50 111 F If you do not get another...

Page 91: ...F to work correctly What to do Move the meter and test strips to a warmer area Insert a new test strip when the meter and test strips are within the operating range 50 111 F If you do not get another...

Page 92: ...ttery power is low but there is still enough power to perform a test What to do Recharge the battery as soon as possible Blinking Low Battery symbol will continue to be displayed on all screens until...

Page 93: ...eans there is not enough battery power to perform a test What to do Recharge the battery now If you need to test your blood glucose right away charge the meter battery until the Low Battery Charging s...

Page 94: ...hat it means No result in memory such as the first time use of the meter What to do No action is needed You can begin using the meter Make sure to pair and initially sync your meter before beginning t...

Page 95: ...est taken before meter and app were initially synced so no date and time appears with the result This result will never be sent to the app What to do Sync the meter and app to be sure date and time ar...

Page 96: ...94 6 Troubleshooting What it means The meter is connected to a computer and is attempting to download data What to do Do Not test until you have disconnected your meter from the computer...

Page 97: ...95 6 Troubleshooting This page left blank intentionally...

Page 98: ...the same way which may cause a difference of more than 20 Specific factors that may cause your meter result to vary from your lab result by more than 20 include You have eaten recently This can cause...

Page 99: ...eter is working properly Do Not eat for at least 8 hours before you test your blood Take your meter and testing supplies with you to the lab Testing with your OneTouch Verio Sync Meter at the lab Test...

Page 100: ...adenine dinucleotide dependent glucose dehydrogenase Power source Rechargeable 3 7 Volt Lithium Ion battery Expected meter battery life At least one week between charges Charging current 100mAh Direc...

Page 101: ...tely 1 7 ounces Operating ranges Temperature 50 111 F Relative humidity non condensing 10 90 Altitude up to 10 000 feet Hematocrit 20 60 Battery type Rechargeable non serviceable 150mAh 3 7 Volt DC no...

Page 102: ...ns Sharing iPod touch 4th generation WiFi Email 3rd generation iPhone iPhone 4S 4G 3G WiFi SMS Email iPhone 4 iPhone 3GS iPad iPad 3rd generation 4G LTE 3G WiFi iMessage Email iPad 2 iPad Standard tex...

Page 103: ...20 of a laboratory method when the glucose concentration is 75 mg dL or higher Samples from 100 patients were tested using both the OneTouch Verio Sync System and the YSI Model 2300 Glucose Analyzer...

Page 104: ...n 5 Within 10 Within 15 Within 20 71 6 174 243 96 7 235 243 99 6 242 243 100 0 243 243 System Accuracy Results across the entire Glucose Range Percent and number of meter results that match the labora...

Page 105: ...ted in duplicate on three test strip lots Results indicate that the OneTouch Verio Sync System compares well with a laboratory method of Subjects of Tests Slope Intercept mg dL 100 300 0 99 2 61 95 CI...

Page 106: ...2 55 2 52 130 134 04 2 98 2 22 200 199 76 4 64 2 32 350 345 58 9 07 2 62 Results show that the greatest variability observed between test strips when tested with blood is 2 62 or less Total Precision...

Page 107: ...esults that match the laboratory test Within 5 mg dL Within 10 mg dL Within 15 mg dL 21 7 5 23 65 2 15 23 95 7 22 23 Fingertip Results for Glucose Concentrations 75 mg dL Percent and number of meter r...

Page 108: ...This meter complies with CISPR 11 2009 Class B Radiated Only Emissions of the energy used are low and not likely to cause interference in nearby electronic equipment The meter has been tested for immu...

Page 109: ...4 75 Cleaning your meter lancing device and cap 68 Comparing meter results to laboratory results 96 Control solution discard and expiration dates 55 56 Control solution testing 55 Data port USB 14 75...

Page 110: ...ended use 8 Kit components 12 13 Lancing device 13 33 Last result 64 LO glucose message 52 82 Low battery charging symbol 4 77 78 Low battery symbol 4 73 77 90 Meter only using it without the app 28 m...

Page 111: ...erature 30 62 66 88 89 98 99 Test strip applying drop of blood 42 44 Test strip discard and expiration dates 31 32 Test strip silver prongs 15 39 57 Test strip port light 14 17 39 Time setting 23 25 T...

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Page 116: ...d 7 846 312 Use of the monitoring device included herein is protected under one or more of the following U S patents 6 413 410 7 749 371 and 8 163 162 Purchase of LifeScan meter does not act to grant...

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