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User Manual | Users Manual | 4.87 MiB | June 05 2015 / February 11 2015 | |||
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Label | ID Label/Location Info | 558.41 KiB | January 22 2015 | |||
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1 2 3 4 | Cover Letter(s) | June 05 2015 / July 05 2015 | ||||||
1 2 3 4 | Cover Letter(s) | June 05 2015 / July 05 2015 | ||||||
1 2 3 4 | Cover Letter(s) | June 05 2015 / July 05 2015 | ||||||
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1 2 3 4 | Test Report | June 05 2015 / July 05 2015 | ||||||
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1 2 3 4 | Block Diagram | Block Diagram | January 22 2015 | confidential | ||||
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Confidentiality of photos | Cover Letter(s) | 29.19 KiB | January 22 2015 | |||
1 2 3 4 | Internal Photos | Internal Photos | January 22 2015 | confidential | ||||
1 2 3 4 | Operation Description | Operational Description | January 22 2015 | confidential | ||||
1 2 3 4 | Operation Description TRx | Operational Description | January 22 2015 | confidential | ||||
1 2 3 4 | Parts List | Parts List/Tune Up Info | January 22 2015 | confidential | ||||
1 2 3 4 | RF Exposure Info | January 22 2015 | ||||||
1 2 3 4 | Schematics 01 | Schematics | January 22 2015 | confidential | ||||
1 2 3 4 | Schematics 02 | Schematics | January 22 2015 | confidential | ||||
1 2 3 4 | Test Setup Photos | January 22 2015 / July 21 2015 |
1 2 3 4 | User Manual | Users Manual | 4.87 MiB | June 05 2015 / February 11 2015 |
Ultra Plus Flex Blood Glucose Monitoring System Owner's Booklet 1 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 1 1/27/15 4:35 PM Yellow= 5mm Red=7mm margin Thanks for choosing OneTouch!
The OneTouchUltra Plus Flex Blood Glucose Monitoring System is one of the latest product innovations from OneTouch. Your OneTouchUltra Plus Flex Meter is designed to connect (sync) with a variety of devices running software applications that let you review and graph your results, and help identify patterns. Meter results are sent to the compatible devices either through BLUETOOTH SMART
(wireless) or USB cable connection. Every OneTouch Meter is designed to help you test your blood glucose and manage your diabetes. This Owner's Booklet offers a complete explanation of how to use your new meter and testing supplies. It reviews the do's and don'ts of testing your blood glucose level. Please keep your Owner's Booklet in a safe place; you may want to refer to it in the future. We hope OneTouch products and services will continue to be a part of your life. 2 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 2 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Compatible Wireless Devices Visit www.LifeScan.co.uk for information on which wireless devices are compatible with your OneTouchUltra Plus Flex Meter, and where/how to download the software application on your compatible wireless device. Meter symbols and icons Meter Power Low Battery Battery Empty Control Solution Syncing BLUETOOTH SMART Feature On History Mode (Past results) Apply Sample Range Indicator Arrow Setting Mode 3 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 3 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Other symbols and icons Cautions and Warnings: Refer to the Owner's Booklet and inserts that came with your system for safety-related information. Direct current Consult Instructions for Use Manufacturer Lot Number Serial Number Storage Temperature Limits In Vitro Diagnostic Device Do Not Re-use Sterilized by irradiation Not for general waste Use By Date Contains sufficient for n tests Underwriters Laboratories certification 4 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 4 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Before you begin Before using this product to test your blood glucose, carefully read this Owner's Booklet, and the inserts that come with the OneTouch Ultra Plus Test Strips, OneTouch Ultra Plus Control Solutions and the OneTouchDelica Lancing Device. IMPORTANT SAFETY INSTRUCTIONS:
This meter and lancing device are for single patient use only. Do Not share them with anyone else, including family members! Do Not use on multiple patients!
After use and exposure to blood, all parts of this kit are considered biohazardous. A used kit may potentially transmit infectious diseases even after you have performed cleaning and disinfection. 5 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 5 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Intended use The OneTouchUltra Plus Flex Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The system is intended to be used by a single patient and should not be shared. The OneTouchUltra Plus Flex Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and with their healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouchUltra Plus Flex Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use. 6 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 6 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Test principle Glucose in the blood sample mixes with the enzyme FAD-GDH (see page100) in the test strip and a small electric current is produced. The strength of this current calculates your blood glucose level. It then displays the blood glucose result and stores it in the meter memory. Use only OneTouch Ultra Plus Control Solutions and Test Strips with the OneTouchUltra Plus Flex Meter. BLUETOOTH SMART wireless technology BLUETOOTH SMART wireless technology is used by some smartphones and many other devices. Your OneTouchUltra Plus Flex Meter uses BLUETOOTH SMART wireless technology to pair and to send your glucose results to compatible wireless devices. The OneTouchUltra Plus Flex Meter is designed to work with the OneTouchReveal Mobile App and many other diabetes applications on compatible wireless devices. NOTE: Some diabetes management apps, including the OneTouchReveal Mobile App, may not be available in your country. Visit www.LifeScan.co.uk to learn if the OneTouchReveal Mobile App is available in your country. 7 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 7 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 8 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin These guidelines help ensure that your meter will not affect the operation of other nearby electronic devices. Additionally, other electronic devices should not affect the use of your meter. WARNING: The BLUETOOTH SMART feature on your meter sends test results to your compatible wireless device. To prevent other people's results from being sent to your compatible wireless device, Do Not let anyone else use your meter to test their blood glucose. This meter is for single patient use only. WARNING: In locations where cell phone use is not permitted, such as hospitals, some healthcare professional offices and airplanes, you should turn the BLUETOOTH SMART feature off. See page27 for more information. BLUETOOTH SMART trademark The BLUETOOTH SMART word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by LifeScan Europe is under license. Other trademarks and trade names are those of their respective owners. 9 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 9 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Table of Contents 1Getting to know your system ................................... 12 2Setting up your system ............................................ 22 Setting up your meter ..................................................... 22 Connecting to a compatible wireless device ............... 27 Turning the meter off ...................................................... 33 3Taking a test .............................................................. 34 Testing your blood glucose ............................................ 34 Testing with control solution.......................................... 58 4Reviewing past results ............................................ 68 10 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 10 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 5Editing Your Settings ............................................... 74 Editing time and date ..................................................... 74 Editing your range limits ................................................ 75 6Caring for your system ............................................ 78 7Battery ....................................................................... 82 8Troubleshooting your system ................................. 86 9Detailed information about your system .............96 10Index ........................................................................ 108 11 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 11 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 1Getting to know your system Your OneTouchUltra Plus Flex Blood Glucose Monitoring System Included with your kit:
OneTouchUltra Plus Flex Meter (CR2032 lithium coin cell battery included) Lancing device Lancets 12 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 12 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Getting to know your system NOTE: If any item is missing or defective in your kit, contact Customer Service. Call OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland) during the hours of 8:30am-6pm Monday-Friday, 9am-1pm Saturday. Or visit www.LifeScan.co.uk. NOTE: If another type of lancing device was included, see the separate instructions for that lancing device. 13 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 13 1/27/15 4:35 PM 1 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Getting to know your system Available separately:
Items pictured below are required, but may not be included in your kit:
They are sold separately. Refer to your meter carton for a list of included items. OneTouch Ultra Plus Mid Control OneTouch Ultra Plus High Control OneTouch Ultra Plus Test Strips*
Solution*
Solution*
(vial with blue cap)
(vial with red cap)
*OneTouch Ultra Plus Control Solution and Test Strips are available separately. For availability of test strips and control solution, contact Customer Service or ask your pharmacist or healthcare professional. You can use either OneTouch Ultra Plus Mid Control Solution or OneTouch Ultra Plus High Control Solution with your OneTouchUltra Plus Flex Meter. 14 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 14 1/27/15 4:35 PM 1 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Getting to know your system WARNING: Keep the meter and testing supplies away from young children. Small items such as the battery door, batteries, test strips, lancets, protective covers on the lancets, and control solution vial cap are choking hazards. Do Not ingest or swallow any items. 15 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 15 1/27/15 4:35 PM 1 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Getting to know your system Getting to know your OneTouchUltra Plus Flex Blood Glucose Monitoring System Meter 16 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 16 1/27/15 4:35 PM 1 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Getting to know your system 17 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 17 1/27/15 4:35 PM 1 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Getting to know your system Getting to know your OneTouch Ultra Plus Test Strip Test strip 18 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 18 1/27/15 4:35 PM 1 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Getting to know your system The Range Indicator feature The OneTouchUltra Plus Flex Meter automatically lets you know if your current result is below, above or within your range limits. It does this by displaying your current result with a Range Indicator Arrow, pointing to a corresponding Range Indicator Color Bar below the meter display. Use the Range Indicator Arrow and Color Bar together to interpret your results. 19 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 19 1/27/15 4:35 PM 1 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Getting to know your system 3 Possible Range Indicator Displays A Range Indicator Arrow will appear just below your result after each test depending upon how you set your low and high range limits in the meter. Things you should know before using the Range Indicator feature:
The meter comes with pre-set range limits. The pre-set low range limit is 3.9mmol/L and the pre-set high range limit is 10.0mmol/L. You can change these limits as needed to meet your needs. See page75 for details on the pre-set range limits and on editing your range limits. If you decide to change your range limits, the Range Indicator Arrows stored with previous results in meter memory will not change. However, any new tests will display Range Indicator Arrows which reflect your changes. 20 Example Below Range Result Example In Range Result Example Above Range Result 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 20 1/27/15 4:35 PM 1 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Getting to know your system This page left blank intentionally. 21 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 21 1/27/15 4:35 PM 1 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 2Setting up your system Setting up your meter Turn your meter on To turn your meter on, press and hold until the start-up test screen appears. Once the device is on, release
. You can also turn the meter on by inserting a test strip. Every time you turn your meter on, a start-up screen will appear for a few seconds. All segments of the display should appear briefly, indicating your meter is working properly. If the meter does not power on, check the battery. CAUTION:
If you see any missing segments within the start-up screen, there may be a problem with the meter. Contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). NOTE: If you turned the meter on for the first time by
, you will not inserting a test strip instead of pressing be able to perform a glucose test until you complete the first time setup. 22 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 22 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system First time setup To turn your meter on, press and hold up screen appears. Once the device is on, release The meter will now automatically prompt you to set the time and date. The SET icon will appear on the screen to indicate that the meter has entered setup mode. until the start-
. Setting the time Hour will flash If the hour displayed to is correct, press confirm. If the hour displayed is not correct, press to change the hour and press or to confirm. Minutes will flash If the minutes displayed is correct, press confirm. to If the minutes displayed is not correct, press to change the minutes and press to confirm. or 23 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 23 1/27/15 4:35 PM 2 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system Setting the date After completing the time setup, the meter will automatically move to date setup. Year will flash If the year displayed is correct, press confirm. to If the year displayed is not correct, press to change the year and press or to confirm. Month will flash If the month displayed to is correct, press confirm. not correct, press If the month displayed is or to change the month to confirm. and press 24 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 24 1/27/15 4:35 PM 2Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system Day will flash If the day displayed is correct, press confirm. to If the day displayed is not correct, press to change the day and press or to confirm. You are now ready to take a test. See the section Testing your blood glucose in Chapter 3. NOTE: After completing first time setup, a screen with three dashes will appear. Once you begin testing, your last result will appear in place of the three dashes, along with the date and time the test was taken. 25 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 25 1/27/15 4:35 PM 2 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system Adjusting the time and date settings after first time setup You can adjust the meter's time and date settings after to turn the meter on, first time setup. Press and hold then press and hold screen will appear. See page74. at the same time. The SET and After adjusting the settings, your meter will exit settings mode and your last result screen will appear. 26 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 26 1/27/15 4:35 PM 2Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system Connecting to a compatible wireless device Turning the BLUETOOTH SMART feature on or off In order to connect your meter with your compatible wireless device, the BLUETOOTH SMART feature will symbol will appear on the need to be turned on. The meter screen when the BLUETOOTH SMART feature is on. When the symbol is not present on the screen the BLUETOOTH SMART feature is off. To turn the BLUETOOTH SMART feature on press and at the same time. To turn the BLUETOOTH SMART feature off press and at the same time. symbol indicates The the BLUETOOTH SMART feature is on NOTE: The BLUETOOTH SMART feature will turn OFF during a blood glucose test. 27 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 27 1/27/15 4:35 PM 2 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system Pairing Overview Pairing allows your OneTouchUltra Plus Flex Meter to communicate with compatible wireless devices. The devices must be within 8meters of each other to pair and sync. Download the OneTouchReveal Mobile App from the appropriate app store before pairing your meter and compatible wireless device. NOTE: Some diabetes management apps, including the OneTouchReveal Mobile App, may not be available in your country. Visit www.LifeScan.co.uk to learn if the OneTouchReveal Mobile App is available in your country. Multiple OneTouchUltra Plus Flex Meters can be paired with your compatible wireless device. For example, your compatible wireless device can be paired with a meter at home and another at work. To pair multiple meters, repeat the pairing instructions for each meter. See page29 for pairing instructions. Your OneTouchUltra Plus Flex Meter can be paired with multiple compatible wireless devices. To pair multiple compatible wireless devices, repeat the pairing instructions for each compatible wireless device. 28 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 28 1/27/15 4:35 PM 2Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system Pairing Instructions 1. Start by turning your meter on using the 2. The BLUETOOTH SMART feature is turned on by pressing The indicate that the BLUETOOTH SMART feature is on. together symbol will appear to and button 3. Open the OneTouchReveal Mobile App and follow instructions to pair meter with your compatible wireless device 29 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 29 1/27/15 4:35 PM 2 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system 4. Look for "OneTouch" and the last 4 characters of the meter serial number on the compatible wireless device display to correctly identify your meter 30 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 30 1/27/15 4:35 PM 2Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system 5. When prompted by the OneTouchReveal Mobile App, the meter will display a six digit PIN number Enter the PIN number into your wireless compatible device using the keypad on your compatible wireless device. CAUTION:
Make sure the PIN you enter on your compatible device matches the PIN on your meter display. If a PIN number unexpectedly appears on your meter display, cancel the PIN request by either inserting a test strip to take a test or press the button to enter History Mode. Example of PIN number display on meter 6. Wait for your compatible wireless device to indicate that your meter and compatible wireless device are paired 31 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 31 1/27/15 4:35 PM 2 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system Syncing to send results wirelessly to the OneTouchReveal Mobile App After pairing the meter with your compatible wireless device, you are ready to send results to the OneTouchReveal Mobile App. 1. Open the OneTouchReveal Mobile App on your compatible wireless device to turn the meter on and make sure 2. Press and hold the BLUETOOTH SMART feature is ON as indicated by ( ) at the same time to turn the If needed, press BLUETOOTH SMART feature on. and
) The Sync symbol (
flashes on the meter display.
"Syncing Data" will appear on the app to notify you that the meter is communicating with the app. Syncing Data After syncing, the Sync symbol will disappear, the
"Syncing Data" message will disappear on the app, and the app will display a list of any new results sent from the meter. NOTE: Inserting a test strip during the transmission will symbol cancel the transfer of all results. The flashing appears on the screen and you can proceed with testing. 32 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 32 1/27/15 4:35 PM 2Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Setting up your system Turning the meter off There are three ways to turn your meter off:
Press and hold for several seconds until the meter turns off. Remove the test strip. Your meter will turn off by itself if left alone for two minutes. NOTE: Following a glucose test, the meter will still be available for BLUETOOTH SMART connection for up to 4 hours. See page69 for more details. 33 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 33 1/27/15 4:35 PM 2 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 3Taking a test Testing your blood glucose Preparing for a blood glucose test NOTE: Many people find it helpful to practice testing with control solution before testing with blood for the first time. See page58. Have these things ready when you test:
OneTouchUltra Plus Flex Meter OneTouch Ultra Plus Test Strips Lancing device Sterile lancets NOTE:
Use only OneTouch Ultra Plus Test Strips. Unlike some blood glucose meters, no separate step to code your OneTouchUltra Plus Flex System is required. Testing must be done within operating temperature range (6-44C). Make sure your meter and test strips are about the same temperature before you test. Keep test strips in a cool, dry place between 5C and 30C. 34 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 34 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Do Not test if there is condensation (water build-up) on your meter. Move your meter and test strips to a cool, dry spot and wait for the meter surface to dry before testing. Do Not open the test strip vial until you are ready to remove a test strip and perform a test. Use the test strip immediately after removing it from the vial. Tightly close the cap on the vial immediately after use to avoid contamination and damage. Store unused test strips only in their original vial. Do Not return the used test strip to the vial after performing a test. Do Not re-use a test strip that had blood, control solution, or any contaminants applied to it. Test 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, record the discard date on the label. Refer to the test strip insert or vial label for instructions on determining the discard date. 35 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 35 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Comparing your blood glucose test results taken with this meter to your results taken from a different meter is not recommended. Results may differ between meters and are not a useful measure of whether your meter is working properly. To check your meter accuracy, you should periodically compare your meter results to those obtained from a lab. See page96 for more information. IMPORTANT: If another person assists you with testing, the meter should always be cleaned prior to use by that person. See page78. CAUTION:
The OneTouchUltra Plus Flex Blood Glucose Monitoring System should not be used for patients within 24 hours of receiving a D-xylose absorption test as it may cause inaccurately high results. Do Not use the OneTouch Ultra Plus Flex Family of Meters when PAM (Pralidoxime) is known or suspected to be in the patient's whole blood sample. Do Not use your test strips if your vial is damaged or left open to air. This could lead to error messages or inaccurate results. Contact Customer Service immediately if the test strip vial is damaged. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). 36 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 36 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test If you 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. The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation. Do Not use test strips after the expiration date (printed on the vial) or the discard date, whichever comes first, or your results may be inaccurate. 37 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 37 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Getting to know your OneTouchDelica Lancing Device 38 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 38 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test NOTE:
The OneTouchDelica Lancing Device uses ONLY OneTouchDelica Lancets. If another type of lancing device was included, see the separate instructions for that lancing device. The OneTouchUltra Plus Flex Blood Glucose Monitoring System has not been evaluated for Alternate Site Testing (AST). Use only fingertips when testing with the system. The OneTouchDelica Lancing System does not include the materials needed to perform Alternate Site Testing (AST). The OneTouchDelica Lancing System should not be used on the forearm or palm with the OneTouchUltra Plus Flex Blood Glucose Monitoring System. 39 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 39 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Lancing precautions CAUTION:
To reduce the chance of infection and disease spread by blood:
Make sure to wash the sample site with soap and warm water, rinse and dry before sampling. The lancing device is intended for a single user. Never share a lancet or lancing device with anyone. Always use a new, sterile lancet each time you test. Always keep your meter and lancing device clean (See page78). The meter and lancing device are for single patient use only. Do Not share them with anyone, including family members! Do Not use on multiple patients!
After use and exposure to blood, all parts of this kit are considered biohazardous. A used kit may transmit infectious diseases even after you have performed cleaning and disinfection. 40 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 40 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Preparing the lancing device 1. Remove the lancing device cap Remove the cap by turning it counterclockwise and then pulling it straight off of the device. 41 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 41 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test 2. Insert a sterile lancet into the lancing device Align the lancet as shown 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 separates from the lancet. Save the protective cover for lancet removal and disposal. See page55. 42 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 42 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test 3. Replace the lancing device cap Place the cap back onto the device; turn clockwise to secure the cap. Do Not overtighten. 43 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 43 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test 4. Adjust the depth setting The lancing device has seven puncture depth settings, numbered 1 through 7. Smaller numbers are for a shallower puncture and the larger numbers 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: A shallower fingertip puncture may be less painful. Try a shallower setting first and increase the depth until you find the one deep enough to get a blood sample of the proper size. 5. Cock the lancing device Slide the cocking control back until it clicks. If it does not click, it may already have been cocked when you inserted the lancet. 44 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 44 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Preparing the meter 1. Insert a test strip to turn the meter on Insert a test strip into the test strip port with the gold side of the test strip and the two silver prongs facing you. NOTE: No separate step to code the meter is required. The flashing blood drop icon
) appears on the display.
(
You can now apply your blood sample to the test strip. 45 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 45 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Getting a blood sample from the fingertip Choose a different puncture site each 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. Puncture your finger Hold the lancing device firmly against the side of your finger. Press the release button. Remove the lancing device from your finger. 46 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 46 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Getting a blood sample from the fingertip Repeated punctures in the same spot may cause soreness Before testing, wash your hands thoroughly with warm, 2. Get a round drop of blood Gently squeeze and/or massage your fingertip until a round drop of blood forms on your fingertip. NOTE: If the blood smears or runs, Do Not use that sample. Dry the area and gently squeeze another drop of blood or puncture a new site. 47 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 47 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Applying blood and reading results Applying the sample 1. Apply the 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. Holding the meter at a slight angle, guide the channel to the blood drop. 48 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 48 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Be sure to apply your sample immediately after you get a Taking a test When it touches your sample, the test strip wicks blood into the channel. 2. Wait for the channel to fill completely The blood drop will be drawn into the narrow channel. The channel should fill completely. The channel turns red and the meter will count down from 5 to 1. Blood should not be applied on the top of the test strip or to the top edge of the test strip. 49 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 49 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test NOTE:
Do Not smear or scrape the sample 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 moved the drop of blood away. Do Not move the test strip in the meter during a test or you may get an error message or the meter may turn off. Do Not remove the test strip until the result is displayed or the meter will turn off. 50 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 50 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Viewing your result Your result appears on the display, along with the unit of measure, and the date and time of the test. After your glucose result appears, the meter will also display a Range Indicator Arrow below your glucose result to indicate if your result is below, above or within your range limits (see page19). The arrow will point to the appropriate Range Indicator Color Bar on the meter as a visual reminder. CAUTION:
Do Not make immediate treatment decisions based on the Range Indicator feature. Treatment decisions should be based on the numerical result and healthcare professional recommendation and not solely on where your result falls within your range limits. Example Below Range Result Example In Range Result Example Above Range Result WARNING: Confirm that the unit of measure mmol/L is displayed. If your display shows mg/dL rather than mmol/L, stop using the meter and contact Customer Service. 51 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 51 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Interpreting unexpected results Refer to the following cautions when your results are higher or lower than what you expect. CAUTION:
Low results If your result is below 3.9mmol/L or is shown as LO (meaning the result is less than 1.1mmol/L), it may mean hypoglycemia (low blood glucose). This may require immediate treatment according to your healthcare professional's recommendations. Although this result could be due to a test error, it is safer to treat first, then do another test. NOTE: When your glucose result is below 1.1mmol/L, both the LO and the Range Indicator Arrow will flash on the meter screen. CAUTION:
Dehydration and low results You may get false low results if you are severely dehydrated. If you think you are severely dehydrated, contact your healthcare professional immediately. 52 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 52 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test CAUTION:
High results If your result is above 10.0mmol/L, 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 is displayed when your result is over 33.3mmol/L. You may have severe hyperglycemia (very high blood glucose). Re-
test your blood glucose level. If the result is HI again, this indicates a severe problem with your blood glucose control. Obtain and follow instructions from your healthcare professional immediately. NOTE: When your glucose result is above 33.3mmol/L, both the HI and the Range Indicator Arrow will flash on the meter screen. 53 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 53 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test CAUTION:
Repeated unexpected results If you continue to get unexpected results, check your system with control solution. If you are experiencing symptoms that are not consistent with your 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 diabetes management program without speaking to your healthcare professional. Unusual red blood cell count A hematocrit (percentage of your blood that is red blood cells) that is either very high (above 60%) or very low
(below 20%) can cause false results. 54 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 54 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Removing the used lancet NOTE: This lancing device has an ejection feature, so you do not have to pull out the used lancet. 1. Remove the lancing device cap Remove the cap by turning it counterclockwise and then pulling it straight off of the device. 2. Cover the exposed lancet tip Before removing the lancet, place the lancet protective cover on a hard surface then push the lancet tip into the cupped side of the cover. 55 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 55 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test 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 position. If the lancet fails to eject properly, cock the device again and then slide the ejection control forward until the lancet comes out. 56 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 56 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test 4. Replace the lancing device cap Place the cap back onto the device; turn clockwise to secure the cap. Do Not overtighten. It is important to use a new lancet each time you obtain a blood sample. Do Not leave a lancet in the lancing device. This will help prevent infection and sore fingertips. 57 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 57 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Disposing of the used lancet and test strip Discard the used lancet carefully after each use to avoid unintended lancet stick injuries. Used lancets and test strips may be considered biohazardous waste in your area. Be sure to follow your healthcare professional's recommendations or local regulations for proper disposal. Wash hands thoroughly with soap and water after handling the meter, test strips, lancing device and cap. Testing with control solution Control solution testing precautions OneTouch Ultra Plus Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. (Control solution is available separately.) NOTE:
Use only OneTouch Ultra Plus Mid Control Solution or OneTouch Ultra Plus High Control Solution with your OneTouchUltra Plus Flex Meter. Either level can be used to check your system. When you first open a new vial of control solution, record the discard date on the vial label. Refer to the control solution insert or vial label for instructions on determining the discard date. 58 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 58 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Tightly close the cap on the control solution vial immediately after use to avoid contamination or damage. See page34 for more information on testing. CAUTION:
Do Not swallow or ingest control solution. Do Not apply control solution to the skin, eyes, ears or nose as it may cause irritation. Do Not use control solution after the expiration date (printed on the vial label) or the discard date, whichever comes first, or your results may be inaccurate. 59 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 59 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test When to do a control solution test When you open a new vial of test strips. If you suspect that the meter or test strips are not working properly. If you have had repeated unexpected blood glucose readings. If you drop or damage the meter. Preparing your meter for a control solution test 1. Insert a test strip to turn the meter on 60 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 60 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test 2. Wait for the flashing blood drop icon (
) to appear on the display or 3. Press control solution icon (
appears on the display until the
) Preparing your meter for a control solution Preparing the control solution 1. Before removing the cap, shake the vial gently 2. Remove the vial cap and place it on a flat surface with the top of the cap pointing up 3. Squeeze the vial to discard the first drop 61 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 61 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test 4. Wipe both the tip of the control solution vial and the top of the cap with a clean, damp tissue or cloth 5. Squeeze a drop into the small well on the top of the cap or onto another clean, non-absorbent surface 62 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 62 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Applying the control solution 1. Hold the meter so that the side edge of the test strip is at a slight angle to the drop of control solution 2. Touch the channel on the side of the test strip to the control solution 3. Wait for the channel to fill completely 63 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 63 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Viewing your control solution result After the control solution is applied, the meter will count down until the test is complete. Your result is displayed along with the date, time, unit of measure, and
(for control solution) and stored in the meter. Control solution results can be seen when reviewing past results on the meter. or CAUTION: Make sure you press until the control appears before you begin a control solution solution icon test. Invalid results may be logged into your history if you applied control solution to the test strip without following the steps beginning on page60. 64 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 64 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Checking if the result is in range Compare the result displayed on the meter to the range printed on your OneTouch Ultra Plus Control Solution vial. If your control solution result falls outside the expected range, repeat the test with a new test strip. Example range OneTouch Ultra Plus Mid Control Solution Control Range 5.7-7.7mmol/L OneTouch Ultra Plus High Control Solution Control Range 16.5-22.4mmol/L CAUTION:
The range printed on the control solution vial is for control solution tests only and is not a recommended range for your blood glucose level. 65 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 65 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Causes of out-of-range results Out-of-range results may be due to:
Not following the instructions for performing a control solution test. Control solution is contaminated, expired, or past its discard date. Test strip or test strip vial is damaged, expired, or past its discard date. Meter, test strips and/or control solution were not all at the same temperature when the control solution test was performed. A problem with the meter. Dirt or contamination in the small well on the top of the control solution cap. CAUTION:
If you continue to get control solution results that fall outside the range printed on the control solution vial, Do Not use the meter, test strips, or control solution. Contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). 66 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 66 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Taking a test Cleaning the control solution cap Clean the top of the control solution cap with a clean, damp tissue or cloth. 67 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 67 1/27/15 4:35 PM 3 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 4Reviewing past results Reviewing past results on your meter Your meter stores your most recent 500 blood glucose and control solution test results and displays them in the order the tests were taken. The (
) symbol will appear on your screen when in History Mode. 1. When the meter is off, press and hold History Mode on The (
results.
) symbol indicates you are viewing your past to turn
) symbol indicates if the result was below, The (
above or within range at the time of the test, by pointing to the appropriate color bar. 2. Scroll through your results by pressing backwards and to move forward through your results to move 68 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 68 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Reviewing past results Using the meter without syncing to an app The meter can be used without a compatible wireless device or the app. You can still test your blood glucose and review up to 500 results on the meter. Sending your results to the app If the BLUETOOTH SMART feature on the meter is turned on, indicated by the BLUETOOTH SMART symbol ( ), the meter will automatically send the latest result to any paired wireless compatible device. The compatible wireless device must have the app running and have already been paired to the meter before sending a result. NOTE: The compatible wireless device must have the app open and have already been paired to the meter before sending a result. See page28. NOTE: If the BLUETOOTH SMART feature on the meter is turned off, or the meter is out of range, the result is not sent to the compatible wireless device. The result is saved in the meter memory with the current date and time, and will be sent to the app the next time you sync. The sent results are also stored in the meter. To sync, the app must be open and running on your compatible wireless device. 69 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 69 1/27/15 4:35 PM 4 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Reviewing past results To ensure that glucose test results are successfully sent to the app, turn on the BLUETOOTH SMART feature and check the following:
The compatible wireless device and meter are both turned on, and the app is running. The meter is correctly paired with your compatible wireless device. The Bluetooth feature on both devices is running
(indicated by ) and the devices are within 8meters of each other. The meter will attempt to transmit results up to 4 hours after a test, even if the meter appears to be off. This is indicated by the BLUETOOTH SMART symbol ( ) remaining on the meter screen. Example 70 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 70 1/27/15 4:35 PM 4 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Reviewing past results If you are still unable to send results to the compatible wireless device, please call Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). NOTE: Inserting a test strip during the transmission will cancel the transfer of all results. The the screen and you can proceed with testing. symbol appears on 71 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 71 1/27/15 4:35 PM 4 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Reviewing past results Downloading results to a computer Your meter can work with diabetes management software, which provides a visual way to track key factors that affect your blood sugar. To learn more about diabetes management tools available to you, contact Customer Service. Call OneTouch Customer Care on 0800121200
(UK) or 1800535 676 (Ireland) during the hours of 8:30am-6pm Monday-Friday, 9am-1pm Saturday. Or visit www.LifeScan.co.uk. Connect only to a computer certified to UL 60950-1 (
). To transfer meter data, follow the instructions provided with the diabetes management software product to download the results from the meter. You will need a standard micro USB interface cable to connect your OneTouchUltra Plus Flex Meter to a computer to download results (not included). 72 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 72 1/27/15 4:35 PM 4 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Your meter can work with diabetes management software, Service. Call OneTouch Customer Care on 0800121200 8:30am-6pm Monday-Friday, 9am-1pm Saturday. Or visit Reviewing past results Once the command to start the download is sent from the computer to the meter, the meter display will show the flashing Sync symbol (
) indicating that the meter is in communication mode. Do Not insert a test strip while the meter is connected to a computer. To transfer meter data, follow the instructions provided
). If you are unable to download your results to a computer, please call Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). 73 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 73 1/27/15 4:35 PM 4 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 5Editing Your Settings Editing time and date You can adjust the meter's time and date settings after first time setup. Press and hold to turn the meter on, then press and hold screen will appear, and the hour will flash. at the same time. The SET and For instructions on adjusting the time and date, see page23. After adjusting the settings, you will exit settings mode and your last glucose result screen will appear. The adjusted time and date will be displayed once a new glucose test has been completed and the result appears on the screen. NOTE: You will not be able to perform a blood glucose test until you finish editing the time and date. NOTE: The OneTouchReveal Mobile App on your compatible wireless device checks and updates the time and date in your meter each time you sync. Check the time and date often on your compatible wireless device to be sure they are correct. See the App instructions for more information. 74 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 74 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Editing Your Settings Editing your range limits Your meter uses low and high range limits to tell you when your result is below, above or within your set range. The meter comes with pre-set range limits that can be changed. The pre-set low range limit is 3.9mmol/L and the pre-set high range limit is 10.0mmol/L. To edit the pre-set range limits press and hold at the same time. The SET screen will appear with the current low range limit displayed, and the number and range indicator arrow will flash. and NOTE: The low and high range limits you set apply to all glucose test results. This includes tests taken before or after mealtimes, medications and around any other activities that may affect your blood glucose. CAUTION:
Be sure to talk to your healthcare professional about the low and high range limits that are right for you. When selecting or changing your limits, you should consider factors such as your lifestyle and diabetes therapy. Never make significant changes to your diabetes care plan without consulting your healthcare professional. 75 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 75 1/27/15 4:35 PM 5 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Editing Your Settings 1. Review the pre-set low range limit displayed To accept the pre-set low range limit, press To edit the pre-set
. or low range limit, press to change the value between 3.3mmol/L-6.1mmol/L, and then press
. 2. Review the pre-set high range limit displayed To accept the pre-set high range limit, press To edit the pre-set
. high range limit, press or to change the value between 5.0mmol/L-16.7mmol/L, and then press
. Your meter will exit settings mode and your last result screen will appear. 76 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 76 1/27/15 4:35 PM 5Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Editing Your Settings NOTE: If you change your range limits, this will only affect whether future test results are displayed as below, above or within your range limits. Changing your range limits does not affect how past results are displayed. NOTE: You will not be able to perform a glucose test until you finish editing the range limits. NOTE: You can use the OneTouchReveal Mobile App on your compatible wireless device to change the range limits stored in your meter. See the instructions that came with the app for more information. 77 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 77 1/27/15 4:35 PM 5 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 6Caring for your system Storing your system Store your meter, test strips, control solution and other items in your carrying case. Keep in a cool, dry place between 5C and 30C. Do Not refrigerate. Keep all items away from direct sunlight and heat. Cleaning and disinfection Cleaning and disinfection are different and both should be performed. Cleaning is part of your normal care and maintenance and should be performed prior to disinfection, but cleaning does not kill germs. Disinfection is the only way to reduce your exposure to disease. For cleaning information, see page78 and for disinfecting information, see page80. Cleaning your meter, lancing device and cap The meter, lancing device and cap should be cleaned whenever they are visibly dirty and before disinfection. Clean your meter at least once per week. For cleaning obtain regular strength liquid dish soap and a soft cloth. Prepare a mild detergent solution by stirring 2.5mL of regular strength liquid dish soap into 250mL of water. 78 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 78 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Caring for your system 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.
(See page16.) Do Not spray cleaning solution on the meter or immerse it in any liquid. 1. Holding the meter with the test strip port pointed down, use a soft cloth dampened with water and mild detergent to wipe the outside of the meter and lancing device Be sure to squeeze out any excess liquid before you wipe the meter. Wipe the outside of the cap. obtain regular strength liquid dish soap and a soft cloth. 79 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 79 1/27/15 4:35 PM 6 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Caring for your system 2. Wipe dry with a clean, soft cloth Disinfecting your meter, lancing device and cap The meter, lancing device and cap should be disinfected periodically. Clean your meter, lancing device and cap prior to disinfecting. For disinfecting, obtain regular household bleach (containing a minimum of 5.5% sodium hypochlorite as the active ingredient)*. Prepare a solution of 1 part household bleach and 9 parts water.
*Follow manufacturers instruction for handling and storage of bleach. 80 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 80 1/27/15 4:35 PM 6Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Disinfecting your meter, lancing device The meter, lancing device and cap should be disinfected household bleach (containing a minimum of 5.5% sodium hypochlorite as the active ingredient)*. Prepare a solution Caring for your system 1. Hold the meter with the test strip port pointed down Use a soft cloth dampened with this solution to wipe the outside of the meter and lancing device until the surface is damp. Be sure to squeeze out any excess liquid before you wipe the meter. 2. After wiping, cover the surface you are disinfecting with the soft cloth dampened with the bleach solution for 1 minute Wash hands thoroughly with soap and water after handling the meter, lancing device and cap. If you see signs of wear, please contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). 81 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 81 1/27/15 4:35 PM 6 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 7Battery Replacing the battery Your OneTouchUltra Plus Flex Meter uses one CR2032 lithium coin cell battery. IMPORTANT: Use only one CR2032 lithium coin cell battery with your meter. Do Not use rechargeable batteries. Use of an incorrect battery type may result in your meter providing fewer tests than normal. If the meter does not turn on, you may need to replace the battery. See below for instructions. WARNING: Certain batteries may cause leaking which can damage the meter or cause the battery to lose power sooner than normal. Replace leaking battery immediately. NOTE: After replacing the battery, you will be prompted to set time and date, as if you are turning the meter on for the first time. 82 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 82 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Your OneTouchUltra Plus Flex Meter uses one CR2032 IMPORTANT: Use only one CR2032 lithium coin cell battery with your meter. Do Not use rechargeable batteries. Use If the meter does not turn on, you may need to replace the Battery 1. Remove the old battery Start with the meter turned off. Remove the battery cover by sliding it downward. Pull up on the battery ribbon to lift the battery out of the compartment. Do Not remove the battery while the meter is connected to a computer. 83 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 83 1/27/15 4:35 PM 7 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Battery 2. Insert the new battery Insert one CR2032 lithium coin cell battery on top of the battery ribbon, with the plus (+) side up. If the meter does not power on after you have replaced the meter battery, check that the battery is correctly installed. If the meter still does not power on, contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). 3. Replace battery cover by sliding it upwards onto the meter 84 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 84 1/27/15 4:35 PM 7Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Battery 4. Check your meter settings Removing the meter battery will not affect your stored results. However, you will need to check your date and time settings. 5. Dispose of battery Dispose of the battery according to your local environmental regulations. 85 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 85 1/27/15 4:35 PM 7 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 8Troubleshooting your system Error and other messages The OneTouchUltra Plus Flex Meter displays messages when there are problems with the test strip, with the meter or when your glucose levels are above 33.3mmol/L or below 1.1mmol/L. Improper use may cause an inaccurate result without producing an error message. NOTE: If the meter is on but does not operate (locks-up), contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). What it means You may have a very low blood glucose level
(severe hypoglycemia), below 1.1mmol/L. NOTE: When your glucose result is below 1.1mmol/L, both the LO and the Range Indicator Arrow will flash on the meter screen. 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. Always treat according to your healthcare professionals recommendations. 86 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 86 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Troubleshooting your system What it means You may have a very high blood glucose level
(severe hyperglycemia), over 33.3mmol/L. NOTE: When your glucose result is above 33.3mmol/L, both the HI and the Range Indicator Arrow will flash on the meter screen. What to do Re-test your blood glucose level. If the result is HI again, obtain and follow instructions from your healthcare professional right away. 87 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 87 1/27/15 4:35 PM 8 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Troubleshooting your system What it means Meter is too hot (above 44C) to perform a test. 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 (6-44C). If you do not get another HI .t message, you can proceed with testing. If this message continues to appear, contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). 88 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 88 1/27/15 4:35 PM 8Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Troubleshooting your system What it means Meter is too cold (below 6C) to perform a test. 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 (6-44C). If you do not get another LO.t message, you can proceed with testing. If this message continues to appear, contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). 89 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 89 1/27/15 4:35 PM 8 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Troubleshooting your system Error Screens If there is a problem with your meter, there are six possible error screens that may appear. Along with an error number, there is also an error code in the upper left corner of your meter screen. If you cannot resolve the error with your meter, contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676
(Ireland). They will refer to the error number and code to help troubleshoot the problem. Example Error Screen Code 90 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 90 1/27/15 4:35 PM 8Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Troubleshooting your system What it means There is a problem with the meter. What to do Do Not use the meter. Contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). What it means Error message could be caused either by a used test strip or a problem with the meter or test strip. What to do Repeat the test with a new test strip; see page48 or page63. If this message continues to appear, contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). 91 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 91 1/27/15 4:35 PM 8 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Troubleshooting your system What it means The sample was applied before the meter was ready. What to do Repeat the test with a new test strip. Apply a blood or control solution sample only after the flashing appears on the display. If this message continues to appear, contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676
(Ireland). symbol 92 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 92 1/27/15 4:35 PM 8Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Troubleshooting your system What it means One of the following may apply:
Not enough blood or control solution was applied or more was added after the meter began to count down. The test 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 page48 or page63. If the error message appears again, contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). 93 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 93 1/27/15 4:35 PM 8 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Troubleshooting your system What it means The meter has detected a problem with the test strip. Possible cause is test strip damage. What to do Repeat the test with a new test strip; see page48 or page63. If the error message appears again, contact Customer Service. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). What it means Meter battery power is low but there is still enough battery power to perform a test. The flashing low
) icon will battery (
continue to appear until the battery is replaced. What to do Replace the meter battery soon. 94 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 94 1/27/15 4:35 PM 8Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Troubleshooting your system What it means There is not enough battery power to perform a test. What to do Replace the battery immediately. What it means No result in memory, such as the first time use or when you have chosen to delete all the results after downloading to a computer. What to do Contact Customer Service to report this occurrence, unless this is your first use of the meter. You can still perform a blood glucose test or control solution test and get an accurate result. Contact OneTouch Customer Care on 0800121200 (UK) or 1800535 676 (Ireland). 95 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 95 1/27/15 4:35 PM 8 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 9Detailed information about your system Comparing meter results to laboratory results Results obtained from the OneTouchUltra Plus Flex Meter and laboratory tests are reported in plasma-
equivalent units. However, your meter result may differ from your lab result due to normal variation. A result from your OneTouchUltra Plus Flex Meter is considered accurate when it is within TBDmmol/L of a laboratory method when the glucose concentration is lower than TBDmmol/L and within TBD of laboratory method when the glucose concentration is TBDmmol/L or higher. 96 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 96 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system Meter results can be affected by factors that do not affect lab results in the same way. Specific factors that may cause your meter result to vary from your lab result may include:
You have eaten recently. This can cause a result from fingertip testing to be up to 3.9mmol/L higher than a lab test using blood drawn from a vein.1 Your hematocrit is above 60% or below 20%. You are severely dehydrated. For additional information, refer to the OneTouch Ultra Plus Test Strip Insert. 1Sacks, D.B.: "Carbohydrates." Burtis, C.A., and Ashwood E.R. (ed.), Tietz Textbook of Clinical Chemistry, Philadelphia: W.B. Saunders Company (1994), 959. 97 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 97 1/27/15 4:35 PM 9 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system Guidelines for obtaining an accurate meter to lab comparison Before going to the lab:
Perform a control solution test to make sure your meter 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. 98 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 98 1/27/15 4:35 PM 9Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system Testing with your OneTouchUltra Plus Flex Meter at the lab:
Test within 15 minutes of the lab test. Use only a fresh, capillary blood sample from your fingertip. Follow all instructions in this Owner's Booklet for performing a blood glucose test. Comparing your meter results to those taken from another meter Comparing your blood glucose test results taken with this meter to your results taken from a different meter is not recommended. Results may differ between meters and are not a useful measure of whether your meter is working properly. 99 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 99 1/27/15 4:35 PM 9 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system Technical specifications Assay method Automatic shutoff Battery ratings Battery type BLUETOOTH SMART Technology Calibration Data port type FAD-GDH (flavin adenine dinucleotide dependent glucose dehydrogenase) Two minutes after last action 3.0 V d.c. (CR2032 lithium coin cell battery), One replaceable 3.0 Volt CR2032 lithium coin cell battery (or equivalent) Frequency range: 2.4-2.4835 GHz Operating Range Distance: minimum 8meters (unobstructed) Operating Channels: 40 Channels Security Encryption: 128-bit AES
(Advanced Encryption Standard) Plasma-equivalent Compatible with USB 2.0 100 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 100 1/27/15 4:35 PM 9Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system Memory Operating ranges Reported result range Sample Sample volume Size Test time Unit of measure Weight 500 test results Temperature: 6-44C Relative humidity: non-condensing 10-90%
Altitude: up to 3048meters Hematocrit: 20-60%
1.1-33.3mmol/L Fresh capillary whole blood 0.4L 52.0(W) x 86.0(L) x 16.0(T)mm 5 seconds mmol/L Approximately 50grams 101 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 101 1/27/15 4:35 PM 9 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system System Accuracy Diabetes experts have suggested that glucose meters should agree within TBDmmol/L of a laboratory method when the glucose concentration is lower than TBDmmol/L, and within TBD of a laboratory method when the glucose concentration is TBDmmol/L or higher. Samples from TBD patients were tested using both the OneTouchUltra Plus Flex System and the YSI 2300 Glucose Analyzer laboratory instrument. System Accuracy Results for Glucose Concentrations <TBDmmol/L Percent (and number) of meter results that match the laboratory test Within TBDmmol/L Within TBDmmol/L Within TBDmmol/L TBD TBD TBD 102 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 102 1/27/15 4:35 PM 9Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system System Accuracy Results for Glucose Concentrations TBDmmol/L Percent (and number) of meter results that match the laboratory test Within TBD Within TBD Within TBD TBD TBD TBD System Accuracy Results for Glucose Concentrations between TBDmmol/L and TBDmmol/L Within TBDmmol/L or TBD TBD NOTE: Where TBDmmol/L represents the lowest glucose reference value and TBDmmol/L represents the highest glucose reference value (YSI value). 103 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 103 1/27/15 4:35 PM 9 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system Regression Statistics Samples were tested in duplicate on each of three test strip lots. Results indicate that the OneTouchUltra Plus Flex System compares well with a laboratory method.
# of Subjects
# of Tests Slope TBD TBD TBD 95% CI Slope TBD 95% CI Intercept
(mmol/L) TBD Std. Error
(Sy.x)
(mmol/L) TBD Intercept
(mmol/L) TBD R2 TBD User Performance Accuracy A study evaluating glucose values from fingertip capillary blood samples obtained by TBD lay persons showed the following results:
TBD% within TBDmmol/L of the medical laboratory values at glucose concentrations below TBDmmol/L, and TBD% within TBD% of the medical laboratory values at glucose concentrations at or above TBDmmol/L. TBD% of the total number of samples were within TBDmmol/L or TBD% of the medical laboratory values. 104 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 104 1/27/15 4:35 PM 9Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system Precision Within Run Precision (TBD Venous Blood Samples Tested per Glucose Level) Data generated using the OneTouchUltra Plus Flex Meter. Target Glucose
(mmol/L) Mean Glucose
(mmol/L) Standard Deviation
(mmol/L) TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD Coefficient of Variation
(%) TBD TBD TBD TBD TBD Results show that the greatest variability observed between test strips when tested with blood is TBDmmol/L SD or less at glucose levels less than TBDmmol/L, or TBD% CV or less at glucose levels at TBDmmol/L or above. 105 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 105 1/27/15 4:35 PM 9 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system Total Precision (TBD Control Solution Tests per Glucose Level) Data generated using the OneTouchUltra Plus Flex Meter. Glucose Level Ranges
(mmol/L) Mean Glucose
(mmol/L) Standard Deviation
(mmol/L) Low
(TBD) Mid
(TBD) High
(TBD) TBD TBD TBD TBD TBD TBD Coefficient of Variation
(%) TBD TBD TBD 106 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 106 1/27/15 4:35 PM 9Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Detailed information about your system Guarantee LifeScan guarantees that the OneTouchUltra Plus Flex Meter will be free of defects in material and workmanship for three years, valid from the date of purchase. The guarantee extends only to the original purchaser and is not transferable. Electrical and safety standards This meter complies with CISPR 11: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 immunity to electrostatic discharge as specified in IEC 61326-2-6. This meter complies with immunity to radio frequency interference as specified in IEC 61326-1 and 61326-2-6. The meter meets the requirements for immunity to electrical interference at the frequency range and test level specified in international standard ISO 15197. Do Not use the equipment where aerosol sprays are being used, or when oxygen is being administered. 107 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 107 1/27/15 4:35 PM 9 Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin 10Index AST Batteries Batteries, replacing Battery empty icon Battery empty warning Battery low icon BLUETOOTH SMART feature BLUETOOTH SMART feature Buttons on meter Cleaning your meter, lancing device and cap Comparing meter results to laboratory results Compatible wireless devices Control solution Control solution, discard and expiration dates Control solution, testing Data port Date setting Dehydration Disinfecting your meter, lancing device and cap Display check Disposal, lancets and test strips Downloading results to a computer Edit date Edit range limits 39 82 82 3 95 3, 94 9, 12, 27, 69 7 18 78 96 3 60 58, 59 58, 64, 66 18 24, 26 52, 97 80 22 58 72 74 75 108 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 108 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Edit time Error messages EXTREME HIGH GLUCOSE message EXTREME LOW GLUCOSE message Fingertip testing procedure First time setup Guarantee Hyperglycemia Hypoglycemia Icons Infection, reduce the chance Intended use Kit components Lancing device mmol/L Pairing PIN Plasma calibration Range Indicator feature Range limits setting Results, reviewing past Serial number Settings Software, diabetes management 109 74 86 53, 87 52, 86 34 23, 28 107 53, 87 52, 86 3, 4 40 6 12 12, 39, 41, 78 18, 101 28, 29 31 96, 100 19 75 68 31 23, 26, 74 72 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 109 1/27/15 4:35 PM Index10Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Index Start-up screen Storing your system Symbols Syncing Technical specifications Temperature Test principle Test strip Test strip, applying drop of blood Test strip, discard and expiration dates Test strip, silver prongs Time setting Turning meter off Turning meter on Unexpected results Unit of measure Unusual red blood cell count (hematocrit) 22 78 3, 4 32, 69 102 34, 66, 78, 88, 89, 101 7 19, 45, 60 48 35 19 23, 26 33 22, 45, 60 52, 54 18, 101 97, 101 110 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 110 1/27/15 4:35 PM 10Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Notes 111 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 111 1/27/15 4:35 PM Yellow= 5mm Red=7mm marginYellow= 5mm Red=7mm margin Notes 112 05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 112 1/27/15 4:35 PM Yellow= 5mm Red=7mm margin t p 5 1 o t t p 9 m o r f s e g n a r e z i s t n o F i n e t S S
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1 2 3 4 | User Manual Statements | Users Manual | 241.99 KiB | June 05 2015 / February 11 2015 |
fl LIFESCAN One Touch Select Plus Flex and Ultra Plus Flex User Manual - FCC Wording Memorandum Document ID: 3130961 Rev: 1 The purpose of this memo is to confirm the exact wording which will be added to the US manual for t One Touch Select Plus Flex and Ultra Plus Flex Blood Glucose Meters. Item Text User Manual Statements to be added before product launch Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not stalled and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/ TV technician for help. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation Sign:
Date: D7APL ZO Dates Ayoc NO! SS Title: a LL Sign: = \
mt BA Specs Type: Project File Name: 3130961 Revision: |
Effectivity Date: Apr 27 2015 Status: Current State: Released Statement of Use: Verify status before cach use
1 2 3 4 | Label | ID Label/Location Info | 558.41 KiB | January 22 2015 |
Verio Flex Edit date/time Edit range On/o SN 12345678 FCC ID: 2ACT5-Z Blood Glucose Meter 1 888 567-3003 (English)/1 888 567-3010 (Espaol) In vitrodiagnostic. For self-testing. Manufactured by:
LifeScan Europe 6300 Zug, Switzerland CR2032, 3V Made in China PF 3125985 Rev 1
1 2 3 4 | Agent Letter | Cover Letter(s) | 169.83 KiB | January 22 2015 |
= L
<TIFESCAN We the undersigned, hereby authori e CSA Group Bayern GmbH, Mr. Thomas Ring Ohmsirasse 1 4, 94342 Strasskirchen, Germany to act on our behalf in all manners relating to application for equipment authorization in luding signing of all documents relating to these matters. Any and all acts carried out by CSA Group Bayern GmbH o our behalf shall have the same affect as acts of our own Federal Communications Commissio 7435 Oakland Mills Road Columbia, MD 21046 Oe OC Externa pe ations Sourcing Director tfeScan Divsi of Cilag GmbH International Gubelstrasse 34, CH-6300 Zug Switzerland This authorization is valid until 31: December 201 LifeScan, Division of Cilag GmbH International Gubelstrasse 34, CH-6300 Zug, Switzerland To whom It may concer 25 September 2014 ae) Ch ayer ner SAAS) CSA
1 2 3 4 | Confidentiality of photos | Cover Letter(s) | 29.19 KiB | January 22 2015 |
American Certification Body Inc. 6731 Whittier Ave, Suite C110 McLean, VA22101 Date: 20-11-2014 FCC ID: 2ACT5-Z Model: Verio Flex Request for Confidentiality of Internal Photographs The model Verio Flex with FCC ID: 2ACT5-Z from our client Clag GmbH International cannot be opened as it is ultrasonically welded, so the general public cannot access the internals of this model, without destroying it. The circuitry would be destroyed if the device would be dismantled. If you have any questions, please feel free to contact me at the address shown below. Yours sincerely, Thomas Ring Manager Certification CSA Group Bayern GmbH Ohmstr. 1-4 94342 Strasskirchen Germany
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2015-05-07 | JBP - Part 15 Class B Computing Device Peripheral | Class II Permissive Change | |
2 | 2402 ~ 2480 | DTS - Digital Transmission System | ||
3 | 2015-01-22 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
4 | JBP - Part 15 Class B Computing Device Peripheral |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 3 4 | Effective |
2015-05-07
|
||||
1 2 3 4 |
2015-01-22
|
|||||
1 2 3 4 | Applicant's complete, legal business name |
Cilag GmbH International
|
||||
1 2 3 4 | FCC Registration Number (FRN) |
0023816598
|
||||
1 2 3 4 | Physical Address |
Gubelstrasse 34
|
||||
1 2 3 4 |
Zug, N/A
|
|||||
1 2 3 4 |
Switzerland
|
|||||
app s | TCB Information | |||||
1 2 3 4 | TCB Application Email Address |
h******@acbcert.com
|
||||
1 2 3 4 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
1 2 3 4 |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
|||||
app s | FCC ID | |||||
1 2 3 4 | Grantee Code |
2ACT5
|
||||
1 2 3 4 | Equipment Product Code |
Z
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 3 4 | Name |
A******** H******
|
||||
1 2 3 4 | Title |
Mr
|
||||
1 2 3 4 | Telephone Number |
41582********
|
||||
1 2 3 4 | Fax Number |
41582********
|
||||
1 2 3 4 |
a******@its.jnj.com
|
|||||
app s | Technical Contact | |||||
1 2 3 4 | Firm Name |
CSA Group Bayern GmbH
|
||||
1 2 3 4 | Name |
T**** K****
|
||||
1 2 3 4 |
T****** K****
|
|||||
1 2 3 4 | Physical Address |
Germany
|
||||
1 2 3 4 |
t******@csagroup.org
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 3 4 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 3 4 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 3 4 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 11/02/2015 | ||||
1 2 3 4 | 07/21/2015 | |||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 3 4 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 3 4 | Equipment Class | JBP - Part 15 Class B Computing Device Peripheral | ||||
1 2 3 4 | DTS - Digital Transmission System | |||||
1 2 3 4 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | One Touch Ultra Plus Flex / Blood Glucose Monitoring System | ||||
1 2 3 4 | ONE TOUCH Verio Flex / Blood Glucose Monitoring System | |||||
1 2 3 4 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 3 4 | Modular Equipment Type | Does not apply | ||||
1 2 3 4 | Purpose / Application is for | Class II Permissive Change | ||||
1 2 3 4 | Original Equipment | |||||
1 2 3 4 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 3 4 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 3 4 | Grant Comments | Also contains a Bluetooth transmitter C2PC for changes to connector | ||||
1 2 3 4 | Power Output listed is conducted. End-users must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. This device is certified for portable applications. This transmitter must not be co-located with other transmitters except in accordance with FCC multi-transmitter product procedures. C2PC for changes to connector. | |||||
1 2 3 4 | Power Output listed is conducted. End-users must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. This device is certified for portable applications. This transmitter must not be co-located with other transmitters except in accordance with FCC multi-transmitter product procedures. | |||||
1 2 3 4 | Also contains a Bluetooth transmitter | |||||
1 2 3 4 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 3 4 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 3 4 | Firm Name |
CSA Group Bayern GmbH
|
||||
1 2 3 4 | Name |
F****** S******
|
||||
1 2 3 4 | Telephone Number |
49-94********
|
||||
1 2 3 4 | Fax Number |
49-94********
|
||||
1 2 3 4 |
f******@csagroup.org
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15B | CC | ||||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0002400 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
3 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0002400 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
4 | 1 | 15B | CC |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC