I5QBOneTouch UltraLink Blood Glucose Meter

i User Handbook Blood Glucose Monitoring System UltraLink ® AW05946101/A_OT UltraLink_UH_Insides_R8.indd 12/23/10 12:02:17 PM ii iii Table of Contents Setting up your system 2 Starting the test process 13 Getting a blood sample 16 Applying blood and reading results 25 Attaching flags or comments to your results 34 Reviewing past results and averages 37 Control solution testing 42 Caring for your system 47 Troubleshooting 52 Detailed Information about your system 60 Index 70 Welcome to the OneTouch® family! OneTouch® is committed to creating a world without limits for people with diabetes. The OneTouch® UltraLink® Meter, developed by LifeScan and Medtronic Diabetes, makes it simple to get a blood glucose test result and review past results. We designed this product to make testing easy and to help you manage your diabetes. A special wireless communication feature lets the meter automatically transmit glucose test results to compatible* Medtronic Diabetes devices. This User Handbook will help you learn how to use your meter properly. Please read it carefully. If you need assistance, please contact Customer Service at 1 866 621-4846 toll free. Customer Service is available 24 hours a day, 7 days a week. If you cannot reach Customer Service, contact your health care professional for advice. If you have specific questions about any partner device** from Medtronic Diabetes, you may contact the manufacturer’s 24-hour line at 1 800 646-4633 (calls within the United States) or 1 818 576-5555 (calls outside the United States), or visit their website at www.medtronicdiabetes.com. * For information on compatible Medtronic Diabetes devices, contact Medtronic directly. ** Medtronic partner devices include MiniMed Paradigm® Insulin Pumps and Guardian® REAL-Time Continuous Glucose Monitoring Systems. Throughout this handbook, references to Medtronic Diabetes devices will be referred to as simply “partner devices”. AW05946101/A_OT UltraLink_UH_Insides_R8.indd 2-32/23/10 12:02:17 PM iv v Before you begin Before using this product to test your blood glucose, carefully read this User Handbook and the inserts that come with the OneTouch® Ultra® Test Strips and OneTouch® Ultra® Control Solutions. Take note of warnings and cautions throughout this booklet, which are identified with m. Many people find it helpful to practice the test with control solution before testing with blood for the first time. See page 42 in the Control solution testing section. Intended use • The OneTouch® UltraLink® Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. • The OneTouch® UltraLink® System is intended for use by people with diabetes in a home setting and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. • Not for the diagnosis of diabetes • Not for use with neonates • Test strips for single use only • Test strips are specific to D-glucose and do not react to other sugars that may be present in the blood • Not for use with serum or plasma The OneTouch® UltraLink® Blood Glucose Monitoring System may also be used with designated partner devices. OneTouch® UltraLink® can be set up to automatically transmit glucose results to the partner device. See your partner device manual for instructions for setting up, using, and troubleshooting problems with your partner device. Test principle Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current, calculates your blood glucose level, displays the result, and stores it in its memory. About RF Radio frequency (RF) is a type of wireless communication. Cell phones use RF technology, as do many other devices. RF is how your OneTouch® UltraLink® Blood Glucose Meter automatically transmits glucose test results to your partner device. You must also program the partner device to recognize the unique meter ID stored in your meter for test results to be received. This will help ensure that only results from your OneTouch® UltraLink® Meter will be received by your partner device. Your meter is subject to and complies with U.S. federal guidelines, Part 15 of the FCC rules for devices with RF capability. These rules state two conditions specific to the operation of the device. They are: • This device may not cause harmful interference. • This device must accept any interference received, including interference that may cause undesirable operation. 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. Other electronic wireless devices that are in use nearby, such as a cell or mobile phone, or a wireless network, may prevent or delay the transmission of data from your meter to your partner device. Moving away from or turning off these electronic devices may allow communication. m WARNING: Failure to carefully follow the directions in this User Handbook can lead to inaccurate test results. AW05946101/A_OT UltraLink_UH_Insides_R8.indd 4-52/23/10 12:02:17 PM vi 1 The meter has been tested and found to be appropriate for use at home. In most cases, it should not interfere with other home electronic devices if used as instructed. However, this meter gives off RF energy when the BG link is turned on and in use; so, if not used correctly, your meter may interfere with your TV, radio, or other electronic devices that receive or transmit RF signals. If you experience meter interference problems, you should try moving your meter away from the source of the interference, or relocate the electronic device or its antenna to another location to resolve the problem. If yo…

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Elliott TCB 684 W. Maude Ave Sunnyvale, CA, 94085 RE: FCC application for LifeScan, Inc FCC ID: I5QB To whom it may concern: The enclosed documents constitute a formal submittal and application for Equipment Authorization for a “OneTouch UltraLink Blood Glucose Meter” pursuant to the following rules: Subpart C of Part 15 of FCC Rules (CFR 47) Section 15.249 The device is Blood Glucose meter which Transmits test results to compatible devices. It operates in 902 - 928 MHz band. It is not intended for connection to a PC. LifeScan, requested for both permanent and short term confidentiality of their Exhibits. Short term confidentiality request is for 180 days. Please refer to confidentiality request for details. Elliott Laboratories, as duly authorized agent prepared this submittal. A copy of the letter of our appointment as agent is included with the application. If there are any questions or if further information is needed, please contact Elliott Laboratories for assistance. Sincerely, Suresh Kondapalli Senior Engineer SK/dmg

I5QB Product Label and Label Location on Product A. Product Label B. Label Location on Product Back of Product

File: R78023 Page 1 of 20 EMC Test Report Application for Grant of Equipment Authorization pursuant to FCC Part 15 Subpart C Model: UltraLink blood glucose meter FCC ID: I5QB APPLICANT: Lifescan Inc. - A Johnson & Johnson Co. 1000 Gibralter Dr. Milpitas, CA 95035-6312 TEST SITE(S): Elliott Laboratories 684 W. Maude Avenue Sunnyvale, CA 94085 IC SITE REGISTRATION #: 2845A-2 REPORT DATE: March 16, 2010 FINAL TEST DATES: January 18 and January 19, 2010 AUTHORIZED SIGNATORY: ______________________________ Suresh Kondapalli Senior Engineer Elliott Laboratories Elliott Laboratories is accredited by the A2LA, certificate number 2016-01, to perform the test(s) listed in this report, except where noted otherwise. This report shall not be reproduced, except in its entirety, without the written approval of Elliott Laboratories Testing Cert #2016-01 Elliott Laboratories -- EMC Department Test Report Report Date: March 16, 2010 File: R78023 Page 3 of 20 TABLE OF CONTENTS COVER PAGE .........................................................................................................................................................................1 REVISION HISTORY .........................................................................................................................................2 TABLE OF CONTENTS ..................................................................................................................................... 3 SCOPE.................................................................................................................................................................. 4 OBJECTIVE ........................................................................................................................................................ 4 STATEMENT OF COMPLIANCE..................................................................................................................... 5 DEVIATIONS FROM THE STANDARDS ........................................................................................................ 5 TEST RESULTS SUMMARY ............................................................................................................................. 6 DEVICES OPERATING IN THE 902 – 928 / 2400 – 2483.5 / 5725 – 5850 MHZ BANDS................................. 6 GENERAL REQUIREMENTS APPLICABLE TO ALL BANDS ...................................................................... 6 MEASUREMENT UNCERTAINTIES .............................................................................................................. 7 EQUIPMENT UNDER TEST (EUT) DETAILS................................................................................................. 8 GENERAL ........................................................................................................................................................ 8 ANTENNA SYSTEM ....................................................................................................................................... 8 ENCLOSURE.................................................................................................................................................... 8 MODIFICATIONS............................................................................................................................................8 SUPPORT EQUIPMENT .................................................................................................................................. 8 EUT INTERFACE PORTS ................................................................................................................................ 9 EUT OPERATION ............................................................................................................................................ 9 TEST SITE ......................................................................................................................................................... 10 GENERAL INFORMATION........................................................................................................................... 10 CONDUCTED EMISSIONS CONSIDERATIONS.......................................................................................... 10 RADIATED EMISSIONS CONSIDERATIONS.............................................................................................. 10 MEASUREMENT INSTRUMENTATION....................................................................................................... 11 RECEIVER SYSTEM ..................................................................................................................................... 11 INSTRUMENT CONTROL COMPUTER ....................................................................................................... 11 LINE IMPEDANCE STABILIZATION NETWORK (LISN) ........................................................................... 11 FILTERS/ATTENUATORS ............................................................................................................................ 12 ANTENNAS ................................................................................................................................................... 12 ANTENNA MAST AND EQUIPMENT TURNTABLE................................................................................... 12 INSTRUMENT CALIBRATION ..................................................................................................................... 12 TEST PROCEDURES ....................................................................................................................................... 13 EUT AND CABLE PLACEMENT .................................................................................................................. 13 CONDUCTED EMISSIONS ........................................................................................................................... 13 RADIATED EMISSIONS .........................…

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Setup photos FCC ID: I5QB