RBV-017OmniPod

Contacts and Important Information o NameAddressTelephone and FaxEmail AddressNameAddressTelephone and FaxEmail Address NameAddressTelephone Number(s)Policy NumberNameAddressTelephone and FaxEmail AddressOmniPod System Start Date : _ ___ ________________________ PDM Model : US T 4 00 Serial Number : _ ___________________ Emergency Services : Dial 911 (USA only; not available in all communities) Insulet Corporation9 Oak Park Drive, Bedford, MA 01370Customer Care (24 hours/7 days): 800-591-3455 When calling from outside the United States: 781-457-5098Customer Care Fax : 877-467-8538 Web site : MyOmniPod.com DoctorNurse/Educator Health InsurancePharmacy Use the spaces below to record important health and product information. © 2011 Insulet Corporation. All rights reserved.OmniPod is a registered trademark of Insulet Corporation.U.S. Patent No. 6,740,059.FreeStyle is a registered trademark of Abbott Laboratories. Third-party trademarks used herein are the trademarks of their respective owners.14421-AW Rev A iii ContentsIntroduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii About This User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiiConventions and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix Important Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xContraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x Your Role: Safely Using the OmniPod System . . . . . . . . . . . . . . . . . . . xi 1 Your New OmniPod Insulin Management System . . . . . . . . . . 1 Insulin Delivery with the OmniPod System. . . . . . . . . . . . . . . . . . . . . . 1How Does the OmniPod System Work? . . . . . . . . . . . . . . . . . . . . . . . . . 2 No tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Automated cannula insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2A fully-integrated design with blood glucose monitoring. . . . 2Suggested bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Reference food library and carb presets . . . . . . . . . . . . . . . . . . . . . . 3Record keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Personalizing your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 The Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4The Personal Diabetes Manager. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Buttons that program and control the OmniPod System. . . . . 5 Primary screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Safety Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Automatic priming, safety checks, and insertion . . . . . . . . . . . . . . 8Rapid occlusion detection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Alerts and alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 2 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 The OmniPod Starter Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Set Up the Personal Diabetes Manager (PDM) . . . . . . . . . . . . . . . . . . . 9 Turn on the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 The Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Enter your PDM ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Select the ID screen color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Set date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Enter basal settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Enter blood glucose sound setting and BG goal. . . . . . . . . . . . . 12Set the suggested bolus calculator. . . . . . . . . . . . . . . . . . . . . . . . . . 12Enter target blood glucose value. . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Enter minimum BG allowed for use in bolus calculation. . . . . 13Enter insulin-to-carbohydrate ratio. . . . . . . . . . . . . . . . . . . . . . . . . . 13Enter correction factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Set reverse correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Contentsiv Enter the duration of insulin action. . . . . . . . . . . . . . . . . . . . . . . . . . 14Se l ect bolus increment and enter maximum bolus. . . . . . . . . . 14 Set extended bolus doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Set low reservoir advisory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Set expiration notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 3 Understanding and Adjusting Basal Rates . . . . . . . . . . . . . . . . 16 What Is a Basal Rate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Personalized Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Create a basal program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Enable a…

Text truncated - open the document above for the full version.

This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. EMC Report for Insulet Corporation on the Eros (UST400) system Page 1 of 29 EMISSION TEST REPORT Report Number: 100193203BOX-004b Project Number: G100193203 Report Issue Date: 08/10/2011 Product Designation: Eros (UST400) system Standards: FCC Part 15 Subpart C Section 15.231 CFR47 FCC Part15, Subpart B:2009 Tested by: Client: Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, MA 01719 Insulet Corporation 9 Oak Park Drive Bedford, MA 01730 Report prepared by Report reviewed by Vathana F. Ven, Senior Project Engineer Michael F. Murphy/EMC Staff Engineer Intertek Report Number: 100193203BOX-004b Issued: 08/10/2011 EMC Report for Insulet Corporation on the Eros (UST400) system Page 2 of 29 1 Introduction and Conclusion The tests indicated in section 2.0 were performed on the product constructed as described in section 3.0. The remaining test sections are the verbatim text from the actual data sheets used during the investigation. These test sections include the test name, the specified test Method, a list of the actual Test Equipment Used, documentation Photos, Results and raw Data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted. Based on the results of our investigation, we have concluded the product tested complies with the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. 2 Test Summary Section Test full name Result 3 Client Information 4 Description of Equipment Under Test 5 System Setup and Method 6 15.231(b) – Fundamental Field Strength Pass 7 15.231(b) – Harmonics and Spurious Field Strength Pass 8 15.231(c) – 20 dB Bandwidth Pass 9 15.231(a)(2) – 5 Seconds Off Pass 10 Revision History Intertek Report Number: 100193203BOX-004b Issued: 08/10/2011 EMC Report for Insulet Corporation on the Eros (UST400) system Page 3 of 29 3 Client Information This EUT was tested at the request of: Company: Insulet Corporation 9 Oak Park Drive Bedford, MA 01730 Contact: Mr. John D'Arco Telephone: (781) 457-4937 Fax: (781) 457-5011 Email: [email protected] 4 Description of Equipment Under Test Equipment Under Test Description Manufacturer Model Number Serial Number EROS PDM (Personal Diabetes Manager) Insulet Corporation EROS PDM 030000006 Insulin Pump Insulet Corporation POD 020017 Receive Date: 10/20/10 Received Condition: Good Type: Production Description of Equipment Under Test (provided by client) Personal diabetes management system. Equipment Under Test Power Configuration Rated Voltage Rated Current Rated Frequency Number of Phases 3.1VDC N/A N/A N/A Operating modes of the EUT: No. Descriptions of EUT Exercising 1 Continuous transmitting with modulation 2 Continuous transmitting without modulation Intertek Report Number: 100193203BOX-004b Issued: 08/10/2011 EMC Report for Insulet Corporation on the Eros (UST400) system Page 4 of 29 5 System Setup and Method Cables ID Description Length (m) Shielding Ferrites Termination None Support Equipment Description Manufacturer Model Number Serial Number None 5.1 Method: Configuration as required by Section 15.231(a) to 15.231(c) of Standard taking Precedence. 5.2 EUT Block Diagram: Turntable EUT Intertek Report Number: 100193203BOX-004b Issued: 08/10/2011 EMC Report for Insulet Corporation on the Eros (UST400) system Page 5 of 29 6 Fundamental Field Strength 6.1 Method Tests are performed in accordance with 15.231(b). TEST SITE: 10m ALSE The 10m ALSE is 13m (Length) x 21m (Depth) x 10m (Height) with the effective size in terms of space from the tips of the absorber is 12m (Length) x 20m (Depth) x 8.5m (Height). This chamber achieves broadband performance using a unique arrangement of hybrid and ferrite tile absorber. This chamber has a built in 3m diameter turntable (Embedded type). The metal structure of the table makes electrical connection around the entire circumference of the turntable to the ground plane with a metal brush type connection. The turntable is located on one end of the chamber and the antennas are mounted 3 and 10 meters away at the other end of the chamber on the adjustable an Antenna Mast. The antenna mast is a non-conductive bore sighted type with remote control of antenna height and polarization. The Antenna Mast and the turntable can be remotely controlled through the controller located in the adjacent Control room. A wooden table 80 cm high is used for table-top equipment. Measurement Uncertainty For radiated emissions, lab U(3.5 dB at 3m and 3.5 dB at 10m below 1 GHz, and 4.2 dB at 3m above 1 GHz) < CISPR U(5.2 dB), which is the reference value in CISPR 16-4-2 Table 1, hence the compliance of the product is only based on the measured value, and no measurement uncertainty correction is required, based on CISPR 22 and CISPR 11 (for 2006 and later revisions) Clause 11. Intertek Report Number: 100193203BOX-004b Issued: 08/10/2011 EMC Report for Insulet Corporation on the Eros (UST400) system Page 6 of 29 Sample Calculation The field strength is calculated by adding the Antenna Factor and Cable Factor, and…

Text truncated - open the document above for the full version.

Intertek Report Number: 100193203BOX-004 Issued: 12/01/2010 EMC Report for Insulet Corporation on the Eros (UST400) system Page 8 of 29 6.4 Setup Photographs: EROS PDM Intertek Report Number: 100193203BOX-004 Issued: 12/01/2010 EMC Report for Insulet Corporation on the Eros (UST400) system Page 9 of 29 EROS POD