RBV-001iXL Pump

Doctor Name: Address: Telephone Number(s): Nurse/Educator Name: Address: Telephone Number(s): Insurance Name: Address: Telephone Number(s): Policy Number: Pharmacy Pharmacist: Address: Telephone Number(s): Prescriptions Script #NameDosageTimes Per Day Emergency Services Dial 911 (USA only; not available in all communities) Insulet Corporation 100 Cummings Center • Suite 239G • Beverly, MA 01915 USA Customer Support:(800) 591-3455 (24 hours/7days) Sales/Supplies:(800) 591-9948 Web Site:www.insulet.com i iXL™ Diabetes Management System User Guide: Contacts and Important Information Use the spaces below to record important health and product information. 10776 Rev A Contacts and Important Information Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi About This User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi Conventions and terms . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi Before You Get Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vii Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vii Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vii Your Important Role in Successful Pump Therapy . . . . . . .viii Your Personal Diabetes Management Information . . . . . . . .ix My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .x 1: Your New iXL™ Diabetes Management System . . . . . . . . . . 1 Insulin-Delivery with the iXL™System . . . . . . . . . . . . . . . . . . 1 How Does the iXL™ System Work? . . . . . . . . . . . . . . . . . . . . . 2 RediSet™ System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Wireless Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Data Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 The iXL™ Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 The iXL™ Remote Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Buttons that program and control the iXL™ System . . . . . 4 Entering and changing text . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Primary screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2: Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 The iXL™ Startup Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Set Up the iXL™ Remote Controller . . . . . . . . . . . . . . . . . . . . 10 Turn on the remote . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 The iXL™ Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 3: Basal Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 What is a Basal Rate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Personalized Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . 15 Create a basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Enable an existing basal program . . . . . . . . . . . . . . . . . . . 19 Change or delete a basal program . . . . . . . . . . . . . . . . . . 20 Preset Temporary Basal Rates . . . . . . . . . . . . . . . . . . . . . . . . 22 What is a temporary basal rate? . . . . . . . . . . . . . . . . . . . . 22 Create a temporary basal preset . . . . . . . . . . . . . . . . . . . . 22 Enable an existing temporary basal preset . . . . . . . . . . . . 23 Cancel an active temporary basal preset . . . . . . . . . . . . . 23 Change or delete a temporary basal preset . . . . . . . . . . . 23 One-Time Temporary Basal Rates . . . . . . . . . . . . . . . . . . . . . 24 Enable a one-time temporary basal rate . . . . . . . . . . . . . . 24 Cancel a one-time temporary basal rate . . . . . . . . . . . . . . 25 Maximum Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 What is the maximum basal rate? . . . . . . . . . . . . . . . . . . . 25 Set a maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . 25 My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 iXL™ Diabetes Management System User Guide:Contentsii 4: Bolus Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 What is a Bolus? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Bolus Dose Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Deliver Bolus Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Deliver a normal bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Deliver an extended bolus . . . . . . . . . . . . . . . . . . . . . . . . . 29 Deliver an iBolus™ (audio bolus) . . . . . . . . . . . . . . . . . . . . 31 Cancel Active Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 5: The iXL™ Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 The Pump Change Process . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Deactivate current pump . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Activate a new pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Fill the new pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Select the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Prepare the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Attach the newpump . . . . . . . . . . . . . . . . . .…

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The iXL system (both pump and remote controller) complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) These devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Insulet could void the user’s authority to operate the equipment. Both iXL pump and remote controller generate, uses, and can radiate radio frequency energy; and may cause harmful interference to radio communications. There are no guarantees that interference will not occur in a particular installation. If iXL system (both pump and remote controller) does cause harmful interference to radio and television reception, the interference may be corrected by one of the following measures: • Move or relocate the iXL system (both pump and remote controller) • Increase the distance between the iXL system (both pump and remote controller) and the other device that is emitting or receiving interference.

Test Report for Insulet Corporation on the Insulin Infusion Pump Model: iXL to FCC Part 15 Subpart C, Section 15. 225 Test Report #: 3050193 Date of Report: January 27, 2004 Project #: 3050193 Dates of Test: January 7, 20, 21, and 22, 2004 Total No of Pages Contained in this Report: 15 Kouma Sinn, Project Engineer Michael F. Murphy, Staff Engineer/EMC This report is for the exclusive use of ITS’s Client and is provided pursuant to the agreement between ITS and its Client. ITS’s responsibility and liability are limited to the terms and conditions of the agreement. ITS 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 copy or distribute this report and then only in its entirety. Any use of the ITS 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 ITS. 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 ITS certification program. FCC Part 15 Subpart C, Section 15. 225 Deleted: M-803 70 Codman Hill Road Boxborough MA 01719 Insulet Corporation, Model No. iXL, Serial No. Prototype Date of Test: January 7, 20, 21, and 22, 2004 Report # 3053853 2 FCC Part 15 Subpart C, Section 15.225 Table of Contents 1.0 Summary of Tests .......................................................................................................................... 3 2.0 General Description ....................................................................................................................... 4 2.1 Product Description ............................................................................................................ 4 2.2 Related Submittal(s) Grants ................................................................................................4 2.3 Test Facility ........................................................................................................................ 4 2.4 Test Equipment and Support Equipment ............................................................................ 6 3.0 Fundamental Field Strength ......................................................................................................... 7 3.1 Test Procedure .................................................................................................................... 7 3.2 Test Results......................................................................................................................... 7 4.0 Transmitter Characteristics.......................................................................................................... 9 4.1 20 dB Bandwidth............................................................................................................... 9 6.0 Field Strength of Spurious Radiation.......................................................................................... 11 6.1 Test Procedure .................................................................................................................. 11 6.2 Test Results....................................................................................................................... 11 7.0 Frequency Stability vs Temperature......................................................................................... 13 7.1 Test Procedure .................................................................................................................. 13 7.2 Test Results....................................................................................................................... 13 8.0 Frequency Stability vs Voltage .................................................................................................. 14 Deleted: M-803 70 Codman Hill Road Boxborough MA 01719 Insulet Corporation, Model No. iXL, Serial No. Prototype Date of Test: January 7, 20, 21, and 22, 2004 Report # 3053853 3 FCC Part 15 Subpart C, Section 15.225 1.0 Summary of Tests FCC RULE DESCRIPTION OF TEST RESULTS REPORT PAGE FCC §15.225 Fundamental Field Strength Passed 7 FCC §15.209 Field Strength of Spurious Radiation Passed 11 FCC §15.225 Frequency Stability Over Temperature Passed 13 Deleted: M-803 70 Codman Hill Road Boxborough MA 01719 Insulet Corporation, Model No. iXL, Serial No. Prototype Date of Test: January 7, 20, 21, and 22, 2004 Report # 3053853 4 FCC Part 15 Subpart C, Section 15.225 2.0 General Description 2.1 Product Description The Insulet iXL Infusion Pump contains electronics for wireless transmission and reception of data, utilizing OOK modulation with a carrier frequency of 13.56 MHz. The system consists of a remote control and an insulin pump. The device is designed to transmit or receive data at rate of 2000 bits per second. A production version of the sample was received on January 7, 2004 in good condition. The EUT has been tested at the request of Company: Insulet Corporation 100 Cummings Center Beverly, MA 01915 Name of contact: Mr. Mohsen Moghaddami Telephone: (978) 299-0230 Fax: (978) 299-0301 2.2 Related Submittal(s) Grants None. 2.3 Test Facility Site 1C (Top Site) is a 3m and 10m sheltered emissions measurement range located in a light commercial environment in Boxborough, Massachusetts. It meets the technical requirements of ANSI C63.4-1992 and CISPR 22:1993/EN 55022:1994 for radiated and conducted emission measurements. The shelter structure is entirely fiberglass and plastic, with outside dimensions of 33 ft x 57 ft. The structure resembles a quonset hut with a center ceiling height of 16.5 ft. The testing floor is covered by a galvanized sheet metal groundplane that is earth-grounded via copper rods around the perimeter of the site. The joints between individual metal sheets are bridged with a 2 inch wide metal strips to …

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