Abbott Diabetes Care AV2-C Insulin Pump/Glucose Meter Transmitter User Manual Regulatory statement

Abbott Diabetes Care Insulin Pump/Glucose Meter Transmitter Regulatory statement

Contents

Regulatory statement

257258 E. FCC Compliance InformationModel Number: PRT12354-xxx and PRT15751-xxx.FCC Rules: Tested to comply with FCC Part 15, Class B, Security/Remote control Transmitter.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.2. This device must accept any interference received, including interference that may cause undesired operation.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 installed 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 o and on, the user is encouraged to try to correct the interference by one or more of the following measures:Reorient or locate the receiving antenna.•Increase the separation between the equipment and transmitter.•Consult the dealer or an experienced radio/TV technician for help.•The user is cautioned that changes or modifications not expressly approved by Abbott Diabetes Care may void the user’s authority to operate this device.F. Electromagnetic InformationElectromagnetic Interference (EMI) from Radio Wave SourcesBattery powered insulin delivery devices such as the Abbott Diabetes Care Inc. FreeStyle Aviator System may be susceptible to electromagnetic interference (EMC) such as Radio and TV station towers, amateur radio (HAM) transmitters, two way radios, cell phones, Electronic Article Surveillance (EAS) systems and Radio Frequency Identication (RFID) systems. The interference from these electromagnetic eld sources may cause the insulin pump to STOP delivery of the insulin or degrade the image on the companion and pump screens. It can also permanently damage the control system of the insulin delivery pump and companion.Immunity LevelThe intensity of the EMI can be measured in volts per meter (V/m). The immunity level of the FreeStyle Aviator System is 10 V/m as mandated by the standard, IEC 60601-2-24.Some cellular telephones and similar products transmit signals while they are turned on, even when NOT being used.EMC/EMI Declaration:Reference Document PerformanceCISPR 11 IEC 61000-4-2 IEC 61000-4-8Criteria Required Performance (Radiated Emissions) Group 1 Class B PassIEC 60601-2-24 IEC 60601-2-24Criteria Met N/A (Electro Static Discharge) +/-8kV Direct, HCP and VCP Discharges +/-15KV Air Discharges Pass(Magnetic Immunity) 400 A/m PassSection 12: AppendicesAppendix G: Accuracy of Flow RateSection 12: AppendicesAppendix G: Accuracy of Flow RateDOC15736_Rev-A-Man.indd 257-258 2/9/09 11:29:56 AM

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