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

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E. FCC Compliance Information
Model 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 Information
Electromagnetic Interference (EMI) from Radio Wave Sources
Battery 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 Level
The 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
Performance
CISPR 11 IEC 61000-4-2 IEC 61000-4-8
Criteria Required Performance (Radiated Emissions)
Group 1 Class B Pass
IEC 60601-2-24 IEC 60601-2-24
Criteria Met N/A (Electro Static Discharge)
+/-8kV Direct, HCP and VCP
Discharges +/-15KV Air
Discharges Pass
(Magnetic
Immunity) 400
A/m Pass
Section 12: Appendices
Appendix G: Accuracy of Flow Rate
Section 12: Appendices
Appendix G: Accuracy of Flow Rate
DOC15736_Rev-A-Man.indd 257-258 2/9/09 11:29:56 AM

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