19 Section 19

Appendix C: Classification/Compliance/Declaration

19 Appendix C: FCC Compliance Information

Electromagnetic Interference and Your FreeStyle Navigator® Continuous Glucose Monitoring System

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Important Information about Electromagnetic Interference

The FreeStyle Navigator® Transmitter and Receiver communicate using radio frequency waves. The FreeStyle Navigator system has been designed to be reliable and immune to common electromagnetic interference so that it is not influenced by such interference. However, under rare circumstances, if you happen to be in an environment of strong electromagnetic radiation, there may be some interference. Examples of possible sources of interference are: store doorways, store checkout counters, metal detectors like those used in airport security systems or electronic surveillance devices, and radio transmitting devices such as cellular phones, 2-way radio and cordless phones.

Interference may occur in the vicinity of equipment marked with symbol.

If such interference happens, it tends to be temporary. This makes it unlikely that you will experience any noticeable difference in the performance of the system. In the event of electromagnetic interference, you may experience loss of communication between the receiver and transmitter, you may see unrecognizable characters on the receiver display screen, or you may not see continuous glucose results. The system is designed to alert you of these conditions through audio (beep or vibrate) or visual (icons, unrecognizable characters on the screen or lack of glucose results) means.

If you observe a significant change in your continuous glucose readings that you think is erroneous, or if you feel the blood glucose measurement in the Blood Glucose mode is erroneous and you are close to an electromagnetic interference source, move away from the source of interference and check to see if the condition fades away. Always maintain a minimum separation distance from potential sources of electromagnetic interference (see Tables 3 and 4 in this section for guidance).

Depending on your distance from the source of interference, the strength of the interfering signal, and the relative orientation between you and the source of interference, you may or may not see or experience these conditions. When in doubt, move away from any likely source of electromagnetic interference. If you experience consistent interference from any source, contact the manufacturer or dealer for that source and have a trained technician assess the situation. In addition, please report any consistent interference issues to Abbott Diabetes Care Customer Care.

If you have a medical appointment that includes X-ray, MRI (Magnetic resonance Imaging), CT (Computed Tomography) scan, or another type of exposure to radiation, keep your system and sensor away from the area. Before exposure to such radiation, discard any sensor you are wearing and insert a new sensor after the radiation session. The effect of these types of radiation on the performance of the system has not been evaluated.

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Arkon PRT03831-xxx manual Appendix C Classification/Compliance/Declaration

PRT03831-xxx specifications

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