Stratos LV/LV-T Technical Manual 15

Based on testing to date, effects resulting from an interaction between cellular phones and the implanted pacemakers have been temporary. Simply moving the phone away from the implanted device will return it to its previous state of operation. Because of the great variety of cellular phones and the wide variance in patient physiology, an absolute recommendation to cover all patients cannot be made.

Patients having an implanted CRT-P who operate a cellular phone should:

•Maintain a minimum separation of 6 inches (15 cm) between a hand-held personal cellular phone and the implanted device. Portable and mobile cellular phones

generally transmit at higher power levels compared to hand held models. For phones transmitting above 3 watts, maintain a minimum separation of 12 inches (30 cm) between the antenna and the implanted device.

•Patients should hold the phone to the ear opposite the side of the implanted device. Patients should not carry the phone in a breast pocket or on a belt over or within 6 inches (15 cm) of the implanted device as some phones emit signals when they are turned ON but not in use (i.e., in the listen or standby mode). Store the phone in a location opposite the side of implant.

1.5.9 Hospital and Medical Environments

Refer to Section 1.5.1 for information regarding CRT-P interaction with the following medical procedures / environments:

•Electrosurgical Cautery

•Lithotripsy

•External Defibrillation

•High Radiation Sources

1.5.10 Device Explant and Disposal

Device Incineration - Never incinerate a CRT-P. Be sure the CRT-P is explanted before a patient who has died is cremated. (see Section 10)

Explanted Devices – Return all explanted devices to

BIOTRONIK.