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Recommended Guidelines for All Implanted Heart Devices

Boston Scientific CRDM

Medtronic CRM

St. Jude Medical for Cardiac Devices

Boston Scientific CRDM, Medtronic CRM and St. Jude Medical manufacture Cardiac Implant Devices. Each manufacturer has a set of standards that state that electromagnetic field exposures should not exceed limits as shown in the table below. These limits were used to establish a benchmark for exposures acceptable to All Manufacturers EMI Guidelines.

Comparison of All EMI Reference Levels
Field Description	Frequency Range	Boston Scientific Reference Levels	Medtronic Ref. Level	St. Jude Medical Ref. Level
E-field strength: Power Frequency (both)	50/60 Hz (AC)	1,000 V/m – 4,000 V/m	6,000 volts per meter	6,000 volts per meter
B-field strength: Static or DC Currents (both)	0 Hz (Static/DC)	1 mT = 10 G	5 Gauss	5 Gauss
H-field strength (B-field): Power Frequency (both)	50/60 Hz (AC)	1 G = 66 A/m =0.1 mT	none	none
“Higher” Frequency (per Boston Scientific)	>1000 Hz or 1 KHZ	ANSI/AAMI PC 29	1 Gauss (80 Amps/meter)	none
Modulated Magnetic Fields (Medtronic)	up to 10 KHz	ANSI/AAMI PC 29	1 Gauss (80 Amps/meter)	1 Gauss (80 Amps/meter)
Greater than 10 KHz (Medtronic)	>10 KHz	ANSI/AAMI PC 29	1 Amp/meter=37699 uW/cm2	none
High Frequency (Medtronic)	150 KHz & up	ANSI/AAMI PC 29	100 volts per meter = 2652 uW/cm2	none

Potential Device Behaviors – Effects of Interference with Pacemakers and Defibrillators
Potential device behaviors	ICDs / CRT-Ds	Pacemakers / CRT-Ps
. Asynchronous pacing (pacing independent of underlying cardiac activity)	■	■
. Inhibition of pacing (pacing therapy not provided when needed)	■	■
. Ventricular pacing at Maximum Tracking Rate	■	■
. Inhibition of tachyarrhythmia therapy (shock therapy not provided when needed)	■	.
. Inappropriate shocks (shock therapy provided when not needed)	■	.
. Deactivation of tachyarrhythmia therapy	■	.