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AAMI EC13
New product
AAMI EC13 2nd Edition, January 1, 2002 Cardiac monitors, heart rate meters, and alarms
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Description / Abstract:
This standard establishes minimum safety and performance
requirements for electrocardiograph (ECG) heart rate and waveform
monitors that are intended for use under the operating conditions
specified in this standard. Subject to this standard are all parts
of such monitors necessary to:
a) obtain a heart rate indication via noninvasive ECG sensing from the patient’s body;
b) amplify and transmit this signal and display the heart rate and/or ECG waveform; and
c) provide alarms, based on adjustable alarm criteria, upon the sustained occurrence of the following ratedependent phenomena: cardiac standstill, bradycardia, and/or tachycardia.
NOTE-The safety and performance criteria defined in this standard are intended principally for use in design qualification or “type” evaluation by the manufacturer. (Type evaluation is the full battery of tests that must be done on a typical instrument or group of typical instruments to verify that all performance design requirements have been met. It is used to officially establish that a product model’s design has achieved compliance with all standards to which a manufacturer claims compliance.)
a) obtain a heart rate indication via noninvasive ECG sensing from the patient’s body;
b) amplify and transmit this signal and display the heart rate and/or ECG waveform; and
c) provide alarms, based on adjustable alarm criteria, upon the sustained occurrence of the following ratedependent phenomena: cardiac standstill, bradycardia, and/or tachycardia.
NOTE-The safety and performance criteria defined in this standard are intended principally for use in design qualification or “type” evaluation by the manufacturer. (Type evaluation is the full battery of tests that must be done on a typical instrument or group of typical instruments to verify that all performance design requirements have been met. It is used to officially establish that a product model’s design has achieved compliance with all standards to which a manufacturer claims compliance.)