ISO 14117:2019 アクティブな植込み型医療機器—電磁両立性—植込み型心臓ペースメーカー、植込み型除細動器、および心臓再同期装置用のEMCテストプロトコル | ページ 6

3.1.1

pacemaker

implantable pacemaker

active implantable medical device intended to treat bradyarrhythmias, comprising an implantable DUT and leads

[SOURCE:ISO 14708-2:2019, 3.3, modified — “DUT” substituted for “pulse generator”, and the admitted term" implantable pacemaker" added.]

3.1.2

ICD

implantable cardioverter defibrillator

active implantable medical device comprising an implantable DUT and lead(s) that is intended to detect and correct tachycardias and fibrillation by application of cardioversion/defibrillation pulse(s) to the heart

[SOURCE:ISO 14708-6:2019, 3.2, modified — “DUT” substituted for “pulse generator”.]

3.1.3

CRT-P

implantable cardiac resynchronization therapy pacing device

active implantable medical device intended to provide improved ventricular activation to optimize cardiac output, comprising an implantable DUT and leads

[SOURCE:ISO 14708-2:2019, 3.7, modified — “DUT” substituted for “pulse generator”.]

3.1.4

CRT-D

implantable cardiac resynchronization therapy/defibrillator device

active implantable medical device intended to detect and correct tachycardias and fibrillation by application of cardioversion/defibrillation pulses to the heart, and to provide improved ventricular activation to optimize cardiac output, comprising an implantable DUT and leads

[SOURCE:ISO 14708-6:2019, 3.34, modified — “DUT" substituted for"pulse generator".]

3.1.5

inhibition generator

equipment that generates a simulated heart signal for devices within the scope of this document

3.1.6

maximum permanently programmable sensitivity

condition where the sensing channels of an ICDorpacemaker are set, either automatically by the device or programmed by a clinician, to detect the lowest amplitude signals

Note 1 to entry: These settings are intended for use without direct medical supervision.

Note 2 to entry: Sensitivity settings are usually expressed in terms of the minimum voltage that can be sensed. Therefore, a sensitivity of 1 mV is actually more sensitive than a setting of 2 mV.

Note 3 to entry: An AIMD can have settings, including those for sensitivity, that by design of the device or its software, are only temporarily available for use during diagnostic testing (such as during manufacture) or for testing at the time of implantation. Such settings are therefore unavailable for use by patients when not under immediate medical care and are not intended to be encompassed by the testing herein.

3.1.7

interference mode

>where asynchronous pacing is delivered in response to detected interference

3.1.8

transient exposure

exposure of the implanted DUT and leads for a period of less than 15 seconds

Note 1 to entry: 15 seconds is considered to be a reasonably foreseeable maximum exposure duration for persons walking past a stationary emitter.