User's Manual

CPR4 – UA10821A

1 INTRODUCTION

1.1 Intended purpose

The CPR4 is the inductive programming head intended to be used with suitable MicroPort CRM programmers for the

interaction with the IMDs manufactured by MicroPort CRM, or by its predecessors Sorin Group and Ela Medical.

The CPR4 is functional to achieve the programmer’s intended purpose:

 Interrogate the device to get information about the device and assist with the diagnosis and monitoring of

pathological heart rhythm disturbances,

 Program the device to configure the device therapies according to patients’ needs,

 Run real-time tests to check device functioning.

1.2 Indication(s), target population(s) and intended user(s)

1.2.1 Indication(s)

The CPR4 provides communication with MicroPort implantable pacemakers and defibrillators and is thus indicated in

patients requiring atrial or ventricular pacing and synchronous atrio-ventricular pacing, or/and ventricular

antitachycardia pacing and defibrillation for automated treatment of life-threatening ventricular arrhythmia, without

or with resynchronization.

The indications are detailed below:

According to the guidelines specified below, atrial or ventricular pacing and synchronous atrio-ventricular pacing are

mainly indicated for the following conditions:

 Accepted patient conditions warranting chronic cardiac pacing which include:

o symptomatic paroxysmal or permanent second- or third-degree AV block;

o symptomatic bilateral bundle branch block;

o symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV

conduction disorders;

o bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of

symptomatic tachyarrhythmias;

o vasovagal syndromes or hypersensitive carotid sinus syndromes.

 Atrial or ventricular pacing and synchronous atrio-ventricular pacing is indicated for patients who may

benefit from maintenance of AV synchrony and for the treatment of conduction disorders that require

restoration of both rate and which include:

o various degrees of AV block to maintain the atrial contribution to cardiac output;

o VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent sinus rhythm;

o Low cardiac output or congestive heart failure secondary to bradycardia.

 Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit

from increased pacing rates concurrent with increases in physical activity.

Guidelines on cardiac pacing are provided by the European Society of Cardiology, the American College of Cardiology

and the American Heart Association ("2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy.”

Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi:10.1093/eurheartj/ehab364. “2012 ACCF/AHA/HRS Focused Update of

the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities”. J Am Coll Cardiol. 2013; 61(3):e6-

75).

According to the guidelines, ventricular antitachycardia pacing and ventricular defibrillation for automated treatment

of life-threatening ventricular arrhythmia without resynchronization is indicated in:

 Patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable

sustained VT after evaluation to define the cause of the event and to exclude any completely reversible

causes.