Introduction; Indications; Intended Use; Contraindications - Abbott Merlin 2 PCS User Manual

Introduction

The Merlin™ 2 Patient Care System (Merlin™ 2 PCS) Model MER3700 User's Manual describes
the components, setup, maintenance, accessories, and technical data of the Merlin 2 PCS. For
information on St. Jude Medical implantable devices, select the ? button from any device session
screen.
The Merlin™ Antenna Model 3638 is a dedicated radio antenna accessory that enables radio
frequency (RF) communication between the Merlin 2 PCS and St. Jude Medical implantable
devices with RF communication capability. This manual describes the components, setup,
maintenance, and technical data of the Merlin Antenna together with the Merlin 2 PCS.
The Merlin™ PSA Model EX3100 is a pacing analyzer for use with the Merlin 2 PCS to evaluate
St. Jude Medical implantable devices and leads. More information on this device can be found in
the on-screen help.

Indications

The Merlin™ 2 PCS (Merlin 2 PCS Programmer, Model MER3700, and Merlin 2 PCS Software,
Model MER3400) is indicated for use for patients with bradyarrhythmias, tachyarrhythmias or
heart failure undergoing implantation, lead revision, explant or device follow-up of a cardiac
monitor, pacemaker, implantable cardioverter defibrillator or cardiac resynchornization therapy
system.

Intended Use

The Merlin™ 2 PCS (Merlin 2 PCS Programmer, Model MER3700, and Merlin 2 PCS Programmer
Software, Model MER3400) is a portable, dedicated programming system designed to interrogate,
program, display data from, and test St. Jude Medical implantable medical devices during implant
and follow up.
The Telemetry Wand Model 3630W is intended to provide inductive communication between the
programmer and the implantable medical device during a programmer session.
The Merlin 2 PCS ECG function when using the ECG cable Models 3617, 3626, and EX3001 is
only intended to support activities related to implanting, programming, and monitoring
St. Jude Medical implantable medical devices.
The Merlin Antenna Model 3638 is a dedicated radio antenna accessory intended to enable
wireless radio frequency (RF) communication between the Merlin 2 PCS and St. Jude Medical
implantable medical devices with RF communication capability during a programmer session.
The Merlin PSA Model EX3100 is a pacing analyzer system intended for use with the
Merlin 2 PCS to evaluate St. Jude Medical implanted leads for integrity, and for pacing and
sensing performance during surgical procedures related to the implanted system. Refer to the
Merlin PSA Help Manual for additional details.

Contraindications

There are no contraindications to the use of the Merlin™ 2 PCS (Merlin 2 PCS Programmer,
Model MER3700, and Merlin 2 PCS Software, Model MER3400) to interrogate, program, display
data from, and test implantable medical devices during implant and follow up.

Potential Adverse Events

Possible adverse events include:
1