Introduction; System Description; Operator Profile - Abbott Merlin PSA EX3100 Help Manual

Introduction

Contents:
System Description (page 1)

Operator Profile (page 1)

Indications for Use (page 1)

Intended Use (page 2)

Contraindications (page 2)

Warnings (page 2)

Precautions (page 3)

Adverse Events (page 4)


System Description

The Merlin™ Pacing System Analyzer (PSA) Model EX3100 system provides you with the ability to
assess the electrical performance of a lead system during pulse generator implantation or invasive
lead-system troubleshooting. The Merlin PSA system uses the St. Jude Medical™ Merlin™
Patient Care System (PCS).
In addition to the Merlin PCS, the Merlin PSA system consists of:
a sterilizable patient cable

The Merlin PSA Patient Cable Model EX3150 connects the Merlin PSA with one to three
implanted leads.
patient-cable adapters

The Merlin PSA Cable Adapter Model EX3170 and the Merlin PSA "M" Adapter
Model EX3180 connect the Merlin PSA to commonly used PSA patient cables (see Connect
the Leads to the Merlin™ PSA). The PSA patient cables are then connected to the implanted
leads.
For information on the Merlin PCS, refer to the Merlin PCS Model 3650 or Merlin 2 PCS MER3700
User's Manual. For technical data and other information on the Merlin PSA and accessories, refer
to Technical Data.
NOTE:
Only persons properly trained to operate the Merlin PSA should do so.

If the user connects both the Merlin PSA Model EX3100 and the PSA Wand

Model 3150 to the Merlin PCS, the programmer only enables the Merlin PSA
Model EX3100.
Refer to the Merlin PCS Model 3650 or Merlin 2 PCS Model MER3700 User's Manual

for Merlin PSA installation instructions.

Operator Profile

The intended operators of the Merlin™ PSA system include trained Abbott Medical employees
and clinical personnel trained in pacing and electrophysiology, such as nurses, technicians, or
physicians.
Indications for Use
The Merlin™ Pacing System Analyzer (PSA) is indicated for use at the time of surgery in patients
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