St. Jude Medical Merlin PSA EX3100, Руководство пользователя

Страница: 8 / 76

1-2 Introduction
Indications for Use
The Merlin™ Pacing System Analyzer (PSA) is indicated for use at the time of surgery in patients with
bradyarrhythmias, tachyarrhythmias, and/or heart failure undergoing implantation or lead revision of a
pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy system.
Intended Use
The Merlin™ PSA is intended to assess the pacing and sensing performance of the lead system prior to
pulse generator implantation, or during invasive lead system troubleshooting.
The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to
connect the Merlin PSA to as many as three IS-1, DF-1, or DF4 leads.
The Merlin PSA Patient Cable Adapter EX3170 is a three-channel adapter intended to connect the
Merlin PSA to as many as three disposable patient cables. The EX3170 Cable Adapter can connect to
the Model 4051L disposable patient cable for IS-1 leads or to the Model 4161 disposable patient cable
for DF4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads.
The Merlin PSA “M” Adapter Model EX3180 is intended to connect the Merlin PSA to the two-channel
Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292
cable connects to implantable pacing leads.
1
Following use, the patient cables must either be disposed or re-sterilized, depending on the
requirements of the cable.
Only use the Merlin PSA with the Merlin PCS.
Contraindications
There are no contraindications to the use of a lead-analysis device. The patient’s age and medical
condition, however, may dictate the pacing modes and lead assessment activities appropriate for the
patient.
The Merlin™ PSA is not intended for use as a temporary pacemaker or for life sustaining pacing
support.
The Merlin PSA is not intended for diagnostic purposes.
Warnings
Line-powered Equipment. An implanted lead or a lead with an extension cable constitutes a direct,
low-resistance current pathway to the myocardium. Due to the danger of tachyarrhythmias resulting
from alternating current leakage, extreme caution must be taken to only use line-powered equipment
according to its intended use as properly grounded line-powered Class I equipment used on or in the
vicinity of the patient.
Electrosurgical Cautery. Electrosurgical cautery could induce ventricular arrhythmias and/or
fibrillation, or may cause device malfunction or damage. If electrocautery is necessary, keep the current
path and groundplate as far away from the leads as possible.
1. The Medtronic Model 2292 re-sterilizable patient cable has an embedded resistor connected via connector pins P3
and P5 that enables Medtronic equipment to distinguish between different supported PSA cables. However, pins
P3 and P5 are not connected to the Merlin PSA which does not support this functionality.