Intended Use; Contraindications; Warnings - Abbott Merlin PSA EX3100 Help Manual

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.
Burst Pacing. Use of atrial or ventricular burst pacing may result in ventricular tachycardia or
fibrillation. Defibrillation equipment should be readily available during the PSA session.
Handling Inserted Leads. Do not touch the terminal pins or exposed metal when handling
inserted leads. Do not allow the terminal pins or exposed metal to unintentionally contact
electrically conductive or wet surfaces.
Unconnected Atrial Leads. Do not operate the Merlin™ PSA in the DDD or VDD pacing mode
with only the ventricular pacing lead connected. Interference detected at the unconnected atrial
The Medtronic Model 2292 re-sterilizable patient cable has an embedded resistor connected via connector pins P3 and P5 that
1
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.
2