Merlin Patient Care
System Programmers

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Indications, Safety & Warnings

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Merlin™ 2 Patient Care System (PCS) Programmer

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The Merlin 2 Patient Care System (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 resynchronization 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 Abbott Medical implantable medical devices during implant and follow-up.

The Telemetry Wand part numbers 100051526 and 100051556 are intended to provide inductive communication between the programmer and the implantable medical device during a programmer session.

The Merlin 2 PCS electrocardiogram (ECG) function when using the ECG cable Models 3617, 3625, 3626 and EX3001 is only intended to support activities related to implanting, programming and monitoring Abbott Medical implantable medical devices.

The Merlin RF Antenna Model 3638 is a dedicated radio antenna accessory intended to enable wireless radiofrequency (RF) communication between the Merlin 2 PCS and Abbott Medical implantable medical devices with RF communication capability during a programmer session.

The Merlin Pacing System Analyzer (PSA) Model EX3100 is a pacing system analyzer intended for use with the Merlin2 PCS to evaluate Abbott 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.

Merlin™ PCS Model 3650 Programmer

RxOnly

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The Merlin 3650 Patient Care System (PCS) (Merlin 3650 PCS Programmer Model MER3650 and Merlin 3650 PCS Software Model MER3300) 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 resynchronization therapy system.

Intended Use: The St. Jude Medical Merlin™ PCS Model 3650 is a portable, dedicated system designed to interrogate, program, display data from, and test St. Jude Medical implantable devices during implant and follow up. At time of implant, it is intended to assess the pacing and sensing performance of the lead after it is connected to the pulse generator.

The Telemetry Wand Model 3630 is intended to provide inductive communication between the programmer and the pulse generator during a programming session.

The Merlin PCS ECG function when using the ECG cable Models 3617, 3626 and EX3001 is intended to display the patient electrocardiogram and used to support activities related to implanting, programming, and monitoring St. Jude Medical implantable pulse generators.

The Merlin Antenna Model 3638 is a dedicated radio antenna accessory intended to enable wireless radio frequency (RF) communication between the Merlin PCS and St. Jude Medical implantable pulse generators with RF communication capability during a programming session.

The Merlin PSA Model EX3100 and the PSA Patient Cable Model 3150 are pacing analyzer systems intended for use with the Merlin PCS to evaluate implanted leads for integrity, and for pacing and sensing performance during surgical procedures related to the implanted system.

The Magnet Model 3630M is intended to support inductive communication with specific pulse generators or to enable device-specific magnet settings, such as high voltage therapy inhibition or asynchronous mode activation, when placed over an implanted pulse generator.

Contraindications: There are no contraindications to the use of the Merlin 3650 PCS (Merlin 3650 PCS Programmer Model MER3650 and Merlin 3650 PCS Software Model MER3300) to interrogate, program, display data from and test implantable medical devices during implant and follow-up.

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