Merlin MER3700 User Manual

Merlin™ 2 Patient Care System

User's Manual

Merlin™ 2 PCS, Model MER3700

™ Indicates a trademark of the Abbott group of companies.

‡ Indicates a third

Bluetooth and Bluetooth logo are regis

St.

Pat.

-party trademark, which is property of its respective owner.

tered trademarks of Bluetooth SIG, Inc.

Jude Medical is a wholly-owned subsidiary of Abbott.

http://www.abbott.com/patents

Contents

Introduction .............................................................................................................. 1

Indications ................................................................................................................ 1

Intended Use ............................................................................................................ 1

Contraindications ...................................................................................................... 1

Potential Adverse Events ........................................................................................... 1

Technical Support ..................................................................................................... 2

Merlin™ 2 PCS Features ........................................................................................... 3

Setup Instructions ..................................................................................................... 7

Merlin™ 2 PCS Setup .......................................................................................................... 7

Merlin™ PSA Model EX3100 Setup .................................................................................... 10

RF Communication Setup .................................................................................................. 10

Bluetooth Wireless Communication Setup ........................................................................... 13

Network Hardware Connection ........................................................................................... 14

Shut Down ......................................................................................................................... 14

Emergency Operation ......................................................................................................... 15

External Device Connection ................................................................................................ 15

Maintenance and Troubleshooting ........................................................................... 17

Maintenance ...................................................................................................................... 17

Cleaning or Disinfecting ...................................................................................................... 17

Programmer Self Test/Preventive Maintenance ................................................................... 17

Troubleshooting ................................................................................................................. 18

Technical Data ........................................................................................................ 21

Merlin™ 2 PCS Specifications ............................................................................................ 21

Merlin™ Antenna Specifications ......................................................................................... 22

Essential Performance ........................................................................................................ 22

Data Security ..................................................................................................................... 23

Electromagnetic Compatibility ............................................................................................. 23

Transportation and Handling Conditions ............................................................................. 29

Operation and Storage Conditions ....................................................................................... 29

Disposal ............................................................................................................................. 29

Accessories ........................................................................................................................ 30

Symbols .................................................................................................................. 30

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:

 Arrhythmia

 Electric Shock

 Prolonged Surgery

 Discomfort

 Infection

 Injury (for example, Burn)

Technical Support

Abbott Medical maintains 24-hour phone lines for technical questions and support:

 1 818 362 6822

 1 800 722 3774 (toll-free within North America)

 + 46 8 474 4147 (Sweden)

 + 61 2 9936 1200 (Australia)

 medical.abbott/manuals

For additional assistance, call your local Abbott Medical representative.

Merlin™ 2 PCS Features

Figure 1. Merlin™ 2 Patient Care System

1. NFC (Near Field Communication) Logo.

2. Fold-away Handle.

3. Two USB Ports. For connection to any USB compatible accessory supported by the

system. Top port is Port 1; bottom port is Port 2.

4. VVI Button. Select this button to reprogram a device to high-output Emergency VVI settings. See Emergency Operation (page 15).

5. Shock Button. Select this button to display the Shock screen (for ICDs). See Emergency Operation (page 15).

6. Display Latch.

Figure 2. Connections between the Merlin™ 2 PCS, and the Merlin Antenna, Telemetry Wand,

Merlin PSA, and ECG Cables

1. ECG Cable connected to the ECG input port. See Merlin 2 PCS Setup (page 7).

2. Inductive Telemetry Wand connected to the telemetry wand inductive port. See

Merlin 2 PCS Setup (page 7).

3. Merlin Antenna connected to the RF telemetry port. See RF Communication Setup (page 10).

4. Merlin PSA connected to the PSA port. See Merlin 2 PCS Setup (page 7).

5. Merlin 2 PCS

Figure 3. Back side

1. ECG input port. See Merlin™ 2 PCS Setup (page 7).

2. Telemetry wand (inductive) port. For connection to inductive telemetry devices. See

Merlin 2 PCS Setup (page 7).

3. RF telemetry port. For connection to the Merlin™ Antenna. See RF Communication Setup (page 10).

4. On/Off switch

5. Fuse holder

6. Power receptacle

7. PSA port. For connection to the Merlin PSA Model EX3100. See Merlin 2 PCS Setup

(page 7).

8. Function button. For use by Abbott Medical personnel only.

9. HDMI port. For connection to an external video monitor. See External Device

Connection (page 15).

10. Display port connector (DVI connection)

11. Ethernet ports

12. Four USB ports. For connection to any USB compatible accessory supported by the

system. Top left port is Port 3; bottom left port is Port 4; top right port is Port 5; bottom right port is Port 6. See External Device Connection (page 15), RF Communication Setup (page 10), and Bluetooth® Wireless Communication Setup (page 13).

13. Microphone jack input port

Setup Instructions

Merlin™ 2 PCS Setup

WARNING: Do not bring any external control devices, such as a programmer, into the scanner magnet room (Zone IV). These devices are considered MR Unsafe.

To set up the Merlin™ 2 PCS to communicate with a device that uses inductive telemetry see Setup for Inductive Telemetry Devices (page 9). To set up the Merlin 2 PCS with a device that uses RF communication, see RF Communication Setup (page 10). To set up the Merlin 2 PCS with a device that uses Bluetooth Communication Setup (page 13).

CAUTION: Do not use if the programmer, cable, or any accessories that connect to the programmer show visible signs of damage.

1. Place the programmer and accessories on a clean, stable, and well-lit surface. Do not place any implantable devices on the inside surface of the programmer when the lid is in the open position and you are attempting to communicate with the Merlin 2 PCS. See the Figure "Merlin 2 Patient Care System" (page 3).

CAUTION: Ensure the programmer is positioned so the vents are not blocked. Blocking the vents may lead to overheating, which may cause the programmer to shut down.

2. Plug the power cord into the power receptacle and then into grounded mains outlet.

CAUTION: The Merlin 2 PCS must be connected to a grounded mains outlet with a hospital-grade cable.

Figure 4. The power receptacle, the fuse holder, and the On/Off switch

Low Energy wireless communication, see Bluetooth Wireless

1. Power receptacle

2. Fuse holder

3. On/Off switch

3. You can attach a 5-lead or 3-lead ECG to the Merlin 2 PCS (see below).

With the 5-lead ECG cable, attach up to five ECG electrodes to the patient: Right Arm, Left

Arm, Right Leg, and Left Leg. For the fifth or chest electrode, choose one C location (see figure below). With the 3-lead ECG cable, attach electrodes to the Right Arm, Left Arm, and Right Leg (see figure below).

CAUTION: Use only the ECG cables listed in the Accessories table (page 30) of this manual to protect the Merlin 2 PCS against possible damage from defibrillator shock.

Do not use the programmer as an ECG monitor or general diagnostic device.

NOTE: With the 3-lead ECG cable, only the Lead I vector is displayed on the Merlin 2 PCS programmer screen.

4. Attach the ECG leads to the appropriate electrodes.

Figure 5. Color codes and positions of ECG cable connections for 5-lead ECG (left) and 3-lead

ECG (right)

1. R (Red)

2. L (Yellow)

3. N (Black)

4. F (Green)

5. C (White)

CAUTION: Do not allow conductive parts of electrodes or connectors to come into contact with other conductive parts, including Earth ground.

5. Turn on the power.

6. Open the screen display by releasing the latch.

Use your fingertip or a soft-tip stylus to contact the touchscreen. Do not use pens or pencils

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