Merlin™ Patient Care System

Introduction and Overview

This document serves as a Help Manual for the Merlin™ Patient Care System (PCS), a device developed by St. Jude Medical. It provides users with essential information regarding the system's operation, supported devices, and troubleshooting. The Merlin PCS is designed for cardiac rhythm management and patient care.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Trademarks and service marks, including ST. JUDE MEDICAL and the nine-squares symbol, belong to St. Jude Medical, LLC and its related companies.

For patent information, visit: http://patents.sjm.com

© 2018 St. Jude Medical, LLC. All Rights Reserved.

Supported Devices

The Merlin™ Patient Care System, equipped with Model 3330 Software, supports a wide range of cardiac devices. The system indicates whether the programmer's telemetry wand should be used with the magnet installed or removed for each device. Interrogating unsupported devices may result in the programmer being unable to identify them.

If the implanted device's model name or number is unknown, interrogate the device without the magnet.

Table 1. Bradycardia devices supported by the Merlin™ PCS (Sample)

Note: Not all device models are available in all countries.

Extensive tables listing Bradycardia, Tachycardia, and Monitoring devices are provided in the original document, detailing model numbers and magnet requirements.

Key Features and Functions

Start-Up Screen

The Start-Up screen provides access to various system functions. Key elements include:

• [?] Button: Accesses the Help manual.
• [Tools Button]: Opens a menu for the PSA application, preferences, and other programmer functions.
• [RF Telemetry Status Icon]: Displays the RF communication status for RF-capable devices.
• [Bluetooth Wireless Technology Icon]: Reports the connection status of the Bluetooth dongle.
• [Waveform Control Buttons]: Control the appearance and configuration of waveforms displayed.
• [Rhythm Display]: Shows up to five ECG waveforms.
• [Adjust Display Button]: Allows adjustment of waveform vector, sweep speed, and filter settings.
• [Freeze Button]: Captures and displays waveform data in the Freeze Capture window.
• [Print Settings Button]: Opens the Print Settings window for configuring print jobs.
• [Printer Status Panel]: Indicates the status of the printer.
• [Interrogate Button]: Initiates device interrogation.
• [Interrogate Monitors Button]: Initiates interrogation of connected monitors.

Printer Icons:

• [Internal Printer Icon]: Indicates the internal printer is in use.
• [External Printer Icon]: Indicates an external printer is connected.
• [PDF Printing Icon]: Indicates paperless or PDF printing is selected.

Tools Menu

The Tools menu provides access to several programmer utilities:

• PSA: Accesses the Pacing System Analyzer application.
• Session Records: Allows searching, reviewing, and exporting programming session records.
• PDFs: Manages reports saved as PDF files, allowing export or deletion.
• Educational Materials: Includes Help resources and device demonstrations.
• Maintenance: Utilities for programmer maintenance (for St. Jude Medical personnel).
• Clinical Studies: Information for studies (for St. Jude Medical personnel).
• Preferences: Configures system settings such as language, date, time, and audio.
• Customer Support: Provides contact information for Technical Support.
• Print Screen: Captures and prints the current screen image.
• Export Screen: Exports the current screen as an image file (e.g., .png) to a storage device.

Session Records and PDFs

Session Records and PDF Reports are automatically erased from the Merlin PCS based on Data Management Preferences. Users should ensure timely export of critical data.

Reports are saved as PDF files, which can be exported to a USB flash drive. Viewing PDFs requires Adobe™ Acrobat™ Reader or Adobe Reader™.

Preferences

The Preferences window allows customization of Merlin PCS settings, including:

• Date and Time: Sets the system's date, time, and time zone.
• Language & Formats: Configures display language, date format, time format, and number format.
• ECG: Adjusts the ECG Notch Filter frequency to reduce AC power line interference.
• Audio: Manages audio cues for programmer activity and charging.
• Printer: Configures printer settings, including selected printer (PDF Only, Internal & PDF, External & PDF) and number of copies.
• Wireless: Enables or disables wireless communications.
• Data Management: Sets the retention period for Session Records and PDF Reports.

Export Data

The Export Data function allows users to export device and session data to compatible patient-tracking software programs. Data can be exported to USB flash drives, floppy drives, or PCs connected via serial port.

Rhythm Display and Waveform Control

The Rhythm Display shows ECG waveforms. Waveform Control buttons allow users to adjust waveform appearance, including drag-and-drop positioning, vector selection, sweep speed, gain, and ECG filtering. The Adjust Display window provides detailed control over these parameters.

Figure 3. Waveform control buttons:

• [Configuration Button]: Opens the ECG Configuration window.
• [AutoGain Button]: Automatically sets waveform gain.
• [Gain +/- Buttons]: Manually adjust waveform gain.

Freeze Capture

The Freeze button captures the most recent 30 seconds of waveform data. Up to six Freeze Captures can be stored in memory. Users can manipulate captured waveforms, use calipers to measure time intervals, and print the frozen waveform.

Print Menu Settings

This feature allows users to customize printed reports, including adding patient/clinic names and automatically printing summary reports.

Error and Informational Messages

The Merlin PCS provides various messages to inform users of system status or potential issues. Common messages include:

• No PSA Wand Communication or Merlin™ PSA is not Functioning: Indicates a potential mechanical, software, or interference issue with the PSA Wand or programmer.
• No PSA Detected: Suggests the Merlin PSA Model EX3100 may not be connected properly.
• Help: Provides context-sensitive information accessible via the [?] button.
• Problem with Media Device: Indicates issues with USB flash drives, floppy drives, or serial port adapters.
• No Media Detected: May occur if the media device is unsupported, the USB port is faulty, or the connector is not fully inserted.
• Media Invalid or Not Present: Can be due to a full device, write protection, or issues with the patient-tracking software or PC.
• Sustained Interruption: Occurs if interrogation is interrupted for 15 minutes due to range issues, wand removal, or electronic interference.
• Older Device: The device may require a magnet, or there may be range or interference issues.
• Device Not Supported: The device cannot be identified or is not supported by the programmer.
• Telemetry Interruption: Communication between the device and programmer is lost due to range, removal, interference, or incorrect wand/magnet usage.
• Invalid Parameters Detected: Indicates invalid parameters that may require resetting the device to nominal settings.
• On-Screen Keyboard: Facilitates data entry with special character keys and support for external keyboards.
• Emergency VVI Programming Interrupted / Backup VVI Procedure Interrupted: Indicates interruption of programming procedures due to telemetry loss.
• Help Not Provided: Context-sensitive help is unavailable for the current topic.
• Requires Connection to Computer: Necessary for exporting data to a computer database.
• BVVI Session Must Be Ended: A procedure cancellation message.
• Unable to Restore Original Parameters: An error during pacer software restoration.
• Check Bluetooth® Wireless Technology Hardware: Indicates an issue with the Bluetooth accessory.
• No Monitors Detected: The programmer cannot communicate with connected monitors.

Technical Support

For technical questions and support, St. Jude Medical provides the following contact information:

• Phone: 1 818 362 6822
• Toll-free (North America): 1 800 722 3774
• International Numbers: +46 8 474 4147 (Sweden), +61 2 9936 1200 (Australia)
• Website for manuals: https://manuals.sjm.com

For additional assistance, contact your local St. Jude Medical representative.