St. Jude Medical Merlin 3650 User Manual
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St. Jude Medical Merlin 3650 User Manual

Patient care system
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Merlin™ Patient Care System
Merlin™ PCS, Model 3650
Merlin™ Antenna, Model 3638
Merlin™ PSA, Model EX3100
User's Manual

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Eva D Mayer
June 11, 2025

I have a merlin. Going on a vacation and will be a !000 miles away. Do I need to take my monitor

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Summary of Contents for St. Jude Medical Merlin 3650

  • Page 1 Merlin™ Patient Care System Merlin™ PCS, Model 3650 Merlin™ Antenna, Model 3638 Merlin™ PSA, Model EX3100 User's Manual...
  • Page 2 Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies.

  • Page 3: Table Of Contents

    Contents Introduction ......................1 Technical Support ..................... 1 Features ........................3 Setup Instructions ..................... 7 Merlin™ PCS Setup ......................7 Shut Down ......................... 10 Merlin™ PSA Model EX3100 Setup ..................10 PSA Wand Model 3150 Setup .................... 14 RF Communication Setup ....................14 Bluetooth Wireless Communication Setup ................

  • Page 5: Introduction

    This manual describes the components, setup, maintenance, accessories, and technical data of the Merlin 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 designed to enable radio frequency (RF) communication between the Merlin PCS and St.

  • Page 7: Features

    Features Figure 1. Merlin™ Patient Care System...
  • Page 8 1. Telemetry Strength Indicators. For the Merlin™ PCS and Merlin™ Antenna. See Merlin™ PCS Setup (page 7) and RF Communication Setup (page 14). 2. Flash Drive Compartment (USB Port 1). See External Device Connection (page 23) and Bluetooth Wireless Communication Setup (page 17). 3.
  • Page 9 Figure 3. Left side 1. On/Off switch 2. Display Out port. Connect an external video monitor here. See External Device Connection (page 23). 3. Two USB ports. Connect an external floppy drive, keyboard, mouse, Merlin Antenna, or connectivity accessory here. Top port is Port 2; bottom port is Port 3. See External Device Connection (page 23), RF Communication Setup (page 14), and Bluetooth Wireless Communication Setup (page 17).

  • Page 11: Setup Instructions

    Setup Instructions Merlin™ PCS Setup To set up the Merlin™ PCS to communicate with a device that uses inductive telemetry, follow these instructions. For instructions to setup the Merlin PCS with devices that use RF communication, see RF Communication Setup (page 14). For instructions to setup the Merlin PCS with devices that use Bluetooth ®...
  • Page 12 Figure 6. 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) WARNING: Do not allow conductive parts of electrodes or connectors to come into contact with other conductive parts, including Earth ground.
  • Page 13 Figure 7. The Adjust Display button, the Interrogate button, the Interrogate Monitors button, and the Tools Menu 1. Adjust Display button 2. Interrogate button 3. Interrogate Monitors button 4. Tools menu Place the inductive telemetry wand over the patient's device. Do not insert the magnet into the wand.

  • Page 14: Shut Down

    Shut Down To power down the Merlin™ PCS: Remove any cables connecting the Merlin PCS to the patient. Either: Move the On/Off switch to the Off position, or Detach the power cable from the unit. The Merlin PCS has a power switch that, when shut off, isolates both conductors of the supply mains simultaneously.
  • Page 15 Figure 8. Merlin PSA Model EX3100 1. Functional Status LEDs 2. Pace and Sense LEDs 3. Receptacle for patient cable or patient-cable adapter 4. Receptacle for inductive telemetry wand 5. Receptacle for ECG input 6. Connectors to Merlin PCS To place the Merlin PSA into the storage compartment, follow the steps below. To remove the Merlin PSA from storage compartment, reverse the steps.
  • Page 16 Figure 9. Storage compartment door removal Loosen the hinge on the other side and pull the hinge and lid free. Save the lid and hinge for future use. Disconnect all cables and remove them from the storage compartment. On the back of the Merlin PSA, locate the gray Merlin PSA connector and connect it to the gray RF Telemetry port in the storage compartment.
  • Page 17 Figure 10. Insertion of the Merlin PSA 13. Connect the inductive telemetry wand into the blue port on the Merlin PSA and the ECG into the black port. 14. Connect the Merlin Antenna to a USB port on the left side of the programmer using the Merlin Antenna cable adapter (Model EX3190).

  • Page 18: Psa Wand Model 3150 Setup

    Do not plug the PSA Wand into the PSA port on the Merlin PSA. RF Communication Setup Some St. Jude Medical™ implantable devices can communicate with the Merlin™ PCS via radio frequency (RF), which allows a greater distance between the device and the Merlin PCS. To establish RF communication, follow the instructions below.
  • Page 19 If the Merlin™ PSA Model EX3100 is not in place in the storage compartment, open the storage compartment door and locate the RF Telemetry port. Connect the cable from the Merlin™ Antenna to the RF Telemetry port. If the Merlin PSA Model EX3100 is already placed in the storage compartment, locate the Merlin Antenna USB adapter (Model EX3190) provided with the Merlin PSA.
  • Page 20 Figure 13. Merlin Antenna, showing the antenna cable, the green telemetry strength indicator LEDs, and the blue status LEDs 1. Antenna cable 2. Green telemetry strength indicator LEDs 3. Blue status LEDs When the programmer startup screen appears, the "Ready to Connect to Device" icon appears under the Tools menu button.

  • Page 21: Bluetooth Wireless Communication Setup

    Start-Up Screen Icons Application Icons Bluetooth Wireless Communication Setup Some St. Jude Medical™ implantable devices can communicate with the Merlin™ PCS via Bluetooth ® 6 Low Energy wireless communication. This allows communication at a greater distance between the Merlin PCS and an implanted device. To establish Bluetooth Low Energy wireless communication, follow the instructions below.

  • Page 22: Network Hardware Connection

    CAUTION: For optimal Bluetooth Low Energy wireless communication, the Merlin PCS and SJM implantable devices should be within 2 m (6.6 ft) in normal use. Do not operate a device that may generate interference, such as a powerful microwave oven, while Bluetooth Low Energy wireless communication is attempted.
  • Page 23 For more information about the network configuration for your clinic, contact your IT department. Figure 15. Ethernet connection using a router port on the wall Figure 16. Ethernet connection using a router NOTE: Only use the supplied St. Jude Medical Ethernet card EX3211.
  • Page 24 Align the Wi-Fi card with the bottom of the Wi-Fi port. Ensure the Wi-Fi card fits snugly in the Wi-Fi port. Figure 17. Insert the Wi-Fi card NOTE: Only use the supplied St. Jude Medical Wi-Fi card EX3213. Wi-Fi USB Wireless Network Hardware Connection To connect the Wi-Fi USB (EX3212): Make sure the programmer is turned Off.
  • Page 25 Figure 18. Open the USB port cover Insert the Wi-Fi USB into the USB port. Figure 19. Insert the Wi-Fi USB...

  • Page 26: Emergency Operation

    Figure 20. Wi-Fi USB Inserted NOTE: Only use the supplied St. Jude Medical Wi-Fi USB EX3212. Emergency Operation Figure 21. Emergency buttons (displayed in red) The console has two red emergency option buttons: SHOCK. Select this button to display the Shock screen (for ICDs). From this screen, you can ...

  • Page 27: External Device Connection

    For a list of compatible mice, contact your St. Jude Medical representative or Technical Support (page 1). ECG Input Cable. The ECG Input Cable, supplied by your St. Jude Medical Representative, can be used to display an ECG waveform generated by an external ECG device on the Merlin PCS, see Accessories (page 37).

  • Page 28: Printer Paper

    External Printer. The Merlin PCS can print to some laser printers with USB connectors . For a list of compatible printers, contact your St. Jude Medical Representative or Technical Support (page 1). To print to an external printer: Connect the printer's USB cable to any of three USB ports on the Merlin PCS.

  • Page 29: Maintenance And Troubleshooting

    Maintenance and Troubleshooting Maintenance Service must be performed at the factory or by an authorized service representative only. The Merlin™ PCS and its accessories contain no user-serviceable parts. NOTE: For information on the Merlin™ PSA maintenance and troubleshooting, see the Merlin PSA on-screen help.
  • Page 30 (page 7), and lift the catch until the fuse holder clicks and pops out. If either fuse is blown, replace it with the appropriate fuse (see Electrical Specifications (page 29)), plug the unit in, and turn the power on. If the fuse blows again, contact St. Jude Medical's Technical Support department (page 1).
  • Page 31 Communication (page 27) below. Suboptimal RF Communication The Merlin™ PCS indicates the quality of the RF communication by the telemetry strength indicator LEDs on both the programmer and the Merlin™ Antenna. Below is a list of potential causes of suboptimal radio communication: Possible Causes The Merlin™...

  • Page 33: Technical Data

    Technical Data Merlin™ PCS Specifications The Merlin™ PCS is Class I, Type BF defibrillation-proof medical equipment Mechanical Length 50.8 cm (20.0 in) Width 38.1 cm (15.0 in) Height 13.3 cm (5.2 in) Case material High-impact plastic Electrical Input power (mains) 100-240 V~, 50/60 Hz, 3-wire (grounded) Power supply Medical grade (shielded)

  • Page 34: Merlin™ Antenna Specifications

    Extension cord 1.22 m (4.0 ft) Merlin™ Antenna Specifications The Merlin™ Antenna Model 3638 is Class I medical equipment Mechanical Length 5.0 cm (2.0 in) Width 10.3 cm (4.0 in) Height 15.3 cm (6.0 in) Case material High-impact plastic Electrical Input power (mains) Powered by Merlin™...
  • Page 35 WARNING: The Merlin PCS and the Merlin Antenna are intended for use only by healthcare professionals. They comply with the limits for medical devices contained in IEC/EN 60601-1-2. However, the Merlin PCS and the Merlin Antenna may cause radio interference or may disrupt the operation of nearby equipment.
  • Page 36 Table 4. Guidance and manufacturer's declaration — electromagnetic immunity Test IEC 60601 Test Level (Actual Electromagnetic Environment — Level) Guidance IEC 61000-4-5 (±1 kV line[s] to line[s]) of a typical commercial or hospital environment. ±2 kV line[s] to earth (±2 kV line[s] to earth) Power Frequency 30 A/m Power frequency magnetic fields...
  • Page 37 Table 5. Guidance and manufacturer's declaration - electromagnetic immunity (conducted RF and radiated RF) Test IEC 60601 Immunity Electromagnetic Environment - Test Level Compliance Level Guidance 2.7 GHz equation applicable to the frequency of the transmitter. Recommended separation distance: 80 MHz to 800 MHz 800 MHz to 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W)
  • Page 38 Table 5. Guidance and manufacturer's declaration - electromagnetic immunity (conducted RF and radiated RF) Test IEC 60601 Immunity Electromagnetic Environment - Test Level Compliance Level Guidance **Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than [V ]V/m.
  • Page 39 2.5 meters in normal use. For Bluetooth ® 26 Low Energy wireless communication, the Merlin PCS and St. Jude Medical implantable devices should be within 2 meters in normal use. Bluetooth® is a registered trademark of Bluetooth SIG, Inc.

  • Page 40: Storage And Operating Conditions

    Over a short range (within 2 meters in normal use)  Wireless Communication Troubleshooting If the Merlin™ PCS is unable to communicate with a St. Jude Medical implanted device: If using inductive telemetry or the RF wand, try re-orienting the wand. ...

  • Page 41: Disposal

    If the unit was stored below 10°C (50°F), it may not function properly. Disposal Return the Merlin™ PCS and the Merlin™ Antenna to St. Jude Medical at the end of their operating lives. The crossed-out trash can symbol marked on the programmer and the Merlin Antenna indicates that St.
  • Page 42 Table 8. Clinical Accessories Model Ordered Accessory Intended Use Number Separately Merlin™ Antenna 3638 Provides wireless radio frequency communication between the programmer and the device during a programmer session Merlin Antenna EX3190 Connect the PSA Wand model 3150 Adapter to the Merlin PCS Merlin™...

  • Page 43: Symbols

    European conformity, affixed according to the relevant provisions of AIMD directive 90/385/EEC and RE directive 2014/53/EU Annex II. Hereby, St. Jude Medical declares that this device complies with the essential requirements and other relevant provisions of these directives. The full text of the European Union RE directive 2014/53/EU declaration of conformity is available at the following internet address: www.sjmglobal.com/euconformity.
  • Page 44 Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem. Return the device to St. Jude Medical at the end of its operating life. Alternating current Type BF applied part...
  • Page 45 Symbol Description Pacing system analyzer wand port Power cord Printer paper Follow the instructions for use (Symbol is colored blue.) Consult instructions for use Follow instructions for use on this website RF Telemetry port Telemetry wand Telemetry wand port Connect to the RF Telemetry port on the Merlin PCS TÜV Listed, US and Canada.
  • Page 46 Symbol Description Manufacturer Country of manufacture; BE- Belgium, MY- Malaysia, US- United States Manufacturing facility Made in USA Date of manufacture Australian Communications and Media Authority (ACMA) and New Zealand Radio Spectrum Management (RSM) Regulatory Compliance Mark (RCM) This equipment is certified for type certification pursuant of Article 38-24 of the Japan Radio Law Korea Certification mark for electrical devices FCC Identification Number...
  • Page 50 Belgium +1 818 362 6822 +32 2 774 68 11 St. Jude Medical Puerto Rico LLC St. Jude Medical Operations (M) Sdn. Bhd. Lot A Interior - #2 Rd Km. 67.5 Plot 102, Lebuhraya Kampung Jawa, Santana Industrial Park Bayan Lepas Industrial Zone...

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Merlin 3638Merlin ex3100

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