Abbott Merlin 2 PCS User manual

Merlin™ 2 Patient Care System
Merlin™ 2 PCS, Model MER3700
User's Manual

™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third
-party trademark, which is property of its respective owner.
Bluetooth and Bluetooth logo are regis
tered trademarks of Bluetooth SIG, Inc.
©
2021 Abbott. All Rights Reserved.
St.
Jude Medical is a wholly-owned subsidiary of Abbott.
Pat.
http://www.abbott.com/patents

i
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

1
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:

2
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.

3
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.

4
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

5
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

7
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®Low Energy wireless communication, see Bluetooth Wireless
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
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

8
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

9
to contact the touchscreen. The touchscreen has a special coating that can be damaged by
contact with other hard surfaces.
7. On the Merlin™ 2 PCS screen, select the Adjust Display button to configure the ECG
waveform. For more information, select the ? button at the top of the screen when the Adjust
Display window appears.
Figure 6. The Adjust Display button, the Interrogate button, and the Tools Menu
1. Adjust Display button
2. Interrogate button
3. Interrogate monitors button
4. Tools menu
Setup for Inductive Telemetry Devices
1. Place the inductive telemetry wand over the patient's device.
NOTE: For devices that use inductive telemetry, use only the Model 3630W telemetry wand
with the Merlin™ 2 PCS.
2. Select the Interrogate button for pacemakers, ICDs, and CRTs.
3. Use the telemetry strength indicator on the telemetry wand to position the wand over the
device. A single lighted LED indicates telemetry is established. A greater number of lighted
LEDs indicates stronger signal strength.
Setup for Insertable Cardiac Monitors
1. Place the magnet on the patient's device for 3 seconds and remove.

10
2. Select the Interrogate Monitors button.
3. The programmer will look for advertising pulses from the Confirm Rx™ Insertable Cardiac
Monitor.
Merlin™ PSA Model EX3100 Setup
Connect the Merlin™ PSA Model EX3100 into the PSA port on the Merlin 2 PCS
For more information on the Merlin PSA Model EX3100, including connection of the patient
cables and patient-cable adapters, refer to the on-screen help on the Merlin 2 PCS and to the
Merlin PSA user's manual.
Figure 7. Merlin™ PSA Model EX3100
1. Functional Status LEDs
2. Pace and Sense LEDs
3. Receptacle for patient cable or patient-cable adapter
4. Connector to Merlin 2 PCS
RF Communication Setup
Some St. Jude Medical implantable devices can communicate with the Merlin™ 2 PCS via radio
frequency (RF), which allows for a greater distance between the device and the Merlin 2 PCS. To
establish RF communication, follow the instructions below.
1. Connect the Merlin™ Antenna to the RF Telemetry port on the back of the Merlin 2 PCS
(see figure below).
NOTE: Connect the Merlin Antenna only to the RF Telemetry port on the back of the
programmer. Do not connect the Merlin Antenna to any other ports.

11
Figure 8. Connection between the Merlin™ Antenna and the Merlin™ 2 PCS
1. Merlin Antenna
2. Merlin 2 PCS
2. Place the Merlin Antenna on a flat surface approximately 1 – 2 m (2 – 6 ft) from the
implanted device. The front panel should face the device.
3. Follow steps 1 through 6 in the Merlin 2 PCS Setup (page 7).

12
When the Merlin 2 PCS is turned on, the green telemetry strength indicator and blue status
LEDs on the Merlin Antenna will light, indicating the unit is powered and operational.
Figure 9. 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. See RF Telemetry Icons (page 13).
4. Place the inductive telemetry wand over the patient's device.
5. On the programmer, select the Interrogate button.
After the interrogation is complete, the Merlin™ 2 PCS displays the FastPath™ Summary
Screen. The "Active RF Telemetry connection" icon appears under the Tools menu button.
See RF Telemetry Icons (page 13).
The telemetry strength indicators on the Merlin Antenna indicate RF telemetry
communication between the Merlin Antenna and the device. A single lighted LED indicates
telemetry is established. A greater number of lighted LEDs indicates stronger signal strength.
If necessary, relocate the Merlin Antenna for better communication. See Suboptimal RF
Communication (page 19).
6. Once RF telemetry is established, you may remove the inductive telemetry wand from the
patient.
7. Begin the programming session.
CAUTION: Position the Merlin Antenna at least 20 cm (8 in) away from the patient and
any other devices that might interfere with the Merlin Antenna's operation.
Do not use the Merlin Antenna if its enclosure is damaged.

13
RF Telemetry Icons
Table 1. RF telemetry icons for tachycardia devices
Start-Up Screen Icons
Application Icons
Disconnected
Antenna/Not Working
Ready to connect to
device
Active RF telemetry
connection
Inactive RF telemetry
connection
Table 2. RF telemetry icons for bradycardia devices
Start-Up Screen Icons Application Icons
Disconnected
Antenna/Not Working
Ready to connect to
device
Active RF
telemetry
connection
Inactive RF
telemetry
connection
Only wand
telemetry is
available
Bluetooth Wireless Communication Setup
The Merlin™ 2 PCS is Bluetooth®Low Energy wireless compatible. Bluetooth is built into the
Merlin 2 PCS. This allows for communication between the Merlin 2 PCS and an implanted device
that supports Bluetooth Low Energy wireless communication without the need for a dongle.
-Do not put anything between the Merlin 2 PCS and the implanted device. People and
objects may interfere with communication between the Merlin 2 PCS and the device.
-Confirm that the Bluetooth icon is visible on the Merlin 2 PCS Start-up screen.
-Follow the instructions provided on the Start-up screen to begin communication
between the Merlin 2 PCS and an implanted device that supports Bluetooth Low
Energy wireless communication.
-Do not use a Bluetooth dongle.
CAUTION: For optimal Bluetooth Low Energy wireless communication, the
Merlin 2 PCS and St. Jude Medical implantable devices should be within 2 m (6.6 ft) of
each other in normal use. Do not operate a device that may generate interference,
such as a powerful microwave oven, when utilizing Bluetooth Low Energy wireless
communication.

14
Network Hardware Connection
You can connect the Merlin™ 2 PCS to a network using the wired ethernet network connection on
the back of the programmer.
Figure 10. Network hardware connection
Shut Down
To power down the Merlin™ 2 PCS:
1. Remove any cables connecting the Merlin 2 PCS to the patient.
2. Move the On/Off switch to the Off position.
The Merlin 2 PCS has a power switch that, when shut off, isolates both conductors of the supply
mains simultaneously.

15
Emergency Operation
Figure 11. 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
deliver therapy1.
VVI. Select this button to automatically reset the device to predefined high-output settings.2
External Device Connection
The Merlin™ 2 PCS can be connected to three types of external devices: data storage devices,
input devices, and output devices.
NOTE: Not every commercially available external device is guaranteed to operate with the
Merlin 2 PCS. External devices that have been tested and verified to operate are listed in the
Accessories table (page 30).
WARNING: The ports on the Merlin 2 PCS are not isolated. Only connect external
devices that provide proper isolation from the power supply or use the external device
with an isolation transformer. Close the cover after disconnecting the device.
CAUTION: Additional non-medical electrical equipment connected to medical electrical
equipment, which includes equipment connected to the input or output ports, must
comply with the respective IEC or ISO standards. Furthermore, all configurations must
comply with the requirements for medical electrical systems (see IEC 60601-1, Clause
16). Anyone who connects additional equipment to medical electrical equipment is
configuring a medical system and is responsible for the compliance of the system. If in
doubt, contact the Abbott Medical Technical Support department or your local
Abbott Medical representative.
Data Storage Devices
Only external storage devices can be connected to the six USB ports on the Merlin™ 2 PCS. The
devices can be used to save session records, screen captures, and database records that will be
uploaded to patient-tracking software.
Flash drive. A flash drive can be plugged into the Merlin 2 PCS to store data from patient devices.
1Emergency Shock is not available during a PSA session.
2Emergency VVI settings for each device are defined in the device's User's Manual.

16
Data Export. Data Export applies to data that displays patient information, such as screen
captures, data base records, and pdf reports. Data Export is nominally set to encrypt exported
data (see Personal Identification Number). Session Records and Programmer Logs are
automatically encrypted, and only Abbott Medical personnel can access the data.
You can view Data Export settings in Preferences from the Tools menu To adjust the patient data
export setting, contact Technical Support.
Personal Identification Number (PIN). To export data you must create a Personal Identification
Number. The PIN cannot:
Repeat a number six times in succession, for example 555555
Have consecutive numbers in either ascending or descending order, for example 123456 or
654321
NOTE: Be sure to document the PIN selected. The PIN will be required later to access the
data from the flash drive.
Input Devices
Keyboard. A USB keyboard can be connected to any of the six USB ports for use in conjunction
with the on-screen keyboard.
Mouse. A USB mouse can be connected to any of the six USB ports for use in conjunction with
the on-screen keyboard while in the presence of a patient. Do not use a third-party device that
enables long range control to send remote mouse input, for example over the Internet. For a list of
compatible mice, contact your Abbott Medical representative or Technical Support (page 2).
ECG Input Cable. The ECG Input Cable, supplied by your Abbott Medical Representative, can be
used to display an ECG waveform generated by an external ECG device on the Merlin™ 2 PCS.
See the Accessories table (page 30). Plug the cable's 6-pin connector into the ECG IN port in the
back of the Merlin 2 PCS, and the 3.5 mm mini-plug into the Signal Out port on the external unit.
NOTE: For the best display, select Lead 1 from the ECG Configuration window on the Merlin
2 PCS.
Output Devices
Video Out. The screen display of the Merlin™ 2 PCS can be sent to a video monitor that supports
HDMI capabilities for use while in the presence of a patient. Connect one end of the video cable
into the HDMI port on the rear of the Merlin 2 PCS, and plug the other end into the monitor port.
External Printer. The Merlin 2 PCS can print to some external printers with USB connectors. For
a list of compatible printers, contact Technical Support (page 2).
1. Connect the printer's USB cable to any of the six USB ports on the Merlin 2 PCS.
2. Turn on both the printer and the Merlin 2 PCS.
3. On the Merlin 2 PCS screen, select the Tools button.
4. On the drop-down menu, select the Preferences button, then select the Printer tab.
5. Under "Selected Printer," select the External & PDF button.
6. Close the window and begin the device session.