Merlin™ Patient Care System Merlin™ PCS, Model 3650 Merlin™ Antenna, Model 3638 Merlin™ PSA, Model EX3100 User's Manual
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Contents Introduction .............................................................................................................. 1 Indications ................................................................................................................ 1 Intended Use ............................................................................................................ 1 Contraindications ......................................................................................................
Introduction The Merlin™ Patient Care System (Merlin™ PCS) Model 3650 User's 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.
For additional assistance, call your local St. Jude Medical representative.
Features Figure 1.
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 18) and Bluetooth Wireless Communication Setup (page 17). 3. Storage Compartment. Connect ECG cable and inductive telemetry wand. Install the Merlin™ PSA Model EX3100 (page 10) or connect the Merlin Antenna (page 14). 4. Carrying Strap Loops. 5. Touchscreen.
Figure 3. Left side 1. On/Off switch 2. Display Out port. Connect an external video monitor here. See External Device Connection (page 18). 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 18), RF Communication Setup (page 14), and Bluetooth Wireless Communication Setup (page 17). Figure 4. Storage compartment connectors (with Merlin PSA not installed) 1 1.
Setup Instructions Merlin™ PCS Setup CAUTION: 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™ PCS to communicate with a device that uses inductive telemetry, follow these instructions. For instructions to set up the Merlin PCS with devices that use RF communication, see RF Communication Setup (page 14).
Figure 6. Color codes and positions of ECG cable connections for 5-lead ECG (left) and 3-lead ECG (right) 1. 2. 3. 4. 5. R (Red) L (Yellow) N (Black) F (Green) C (White) WARNING: 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. 7. On the Merlin PCS screen, select the Adjust Display button to configure the ECG waveform.
Figure 7. The Adjust Display button, the Interrogate button, the Interrogate Monitors button, and the Tools Menu 1. 2. 3. 4. 8. Adjust Display button Interrogate button Interrogate Monitors button Tools menu Place the inductive telemetry wand over the patient's device. Do not insert the magnet into the wand. NOTE: For devices that use inductive telemetry, use only the Model 3630 wand with the Merlin PCS.
Shut Down To power down the Merlin™ PCS: 1. 2. 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. Merlin™ PSA Model EX3100 Setup The Merlin™ PSA Model EX3100 must be inserted into the Merlin™ PCS storage compartment.
Figure 8. Merlin PSA Model EX3100 1. 2. 3. 4. 5. 6. Functional Status LEDs Pace and Sense LEDs Receptacle for patient cable or patient-cable adapter Receptacle for inductive telemetry wand Receptacle for ECG input 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. 1. Turn off the Merlin PCS. 2. Remove the Merlin PCS storage compartment door by raising it at a 90 degree angle. 3.
Figure 9. Storage compartment door removal 5. Loosen the hinge on the other side and pull the hinge and lid free. Save the lid and hinge for future use. 6. Disconnect all cables and remove them from the storage compartment. 7. 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. 8.
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). See RF Communication Setup (page 14). 15. Turn on the Merlin PCS. The blue LED on the Merlin PSA should be illuminated within 10 seconds, indicating the unit is powered and operational.
Figure 11. Connection between the Merlin PCS and the PSA Wand Model 3150 using the PSA Wand adapter Model 3615 1. Merlin PCS 2. PSA Wand Model 3150 3. PSA Wand adapter Model 3615 PSA Wand Model 3150 Setup 1. Connect the PSA Wand adapter Model 3615 to the PSA Wand Model 3150. 2 2. Insert the adapter into the PSA port on the right side or into the inductive telemetry port inside the storage compartment. 3. When the Start-Up screen appears, select the Tools button, and then select the PSA button.
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. Connect the USB connector on the adapter to one of the USB ports on the left side of the Merlin PCS. Then, connect the Merlin Antenna to the remaining connector on the adapter. NOTE: Connect the Merlin Antenna only to the USB ports on the left side of the programmer. Do not connect the Merlin Antenna to the USB port in the flash drive compartment.
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 4. When the programmer startup screen appears, the "Ready to Connect to Device" icon appears under the Tools menu button. See RF Telemetry Icons (page 16). 5. Place the inductive telemetry wand over the patient's device. 6. On the programmer, select the Interrogate button.
Table 1. RF telemetry icons for tachycardia devices Start-Up Screen Icons Disconnected Antenna/Not Working Application Icons Ready to connect to device Active RF telemetry connection Inactive RF telemetry connection Table 2.
The Merlin PCS may be powered down with the USB dongle in place. 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. Emergency Operation Figure 14. Emergency buttons (displayed in red) The console has two red emergency option buttons: SHOCK.
Storage Devices These devices can be connected to any of the three USB ports on the Merlin™ PCS. The devices can be used to save session records, screen captures, and database records for patient-tracking software to other media. The media include: Flash drive. See Accessories (page 34) for Flash drive requirements. Floppy drive. This device must be powered through the USB port and cannot use an external power supply. PC Database.
Printer Paper The paper tray on the top of the Merlin™ PCS holds 200 sheets of fan-fold thermal paper (21 x 14 cm) (8.25 x 5.5 in) 6. It is not necessary to advance the paper once it is loaded. The printer autofeeds the paper after a two-second delay. The paper tray cover contains instructions on loading printer paper. When the paper supply runs low, a paper-low mark can be seen on the paper and the Merlin PCS displays a paper-low message. CAUTION: The thermal paper is heat-sensitive.
Maintenance and Troubleshooting Maintenance Merlin™ PCS and Merlin PSA: Service must be performed at the factory or by an authorized service representative only. The Merlin PCS and its accessories, including the Merlin PSA, contain no user-serviceable parts. NOTE: For information on the Merlin PSA maintenance and troubleshooting, see the Merlin PSA on-screen help.
Troubleshooting Start-Up Problems Possible Causes Failure to start is most commonly caused by a lack of power. Solutions Check that the outlet is working and that the appropriate power cord is plugged in properly. Check that the appropriate power cord is plugged into the back of the Merlin™ PCS and that the power switch is on. Check both fuses. Remove the power cord, place a finger under the middle of the fuse holder (page 7), and lift the catch until the fuse holder clicks and pops out.
icons (page 16). Few or no telemetry strength indicator LEDs are lit on the Merlin PCS and Merlin™ Antenna. The Merlin PCS displays a communication alert. Make sure that the cable from the Merlin Antenna to the Merlin PCS is properly connected and the blue status LEDs on the Merlin Antenna are on. Follow the steps in RF Communication Setup (page 14). If the problem persists, consider the options in the section Suboptimal RF Communication (page 23) below.
CAUTION: To avoid breakage, do not lift the Merlin PCS by its display or by the storage compartment lid.
Technical Data Merlin™ PCS Specifications The Merlin™ PCS is Class I, Type BF defibrillation-proof medical equipment 8. 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) AC power cord 3 m (10 ft) Current consumption 3 A - 1.7 A Fuse (2) 5x20 mm, fast-acting, 6.
Extension cord 1.22 m (4.0 ft) Merlin™ Antenna Specifications The Merlin™ Antenna Model 3638 is Class I medical equipment 9. 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™ PCS Input voltage 5.0 V Maximum power consumption 0.5 A Merlin™ Antenna Cable Cable to Merlin™ PCS 2.9 m (9.
All safeguards for the devices will be provided throughout the stated warranty period or until a replacement product is available. In the rare event of a cybersecurity attack on the programmer that affects its ability to program the pulse generator, implanted device therapy will continue. St. Jude Medical encourages the clinics to allow only authorized healthcare providers to use the Merlin™ PCS, for example by requiring badged access to programmer locations.
disrupt the operation of nearby equipment. It may be necessary to mitigate this effect by reorienting or relocating the receiving device or shielding the location. Table 3. Guidance and manufacturer's declaration — electromagnetic emissions Test Compliance Electromagnetic Environment — Guidance RF Emission CISPR 11 Group 1 The Merlin™ PCS and the Merlin™ Antenna use RF energy only for their internal function.
Table 4. Guidance and manufacturer's declaration — electromagnetic immunity Test IEC 60601 Test Level (Actual Level) 10 Electromagnetic Environment — Guidance (50/60 Hz) Magnetic Field, IEC 61000-4-8 (30 A/m) should be at levels characteristic of a typical location in a typical commercial or hospital environment. Voltage dips, shorts, interruptions, and voltage variations on power supply input lines IEC 61000-4-11 <5% UT 12 [>95% dip in UT] for 0.5 cycle (<5% UT [>95% dip in UT] for 0.
Table 5. Guidance and manufacturer's declaration - electromagnetic immunity (conducted RF and radiated RF) Test IEC 60601 Test Level 13 Immunity Compliance Level Electromagnetic Environment Guidance 14 80 MHz to 800 MHz 16 800 MHz to 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
mobile RF communications equipment (transmitters) and the Merlin PCS as recommended in the table below, according to the maximum output power of the communications equipment. For transmitters rated at a maximum output power not listed in the table below, the recommended separation distance (d) in meters can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE: Maintain a reasonable distance between other electronic equipment and the Merlin™ PCS and its accessories. WARNING: This transmitter is authorized by rule under the Medical Implant Communications Service (part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150 - 406.
less than 7 centimeters in normal use. The Merlin PCS then switches to Medical Implant Communications Service (MICS)-based (RF) telemetry if the implanted device supports it. The RF telemetry range is less than 2.5 meters in normal use. For Bluetooth® Low Energy wireless communication, the Merlin PCS and St. Jude Medical implantable devices should be within 2 meters in normal use. St.
Storage and Operating Conditions Table 8. Storage and operating conditions Property Storage Operating Minimum Temperature (°C (°F)) -40 (-40) 10 (50) Maximum Temperature (°C (°F)) 70 (158) 40 (104) Minimum Humidity (% non-condensing) 10 30 Maximum Humidity (% non-condensing) 90 75 Minimum Atmospheric Pressure (hPa) 500 700 Maximum Atmospheric Pressure (hPa) 1060 1060 CAUTION: Allow the unit to warm to ambient temperature after transporting it from a cold environment.
Table 9.
Symbols For information on symbols pertaining to the Merlin™ PSA Model EX3100 and its accessories, please refer to the Merlin PSA on-screen help. The symbols below and harmonized symbols may be found on the product or product label. For harmonized symbols, refer to the Universal Symbols Glossary at https://manuals.sjm.com. Symbol Description Part number European conformity, affixed according to the relevant provisions of AIMD directive 90/385/EEC and RE directive 2014/53/EU Annex II. Hereby, St.
Symbol Description Flash drive Fuse Merlin Patient Care System Model 3650 An accessory to Merlin Patient Care System Model 3650 Off On Pacing system analyzer wand port Power cord Printer paper Follow instructions for use on this website RF Telemetry port Telemetry wand Telemetry wand port 37
Symbol Description Connect to the RF Telemetry port on the Merlin PCS TÜV Listed, US and Canada. Conforms to UL60601-1. Certified to CAN/CSA C22.2 No.601.1-M90 (Symbol is colored blue.
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