Merlin™ 2 Patient Care System Merlin™ 2 PCS, Model MER3700 User's Manual
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. ™ 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 registered trademarks of Bluetooth SIG, Inc. Pat. http://www.abbott.com/patents © 2022 Abbott. All Rights Reserved.
Contents Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contraindications. . . . . . . . . . . . . . . . . . .
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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 Abbott 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 Abbott Medical implantable devices with RF communication capability.
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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 11). 5. Shock Button. Select this button to display the Shock screen (for ICDs). See Emergency Operation (page 11). 6.
1. 2. 3. 4. 5. ECG Cable connected to the ECG input port. See Merlin 2 PCS Setup. Inductive Telemetry Wand connected to the telemetry wand inductive port. See Merlin 2 PCS Setup. Merlin Antenna connected to the RF telemetry port. See RF Communication Setup (page 8). Merlin PSA connected to the PSA port. See Merlin 2 PCS Setup. Merlin 2 PCS Figure 3. Back side 1. ECG input port. See Merlin™ 2 PCS Setup. 2. Telemetry wand (inductive) port. For connection to inductive telemetry devices.
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. To set up the Merlin 2 PCS with a device that uses RF communication, see RF Communication Setup (page 8).
Figure 5. Color codes and positions of ECG cable connections for 5-lead ECG (left) and 3-lead ECG (right) 1. 2. 3. 4. 5. RA (White) LA (Black) RL (Green) LL (Red) V (Brown) 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 to contact the touchscreen.
Figure 6. The Adjust Display button, Interrogate button, Interrogate Monitors button, and 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.
Figure 7. Merlin™ PSA Model EX3100 1. 2. 3. 4. Functional Status LEDs Pace and Sense LEDs Receptacle for patient cable or patient-cable adapter Connector to Merlin 2 PCS RF Communication Setup Some Abbott 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.
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 9). 4. Place the inductive telemetry wand over the patient's device. 5. On the programmer, select the Interrogate button.
Table 2. RF telemetry icons for bradycardia devices Disconnected Antenna/Not Working Ready to connect to Active RF device 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.
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. 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).
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 27). WARNING: The ports on the Merlin 2 PCS are not isolated.
2. 3. 4. 5. 6. Turn on both the printer and the Merlin 2 PCS. On the Merlin 2 PCS screen, select the Tools button. On the drop-down menu, select the Preferences button, then select the Printer tab. Under "Selected Printer," select the External & PDF button. Close the window and begin the device session.
Maintenance and Troubleshooting Maintenance Merlin™ 2 PCS and Merlin PSA: Service must be performed at the factory or by an authorized service representative only. The Merlin 2 PCS and its accessories, including the Merlin PSA, contain no userserviceable 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 grounded mains outlet is working and the Merlin™ 2 PCS power cord (or other medical grade power cord) is plugged in properly. ▪ Check that the Merlin 2 PCS power cord (or other medical grade power cord) is plugged into the back of the Merlin 2 PCS and the Merlin 2 PCS power switch is on. ▪ Check both fuses.
Suboptimal RF Communication The Merlin™ 2 PCS indicates the quality of the RF communication by the telemetry strength indicators on both the programmer and the Merlin™ Antenna. Below is a list of possible causes of suboptimal radio communication: Possible Causes ▪ The Merlin™ Antenna orientation or location is suboptimal. ▪ People or objects are interfering with the communication between the Merlin Antenna and the device. ▪ The Merlin Antenna is too far away from the device.
NOTE: If you disable the BLE to use the inductive telemetry wand it may take up to seven seconds to connect. You cannot deliver emergency shock during that time. Inductive Communication Problems If there are any communication problems with the inductive telemetry wand: ▪ Try re-orienting the wand. ▪ Avoid holding the wand. ▪ Try moving the wand farther away from the implanted device. ▪ Move away or turn off the power from equipment that could generate electromagnetic interference or strong magnetic fields.
Technical Data Merlin™ 2 PCS Specifications The Merlin™ 2 PCS is Class I, Type BF defibrillation-proof medical equipment. Mechanical Length 36.3 cm (14.3 in) Width 34.9 cm (13.75 in) Height 7.4 cm (2.9 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 0.5 / 0.25 A Fuse 5x20 mm, slow-acting, 2.
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™ 2 PCS Input voltage 5.0 V Maximum power consumption 0.5 A Merlin™ Antenna Cable 2.9 m (9.
Bluetooth Communication For Bluetooth® Low Energy wireless communication, the Merlin™ 2 PCS and Abbott Medical implantable devices should be within 8.25 feet (2.5 meters) in normal use; 6.6 feet (2 meters] when used with insertable cardiac monitors. The programmer uses BLE with authentication methods to ensure that the programmer communicates only with Abbott Medical authorized products.
Table 3. Guidance and manufacturer's declaration — electromagnetic emissions Test Compliance Electromagnetic Environment — Guidance RF Emission CISPR 11 Group 1 The Merlin™ 2 PCS and the Merlin Antenna use RF energy only for its internal function. Therefore, the RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Table 4. Guidance and manufacturer's declaration — electromagnetic immunity Test IEC 60601 Test Level (Actual Level) Electromagnetic Environment — Guidance Voltage dips, shorts, interruptions, and voltage variations on power supply input lines IEC 61000-4-11 <5% UT 6[>95% dip in UT] for 0.5 cycle Mains power quality should be that of a (<5% UT [>95% dip in UT] for 0.5 cycle) typical commercial or hospital environment.
Table 5. Guidance and manufacturer's declaration - electromagnetic immunity (conducted RF and radiated RF) Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 Test Level 7 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.
Table 5.
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Merlin 2 PCS as recommended in the table below, according to the maximum output power of the communications equipment.
CAUTION: 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.
Table 7. Transportation and handling conditions Minimum Atmospheric Pressure 500 (hPa) Maximum Atmospheric Pressure (hPa) 1060 *Found on box label Operation and Storage Conditions Table 8.
Table 9.
Symbol Description Display Out port ECG Cable ECG IN cable port Ethernet port (non-functional) Flash drive Fuse Merlin 2 Patient Care System Model MER3700 An accessory to Merlin 2 Patient Care System Model MER3700 Off On Pacing system analyzer port Power cord Follow instructions for use on this website Malaysian Communication and Multimedia Commission (MCMC) certification mark for products meeting applicable MCMC Technical Codes 29
Symbol Description 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 RF Telemetry port Telemetry wand Connect to the RF Telemetry port on the Merlin 2 PCS Conforms to AAMI Std ES60601-1 IEC Std 60601-1-11 Certified to CAN/CSA std C22.2 No.
Symbol Description The Merlin 2 PCS, FCC ID: XXX-XXXXXXXXXX, contains certified Bluetooth® Low Energy wireless communication with FCC ID: XXXXXXXXX. FCC ID: XXX-XXXXXXXXXX and FCC ID: XXXXXXXXX are FCC Identification Numbers. The Merlin 2 PCS, IC ID: XXXXX-XXXXXXXXXX, contains certified Bluetooth® Low Energy wireless communication with IC ID: XXXXXXXXXXX. IC ID: XXXXXXXXX and IC ID: XXXXX-XXXXXX are Industry Canada certifications.
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