Abbott Merlin PSA EX3100 Help Manual
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Abbott Merlin PSA EX3100 Help Manual

Abbott Merlin PSA EX3100 Help Manual

Pacing system analyzer
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Merlin™ PSA
Pacing System Analyzer
Model EX3100
Help Manual

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Summary of Contents for Abbott Merlin PSA EX3100

  • Page 1 Merlin™ PSA Pacing System Analyzer Model EX3100 Help 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. Pat. http://www.abbott.com/patents © 2021 St. Jude Medical, LLC. All Rights Reserved.

  • Page 3: Table Of Contents

    Contents Introduction ......................1 System Description ......................1 Operator Profile ......................... 1 Indications for Use ......................1 Intended Use ........................2 Contraindications ....................... 2 Warnings .......................... 2 Precautions ........................3 Adverse Events ........................4 Tools Menu ....................... 1 ? Button ........................1 Tools .........................
  • Page 4 Parameters ......................21 AV Delay ......................... 22 Base Rate ........................22 Interventricular Delay ....................... 22 Low Frequency Attenuation ....................22 Max Track Rate ....................... 22 Mode ..........................23 Pacing ..........................23 Pulse Amplitude ......................23 Pulse Width ........................23 Refractory ........................23 S1S1 ..........................

  • Page 5: Introduction

    Refer to the Merlin PCS Model 3650 or Merlin 2 PCS Model MER3700 User's Manual  for Merlin PSA installation instructions. Operator Profile The intended operators of the Merlin™ PSA system include trained Abbott Medical employees and clinical personnel trained in pacing and electrophysiology, such as nurses, technicians, or physicians. Indications for Use...

  • Page 6: Intended Use

    with bradyarrhythmias, tachyarrhythmias, and/or heart failure undergoing implantation or lead revision of a pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy system. Intended Use The Merlin™ PSA is intended to assess the pacing and sensing performance of the lead system prior to pulse generator implantation, or during invasive lead system troubleshooting.

  • Page 7: Precautions

    input of the Merlin PSA can result in false sensing and can drive the ventricular pacing rate to the Max Track Rate setting. Asystole. During threshold tests, asystole may result due to loss of capture. Electromagnetic Interference (EMI). At high sensitivity (low numerical settings) and in the presence of excessive levels of interference, the Merlin PSA may inhibit completely or revert to asynchronous operation, pacing at the Base Rate.

  • Page 8: Adverse Events

    do not expose the Merlin PSA to extreme temperatures and/or humidity as that may result in  inaccurate measurements do not expose the Merlin PSA to mechanical shock as it may damage the Merlin PSA and  result in unreliable measurements do not store the Merlin PSA near magnets or magnetic-field-inducing coils as it may shorten ...

  • Page 9: Indications For Use

    Maintenance. Opens utilities for programmer maintenance (for use by Abbott Medical  personnel only). Clinical Studies. Opens information for studies (for use by Abbott Medical personnel only;  inactive during the PSA session). Preferences (page 1). Opens the Merlin™ PCS or Merlin™ 2 PCS settings.

  • Page 10: Audio Preferences

    frequency. Audio Preferences (page 2)  Printer Preferences. (inactive during the PSA session)  Accessed From: Tools menu > Preferences button NOTE: It is important to set an accurate date and time because the device's functions use the date and time from the programmer. You must exit the PSA session to set the date and time from the Tools menu.

  • Page 11: Rhythm Display

    EGM Configuration (page 8)  Freeze Capture (page 8)  Rhythm Display The Rhythm Display, seen on the Main Programming Window (page 31), can show up to five concurrent waveforms (or channels) that can be individually configured and adjusted. You can also freeze the display or print it in real time.

  • Page 12: Markers

    the Merlin™ 2 PCS Model MER3700 User's Manual.. For more information, see ECG Configuration (page 8). Markers Markers are symbols that represent paced and sensed events, intervals, and refractory periods. You can choose markers as one of the five channels. Markers can be configured either as: Basic.
  • Page 13 Ventricular sensed event within the refactory period Table 3. Biventricular paced event For CRT-Ds and CRT-Ps, when the V. Pacing parameter is set to:  Simultaneous; RV->LV with a 10 ms delay. The BP marker points down.  RV->LV with a 15 ms or greater delay. The BP marker points right.

  • Page 14: Egm

    The configurations available are Unfiltered or Sense Amp (narrow band filtered data). The Sense Amp filtering characteristics of the Merlin™ PSA are designed to match those of Abbott Medical pulse generators. The default configuration is Unfiltered, and once it's changed, the new configuration is saved for future sessions.

  • Page 15: Waveform Control

    Select the Current of Injury button to return to the Rhythm Display. Accessed From: Rhythm Display > Channel Control button Waveform Control The Waveform Control buttons on the left side of the Rhythm Display control the waveform's appearance. To open the controls, select one of the buttons. The buttons shown depend on the selected Source for that channel.

  • Page 16: Adjust Display

    Adjust Display The Adjust Display window changes the: Source for each waveform in the Rhythm Display window (ECG (page 3), Markers (page 4),  or EGM (page 6)) Configuration of the waveform  Sweep Speed  ECG Filter to reduce electromagnetic interference ...

  • Page 17: Merlin™ Psa Session Information

    Show Calipers button, which shows calipers that can be moved with button controls to  display time measurements for a portion of the freeze Hide Calipers button, which toggles to the Show Calipers button  Scroll buttons  You can also print the frozen waveforms immediately (select the Print button) or print all Freeze Captures with the Freezes report.
  • Page 18 Step 1: Insert the PSA Cable Figure 3. Inserting the PSA cable Step 2: Coil the Remaining Cables and Place the PSA on the Tracks in the PSA Case Figure 4. Coiling remaining cables and placing the PSA on the tracks in the PSA Case.
  • Page 19 NOTE: Tracks are located next to the window. Step 3: Tuck the Remaining Cables into the PSA Box Figure 5. Tucking the remaining cables into the PSA Case. NOTE: The Wand (blue cable) and ECG (black cable) are the cables to go inside of the PSA box.

  • Page 20: Connect The Leads

    Step 4: Close the PSA Case Lid Figure 6. Closing the PSA Case Lid. NOTE: Grayed out cable represents portion inside of case. Connect the Leads Turn on the Merlin™ PCS or Merlin™ 2 PCS programmer and check that the blue LED on the Merlin™...
  • Page 21 Figure 7. Merlin PSA 1. Functional Status LEDs 2. Pace and Sense LEDs 3. Receptacle for patient cable or patient-cable adapter 4. Connector to Merlin PCS or Merlin 2 PCS Inspect the Merlin PSA, cable, or cable adapter for any visual damage. Insert the connector on the cable or cable adapter into the green PSA port on the Merlin PSA.

  • Page 22: Start A Merlin™ Psa Session

    Connect the (+) and (-) patient-cable to the appropriate connection on the lead. Refer to the appropriate lead manual for information on the lead configuration. The clips on the Model EX3150 patient cable can be positioned side by side, with the lead electrodes visible through the clip.

  • Page 23: End A Merlin™ Psa Session

    If you started from the Start-Up Screen, you will be prompted to select the device implant type. This enables the Merlin PSA to use appropriate filters, default Pulse Width settings, and the correct number of test channels. Select the Start PSA button. The PSA session starts.

  • Page 24: Enable/Disable Pacing

    View and Store Lead Impedance Measurements (page 17).  Open the Capture Test (page 18) window. Perform a Capture Test (page 18).  Perform a Phrenic Nerve Stimulation Check (page 19).  Annotate Test Results (page 19).  In CRT devices, select the connected Ventricular Sensing Buttons (page 20) channel. ...

  • Page 25: Intrinsic Signal Amplitude And Slew Rate Measurements

    A Pacing RV Pacing LV Pacing Mode Setting V. Pacing Setting LV Only RV Only Biventricular LV Only RV Only Biventricular Accessed From: Lead Tests button Intrinsic Signal Amplitude and Slew Rate Measurements CAUTION: Ensure the lead is connected to the appropriate channel. If you inadvertently reverse the connections, the Merlin™...

  • Page 26: Capture Test

    To save a lead impedance measurement, select the impedance button. You can update a lead impedance measurement for each channel as many times as desired. Up to five measurements for each channel are saved and can be included in the PSA report. Once five measurements for a single channel are saved, the next measurement retrieved for that channel replaces the oldest saved measurement for that channel.

  • Page 27: Phrenic Nerve Stimulation Check

    Decrement the Pulse Amplitude setting. Watch the Rhythm Display for signs of loss of capture. When loss of capture occurs, increase the Pulse Amplitude to restore capture. Select the Save as Threshold button to save the threshold measurements. NOTE: The Merlin™ PSA reverts back to the originally programmed settings for the Pulse Amplitude and Pulse Width parameters when the test results are saved or the Capture Test window is closed.

  • Page 28: Additional Parameters

    If you select Bipolar, all the checked results are annotated "Bi." Once you select the button, the check-marks are erased, and the annotations are added to the printed report. Repeat this procedure for different chambers and for different annotations. To erase any annotations, check the desired results and select the No Annotation button. Close the window to save the results and annotations.

  • Page 29: Burst Pacing Instructions

    S1S1 (page 23)  Pulse Amplitude (page 23)  Pulse Width (page 23)  Ventricular Support Rate (VOO) (page 24)  See also: Burst Pacing Instructions (page 21)  Parameter Settings and Availability (page 34)  Burst Pacing Instructions WARNING: Always have a separate standby external defibrillator immediately available.

  • Page 30: Av Delay

    Refractory (page 23)  S1S1 (page 23)  Sensitivity (page 24)  V. Pacing (page 24)  V. Sensing (page 24)  Ventricular Support Rate (VOO) (page 24)  AV Delay The AV Delay parameter determines the interval between a sensed or paced atrial event and a paced ventricular event.

  • Page 31: Mode

    Mode The Mode parameter determines the stimulation and sensing method. The selected mode is in effect at all times except during Burst Pacing (page 20). Details of each mode can be found in Mode Descriptions (page 24). See also: Parameter Settings and Availability (page 34) ...

  • Page 32: Sensitivity

    Sensitivity The Sensitivity parameter determines the threshold above which the device responds to intrinsic cardiac events. See also: Parameter Settings and Availability (page 34)  V. Pacing The Ventricular Pacing parameter determines which ventricles receive stimulation and the order in which the stimulation is applied. When you select the LV—>RV or RV—>LV settings, you can also set the Interventricular Delay parameter.

  • Page 33: Ddd

    (Dual-Chamber Pacing, Sensing, and Inhibition; Atrial Tracking) The DDD Mode is a dual-chamber, atrial-based timing mode in which increases or decreases in the sensed atrial rate are duplicated by similar changes in the ventricular rate. Sensed P-waves or R-waves inhibit output pulses, while no intrinsic activity during the alert periods result in delivered pulses.

  • Page 34: Doo

    Figure 10. DDI Mode timing diagram (Dual-Chamber Asynchronous Pacing) In DOO mode, the device paces in the atrium and ventricle(s) at the programmed Base Rate and AV Delay regardless of intrinsic activity. CAUTION: DOO mode is primarily intended for temporary use. Long-term use may result in competitive pacing, which may induce potentially dangerous tachyarrhythmias.

  • Page 35: Vdd

    Figure 11. DOO Mode timing diagram (Ventricular Pacing; Dual-Chamber Sensing and Inhibition; Atrial Tracking) The VDD mode is a dual-chamber, atrial-tracking mode with no atrial output in which ventricular pacing is synchronized to intrinsic atrial activity. The device senses in the atrium and ventricle(s) but only paces in the ventricle(s).

  • Page 36: Vvi

    Figure 12. VDD Mode timing diagram (Ventricular Pacing, Sensing, and Inhibition) In VVI mode, the device paces the ventricle(s) at the programmed rate if it does not detect a sensed event. If the device detects a sensed event during the alert period, it withholds the pulse and it resets the timing period to the start of the Ventricular Refractory Period.

  • Page 37: Voo

    (Ventricular Asynchronous Pacing) In VOO mode, the device paces the ventricle(s) at the programmed rate regardless of the intrinsic rhythm. CAUTION: VOO mode is primarily intended for temporary use. Long-term use may result in competitive pacing, which may induce potentially dangerous tachyarrhythmias.

  • Page 38: Odo

    (Atrial Asynchronous Pacing) In AOO mode, the device paces the atrium at the programmed rate regardless of intrinsic rhythm. CAUTION: AOO mode is primarily intended for temporary use. Long-term use may result in competitive pacing, which may induce potentially dangerous tachyarrhythmias.

  • Page 39: Technical Support

    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) ...

  • Page 40: Patient Data: Lead Information

    Implant Notes button. Opens a field for entering implant notes.  Accessed From: Main Programming window Patient Data: Lead Information The Patient Data: Lead Information window allows you to set the following characteristics for all implanted leads: Manufacturer  Lead Model ...

  • Page 41: Safe Pacing

    The reports are saved as a PDF file. PDF files can be exported using the tools menu only after exiting the PSA session or from within the device session. Accessed From: Print Menu button > Reports tab Settings The Settings window allows you to set print preferences for the PSA and Freezes reports. Select the check-box to the left to include the following in the report headers or footers: Patient Name ...

  • Page 42: Parameter Settings And Availability

    Table 10. Emergency VVI settings for the Merlin PSA Parameter EVVI Setting V. Pulse Width 1.5 ms V. Sensitivity 2.0 mV V. Refractory 400 ms V. Pacing Simultaneous V. Sensing 1. CRT devices only. NOTE: Pressing the VVI hard key from the Start-Up screen initiates Emergency VVI pacing ...

  • Page 43: Technical Data

    Table 11. Parameter settings and availability Parameter Availability Settings Nominal All sessions CRT-Ds, ICDs: 0.1; 0.2; ... 1.5 ms 0.5 ms (1.0 ms for Pulse Width Burst Pacing Pulse Width) CRT-Ps, Pacemakers: 0.1; 0.2; ... 0.4 ms (1.0 ms for Burst Pacing Pulse 1.5 ms Width)
  • Page 44 Disposal (page 51)  Troubleshooting (page 51)  Mechanical Specifications Figure 17. Top dimensions PSA only Figure 18. Top dimensions PSA in case...
  • Page 45 Figure 19. Front dimensions PSA only Figure 20. Side dimensions PSA only...
  • Page 46 Figure 21. Front and side dimensions PSA in case Table 12. Merlin PSA mechanical specifications Specification 0.52 kg (including batteries) Weight (PSA only) 0.44 kg (excluding batteries) 0.84 kg (includes batteries and case) Weight (PSA in case) PC/ABS Polymer Materials (PSA and case) Four (4) AA-size LR6 (alkaline) batteries Battery 1.
  • Page 47 Electrical Specifications Table 13. Merlin PSA electrical specifications Specification 5 Vdc (+/- 5%) Supply voltage Power dissipation LED States Figure 22. LED status indicators (for explanations, see table below) Table 14. LED Status Indicator Descriptions Color/Status Description PSA Status Blue/On PSA is on, powered through Merlin PCS.
  • Page 48 Table 15. Ranges and tolerances for Merlin™ PSA measurements Measurement Range Tolerance Intrinsic signal amplitude 0.1 - 35.0 mV ±0.1 mV or ± 10% Slew rate 0.1 - 8.0 V/s ±0.1 V/s or ± 10% Pacing lead impedance ±10% for impedances in the range of 200 - 4000 ¬...
  • Page 49 communications equipment (transmitters) and the Merlin PSA. Table 16. Guidance & manufacturer's declaration - electromagnetic emissions Test Compliance Electromagnetic Environment - Guidance RF Emission Group 1 The Merlin PSA uses RF energy only for its internal CISPR 11 function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
  • Page 50 Table 17. Guidance & manufacturer's declaration - electromagnetic immunity IEC 60601 Test Level Test Electromagnetic Environment - Guidance (Compliance Level) Surge ±1 kV line[s] to line[s] Mains power quality should be that of a typical (±1 kV line[s] to IEC 61000-4-5 commercial or hospital environment.
  • Page 51 Table 17. Guidance & manufacturer's declaration - electromagnetic immunity IEC 60601 Test Level Test Electromagnetic Environment - Guidance (Compliance Level) Conducted RF 3 Vrms (3 Vrms) Portable and mobile RF communications IEC 61000-4-6 [V1=3] equipment should be used no closer to any part of 150 kHz to 80 MHz the Merlin PSA, including cables, than the Radiated RF...
  • Page 52 Table 17. Guidance & manufacturer's declaration - electromagnetic immunity IEC 60601 Test Level Test Electromagnetic Environment - Guidance (Compliance Level) 1. Figures in parentheses are the immunity compliance levels for each test. 2. U is the a.c. mains voltage level prior to application of the test level. 3.
  • Page 53 Battery Information In case of power failure or other system error, the batteries in the Merlin™ PSA support operation of the unit at the maximum Pulse Amplitude settings in all channels and at the maximum Base Rate setting for at least 30 minutes. The batteries do not power the screen of the Merlin™...
  • Page 54 To ensure that the batteries are not inadvertently depleted, end every PSA  session by selecting the End Session button. See End a Merlin™ PSA Session (page 15). Remove the batteries from the unit if you do not plan to use the Merlin PSA. ...
  • Page 55 Special Instructions for the Patient Cable Model EX3150 Abbott Medical has validated the procedures outlined below as adequate preparation for re-use of the Patient Cable Model EX3150. It remains the responsibility of the processor to ensure that the procedures are properly performed to completely clean, disinfect, and sterilize the patient cable.
  • Page 56 patient cable with a disposable cloth or paper wipe. Do not attempt to disassemble the patient cable.  Carefully release the clips to separate the three pairs of connectors.  Within an hour of its last use, soak the patient cable in potable water and Cidezyme™ ...
  • Page 57 If you use Neodisher FA detergent, rinse with cold, potable water (15°C) for five minutes using Neodisher Z detergent according to the manufacturer's instructions. Rinse with cold, potable water (15°C) for five minutes. Begin thermo-disinfection at 93°C for five minutes. Unload the patient cable and check for complete removal of soil.
  • Page 58 After rinsing, ensure that no visible residue of detergent is left.  Manual Disinfection The goal of disinfection is reduce the bioburden to a level so that the sterilization process will reach a SAL of 10 Equipment: Cidex™ OPA (Orthophthalaldehyde (OPA)-based disinfection solution) Demineralized water Instructions: Visually inspect the Patient Cable Model EX3150 for any trace of soil and repeat Manual...
  • Page 59 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 Abbott Medical at the end of its operating life.

  • Page 60: Symbols

    Symbol Description Affixed in accordance with European Council Directive 90/385/EEC. Hereby, Abbott declares that this device is in compliance with the essential requirements and other relevant provisions of these Directives. Affixed to this device in accordance with European Council Directives 2002/96/EC.
  • Page 64 St. Jude Medical St. Jude Medical Cardiac Rhythm Coordination Center BVBA Management Division The Corporate Village 15900 Valley View Court Da Vincilaan 11 Box F1 Sylmar, CA 91342 USA 1935 Zaventem +1 818 362 6822 Belgium +32 2 774 68 11 St.

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