St. Jude Medical Merlin PSA EX3100 Help Manual
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St. Jude Medical Merlin PSA EX3100 Help Manual

St. Jude Medical Merlin PSA EX3100 Help Manual

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Merlin™ PSA
Pacing System Analyzer, Model EX3100
Help Manual

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Summary of Contents for St. Jude Medical 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.

  • Page 3: Table Of Contents

    Table of Contents Introduction ..........1-1 System Description .
  • Page 4 Merlin™ PSA Session Information ......4-1 Connect the Leads to the Merlin™ PSA ....... . 4-1 Start a Merlin™...
  • Page 5 Mode Descriptions ..........8-1 DDD .
  • Page 6 Special Instructions for the Patient Cable Model EX3150 ....A-13 Maintenance ...........A-17 Disposal .

  • Page 7: Introduction

    Refer to the Merlin PCS Model 3650 User’s Manual for Merlin PSA installation instructions. Operator Profile The intended operators of the Merlin™ PSA system include trained St. Jude Medical employees and clinical personnel trained in pacing and electrophysiology, for example, nurses, technicians, or physicians.

  • Page 8: Indications

    Indications for Use The Merlin™ Pacing System Analyzer (PSA) is indicated for use at the time of surgery in patients 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™...

  • Page 9: Precautions

    Burst Pacing. Use of atrial or ventricular burst pacing may result in ventricular tachycardia or fibrillation. Defibrillation equipment should be readily available during the PSA session. Handling Inserted Leads. Do not touch the terminal pins or exposed metal when handling inserted leads.

  • Page 10: Adverse Events

    Defibrillation/Cardioversion. The Merlin PSA may be damaged by defibrillation shocks when it is connected to an implanted lead system. Test the Merlin PSA after it has been exposed to such charges by launching the PSA application and verifying that the Merlin PSA is functional. Whenever possible, for the safety of the patient, disconnect the Merlin PSA from the lead system before defibrillation or cardioversion.

  • Page 11: Tools Menu

    • Maintenance. Opens utilities for programmer maintenance (for use by St. Jude Medical personnel only). • Clinical Studies. Opens information for studies (for use by St. Jude Medical personnel only; inactive during the PSA session). • Preferences. Opens the Merlin™ PCS settings.

  • Page 12: Audio Preferences

    • Date, Time, and Number Formats (inactive during the PSA session) • ECG Notch Filter Frequency. The ECG Notch Filter Frequency reduces ECG interference from the programmer’s AC power line. Check with your local authorities for your power line frequency. •...

  • Page 13: Rhythm Display

    3. Rhythm Display Contents: • Rhythm Display • • Markers • • Waveform Control • Rhythm Display Setup Instructions • Adjust Display • ECG Configuration • EGM Configuration • Freeze Capture Rhythm Display The Rhythm Display, seen on the Main Programming Window, can show up to five concurrent waveforms (or channels) that can be individually configured and adjusted.
  • Page 14 The controls for the Rhythm Display include the: • Channel Control buttons. Indicates the current waveform for each channel. Select this button to show the Waveform Control buttons or the Marker Control buttons. • Waveform Control buttons. Select the Channel Control buttons on the left side of the waveform to show the Waveform Control buttons.

  • Page 15: Ecg

    The Rhythm Display shows up to five ECG waveforms simultaneously from seven possible ECG vectors. There are two ways to change the ECG display: • Adjust Display button. Selects the waveform source and configuration and the ECG filter. • Waveform Control buttons, which set the gain and the waveform source.
  • Page 16 Marker Description Example Atrial sensed event Atrial paced event For CRT-Ds and CRT-Ps, when the V. Pacing V. Sensing parameter is set to: Ventricular • RV Only. The marker has a sensed event right-pointing tick mark. • LV Only. The marker has a Ventricular paced left-pointing tick mark.

  • Page 17: Interval And Refractory Markers (Full Markers)

    Interval and Refractory Markers (Full Markers) Interval and refractory markers are shown in the following diagram. Refractory A-A Interval Period (Line) A-V Interval V-V Interval Absolute Refractory Period (Thicker Line) Figure 3-1. Interval and refractory markers (full markers) Special Event Markers Marker Description Example...

  • Page 18: Full-Display Markers

    Full-Display Markers Marker Description Example Pulse Updated Pulse Amplitude Amplitude setting A. Burst or Starting burst RV Burst stimulation Started delivery A. Burst or Ending burst RV Burst stimulation Ended delivery Table 3-3. Full-display markers Waveform Channel Markers Marker Description Example Signal Intrinsic signal...

  • Page 19: 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 St. Jude Medical™ pulse generators. The default configuration is Unfiltered, and once it’s changed, the new configuration is saved for future sessions.

  • Page 20: Rhythm Display Setup Instructions

    Rhythm Display Setup Instructions 1. Select the Adjust Display button to the right of the Rhythm Display. Adjust Display window appears. 2. Locate position 1. 3. Select the Source you want to see in position 1 (ECG, EGM, Markers, or Off). The programmer selects a default Configuration for the Source.

  • Page 21: Egm Configuration

    • aVF. F(+) to [R(-) + L(-)] • Chest. C Accessed From: Adjust Display > Configuration button EGM Configuration The EGM Configuration window changes the EGM source on the Rhythm Display. Accessed From: Adjust Display > Configuration button Freeze Capture The Freeze button captures the most recent 30 s of the waveform and shows the data in the Freeze Captures window.
  • Page 22 3-10 Rhythm Display...

  • Page 23: Merlin™ Psa Session Information

    4. Merlin™ PSA Session Information Contents: • Connect the Leads to the Merlin™ PSA • Start a Merlin™ PSA session • End a Merlin™ PSA Session • Suspend the Merlin™ PSA Session Connect the Leads to the Merlin™ PSA 1. Turn on the Merlin™ PCS programmer and check that the blue LED on the Merlin PSA is lit.
  • Page 24 EX3170 4161 EX3180 4051L EX3150 Figure 4-1. Merlin PSA and approved patient cables and cable adapters 3. Inspect the Merlin PSA, cable, or cable adapter for any visual damage. 4. Insert the connector on the cable or cable adapter into the green PSA port on the Merlin PSA.

  • Page 25: Start A Merlin™ Psa Session

    Figure 4-2. Two views of the Model EX3150 clips connected to an DF4 lead: 1) Single clip connected to the lead connector electrode, approached from the front; 2) Two clips connected to the lead connector electrode rings, approached from the side. Use the window on the top of the clip to visualize the connection to the electrode.

  • Page 26: End A Merlin™ Psa Session

    To begin a PSA session: 1. From the Start-Up Screen or during a device programming session, select Tools > PSA. 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.

  • Page 27: Lead Tests

    5. Lead Tests When the Lead Tests window appears, the Merlin™ PSA begins sensing and measuring the intrinsic signal amplitude and slew rate. From the Lead Tests window you can: • Enable/Disable Pacing. • Reset the Mode, Base Rate, and Additional Parameters.

  • Page 28: Pacing, Mode, And V. Pacing Parameter Autoprogramming

    CAUTION Leaving the atrial connector disconnected when the Merlin PSA is in DDD or VDD modes may result in the unit sensing external noise and increasing the ventricular pacing rate to the Max Track Rate. Pacing, Mode, and V. Pacing Parameter Autoprogramming The Pacing, Mode, and V.

  • Page 29: Intrinsic Signal Amplitude And Slew Rate Measurements

    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 PSA may deliver inappropriate or harmful stimulation and display inaccurate intrin- sic signal measurements. The Intrinsic Signal Amplitude measures the P/R-wave baseline-to-peak. To retrieve an intrinsic signal amplitude and a slew rate measurement: 1.

  • Page 30: Capture Test

    Note To obtain the most accurate lead impedance measurement, ensure that the Pulse Amplitude is set to a minimum of 2.0 V. Accessed From: Lead Tests Capture Test From the Capture Test window you can Perform a Capture Test for each channel as many times as desired.

  • Page 31: Phrenic Nerve Stimulation Check

    7. 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. Phrenic Nerve Stimulation Check To ensure that there is no phrenic nerve stimulation due to suboptimal lead placement, perform a 10 V stimulation check, which applies 10 V through the lead.

  • Page 32: 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. 3. Repeat this procedure for different chambers and for different annotations. 4.

  • Page 33: Burst Pacing

    6. Burst Pacing You can use the Burst Pacing function to terminate an arrhythmia. From the Burst Pacing window you can adjust the following parameters: • Chamber • S1S1 • Pulse Amplitude • Pulse Width • Ventricular Support Rate (VOO) See also: •...
  • Page 34 Burst Pacing...

  • Page 35: Parameters

    7. Parameters • AV Delay • Base Rate • Interventricular Delay • Low Frequency Attenuation • Max Track Rate • Mode • Pacing • Pulse Amplitude • Pulse Width • Refractory • S1S1 • Sensitivity • V. Pacing • V. Sensing •...

  • Page 36: Max Track Rate

    ratio, which may enhance sensing performance and may reduce oversensing T waves. Turning the Low Frequency Attenuation filter On or Off changes the device’s sensing performance and may impact the reported R wave amplitude. For more information on how turning the Low Frequency Attenuation filter On or Off affects the sensing ability of the device, refer to the device manual.

  • Page 37: Pulse Width

    See also: • Parameter Settings and Availability Pulse Width The Pulse Width parameter determines the duration of the pacing pulse applied to the myocardium. See also: • Parameter Settings and Availability Refractory The Refractory parameter determines the amount of time that the device is unresponsive to signals following a sensed or paced event for the corresponding channel.

  • Page 38: Sensing

    V. Sensing The V. Sensing parameter determines the channel in which ventricular sensing occurs when the selected device implant type is CRT-D or CRT-P. When the V. Pacing parameter is changed, the V. Sensing parameter is autoprogrammed to match the chamber selected for V.

  • Page 39: Mode Descriptions

    8. Mode Descriptions The Merlin™ PSA may be programmed to the following operating modes. Dual-Chamber Atrial Ventricular Off Modes Table 8-1. Available Modes (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.

  • Page 40: Ddi

    (Dual-Chamber Pacing, Sensing, and Inhibition; No Atrial Tracking) The DDI mode is a non-tracking, dual-chamber mode in which sensed atrial activity does not cause a change in timing. Atrial tachycardias do not result in increased pacing rates. Programmed Rate Blanking Period Refractory Period Output Pulse AV Delay...

  • Page 41: Vdd

    Programmed Rate Programmed Rate Output Pulse AV Delay Figure 8-3. 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 pac- ing is synchronized to intrinsic atrial activity. The device senses in the atrium and ventricle(s) but only paces in the ventricle(s).

  • Page 42: Vvi

    (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 43: Aai

    Programmed Rate Programmed Rate Output Pulse Figure 8-6. VOO Mode timing diagram (Atrial Pacing, Sensing, and Inhibition) In AAI mode, the device paces the atrium at the programmed rate if the atrial events are not sensed. If the device detects a sensed event during the alert period, it withholds the pulse and resets the timing to the start of the Atrial Refractory Period.

  • Page 44: Odo

    CAUTION AOO mode is primarily intended for temporary use. Long-term use may result in competitive pacing, which may induce potentially dangerous tachyarrhythmias. Programmed Rate Programmed Rate Output Pulse Figure 8-8. AOO Mode timing diagram CAUTION ODO mode is not recommended for pacemaker-dependent patients or patients who might be affected by even a short cessation of the device’s operation.

  • Page 45: Additional Information

    Safe Pacing • Emergency VVI Pacing Technical Support St. Jude 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) •...

  • Page 46: Patient Data

    • Print Menu button. Opens the Reports and Print Settings windows. • Programmer. Select the Programmer button to suspend the ongoing PSA session and interrogate a device to begin a device programmer session or return to a suspended session. See Suspend the Merlin™...

  • Page 47: Device Parameters And Settings Selection

    • Inactive Keys. Unsupported characters. • Repeating Keys. If you press and hold most keys on the on-screen keyboard, they are not repeatedly typed. The exceptions are the arrow keys, the Space key, the Enter key, and the Backspace key. •...

  • Page 48: Safe Pacing

    Note The reports printed during a PSA session are always printed to the internal printer and saved as a PDF file. Accessed From: Print Menu button > Settings tab Safe Pacing The Merlin PSA switches to Safe Pacing Mode if pacing is enabled and there is a loss of power or other programmer error that prevents normal programmer function.
  • Page 49 Note Pressing the VVI hard key from the Start-Up screen initiates Emer- gency VVI pacing parameters in the implanted device if the wand is within the necessary telemetry distance. To initiate Emergency VVI pacing for the Merlin PSA system, launch the PSA application, then press the VVI hard key.
  • Page 50 Additional Information...

  • Page 51: Parameter Settings And Availability

    10. Parameter Settings and Availability Parameters below are described in this help manual. Parameter Availability Settings Nominal AV Delay All sessions 25; 30; 35; 40; 50; ... 200; 225; ... 150 ms 450 ms 30; 35; ... 100; 110; ... 220 min 90 min §...
  • Page 52 Parameter Availability Settings Nominal V. Pacing CRT-P, CRT-D RV only; LV only; LV->RV; RV->LV; RV only sessions Simultaneous V. Sensing CRT-P, CRT-D RV; LV sessions Off; 30; 35; ... 95 min § Ventricular All sessions Support Rate (VOO) Table 10-1. Parameter settings and availability (continued) 10-2 Parameter Settings and Availability...

  • Page 53: Technical Data

    A. Technical Data For information on the St. Jude Medical™ Merlin™ Patient Care System (PCS), refer to the Merlin PCS Model 3650 User’s manual. • Mechanical Specifications • Electrical Specifications • LED States • Measurement Ranges and Tolerances • Essential Performance •...

  • Page 54: Electrical Specifications

    93 mm 85 mm 77 mm 150 mm Figure A-2. Front and Side Dimensions Specification Weight 0.52 kg (including batteries) 0.44 kg (excluding batteries) Materials Polycarbonate + Acrylonitrile butadiene styrene Battery Four (4) AA-size LR6 (alkaline) batteries Table A-1. Merlin PSA mechanical specifications 1.

  • Page 55: Led States

    LED States Figure A-3. LED status indicators (for explanations, see table below) Color/Status Description PSA Status Indicator Blue/On PSA is on, powered through Merlin PCS. Blue/Off PSA is not on or is using batteries. Battery Status Yellow/Off Not operating on batteries. Yellow/On PSA is operating on batteries.

  • Page 56: Measurement Ranges And Tolerances

    The Merlin PSA operates in conjunction with the Merlin™ PCS Model 3650; therefore, the essential performance defined for the Merlin PCS governs and limits the available performance that is exhibited by the Merlin PSA EX3100. Technical Data...

  • Page 57: Electromagnetic Compatibility

    Note For single fault conditions, see Troubleshooting (page A-18). Electromagnetic Compatibility The Merlin PSA requires special precaution with regard to electromagnetic compatibility (EMC) and should be used in accordance with the EMC information provided in this section of the manual. Do not use the Merlin PSA near other electronic equipment.
  • Page 58 IEC 60601 Test Level Electromagnetic Environment Test (Compliance Level) – Guidance Electrostatic Discharge ±8 kV contact Floors should be wood, concrete, (ESD) (±8 kV contact) or ceramic tile. If floors are IEC 61000-4-2 covered with synthetic material, ±15 kV air the relative humidity should be at (±15 kV air) least 30%.
  • Page 59 IEC 60601 Test Level Electromagnetic Environment Test (Compliance Level) – Guidance Power Frequency (50/ 30 A/m Power frequency magnetic fields 60 Hz) Magnetic Field (30 A/m) should be at levels characteristic IEC 61000-4-8 of a typical location in a typical commercial or hospital environment.
  • Page 60 IEC 60601 Test Level Electromagnetic Environment Test (Compliance Level) – Guidance Conducted RF 3 Vrms (3 Vrms) [V1=3] Portable and mobile RF IEC 61000-4-6 150 kHz to 80 MHz communications equipment should be used no closer to any Radiated RF 3 V/m (3 V/m) [E1=3] part of the Merlin PSA, including IEC 61000-4-3...
  • Page 61 3. These guidelines may not apply in all situations. Electromagnetic propagation is affection by absorption and reflection from structures, objects, and people. 4. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. 5. Electromagnetic site survey- Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.

  • Page 62: Battery Information

    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 PCS.

  • Page 63: Merlin™ Psa Accessories

    CAUTION Use only high-quality AA-size LR6 (alkaline) batteries in the Merlin PSA. 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. Remove the batteries from the unit if you do not plan to use the Merlin PSA.

  • Page 64: Storage And Operating Conditions

    Storage and Operating Conditions Model Property/Parameter Storage Operating Merlin PSA Temperature -40°C 10°C Model EX3100 70°C 40°C Humidity 10% (non-condensing) 30% (non-condensing) 90% (non-condensing) 75% (non-condensing) EX3150 Temperature -10°C 10°C EX3170 50°C 40°C EX3180 Humidity 10% (non-condensing) 30% (non-condensing) 90% (non-condensing) 75% (non-condensing) EX3190 Temperature...

  • Page 65: Special Instructions For The Patient Cable Model Ex3150

    Table A-10. Cleaning, disinfecting, and sterilization methods Special Instructions for the Patient Cable Model EX3150 St. Jude 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 66 - Detergent and neutralizer: Neodisher™ FA & Neodisher™ Z , or 2. Cidezyme™ is a trademark of Advanced Sterilization Products. 3. St. Jude Medical has validated the following challenge parameters for cleaning efficiency: Cidezyme enzymatic detergent solution 0.8% v/v, 20°C +/- 2°C, 60 min soak. A-14...
  • Page 67 4. Neodisher™ FA, Neodisher™ Z, and Neodisher™ MediClean are trademarks of Chemische Fabrik DR. WEIGERT GmbH & Co. KG. 5. St. Jude Medical has validated the following challenge parameters for cleaning and disinfection efficiency: Pre- wash water one minute. Cleaning temperature 55°C (-0°C +3°C), Neodisher FA detergent 0.2% v/v, Neodisher MediClean detergent 0.2% v/v.
  • Page 68 7. Cidex™ OPA is a trademark of Advanced Sterilization Products, Johnson & Johnson. 8. St. Jude Medical has validated the following challenge parameters for disinfection efficiency: Cidex OPA solution delivered ready for use, OPA 0.55%, 20°C +/-2°C. Immerse cold demineralized water one min.

  • Page 69: Maintenance

    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.

  • Page 70: Troubleshooting

    Troubleshooting Loss of Communication If communication between the PSA software and the Merlin PSA device is broken, for example, due to a cable disconnection, burst stimulation is terminated and you will no longer be able to change any parameter settings. In case of a communication loss, the Merlin PSA stores the current parameter settings and restores them when communication is restored.

  • Page 71: Symbols

    Universal Symbols Glossary at https://manuals.sjm.com. Symbol Description European conformity, affixed in accordance with European Council Directive 90/385/EEC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive. Manufacturing facility Affixed to this device in accordance with European Council Directive 2002/96/EC.
  • Page 72 Symbols...

  • Page 73: Index

    Index EGM Configuration Electrical Specifications AAI Mode Electromagnetic Compatibility (EMC) A-11 Accessories Electromagnetic Interference (EMI) A-11 Adapter, Cable Electrostatic Discharge (ESD) Additional Information Emergency (EVVI) Pacing Additional Parameters Enable/Disable Pacing Adjust Display End Session Annotate Test Results Export Screen A-11 Antenna Adapter AOO Mode Audio Preferences...
  • Page 74 End Session Start Main Programming Window Suspension A-17 Maintenance Maintenance Button, Tools Menu Marker Control Buttons Markers Reports, Print Basic Event Markers Restore Channels Button Full-Display Rhythm Display Interval and Refractory Markers (Full Markers) AutoGain All Button Setup Instructions Special Event Waveform Channel Markers Mechanical Specifications A-11...
  • Page 76 St. Jude Medical Coordination Center BVBA St. Jude Medical The Corporate Village Cardiac Rhythm Da Vincilaan 11 Box F1 Management Division 1935 Zaventem 15900 Valley View Court Belgium Sylmar, CA 91342 USA +32 2 774 68 11 +1 818 362 6822 St.

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