St. Jude Medical Merlin PSA EX3100 Help Manual Download Page 5

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Merlin™ PSA Help Manual

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Mode Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

DDD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

DDI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

DOO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

VDD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

VVI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

VOO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

AAI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

AOO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

ODO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Main Programming Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Patient Data: Lead Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

On-Screen Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Device Parameters and Settings Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Print Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Safe Pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

Emergency VVI Pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

Parameter Settings and Availability . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Merlin™ PSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Mechanical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  A-1
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  A-2
LED States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  A-3

Measurement Ranges and Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5

Battery Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10

Merlin™ PSA Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11

Storage and Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12

Cleaning, Disinfecting, and Sterilization Methods . . . . . . . . . . . . . . . . . . . . . . . A-12

Summary of Contents for Merlin PSA EX3100

Page 1: ...Merlin PSA Pacing System Analyzer Model EX3100 Help Manual ...

Page 2: ...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 2020 St Jude Medical LLC All Rights Reserved ...

Page 3: ...rences 2 1 Audio Preferences 2 2 Print Screen 2 2 Export Screen 2 2 Rhythm Display 3 1 Rhythm Display 3 1 ECG 3 3 Markers 3 3 Basic Event Markers 3 3 Interval and Refractory Markers Full Markers 3 5 Special Event Markers 3 5 Full Display Markers 3 6 Waveform Channel Markers 3 6 EGM 3 7 Current of Injury 3 7 Waveform Control 3 7 Rhythm Display Setup Instructions 3 8 Adjust Display 3 8 ECG Configura...

Page 4: ...s 5 3 Lead Impedance Measurements 5 3 Capture Test 5 4 Perform a Capture Test 5 4 Phrenic Nerve Stimulation Check 5 5 Annotate Test Results 5 5 Additional Parameters 5 6 Ventricular Sensing Buttons 5 6 Burst Pacing 6 1 Burst Pacing Instructions 6 1 Parameters 7 1 AV Delay 7 1 Base Rate 7 1 Interventricular Delay 7 1 Low Frequency Attenuation 7 1 Max Track Rate 7 2 Mode 7 2 Pacing 7 2 Pulse Amplitu...

Page 5: ...Settings Selection 9 3 Print Menu 9 3 Reports 9 3 Settings 9 3 Safe Pacing 9 4 Emergency VVI Pacing 9 4 Parameter Settings and Availability 10 1 Technical Data A 1 Merlin PSA A 1 Mechanical Specifications A 1 Electrical Specifications A 2 LED States A 3 Measurement Ranges and Tolerances A 4 Essential Performance A 4 Electromagnetic Compatibility A 5 Battery Information A 10 Merlin PSA Accessories ...

Page 6: ... Instructions for the Patient Cable Model EX3150 A 13 Maintenance A 17 Disposal A 17 Troubleshooting A 18 Loss of Communication A 18 System Failure A 18 Low Batteries A 18 EGM Noise A 18 Symbols B 1 Index Index 1 ...

Page 7: ...and the Merlin PSA M Adapter Model EX3180 connect the Merlin PSA to commonly used PSA patient cables see Connect the Leads to the Merlin PSA The PSA patient cables are then connected to the implanted leads For information on the Merlin PCS refer to the Merlin PCS Model 3650 User s Manual For technical data and other information on the Merlin PSA and accessories refer to Technical Data Operator Pro...

Page 8: ...ng use the patient cables must either be disposed or re sterilized depending on the requirements of the cable Only use the Merlin PSA with the Merlin PCS Contraindications There are no contraindications to the use of a lead analysis device The patient s age and medical condition however may dictate the pacing modes and lead assessment activities appropriate for the patient The Merlin PSA is not in...

Page 9: ...azardous to patients with acute myocardial infarction or who are otherwise predisposed to arrhythmias Precautions Temporary Pacing Do not use the Merlin PSA as a temporary pacemaker It should not be used to provide extended external pacing in situations where the patient is left unattended Testing has not been performed to support this function Power Loss In the event of a power loss to the progra...

Page 10: ... avoid damaging the device including but not limited to the following examples 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 sho...

Page 11: ...the PSA session Educational Materials Help Opens links for on line Help for all supported devices Demos Opens device demonstrations inactive during the PSA session 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 ...

Page 12: ...Shock regardless of the Charging Audio setting Accessed From Tools menu Preferences button Audio tab Print Screen The Print Screen button prints an image of the current screen to the internal printer For more information on printing see Print Menu Accessed From Tools menu Print Screen button Export Screen The Export Screen button opens a window which allows you to save the current screen as an ele...

Page 13: ...onfiguration 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 You can also freeze the display or print it in real time Three types of waveforms can be shown in the Rhythm Display ECG electrocardiogram Markers EGM intracardiac electrogram ...

Page 14: ...buttons Waveform Control buttons Select the Channel Control buttons on the left side of the waveform to show the Waveform Control buttons Top view shows buttons for ECG Bottom two views show buttons for EGM See also Current of Injury Marker Control buttons Select the Channel Control buttons on the left side of the Marker Control buttons Select the desired configuration or select the button to show...

Page 15: ...annels Markers can be configured either as Basic Basic Event Markers appear along a time line Full In addition to the Basic Event Markers the Interval and Refractory Markers Full Markers appear The following markers always appear in both the Basic and Full marker configurations Special Event Markers Full Display Markers Waveform Channel Markers There are two ways to change the marker configuration...

Page 16: ... AP Atrial paced event VS Ventricular sensed event VP Ventricular paced event Ventricular sensed event within the refractory period BP 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 LV RV with a 15 ms or greater delay The BP marker po...

Page 17: ...l markers Special Event Markers Marker Description Example A Noise or V Noise Entry into noise reversion mode A noise or V Noise Continuation of noise reversion mode A Noise or V Noise Exit from noise reversion mode Burst Burst stimulation Table 3 2 Special event markers 1 6 4 914 907 A V Interval A A Interval V V Interval Refractory Period Line Absolute Refractory Period Thicker Line ...

Page 18: ... Starting burst stimulation delivery A Burst or RV Burst Ended Ending burst stimulation delivery Table 3 3 Full display markers Marker Description Example Signal Amplitude Measure ment Intrinsic signal amplitude mea surements above the associated complex Impedance Measure ment Lead impedance measurement above the associ ated complex Table 3 4 Waveform channel markers ...

Page 19: ...plitude of the unfiltered EGM is shown in the upper left corner of the Current of Injury view The Current of Injury view updates with every sensed beat Use the Plus and Minus buttons to manually set the gain AutoGain is not available in the Current of Injury view Select the Current of Injury button to return to the Rhythm Display Accessed From Rhythm Display Channel Control button Waveform Control...

Page 20: ...s reduced when the ECG filter is enabled 9 Select the AutoGain All button to refresh the AutoGain settings Adjust Display The Adjust Display window changes the Source for each waveform in the Rhythm Display window ECG Markers or EGM Configuration of the waveform Sweep Speed ECG Filter to reduce electromagnetic interference The following buttons are also available AutoGain All Sets all waveforms to...

Page 21: ...rammer memory The controls on the Freeze Captures window include the Waveform Control buttons including the Hide button which hides the selected waveform Restore Channels button which restores the hidden waveforms Sweep Speed button 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 to...

Page 22: ...3 10 Rhythm Display ...

Page 23: ...ee sets of connector clips for three channels A RV LV 2 Merlin PSA Cable Adapter Model EX3170 terminates to a connection for Models 4051L and 4161 patient cables Merlin PSA M Cable Adapter Model EX3180 terminates to a connection for a Medtronic Model 2292 patient cable3 For more details on the cables and adapters see Merlin PSA Accessories 1 It may take up to 10 seconds for the blue LED to illumin...

Page 24: ... the cable adapter to its respective patient cable 7 Connect the patient cable connectors to the implanted lead you wish to test For appropriate measurements Connect the lead to the appropriate channel 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...

Page 25: ...ive parts including Earth ground Ensure that the leads are connected to the appropriate channel Incorrect connections could result in inappropriate or harmful stim ulation as well as inaccurate intrinsic signal amplitude and slew rate measurements In the event of power loss or communication failure the Merlin PSA switches to battery power to continue operation If this occurs the Merlin PSA operate...

Page 26: ...e End Session button to end the PSA session The Merlin PSA clears all test results and patient data Pacing from the PSA ends Suspend the Merlin PSA Session You can suspend the PSA session and return to other programmer functions by selecting the Programmer button If a device session is not already suspended you can interrogate a device and later return to the PSA session When you exit the programm...

Page 27: ...g on or off for the corresponding channel When you enable or disable pacing for a particular channel with the Pacing button the Merlin PSA automatically changes the Mode and V Pacing settings depending on the pacing status of other channels see Table 5 1 and Pacing Mode and V Pacing Parameter Autoprogramming below You can also select a different setting for the Base Rate and Additional Parameters ...

Page 28: ...in the LV channel if the Mode parameter is set to DDD or VVI The following table above shows how the Merlin PSA is programmed for all combinations of the Pacing V Pacing and Mode parameters Accessed From Lead Tests button 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 r...

Page 29: ...n PSA measures and saves the most recent intrinsic signal amplitude and slew rate unless the measurements have been previously saved Accessed From Lead Tests button Lead Impedance Measurements When you initially enable pacing for a particular channel the Merlin PSA measures and saves the lead impedance result The Merlin PSA displays the real time impedance measurements on the Impedance button and ...

Page 30: ...for the desired channel 2 Check the Rhythm Display to ensure that you have capture 3 Select the Run Test button The Capture Test window opens showing the current Pulse Amplitude setting the pulse current measurement and settings for additional parameters 4 Select the Pulse Amplitude and other parameter settings for the test To adjust any addi tional parameter settings select the See Additional Par...

Page 31: ... The Annotate Test Results window has a tab for each channel Each window consists of three columns for the three available tests P R wave slew rate Impedance and Capture Each column can contain up to five test results and a time date stamp with the most recent results at the top of the window If six or more tests were recorded the oldest result is overwritten by the latest To view other available ...

Page 32: ...ase Rate Max Track Rate AV Delay V Pacing V Sensing Advanced Settings Select the Advanced Settings button to access the Low Frequency Attenuation parameter Accessed From Lead Tests Additional Parameters button Ventricular Sensing Buttons In CRT devices ventricular sensing occurs in a single chamber To select the chamber to be sensed select the appropriate V Sensing radio button at the bottom of th...

Page 33: ...d Ventricular Support Rate VOO settings The Pulse Amplitude and Pulse Width settings selected for Burst Pacing are temporary settings When Burst Pacing is completed the Merlin PSA restores the original Pulse Amplitude and Pulse Width settings 4 Select the Enable Burst button 5 Press and hold the Hold to Apply Burst button to deliver burst pacing Burst markers STIM are shown on the Rhythm Display T...

Page 34: ...6 2 Burst Pacing ...

Page 35: ...ngs and Availability Base Rate The Base Rate parameter sets the minimum stimulation rate See also Parameter Settings and Availability Interventricular Delay The Interventricular Delay parameter determines the interval between the pulses delivered to the ventricles when the V Pacing parameter is set to either LV RV or RV LV See also Parameter Settings and Availability Low Frequency Attenuation The ...

Page 36: ...ate The Max Track Rate parameter determines the maximum ventricular stimulation rate allowed in atrial tracking modes See also Parameter Settings and Availability Mode The Mode parameter determines the stimulation and sensing method The selected mode is in effect at all times except during Burst Pacing Details of each mode can be found in Mode Descriptions See also Parameter Settings and Availabil...

Page 37: ... AAI Mode the Refractory parameter determines the atrial refractory period In dual chamber modes the Refractory parameter determines the post ventricular atrial refractory period See also Parameter Settings and Availability S1S1 The S1S1 parameter determines the interval at which the Burst Pacing stimulation pulse is applied See also Parameter Settings and Availability Sensitivity The Sensitivity ...

Page 38: ... buttons on Lead Tests window Parameter Settings and Availability Ventricular Support Rate VOO The Ventricular Support Rate VOO parameter determines the stimulation rate applied to the ventricle during atrial Burst Pacing See also Parameter Settings and Availability VOO mode description CAUTION For CRT devices if only one ventricular channel is connected to the Merlin PSA ensure that the Ventricul...

Page 39: ...ensed 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 Figure 8 1 DDD Mode timing diagram Dual Chamber Atrial Ventricular Off Modes DDD AAI VVI ODO DDI AOO VOO DOO VDD Table 8 1 Available Modes Refractory Period Blanking Period Alert Period AV Delay O...

Page 40: ...8 2 DDI Mode timing diagram DOO 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 Refractory Period Blanking Period Alert Pe...

Page 41: ... 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 Figure 8 4 VDD Mode timing diagram A V Programmed Rate Programmed Rate AV Delay Output Pulse AP AP AP VP VP VP V AV Delay Refractory Period Alert Period Output Pulse A Sensed Event Programmed Rate PVARP AS VP VP VS VS AS ...

Page 42: ...iming period to the start of the Ventricular Refractory Period Figure 8 5 VVI Mode timing diagram 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 Out...

Page 43: ... a sensed event during the alert period it withholds the pulse and resets the timing to the start of the Atrial Refractory Period Figure 8 7 AAI Mode timing diagram AOO Atrial Asynchronous Pacing In AOO mode the device paces the atrium at the programmed rate regardless of intrinsic rhythm Output Pulse Programmed Rate Programmed Rate VP VP VP Output Pulse Refractory Period Alert Period Programmed R...

Page 44: ...aluation and recording of intrinsic activity CAUTION AOO mode is primarily intended for temporary use Long term use may result in competitive pacing which may induce potentially dangerous tachyarrhythmias 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 Output Pulse Programmed Rate AP AP Progr...

Page 45: ...ing window is the upper portion of the screen that contains the following buttons and indicators button Opens the context sensitive on screen help menu Tools menu Opens a menu for the Merlin PSA application preferences and other functions Patient Data Patient data is either entered directly in the PSA session or imported from a device programming session Select the Patient Data button to view or e...

Page 46: ...rmation on the device and patient However you cannot export data entered during the PSA session to a device programmer session The data fields include Patient Name and ID buttons Opens an on screen keyboard for data entry Lead Information buttons Opens the Patient Data Lead Information window to set the manufacturer model length serial number and lead implant date for each lead Device Model and Se...

Page 47: ... a report to print select the check box on the left The available report types include PSA Report Select the PSA Report button to open the Report Settings window to include all test results or only the latest test results Freezes All Freeze Captures are included in the report To print individual Freeze Captures select the Freeze button to open the Freeze Capture window Select a Freeze Capture Sele...

Page 48: ... mode until the batteries are depleted or until the Merlin PSA has counted 60 consecutive cycles with no impedance load that is the leads have been disconnected Emergency VVI Pacing Emergency VVI pacing can be initiated using the programmer To begin emergency VVI pacing Press the red VVI hard key on the Merlin PCS console All other Merlin PSA system activities are terminated when Emergency VVI Pac...

Page 49: ...ithin the necessary telemetry distance To initiate Emergency VVI pacing for the Merlin PSA system launch the PSA application then press the VVI hard key The Merlin PSA only delivers Emergency VVI Pacing through the ven tricular channel EVVI pacing is not delivered through the atrial chan nel CAUTION The Emergency Shock function is not available during a PSA session ...

Page 50: ...9 6 Additional Information ...

Page 51: ...D VOO DDI DDD DOO ODO ODO Pacing All sessions On Off Off Pulse Amplitude All sessions 0 1 0 2 4 0 4 5 8 0 9 0 10 0 V 5 0 V 7 5 V for Burst Pacing Pulse Amplitude Pulse Width All sessions CRT Ds ICDs 0 1 0 2 1 5 ms 0 5 ms 1 0 ms for Burst Pacing Pulse Width CRT Ps Pacemakers 0 1 0 2 1 5 ms 0 4 ms 1 0 ms for Burst Pacing Pulse Width A Refractory All sessions 100 125 500 ms 400 ms for AAI AOO modes 2...

Page 52: ... D sessions RV only LV only LV RV RV LV Simultaneous RV only V Sensing CRT P CRT D sessions RV LV RV Ventricular Support Rate VOO All sessions Off 30 35 95 min Off Parameter Availability Settings Nominal Table 10 1 Parameter settings and availability continued ...

Page 53: ...l Mechanical Specifications Electrical Specifications LED States Measurement Ranges and Tolerances Essential Performance Battery Information Merlin PSA Accessories Storage and Operating Conditions Cleaning Disinfecting and Sterilization Methods Maintenance Disposal Troubleshooting Merlin PSA Mechanical Specifications Figure A 1 Top Dimensions 161 mm 98 mm 85 mm ...

Page 54: ...4 kg excluding batteries Materials Polycarbonate Acrylonitrile butadiene styrene Battery Four 4 AA size LR6 alkaline batteries1 1 See also Battery Information Table A 1 Merlin PSA mechanical specifications Specification Supply voltage 5 Vdc 5 Power dissipation 3 W Table A 2 Merlin PSA electrical specifications 77 mm 93 mm 85 mm 150 mm ...

Page 55: ... PSA is not on or is using batteries 2 Battery Status Yellow Off Not operating on batteries Yellow On PSA is operating on batteries Yellow Flashing PSA is operating on batteries near depletion Replace the batteries immediately 3 A RV LV Pace Green On Paced event Green Off No paced event 4 A RV LV Sense Amber On Sensed event Amber Off No sensed event Table A 3 LED Status Indicator Descriptions 1 2 ...

Page 56: ...lay gain Sensed intervals 100 1991 ms 10 ms Measured heart rate 30 300 min 1 min or 1 1 Intrinsic signal amplitude 0 1 35 0 mV 0 1 mV or 10 1 1 Whichever is greater Slew rate 0 1 8 0 V s 0 1 V s or 10 1 Pacing lead impedance 200 4000 10 for impedances in the range of 200 2499 at 5 0 V 15 for impedances in the range of 2500 4000 at 5 0 V AV Delay 25 450 ms 5 ms Base Rate 30 220 min 2000 273 ms 5 ms...

Page 57: ... PSA is intended for use in an electromagnetic environment where radiated RF disturbances are controlled Maintain a reasonable distance between portable and mobile RF communications equipment transmitters and the Merlin PSA Note For single fault conditions see Troubleshooting page A 18 Test Compliance Electromagnetic Environment Guidance RF emission CISPR 11 Group 1 The Merlin PSA uses RF energy o...

Page 58: ...lity should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 1 kV line s to line s 2 kV line s to earth 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips shorts interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 2 95 dip in UT for 0 5 cycle 5 UT 95 d...

Page 59: ...ower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Test IEC 60601 Test Level Compliance Level 1 Electromagnetic Environment Guidance Table A 6 Guidance manufacturer s declaration electromagnetic immunity continued ...

Page 60: ...rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey 5 should be less than the compliance level in each frequency range6 Interference may occur in the vicinity of equipment marked with the following symbol 1 Figures in parenth...

Page 61: ...c environ ment in which radiated RF disturbances are controlled The user of the Merlin PCS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Merlin PCS as rec ommended in Table A 7 according to the maximum output power of the communications equipment For transmitters rated at a maxi mum outpu...

Page 62: ... leads and patient cables from the Merlin PSA 2 End the PSA Session and turn off the Merlin PCS programmer 3 Lift the Merlin PSA unit from the storage compartment and remove the connections from the Merlin PSA to the Merlin PCS 4 Locate the blue battery compartment hatch door on the bottom of the Merlin PSA 5 Push down the tabs on the door and lift the door open 6 Remove all four batteries 7 Inser...

Page 63: ...ch the patient while you are changing the batteries Note The Merlin PSA is an accessory to the Merlin PCS While connected to the Merlin PCS the Merlin PSA system is a Class I system and complies with EN 60601 1 and EN 60601 1 2 Accessory Description Model Number Merlin PSA Patient Cable Sterilizable patient cable 4 m EX3150 IS4 DF4 Connector Sleeve EX3151 Merlin PSA Cable Adapter Disposable patien...

Page 64: ...ondensing 75 non condensing EX3150 EX3170 EX3180 Temperature Min 10 C 10 C Max 50 C 40 C Humidity Min 10 non condensing 30 non condensing Max 90 non condensing 75 non condensing EX3190 Temperature Min 40 C 10 C Max 70 C 40 C Humidity Min 10 non condensing 30 non condensing Max 90 non condensing 75 non condensing Table A 9 Operating and storage conditions for Merlin PSA and accessories CAUTION Allo...

Page 65: ...3170 and EX3180 and the Merlin Antenna Adapter Model EX3190 Product Cleaning Method Disinfecting Method Sterilization Method Merlin PSA Model EX3100 Wipe with a damp cloth moistened with a mild soap Cannot be disinfected Cannot be sterilized Merlin PSA Patient Cable Model EX3150 See Special Instructions for the Patient Cable Model EX3150 below Merlin PSA Disposable Cable Adapter Model EX3170 Wipe ...

Page 66: ...amination on the product to facilitate the disinfection and sterilization of the cable Thus cleaning must be viewed as the first step in the process that includes disinfection and sterilization for eventual re use of the cable The goal of disinfection is reduce the bioburden to a level so that the sterilization process will reach a sterility assurance level SAL of 10 6 Equipment Washer disinfector...

Page 67: ...ic cleaner sized to fully immerse the Patient Cable Model EX3150 Potable water Cidezyme enzymatic detergent solution Instructions 6 1 Clean the Patient Cable Model EX3150 ultrasonically for 10 minutes using Cidezyme enzymatic detergent solution according to the manufacturer s instructions 4 Neodisher FA Neodisher Z and Neodisher MediClean are trademarks of Chemische Fabrik DR WEIGERT GmbH Co KG 5 ...

Page 68: ...free cloth Note Do not exceed 30 minutes of ultrasonic cleaning The ultrasound must achieve a minimum of 35 kHz The temperature of the cleaning solution should not exceed 35 C Make sure no residues of soil can be seen on the cable Do not exceed concentration recommended by the manufacturer of the detergent Follow the detergent s instruction for use to optimize cleaning efficiency After rinsing ens...

Page 69: ...erlin PSA and its accessories do not contain any user serviceable parts Preventive maintenance including periodic safety checks is not required Do not modify the Merlin PSA or its accessories If there is a problem with the Merlin PSA or its accessories contact Technical Support Disposal The device contains a battery and the label is affixed to this device in accordance with European Council Direct...

Page 70: ...e compartment and re install the Merlin PSA cable into the PSA port on the Merlin PCS System Failure Each time the Merlin PCS is turned on the Merlin PSA conducts a self test If the test fails the Merlin PCS will not begin a PSA session and the blue LED on the unit will not illuminate Contact Technical Support If the Merlin PCS fails during an ongoing PSA session the unit will resort to Safe Pacin...

Page 71: ...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 See Disposal on page A 17 Prescription use only Consult instructions for use on this website Product literature TÜV Listed US and Canada Conforms to UL STD 60601...

Page 72: ...B 2 Symbols ...

Page 73: ...1 DDI Mode 8 2 Disposal A 17 DOO Mode 8 2 E ECG 3 3 ECG Configuration 3 8 ECG Notch Filter 2 2 Educational Materials 2 1 EGM 3 7 EGM Configuration 3 9 Electrical Specifications A 2 Electromagnetic Compatibility EMC A 5 Electromagnetic Interference EMI 1 3 Electrostatic Discharge ESD 1 3 Emergency EVVI Pacing 9 4 Enable Disable Pacing 5 1 End Session 4 4 Export Screen 2 2 F Freeze Button 3 9 Freeze...

Page 74: ...5 Power Loss 4 3 Precautions 1 3 Preferences 2 1 Audio 2 2 Print Reports 9 3 Print Screen 2 2 Print Settings 9 3 Printer Preferences 2 2 Programmer Button 4 4 PSA Accessories A 11 PSA Session End Session 4 4 Start 4 3 Suspension 4 4 R Reports Print 9 3 Restore Channels Button 3 9 Rhythm Display 3 1 AutoGain All Button 3 8 Setup Instructions 3 8 S Safe Pacing 4 3 9 4 Session Information 4 1 Session...

Page 75: ......

Page 76: ...t Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court Sylmar CA 91342 USA 1 818 362 6822 St Jude Medical Puerto Rico LLC Lot A Interior 2 Rd Km 67 5 Santana Industrial Park Arecibo PR 00612 USA St Jude Medical Operations M Sdn Bhd Plot 102 Lebuhraya Kampung Jawa Bayan Lepas Industrial Zone 11900 Penang Malaysia sjm com 600130218 ...

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St. Jude Medical Merlin PSA EX3100, Help Manual

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Summary of Contents for Merlin PSA EX3100

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