St. Jude Medical EP-4 Series System Manual
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St. Jude Medical EP-4 Series System Manual

The computerized electrophysiology stimulator
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TM
EP-4
The Computerized Electrophysiology Stimulator
System Manual
Document # 8258-ENG Rev. B
Part # 100010286
Software Version 2.0.0(PC)/1.1.2(EP-4)

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Summary of Contents for St. Jude Medical EP-4 Series

  • Page 1 EP-4 The Computerized Electrophysiology Stimulator System Manual Document # 8258-ENG Rev. B Part # 100010286 Software Version 2.0.0(PC)/1.1.2(EP-4)
  • Page 2 © 2003-2008 St. Jude Medical All Rights Reserved ST. JUDE MEDICAL, SJM, the stylized SJM, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered or unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.

  • Page 3: Intended Use

    Introduction The EP-4 Clinical Stimulator is a flexible, easy to use tool for performing electrophysiological studies either in the clinic or the research lab. The EP-4 has many features that simplify the execution and documentation of stimulation protocols. Stimulation Module The EP-4 consists of an AC line powered stimulation module, a touch screen computer, and a keyboard.
  • Page 4 EP-4 function is not guaranteed to be uninterrupted or error free. St. Jude Medical offers several programs that warrant the EP- 4 to operate according to specification however there is no guarantee that the device will do so in all circumstances, over an indefinite period of time.
  • Page 5 PRECAUTION: The EP-4 is not a life support device – Operator must have available backup temporary external pacemaker. The EP-4 is intended for provocative stimulation of the human heart during diagnostic electrophysiological procedures. The EP-4 is not intended or designed for use as a life support device.
  • Page 6 • The EP-4 has an integrated speaker with a hardware volume control. The device will beep during stimulation and sensing as programmed. The EP-3 used the PC speaker for this function that had no volume control. • The EP-4 has an emergency stimulation hardware button which will start the stimulator pacing on all channels turned on at 10mA(2mS) and 1000mS cycle length.
  • Page 7 Operating the EP-4 The EP-4 is operated by pressing command keys on the keyboard or buttons on the touch screen computer. Stimulation parameters (such as the stimulus duration) are displayed on the touch screen computer. These stimulation parameters are easily modified using the touch screen or keyboard and are stored on the computer hard drive .

  • Page 8: Front Panel

    Refer service to The EP-4 has no field serviceable internal parts. If service is qualified required contact St. Jude Medical Technical Support in the personel United States at 1-856-753-8533. DANGER: This cautionary note informs the user that this device may...
  • Page 9 Figure 1-2 – EP-4 Front Panel (2 channel version) Power switch The left of the front panel contains the power switch and and Indicators power on green LED indicator. In the ON position the LED is illuminated. The power switch connects the stimulation module to AC power.
  • Page 10 Output switches Along the front panel, the stimulation module outputs are and indicators turned on and off using an output switch. There are two or four gray output switches and one red EMERGENCY STIM button. There are two or four green LEDs associated with each channel which indicate when each output has been enabled.

  • Page 11: Rear Panel

    Figure 1-3 – EP-4 Rear Panel Rear panel The rear panel of the stimulation module contains the connectors for the touch screen computer, the power cord, the ECG input, and three marker outputs. All these electrical connections are non-isolated. WARNING The ECG input, the auxiliary and marker outputs are NOT isolated.

  • Page 12: Computer Components

    ECG Input The ECG input accepts a signal which is used to synchronize the EP-4 to an external event such as a surface ECG lead. This input is not isolated and should never be connected directly to a patient. Sense and The back panel contains 3 outputs, which can be used as Auxiliary event markers on a chart recorder.
  • Page 13 Clinical Stimulator TOUCH SCREEN COMPUTER / MONITOR STIMULATION EP-4 The C o m p u t e r i z e d MODULE WARNING Electrophysiology Stimulator ALL PATIENT CONNECTIONS Hazardous electrical output. ARE ELECTRICALLY ISOLATED This equipment is for use only by qualified personnel.

  • Page 14: System Initialization

    Tutorial This tutorial covers the most important features of the EP-4 Stimulator. It will take you through the protocols and give you some experience in changing and storing values within a function. It supplements the information in the reference section of this manual and should take less than an hour to complete.

  • Page 15: Main Menu Display

    Normal operation of the EP-4 is possible using any channel that has passed the self-test. St. Jude Medical recommends that users contact our technical services group at their earliest convenience to arrange for service for any stimulator unit with self-test failures.
  • Page 16 it performs. For example, F1 is shown next to “Threshold Determination”. This indicates that the threshold protocol can be executed by pressing the F1 key. The custom protocol keys (P1-P9 or Shift F1-F9) either display the title of a modified protocol or “None” if nothing else has been stored in them.
  • Page 17 Figure 3-1 Threshold Determination Screen Pressing a protocol key stops all stimulation and displays the selected protocol. Examine for a moment the Threshold Determination screen. All the screens of the stimulus protocols have a similar layout. The title, together with the key used to invoke the protocol, is displayed on the top line of the protocol tab.

  • Page 18: Specifications

    Specifications Isolated Stimulus Channels: Stimulus Channel On Off Button: 4 Standard Output Channel Buttons 1 Emergency Pacing Button. Output out of channel 1-4 simultaneously Pulse Amplitude constant current source): Range: 0.1 – 20 (2500 Ω load) Increment: Accuracy: 5% or 0.1 mA (whichever is larger) Impedance Measuring: Range:...
  • Page 19 Threshold Determination, Sinus Node Recovery Overdrive Pacing, Decremental Pacing, Refractory study Arrhythmia Induction, Burst, Pace Wenckebach block Programmable Protocol Keys: Number of Extrastimuli: (S2-S7) Emergency Pacing Function 1000 msec cycle length 10 mA constant current 2 ms pulse duration Output out of Channel 1-4 simultaneously External Non-Isolated Sensing (ECG Trigger from ECG Input): Input range: 1mV - 0.5V In...
  • Page 20 AC Power Cord: 10A Rated Stimulation Module: Dimensions: 16 3/4" L x 14" W x 3 1/2" H Weight: 15 lbs Computer: Type: Color touch screen display Dimensions: Varies Weight: Varies Processor: Intel® Pentium Class Computer Keyboard: Dimensions: 18.8" x 7.8" x 1.7" Weight: 3.3 lbs.

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