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St. Jude Medical EP-4 Series, System Manual

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St. Jude Medical EP-4 Series System Manual Download Page 2

St. Jude Medical 
Cooper Run Executive Park 
575 Route 73 North - Bldg. D 
West Berlin, New Jersey  08091 
U.S.A.  
856-753-8533 
www.sjm.com

 

Quality First International 
317 & 318 Burford Business Centre 
11 Burford Road 
London E15 2ST 
Tel: +44 (0) 208 221 2361 
Fax: +44 (0) 208 522 1937 

© 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.

 

Explanation of Symbols 

Manufacturer 

Authorized representative in the 
European community 

Caution: Consult accompanying 

documents 

Separate collection of waste at end of life 
as required by European Directives. 
Dispose of in accordance with the 
applicable country regulation. 

Summary of Contents for EP-4 Series

Page 1: ...EP 4 TM 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: ...l 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 Explanation of Symbols Manufacturer Authorized representative in the European community Caution Consult accompanying documents Separate collection of waste at end of life as require...

Page 3: ...le contains the microprocessor circuitry that controls the intensity and duration of two or four isolated stimulation outputs The output stimuli can be synchronized to the intracardiac signals or external signals This signal is also used to report spontaneous heart rates and to provide suggested pacing cycle lengths for the overdrive and other protocols Intended Use The EP 4 stimulator is intended...

Page 4: ...ular tachycardia or ventricular fibrillation occurring despite cardioversion defibrillation during the use of the EP 4 disconnect the patient from the device and all other equipment If micro electrocution or recurrent DC current stimulation are detected immediately disconnect patient at the intra cardiac electrode catheter connectors on the front panel of the device WARNING Do not stimulate any ou...

Page 5: ...rhythmias is likely to occur The EP 4 must only be used by appropriately qualified and experienced personnel in appropriate facilities and in conjunction with adequate safety equipment Difference Between the EP 4 and EP 3 The EP 3 stimulator has been in clinical usage since 1993 The following are the functional differences between the EP 3 and the EP 4 The EP 4 has either two or four stimulation o...

Page 6: ...ould be erased The connection to the EP 4 is a 9 pin RS 232 cable instead of the EP 3 s 25 pin This is for convenience The EP 4 has two or four push button relays controlling whether channels are off or on The EP 3 used toggle switches The EP 4 has the ability to measure stimulation impedance in real time This is important to understand whether there is a current path to the patient or not to help...

Page 7: ... Warning labels are placed next to certain cable connections and other components that require the operator s attention Such warning labels are located on the front and rear panels of the device The symbols are described below Read Instruction Manual This is a general indication to notify the user to read and understand the instruction related to this component before operating this device This in...

Page 8: ...tion of a flammable gas if operated in presence of flammable anesthetics The user should not operate this device in such condition under any circumstances Equipotential Post This device is specified to operate only with a medical grade grounded power cord Should the user elect to utilize additional grounding to the device this post provides a central equipotential connection post Front panel The s...

Page 9: ...er is disconnected and the LED is dark Note that there is a power switch on the back panel IMPORTANT The power switch can be used to turn the unit off if rapid termination of all pacing from all channels is required WARNING Do not stimulate any output channel connected directly to another device delivering energy to the patient WARNING The output of the EP 4 delivers potentially harmful voltage an...

Page 10: ...D is flashing it indicates that output is present when the output switch is turned ON and the Green LED is turned on EMERGENCY STIM BUTTON The EMERGENCY STIM button is used to provide constant pacing to the patient through the output of all channels This output is a 1000 msec cycle length 10 mA pacing signal that is activated when the red button is pressed This pacing function is described in deta...

Page 11: ... by the power input module located on the upper left side of the rear panel A mains power switch is locaed next to the power input A 10 Amp rated hospital grade power cord is provided and should be used to plug into the wall to provide power The stimulator does not need to be un plugged WARNING The AC power cord must remain plugged in while the stimulator is in use There is no battery backup for o...

Page 12: ...er This output can be turned on and off from the keyboard Chassis Grounding Terminal This terminal attaches internally to the stimulation module s case and is provided as a convenient equipotential point connection for grounding the case This terminal can either be connected to other grounded equipment or a suitable grounding point Speaker Volume This rotary knob is provided to adjust the volume o...

Page 13: ...re should be taken to avoid spillage of liquid onto the keyboard This could cause the keyboard to become inoperable during use Use a plastic shield if there is a chance of this happening in your environment TOUCH SCREEN COMPUTER MONITOR KEYBOARD STIMULATION MODULE POWER SHUT OFF The C o m p u t e r i z e d Electrophysiology Stimulator EP 4 OUTPUT CHANNEL 2 CHANNEL 3 CHANNEL 4 OUTPUT OUTPUT OUTPUT ...

Page 14: ...On position using the power switches on the front and back panels Wait for the self test to complete Turn On push the stimulus output switches The Stimulus output switches are provided as a convenient way to physically disconnect the stimulator from the patient They are normally left in the On position during a study System Initialization Each time the EP 4 system is turned on the touch screen com...

Page 15: ...off the power switch of the stimulation module Switching off the stimulation module causes a message to appear within 5 seconds Turn on the power switch of the stimulation module EP 4 Keyboard Take a moment to examine the EP 4 keyboard The keyboard contains the standard keys found on an ordinary typewriter as well as dedicated stimulation keys The top row of keys select either a stimulation protoc...

Page 16: ...has been stored in them You can return to the main menu at anytime by pressing the Menu key Pressing this key will stop stimulation and display the main menu Stimulus Protocols The first selection listed on the main menu is F1 the Threshold Determination protocol This protocol is designed to conveniently determine the current threshold at the selected site The protocol is executed by pressing the ...

Page 17: ...with the key used to invoke the protocol is displayed on the top line of the protocol tab The central part of the display contains rows of boxes These boxes are the parameters for the protocol The parameter boxes can be considered the dials used to control the action of the stimulator The bottom left side of the screen contains check boxes that control which stimulus channels are active The bottom...

Page 18: ...nt 0 1 mA Accuracy 5 or 0 1 mA whichever is larger Impedance Measuring Range 10 to 10 000 Ohm Load Accuracy 5 above 1mA 10 above 5 000 Ohm Pulse Duration Range 0 1 10 0 msec Increment 0 1 msec Accuracy 0 05 msec Pulse amplitude 1 mA Interstimulus Interval ISI Range S1 100 30000 msec S2 S7 50 10000 msec Burst 10 1000 msec Accuracy 1 msec Increment 1 msec Sequential AV Delay Range 10 1000 msec Accur...

Page 19: ... 10mV 1 0mV steps to 0 5V Absolute max input 5V Minimum refractory 50 msec After the start of the pacing pulse Frequency range 3 5 250Hz Internal Isolated Sensing ECG Trigger from Stimulation Channels Input range 0 1mV 10mV in 0 1mV steps Absolute max input 500 mV Minimum refractory 50 msec after the start of the pacing pulse Frequency range 30 250Hz Additional Outputs Four marker outputs Pace Mar...

Page 20: ...mperature 10 35 C Storage Temperature 20 60 C Relative Humidity 30 75 non condensing Operating Altitude 0 4572 m 7620 m storage Intended use The EP 4 stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements initiation and termination of tachyarrhythmias and measurements of electrical conduction Electrical Safety Chassis Leakage...

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