EP-WorkMate - Docket Alarm
Contents
1. Setup Screen 124 Optical Disks wee 125 Technical 4 2 222 125 127 Component 127 Recommended Backup Strategies 128 Software Upgrade Installation 2 1928 Specifications ccccccccsccccenseccecccccsseessesssssessssseascoses 129 Index sscssescsesassssasonccssesecsascsoccaccocosssecososcsseessessessesecees 131 000009 SJM03074950 Figures Figure 1 The EP WorkMate Cart and Components 3 Figure 2 Basic EP Lab 4 Figure 3a The EP WorkMate Main Computer older 76 Figure The EP WorkMate Main Computer newer 77 Figure 4 EP 3 2 2 1 79 Figure 5a The EP WorkMate 72 Channel Signal Conditioning UNit W 0 PLOSSUTE 81 Figure 5b The EP WorkMate 140 Channel Signal Conditioning Unit with Pressure 82 Figure 5c The EP WorkMate 44 and 76 Channel Signal Conditioning Unit with Pressure 222 2 2 82 Figure 6 The EP WorkMate Catheter Interface Box 83 Figure 7 Power diagram for the EP WorkMate 84 00002. 14 TS Assembling the Cart ccccssccssscscosscorscsessccssesconeessoseees 75 The EP WorkMate Main Computer 22222 76 Sad cous 78 The EP WorkMate Signal Conditioning Unit 5 80 The Pressure Marker Interface 82 ECG Sync Output 83 EP WorkMate Catheter Interface Box CIB 83 84 Cine 84 Turning on the EP WorkMate Preliminary test 85 000008 5 03074949 System Configuration 87 BPWM INT Bile ET AE E OASE 87 SHELL INI File TIGA Board Configuration 2 96 CONFIG SYS 98 AUTOEXEC BAT File 98 Error 98 Signal Conditioning Unit Configuration 99 SCU Beep Sequence 24 Channel SCU 56 Channel SCU 120 Channel SCU Cine Capture Board Reporting Report Menu Report Editor Exporting Data Exporting Signals Export File Names Export Channel File Formats Exporting Patient 22 22 115 Troubleshooting 7
3. Database Measurement menu appears and all of the proper measurements are in their proper locations Utilizing this button allows the user to take advantage of a quick and easy method for selecting and entering baseline measurements without having to question the validity of those measurements Intervals Selecting this button will toggle on or off the automatic on by line analysis of the analyzed channels as defined in the Setup screen Horizontal Selecting the horizontal caliper will display a caliper in the Caliper Review screen that measures time in milliseconds ms from one point to another To make a measurement select the horizontal caliper and move the left leg of the caliper to the Ctrl C desired ECG and press the left mouse button The left leg of the caliper has turned yellow and become fixed Roll the right leg of the caliper by moving the track ball to the end of the desired interval and press the right mouse button To remove the calipers press the right mouse button again SJM03074985 Using the calipers in this manner allows the user to make repeated measurements over and over and does not enter any of these measurements into the database Entering a measurement into the database is done in exactly the same manner as making a measurement except when fixing the right leg of the caliper the left mouse button should be pressed again A menu will appear on the screen Select with the left mouse button t
4. REC is the manual record When the system starts any recording it displays in the bottom right of the display the amount of time recorded as well as the free time remaining on the hard disk To stop recording select the Start Stop REC button again One important option is Past Ctrl R which will acquire the previous 30 seconds and keep recording When the Start Stop button is activated the start window displays red and the bottom of the screen turns yellow until you stop recording when they return to their original color The Auto REC automatic record will begin recording automatically for four defined triggers Two of them are the rate or the beats per minute bpm based on a High or Low Rate Thus if the patient goes outside a range of heart rates the EP WorkMate will begin recording until the bpm falls back inside the pre defined high and low rates as defined in the background Setup screens One option is Stim Train stimulus train which automatically records on the sensing of the stimulus train as defined in the Setup screen The amount of time to record before and after the stimulation event is defined in the background Setup screens The final option is RF radio frequency ablation which automatically start stops recording on detecting RF energy from supported RF generators The time to pre and post RF recording is defined in the background Setup screen The Auto REC button turns red when it is activated until the auto record functi
5. Real time 000043 SJM03074984 screen Drug Syringe Selecting this button will display a menu displaying the Ctrl D options Study Drug ON Study Drug OFF and Sedation Selecting the Study Drug ON option will display another menu of study drug options Selecting a study drug will display a text input box prompting the user to enter the drug s dosage Once this process is completed the Syringe button will turn red until the Study Drug OFF option has been selected Selecting the Sedation option will display a different menu for sedatives Selecting a sedative will display a text input box prompting the user to enter the drug s dosage All Drug events are entered into the log and database automatically Sedatives entered will be summed and displayed on the MEDS database page Camera Icon Selecting this icon will only work after several specific measurements have been selected with the Single Line Caliper see Single Line Caliper below These measurements include on a surface lead P Q R S T P and Q again The tick marks placed by the caliper must all lie on the same surface lead Moving the caliper to the signal labeled as the atrial channel measure the A A interval Moving the caliper to the HIS channel measure the A H and H V intervals Finally move the caliper to the ventricular channel measure the V V interval and select the Camera button Notice that a
6. YES to add the new label to the menu To delete a label select DEL and the label will be removed Press Menu Esc to exit The screen will then ask if you want to store any changes made Select YES to save changes 000034 JM03074975 The DEL button erases the current protocol along with its channel setup and pages Repeat these steps until the protocol list is complete for the study type Then using the Copy and Paste functions add the initial setup to all the selected protocols and Save them with the correct study name as initially selected It should be noted that once a page is defined in a protocol only minor variations of that page are generally made for most of the other protocols of the study type These types of changes are often small and require little work once the protocols have been defined Beginning an EP After selecting Begin Review Study enter the patient s Study name last then first with no commas then press Return Enter The system then displays a list of the patients on the hard drive you can select from this list if the patient has had a previous study or select the patients name from the top of the list The next input field is the patients ID number It should be noted that the only information required to save a study is the patient name and ID number Finally a list of the catheter maps currently stored is displayed Select the map and the EP WorkMate will go directly to the first page and protocol of
7. between it and the closest tick to its left on the same signal Pressing the right mouse button will display the original cursor Pressing the middle mouse while the cursor is placed to the left of any tick will pick up that tick and display a Single Line Caliper Arrow Selecting the Arrow button displays a pointing hand on the r Review screen as the mouse cursor The hand can be moved to the point in time in the Review screen where the arrow is to begin with the track ball Pressing the left mouse button will begin the drawing of the arrow and 000045 SJM03074986 display an arrow head at the end of the arrow Pressing the left mouse button again will fix the arrow Pressing the middle mouse when the cursor is over the box displayed in the middle of the arrow will pick up the arrow and allow its end point to change When the arrow is active blue pressing the right mouse button will erase it from the screen The Arrow works very much in the same fashion as the Single Line Caliper Caliper Off This button removes any calipers or arrows fixed on the Arrow Head screen as well as terminating any active calipers or arrows Auto REC Recording will automatically begin when four pre defined A criteria are met The first is when any stimulation is given by the stimulator The EP WorkMate knows to begin recording because stim markers can be seen on the stim channel therefore a stim channel must be setup on at least one of the
8. channel with the auto analysis set to Stim and the correct pins assigned for the channel The Split This allows for two review screens to be placed side by side Screen for comparison of electrograms Press Split to display the split screen window Press it again to remove it Both windows open function independently To select either review screen click on the screen or the scroll bar The right review screen will be the screen that updates with current recorded electrograms for comparison The Holter Another split screen option is the holter window Press Window Holter to display the Holter window Press it again to 000037 JM03074978 remove it This shows the entire case from start to finish in a compressed one channel view Selecting any portion of the Holter view signal will display the signals recorded at that time in the study Operation Overview The following is a step by step description to begin and perform an EP study e Turn the entire EP WorkMate system ON using the main power button between the two monitors Select BEGIN NEW STUDY and input patient s name and ID number It will show a menu of patients currently on the hard drive Pressing the right mouse button will remove the menu and add the patient as a new patient Clicking on a patient name with the left button will select that patient for re study Next pick the type of study to perform from the list of catheter maps displayed e Select the
9. from all obligations under its warranty if repairs or modifications are made to the Product by persons other than EP Med s own or authorized service personnel EP Med shall be released from all obligations under its warranty for defects resulting from improper assembly of the Product or the operation of the Product outside of the environmental electrical and other Product specifications EP Med shall be released from all obligations under this warranty in the event the Product or component thereof is used by anyone other than a board certified cardiologist or a qualified electrophysiologist The warranty provided herein is the sole and exclusive warranty with respect to the Product No representations or warranties made by any person including dealers employees and other representatives of EP Med shall be of no effect whatsoever unless approved by a duly authorized officer of EP Med Product EP MedSystems will accept for return all products which are Return 1 shipped in error by EP MedSystems 2 returned at the Policy request of EP MedSystems or 3 held by customers for more than thirty 30 days In obtaining credit all merchandise must be returned postage pre paid and in good unopened condition Credit will be provided by EP MedSystems for all products conforming to the foregoing as follows Full credit will be issued for all merchandise described in 1 and 3 above Credit less than 20 restocking charge will be give
10. log of events the stimulator and a holter window Buttons along the top and bottom of the screen control how the signals are reviewed and annotated Hot Keys The EP WorkMate has dedicated keys for fast operation Many of the keys defined below not listed on the screens 000029 JM03074970 Review Screen RF Split Window Middle Mouse Pop up the previous caliper on the review screen M Mark a real time event in the log Reset the SCU notch filter All auto record features enabled View the signals for the previous log entry Ctrl C Horizontal caliper Ctrl D Drugs and sedation pop up menu Print 12 lead at 25mm sec Print 12 lead at 50mm sec Ctrl G Print 12 lead view of review screen Ctrl H Enter or exit DEMO mode Ctri I Creates a slide of the current screen in PCX format Ctri J View the signals for the previous event Ctrl K View the signals for the next event Ctrl L Begin level triggered sweep Ctrl M View the signals for the last log event Ctrl N View the signals for the next log entry Ctrl O Creates a slide of the current screen in JPG format Ctrl P Display CINE split screen and play the top CINE window Ctrl Q Record the currently viewed real time screen Ctrl R Start recording from the past Ctrl S Change stimulator screen format Ctrl T Begin stim triggered sweep Ctrl U Move review monitor page to the last page stored or currently viewed on the real
11. purchaser of the Product Obtaining To obtain warranty service the customer must contact EP Warranty Med 1 800 361 6464 for an initial assessment of the Service problem The EP Med customer service department shall assign a Return Authorization Number to the Product and instruct the customer as to its return The customer shall be responsible for all charges incurred in shipping the product to EP Med and shali insure and accept all liability for loss or damage to the Product during shipment In the event EP Med determines that the Product or component thereof is covered by the warranty described above EP Med shall pay for the return of the product to the customer Otherwise the item will be returned to the customer with transportation charges collect The customer shall pay all shipping charges duties and taxes for products returned to EP Med from a country other than the United States All returns should be shipped to the following address 000003 SJM03074944 EP MedSystems 100 Stierli Ct Suite 107 Mt Arlington New Jersey 07856 Optional The customer may choose to purchase an extended Extended warranty at any time during the warranty period This Warranty extended warranty extends the warranty period described above for a period of one 1 year coverage of service for the Product only to begin with the end of the initial warranty period Exclusions In addition to the exclusions described above EP Med shall be released
12. six catheter map pages The second is when the heart rate falls below a preset user defined interval The third is when the heart rate accelerates above a preset user defined interval the previous two are triggered from a channel with R R analysis enabled The fourth is when the RF generator begins sending data to the EP WorkMate via the serial COM 2 or COM B cable The PRE RECORD TIME is the recorded signal time before the event The POST RECORD TIME is the recorded signal time after the event Both times must add up to less than 31 seconds In other words the pre record time can be up to 21 seconds if the post record time is 10 seconds If you do not want the recording to automatically terminate set the post record time to 0 The DETECTION LIMIT is the interval in milli seconds that triggers the event For stimulation it is normally set to 1000 high rate to 400 and low rate to 1500 The DETECTION COUNT is the number of intervals above or below the limit to trigger the event This is normally set to at least 3 for high and low rate The EDIT button in the Auto REC menu allows the user to setup the parameters of the auto record functions When the pre defined criteria are met the EP WorkMate automatically labels the event that occurred in the log All of the auto record functions can be turned on or off by striking Ctrl A Start REC When the Start Ree button is selected a menu appears with t three options The first option is
13. study Defining an EP In order to define a study the user should first name the Study and its study type The user would first go into the Setup screen Protocols and setup the pages as required Six independent pages of 32 choices are allowed per protocol On each protocol page the names and positions of these channels are defined The amplitude high and low pass filter settings analysis type catheter pins and screen color are also specified on the Setup screen Finally we will define our Holter channel our synchronization channel for our stimulator and the pacing sites for the stimulator Then save the study using the Save CathMap button with the appropriate name of the study and press Return Enter to store the name Next the user would then label or name the study s protocols To define a protocol name or label we would select the Protocol button One can modify the existing names in the defined protocols screen by selecting EDIT this will display the existing protocol names in the EP WorkMate Selecting a protocol name replaces the edited protocol Selecting DEL delete erases the defined protocol name from the menu Selecting INS insert adds a new protocol to the defined protocol list Select the protocol label to be inserted While in this menu pressing EDIT will allow the user to add edit or remove protocols on the main protocol menu To add a new label select INS and type in the name and press Return Select
14. the selected catheter map All other entries are optional If you wish to enter further demographics go to the database function B The Database screen is for entering patient demographics generating reports and for patient study management We can either begin a study for a new patient or for a previous patient When entering new patient information press Return Enter after typing in the patient s name and you will be led through the succeeding database fields Study date and time and tape disk catalog will be entered automatically A unique patient name ID number must be entered for each patient Many other fields have user definable menus and do not have to be entered After selecting the type of study go to the Setup screen and verify the signal information for the real time screen such as name position size Amp for amplitude and Clip for clipping limit high and low pass filters color box and for catheter inputs analysis types and any output signals Also verify the signals on the following pages by selecting the up and down arrows in the upper right hand corner of the Setup screen This is the point where you may make any minor adjustments necessary to that catheter map Recording an After we have set up the real time signals we are ready to 000035 5 03074976 EP Study begin recording the study Select the Review button and choose either Start Stop REC OR Auto REC to begin recording The Start Stop
15. time screen Ctrl V View the signals for the first log event Ctrl W Change review screen speed Ctrl X Decrease review screen speed Horizontal single caliper Ctrl Z Increase review screen speed Ctrl 2 Print review screen to fit Ctri 6 Save demo mode signals Ctrl up arrow Review monitor page up Ctri down arrow Review monitor page down Ctrl left arrow Review left one page Ctrl right arrow Review right one page Alt left arrow Review scroll left Alt right arrow Review scroll right Shift left arrow Split or holter screen left one page Shift right arrow Split or holter screen right one page Shift up arrow Split review page up or faster scroll for stimulator parameter Shift down arrow Split review page down or faster scroll for stimulator _ parameter Alt up arrow Review channel amplitude up Alt down arrow Review channel amplitude down Ctrl number pad 2 Real time monitor page up Ctrl number pad 4 Real time monitor speed decrease Ctrl number pad 6 Real time monitor speed increase Ctrl number pad 8 Real time monitor page down Ctrl number pad Real time channel amplitude up Ctrl number pad 9 Real time channel amplitude down Alt function keys Select protocols Ctrl function keys Select events Ctrl number pad dash or Manual Stim Toggle strip chart records and off Ctrl B Previous session Ctrl N Next session 000030 JM03074971 Setup Screen Reset the SCU notch filter Ctrl A All butt
16. 10 SJM03074951 About this Manual This manual is intended to help you get the most out of your EP WorkMate computerized EP system Although you will find the EP WorkMate easy to use we strongly recommend that you read chapters 1 through 6 before you begin to use the product clinically These chapters contain important information basic to the safe operation of the system as well as some time saving tips that will allow you to use the full power of the EP WorkMate For information on the operation and specifications of the EP 3 stimulator please refer to the EP 3 stimulator manual provided with the system We strongly recommend you read the tutorial chapter before you use the product clinically Manual Overview Here is an introduction into the manual s organization Chapter 1 This is an introduction chapter to the EP WorkMate It Introduction describes the various components that make up the EP WorkMate Chapter 2 This chapter introduces the user interface of the EP User Interface WorkMate Chapter 3 This chapter gets you started using the device and includes Getting Started a tutorial on using the EP WorkMate This tutorial covers the basic skills needed to operate the EP WorkMate Chapter 4 This reference chapter describes the Review Screen Review Screen including the purpose and function of each menu and key This includes stimulation and cine functions Chapter 5 This referen
17. Database b button and enter the patient s other demographic information by selecting the database field on the screen e Select the Review R button to return to the review screen Select the Stimulator S button and turn the EP 3 ON Verify the self test performs correctly e Select the Real time 12 Lead ECG key The review is automatically updated and a 12 Lead ECG is recorded and sent to the printer Once the catheters are in position record data by either pushing record hot key or update screen hot key This will display intra cardiac signals on the review screen Select the single horizontal caliper button and use the left mouse button to measure intervals on a specific channel then click the camera icon Measurements will be stored in the log and in the database under measurements e Press the F1 key and perform a threshold test for the current pacing catheters using the STIM key Be sure to turn the EP 3 pacing site output switches ON 000038 SJM03074979 Remember to change Protocols as you jump through the different stages of the case This will help you manage the log information more efficiently e Using the stimulator press the F8 key to perform arrhythmia induction mapping stimulation pacing trains Press the MENU key and corresponding F or P function keys to select new pacing protocols and perform them at will Use the Start REC button to start and stop recording as needed or use the Auto Record fea
18. EPMedSystems EP WorkMate User s Guide EP MedSystems Inc 100 Stierli Court Ste 107 Copyright 1996 2000 Mount Arlington New Jersey 07856 All Rights Reserved U S A Part 04 0002 0000 Rev I 2 7 00 973 398 2800 Software Version 2 11 5 000001 SJM03074942 ST JUDE MEDICAL 1121 ais JM03074943 Warrant Limited MedSystems Inc Med warrants subject to the Warranty exceptions and upon the conditions specified below that the Product will be free of defects in materials and workmanship for a period of one 1 year from the date of shipment to the original purchaser provided however that the warranty with respect to all cables and other connective devices provided with the Product shall be for a period of ninety 90 days only In the event EP Med receives notification of any such defects during the warranty period EP Med shall at its option and expense either repair or replace defective components or parts of the Product which in the sole and reasonable judgement of EP Med is defective by reason of material or workmanship In no event shall EP Med be required to repair or replace any Product or any portion thereof with respect to any defect regardless of the cause of such a defect if the Product was not used in a normal and proper manner in accordance with the use and specification guidelines provided by EP Med The warranty provided herein is limited solely to the original
19. URCHASER S SOLE REMEDY SHALL BE REPAIR OR REPLACEMENT AT EP MEDSYSTEMS OPTION AS PROVIDED ABOVE IN NO EVENT WILL EP MEDSYSTEMS BE LIABLE FOR DAMAGES LOST REVENUE OR ANY OTHER INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING FROM THE PURCHASE USE OR INABILITY TO USE THIS PRODUCT WHETHER BASED ON CONTRACT TORT OR OTHER LEGAL THEORY EP MEDSYSTEMS DISCLAIMS LIABILITY FOR PERSONAL INJURY DEATH OR PROPERTY DAMAGE OCCURRING IN CONNECTION WITH THE USE OF THE PRODUCT BY ANYONE OTHER THAN A BOARD CERTIFIED CARDIOLOGIST OR QUALIFIED ELECTROPHYSIOLOGIST ANY USE OF THE PRODUCT CONSTITUTES AN AGREEMENT BY PURCHASERS AND ALL USERS TO INDEMNIFY AND HOLD HARMLESS EP MEDSYSTEMS INC ITS OFFICERS DIRECTORS EMPLOYEES AND AGENT FROM ANY AND ALL CLAIMS SUITS COSTS JUDGEMENTS AND REASONABLE LEGAL FEES ARISING FROM PERSONAL INJURY DEATH OR PROPERTY DAMAGE OCCURRING IN CONNECTION WITH THE USE OF THE PRODUCT BY ANYONE OTHER THAN QUALIFIED PERSONNEL AS DESCRIBED ABOVE This agreement is subject to and is governed by the laws of the State of New Jersey Any action brought in respect of the Product shall be brought in the State of New Jersey The purchaser and all parties seeking claims in respect of the Product attorn to the jurisdiction of the State of New Jersey 090005 JM03074946 EPMedSystems Inc New Jersey U S A 000006 5 03074947 Table of Contents Warrant y ccsccsccsveccccccvecccrscss
20. age 2 to page 3 000050 JM03074991
21. all on one monitor 000041 5 03074982 Database Selecting the Database button will display the Database p screen Please see more information about the Database screen below Setup Selecting the Setup button will display the Setup screen Please see more information about the Setup screen below Stim Selecting the Stim button will display the stimulator 3 window Please see more information about the Stimulator below as well as from the EP 3 manual Holter Selecting the Holter button will display the Holter window H in a split screen fashion on the left or right side of the review monitor The Holter channel is defined in the Setup screen At any time during or after a study a different Holter channel may be selected NOTE It may take several minutes to load a new Holter channel The channel name will display Loading when a new channel is loading and display the channel name when finished Pressing the left mouse anywhere in the Holter signal area will highlight the ECG with a small white box and display the corresponding ECG in the Review screen The Holter screen window has many of the scrolling review buttons as the review screen Split Selecting the Split button will display a second Review screen to the left of the initial Review screen Both screens will function independently the right screen will display updated ECGs when triggered and the left screen will display user selecte
22. and retrieval of electrophysiological signals The main monitor is dedicated to real time visualization of signals Signals which can be accommodated are typically surface ECG intra cardiac signals stimulation markers and output of blood pressure transducers Automated wave form recognition and interval measurement are available for any of the electrocardiographic signals The page number is also displayed The secondary monitor is used as a menu driven review console for display and retrieval of data from either the current study or a previous study contained in the patient data base The presentation of menus provides for selection and control of system features These features may be either mouse or keyboard activated and include such options as e Catheter or lead identification e Choice of location size and color of the signal display e Selection of signals to be automatically analyzed 000020 5 03074961 e Entry of customized study protocols e Enabling or disabling permanent storage of signals and measurements onto system storage media The review monitor serves as the display medium for previously recorded data In the Review screen any portion of the recorded file can be accessed by event marker time of event or by scrolling through in a continuous or page by page mode Other options available in the Review screen are a Holter screen zoom capabilities post acquisition filtering and automatic analysi
23. ause the keyboard to become inoperable during operation Use a plastic shield if there is chance of this happening in your environment The EP WorkMate Main Menu Shell Introduction The Main menu appears when the computer is turned on To initiate an option select the appropriate label by pressing the left mouse button Begin Review Selecting this option will initiate the EP WorkMate software Study This is the choice you will select the majority of the time Archive Log Selecting this option displays the Archive Log Files Utility Files This utility allows previously recorded patients to be stored to either a 2 6 4 8 Giga byte optical disk MO or a 4 0 Gbyte Digital Audio Tape DAT Before selecting this option place an optical disk or digital tape into the correct drive The EP WorkMate will prompt the user to name the disk if it already has not been previously named and will automatically calculate the free 000025 SJM03074966 disk space available Patients data that will fit onto the disk will have a check mark to the right of their names Striking the Menu Ese key or pressing the right mouse button will begin the downloading process after confirmation The Main Menu will reappear when the process is complete Restore Log Selecting this option wili load a patient from the DAT to the Files EP WorkMate s hard drive cases cannot be reviewed from the DAT NOTE This is only for those systems with DAT st
24. buttons displayed on the review screen with their corresponding action NOTE Hot Key functions can be turned on and off by the same key Exit Selecting this button will return the user to the main menu If any data has been recorded without a patient name entered the EP WorkMate will prompt the user enter a name at this time and may prompt to save changes to the catheter maps If the EP WorkMate is accidentally powered down and patient data has been recorded without a patient name the EP WorkMate will restore the data automatically If this occurs while recording at most the previous 2 3 seconds of data may be lost NOTE When the Exit button is selected the EP 3 stimulator is no longer functional Monitor Selecting the Monitor button will display the real time p signals on the right most review window You can activate this by selecting the Monitor button on the top left of the screen or by pressing the R key This will start a sweep mode real time display of current electrograms These electrograms do not have to be recorded but recording is available Additionally you can use the Split function to monitor in on the right side of the split and review on the left side When using the Split function with the new monitor mode and the new stimulator on the bottom of the review screen you can see your stimulation parameters triggered updates based on the last paced beat and real time electrograms
25. cccccccsccsccesvescesescssrsessesceeee Table of 4 1 0 v FUGUES AE E T EE viii About this Manual Manual Overview Vital Information vee X Definitions Acronyms and Abbreviations xi Introduction 1 Functional Description 2 Operating the EP WorkMate 5 EP WorkMate 24 5 Patient Connections 5 User 6 Cautions and Disclaimers 7 Turning Off the EP WorkMate 8 Th Millennium ANIELE A st 8 User Imterface 2 1 9 EP WorkMate Main Menu 11 The EP WorkMate 000 15 OVS Getting Started POWER User Interface The Basics of Electrophysiology Studies af Operation Overview is si cccccccccccaseuesntersesvnceceseseecateaceeensenee Review 27 Real time Monitor 1 34 Review Scrolling 1 8 Changing the Real time or Stored Electrograms 37 000007 5 03074948 Signal Intensity Marking Eve
26. ce chapter describes the Setup Screen including Setup Screen the purpose and function of each menu and key The Setup screen defines all signals and viewed protocols This 000011 JM03074952 Chapter 6 Database Screen Chapter 7 Advanced Techniques Chapter 8 Query Utility Chapter 9 Installation and Assembly Chapter 10 System Configuration Chapter 11 Reporting Chapter 12 Exporting Data Chapter 13 Troubleshooting Guide Chapter 14 Maintenance Appendix A Specifications includes instructions in changing the real time monitor This reference chapter describes the Database Screen including the purpose and function of each menu and key The database is a key feature of this device controlling signal review query reporting and archiving of stored signals The FAX utility is explained as well This chapter explains advanced concepts including unipolar signal recording filter theory pressure waveforms and measurements stimulator ECG syncronization and others This is meant to be read after previous chapters and the EP 3 user s manual are read This chapter explains the query utility The query is a useful tool to search all patient data A demo tutorial is included for practice This chapter is a description of the components and assembly of the EP WorkMate It is intended for bio medical engineers and EPMedSystems personnel It is also useful for device re assembly after moves This chapter
27. d ECGs fixed in time Cine Selecting the Cine button will display the Cine window on n the review screen Please see more about the Cine window below RF Selecting the RF button will display the RF window on the F review screen The RF screen allows the user to view the RF data in graphical and numeric form Please see more about the RF window below LOG Selecting the LOG button will display a window on the review screen containing color coded events including Stimulation events RF events High and Low Rate events user selected annotation protocol changes and measurements Please see more about the log window below 000042 SJM03074983 Print Selecting this button will display the available print options p Included in these options are printouts of the signals as viewed in the Review screen the RF data three different 12 lead formats PCX files for further manipulation on either a PC or Macintosh continuous printing beginning with the data displayed for those former strip chart users and finally an option to send all printouts to the FAX utility see FAX utility above Print Review Fit prints the current review screen shown the screen Print Review prints the current review screen at the speed it was recorded Because the review monitor is usually wider than the laser printer paper the right most signals may not print Print Continuously prints the current review screen using the split revi
28. d position in the review screen Selecting this option initiates recording and displays a horizontal single line amplitude caliper When this caliper is moved to the desired signal to be triggered from the screen updates at the intersection point between the caliper and the triggered sweep triangle indicator at the bottom of the screen For example placing the caliper on the QRS of a surface lead will place the QRS in the exact same screen position every time the screen is updated When the screen is updating consistently in the correct position if the caliper is set too close to the baseline of the signal the EP WorkMate may become confused and update inconsistently press the right mouse button Note Saving signals is optional during triggered sweep You do not have to record during triggered sweeps Turn the auto record feature off and use the triggered sweep button Trigger to select a sweep mode Recording can be started during any triggered sweep if needed by pressing the Record key the Save button at the bottom of the window the mark key or Ctrl R 000047 JM03074988 Show Selecting this button will display a menu listing several tw options This function works in conjunction with the triggered sweep It is only active when the triggered sweep is turned ON It allows the user to make fast visual comparisons of triggered ECGs Two or more triggered ECGs can be overlaid for a fast visual comparison The overlay feature ta
29. e any changes you made System System Maintenance starts a software self diagnostic test Maintenance that will look for problems and compress all system database files The test will search for errors with database files and report any problems and re organize the files Please call technical support with any problems found Backup System Before selecting this choice place a backup optical disk or digital tape into the drive When this function is selected the contents of your hard drive will be copied to the digital tape or optical disk The backup will take a few minutes 000027 5 03074968 Restore System Before selecting this choice place the most recent backup tape or disk into the drive This will restore the system AS IT WAS THE LAST TIME THE SYSTEM WAS BACKED UP All data stored in the patient database or catheter map database since the last backup will be lost Be sure you want to do this before proceeding This operation will take a few minutes to perform WARNING Restoring should only be done after extreme system failure or under direction from technical support recently stored data will be erased over written Communication This option runs a diagnostic test of the communications Test between the main computer and the signal conditioning unit It is helpful in diagnosing cable connector or board failures This test utility measures the packet transmission rate between the amplifier and the main com
30. e cardiac signals are monitored by viewing a real time monitor and are analyzed by viewing and measuring these signals on the review monitor The cardiac signals are captured and conditioned with signal conditioning unit and then stored by the computer The stimulator sends electrical impulses to indwelling catheters through the signal conditioning unit The computer then sends the signals to the monitors and stores these signals for future retrieval Significant events and user notes are also stored for each electrophysiology procedure Electrophysiology summary reports and electrograms can be printed as desired Real time Review Monitor Catheters 12 Lead ECG Figure 2 Basic EP Lab Connections 000018 SJM03074959 Operating the EP WorkMate Turning on the main power switch located between the monitors will power the entire cart provided the isolation transformer is plugged into an electrical outlet IMPORTANT The EP 3 stimulator is powered by a battery and only charges when it is OFF Care must be taken to ensure the EP 3 is charging after the cart is turned off by verifying the charging light is lit EP WorkMate 24 Most of this manual describes the EP WorkMate configuration with a review monitor a slave monitor and at least a 56 channel signal conditioning unit The EP WorkMate 24 has only one monitor so all mentions of independent review and real time monitors are not applicable Us
31. e the split screen buttons such as Split RF Holter and Monitor to control the real time and review portions of the monitor Patient Connections The patient is connected to the EP WorkMate through a surface ECG cable catheters and pressure transducers These are plugged into the amplifier and the catheter junction box These inputs are electrically isolated from earth ground The stimulator is electrically isolated as well and is plugged into the amplifier Non isolated inputs available through the pressure marker interface Analog signals from other devices may be displayed using the non isolated channels Marker channels or pressure signals from isolated pressure amplifiers can be displayed from these inputs 000019 5 03074950 IMPORTANT Special attention must be given to proper grounding and electrical safety Even small chassis leakage currents passing through the heart can induce fibrillation Never connect non isolated inputs or outputs directly to a patient A functioning defibrillator should always be available WARNING The stimulator back panel connectors the pressure marker interface box NOT isolated Never connect them directly to a patient Always plug external devices into an isolation transformer User Interface EP WorkMate consists of two independent 21 inch high resolution screens as well as a keyboard and a mouse for control of data acquisition storage
32. ens When any of these menu selections are printed onto reports their corresponding entry in Menu Used for Forms will be printed Selecting the INS Insert will prompt the user to type in the new menu item That item is stored by pressing Return Selecting DEL Delete to delete the highlighted choice 000024 SJM03074965 Yes No Inputs A Yes No Input Box is displayed when a selected function may result in unwanted results e g when deleting a patient s data from the memory A question is displayed within the box along with two buttons labeled Yes and No Most questions are worded so that Yes is the desired response Striking the Return key will always answer Yes Text Inputs A Text Input Box allows the user to enter free form text into the selected area Striking the Return key or pressing the right mouse button will enter the input On the EP 3 keyboard there is both a Return key and a Enter key Use the Enter key to insert a carriage return or new paragraph into a comment On a normal PC keyboard the right Ctrl key performs the same function Keyboard The main purpose of the keyboard is to control the EP 3 stimulator However all alphanumeric keys can be used to select buttons or functions and enter data function keys and the keys on the right side of the keyboard control EP 3 functions WARNING gt Care should be taken to avoid spillage of liquid onto the keyboard This could c
33. ents are stored concurrently with the digitized signals The following intervals are presented on the display monitor as they occur atrial to atrial AA ventricular to ventricular VV surface QRS to QRS RR ventricular to atrial atrial to His His to ventricular HV and ventricular to atrial VA Continuous capture of the digitized signals can be invoked for any portion of the study protocol or for the entire study Retrieval of earlier passages of the current study or an earlier study of the same patient can be enabled on a secondary monitor without interruption of the real time display Review by protocol or by time of event can be invoked by use of user interface buttons and hot keys Editing of computer generated trigger markers can be done 000016 SJM03074957 under operator control in the retrieval mode Archival storage of edited patient records is provided on large optical disks or digital audio tape Figure 1 is a picture of the EP WorkMate Cart and its components Figure 1 The EP WorkMate Cart and Components 000017 5 03074958 WARNING cart pictured figure 1 is mounted on wheels and is portable During operation it is important to set the front wheel locks to prevent unexpected movement Failure to do so could result in possible damage to the equipment and or disruption of desired operation Figure 2 is a block diagram of most EP recording systems in use today Th
34. erforming separate tasks controlled by a single mouse or trackball For the remainder of this manual the terms mouse and trackball are interchangeable Mouse Control The EP WorkMate s functions may be activated through the display buttons presented on the screens A menu option is activated by placing the cursor on the option and pressing the LEFT mouse button Also simply typing the single highlighted character in all the displayed options will select the associated menu item Menus Menus appear for many button selections Some menus scroll because they contain more items than can be shown in the allocated space Selecting the up and down arrows on the scroll bar will move the cursor up and down Clicking in the scroll bar will also move the cursor Pressing Return Enter selects an item and Menu Esc the Menu key on the EP 3 keyboard returns to the previous level 000033 SJM03074974 The Basics of Electrophysiology Studies Introduction An electrophysiology EP study defines the type of protocols that will occur during an EP procedure Protocols define the names for the catheters and their pins and the location of catheters in the heart Protocols also define the types of diagnostic test such as stimulus and types of treatment such as drug therapy or RF ablation The purpose of the EP WorkMate is to combine these types of protocols and make the changing of the protocols simple as well as events that will occur during the
35. ew screen Note The split review screen must be used to define the beginning on the left and ending on the right signals when performing the export or print continuous functions The Menu Esc keys can be used to abort either function Protocol Selecting this button displays a list of the current protocols te available for the selected CathMap These options can only be edited when in the Setup screen see below Notes Selecting this button displays a text input box The user can type into this box an annotation specific to the ECGs displayed in the Review screen This annotation will remain fixed with this data and will also be placed into the log Once an annotation is entered it can be picked up by moving the cursor over it and pressing the left mouse button and moved to any point in the Review screen within the Signal Viewing Area Releasing the annotation is accomplished by pressing the right mouse button Events Selecting this button displays a user defined menu of E frequently used annotations Selecting one of the options displays a text input box allowing for further annotation The first twelve events is associated with the function keys When striking the function keys at the same time as the Ctrl key the associated event appears as described above If recording the user will be prompted to answer a Yes No Input box asking whether the event is to be placed with the data in the Review screen or the data in the
36. had a left postero septal accessory pathway can be obtained or a list of all the cases a Josephson catheter was used For more information see the section titled Performing a Query in chapter 8 FAX Utility The FAX utility is where reports can be sent via the EP WorkMate s FAX modem Selecting this function from the main menu allows the user to select the desired pages to be FAXed as well as their destination For more information see the section titled FAX Utility in chapter 6 NOTE EP WorkMate functions will be inaccessible while FAX ing occurs The EP WorkMate Screens Introduction The EP WorkMate main application can be broken down into three screens The Review screen the Database screen and the Setup screen Each screen may then have multiple windows A screen is defined by a control button area at the top and sometimes bottom a data presentation area in the middle and a message display area at the bottom Real time The real time monitor displays signals continuously for the Monitor signals defined in the Setup screen The signals are grouped into 6 pages of up to 32 channels The pages can be controlled using the up and down arrows in the upper right hand corner of the review monitor Note The EP WorkMate 24 does not have a separate real time monitor Use the Monitor split screen button defined in the review screen keys section Review Monitor The review monitor is used to view stored signals along with a
37. he description of the interval just measured and then press the right mouse button The measurement has been entered Releasing any caliper leg can be accomplished by pressing the right mouse button The right leg of the caliper can be set first by pressing the middle mouse Releasing fixed calipers is done by pressing the middle mouse when the cursor is placed over the caliper s measurement Vertical Caliper Selecting this button will display an amplitude caliper that measures voltage in mV or pressure in mmHg It functions exactly as the horizontal caliper above with the caliper rotated 90 degrees This measurement does not store with the signals Single Line Selecting this button will display a single line with a triangle Caliper adjacent to it This special caliper measures time in Ctrl milliseconds from one point to another point on the same channel To make a measurement move the triangle to the starting point of the measurement and press the left mouse button Next move the triangle to the end of the interval being measured and press the left mouse button again Notice that when the left mouse button is selected a tick is left on the signal chosen by the triangle The measurement between the two ticks will be displayed on the left hand side of the right most tick Pressing the left mouse button again on the same signal will display another tick with another value in ms displayed This new value is the measured interval
38. ias under the safest possible conditions for the patient Treatment of an arrhythmia is then initiated with radio frequency ablations drug therapy or placement of cardiac devices that will control the heart s rhythm The system is also intended for recording electrocardiograms from multiple sites during clinical assessment of electrophysiological interventions The EP WorkMate provides on line measurements of intra channel intervals and presents these measurements on the display monitor Retrieval and display are provided without interruption of the multi channel acquisition process An optical disk drive MO or digital audio tape DAT is used for archival storage of digitized data The standard hardware configuration consists of three 21 high resolution display monitors a Pentium processor 2 Gbyte hard disk drive 1 44 Mbyte floppy disk drive 3 5 2 6 5 2 Gbyte Optical MO drive or 4 Gbyte Digital Audio Tape DAT tape drive TI 34020 Advanced Graphics Coprocessor 76 channel analog to digital A D signal conditioning data acquisition module 56 intra cardiac with integrated pressure marker interface catheter interface box EP 3 000015 5 03074956 integrated stimulator and HP LaserJet 6 series printer Available options include 24 intra cardiac channel signal conditioning unit 44 total 120 intra cardiac channel signal conditioning unit 140 total 32 channel strip chart recorder cine capture and additi
39. is a technical description of software and hardware configuration settings It is intended for bio medical engineers and EPMedSystems personnel It is also useful in troubleshooting performance problems This chapter describes the report templates and functional use of the report editor The report editor is useful for customizing reports generated by the EP WorkMate This chapter describes signal and data export capabilities of the EP WorkMate Data can be exported via DOS files with each signal contained in a separate file at the sample frequency This chapter describes troubleshooting techniques Answers to many common questions and problems are included Please review this chapter when in need of technical support This chapter describes required maintenance of the EP WorkMate It describes preventative maintenance procedures for the product This appendix contains technical specifications of the EP WorkMate 000012 SJM03074953 Vital Information Throughout this manual critical information will be set off from the rest of the text in the following ways IMPORTANT Text set off in this manner and with a tag in the margin presents important information Information that is vital to the proficient use of the system is labeled as Important WARNING warning indicates information which is related to patient gt lor operator safety or possible damage to the equipment Throughout the manua
40. kes the first previous or all triggered electrograms from the triggered sweep turns them gray and overlays them with the most recent ECGs Real time Monitor Controls This group of buttons on the top right hand side of most of the EP WorkMate screens controls the characteristics of the signals in the Real time screen Speed Selecting this button will display a menu listing the d available choices for the sweep speed of the real time screen in mm sec Mode Selecting this button will change the way that new data is Ctrl M presented on the Real time monitor Two options are available We call them wiper mode and scroll mode The scroll mode places all new data on the right edge of the monitor moving all previous past data to the left The wiper mode fixes all new data onto the screen with the newest data overwriting previous data by a vertical line that moves from left to right Real time Page Selecting this button will display the next lower page Up 7 number on the Real time screen e g page 3 to page 2 Ctrl num pad 8 Real time Page Selecting this button will display the next higher page Down J number on the Real time screen e g page 2 to page 3 Ctrl num pad 2 Amplitude Up Selecting this button will increase the amplitude of every At signal displayed on the Real time screen 000058 5 03074989 Amplitude Down Al Selecting this button will decrease the a
41. l references to particular keys on the computer display and keyboard will shown in BOLD type Definitions Acronyms and Abbreviations Electrophysiology EP 3 An EP stimulator SCU Signal Conditioning Unit Amplifier PMI Pressure Marker Interface CIB Catheter Interface Box DOS Disk Operating System A D Analog to Digital Converter D A Digital to Analog Converter Selecting Clicking the left mouse button once while the mouse pointer is pointing to a selectable item 000013 5 03074954 This page is left intentionally blank 000014 5 03074955 CHAPTER Introduction EP WorkMate is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology laboratory It provides digital signal acquisition and display of those electrical signals on high resolution monitors An Electrophysiology system is used to monitor and analyze surface ECGs and intra cardiac signals Catheters are guided into the heart and intra cardiac electrical signals are acquired from the electrodes on the indwelling catheters from various heart locations These signals are then used to measure irregular cardiac electrical activity that may occur in the heart A cardiac stimulator is used to send an electrical pulse via a catheter to the heart These electrical pulses are called pacing protocols Pacing protocols are performed in order to reproduce any life threatening arrhythm
42. mplitude of every signal displayed on the Real time screen Review Scrolling Controls Review Scroll Bar Replay Previous Event E lt Event Menu E Next Event E 2 Review Page Left lt lt Review Scroll Left lt Previously recorded data can be viewed using the scrolling controls at the bottom of the Review screen The display in the review scroll bar displays the point in time that the currently displayed data was recorded Selecting any other location in the scroll bar with the left mouse button will display the data for that point in time Selecting this button will replay the currently displayed review image on the real time monitor at the current displayed speed This is useful to view signals exactly as they were recorded real time The signals will continue to display until the Replay button is pressed again or until about 30 seconds elapses Selecting this button will display the data corresponding with the previous event marked in the log Selecting the event menu button will display the entire log in a free text box allowing the user to select edit previously recorded events Use this when the LOG split window cannot be used Selecting this button will display the data corresponding with the next event marked in the log Selecting this button will display in the review screen one page of data previous to the one currently displayed Selecting and holding this button will continuously sc
43. n for the merchandise described in 3 above All credits will be directed adopted from original invoice and reflected as a credit amount In order to obtain credit for returns customers should call 000004 SJM03074945 EP MedSystems Customer Service Department at 1 800 361 6464 to receive authorization to return the product When returning the product the customer must provide 1 return goods authorization number which was obtained from customer service 2 the purchase order and EP MedSystems invoice number 3 the quantity lot number or serial number of each item being returned and 4 written description of the reasons for returning the product All returns must be shipped postage pre paid in EP MedSystems s_ original protective package to MedSystems 100 Stierli Ct Suite 107 Mt Arlington New Jersey 07856 No credit will be given for any merchandise which is returned without strict compliance with the foregoing or for any product which is opened damaged or otherwise used by the customer Except for merchandise shipped in error or recalled by EP MedSystems the customer is responsible for all shipping and insurance charges Disclaimer EP MEDSYSTEMS MAKES NO OTHER WARRANTY EITHER of EXPRESSED OR IMPLIED WITH RESPECT TO THE PRODUCTS MEDYSTEMS SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES Warranties OR MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE IF THIS PRODUCT DOES NOT PERFORM AS WARRANTIED HEREIN P
44. nts Annotation Font 39 The Split Window 2 24 4 2 39 The Holter Window 40 The Stimulator 41 4 Pacing Sites from 2 Pacing Channels 44 RF 44 The Cine Window 2 46 THE LOG Wind Ow os 47 Strip Chart Recorder 48 Setup 51 What is a Cath 51 Setup Screen Controls Define Setup Channels Changing Real time Signal Attributes 57 Signal 58 Invasive Pressure Monitoring 1122 58 Save CathMap Changes 59 Database OL Bipolar vs Unipolar 65 Sample Rate and 65 Integrated Pressure i iiare niey 66 Synchronizing Stimulus to the 2 67 Query Utility 599054549255 69 Advanced Query Performing a Query Tutorial Exporting Patient Demographics 2 221221 72 Installation and Assembly
45. olor than the others Pressing that letter or Alt letter will invoke the button function Menus Menus may appear when a button is selected Menus display lists of options when appropriate The right hand side of all menus contains a scroll bar allowing the user to move through the list of options quickly One of the these options within the main menu is always highlighted The highlighted option can be changed by selecting the Up Arrow and Down Arrow buttons above and below the scroll bar respectively These buttons can also be used to view options not listed currently on the screen Pressing the left mouse button when the cursor is over one of the options will place a check mark to the right of that option Pressing the right mouse button or striking the Return key will enter that option into the appropriate position on the monitor Pressing the right mouse button will always remove any menu from the screen When any menu is displayed simply typing the desired option will highlight that option if it has been previously defined Selecting the EDIT button at the bottom of all menus will display the menu editor The menu editor allows the user to insert new and delete unwanted menu options These options are listed in two columns the left column is labeled Menu Used for Screens and the right column is labeled Menu Used for Forms Menu Used for Screens entries will be displayed on the menus within the EP WorkMate scre
46. on to make same change to all in column Ctrl C Copy the current screen to the memory copy buffer Ctrl E Put a full 12 lead page on the current screen Ctrl I Creates a slide of the current screen in PCX format Ctrl N Add a new channel Ctrl O Creates a slide of the current screen in JPG format Ctrl V Paste the screen from the copy memory buffer onto the current page Ctri X Clear the current channels Ctrl F1 to F4 Activate stimulation markers for next channel of Ctrl F5 to F8 Increase pressure offset for channels 1 4 Database Screen Ctrl C Clear the entire page of catheters Ctrl D Change the date the study is stored under Ctrl I Creates a slide of the current screen in PCX format Ctrl N Change the log directory number use with extreme caution Ctrl O Creates a slide of the current screen in JPG format Ctrl T Change the name of the optical disk or tape the study is stored to 000031 SJM03074972 This page left intentionally blank 000032 5 03074973 CHAPTER 3 Getting Started This chapter will give you a good understanding of the fundamentals in using the device Power On The main power switch for the entire cart is located on the power strip usually located between the two monitors The power switch for the stimulator is located on the front panel of the EP 3 User Interface The user interface consists of two monitors p
47. onal slave monitors Menu driven software is incorporated for data acquisition analysis interval posting instant retrieval with waveform markers and intervals displayed marker editing capability and personal form generation EP WorkMate has an integrated patient data base system for rapid access to all patient records Unique features of the system include On line interval measurement two channel integrated stimulator a choice of scrolling or wiper mode display during real time signal acquisition a comprehensive database with a query function integrated RF graphics and a user configured report editor with fax capabilities Functional Description EP WorkMate is a computer based electrocardiographic recording and monitoring system designed for efficient capture display and retrieval of surface and intra cardiac signals during cardiac electrophysiology studies The system contains a fully automated software waveform detector trigger which performs on line recognition of cardiac activation pre selected leads Temporal interval measurements are computed on a beat by beat basis on multiple channels and dynamically posted on the real time display Intervals are calculated between waveforms from the same source on specific channel intra channel measurements and from multi source signals across two or more channels inter channel measurements All trigger locations with notes or annotations as well as interval measurem
48. ons are switched off Recalling an EP To recall an EP study first go into the Database screen and Study press the Select Patient button Scroll down until the right patient is highlighted and press Return Enter Next press the Select Study button and select the desired study date The last study date is always selected for you by default If there is only one study there will be no drop down screen and the study recorded will be automatically selected as it is the last one recorded If you have multiple patients on the hard drive you can select a patient by entering the first letter of their last name and the list will automatically jump to that letter Recalling an EP The simplest method to find a patient with signals located Study on the on the hard drive or optical drive is to first go into the hard drive or Database screen and press New Patient Then press Select optical disk Study and pick either the hard or optical drive Scroll through the list of available patients until the desired 000036 5 03074977 patient is highlighted and press Return Enter The Stimulator Selecting the Stim button or any Function key or the Window Menu Ese key will invoke the stimulator window Make sure the stimulator module is turned ON The operation of the stimulator is defined in the EP 3 User s Manual supplied with the system Scrolling In the Use the bottom scroll bar and the bottom right buttons to Review Screen scroll through the stored
49. orage capabilities Before selecting this choice place the digital tape into the digital tape drive The EP WorkMate will initially ask if the user desires to restore all of the patient s on the tape If NO is selected then the EP WorkMate will prompt the user to select the patient s desired to be restored Type the patient name or press Return Enter for a list of patients on the EP WorkMate If the patient has more than one procedure select the ones to be restored The system will then restore the files to the EP WorkMate log files If the patient has been deleted from the database use catalog below to find the patient on the tape Restoring the files will take a few minutes The EP WorkMate Main Menu will appear when the files have been restored Catalog Tape Before selecting this choice place the digital tape into the digital tape drive After selecting this option the patients that have been stored on the DAT will be listed on the screen Striking the Return key on a specific patient will restore that patient to the hard drive and database If it asks you to restore additional patients press N Edit Menus Selecting this option will allow the user to print edit or view all of the user definable menus e g catheters events used by the EP WorkMate The Menu Editor screen will display Edit View Menus or to Print Menus Print Menus will print a list of all menus available To edit or view a selected men
50. puter The results will be in packets transmitted and total errors occurring Errors can only occur if packets data are lost during transmission because of a communication error causes by hardware software or cabling problems Technical This function is useful in diagnosing software problems Support experienced by the user as well as for software upgrades It allows for modem connection with engineering technical support at EP MedSystems Inc First select Technical Support from the EP WorkMate Menu The review screen will show the modem initializing and then a message stating Waiting for Connection will appear Next connect up the telephone line to the Line slot of the Modem in the back of the EP WorkMate computer This jack will have a picture of a phone plug in jack or be labeled LINE The EP WorkMate is now ready to receive a call from Technical Support at EP MedSystems Inc Please contact EP MedSystems Inc to request a Technical Support communication call after these steps have been completed The EP WorkMate will return to EP WorkMate Menu Main Menu after EP MedSystems Inc has finished their communication session If it is not at the main menu turn the computer off and back on before using the EP WorkMate 000028 5 03074969 again Query DataBase Selecting this function allows the user to search the entire patient database for specific patient defined data For instance a list of all patients that
51. roll through data previous to the data currently displayed 000049 5 03074990 Review Scroll Right gt Review Page Right gt gt Review End of Signals gt Speed Amplitude Up at Amplitude Down Al Review Page Up Ctrl up arrow Review Page Down Ctrl down arrow Selecting and holding this button will continuously scroll through data following the data currently displayed Note The rate of scroll can be varied using the background Setup entries SCROLL WAIT and SCROLL PIXEL SHIFT To adjust these press the Setup button twice to enter the background Setup screen For slow smooth scrolling set SCROLL WAIT 0 and SCROLL PIXEL SHIFT 4 For faster block moves set SCROLL WAIT 300 and SCROLL PIXEL SHIFT 128 Selecting this button will display in the review screen one page of data following the one currently displayed Selecting this button will display the last page of signals stored Selecting this button will display a menu listing the available choices for the sweep speed of the review screen Selecting this button will increase the amplitude of all of the signals displayed in the review screen Selecting this button will decrease the amplitude of all of the signals displayed in the review screen Selecting this button will display the next lower page number on the Review screen i e page 3 to page 2 Selecting this button will display the next higher page number on the Review screen p
52. s Cautions and Disclaimers EP WorkMate detection algorithms contain a sophisticated software trigger for electrocardiograms However the accuracy of trigger placement and interval measurement cannot be guaranteed particularly in the case of poor signal quality Therefore verification of trigger locations and associated measurements is required on the part of the user before full confidence can be placed in reports produced by EP WorkMate s automated analysis The equipment is intended for use by qualified medical personnel and only after they have been trained in the proper use of this equipment EPMedSystems Inc does NOT assume responsibility for damage to the equipment caused by improper ventilation improper or faulty power or improper monitor booms For continued safety it is necessary that the instructions listed in this manual are followed It is important that instructions in this manual in no way supersede established medical procedures concerning patient care Federal law restricts this device to sale by or on the order of a physician WARNING EXPLOSION HAZARD Do not use this equipment in the presence of flammable anesthestic 000021 JM03074962 WARNING Installing un approved software or operating system on the EP WorkMate hard drive may severely affect system performance and device safety Turning Off the EP WorkMate Exit the software to the main menu using the user interface naviga
53. signals and to change the viewed page If you press the left mouse button on the single lt or gt icons this will scroll through forwards or backwards through the recorded data If you click on the lt lt or gt gt this will move a page at a time forwards or backwards Finally if you click on the lt E icon the system will jump from event to event as recorded in the log LOG Select the LOG button to see a history of all events recorded during the study Using the left mouse button select any item in the log list to view the signals for that event It is also possible to delete edit and filter various lines from the log Filtering involves the ability to show all of the recorded events or just the events or just the protocols to allow the user to search and use the log more efficiently See the LOG Window section for more details Triggered Sweep When performing induction stimulation trains it is useful to see last beat of the drive train updated automatically on the review screen By selecting Stim Train from the auto record menu this can be done automatically The point where the screen refreshes is the blue triangle at the screen bottom Select a new trigger point with the left mouse button or by dragging the triangle to the desired location Now start a stimulation train and watch the review screen update at the end of each train For this function to work one channel in any of the catheter map pages must be a stimulus
54. simply Start Selecting 000046 5 03074987 this option will begin recording until the user turns it off The second option is Screen Selecting this option the EP WorkMate will record enough data to fill the rhythm strip as if a 12 lead were being printed The final option Past will record to memory the previous 30 seconds of data as well as recording indefinitely until turned off by the user All of these functions will update the Review screen when chosen Trigger One of the unique features of this product is its ability to g trigger the update of the review screen via stimulation trains or an attained signal voltage level Selecting the Trigger button displays a menu with two choices Stim Train The first option is Stim Train When this option is selected a blue triangle with a vertical line above it appears at the bottom of the Review screen When stimulation is given the last stimulus delivered will be displayed at the blue triangle This triangle can be moved to any point on the screen by simply pressing left mouse button when the cursor is over it and dragging it to the desired point or pressing the left mouse button at the new desired location at the bottom of the Review screen Selecting Stim using the Auto REC button will perform this function automatically in addition to recording Voltage Level The second option Voltage Level allows the user to view the signals beat to beat in a fixe
55. t on the real time will not wrap around to the review monitor Of course moving it to the right will move from the right edge of the real time to the left edge of the review If the monitors are reversed the opposite will happen The left mouse button always selects the item that the mouse pointer is pointing to It is used to select menu items buttons move annotations store intervals to the database edit signal attributes move review screen traces edit database fields and a variety of similar functions The middle mouse button is used to change the attributes of the item the mouse pointer is pointing to It is used to edit annotations mark log entries move calipers and similar functions When the mouse pointer is not pointing to an editable item it invokes the previously invoked caliper in the review screen Thus pressing the middle mouse button in the review signal area when not pointing to an annotation or caliper interval will pop up a caliper The right mouse button is used to remove any currently viewed menu or text input box Thus the right mouse button returns to the previous level of menus 000023 SJM03074964 Buttons Each major task or control feature is implemented by a button Clicking the left mouse button on one of these control buttons performs its function When the buttons are not accessible they are either removed from the screen or turn a different color One of the letters of most buttons are a different c
56. tion techniques presented in the following sections Always remember to return the main stimulation menu before turning off the EP 3 to save changed protocols WARNING EXIT THE SYSTEM VIA THE MENU DRIVEN SELECTIONS BEFORE TURNING THE POWER OFF Advanced buffering techniques are used for both the database and real time acquisition Simply turning off the system or a power failure while running the system could cause loss of data The Millennium The EP WorkMate and EP 3 stimulator are fully compliant with year 2000 requirements For all database fields in the EP WorkMate the century is stored with all dates February 29 2000 is recognized as a leap year and all date calculations such as patient age utilize the century allowing the age to be more than 100 years 000022 SJM03074963 CHAPTER 2 User Interface The user interface consists of two monitors performing separate tasks controlled by a single mouse trackball Each monitors interface is defined in detail in sections below Mouse Control The mouse trackball controls a mouse pointer that moves around on the screen as the user moves its controlling device It will also move from monitor to monitor The mouse pointer will partially disappear on one monitor as it appears on the other The orientation of the monitors is important If the real time monitor is left of the review moving the mouse to the lef
57. tures so the system will start and stop recording for you Note Stim analysis must be present in one of the Setup screens for the Stim channel to automatically update the review screen Use the Event and Notes buttons to mark events while saving or while reviewing signals Use the M key to mark events quickly even if not saving Use the scroll bar at the bottom of the screen with its left and right page arrows to move around through all stored signals Use the LOG menu to navigate through the stored signals IMPORTANT Before turning off the EP WorkMate first turn off the EP 3 stimulator by returning to the stimulator protocol menu of the stimulator press the Menu Esc key Now turn off the stimulator using the front panel power switch Now select the Exit button and return to the main menu Now it is safe to turn the entire system OFF using the main power switch usually located between the two monitors Failure to turn off the EP 3 stimulator at its main menu can result in loss of all P key stored stimulator protocols _ 000039 SJM03074980 000040 SJM03074981 CHAPTER 4 Review Screen The Review screen is the first screen that is drawn once the Begin Review Study has been selected from the Main Menu The review screen displays all stored signals with intervals and events annotated operates the stimulator and records the study The following are the
58. u first select the menu The selected menu will then display two different categories MENU USED FOR SCREENS are the screen menus used 000026 SJM03074967 with the EP WorkMate MENU USED FOR FORMS displays the way that menu choices will be presented in study reports Thus on the screen the data can be shown in an abbreviated form and on the report the data can be printed in an expanded way in sentence form for example To edit a menu category or insert a new menu entry select Edit View Menus Then select the menu title you want to edit To insert a new menu entry select INS for insert The new entry will be inserted above the screen bar cursor in the menu screen To edit a menu category select the entry with the mouse or screen bar cursor and a free text screen allows you to change or modify the name To enter click the right button or press Return Enter To delete a menu entry highlight the entry with the screen bar cursor and select the DEL for delete button The menu item will be removed from the menu The Default button will set the item currently highlighted by the cursor to be the default menu item which is the highlighted item whenever the menu is selected without previous data The Alphabetize button will alphabetize the screen menu The Print button will print the displayed menus to the printer To escape the menu editor as usual press the right mouse button or Menu Ese and choose to store or not to stor
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