EP-TRACER Software Manual 0197
Manual Version 1.10 February 2015 © CardioTek
EP-TRACER
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EC-Declaration of Conformity Medical product Class IIb type CF Product:
Electrophysiological Measurement System
Name:
EP-TRACER
Manufacturer:
CardioTek B.V. Amerikalaan 70 6199 AE Maastricht-Airport The Netherlands Phone: +31 43 3656006 Fax : +31 43 3656007 www.cardiotek.com
Information:
General information:
[email protected] Technical information & support:
[email protected]
0197
PLEASE NOTE: The Year that your EP-Tracer device was manufactured can be derived from the first four (4) digits of the Serial Number present on the backside of the device.
Software version information: This manual is applicable for EP-Tracer System Software version 1.05.
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INSTRUCTIONS PERTAINING TO A RISK OF FIRE, ELECTRIC SHOCK, OR INJURY TO PERSONS.
IMPORTANT SAFETY INSTRUCTIONS (part 1) SAVE THESE INSTRUCTIONS 1. Read all instructions before using the product. 2. EP-TRACER is intended for use in a medical environment only. 3. The unit and the accompanying PC-software are only to be operated by qualified medical staff such as cardiologists, electrophysiologists or lab technician (for assistance only).
4.
The operating staff named in 3. has to be trained in using the EP-TRACER by qualified application specialist from Cardiotek B.V. or by one of our certified service person.
5. The functioning of the EP-TRACER system could possibly interfere with implantable cardiac pacemakers, internal cardiac defibrillators, or any other such equipment. Never use the EP-TRACER system while programming or interrogating such equipment.
6. The EP-TRACER unit shall only be connected to the Personal Computer’s USB
connection. The EP-TRACER and PC must be connected to the mains by the use of a medical safety transformer that meets the EN60601-1requirements. Further, connection to the mains should be via a suitably protected socket outlet, using the mains lead and plug provided by the manufacturer or one of an equivalent quality. For safety reasons, extension leads or multi-socket connections should not be used.
7.
The EP-TRACER is only to be used with certified catheters, electrodes and sensors.
8. The unit can be placed on any flat surface of at least the size of the unit. Care must be taken to ensure a free flow of air around the unit. Do not cover the unit with blankets or similar.
9. The unit should be protected from the risk of fluids entering it. 10. The unit should be serviced by a qualified service technician when:
a. The unit does not appear to operate normally or shows a marked change in performance; or b. The unit has been dropped, or the enclosure damaged; or c. Liquid has been spilled onto the product.
11. The power supply is not protected against ingress of liquids. Therefore it should be placed in a position where there is no chance of any liquid to get in contact with the power supply. Do NOT place the power supply on the floor. 3
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INSTRUCTIONS PERTAINING TO A RISK OF FIRE, ELECTRIC SHOCK, OR INJURY TO PERSONS.
IMPORTANT SAFETY INSTRUCTIONS (part 2) SAVE THESE INSTRUCTIONS 12. To prevent the patient from exposure to an electrical shock, connect the CCB
cables only to the EP-TRACER unit. NEVER connect the CCB cables to any other device, such as a computer, a printer, etc.
13. Do not attempt to service the product beyond that described in the usermaintenance instructions. All other servicing should be referred to qualified service personnel.
14. A distance of at least 2 meter should be observed between the patient and the PC configuration of the EP-TRACER.
15. Any Fault-situation that compromised the safety of the patient should be reported to CardioTek immediately. FAX: 0031-43-3656007.
16. This
equipment complies with International Standard EN 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radiofrequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of interference due to close proximity or strength of a source might disrupt the device’s performance. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according to the EMC information specified in chapter 13 of this document.
17. This device has not been tested for immunity to magnetic disturbances. 18. Portable and mobile RF communications equipment can affect medical equipment. 19. The EP-TRACER unit and the patient connections are the only system parts allowed to be inside the patient environment (PE).
20. Do not touch accessible metal parts of the medical electrical equipment and the patient simultaneously.
21. The EP-TRACER system cannot be used in combination with High Frequency Surgical Equipment.
22. To prevent the patient from exposure to an electrical shock make sure that conductive parts of ELECTRODES and associated connectors for APPLIED PARTS including the NEUTRAL ELECTRODE do not contact other conductive parts and earth. All input channels connected together are considered to be one applied part. 4
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23. To prevent the RISK of electric shock, only connect the Powerbox to a power socket with a protective earth connection.
USING EP-TRACER SAFELY 1.
Before using EP-TRACER, make sure to read and fully understand the previous safety instructions, and the User Manual.
2.
The EP-TRACER unit does not contain user serviceable parts. Do not open nor perform any modifications to the unit.
3.
Avoid damaging the power cord. Do not bend it excessively, step on it, place heavy objects on it, etc. A damaged cord can easily cause an electrical shock or fire hazard.
4.
Always grasp only the plug on the power cord when plugging into, or unplugging from, an outlet.
5.
Never handle the power cord or its plugs with wet hands when plugging into, or unplugging from, a mains outlet.
6.
Be sure the protective earth cable (yellow/green) is always connected to a protective earth terminal.
7.
Prevent cords and cables from becoming entangled.
8.
The EP-TRACER should be placed free accessible to ensure the possibility to isolate the EP-TRACER device from the supply mains.
9.
Basic knowledge of the Windows operating is required.
10. Changes of hard- and software, which are executed without our written permission and without adaptation of the declaration of conformity, are not allowed and will lead to an extinction of any warranty. 11. We see us responsible for safety, reliability and suitability of our products only, if: - installation, instruction, service, new settings or repairs are done by medical technicians and advisers, who are trained by us; - the electrical installation of the concerned room is in accordance with the corresponding requirements (see EP-TRACER Hardware manual); - the device/system is used according to the manual and - only equipment will be used, which is authorized by the Cardiotek B.V.
PROPER USE 1.
Connect the patient cables only to the front-panel of EP-TRACER. Never try to connect a patient cable to another connector such as the PC or any other device.
2.
Prevent connecting cables to the patient-catheters or -electrodes while the cable is not connected to EP-TRACER. 5
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3.
Make sure that a defibrillator is always available at the patient’s side.
4.
When using a defibrillator be sure not to touch the device or any loose ends of patient cables.
5.
Always make sure that a temporary pacemaker is available. EP-TRACER contains a programmable stimulator for performing the electrophysiologic study. This stimulator is not to be used for pacemaker functions.
6.
During stimulation the pulse current is measured to check if the stimulator is functioning properly. When the current measured is more then 5 mA below the set value, a warning is issued “OUT1 NOT CONNECTED?”. In this case the catheter connections should be checked. When the current measured exceeds the set value by more than 5 mA, also a warning is issued “OUT2 TOO HIGH”. This could result in a dangerous situation for the patient and the procedure should be stopped immediately. Please check Chapter “14.1 Warnings” for additional explanation of warnings.
7.
EP-TRACER is not a diagnostic system. The diagnosis is left to the operator (cardiologist). The operator has to verify the readings and information provided by EP-TRACER.
8.
The personal computer, that is part of the EP-TRACER system, is intended to serve as a dedicated workstation for this system. It should not be used for any other purpose.
9.
The EP-TRACER system is not intended for use as a patient monitor. For ECG monitoring purposes, a dedicated patient monitor should be used.
SPECIAL CONSIDERATIONS 1.
When a signal on the PC-screen disappears, or only the baseline is shown, or only a line at maximum/minimal amplitude level, this can indicate that the appropriate channel of the amplifier has become defective. In this case verify the connection to the patient. In any case of doubt qualified service personnel must check the unit.
2.
When the stimulator is stimulating but there is no capturing, check the connections of the stimulator to the patient. Check also for the correct stimulation electrode. In any case of doubt qualified service personnel must check the unit.
SYSTEM COMBINATIONS 1.
The requirements of the European standard EN60601-1 have to be known by the user and the system integrator.
2.
The one who is connecting devices and accessories together, integrates or uses them is fully responsible and liable for this system. He is also responsible and 6
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liable for the compliance with this standard. 3.
All system components have to be in compliance with the applicable requirements and standards and labeled according to these standards.
4.
If there are concerns about the use of a component contact the manufacturer of that component and request a certificate stating compliance.
5.
A system in total has to be as safe inside the patient area as a medical electrical device that is in compliance with EN60601-1 standard.
6.
If devices are connected together they still and in total have to be as safe for the patient as specified in the EN60601-1. Please notice that there is a direct electric connection to the heart through the patient cables of EP-TRACER. Improper usage of these connections can be dangerous for the patients’ life. Please take care that the leakage current of the system connected in whatever system combination is never higher than the maximum allowed value (patient leakage current 0,01 mA).
PREVENTIVE INSPECTION 1.
The EP-TRACER system consisting of the EP-TRACER unit, the PC-configuration and the medical safety transformer must be tested for electrical safety according to EN60601-1. Qualified personnel must carry out this inspection at least once a year.
2.
Accessories such as Catheter Connection Boxes, ECG cables and or other patient cables may degrade or deform when in use for a long period. In this case they should be replaced to prevent artifacts on signals or mal-functioning. Also for replacement use certified accessories only.
3.
For the EP-TRACER models 70 and 102 the fan filter at the rear end of the unit should be inspected regularly and replaced at least every six months.
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ACCOMPANYING LABELS The EP-TRACER system is shipped with accompanying documents. Please read all documents before operating the system.
Refer to the user manual before using the system
Check accompanying documents
The EP-TRACER system patient-connections are designed to be defibrillator proof, as indicated by the following symbol:
Device of CF type, defibrillator proof
To prevent the patient from exposure to an electrical shock, connect the CCB cables only to the EP-TRACER unit. NEVER connect the CCB cables to any other device, such as a computer, a printer, etc. The cables are labeled with following warning.
Warning label on CCB cables
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Manufacturer information CardioTek B.V. Amerikalaan 70 6199 AE Maastricht-Airport The Netherlands
Indicates the serial number of the device
Indicates the model of the device
Maximum Input DC power
Warning: electricity!
The unit contains hazardous voltage, please don’t open enclosure.
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INTENDED USE: The EP-Tracer System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related electrophysiological procedures in hospitals or EP-Labs. The system allows the user to view and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
INDICATION/CONTRAINDICATION: The purpose of the equipment is to help with the diagnosis of people (no specific demographic requirements) suffering from arrhythmias. The EP-Tracer is not a diagnostic system in order to provide diagnostic hints. Signals are only displayed, but not evaluated in order to provide diagnostic assistance. The diagnosis is up to the user (electrophysiologists). The user must verify the data and information provided by the EP-Tracer. The EP-Tracer system is not suitable for the monitoring of a patient. For ECG monitoring, a special patient monitor should be used. The EP-Tracer includes a programmable stimulator for electrophysiological studies. This stimulator must not be used as a pacemaker. The EP-Tracer is not designed to meet life-sustaining functions. Instead, use an external pacemaker.
APPLICATION SPECIFICATION: User: Electrophysiologist Discipline: Electrophysiology Indication: Patient suffering from arrhytmias Patient population: No demographic restrictions Contraindications: None Place of use: Bedside at Hospital, CCU or EP-lab Type of use: Regular and experimental EP-studies User interface: PC with EP-Tracer SW installed
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Table of contents 1. Introduction to the EP-TRACER System
13
2. Getting Started 14 2.1 Recommended minimum PC Configuration 14 2.2 Electric Installation 14 2.3 EP-TRACER Software Installation (WINDOWS 2000 or WINDOWS XP) 14 2.4 Patient Connections to EP-TRACER System 16 2.4.1 Model EP-TRACER/38 16 2.4.2 Models EP-TRACER/70 and EP-TRACER/102 17 2.5 Catheter Connection Block Models CCB4 and CCB5 18 2.5.1 Explaining the Labels 18 2.6 Connecting Pressure Transducers 19 3. The EP-TRACER Software 3.1 Starting up the EP-TRACER System 3.2 The Menu Structure 3.3 Entering Patient Data 3.4 Setting up Channels 3.4.1 Settings 3.4.2 Buttons 3.4.3 Setting up the STIM Channel 3.5 Saving and Loading a Configuration
20 20 21 26 27 28 30 31 31
4. Using the Program 4.1 Selecting a Window 4.2 Storing Traces 4.3 View mode 4.4 The Stimulator (Pacer) 4.4.1 Stimulator (Pacer) Parameters 4.4.2 Stimulation (Pacer) Protocols 4.4.2.1 Preprogrammed Pace Protocols 4.4.2.2 Saving your own Pace Protocols 4.4.3 Stimulator (Pacer) Control Keys 4.4.4 Stimulation (Pacer) Status 4.5 Calibrating Pressure 4.6 QRS Detection
32 32 32 33 34 34 35 35 36 36 37 38 41
5. View Mode (Alt+F1) 5.1 Special Keys in View Mode 5.2 Calipers 5.3 Printing
42 42 42 43
6. Triggered Mode (Alt+T) 6.1 Triggering 6.2 Display 6.3 Calipers Timing 6.4 Printing 6.5 Stimulator Commands 6.6 Optional Wide Screen
44 44 44 44 44 45 45
7. Split screen Mode (Alt+Y) 7.1 Triggering 7.2 Calipers Timing 7.3 Printing
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8. Templates 8.1 Acquisition of Templates 8.2 Presentation of Templates
47 47 48
9. Using the LOG
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10. Interfacing with RF Generators 10.1 Introduction 10.2 Connections 10.3 Functioning 10.4 Setup in Configuration File
50 50 50 50 52
11. Bipolar and Unipolar Recordings 11.1 Recording Unipolar and Bipolar Signals from the Same Electrode 11.2 Use of Another Reference (10- input)
53 53 53
12. List of Commands
54
13. Panel Descriptions 13.1 EP-TRACER Front Panel 13.2 EP-TRACER Rear Panel
56 56 57
14. Diagnostics 14.1 Warnings
58 59
15. Upgrading
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1. Introduction to the EP-TRACER System The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. In the clinic it is being used for a variety of applications. For example small EP studies at the bedside or in the CCU, for demanding RF ablation procedures of accessory pathways, as for mapping during arrhythmia surgery. In the field of basic electrophysiology it is used for experimental studies with animals. An EP-TRACER system consists of an EP-TRACER unit and a Personal Computer. The EP-TRACER unit is connected to the computer by a USB cable. The EP-TRACER unit contains a two-channel stimulator and a multi-channel amplifier. A basic system uses a standard Personal Computer with an LCD or CRT monitor. The monitor is used to display the ECG traces and to inspect, command and control the EP-TRACER unit. A user selectable set of ECG and electrogram traces is displayed on the monitor. The monitor is able to show all channels at real time with a user settable display speed from 10 mm/sec to 300 mm/sec. The display can be frozen for analysis. A data buffer is available to trace 60 seconds back in time. A separate window is available for continuously monitoring the patient during a procedure. A user selectable set of measurement channels can be stored on hard disk, either continuously or for a fixed period of 12 or 60 seconds. After a study it is possible to archive the recorded data on a CD-Recordable or DVD-Recordable. The EP-TRACER basic version, EP-TRACER/38, provides the acquisition of the 12 lead Surface ECG, 20 intracardiac channels and 6 auxiliary channels. The EP-TRACER/70 offers the same as the EP-TRACER/38 with additional 32 intracardiac signals. The EPTRACER/102 offers 84 intracardiac signals. The patient connections of the EP-TRACER unit are optically isolated from the PC side. Stimulator output can be redirected to one of the intracardiac channels allowing the operator to stimulate through any connected catheter without changing connections. The EP-TRACER system provides fast hardcopies of patient data working with standard types of LaserJet printers.
EP-TRACER stationary system 13
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2. Getting Started The EP-TRACER system consists of the EP-TRACER unit, a POWERBOX mains adapter and the necessary cables and accessories (Overview Accessories, parts and additional materials see chapter 9 in the Hardware manual). The EP-TRACER unit is a cardiac amplifier with a built in two-channel stimulator. The EP-TRACER unit is connected to the computer by a USB cable.
2.1 Recommended Minimum PC Configuration a. Pentium IV 2.0 GHz, 512 MB RAM b. Graphics adapter VGA 32 MB RAM resolution 1280x1024 pixels c. 80 GB hard disk d. CD or DVD recorder e. At least 2 USB ports (USB1.1 or USB 2.0 compliant) f. Windows 2000/XP/ Windows 7 (32-bit version only) g. LaserJet printer h. 19” LCD monitor Warning: The EP-TRACER system has to be used as a local working system and not intended to be used in any IT-Network. Network operations of any kind are within the customers responsibility.
2.2 Electrical Installation For electrical installation of the system please refer to the EP-TRACER Hardware Manual also supplied with the system.
2.3 EP-TRACER Software Installation (WINDOWS XP) 1. For best performance set the Windows desktop to a resolution of 1280 x 1024 with 16bit color. Higher resolutions (e.g. 1600x1200 or 1920x1200) are also possible. 2. From the EP-TRACER installation CD copy directory ‘\EP-TRACER’ to ‘C:\EPTRACER’. 3. Create a shortcut on the desktop for file ‘EP-TRACER.exe’. 4. Power up the EP-TRACER unit (refer to HW Manual for details). 5. Connect the USB cable to the EP-TRACER unit and to the computer. 6. The computer will notice that a new USB device is connected. 7. Follow the instructions of Window's Device Driver Wizard. Select the C:\EP-TRACER directory to load the driver. Select the file ‘EPTRAUSB.INF’ for installation. After that the wizard will automatically load the files ‘EPTRALDR.SYS’ and ‘EPTRAUSB.SYS’. 14
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8. In the file ‘C:\EP-TRACER\Heading.txt’, the name of the hospital should be defined. The contents of this file can be changed using the program NOTEPAD. The text in this file will appear on top of each hardcopy.
NOTE: To keep your system working properly, please follow these recommendations: 1. Do not use the EP-TRACER system computer for any other tasks. 2. Do not use floppies and do not use CDROMS from other systems in order to prevent the risk of virus contamination. 3. Use the NT file system (NTFS) and not the FAT32 file system. 4. For shut down of the system please close the EP –TRACER software with the “Exit” (see 3.2 The Menu Structure: Submenu-File) and shut down the computer properly with the windows system shut down.
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2.4 Patient Connections to EP-TRACER System 2.4.1 Model EP-TRACER/38
EP-TRACER Panel
Front
Warning: To prevent the patient from exposure to an electrical shock, do not connect the CCB cables to any other device, such as a computer, a printer, etc.
CCB Cable
ECG Cable
L
V6
V5 V4 F V3
R
V1 V2
N
Catheter(s)
CCB 4 or CCB 6 Note: - This is an illustration. - The positions of ECG electrodes are not correct. - The connection of the catheter to the catheter connection block is just an example.
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2.4.2 Models EP-TRACER/70 and EP-TRACER/102 Model EP-TRACER/70 is similar to EP-TRACER/102 but INT5, INT6 and CONN B inputs are not present.
EP-TRACER Panel
Front
CCB Cables Warning: To prevent the patient from exposure to an electrical shock, do not connect the CCB cables to any other device, such as a computer, a printer, etc.
CCB 4 or CCB6 ECG Cable
L
V6
CCB 5
V5 V4 F V3
R
V1 V2
Note: - This is an illustration. - The positions of ECG electrodes are not correct. - The connection of the catheter to the catheter connection block is just an example.
N
Catheters 17
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2.5 Catheter Connection Block Models CCB4, CCB5 and CCB6 The catheter pins are connected to the EP-TRACER unit using Catheter Connection Blocks. CCBs are only to be connected to the EP-TRACER unit using the CCB connection cable (bearing a red warning label) provided. Following CCB models are available. Model CCB4 (used in combination with EP-TRACER/38, EP-TRACER/70 and EPTRACER/102) Model CCB5 (used only in combination with EP-TRACER/70 and EP-TRACER/102) Model CCB6 (used for connecting circular mapping catheters in combination with EPTRACER38, EP-TRACER70 and EP-TRACER102) 2.5.1 Explaining the Labels 1 INPUTS (Intracardiac inputs to amplifier).
A pair of one red and one black socket forms a signal on the display. The stimulator outputs can be redirected to one of these inputs to stimulate the heart through the connected catheter. The input to be used for stimulation is selected through the EP-TRACER software.
2 OUT (Stimulator outputs).
These outputs are connected directly to the stimulator output and are intended for emergency backup in case of computer failure.
CCB4 (Int1/2) Signals are measured between each + and – terminal and visualized as a channel on the display. Up to 10 channels are available. Stimulation is possible on each red and black terminal pair indicated by a black rounded rectangle.
1
2
CCB5 (Int3-6) Signals are measured between terminals 1 and 2, 2 and 3, 3 and 4 and so on. Up to 16 channels are available. Stimulation is possible on each red and black terminal pair indicated by a black rounded rectangle.
1
2
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CCB6 (for circular mapping catheters) (Int1/2) Signals are measured between each terminal as indicated on the label and visualized as max 10 channels on the display. Stimulation is possible on each channel. This box can ONLY be connected to INT1 or INT2 connections on all EP-Tracer device models
2.6 Connecting Pressure Transducers Up to three pressure transducers can be connected to the unit. Each pressure transducer is connected with its extension cable to one of the AUX inputs located at the bottom right corner of the EP-TRACER front panel. The EP-TRACER system is only to be used with recommended transducers. For information about supported transducer types and or available interconnection cables contact us at
[email protected].
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3. The EP-TRACER Software 3.1 Starting up the EP-TRACER System After installation of the EP-TRACER program the icon of the EP-TRACER program will be shown on the PC desktop. Double click on the icon to start the EP-TRACER program.
EP-TRACER icon on desktop The EP-TRACER program immediately shows a basic set of traces on the display and performs a system-integrity test. The basic set of traces allows a first inspection of the ECG. Later when the procedure starts the specific patient data can be entered.
EP-TRACER main screen example 20
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The EP-TRACER program starts in the so-called running mode. The traces are shown in real-time in a sweeping way. The following is displayed: a. The menu at the top of the screen with the general function keys. b. The trace-window with sweeping traces. c. The numerical data-field with heart rate and RR-interval (HR, RR). The heart rate is a value which is measured beat-to-beat. The detection of HR and RR is dependent on the settings of the QRS detector. For detailed information please see chapter 4.6. “QRS Detection”: d. The Main Status at the bottom: RUNNING/VIEWMODE and the status of the storage: STORE ON/STORE OFF. e. The bottom information line: patient name, filename for recording, Notch filter status and time information. f. A window viewing the holter signal. g. A multi tab window containing the so-called log, ablator data, pressure data or holter data.
3.2 The Menu Structure This chapter contains an overview of the EP-TRACER menu structure. After each item you will find a short explanatory comment. Main menu
Submenu - File Enter specific patient data Load recording for reviewing Load log for reviewing a complete study of a patient Open patient directory with explorer Load next recording Load previous recording Show recording details Recording Edit, Cut/Paste Exit program
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Submenu - Display Temporary hold update of traces display Set traces display in view mode View Intervals on the display Set traces display in triggered mode Set traces display in normal mode Update viewmode display with last 60 seconds Hide holter display and enlarge traces display Show holter display Display option for basket catheter Split the screen vertically to show two trace displays Split the screen horizontally to show two trace displays Change Change Change Change
the the the the
display speed faster (mm/sec) display speed slower (mm/sec) display scale (V/mm) intensity of the traces
Distribute traces equally or unequally on the display Show ECG leads only or all channels Set the stopwatch to zero Move cursors as a pair or separately Set the cursor time indicator Select the source for triggering Allows Review window on last-stim trigger automatically Copy signal layout to memory (dual monitor only) Paste signal layout to monitordisplay (dual monitor only) Select monitor type Select display mode for signal data Change the color of the display background Save screen dump as a bitmap file Save screen dump as a JPEG file
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Submenu - Stimulator Start the stimulator protocol Stop the stimulator Use the automatic stimulator protocol Use automatic In/Decrement in Pace mode Change the Pacemaker Parameters / Protocols X will toggle between the 2 stimulator outputs Ins will add an extra stimulus in the stimulator protocol Del will delete an extra stimulus in the stimulator protocol Single / Cont key will toggle between these 2 modes Sync / Nosync key will toggle between these 2 modes Changes the pacing stimulus interval in ms Toggles between intervals on screen in msec or beats Loads the pacer protocol Saves the pacer protocol Loads acute pacing protocol Toggles between 3 preset pacing protocols Shows the stored protocols meant for Induction Shows the stored protocols meant for Termination Turns Stimulator beeper sound on Toggles pacer output mode between Biphasic / Monopasic Submenu – Amplifier Turn ECG notch filter on/off Turn INT notch filter on/off Generate 1mV calibration pulse on all inputs Force signals to the baseline (after defibrillation) Set reference for unipolar signals to Wilson or I10Select a calculated reference Switch ECG audio ON/OFF (option) Send current channel configurations to the amplifier
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Submenu _ Print Print Print Print Print Print
traces of active display 12 lead ECG standard ECG 3 x 4 a 60 seconds registration of the holter channel a 60 seconds registration of two holter channels
Select the channel to be used for the holter display
Submenu - Storage Store 12 seconds from memory Store 60 seconds from memory Store a snapshot Generate 1mV calibration pulse on all inputs Force signals to the baseline (after defibrillation) Store 12 seconds from display in viewmode Store 60 seconds from display in viewmode Change settings for Auto Storage
Submenu - Templates Show templates Load templates Save templates
Submenu - Pressure Show or hide pressure display Show the pressure calibration dialog Set the value for the pressure low-pass filter
Submenu - Report Insert text in the Log file Show the contains of the Log file in report form 24
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Submenu – Rf-Ablator
Displays the graphs of the parameters on the screen Show the contain of the ablator report Makes in report subtotals for RF energy Will calculate total of RF energy at end of report Print the RF report Turns auto storage on RF delivery On/Off Submenu – Setup Show dialog for setting channel properties Show dialog for setting the QRS detector Select channel for holter display Show dialog for setting the ECG muscle filter Load a configuration from disk Save a configuration to disk Show dialog with all system settings
Submenu – Cardiotek Contact details about the Cardiotek office Starts the EP-TRACER diagnostics function Show the diagnostic log file for the EP-TRACER system Clears the EP-TRACER system diagnostic log file
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3.3 Entering Patient Data A new study starts from menu File - New Patient. The following window appears:
The EP Study Number will be used as name for the directory to store all data of this patient. This field has mandatory to be filled. Use characters that are allowed in directory names (don’t use / , \ , : , ; or . in the study number)
When traces are printed on paper the patient data are printed in the footer of the page.
All patient related information including the recorded traces is archived on the harddisk of the PC in a separate folder. The EP Study number is used as name for this folder. When the study number already exists the user can decide to erase existing recordings or to append new recordings.
If you choose to erase files then all existing information from previous examinations of this patient will be irrevocably lost. Therefore it is strongly advized that you make a backup copy of each study on a CD or DVD.
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3.4 Setting Up Channels From menu Setup – Channels (Alt+D) the following dialog is displayed:
This dialog displays all available channels and their properties. The dialog shows tabs at the top: ECG, INT1 (intracavitary signals 1..10), INT2 (intracavitary signals 11..20) and AUX 1,2,3 (the auxiliary channels e.g. for pressure recording). These tabs correspond to the connectors on the amplifier section of the front panel of the EP-TRACER unit. The more channels your EP-TRACER unit has the more corresponding tabs you will find in this dialog box. Final tab is STIM for setting up the derived STIM channel (see section 3.4.3). All items can be selected by mouse or from keyboard with the arrow keys. Items can be toggled by double clicking with the mouse or from the keyboard with the space 27
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bar. 3.4.1 Settings Chan Channel number – indication only. Label Channel name. Type the name for the channel. The color of a data channel is userselectable and can be changed by + or – keys. Store When set ON the channel is stored when making recordings. When set OFF the channel is not stored nor can it be displayed on the screen. Unused channels should have Store set to OFF to reduce the size of recordings. NOTE: Be aware that unrecorded channels will also not be available for future review. If you want to record data from a channel but you don’t need to see it on screen during the procedure set the position (Pos) of such channel to 0. Clip When set ON the amplitude of a trace will be limited to prevent it from crossing other traces. When set OFF the amplitude of a trace is limited to the display window borders only. Pos Represents the vertical position of a trace in the display window. A value of 1 will show the trace at the top of the display. A value of 999 will display the trace at the bottom of the display. A value of 0 will prevent the trace from being displayed. Note: the trace can also be positioned by dragging its label with the mouse on the traces display. SGain Controls the amplitude of a trace on screen. SGain does not influence the amplitude of the signal stored on the harddisk. SGain can also be used when reviewing recordings and when larger amplitude and more detail are required. SGain can have a value of 0 to 160. A value of 10 is standard. Gain Controls the amplitude of a signal in the amplifier unit. It has a permanent effect on the signal data. The range for Gain is 0 to 255, where 0 to 9 reduces the signal amplitude and 10 to 255 increases the signal amplitude. For the ECG a Gain of 20 results in a calibrated presentation of 10 mm/mV. We recommend NOT changing the Gain of the ECG channels, as it would result in an uncalibrated ECG. For intracavitary signals the Gain is used to get useful signal amplitudes. For atrial and ventricular signals a gain of 30 is usually adequate. For His bundle recording a gain of 100 to 200 is used. Remark: If you want to amplify one of the ECG signals more than the other ECG signals then use of SGain is recommended. All ECG signals will be recorded with the same amplification on the harddisk but the visual amplitude of the selected ECG channel will be augmented.
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Filter (Surface ECG only) Controls the setting for the surface ECG high-pass filters. A Low or High filter can be selected. The Low filter has a high pass frequency of 0.05 Hz and the High filter has a high pass frequency of 0.2 Hz.
Filter (intracavitary signals only) Sets the high-pass filter to one of the following positions: U-low 0.05 Hz, used for unipolar signals U-high 0.2 Hz, used for unipolar signals B-low 40 Hz, used for bipolar signals B-high 80 Hz, used for bipolar signals. When changing the filter from a unipolar filter (U-low or U-high) to a bipolar filter (Blow or B-high) the Input of the signal is changed accordingly. But it is possible to use the unipolar filters with bipolar inputs. Therefore you may override the input mode setting. Input An intracavitary signal input can be either bipolar (BIP) or unipolar (UNI). For a bipolar signal two electrodes have to be connected, for example the distal and 2 of a catheter. The trace on the display shows the difference of these two electrodes. For a unipolar signal only one electrode is needed, for instance the distal. The trace on the display shows this signal referenced to the Wilson triangle. Out1 The stimulator outputs can be directed to one of the intracavitary inputs. Select a channel for stimulation by double clicking with the mouse in the Out1 column. In the example above the HRAd channel is used for stimulation using stimulator Out1. The HRAd channel catheter is used simultaneously for stimulation of the heart and at the same time for recording the signal. Out2 Same functionality as Out1, for stimulator output Out2. In the example shown above Out2 is redirected to the RVd catheter. The box around the X indicates the active parameter. This parameter can be changed using the keyboard.
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3.4.2 Buttons The buttons at the bottom of the dialog affect the appearance of the traces on the display. After pressing one of these buttons the dialog is closed directly. Keep No changes are made to the traces on the screen. Equal Traces are distributed evenly over the vertical space of the display. Unequal Traces for ECG channels have less vertical space than INT channels. Re-order Traces are ordered on the screen in the same order as they are listed in the dialog. Show All All traces with Store set to ON will be displayed on the screen. 12 Lead Only the 12 lead surface ECG traces will be displayed. Undo This will undo the affect of the 12 Lead button, so all previously visable traces will be shown agian.
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3.4.3 Setting Up the STIM Channel
The STIM channel is not a measured channel, but it is a derived channel indicating the stimuli as wel as the intervals between stimuli. The STIM channel will always be positioned at the bottom of the screen. STIM channel can be turned on and off by using Store on/off.
3.5 Saving and Loading a Configuration After changing the configuration of the channels it is possible to save the configuration on the harddisk. From menu Setup – Save Configuration (Shift+F4) the configuration is saved. From menu Setup – Load Configuration (F4) a pre-programmed configuration is loaded. This way it is possible to store and reload configurations you find most suitable for a procedure. 31
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4. Using the Program Basically the EP-TRACER software provides three different modes to present collected signal data. These modes are: 1. Running Mode 2. View Mode (see also chapter 5.View Mode) 3. Triggered Mode (see also chapter 6.Triggered Mode) Based on the type of examination performed durring an EP procedure the presentation mode can be selected. Also combinations of the above mentioned modes are provided. To do that the display is splitted either vertically or horizontally. In the dynamic presentation modes 1 and 3, the displayed data can be frozen. The different presentation modes and its features are explained later in this manual. The EP-TRACER software starts always with the Running Mode. By default the following channels are displayed: ECG: I, II, III, AVF, V1, V6 IECG: HRAd, HRAp, HISd, HISp, RVd, RVp, MAPd, MAPp, STIM. The Notch filter for the ECG and IECG channels are off. The system is not recording automatically when starting the software. For security reasons the stimulator outputs are not connected to any channel. For changing the default settings please ask our application specialist on site or contact the Cardiotek B.V.
[email protected]. The presentation of the traces can be changed: F1
Display - Freeze/Continue Temporary hold the sweep of the traces.
Alt+F1
Display - ViewMode Sets the display in viewmode. The last 60 seconds are displayed.
F4
Setup – Load Configuration A configuration file can be loaded from disk. 1. The channels that appear on the screen 2. The channels that will be stored to disk 3. The settings for each channel
F5
Display Rate The sweep-speed can be selected from 10, 25, 50, 100, 150 to 300 mm/sec. These scales are applicable for a 21" CRT monitor or a 19” LCD monitor. A PC monitor is not calibrated. Therefore scales are approximate values only!
Note: When using the EP-TRACER dual monitor software then the left monitor is used to operate and control the system and the right monitor is used for watching the condition of the patient, with both ECG and intracardiac signals, continuously.
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4.1 Selecting a Window Whenever multiple displaywindows are present (e.g. Alt+U mode, Alt+T mode, Alt+Y mode or with Dual monitor Software) only the active displaywindow can be changed using the commands Alt+D and F5. The window that has the blue speed bar is the "active" window. Another window can be made active using the TAB-key or by clicking with the mouse somewhere in that window.
4.2 Storing Traces During the study data of all traces is temporarily stored in the memory of the PC. This memory contains trace data from the last 60 seconds, and is continuously updated. Traces can be stored on harddisk: a. As fixed period episodes (12 or 60 seconds) or b. Continuous (the future) Fixed period storage stores traces from this memory to harddisk. Storage can take place from a sweeping display (running mode) or from a viewmode display. Storing from a display in running mode directly stores 12 or 60 seconds from the past. Storing from a display in view mode stores 12 or 60 seconds as shown on the display. Continuous storage stores all selected traces on harddisk until the storage is deactivated. Recordings of some seconds up to several hours can be made. The recording time is limited only by the disk capacity. With disk capacities of 120 or 240 Gbyte the user can make something like 400 hours of recording. The following Function-Keys are available: F8
Storage - 12 seconds. Store the most recent 12 seconds.
F9
Storage - 60 seconds. Store the most recent 60 seconds.
Ctrl+F9 Or R
Storage - Continuous. Start or stop continuous storage. The actual state is indicated on the bottom status bar: STORE ON / STORE OFF.
Ctrl+F8
Storage - 12 sec cont. Same functionality as Ctrl+F9 or R, with the difference that recording starts with first 12 seconds of history.
All recordings are stored on harddisk with a specific filename. The system provides a list of suggested filenames. The user can pick one of these names, or can type a new filename. The default filename is the study number. The files are saved with the filename and an index number as extension. The first default filename of study number 2005-1-17 will be 2005-1-17.000, then 2005-1-17.001, and so on. Alternatively one can select one of the other default names like VT, SINUS, REST_ECG, etc. 33
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4.3 View Mode The view mode is entered with the Alt+F1 function key. Pressing the Esc-key resets the display to running mode. When the display goes into view mode the traces of the last 60 seconds are displayed. Also an index window of this episode is shown. A segment is indicated in blue, to show which part is displayed in the trace window. Through traces can be scrolled by using the scrollbar or by dragging the blue segment in the holter display with the mouse. In view mode also a recording can be loaded from disk. Menu File – Load Recording (Alt+F) displays a list of recordings of the current study. In the view mode also a holter window is displayed to monitor the patient. The actual ECG of the patient keeps refreshing the 1-minute acquisition memory. At a sudden onset of arrhythmia one should respond within 1 minute by leaving the view mode (Esc-key) and entering the view mode again to inspect the traces of the last minute.
4.4 The Stimulator (Pacer) The EP-TRACER unit has a two-channel stimulator built-in. The stimulator output connections are located at the front side of the EP-TRACER unit. But the EP-TRACER unit gives you the possibility to direct the stimulator outputs to any of the 20 catheter-input pairs on the unit. Under software control the stimuli are directed to the selected catheter. This enables both pacing and sensing on the same catheter. However, due to pacing the amplifier blanks for a short period. This stimulator is controlled through the software. The data regarding settings and status of the stimulator can be found in the stimulator window located at the upper right corner of the EP-TRACER display. The stimulator control window has two levels that you can toggle between using the F2-key. Level one of the stimulator control window contains information about the pacing protocol and the active stimulator channel. The second level contains the parameters (i.e. current, duration and catheter selected for stimulating) set for both stimulator channels. The upper edge of the stimulator window indicates the Stimulator status. Note: During stimulation the functional output current can exceed the limits for allowed leakage current.
4.4.1 Stimulator (Pacer) Parameters The PARAMETER window provides an overview of destination, duration (0.1 up to 9.9 milliseconds) and current (0.1 up to 25.5 milli-ampere) of the A (Out1) and V (Out2) stimulation pulses. One parameter can be changed at a time. A parameter can be selected for changing by clicking it with the mouse or using the Up and Down commands. The active parameter indicated by a blue field can be changed using the + and - keys. 34
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The coupling interval for AV sequential pacing (A-V ms) can be programmed between 2 and 255 milliseconds. The coupling time can be as short as 2 milliseconds for AV "simultaneously" pacing, but has to be longer then the Atrial pulse length.
In the picture shown above the output selection field of the V (Out2) output is active and can be changed. The A (Out1) pulses are directed to the catheter at input 1. The V (Out2) pulses are redirected to the catheter connected to input 4. 4.4.2 Stimulation (Pacer) Protocols Within the EP-TRACER software a stimulation protocol can contain up to 6 protocol lines. These 6 protocol lines provide a stimulation protocol consisting of a basic rate with up to 5 extras each with a settable interval. Every protocol line defines a number of stimuli (1 up to 9999), the interval time (time between the stimuli, 10 up to 9999 milliseconds) and the output channel of the stimulation (1: A (Out1), 2: V (Out2), 3: A-V sequential and 0: no stimulation). Extra’s can be added and removed using keys Insert and Delete. The active parameter of the stimulation protocol is indicated in blue. It can be changed using the increment and decrement commands; the I or D keys or alternatively the +, - keys. Use left, right, up and down arrow keys to select the active parameter.
The shown pacer protocol consists of 2 protocol lines. It starts with 10 stimuli with an inter-stimulus interval of 600 milliseconds. This is followed with one stimulus at 360 milliseconds. All stimuli are directed to the Atrium (Out1). The protocol is executed only once (SINGLE) and the protocol starts synchronized (SYNC). The stimulator is waiting for the command to start execution (Ready). The active field is the interval of 35
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the last extra. For automatic mode; Step defines the value added to the active interval. If active the step value can be changed using the left and right arrow keys. A negative step will result in decrementing intervals. Last specifies the minimum interval time that the stimulator will set. Delay specifies the time between executions of consecutive pace protocols. 4.4.2.1 Preprogrammed Pace Protocols
The EP-TRACER comes with a set of preprogrammed pace protocols to facilitate rapid operation of the stimulator. BASIC1, BASIC2, BASIC3 The pace protocols BASIC1, BASIC2 and BASIC3 are loaded when the EP-TRACER program starts. The program BASIC1 is immediately shown in the stimulator protocol window and is available to be changed and executed. With the command Ctrl+F2 the actual stimulator protocol is memorized and the next BASIC protocol is shown and made available. This way the user has 3 working protocols available. The idea is to use BASIC1 as the induction protocol, BASIC2 as the termination protocol and BASIC3 as the backup protocol. Following this idea the user starts the induction protocol and when successful will change to the termination protocol with the command Ctrl+F2. After termination of the arrhythmia the user can switch to the backup protocol by Ctrl+F2, or return to the induction protocol by pressing Ctrl+F2 once more. In this way the user can rapidly switch between the (successful) induction and the (successful) termination protocol. ACUTE The ACUTE protocol is also loaded at program start. The protocol ACUTE can replace temporarily the actual protocol (ACTUAL). With the command Ctrl+F1 the actual protocol is memorized and replaced by the ACUTE protocol. The purpose could be to use this as a facility to switch rapidly to an arrhythmia termination protocol. The ACUTE program can be changed and executed. When finished the command Ctrl-F1 memorizes the (changed) ACUTE program and replaces it by the memorized actual protocol. ALT_0, ALT_1.. ALT_9 These 10 programs are also loaded at program start. They can be called with corresponding command Alt+0, Alt+1...Alt+9. These protocols are fixed within the TRACER program. The idea is to use a systematic order in the protocols. By default Alt+1, Alt+2, Alt+3 and Alt+4 are used for induction protocols. The Alt+0 and Alt+9 used for termination protocols.
the EPthe are
4.4.2.2 Saving Your Own Pace Protocols
You can also save your own pace protocol. If all your protocol settings are correct it can be saved using the command Shift+F2. You will be prompted to name the new protocol. Next time you can re-load this protocol using the Alt+F2 command. 4.4.3 Stimulator (Pacer) Control Keys The stimulator is keyboard commands are available: Key
Function
controlled
using
single-key commands.
Following
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G
Go
Starts the stimulator, the selected protocol is send to stimulator first and then executed.
A
Automatic mode
Starts the stimulator in automatic mode. Make sure that the right interval is active for auto in- or decrementing. Also a value for delay must be set.
W
Wenckebach mode
Will during standard pacing in continues mode decrement S1 by set step value for a set# of beats.
Space
Stop pacing
Stops all pacing activity immediately
I or +
Increment active parameter
Changes effective after next Go command
D or -
Decrement active parameter
Changes effective after next Go command
X
Toggle the stimulator output
The protocol remains unchanged but output will be toggled between Out1 and Out2.
Key Insert
Function Insert one extra (S..) in the protocol
Note Up to five extras are available for your pacing protocols. Extras are inserted at the end of the protocol and a last line parameter must be active.
Delete
Remove one extra
The last extra will be removed.
4.4.4 Stimulator (Pacer) Status The STIMULATOR STATUS LINE located at the upper edge of the stimulator window shows the actual status of the stimulator. It shows when pacing is in progress or that the stimulator is waiting. The stimulator can be either waiting for the next execution command, or waiting for the synchronization trigger. During pacing the execution of the stimulation Protocol can be followed. CAUTION: During stimulation the pulse current is measured to check if the stimulator is functioning properly. When the current measured is more then 5 mA below the set value, a warning is issued “OUT1 NOT CONNECTED?”. In this case the catheter connections should be checked. When the current measured exceeds the set value by more than 5 mA, also a warning is issued “OUT1 TOO HIGH”. This could result in a dangerous situation for the patient and the procedure should be stopped immediately. Please check Chapter 21 for additional explanation of warnings.
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4.5 Calibrating Pressure 1. Connect pressure sensor to inlet ‘AUX1’ on the EP-TRACER unit. Fill the sensor and the rest of the pressure monitoring kit with flush solution. Flush the sensor and make sure no air bubbles remain in the kit. 2. From menu Setup – Channels the following dialog appears:
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3. Select the Zero value for the pressure channel to be calibrated:
The pressure is measured relative to the atmospheric pressure. For nulling the sensor open the vent port of the pressure sensor to open air. The sensor is measuring the atmospheric pressure. Press the ‘Auto Zero/Calib’ button on the dialog. Now the atmospheric pressure for P1 is indicated as 0 mmHg.
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4. Select the Calib value for the pressure channel to be calibrated:
Close the vent port of the pressure sensor. Apply 100mmHg to the sensor using a mercury column. Press the ‘Auto Zero/Calib’ button on the dialog. Now the value for P1 should indicate 100mm Hg. 6. Note the values for Zero and Calib. Most of the time only the value for Zero will vary. The value for Calib will remain around 83. 7. Connect a sensor to EP-TRACER input ‘AUX2’. Repeat steps 3, 4 and 5 for pressure channel 2 (P2).
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4.6 QRS Detection QRS detection is used to indicate numerical values for the heart rate and the RR interval time. The heart rate is indicated as beats per minute (bpm). The RR interval time is presented in milliseconds (msec). A good detection of the QRS complex is also mandatory for using the stimulator for synchronized pacing.
The QRS detection is based on the analysis of the waveform of one channel. Any channel can be selected for QRS detection. To provide fast switching from ECG to intracardiac channels, one of three presets can be selected: R-Wave, Intracardiac or Spike. The QRS detection of an R-wave or Intracardiac channel is done using a triangle with a base of Width ms. In this case (Width is 60) the upslope and the downslope are calculated over a time of 30 ms each. The calculated value of the QRS detector should be higher then the value of Level (in this case 20) for at least Minimum Length ms (in this case 10 ms) in order to positively detect a QRS. The Slope can be set either Positive (for detection of an R-wave), Negative (for detection of S-wave), or Positive and Negative (Pos/Neg) for detection on both Rwaves and S-waves. This way it is possible to detect QRS complexes during Sinus rythm and during tachycardias. For detection of wide QRS complexes, you should set the value of Width to a value of 120 ms. Then it is possible to detect wide QRS complexes with low amplitudes. With the help of Refractory Period one can adjust the time after a detected QRS whithin which the software doesn’t try to detect a QRS complex again. This can prevent unwanted detection of or triggering on a following peak similar to the QRS complex, e.g. by tall T-waves. The spike detection will detect rapid changes on an (intracavitary) channel. As the 42
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Width is only a few ms, the minimum length is not applicable. Pos/Neg allows triggering on a positive or negative spike.
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5. View Mode (Alt+F1) Within the EP-TRACER software means are provided to inspect recorded data in more detail during a procedure. The functionality is similar to reviewing recorded data after a procedure. The basic idea is when an interesting phenomenon occurs during a procedure there is the opportunity to check it. Therefore a sixty seconds window is available containing pre- and post occurrence data. Using this mode does not interfere with any ongoing data storage. In the VIEW mode the HOLTER window monitors the patient. The actual ECG of the patient keeps refreshing the 1-minute acquisition memory. At a sudden onset of arrhythmia one should respond within 1 minute by leaving the VIEW mode (Esc-key) and entering the VIEW-mode again (Alt+F1) to inspect the traces of the last minute. The HOLTER and INDEX windows can be suppressed in order to give a wide screen for inspection of the traces. In dual monitor version of the software there is no need for a holter window as the right-side display is used for continuous monitoring of the patient. In the VIEW mode the use of the mouse offers speed and ease of use. Moving the mouse in the trace windows works as a caliper. The left mouse button activates the zeroing of the interval measurement and setting the time reference. Moving the indicated part in the index field offers the possibility to scroll through the memory. Alternatively the slide bar at the bottom of the screen can be used. Recorded files can be inspected in the VIEW mode. With Alt+F a list of available files is presented. The first minute of the selected file is then loaded. Use the scroll bar at the bottom side of the window to select the interesting part in the file. The cursor time in the file is indicated in milliseconds.
5.1 Special Keys in View Mode Esc
Leave view mode and return to the MAIN MENU and the running mode.
Home, End
Go to begin, end of the traces
Alt+F
Load file from disk. A list of all available files is shown. The user can select from that list.
5.2 Calipers In view mode calipers can be used for interval measurements. A yellow caliper line will appear by clicking with the left mouse button on the traces display. When moving the mouse a red caliper will stay were the yellow one was positioned. And a green caliper line will appear which can be dragged with the mouse. This caliper can be released by clicking with the right mouse button. The difference in time between the calipers is indicated on the bottom status line on the screen. 44
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Calipers can be moved and positioned separately or combined using the 2-command.
5.3 Printing All printing options are available in the view mode also. With the LaserJet it is possible to make a high resolution/high speed hardcopy. With Alt+F10 a hardcopy is made with the same layout as the display. A paper-speed of 10, 25, 50, 100, 200 mm/s can be selected. The hardcopy is made starting at the same position of the trace display. The end is depended on the paper-speed. In dual monitor version of the software there is no need for a holter window as the right-side display is used for continuous monitoring of the patient.
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6. Triggered Mode (Alt+T) The triggered mode offers a beat-to-beat updated presentation of recorded data. It is of great value for positioning catheters and activation timing on a beat-to-beat basis. In this mode the waveform is displayed at maximum resolution at 150 mm/sec or at 300 mm/sec.
6.1 Triggering Using the triggered mode is only feasible with good triggering. Trigger is normally derived from the QRS DETECTOR. Alternatively the triggering can be derived from the stimulator. Triggering can be derived from all stimuli, or from the extra stimulus. The default trigger source is the QRS DETECTOR combined with the Stimulator simultaneous. This results in triggering irrespective of pacing. However if there are to many triggers the data displayed will show jumps back and forth. To avoid that select only one source of triggering instead of the combined source. The source of triggering is indicated in the left bottom corner of the screen and can be changed using Ctrl+T. Possible sources - QRS+Pacer - Pacer+QRS - QRS - Pacer - Last Pacer For achieving correct triggering it may be necessary to adjust the QRS detector as described in section 4.6.
6.2 Display Any configuration of channels can be displayed, as arranged in the Alt+D menu. With F5 the display speed is toggled between 150 mm/sec and 300 mm/sec.
6.3 Calipers Timing In the triggered mode a cursor-line can be moved to the position of first activation. With the left mouse button this moment is accepted as reference. A red cursor line indicates the reference position. A second cursor-line (the green cursor line) is used to indicate the time difference in respect to the reference. During dynamic situations it might be helpful to freeze the triggered display to carry out the measurement.
6.4 Printing All printing options are available in the triggered mode also.
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6.5 Stimulator Commands All stimulator commands are available as described in section 4.4.
6.6 Optional Wide Screen Per default the triggered mode starts with a 600-millisecond window for presentation of the triggered waveform. In single monitor version this window is shown in combination with stimulation protocol window and the 1-minute HOLTER window. The HOLTER window offers a comprised mode to monitor the patient. Optionally the user can change to the wide screen mode for the display of a longer episode preceding the triggered waveform as needed to display the atrial and ventricular electrograms of patients with a prolonged AV time. Disadvantage of this option is that the pacer protocol window is hidden. However the pacer status field indicates any pace protocol in action. Alt+W displayed.
The wide screen is used for the triggered display. No Holter-window is
Alt+H
Holter-window is displayed.
In dual monitor version of the software there is no need for a holter window as the right-side display is used for monitoring the patient.
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7. Splitscreen Mode (Alt+Y) The split screen mode is designed for use with pacer protocols working with one or more extras. The top half of the screen shows the running mode in a compressed form with a speed of 25 mm/sec up to 300 mm/sec. The bottom half of the screen offers a triggered display at 300 mm/sec focused around the last extra. The last extra (and with shorter intervals the last two stimuli) is displayed in a strip of approximately 1100 ms of length. The triggered display is refreshed with each last extra. A pair of electronic calipers is availble to indicate the time of atrial or ventricle activation, and the conduction time. In combination with the automatic increment/decrement mode of the stimulator the user can easily observe the execution and resulting effect of pace protocols. The running display monitors the patient, and gives information about the capture of the stimuli, the triggered part presents the conduction time differences in highest possible time resolution.
7.1 Triggering Triggering is per default on the Last Pacer, which is caused by the last extra. Triggering on other events is also possible. With the Ctrl+T key the trigger source can be switched to a different condition/source comparable to the triggered mode.
7.2 Calipers Timing In the triggered window callipers are available. During dynamic situations it might be helpful to freeze the triggered display (using F1) for doing the measurements.
7.3 Printing All printing options are available in the splitscreen mode also.
7.4 Stimulator Commands All stimulator commands are available as described in section 4.4.
7.5 Additional Remark The triggered display can be shifted in time allowing a different ratio of pre- and post occurrence info to be shown. At the bottom of the screen a small green triangle indicates the trigger point. By dragging this trigger point with the mouse the user can divide the window in pre- and post-trigger information to be displayed.
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8. Templates The EP-TRACER has the possibility to acquire and show up to 20 templates. It can show the template in the side-by-side mode: at the left side the template and at the right side the actual recording. The actual recording can be in the normal running mode, or in the triggered mode. Remark: One should not change the number of signals to store when using templates. Changing it, for example by loading a different configuration file (F4) or by inserting/deleting channels through the Alt-D menu, disrupts the way the templates are stored.
8.1 Acquisition of Templates A template is acquired in the VIEWMODE. It can be acquired from the last minute, or from a file. Indicate the beginning of the template with the mouse cursor. Make it zero with right mouse click. To save it as a template open the template menu (F7) and select save template (or use Shift+F7). A list of 20 entries is shown. Select one of them and enter a comment to identify it for later reference.
If the template is made from the Last minute buffer then the buffer will be saved with the name template. (in the above example the Template.001, Template.002, Template.003) If the template is made from a recorded file then the filename will be 49
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stored with the name of the source file. In the above example the template 4 is from the file ARRHYTM.000. Remark: This can offer a nice way to gather 20 different templates for comparison. But take care that these files have the same number and type of channels recorded.
8.2 Presentation of Templates After saving one or more templates you can use the template for review. Open the menu Templates and select Show (F7). This will result in the side-by-side presentation mode. With the menu Templates, Select (Alt+F7) the template can be selected. At the first time presentation it can be necessary to adjust the position of the template. This is done using the scrollbar at the bottom or with the PageUp or PageDn keys. Indicate the beginning of the template by the mouse left button click. Then save the template again. The cursor zero-position will be recorded as start position for the template. The template can be saved with the same comment and with the same template number. Of course it can also be stored as a different template. The template will stay at the left side until the template mode is left using the ESC key. To get the template back on screen press F7 and the last shown template will be exactly as programmed before. Use Alt+F7 to select one of the other templates.
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9. Using the LOG For ease of use the EP-TRACER programs keeps record of each step during a procedure. Each significant action is stored in a so-called LOG file for later reference. An example of a typical LOG file is shown below. For clarity reasons different type of entries are indicated by diferent font colors. Entry Type
Font Color
Recordings Executed stimulation protocols Executed Ablations Annotations in a recorded file Free text entered using F3
Green Red Orange Yellow White
Patient data and system comments
White
Typical log file For reviewing patient data during or after a procedure the log file is of great value. Each entry is time-stamped. Double clicking on the item will result in immediate display of the events of that time. Of course the best results are achieved if major events are recorded during the procedure. Also when reviewing studies afterwards the log comes in very handy and time saving. The log file is stored in the directory named after the study performed. During a review it is possible to make timestamped notes e.g. for marking interesting events in a file. These notes are indicated in the log file in yellow and can be treated as all other entries. The best way to experience the great comfort of the log file is by using it.
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10. Interfacing with RF Generators 10.1 Introduction The EP-TRACER software provides an interface with common used RF generators /ablators. Table 1 provides an overview of available generators. Manufacturer Stockert
Model EP-Shuttle
Firmware version 1.032 1.034
Irvine Biomedical
IBI-1500T
2.3
Medtronic
Atakr Atakr II
n.a. 1.36
Osypka
HAT300Smart
2.12
Boston Scientific
EPT-1000
REVB 8/97
Table 1: Ablators. Note: for supported generators and version information please contact CardioTek B.V. (
[email protected]). Warning: Though the EP-TRACER displays information from the connected Ablator device, the user of the EP-TRACER always needs to confirm/check the display of the actual connected/used Ablator.
10.2 Connections The most common connection of a generator to the PC is by an RS232 serial link. The communication port of the generator is connected to a COM port of the PC. Note: For detailed information about connecting the generator to the PC please check the user-manual and or other documents supplied with the generator.
10.3 Functioning Note: For detailed information about the generator please refer to the user-manual of the generator. During ablation the generator transmits measured data to the EP-TRACER PC. The EPTRACER software interface provides information about the most important ablation parameters: 1. 2. 3. 4.
Duration Temperature Power Impedance
-
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These values are presented as numerical values in the window marked generator. This window is located in the lower right corner of the EP-TRACER control display. The data is presented as shown in the left picture on the next page.
Figure 1: Screen during ablation
Figure 2: Log after ablation
When the generator starts delivering energy (for instance when the foot pedal is pressed) the screen automatically switches to the Ablator Tab, so the information is visible. The background color of the indicators turns green. And a recording is started automatically. At the end of RF application the color turns blue and all values are set to 0. If a recording was automatically started it will be stopped after the preset post ablation time has elapsed. At the end of each ablation the following values are stored as an entry in orange in the log: 1. 2. 3. 4.
Duration Last Temperature Mean Power Impedance
A typical RF log entry is shown in the right-side picture on this page. If during the procedure the generator is switched off, the software will detect this. All indicators will display ‘---’. If the generator is switched on again, the communication with the generator will automatically resume. 53
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10.4 Setup in Configuration File In the configuration file (EP_Tracer.cfg) the type of generator is indicated, as well as the COM port of the PC it is connected to. Following section of the config file indicates the correct setting for the EPSHUTTLE type of generator connected to COM1. % % % ABL
Ablator Types can be: NONE, IBI1500T, EPSHUTTLE, HAT300, ATAKR, EPT1000 ------COM1..4 TYPE COM1 EPSHUTTLE
Take great care whenever you are editing a configuration file. Errors in the structure of this cfg file may result in a faulty and or instable system. In case of any doubt contact us at
[email protected] for assistance.
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11. Bipolar and Unipolar Recordings Normally the catheter signals are shown in bipolar mode. The signals are filtered to show only the higher frequency components with a large amplification. EP-TRACER has 2 filter settings for the bipolar signals. They are called B-low (40 Hz) and B-high (80 Hz). Both are high-pass type filters. The B-high filter is most commonly used, as with this filter the signals will show a straight baseline with rapid deflections. Some EP specialists like to work with the B-low filter because it allows a little more low frequency components to pass. And because of the filter characteristic the signals will be shown with larger amplitude. An amplifier channel can be set to the unipolar mode by selecting the filter setting of U-low (High-pass filter at 0.05 Hz) or U-high (High-pass filter at 0.2 Hz). Selecting one of these filter settings will disconnect the - input of the catheter and connect the - input of that channel to the WILSON TERMINAL. This is the same reference as used for the pre-cordial ECG leads (V1..V6). This way the catheter + input signal will be amplified in reference to the WILSON REFERENCE signal. All filters are high-pass type therefore DC components are filtered. Due to the time constants U-low and U-high will react slowly. For normal EP procedures U-high will be the best option.
11.1 Recording Unipolar and Bipolar Signals from the Same Electrode Usually it is of interest to have both the bipolar and the unipolar signal of the same catheter. The most practical way is to connect the catheter signals 1 and 2 (or distal and 2) to a bipolar channel e.g. channel 8. The distal should be connected to the 8+ input and the 2 to the 8- input. The amplifier for channel 8 should be set to B-low (40 Hz) or B-high (80Hz). With a gain of approx. 100 this should result in a good bipolar signal. The distal from the catheter should also be connected to a second amplifier channel to get a unipolar signal from the distal. For example connect it to amplifier channel 7 by making an electrical connection from 8+ to 7+. Use one of the UNI/BIPOLAR adapter cables supplied with the system to do so. Channel 7 should be set to unipolar mode by selecting a unipolar filter setting U-low (0.05Hz) or U-high (0.2 Hz). The gain of channel 7 should be 5 or 10 to get a good unipolar signal.
11.2 Use of Another Reference (10- input) In case of excessive power-line interference (the ECG shows 50/60 Hz interference) the unipolar signal can become unusable. This usually varies from patient to patient. In this situation the WILSON TERMINAL is not a good reference for the catheter signals. Better results are possible by having a reference catheter in the heart as it has been done in the past. EP-TRACER provides the possibility to use either the WILSON TERMINAL as reference or, alternatively, to use the catheter that is connected to the 10– input as a reference. The reference is switched using Alt+I. After changing the reference you will be get feedback from the system showing the current setting. If a floating catheter present in the heart or in the Vena Cava is connected to the 10- input and used as reference then the quality of the unipolar signals will be spectacularly good.
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12. List of Commands Function-keys F1 Alt+F1 Ctrl+F1
Toggle between freezing and updating the signal traces Enter VIEW Mode (return with Esc-key) Load the ACUTE pace-protocol (and back again)
F2 Alt+F2 Ctrl+F2
Toggle between Protocol and Parameter windows of the Stimulator Load a pace protocol from disk Switch from pace-Protocol BASIC1 to BASIC2 and BASIC3
Ctrl+F3
Set stopwatch to zero
F4 Alt+F4 Shift+F4
Load configuration file Equal/Unequal distribution of display area per channel on the Display Save the current configuration in a file. The new file gets extension .CF_
F5
Change display speed of traces
F6 Shift+F6
Amplitude of all channels is changed to 5, 10 or 20mm/mV Intensity of the traces changes to 1, 2 or 3 pixels wide
F8 Ctrl+F8
Save 12 seconds Save last 12 seconds and store data continuous
F9 Ctrl+F9
Save 60 seconds of tracings Switch continuous storage on or off
Alt+F10 Ctrl+F10 Shift+F10
Make hardcopy of traces as displayed Make hardcopy of ECG in 3x4 format Make hardcopy of 12 lead ECG @25 mm/sec
F11 Alt+F11 Shift+F11
Toggle between trace display and sole 12 lead ECG display Make a hardcopy of the Holter channel Make a hardcopy of the 2-channel Holter
Special key combinations Ctrl+B
Toggles the stimulator pulse shape monophasic<>biphasic
Alt+C Alt+D
Calibration pulse, 1 mV in surface ECG and intracardiac channels Setup channels menu
Alt+N Ctrl+N
Powerline interference filter (notch filter) ECG on/off Powerline interference filter (notch filter) Intracardiac on/off
Alt+Q Alt+S
QRS detector menu Stimulator sound on/off
Alt+T Alt+U
Triggered mode Triggered mode and running mode, side by side. 56
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Alt+Y Alt+W Alt+H
Split Screen mode Wide trace display Activate Holter window
Alt+0 up to Alt+9
Load Pace Protocol ALT_0
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Load Pace Protocol Alt_9
Other key commands: Esc Tab Go Spacebar Inc(+) Dec(-) Automatic
Leave (sub-) menu Change active window Starts the execution of the pace Protocol Stops the execution of the actual pace Protocol immediately Increments the value in the active window (stimulator) Decrements the value in the active window (stimulator) Starts the stimulator in auto increment or auto decrement mode.
j,J X R W
Increments/Decrements all intervals of one pace protocol Exchange stimulator output Atrium (out1) <> Ventricle (out2) Starts or stops a recording. Starts pacing in Wenckebach mode.
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13. Panel Descriptions 13.1 EP-TRACER Front Panel Stimulator: 7. Output channel 1. 8. Channel1 activity indicator. 9. Output channel 2. 10. Channel2 activity indicator. 11. Backup pacing switch. 12. Backup pacing indicator. 13. Beep volume. 14. Sense indicator. 15. Sense volume (option).
Amplifier: 0. Surface ECG input. 1. Intracardiac inputs 1..10. 2. Intracardiac inputs 11..20 3. Auxiliary inputs 1, 2. 4. Auxiliary inputs 3, 4. 5. Auxiliary inputs 5, 6. Power: 16. Power indicator.
7
1
8
9
2
11
3
Models 102 and 70 17. Intracardiac inputs 21..36. 20. only). 18. Intracardiac inputs 37..52. 102 only). 19. Combination of 17 and 18. 22. only). 20 23.
17
10
18
12
13
4
14
15 5
5
16
6
only: Intracardiac inputs 53..68 (Model 102 21. Intracardiac inputs 69..84 (Model Combination of 20 and 21 (Model 102
21 Reference Input. Additional
23
22
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13.2 EP-TRACER Rear Panel 1. Power Supply fuses. Replace fuses only by value and type indicated on the rear panel of EP-TRACER unit. 2. PC-DI Connects to the POWERBOX transformer to supply the unit with energy. 3. PC-COM Communication port. (Not used for USB systems). 4. PC-AUX Auxiliary. (Not used for USB systems). 5. BUS Connects EP-TRACER unit to USB port of the computer with CardioTek B.V. type of USB cable. 6. MISCELLANEOUS Used for connecting an external speaker (optional). 7. USB Connects EP-TRACER unit to the computer with standard USB cable. 1
2
3
4
5
6
7
In normal setup of the EP-TRACER system the power for the EP-TRACER unit is coming from the powerbox attached to connector 2. And the unit is connected to the PC using the USB interface and then either connection 5 or connection 7 is used depending on the type of USB cable used. Do not to use both connections at the same 59
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time.
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14. Diagnostics From menu CardioTek - Diagnostics the following window appears: Important system information is displayed. Supply voltages and some other settings of the electronics inside the EP-Polygraph unit. Also some computer system information is provided. CardioTek B.V can use this information for support. In case a value is out of range it will be highlighted in red and an additional error/warning will be presented. NOTE: This diagnostics window will also appear whenever a problem is found during the system integrity test of the EP-TRACER system at startup. In this case an additional allert box indicating the problem found shall always accompany this window.
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14.1 Warnings At startup the software checks the EP-Polygraph systems integrity. When a problem is detected the following dialog appears:
A red colored square will indicate the problem.
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15. Upgrading The following actions are only needed in case of system trouble and or for upgrading:
Checking the installation of the EP-TRACER USB driver 1. 2. 3. 4. 5. 6.
From the windows Start menu select Settings, Control Panel. Open "System". Select Tab "Hardware". Press button "Device Manager". Open "Universal Serial Bus controllers". Check if "CardioTek EP-TRACER USB Interface" is listed.
Upgrading EP-TRACER USB driver Copy the new eptrausb.sys and eptraldr.sys files to the directory WINNT->System32>Drivers. Reboot the system.
Upgrading EP-TRACER.exe Make a safety copy of the current EP-TRACER directory on the HDD of your system. Copy the new version of the EP-TRACER.exe and all other files supplied with the upgrade to the original EP-TRACER directory. Start the EP-TRACER.exe program and verify correct operation. In case of any doubt contact us at
[email protected] for assistance.
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