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Dokumen - Tips Eptracer SW Manualv110enpdf
Dokumen - Tips Eptracer SW Manualv110enpdf
Dokumen - Tips Eptracer SW Manualv110enpdf
EP-TRACER
Software Manual
0197
February 2015
© CardioTek
EC-Declaration of Conformity
Medical product Class IIb type CF
Name: EP-TRACER
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.
2
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).
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.
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
13. Do not attempt to service the product beyond that described in the user-
maintenance 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.
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
23. To prevent the RISK of electric shock, only connect the Powerbox to a power
socket with a protective earth connection.
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.
8. The EP-TRACER should be placed free accessible to ensure the possibility to
isolate the EP-TRACER device from the supply mains.
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
3. Make sure that a defibrillator is always a vailable 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
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.
7
ACCOMPANYING LABELS
The EP-TRACER system is shipped with accompanying documents. Please read all
documents before operating the system.
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.
8
Manufacturer information
CardioTek B.V.
Amerikalaan 70
6199 AE Maastricht-Airport
The Netherlands
Warning: electricity!
9
INTENDED USE:
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
10
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
8. Templates 47
8.1 Acquisition of Templates 47
8.2 Presentation of Templates 48
15. Upgrading 60
12
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 EP-
TRACER/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.
13
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.
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.
For electrical installation of the system please refer to the EP-TRACER Hardware
Manual also supplied with the system.
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.
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 installati on. After
that the wizard will automatically load the files ‘EPTRALDR.SYS’ and
‘EPTRAUSB.SYS’.
14
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:
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.
15
EP-TRACER Front
CCB Cable
ECG Cable
L V5 V4
V6 F
V3
R V1 V2
N
Catheter(s)
CCB 4 or CCB 6
16
Model EP-TRACER/70 is similar to EP-TRACER/102 but INT5, INT6 and CONN B inputs
are not present.
EP-TRACER Front
CCB Cables
CCB 4 or CCB6
ECG Cable
V5 V4 CCB 5
L V6 F
V3
R V1 V2
N
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.
CCB4 (Int1/2)
Signals are measured between each +
and – terminal and visualized as a channel
on the display.
Up to 10 channels are available.
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.
1 2
18
19
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.
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.
20
The EP-TRACER program starts in the so-called running mode. The traces are shown
in real-time in a sweeping way.
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
Exit program
21
Submenu - Display
22
Submenu - Stimulator
Submenu – Amplifier
23
Submenu _ Print
Submenu - Storage
Submenu - Templates
Show templates
Load templates
Save templates
Submenu - Pressure
Submenu - Report
24
Submenu – Rf-Ablator
Submenu – Setup
Submenu – Cardiotek
25
A new study starts from menu File - New Patient. The following window appears:
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.
26
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
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.
28
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.
29
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.
30
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.
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
For changing the default settings please ask our application specialist on site or
contact the Cardiotek B.V. support@cardiotek.com.
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.
32
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.
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.
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
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.
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.
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.
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
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.
The EP-TRACER comes with a set of preprogrammed pace protocols to facilitate rapid
operation of the stimulator.
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.
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.
X Toggle the stimulator output The protocol remains unchanged but output
will be toggled between Out1 and Out2.
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.
37
38
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.
39
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.
40
Most of the time only the value for Zero will vary. The value for Calib will remain
around 83.
41
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 R-
waves 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
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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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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.
Esc Leave view mode and return to the MAIN MENU and the running mode.
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.
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Calipers can be moved and positioned separately or combined using the 2-command.
5.3 Printing
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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6.1 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
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
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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 The wide screen is used for the triggered display. No 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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7.1 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.
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
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.
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
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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.
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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Recordings Green
Executed stimulation protocols Red
Executed Ablations Orange
Annotations in a recorded file Yellow
Free text entered using F3 White
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 time-
stamped 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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Table 1: Ablators.
Note: for supported generators and version information please contact CardioTek B.V.
(support@cardiotek.com).
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 EP-
TRACER software interface provides information about the most important ablation
parameters:
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.
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. Duration
2. Last Temperature
3. Mean Power
4. Impedance
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.
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% Ablator Types can be: NONE, IBI1500T, EPSHUTTLE, HAT300, ATAKR, EPT1000
% -------
% COM1..4 TYPE
ABL 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 support@cardiotek.com for assistance.
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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.
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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F8 Save 12 seconds
Ctrl+F8 Save last 12 seconds and store data continuous
F11 Toggle between trace display and sole 12 lead ECG display
Alt+F11 Make a hardcopy of the Holter channel
Shift+F11 Make a hardcopy of the 2-channel Holter
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57
7 8 9 10 11 12 13 14 15 16
1 2 3 4 5 6
17 18 23 19
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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
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time.
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14. Diagnostics
From menu CardioTek - Diagnostics the following window appears:
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:
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15. Upgrading
The following actions are only needed in case of system trouble and or for
upgrading:
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.
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