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0197
EP-TRACER
Software Manual
EC-Declaration of Conformity
Medical product Class IIb type CF
Product:
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:
info@cardiotek.com
Technical information & support:
support@cardiotek.com
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.
EP-TRACER
Software Manual
4.
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 Computers 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.
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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
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.
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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.
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.
7.
8.
9.
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.
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3.
4.
When using a defibrillator be sure not to touch the device or any loose ends of
patient cables.
5.
6.
7.
8.
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.
2.
SYSTEM COMBINATIONS
1.
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
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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.
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.
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.
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Software Manual
Manufacturer information
CardioTek B.V.
Amerikalaan 70
6199 AE Maastricht-Airport
The Netherlands
Warning: electricity!
EP-TRACER
Software Manual
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
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2.4.1 Model EP-TRACER/38
16
2.4.2 Models EP-TRACER/70 and EP-TRACER/102
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2.5 Catheter Connection Block Models CCB4 and CCB5
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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
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20
21
26
27
28
30
31
31
32
32
32
33
34
34
35
35
36
36
37
38
41
42
42
42
43
44
44
44
44
44
45
45
46
46
46
46
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8. Templates
8.1 Acquisition of Templates
8.2 Presentation of Templates
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47
48
49
50
50
50
50
52
53
53
53
54
56
56
57
14. Diagnostics
14.1 Warnings
58
59
15. Upgrading
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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.
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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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EP-TRACER
Panel
Front
CCB Cable
ECG Cable
V6
V5 V4
F
V3
V1 V2
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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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
V6
CCB 5
V5 V4
F
V3
V1 V2
Catheters
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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.
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.
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.
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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.
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
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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
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
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Submenu Rf-Ablator
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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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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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 dont 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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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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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.
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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
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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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
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.
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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). Extras 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
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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
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
Note
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Go
Automatic mode
Wenckebach mode
Space
Stop pacing
I or +
D or -
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
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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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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 doesnt 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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Leave view mode and return to the MAIN MENU and the running mode.
Home,
End
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
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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6.1 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.
6.4 Printing
All printing options are available in the triggered mode also.
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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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7.1 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.
7.3 Printing
All printing options are available in the splitscreen mode also.
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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.
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.
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Font Color
Recordings
Executed stimulation protocols
Executed Ablations
Annotations in a recorded file
Free text entered using F3
Green
Red
Orange
Yellow
White
White
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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.
(support@cardiotek.com).
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.
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
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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 support@cardiotek.com for assistance.
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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.
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F2
Alt+F2
Ctrl+F2
Ctrl+F3
F4
Alt+F4
Shift+F4
F5
F6
Shift+F6
F8
Ctrl+F8
Save 12 seconds
Save last 12 seconds and store data continuous
F9
Ctrl+F9
Alt+F10
Ctrl+F10
Shift+F10
F11
Alt+F11
Shift+F11
Alt+C
Alt+D
Alt+N
Ctrl+N
Alt+Q
Alt+S
Alt+T
Alt+U
Triggered mode
Triggered mode and running mode, side by side.
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Alt+Y
Alt+W
Alt+H
Alt+0
up to
Alt+9
j,J
X
R
W
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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.
11
17
10
18
12
13
14
15
5
16
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
19
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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:
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:
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15. Upgrading
The following actions are only needed in case of system trouble and or for
upgrading:
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 support@cardiotek.com for assistance.
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