Boston Scientific EPT-1000 XP User manual

EPT-1000 XP TM
Cardiac Ablation System
Aflutter IDE 110V
Operator’s Manual
CAUTION- Investigational Device. Limited by Federal (or United States) law to investigational use.
EP Technologies, Inc.
2710 Orchard Parkway
San Jose, CA 95134
Phone: [phone] P/N 13754-901 EAW Ver AA 6/01

i
Preface
Manual Conventions
The following naming conventions are used in the EPT-1000 XPTM Cardiac Ablation
System Operator’s Manual:
•The EPT-1000 XPTM Cardiac Ablation System is referred to as the “System.” For a
complete description of the System’s components, refer to Section 1, System
Description.
•The EPT-1000 XPTM Cardiac Ablation Controller is referred to as the “Controller.”
•The High Power Automatic Personality Module is referred to as the “XP APM.”
The Catheters are referred to as follows:
•Steerable Ablation Catheter with temperature measuring capability: “Catheter(T°).”
•Steerable Ablation Catheter without temperature measuring capability:
“Catheter(Non-T).”
•Catheter information pertaining to both Catheter styles: “Catheter.”
General Information
The use of all components and accessories of the EPT-1000 XPTM Cardiac Ablation
System is fully described in this Manual, except for the Steerable Ablation Catheters.
This Manual provides a description of the Controller, its controls and displays, and a
sequence for its operation. In addition, it provides information relevant to the operation of
the XP APM with the EPT-1000 XPTM only, as well as other information of importance
to the user.
!Precaution Do not attempt to operate the System before thoroughly reading this
Operator’s Manual. It is important that the equipment’s operating instructions be read,
understood and followed. For future reference, retain this Manual in a convenient,
readily accessible place.

ii
Contents
Preface
Manual Conventions................................................................................................i
General Information.........................................................................................i
1. System Description .................................................................................1-1
System Features.......................................................................................................1-2
Safety Features.................................................................................................1-2
Control Modes..................................................................................................1-3
2. Indications/Contraindications...............................................................2-1
Indications for Use ..................................................................................................2-1
Contraindications....................................................................................................2-1
3. Warnings, Precautions, and Adverse Reactions...................................3-1
Warnings..................................................................................................................3-1
Precautions..............................................................................................................3-2
Adverse Reactions....................................................................................................3-4
4. Unpacking the Controller.......................................................................4-1
Unpacking................................................................................................................4-1
Repackaging the Controller.....................................................................................4-1
5. Controls and Displays ............................................................................5-1
Front Panel..............................................................................................................5-1
CONTROL Panel..............................................................................................5-2
POWER Panel ..................................................................................................5-4
TEMPERATURE Panel....................................................................................5-5
IMPEDANCE Panel.........................................................................................5-7
TIME Panel ......................................................................................................5-9
COUNTER Panel..............................................................................................5-10
RF POWER CONTROL Panel .........................................................................5-10
CALIBRATION Panel.......................................................................................5-11
Isolated Patient Connector...............................................................................5-12
MAINS (Power “ON”) Display........................................................................5-12

iii
Rear Panel ...............................................................................................................5-13
Accessories ..............................................................................................................5-16
Footswitch ........................................................................................................5-16
High Power Automatic Personality Module (XP APM)...................................5-16
6. Operational Sequence ............................................................................6-1
Initial Installation....................................................................................................6-1
Turning the Controller “ON”..................................................................................6-5
READY Mode...........................................................................................................6-6
Calibrating the Controller Analog Outputs for the Recorder.................................6-8
Selecting the Control Mode.....................................................................................6-8
Selecting the Power Output .....................................................................................6-9
Selecting the Desired Catheter Tip Temperature....................................................6-10
Selecting Temperature When Using the Catheter(T°) in TEMPERATURE
Control Mode........................................................................................6-10
Selecting Temperature When Using the Catheter(T°) in POWER Control
Mode.....................................................................................................6-11
Setting the Time Control..........................................................................................6-11
Clearing the Counter...............................................................................................6-12
Adjusting the Audio Control....................................................................................6-13
Turning the RF Power Delivery “ON” ...................................................................6-14
Directions for Use....................................................................................................6-18
Turning the RF Power Delivery “OFF” .................................................................6-19
Possible Causes of RF Power Delivery Interruption .......................................6-19
7. Service and Maintenance.......................................................................7-1
Cleaning/Disinfecting..............................................................................................7-1
Replacing the Fuses.................................................................................................7-1
8. Product Specifications............................................................................8-1
General Specifications.............................................................................................8-1
Environmental Specifications..................................................................................8-5
Power Delivery........................................................................................................8-6
Error Codes.............................................................................................................8-7
9. Limited Warranty and Disclaimer.........................................................9-1
Limited Warranties..................................................................................................9-1
Disclaimer and Exclusion of Other Warranties ......................................................9-1
Limitation of Liability for Damages........................................................................9-1
10. Index......................................................................................................10-4

iv
List of Figures
Figure 1-1: System Installation Diagram.........................................................................1-4
Figure 1-2: Cable Configuration for Quick Connect XP APM .......................................1-5
Figure 5-1: Controller Front Panel...................................................................................5-1
Figure 5-2: CONTROL Panel Indicator LEDs and Button.............................................. 5-2
Figure 5-3: POWER Display and Buttons.......................................................................5-4
Figure 5-4: TEMPERATURE Display and Buttons........................................................5-5
Figure 5-5: IMPEDANCE Display..................................................................................5-8
Figure 5-6: TIME Display and Buttons............................................................................5-9
Figure 5-7: COUNTER Display and Clear Button........................................................5-10
Figure 5-8: RF POWER CONTROL Panel and Button/Light.......................................5-11
Figure 5-9: CALIBRATION Display and Button/LED.................................................5-12
Figure 5-10: Controller Rear Panel................................................................................5-13
Figure 5-11: High Power Automatic Personality Module with Quick Connect............5-17
Figure 6-1: Connecting the XP APM to the Controller Front Panel................................6-1
Figure 6-2: Connecting the XP APM to the Recording Equipment ................................6-2
Figure 6-3: Connecting the Catheter to the XP APM Front Panel...................................6-3
Figure 6-4: Connecting the Disposable Indifferent Patch Electrodes..............................6-4
Figure 6-5: Connecting the Footswitch to the Controller Rear Panel..............................6-5
Figure 6-6: Turning the Controller to the ON Position....................................................6-6
Figure 6-7: Ready Mode, Initialization - Catheter(T°) Connected .................................. 6-7
Figure 6-8: Ready Mode, Initialization - Catheter(Non-T) Connected............................6-7
Figure 6-9: Calibrating the Controller Analog Outputs................................................... 6-8
Figure 6-10: Adjusting Audio Control...........................................................................6-13
Figure 8-1: Output Power vs. Tissue Impedance.............................................................8-6
Figure 8-2: Labeling Symbols..........................................................................................8-8

v
List of Tables
Table 1-1: Power Delivery Protocol ................................................................................1-3
Table 5-1: Maximum Amount of Power Output for Catheters........................................ 5-3
Table 5-2: Summary of TEMPERATURE Display Readings.........................................5-6
Table 5-3: Individual Analog Outputs...........................................................................5-12
Table 6-1: TEMPERATURE Display Readings............................................................6-15
Table 6-2: Impedance Display Readings .......................................................................6-16
Table 8-1: System Specifications..................................................................................... 8-1
Table 8-2: Environmental Specifications.........................................................................8-5
Table 8-3: Error Codes.....................................................................................................8-7

System Description
1-1
1. System Description
The EPT-1000 XPTM Cardiac Ablation System (see Figure 1-1) consists of two principal
subsystems:
•EPT Model #800XP Cardiac Ablation Controller (RF Generator)
•Catheter(T°) or Catheter(Non-T) with Quick Connect Instrument Cables for
connection to the EPT Model #822T High Power Automatic Personality Module
"Note Refer to Figure 1-2 for cable configuration.
Two accessories are provided with the Controller:
•EPT Model 822T High Power Automatic Personality Module (XP APM)
•EPT Model 840 Footswitch
For system operation and power level access greater than 50 W/1 A, it is mandatory to
use the XP APM. If accessing up to 100 W/2 A power levels, both an XP APM and a
special high power catheter must be used. The Footswitch usage is optional as the
Controller can be operated directly from its front panel controls. The EPT-1000 XPTM
Cardiac Ablation System is operated in conjunction with commercially available external
Disposable Indifferent (Dispersive) Patch (DIP) Electrodes, which are in compliance with
ANSI/AAMI Standard HF-18.
"Note When using special high power catheters with the EPT-1000 XPTM Controller, two
DIP Electrodes are required.
The Catheter delivers RF power in a monopolar mode between its distal electrode and the
large DIP Electrode(s). Detailed information regarding the Catheter is contained in the
accompanying manual titled, Blazer II XP (High Power) Cardiac Ablation Catheter
Instructions for Use.

Operator’s Manual
1-2
System Features
The EPT-1000 XPTM Cardiac Ablation System features the following:
•The Controller produces a continuous unmodulated radio frequency (RF) output at
500 kHz.
•The front panel displays the actual power output, tissue impedance, and if a
Catheter(T°) is connected to the Controller, catheter tip temperature.
•The Controller measures RMS voltage, RMS current, and actual power output by
taking the average value of the product of voltage and current. (This reflects the
effective heating power delivered to the tissue from the Catheter electrode tip.
Impedance is calculated as RMS voltage divided by RMS current.)
•The amount and duration of RF power delivery is user-selectable, and if a
Catheter(T°) is connected, the desired catheter tip temperature or maximum catheter
tip temperature is also user-selectable.
•The number of RF power deliveries is automatically counted for the physician.
•The XP APM provides RF filtering to allow continuous electrogram recording during
RF power delivery via the catheter tip electrode.
•The XP APM allows for safe use of either standard or special high power EPT
ablation catheters.
Safety Features
The System’s built-in safety features include automatic shutoff for the following
conditions:
•If accessing up to 50 W of RF power and measured tissue impedance is less than 50
Ω.
•If accessing up to 100 W of RF power and measured tissue impedance is less than 25
Ω.
•If measured tissue impedance exceeds 300 Ω.
•If maximum voltage or current limits are exceeded.
•The Controller shuts off if the measured temperature exceeds 85°C for greater than 1
second, or if measured temperature exceeds the upper temperature limit selected in
the Power Control mode. This temperature is not the maximum tissue temperature.
The recorded temperature may be up to 15°C different from the maximum tissue
temperature. Do not set the temperature greater than 80°C.

System Description
1-3
•The Controller shuts off if the measured temperature exceeds the user-selected
temperature setpoint by 5°C for greater than 4 seconds. This temperature is not the
maximum tissue temperature. Do not set the temperature greater than 80°C.
•If greater than 1 A of current is delivered to either of the two DIP Electrodes
connected to the XP APM, the Controller shuts off.
Control Modes
The Controller is capable of operating in two “control modes” (Power Control or
Temperature Control).
Power Control
The Power Control mode is compatible with either Catheter type and allows selection of
the quantity of RF power that is delivered by the Catheter. If using a Catheter(T°), the
Controller delivers the set power unless the upper temperature limit is exceeded, which
results in a reduction in the amount of power delivered.
Temperature Control
The Temperature Control mode is only compatible with Catheter(T°) and allows selection
of a desired catheter tip temperature.
The maximum amount of power to be delivered by the Catheter must be selected for both
control modes (Power Control or Temperature Control). If insufficient power is selected
for the Temperature Control mode, the desired catheter tip temperature (temperature
setpoint) may not be achieved. This may indicate that the Catheter should be repositioned
to achieve better tip contact or a higher power setpoint should be selected.
"Note When using the EPT-1000 XPTM Cardiac Ablation Controller in the Temperature
Control mode, ALWAYS ensure that the TEMP LED on the Control Panel is
illuminated.
The following table defines the power delivery protocol for both the Power Control and
Temperature Control modes for the Controller with XP APM connected.
Table 1-1: Power Delivery Protocol
Catheter Type Maximum
Power Setting
(W)
Maximum
Current
(A)
Catheter(Non-T) 50 1
Catheter(T°) 50 1
Special High Power Catheter(T°) 100 2

Operator’s Manual
1-4
Figure 1-1: System Installation Diagram

System Description
1-5
Figure 1-2: Cable Configuration for Quick Connect XP APM
9-PIN QC OUT
Model 651
Quick Connect 9-Pole 3 ft.
Thermistor Instrument Cable
Model 652
Quick Connect 6-Pole to 9-Pole 3ft.
Adapter Cable
Model 703
Quick Connect 9-Pole
Quadripolar
Adapter Cable
Model 654
APM Extension Cable
(10ft.)
(Optional)
Model 653
Quick Connect 6-Pole 3ft.
APM to EGM
Instrument Cable
THERMISTOR
CATHETER
WITH
QUICK
CONNECT
NONTHERMISTOR
CATHETER
WITH
QUICK
CONNECT
6-PIN QC OUT PINS OUT
THERMISTOR/
NONTHERMISTOR
CATHETER
PIN
CONNECTS
Model 822T
Quick Connect XP APM
(Switch Box) EPT-1000 XP
CARDIAC
ABLATION
CONTROLLER
EGM
EQUIPMENT

2-1
2. Indications/Contraindications
Indications for Use
The System is indicated for interruption of accessory atrioventricular conduction
pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia,
for treatment of atrial flutter tachycardia, and for creation of complete AV block in
patients with a rapid ventricular response to an atrial arrhythmia – typically chronic, drug
refractory atrial fibrillation.
Contraindications
•Use of the device is contraindicated for patients with active systemic infection.
•Use of the device in patients with implanted permanent leads of an implantable
device of any kind.
•Patients with implanted mitral/tricuspid artificial valve.
•Pregnant women.
•Presence of tumors or clots in atrium and/or ventricules.
•The retrograde transaortic approach is contraindicated in patients with aortic valve
replacement.
#Note: Refer to individual Directions for Use for the Catheter and ground pads
contraindications.

3-1
3. Warnings, Precautions, and Adverse Reactions
Warnings
Before operating the System, read these warnings carefully:
•The displayed temperature is not the maximum tissue temperature. Do not set the
maximum temperature higher than 80°C.
•Use Lower Power First - When first delivering RF energy, begin by using a low
power setting (i.e., 50W). If the created lesion is unsuccessful or inadequate,
incrementally increase the power output with successive ablation attempts to
minimize the potential for thrombus formation and /or inadvertent damage to cardiac
tissues.
•Catheter ablation procedures present the potential for significant X-ray exposure,
which can result in acute radiation injury as well as increased risk for somatic and
genetic effects, to both patients and laboratory staff due to the X-ray beam intensity
and duration of the fluoroscopic imaging. Catheter ablation should only be performed
after adequate attention has been given to the potential radiation exposure associated
with the procedure, and steps taken to minimize this exposure. Careful consideration
must therefore be given for the use of the device in pregnant women.
•Patients undergoing AV nodal modification or ablation of septal accessory pathways
are at risk for inadvertent AV block. It is advisable to use lower initial power in such
patients and to monitor anterior conduction closely during RF power delivery.
•Pacemakers and implantable cardioverter/defibrillators can be adversely affected by
RF signals. It is important to:
a) Retain temporary external sources of pacing available during ablation.
b) Reprogram the pacing system temporarily to minimum output or 000 mode to
reduce risk of inappropriate pacing.
c) Exercise extreme caution during ablation when in close proximity to atrial or
ventricular permanent pacing leads.
d) Perform complete pacing system analysis on all patients after ablation.
•Implanted cardioverter/defibrillators should be deactivated during delivery of RF
power.
•During a transaortic approach, adequate fluoroscopic visualization is necessary to
avoid placement of the ablation catheter within the coronary vasculature. Catheter
placement and RF power application within the coronary artery has been associated
with myocardial infarction and death.

Operator’s Manual
3-2
•Patients undergoing left-sided ablation procedures should be closely monitored
during the post-ablation period for clinical manifestations of infarction.
•The Steerable Ablation Catheter is intended for single patient use only. Do not
reprocess or reuse. Reuse can cause patient injury and/or the communication of
infectious disease(s) from one patient to another.
•Catheter entrapment within the heart or blood vessels is a possible complication of
cardiac ablation procedures. The potential for catheter entrapment may be increased
when the Catheter is positioned in the vicinity of the chordae tendinae. The occurrence
of this complication may necessitate surgical intervention and/or repair of injured
tissues.
•The possibility of skin burns to the patient may exist whenever a special high power
catheter is utilized.
•The use of catheters or cables with unprotected male pin connectors presents a risk of
electrical hazard. Inadvertent attachment of pin connectors to power supply sockets or
connectors could result in electrocution of the patient or operator. Misconnection of
the pins could also lead to inappropriate delivery of RF current through a band
electrode. The users of components with unprotected male pin connectors must
exercise extreme caution during device set-up to prevent patient or operator injury.
Unused pins should be secured so that they do not inadvertantly touch other equipment
or surfaces. Never insert pins into mains outlets or into any equipment other than
systems providing patient electrical isolation in accordance with IEC-601.
•The APM output labeled recorder must only be connected to a medically isolated
recorder.
•Grounding reliability can only be acheived when the power supply cord is connected to
a receptacle marked Hospital Only or Hospital Grade.
Precautions
Observe these precautions, before using the System:
•Careful catheter manipulation must be performed in order to avoid cardiac damage,
perforation, or tamponade. Catheter advancement should be done under fluoroscopic
guidance. Do not use excessive force to advance or withdraw the Catheter when
resistance is encountered.
•The sterile packaging should be inspected prior to use.
•When using special high power catheters, it is required that two Disposable
Indifferent Patch Electrodes satisfying the requirements of ANSI/AAMI Standard
HF-18 be used as the ablation return electrodes or skin burns may result.
•It is recommended not to exceed thirty (30) RF power applications per Catheter.
•The EPT-1000 XPTM Cardiac Ablation Controller is intended for use with EP
Technologies Steerable Ablation Catheters and accessories only.

Warnings, Precautions, and Adverse Reactions
3-3
•Do not attempt to operate the EPT Cardiac Ablation System before thoroughly
reading the EPT-1000 Cardiac Ablation Controller Operator's Manual.
•The IMPEDANCE Display of the Controller should be continuously monitored
during RF power delivery. If a sudden rise in impedance is noted, power delivery
should be discontinued. The Catheter should be removed and the distal tip of the
Catheter cleaned to eliminate any coagulum.
•Excessive bending or kinking of the catheter shaft may damage internal wires.
Manual prebending of the distal curve can damage the steering mechanism and may
cause patient injury.
•Cardiac ablation procedures should be performed only by physicians thoroughly
trained in the techniques of RF Powered Catheter Ablation in a fully-equipped
electrophysiology laboratory.
•Adequate filtering must be used to allow continuous monitoring of the surface
electrocardiogram (ECG) during RF power applications.
•The long-term risks of protracted fluoroscopy have not been established. Careful
consideration must therefore be given for the use of the device in prepubescent
children.
•The long-term risks of lesions created by RF ablation have not been established. In
particular, any long-term effects of lesions in proximity to the specialized conduction
system or coronary vasculature are unknown. Furthermore, the risk/benefit in
asymptomatic patients has not been studied.
•Read and follow the Disposable Indifferent (Dispersive) Patch (DIP) Electrode
manufacturer’s instructions for use; the use of DIP Electrodes which meet or exceed
ANSI/AAMI HF-18 requirements is required.
•Placement of a DIP electrode on the thigh could be associated with higher
impedance, which could result in automatic RF power shut-off.
•The Controller is capable of delivering significant electrical power. Patient or
operator injury can result from improper handling of the Catheter and DIP Electrode,
particularly when operating the device. During power delivery, the patient should not
be allowed to come in contact with grounded metal surfaces.
•Apparent low power output or failure of the equipment to function correctly at
normal settings may indicate faulty application of the DIP Electrode or failure of an
electrical lead. Do not increase power before checking for obvious defects or
misapplication.
•The risk of igniting flammable gases or other materials is inherent in the application
of RF power. Precautions must be taken to restrict flammable materials from the
ablation site.
•Electromagnetic interference (EMI) produced by the Controller during the delivery of
RF power may adversely affect the performance of other equipment.

Operator’s Manual
3-4
•Regularly inspect and test re-usable cables and accessories.
•EP Technologies relies on the physician to determine, assess and communicate to the
individual patient all foreseeable risks of the cardiac ablation procedure.
Potential Adverse Reactions
The risks involved in RF ablation for the treatment of conditions outlined in the
Indications for Use include those associated with all cardiac catheter ablation procedures.
These potential adverse events may differ in severity from mild to severe. Additionally,
these complications may necessitate additional medical treatment including surgical
intervention. Complications may include the following: death, perforation or tamponade,
stroke, myocardial infarction, spasm of the coronary artery, endocarditis, pericarditis,
pericardial/pleural effusion, pleurisy, hemoptysis, hemorrhage, pulmonary edema,
embolus, vessel thrombus, valve damage, infection, catheter entrapment, skin burns,
pseudoaneurysm, cardiac/respiratory arrest, sinoatrial (SA) node damage, atrioventricular
(AV) node damage, phrenic nerve damage, aspiration, atrial septal defect, ruptured
chordae tendineae, femoral artery thrombus, aortic puncture, vasovagal reaction, allergic
reaction, vascular and heart damage, radiation exposure, hypotension and
hematoma/bruising at the insertion site. In addition, abnormal heart rhythms
(bradycardia, tachycardia, or heart block) requiring drugs, and/or electric shock, and/or
implantation of a permanent pacemaker can occur.
In the presence of anticoagulation there may be an increase risk of bleeding from all
causes.
Chest discomfort, particularly during the radiofrequency power delivery, may necessitate
the added risks associated with sedatives or general anesthesia.