Boston Scientific EPT-1000 XP Operator's 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

Manual Conventions

Preface

The following naming conventions are used in the EPT-1000 XP
System Operator’s Manual:

• The EPT-1000 XP

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.

TM

Cardiac Ablation

TM

Cardiac Ablation System is referred to as the “System.” For a

!

Precaution

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.

Do not attempt to operate the System before thoroughly reading this

i

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

ii

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

iii

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

iv

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

v

System Description

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

"

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 XP
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.

"

When using special high power catheters with the EPT-1000 XPTM Controller, two

Note

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.

Refer to Figure 1-2 for cable configuration.

Note

TM

1-1

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.

Operator’s Manual

• 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.

1-2

System Description

• 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.

"

When using the EPT-1000 XPTM Cardiac Ablation Controller in the Temperature

Note

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

1-3

Figure 1-1: System Installation Diagram

Operator’s Manual

1-4

System Description

Figure 1-2: Cable Configuration for Q ui ck Connect XP APM

CARDIAC

ABLATION

EPT-1000 XP

CONTROLLER

(10ft.)

Model 654

Model 822T

(Optional)

APM Extension Cable

(Switch Box)

Quick Connect XP APM

EGM

EQUIPMENT

Model 653

APM to EGM

Instrument Cable

Quick Connect 6-Pole 3ft.

Model 651

Quick Connect 9-Pole 3 ft.

Thermistor Instrument Cable

9-PINQCOUT

WITH

QUICK

CONNECT

CATHETER

THERMISTOR

Model 652

Adapter Cable

Quick Connect 6-Pole to 9-Pole 3ft.

6-PINQCOUT

WITH

QUICK

CONNECT

CATHETER

NONTHERMISTOR

Model 703

Quadripolar

Adapter Cable

Quick Connect 9-Pole

PINS

OUT

PIN

CATHETER

CONNECTS

THERMISTOR/

NONTHERMISTOR

1-5

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.

2-1

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.

3-1

Operator’s Manual

• 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 I EC-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.

3-2

Warnings, Precautions, and Adverse Reactions

• 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.

3-3

• 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.

Operator’s Manual

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.

3-4

4. Unpacking the Controller

Unpacking

The System’s shipping carton contains all of the components identified below:

$ 1 - Controller
$ 1 - Footswitch
$ 1 - XP APM with Quick Connect Connectors
$ 2 - EPT-1000 XP
$ 1 - Interconnect Cable for XP APM to EGM Equipment
$ 1 - Quick Connect Temperature Instrument Cable
$ 1 - Quick Connect Non-Temperature Instrument Cable
$ 1 - Catheter Pin Connect Adapter Cable

TM

Cardiac Ablation System Operator’s Manuals

To unpack the System, following these steps:

1. Unpack the Controller and accessories carefully and inspect for damage.

2. Notify the carrier immediately if the shipment carton is damaged.

3. Verify that the items listed above are received.

% Call EPT for Service

Number: 408.895.3500).

4. Read Section 6, Operational Sequence in this Manual very carefully and follow the
installation and setup instructions.

Repackaging the Controller

When the Controller requires service or transfer to other location, use the original shipping
carton and packing materials to repack and ship the Controller.

For shipping, disconnect the XP APM and Footswitch. Place all the components into the
locations reserved for these units in the c ar ton.

If there are any discrepancies, notify EPT (Telephone

4-1

5. Controls and Displays

Front Panel

The operator controls for the EPT-1000 XPTM Cardiac Ablation System are located on the
front panel of the Controller. The buttons on the Controller’s front panel allow the user to
control the operation of the Controller. The lights/LEDs on the front panel show the
Controller’s status and/or report error conditions.

This section describes the operator controls on the front panel shown in Figure 5-1.

Figure 5-1: Controller Front Panel

Isolated Patient

Connector

POWER

ISOLATED PATIENT

CONNECTOR

Power

Panel

(W)

POWER TEMP

CONTROL

Control

Panel

Temperature

TEMPERATURE

CALIBRATION

Calibration

Panel

Panel

(°C)

Impedance

IMPEDANCE

COUNTER CLEAR

Counter

Panel

Panel

CARDIAC ABLATION CONTROLLER

TIME (S)

()

Mains

Display

Time

Panel

EPT-1000 XP

RF POWER

CONTROL

MAINS

RF Power

Control Panel

5-1

CONTROL Panel

l

CONTROL Indicator LEDs

The control mode of the Controller is indicated by either of two green LEDs (POWER or
TEMP) on the CONTROL Panel (see Figure 5-2). When the Controller is initially
powered on, one of the green LEDs displays the control mode which depends on the type
of Catheter connected to the Controller.

If a Catheter(T°), the Controller automatically switches to the Temperature Control mode
when initially powered on, as indicated by the flashing green TEMP LED. If it is
desirable to operate the Controller in the Power Control mode while using a Catheter(T°),
pressing the CONTROL Button (see Figure 5-2) changes the control mode to Power
Control, as indicated by the flashing green POWER LED.

If a Catheter(Non-T) or no Catheter is connected, then the Controller automatically
switches to the Power Control mode when initially powered on, as indicated by the
flashing green POWER LED.

Operator’s Manual

"

POWER, TIME, and TEMPERATURE setpoints all reset to default values

Note

whenever a Catheter(T°) is disconnected and reconnected, or when a switch is made
between control modes (Power Control to Temperature Control or vice versa). During RF
power delivery, the control mode cannot be changed.

Figure 5-2: CONTROL Panel Indicator LEDs and Butt on

Control

Panel

CONTROL

Power

LED

POWER TEMP

Temp
LED

Contro
Button

5-2

Controls and Displays

CONTROL Button

The Controller is capable of operating in Power Control or Temperature Control mode.
Press the CONTROL Button to toggle (or change) to a new control mode, as indicated by
a flashing LED.

The Power Control mode is compatible with Catheter(T°) and Catheter(Non-T) and
allows selection of the quantity of RF power that is delivered by the Steerable Ablation
Catheter (see Table 5-1). It also allows selection of an upper temperature limit from 55oC
to 85oC (the default value).

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, from a value of 0 W to a maximum of either 50 or 100 W depending on
catheter type, must also be selected in the Temperature Control mode (see Table 5-1).
If insufficient power is selected, the desired catheter tip temperature may not be achieved.

Catheters are designed to transmit three distinct quantities of RF power, based on their
electrode size, internal construction and intended use. The maximum amount of power
the Catheters can access is limited by the control mode and catheter type as follows:

Table 5-1: Maximum Amount of Power Output for Catheters

Catheter Type Power Control (W) Temperature Control (W)

Control Modes

Catheter(Non-T) 50 N/A
Catheter(T°) 50 50
Special High Power

100 100

Catheter(T°)

5-3

POWER Panel

POWER Display

The POWER Display (see Figure 5-3) shows the RF power output in Watts. The available
power output ranges are dependent on the catheter type and the control mode. Ranges are
from a value of 0 Watt to the maximum amount of power output (see Table 5-1).

When the Controller is initially powered on, the POWER Display indicates the default
power setpoint of 0 Watt. After the user sets the power setpoint and presses the RF
POWER CONTROL Button, the display changes from the setpoint value and begins
displaying the actual power output the Catheter delivers to the tissue.

In the Power Control mode, the Controller adjusts its output to maintain the measured
power at the power setpoint, and in the Temperature Control mode, the Controller adjusts
its output to maintain the measured temperature at the temperature setpoint. In the
Temperature Control mode, measured power may be lower than the power setpoint value,
depending on the measured catheter tip temperature and/or tissue impedance. When RF
power is discontinued (DONE operational mode), the last measured value of RF power
delivered remains on the display, flashing at 1-second intervals.

Operator’s Manual

Figure 5-3: POWER Display and Buttons

POWER

Power

Panel

Power

Increase

Button

(W)

Power
Display

Power
Decrease
Button

5-4

Controls and Displays

POWER &

&/'''' Buttons

&&

The POWER &/' (increase/decrease) Buttons select the desired level of delivered RF
power for the Power Control mode, or the maximum amount of RF power available for
the Temperature Control mode.

For instructions on how to select the level of delivered RF power, see the section
Selecting the Power Output on page 6-9.

"

Access to greater than 50 W of power requires the use of appropriately coded

Note

(special high power) catheters and the XP APM.

TEMPERATURE Panel

TEMPERATURE Display

The TEMPERATURE Display (see Figure 5-4) shows the temperature setpoint (desired
catheter tip temperature) in degrees Centigrade. This feature is only available if a

Catheter(T°) is connected to the Controller.

Figure 5-4: TEMPERATURE Display and Buttons

Temperature

Panel

Temperature

Increase

Button

TEMPERATURE

( C)

Temperature
Display

Temperature
Decrease
Button

5-5

Operator’s Manual

Table 5-2 lists all possible temperature display readings under specific operating

conditions. Refer to the instructions specified in the table for additional information.

Table 5-2: Summary of TEMPERATURE Display Readings

Catheter Type Control Mode TEMPERATURE Display Readings

Catheter(T°) Temperature

Control Mode

• At initial power on, display reading is 30°C.

• After setting temperature setpoint per

instructions, display indicates desired catheter tip
temperature. (Refer to instructions on page
6-10, Selecting Temperature When Using the
Catheter(T°) in TEMPERATURE Control Mode.)

• In ON or CALIBRATE operational modes,

display indicates measured catheter tip
temperature.

• In ON operational mode:

− If the temperature is within 20°C – 120° C

range, the measured temperature displays.

− If the measured temperature is below 20°C, the

message “LO” displays.

− If the measured temperature is above 120°C,

the message “HI” displays.

• In DONE operational mode: When RF power is

discontinued, the last measured value of
temperature is shown on the display, flashing at
1-second intervals.

Catheter(T°) Power Control

Mode

• In READY mode, display reading is 85°C.

• In ON or CALIBRATE operational modes,

display indicates measured catheter tip
temperature.

• In ON operational mode:

− If the temperature is within 20°C – 120° C

range, the measured temperature displays.

− If the measured temperature is below 20°C, the

message “LO” displays.

− If the measured temperature is above 120°C,

the message “HI” displays.

• In READY mode, upper temperature limit can be

selected. After setting temperature setpoint per
instructions, display indicates desired catheter tip
temperature. (Refer to instructions on page
6-11, Selecting Temperature When Using the
Catheter(T°) in POWER Control Mode.)

When RF power is discontinued, the last

•

measured value of temperature is shown on the

5-6

Controls and Displays

display,

Catheter(Non-T)* N/A

* Temperature Control is not accessible for this Catheter.

In Power Control mode only, when the measured catheter tip temperature

Note

• Display shows three dashes (---)

flashing at 1-second intervals.

decreases to a value that is below the upper temperature limit, the Controller resumes
delivery of RF power at a value that is 50% of the power which caused the upper
temperature limit to be exceeded. If the upper temperature limit is exceeded a second
time, the Controller immediately ceases delivery of RF power and display an error code
indicating that the upper temperature limit has been exceeded a second time. It is
recommended that if this error condition arises, the power level should be decreased to
prevent the upper temperature limit from being exceeded. The Controller can be placed
into the READY mode by depressing the RF POWER CONTROL Button, which allows
adjustment of Controller parameters such as RF power, upper temperature limit, etc.

&

&/'

TEMPERATURE

&&

'

Buttons

''

The TEMPERATURE &/' (increase/decrease) Buttons select the temperature that the
Contro ller attemp ts to achieve during RF power delivery. In Temperature Control mode,
the Controller automatically adjusts power, within the user-selected upper power limit, to
achieve the desired catheter tip temperature. In Power Control mode, the Controller
automatically decreases RF power to the Catheter if this value of user-selected upper
temperature limit is exceeded.

For instructions on how to select the temperature setpoint, see the section Selecting the
Desired Catheter Tip Temperature on page 6-10.

IMPEDANCE Panel

IMPEDANCE Display

The IMPEDANCE Display (see Figure 5-5) shows the measured impedance value in Ω
(1 Ω resolution). When the Controller is initially powered on, the display shows three
dashes “---”, indicating that no measurement is being made. As soon as RF power is
delivered by pressing the RF POWER CONTROL Button or the Footswitch, the
Controller begins to measure impedance. Because this display reflects the actual tissue
impedance, the value shown may fluctuate slightly, depending on the quality of the
electrode/tissue interface, but should remain relatively stable throughout power deliveries.
For a summary of the impedance ranges, see Table 6-2 in section Turning the RF Power

Delivery “ON”

5-7

Operator’s Manual

When RF power is discontinued, the last measured value of impedance remains on the

display, flashing at one second intervals. If the Controller is placed into the
CALIBRATION mode (by depressing the CALIBRATION Button) and if a Catheter has
been positioned within the heart, then the Controller delivers 1 Joule of energy which
allows a single measurement of impedance, and continuously displays the value of
impedance measured. When either the CALIBRATION or RF POWER CONTROL
Buttons are depressed, the Controller returns to the READY mode and the IMPEDANCE
Display returns to three dashes “---”.

Figure 5-5: IMPEDANCE Display

Impedance

Panel

IMPEDANCE

()

Impedance
Display

5-8

Controls and Displays

e

TIME Pa nel

TIME Display

The TIME Display (see Figure 5-6) shows the user-selected duration (in seconds) of RF
power delivery to the Catheter. When the Controller is initially powered on, the TIME
Display reads zero. After the user sets the duration and presses the RF POWER
CONTROL Button, the displayed value changes to zero and initiates counting upward at
1-second intervals until the preset time limit is reached (or the RF POWER CONTROL
Button is actuated a second time or the Footswitch is released), stopping RF power
delivery. If RF power delivery is stopped before the preset maximum duration has been
reached, actual duration of RF power delivery is displayed, flashing at 1-second intervals.

&

&/''''

TIME

&&

The POWER &/' (increase/decrease) Buttons select the maximum durati on of each RF
power delivery. The range of times available is 1 to 120 seconds in increments of one.

Buttons

"

These buttons are inoperative during RF power delivery.

Note

For instructions on how to select the duration of RF power delivery, see the section

Setting the Time Control on page 6-11.

Figure 5-6: TIME Display and Buttons

Time

Panel

Time

Increase

Button

TIME

(S)

Time
Display

Time
Decreas
Button

5-9

COUNTER Panel

COUNTER Display

The COUNTER Display (see Figure 5-7) automatically counts and displays each delivery
of RF power. When the Controller is initially power on, the display clears and reads zero.
The range of values available is 0 to 99 in increments of one.

CLEAR (Counter) Button

The CLEAR Button clears the COUNTER Display (Figure 5-7) to zero and allows the
user to keep an accurate count of the number of RF power deliveries to the patient. Press
this button before starting initial RF power application on a patient.

Figure 5-7: COUNTER Display and Clear Button

Operator’s Manual

Counter

Panel

Counter

Display

RF POWER CONTROL Panel

RF POWER CONTROL Button/Light

The RF POWER CONTROL Button (see Figure 5-8) controls the three operational
modes of the Controller:

• READY mode – This mode allows the ablation parameters to be adjusted.

• ON mode – This mode is the Controllers’ state during the delivery of RF power.

• DONE mode – This mode defines the system state after cessation of RF power

delivery.

"

This button can also be used for exiting the CALIBRATION or Error

Note

modes and returning the Controller to the READY mode.

COUNTER CLEAR

Clear
Button

When the Controller is initially powered on, the RF POWER CONTROL Light flashes,
indicating the Controller is in the READY mode and prepared for RF power delivery.
Press the yellow RF POWER CONTROL Button once to place the Controller into the ON
mode and allow the Catheter to transfer RF power to the tissue. To alert the user, this
button is backlit with a light which is ON during the delivery of RF power (RF Power ON
mode), and OFF when RF power delivery stops (DONE mode).

5-10

Controls and Displays

If the Controller is in the Temperature Control mode, a test of the temperature sensor

functionality is made prior to delivery of RF power. If a faulty temperature sensor is
detected by the Controller, which can be caused by the temperature sensor indicating a
temperature outside the operating range of 31o C to 43o C, or a short or open in the
temperature measurement circuit, the Controller does not enter the RF Power ON mode.
It enters an Error mode, indicating a faulty temperature measuring circuit has been
detected or the temperature is outside the operating range. To exit the Error mode,
depress the RF POWER CONTROL Button, which returns the Controller to the READY
mode.

Figure 5-8: RF POWER CONTROL Panel and Button/Light

RF Power

Control

Panel

CALIBRATION Panel

CALIBRATION Button

Pressing the CALIBRATION Button (see Figure 5-9) places the Controller into the
CALIBRATION mode which performs the following functions:

• Approximately 1 Joule of energy is delivered to the tissue which is used to make a
single measurement of tissue impedance. This value is continuously displayed on the
front panel.

• The catheter tip temperature is continuously monitored and displayed on the front
panel. This allows assessment of the temperature measuring function of the
Catheter(T°). If this value differs significantly from the normal body temperature of
37o C, the Catheter(T°) should be removed and replaced with another Catheter(T°).

RF Power

Control

Button/Light

RF POWER

CONTROL

• A zero to one volt square-wave signal representing a minimum-to-full-scale signal is
transmitted from each of the rear panel analog outputs (for calibration of an optional
recorder). This square-wave calibration signal is transmitted continuously to the rear
panel analog output ports.

5-11

Operator’s Manual

All of the above functions continue to operate as described above until either the

CALIBRATION or RF POWER CONTROL Buttons are pressed again. Pressing either of
these buttons causes the Controller to return to the READY mode. The minimum-to-full­scale values for the individual analog outputs are shown in Table 5-3.

Table 5-3: Individual Analog Outputs

Power 0.0 - 1.0 volt corresponds to 0 -100 W
Impedance
Temperature

The CALIBRATION LED illuminates when a calibration signal is transmitted to the
analog output ports. The calibration signal automatically discontinues if the RF POWER
CONTROL Button or the Footswitch is pressed.

Figure 5-9: CALIBRATION Panel and Button/LED

Calibration

Calibration

Isolated Patient Connector

Panel

Button

0.0 - 1.0 volt corresponds to 0 - 300 Ω

0.0 - 1.0 volt corresponds to 20o - 120°C

CALIBRATION

Calibration
LED

The ISOLATED PATIENT CONNECTOR (see Figure 5-1) provides for connection of
the XP APM to the Controller. The connector has a screw-on/locking mechanism for
secure cable installation. The XP APM Patient Cable must be installed in the ISOLATED
PATIENT CONNECTOR before the Controller delivers any RF power. This cable uses a
circular connector that is keyed for proper alignment.

MAINS (Power “ON”) Display

The MAINS Display (see Figure 5-1) indicates that the power swit ch (see Figure 5-10)
located on the rear panel is ON (“1” position) and the Controller is plugged into an
electrical outlet.

5-12

Controls and Displays

Rear Panel

This section describes the output ports and power controls on the rear panel shown in
Figure 5-10.

Figure 5-10: Controller Rear Panel

Footswitch

Cable

Connector

Analog
Outputs

ANALOG OUTPUT

RF POWER

OUTPUT POWER 150W
OPERATING FREQUENCY 500KHz

Ω

IMPEDANCE TEMPERATURE SPARE VOLUME

FOOT SWITCH RS-232

Serial

Port

Volume
Control

Knob

SPEAKER

CAUTION: DO NOT OPEN

ELECTRICAL SHOCK HAZARD

Mains

Power

Switch

CAUTION: THE TOTAL SYSTEM
CHASSIS RISK CURRENT SHOULD NOT

A

EXCEED 100

µµµµ

ATTENTION: LE COURANT DE TISQUE
TOTAL'ADMISSIBLE AU CHASSIS NE
DOIT PAS DEPASSER 100

MAINS

MAIN

FUSES

2X

T3A 250V

T1,6A 250V

WARNING

RISK OF FIRE.

REPLACE FUSE

AS MARKED.

100-120V

3A 50/60 Hz

220-240V

1,6A 50/60 Hz

Ground

Stud

Fuse

Holder

A.

µµµµ

AUX

AUX

2X

FUSES

WARNING

RISK OF FIRE.

REPLACE FUSE

AS MARKED.

100-120V

1A 50/60 Hz

220-240V

500mA 50/60 Hz

T1A 250V

T500mA 250V

Auxiliary

Power
Outlet

Fuse

Holders(2)

Power

Cord

POWER Switch

The power switch (rocker switch) on the rear panel powers the Controller ON (“1”
position) or OFF (“0” position).

Analog Outputs

5-13

Operator’s Manual

There are 4 analog output ports (see Figure 5-10), which are labeled as follows: RF

POWER, IMPEDANCE, TEMPERATURE, and SPARE.

Power Analog Output

RF POWER – This output port provides direct connection to an electrically isolated
general-purpose recorder or monitor, satisfying the requirements of IEC-601, using a
standard BNC connector to facilitate recording of the RF power output during delivery of
RF power.

Impedance Analog Output

IMPEDANCE – This output port provides direct connection to an electrically isolated
general-purpose recorder or monitor, satisfying the requirements of IEC-601, using a
standard BNC connector to facilitate recording of the tissue impedance during delivery of
RF power.

Temperature Analog Output

TEMPERATURE – This output port is active only when a Catheter(T°) is in use. It
provides direct connection to an electrically isolated general-purpose recorder or monitor,
satisfying the requirements of IEC-601, using a standard BNC connector to facilitate
recording of the Catheter(T°) measured catheter tip temperature during delivery of RF
power.

Spare

SPARE – This output port is not in use at this time.

Power Cord

The Power Cord is “Hospital Grade” and must be installed at an AC electrical wall outlet
designated “Hospital Grade” or “Hospital Only.”

MAINS Fuse Holder

Housing for AC fuse. (See Controller rear panel for appropriate type of fuse.)

Fuse Holders (2)

Housing for AC fuses. (See Controller rear panel for appropriate type of fuse.)

Footswitch Cable Connect or

This connector is polarized for connecting the Footswitch Cable.

5-14

Controls and Displays

Volume Control Knob

This knob provides the user with volume control for the audio signal that accompanies
RF power delivery. If no audio tone is heard, check the knob to determine if the volume
level has been adjusted too low.

Serial Port

This port is labeled “RS-232.” It provides for computer interface to EPT approved
accessory computers only.

Auxiliary Power Outlet

This outlet is labeled “Auxiliary Power Outlet.” It provides for future optional EP
Technologies’ approved accessories only.

Ground Stud

Protective Earth Ground stud (chassis ground).

5-15

Accessories

Footswitch

An easy-to-use Footswitch (see Figure 1-1) can alternatively be used to provide ON/OFF
control of the RF power delivery. The connecting cable’s 10-ft length allows the user to
stand at the catheterization table near the patient without requiring another person for
starting/stopping RF power delivery. The Footswitch functions similarly to the RF
POWER CONTROL Button except that the user must continuously hold the Footswitch
down for RF power to be delivered. The RF power delivery is immediately terminated
when the user’s foot is lifted off the Footswitch. Use only the EPT Model 840
Footswitch, which is rated IPX8 (continuous immersion).

High Power Automatic Personality Module (XP APM)

The XP APM provides RF filtering to allow continuous electrogram recording during RF
power delivery via the catheter tip electrode. Additionally, the XP APM allows for safe use
of either standard or special high power EPT ablation catheters. The XP APM passes RF
energy (at 500 kHz) from the Controller to the patient via the catheter and one or two DIP
Electrodes. The maximum power delivered depends on the configuration of the attached
catheter. The XP APM detects the presence of a special hi gh power catheter and enables
the Controller to deliver RF power up to 100 W. If a standard catheter is detected, the
Controller is not able to deliver power greater than 50 W.

Operator’s Manual

The Module connections are as follows (see Figure 5-11):

• One 9-pin Quick Connect Connector labeled “CATHETER” for attaching the Quick
Connect Instrument Cable to the catheter.

• One 6-pin Recorder Connector labeled “RECORDER” for attaching the XP
APM/EGM Interconnect Cable to the recording equipment.

• Two male 2-pin connectors labeled “INDIFFERENT ELECTRODE” for attaching
the two DIP Electrodes.

"

If greater than 1 A of current is delivered to either of the two DIP

Note

Electrodes, the System shuts down.

For additional information on the XP APM, refer to Table 8-1: System Specifications in
Section 8.

5-16

Controls and Displays

Figure 5-11: High Power Automatic Personality Module with Quick Connect

EP Technologies, Inc.

CARDIAC ABLATION SYSTEM
XP AUTOMATIC PERSONALITY MODULE

FOR USE WITH EP TECHNOLOGIES

CARDIAC ABLATION SYSTEM ONLY!

Top View

!

EPT-1000 XP APM

RECORDER

RECORDER

INDIFFERENT

INDIFFERENT ELECTRODES

ELECTRODES

X 2

Front Panel

CATHETER

Side Panel

CATHETER

5-17

6. Operational Sequence

Initial Installation

Follow the instructions in this section carefully to prepare the System for operation:

1. Connect the Controller Power Cord plug into a properly grounded AC electrical
outlet designated “Hospital Grade” or “Hospital Only.”

!

Precaution

Never use an outlet without a grounding connection.

2. Position the Controller for easy viewing of its front panel displays.

3. Install the XP APM Patient Cable to the ISOLATED PATIENT CONNECTOR

socket on the Controller front panel by carefully lining up the connector pins with the
socket. Push the connector firmly into the socket; then secure in place by rotating the
locking ring in a clockwise direction.

"

Do not twist the XP APM Patient Cable connector while inserting or

Note

removing it from the Controller ISOLATED PATIENT CONNECTOR socket or
the connector pins may be damaged.

Figure 6-1: Connecting the XP APM to the Controller Front Panel

POWER

ISOLATED PATIENT

CONNECTOR

(W)

CONTROL

TEMPERATURE

CALIBRATION

(°C)

IMPEDANCE

COUNTER CLEAR

TIME

(

)

ΩΩΩΩ

RF POWER

CONTROL

(S)

MAINS

XP APM

Patient

Cable

INDIFFERENT ELECTRODES

X 2

CATHETER

XP APM

6-1

Operator’s Manual

4. To disconnect the XP APM from the Controller, rotate the locking ring counter
clockwise to unlock; then grasp the connector and gently pull it out of the socket.

"

Do not twist the XP APM Patient Cable connector while inserting or

Note

removing it from the Controller ISOLATED PATIENT CONNECTOR socket or
the connector pins may be damaged.

!

Precaution

Never disconnect the XP APM by pulling on the cable.

5. For Optional Patient Monitor Equipment Installation only, follow these instructions:
a) Use the XP APM/EGM Interconnect Cable to connect the XP APM to optional

recording equipment (see Figure 6-2).

b) Plug in the Quick Connect fitting from the XP APM/EGM Interconnect Cable

into the connector located on the XP APM side panel labeled “RECORDER” and
plug the opposite end of this cable into isolated recorder inputs.

"

Ensure that the pins are not bent or broken and that the monitoring

Note

connectors are securely in place. 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.

Figure 6-2: Connecting the XP APM to the Recording Equipment

XP APM

Recorder

INDIFFERENT ELECTRODES

X 2

CATHETER

6-2

Controls and Displays

6. Position the XP APM near the table where the procedure is to be performed. The
System may only be connected to recording systems providing patient electrical
isolation in accordance with IEC-601.

7. Install the Catheter Quick Connect Instrument Cable fitting into the XP APM front
panel fitting labeled “CATHETER.”

Figure 6-3: Connecting the Catheter to t he XP APM Front Panel

INDIFFERENT ELECTRODES

X 2

EP Technologies, Inc.

CATHETER

Quick Connnect
Instrument Cable

Catheter

8. Install a DIP Electrode (or 2 DIP electrodes, if using a special high power catheter)

into either of the two the INDIFFERENT ELECTRODE receptacles located on the
XP APM front panel (see Figure 6-4) as follows:

a) Read the manufacturer’s manual before installing the DIP Electrode pads.
b) Gently push each DIP Electrode fitting straight and firmly into place.
c) To disconnect a DIP Electrode, grasp the DIP Electrode fitting and gently pull it

out from the XP APM Indifferent Electrode receptacle.

!

Precaution

Do not disconnect a DIP Electrode Connector by pulling on its

cable.

d) Before use, it is important to check the DIP Electrode(s) for damage to the sealed

foil package. Exposure to air, due to a damaged package, could cause the DIP
Electrode(s) to become dry and limit their grounding capability.

e) Be sure the pads are moist and sticky to the touch before placing on the patient.

!

Precaution

Do not attempt to relocate the patient grounding pad after initial

application. Electrode gel is NOT required and should NOT be used.

6-3

Operator’s Manual

)

f) The DIP Electrode(s) should be placed on a well-vascularized, convex skin

surface that is in close proximity to the ablation site (left upper quadrant of the
back is suggested unless the patient’s scapula is especially prominent or patient is
extremely thin). Other possible locations are the upper arm or left flank area.
Avoid scar tissue, bony prominence, adipose tissue, or any areas where fluid may
pool. Shave, clean, and dry the application site as needed. Check for wrinkles or
folds when applying the pad as these decrease conductivity.

"

RF output ceases to the patient if more than 1 A flows through either of the

Note

DIP Electrodes.

Figure 6-4: Connecting the Disposable Indi fferent Patch Electrodes

CATHETER

Polarity
Unimportant

INDIFFERENT ELECTRODES

X 2

DIP Electrodes (2

6-4

Controls and Displays

9. If using the Footswitch, install its cable connector into the FOOTSWITCH Cable
Connector on the Controller rear panel (see Figure 6-5). Carefully push the cable
connector into the FOOTSWITCH connector until it is seated firmly in place.

"

Do not twist or bend the FOOTSWITCH connector during insertion as this

Note

action might cause damage to the pins.

10. Position the Footswitch to allow easy access by the physician.

Figure 6-5: Connecting the Footswitch to the Controller Rear Panel

CAUTION: THE TOTAL SYSTEM
CHASSIS RISK CURRENT SHOULD NOT
EXCEED 100

A

µµµµ

ATTENTION: LE COURANT DE TISQUE
TOTAL'ADMISSIBLE AU CHASSIS NE
DOIT PAS DEPASSER 100

MAIN

FUSES

2X

T1,6A 250V

WARNING

RISK OF FIRE.

REPLACE FUSE

AS MARKED.

100-120V

3A 50/60 Hz

220-240V

1,6A 50/60 Hz

A.

µµµµ

MAINS

T3A 250V

Footswitch

Cable

Connector

ANALOG OUTPUT SPEAKER

Ω

RF POWER

IMPEDANCE TEMPERATURE SPARE

FOOT SWITCH

OUTPUT POWER 150W
OPERATING FREQUENCY 500KHz

RS-232

CAUTION: DO NOT OPEN

ELECTRICAL SHOCK HAZARD

VOLUME

AUX

AUX

FUSES

WARNING

RISK OF FIRE.

REPLACE FUSE

AS MARKED.

100-120V

1A 50/60 Hz

220-240V

500mA 5 0 / 60 Hz

2X

T500mA 250V

T1A 250V

11. The System is now ready to record electrograms prior to and during delivery of RF

power.

Turning the Controller “ON”

1. Turn the Controller ON by pressing the power switch (to the “1” position) located in

the power input module on the Controller rear panel (see Figure 6-6).
The Controller automatically initiates a self-test procedure which is indicated by the

illuminated front panel displays and continuous audio tone generated for
approximately 2 seconds. If no system malfunction is detected, the Controller
changes to the READY Mode.

"

The connection between the XP APM and Controller is not required to

Note

complete the initial self-test.

Footswitch

6-5

Operator’s Manual

2. If a system malfunction is detected during self-test, all front panel displays remains
lit and the Controller does not operate. To clear any malfunctions found during self­test, the Controller must be powered OFF, then back ON. The self-test repeats.

%

Call EPT for Service

A second self-test failure is indicative of a Controller

malfunction and should be referred to EPT for service (Telephone Number:

408.895.3500). The Controller does NOT operate unless the initial self-test has
been successfully completed.

Figure 6-6: Turning the Controller to the ON Positi on

MAINS

Press Power Switch to "1" position.

Power Switch

Power Input

Module

READY Mode

The Ready mode is designed for setting the desired parameters for RF power delivery. It
is automatically initiated after completion of a successful Controller self-test. Ready
mode is indicated by a flashing RF POWER CONTROL Button on the Controller front
panel; TEMPERATURE, IMPEDANCE, TIME, and COUNTER Displays are
continuously lit. Values displayed when the Controller is first initialized are zero in the
POWER, TIME, and COUNTER Displays and dashes (---) in the IMPEDANCE Display.
(Refer to Figure 5-1 for the location of displays and buttons.)

Controller in Temperature Control Mode - Catheter(T°) Connected

If a Catheter(T°) is connected, the TEMPERATURE Display shows one of two values
depending on the control mode. When the Controller is initially powered on and a
Catheter(T°) is connected, the TEMPERATURE Display indicates 30°C, since the
Controller is automatically entered into the Temperature Control mode. The user must
enter the desired catheter tip temperature, the maximum power that the Controller can
deliver to achieve the desired temperature, and the ablation time before RF power
delivery.

6-6

Controls and Displays

r

r

Controller in Power Control Mode - Cathet er(T°) Connected

If the control mode is manually changed to Power Control, by pressing the RF POWER
CONTROL Button, the TEMPERATURE Display indicates 85o C during the READY
mode of the Controller, indicating the upper temperature limit at which the Controller
continues to deliver set power.

Controller in ON or CALIBRATE Operational Modes - Cat heter(T°) Connected

When the Controller is in either the ON or CALIBRATE operational modes, the
TEMPERATURE Display indicates “LO” if the measured temperature is less than 20°C,
“HI” if temperature is greater than 120°C; otherwise, it shows the measured temperature
(see Figure 6-7).

Figure 6-7: Ready Mode, Initialization - Catheter(T°) Connected

TEMPERATURE

( C)

Measured
Temperatu
Reading

Catheter(Non-T) or No Catheter Connect ed

If a Catheter(Non-T) or no Catheter is connected, the display shows “---” (Figure 6-8).

Figure 6-8: Ready Mode, Initializati on - Cat heter(Non-T) Connected

TEMPERATURE

( C)

Temperatu
Display

6-7

Calibrating the Controller Analog Outputs for the Recorder

Each time the Controller is powered on, the analog outputs (see Figure 5-10) should be
placed in the CALIBRATION mode to verify that the optional strip chart recorder and/or
monitor are calibrated correctly, if used.

To perform calibration of the Controller analog outputs, follow these steps:

1. Check that all connections to the analog outputs are secure.

2. Ensure that the recorder/monitor is powered on and functioning properly.

3. Ensure the recorder satisfies the requirements of IEC-601 prior to connection to

Controller analog outputs.

4. To calibrate with the analog outputs, press the CALIBRATION Button (Figure 6-9)
at the Controller front panel. This generates a minimum-to-full-scale (0.0 to 1.0 volt)
continuous square-wave calibration signal which is sent continuously and
simultaneously to each of the analog outputs (until the CALIBRATION Button is
pressed again or until the RF POWER CONTROL Button is pressed).

Operator’s Manual

Figure 6-9: Calibrating the Controll er Analog Outputs

Calibration

Button

CALIBRATION

COUNTER CLEAR

RF POWER
CONTROL

MAINS

5. With the C ontroller in the READY mode, analog output calibration can be repeated

or checked at any time by repeating the steps identified in steps 1 through 3 above.

6. When RF power is delivered, the analog signals corresponds to the Controller’s
measured power, temperature, and impedance values.

Selecting the Control Mode

The Controller is capable of operating in Power Control or Temperature Control mode.
Control mode selection is made via the CONTROL Button. (For complete description of
the CONTROL Button, see CONTROL Panel in Section 1.)

6-8

Controls and Displays

To select the proper control mode, follow these steps:

1. Ensure that the Controller is in the READY mode.

"

Note

The control mode can only be changed when the Controller is in the

READY mode.

2. Press the CONTROL Button to select the appropriate control mode. The CONTROL
Indicator LEDs display the selected mode.

Selecting the Power Output

To deliver RF power, it is necessary to select a Controller power output. This is true for

both Temperature Control mode and Power Control mode.

" Note 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.

Controller in Temperature Control Mode - Catheter(T°) Connected

The Controller is automatically entered into the Temperature Control mode and the RF

power setpoint is the maximum amount of power that the Controller can access to achieve
the desired catheter tip temperature. If the RF power setpoint is equal to or greater than the
amount of power necessary to achieve the desired catheter tip temperature, then the
Controller supplies the appropriate amount of power to achieve the temperature setpoint.
The Controller only supplies as much RF power as necessary to achieve the desired catheter
tip temperature.

If the RF power setpoint is less than the amount of power required to achieve the desired

catheter tip temperature, then the Controller may not be capable of achieving the desired
catheter tip temperature and thus the measured temp erature is less than the desired cathet er
tip temperature.

Controller in Power Control Mode - Cathet er (Non-T) or Catheter(T°) Connected

If a Catheter(Non-T) or Catheter(T°) is connected, the Controller is manually placed into

the Power Control mode, then the RF power setpoint corresponds to the actual amount of
power that is delivered to the tissue, unless the upper temperature limit is exceeded, in
which case, the Controller reduces and/or ceases delivery of set power.

Controller in Power Control Mode - Cathet er(T°) Connected

If using a Catheter(T°) with the Controller in the Power Control mode, the

TEMPERATURE Display shows 85oC when the Controller is in the READY mode and
displays measured temperature when the Controller is in the ON, CALIBRATE, and DONE
operational modes.

6-9

Operator’s Manual

Selecting the RF Power Setpoint

To set the RF power setpoint (in W), follow these steps:

1. Press the appropriate POWER (&/') Butt on to increase or decrease the RF power
setpoint by 1 W.

2. To scroll rapidly to the desired power setpoint, depress and hold the appropriate
POWER (&/') Button down.

3. Release the POWER (&/') Button when the POWER Display shows the
appropriate RF power setpoint.

4. During RF power delivery (RF Power ON mode), the power setpoint can be adjusted
in 1-W increments to provide better control during the procedure by pressing the
appropriate POWER (&/') Button. When the button is released, the POWER
Display returns to showing the current value of measured power.

• Holding the POWER & Button down while RF power is being delivered (RF

Power ON mode) does NOT cause the power setpoint to scroll as it does when
the Controller is in the READY mode.

• Holding the POWER ' Button down while RF power is being delivered (RF

Power ON mode) causes the power setpoint to scroll at a greater rate than it does
when the Controller is in the READY mode.

Selecting the Desired Catheter Tip Temperature

For ablation procedures involving automatic temperature control, it is recommended that
the operator initially select a lower set temperature range (from 55°C to 70°C). The
operator should consider a lower initial set temperature to avoid excessive thermal
damage to tissue, or collateral damage to adjacent tissue not intended for ablation,
particularly in areas where high blood flow and correspondingly high convective cooling
may be present.

The displayed catheter tip temperature may be significantly lower than the

Note:

maximum tissue temperature, which typically occurs at a depth of a few millimeters. The
displayed catheter tip temperature is measured at the electrode-tissue interface and may
be influenced by the degree of tissue contact and the convective cooling effects of blood
flow. Do not set the maximum temperature higher than 80ºC.

Selecting Temperature When Using the Catheter(T°) in TEMPERATURE Control Mode

If a Catheter(T°) is connected to the Controller, a desired value of catheter tip temperature
(temperature setpoint) can be selected. The Controller automatically adjusts power,
within a user-selected upper power limit, to achieve the desired catheter tip temperature,
in the Temperature Control mode.

To select the temperature setpoint for the Controller, follow these steps:

1. Ensure that the Controller is in READY mode.

6-10

Controls and Displays

2. Press the appropriate TEMPERATURE (&/') Button to increase or decrease the
temperature setpoint by 1°C.

3. To scroll rapidly to the desired temperature setpoint, depress and hold the appropriate
TEMPERATURE (&/') Button down.

4. Release the TEMPERATURE (&/') Button when the TEMPERATURE Display
shows the appropriate temperature setpoint.

The catheter tip temperature selection range is 30° to 80°C in increments of 1°C,
although the Controller cannot achieve a temperature which is less than the ambient
blood temperature (normally 37°C).

5. During RF power delivery (RF Power ON mode), the temperature setpoint can be
increased or decreased by pressing the appropriate TEMPERATURE (&/') Button.
When the TEMPERATURE (&/') Button is depressed, the display shows the new
temperature setpoint. When the button is released, the display shows the present
value of catheter tip temperature. Depressing and holding the TEMPERATURE
(&/') Button down while RF power is being delivered does NOT cause the
temperature setpoint to scroll up, but allows it to scroll down at a slightly greater rate
than it does when the Controller is in the READY mode.

Selecting Temperature When Using the Catheter(T°) in POWER Control Mode

If a Catheter(T°) is connected to the Controller, an upper temperature limit can be
selected. The Controller automatically decreases RF power to the Catheter if this value of
temperature is exceeded in the Power Control mode.

To select the temperature setpoint for the Controller, follow these steps:

1. Ensure that the Controller is in READY mode.

2. Press the appropriate TEMPERATURE (&/') Button to increase or decrease the

upper temperature limit by 1°C during RF power delivery.

3. To scroll rapidly to the desired temperature setpoint, depress and hold the appropriate
TEMPERATURE (&/') Button down. (The temperature value shown in the
TEMPERATURE Display is the maximum catheter tip temperature at which the
Controller attempts to deliver RF power for.)

4. Release the TEMPERATURE (&/') Button when the TEMPERATURE Display
shows the appropriate temperature setpoint.

The catheter tip temperature limit selection range is 55° to 85°C in increments of
1°C.

Setting the Time Control

The TIME Display, TIME & (increase) Button, and TIME ' (decrease) Button allow the
user to select the duration (in seconds) that RF power is delivered to the Catheter.

6-11

Operator’s Manual

To select the duration for RF power delivery, follow these steps:

1. Ensure that the Controller is in READY mode.

2. Press the appropriate TIME (&/') Button to increase or decrease the RF power

output duration (up to a maximum of 120 seconds).

3. To scroll rapidly to the desired duration, depress and hold the appropriate TIME
(&/') Button down.

4. Release the TIME (&/') Button when the TIME Display shows the appropriate
duration. (When the selected value is programmed into the Controller control
circuit.)

"

The value can be changed at any time during the READY mode by

Note

depressing the TIME & Button (increase) or TIME ' Button (decrease).

Clearing the Counter

"

Important

1. To clear the counter to zero, depress the CLEAR Button.

Always clear the Counter between patients.

6-12

Controls and Displays

f

Adjusting the Audio Control

The user may adjust the volume of the audio signal when the Controller is initially powered

on or during a clinical procedure.

1. Adjust the volume of the audio signal by rotating the Volume Control Knob on the
Controller rear panel (see Figure 6-10).

2. If desired during a clinical procedure, the Volume Control Knob may be rotated fully
counter-clockwise to its lowest setting

"

At the minimum setting, the tone may NOT be audible during RF power

Note

delivery.

Figure 6-10: Adjusting Audio Control

ANALOG OUTPUT

RF POWER

IMPEDANCE TEMPERATURE SPARE VOLUME

FOOT SWITCH RS-232

SPEAKER

Volume
Control

Knob

VOLUME

VOLUME

To increase the volume of
the audio signal, turn the
Volume Control Knob
clockwise.

To decrease the volume o
the audio signal, turn the
Volume Control Knob
counter-clockwise.

6-13

Turning the RF Power Delivery “ON”

Operator’s Manual

"

Important

Do not continue with this procedure unless all preceding procedures in this

chapter have been completed.

To deliver RF power to the Catheter, follow these steps:

1. Ensure that all connections are secure and correct.

2. Verify that all aforementioned selections have been made.

3. To begin RF power delivery, press the RF POWER CONTROL Button once or hold

the Footswitch down. The POWER Display shows the RF power delivered to the
Catheter (in W).

The Audible tone sounds during RF power delivery.

"

If the Controller is in the Temperature Control mode and the measured

Note

temperature is outside the range of 31oC to 43oC, the Controller does not deliver
RF power and an E07 error code message displays.

When RF power is delivered to the Catheter, the displays function as follows:

RF POWER CONTROL BUTTON/Light

This light illuminates and remains lit until RF power delivery is discontinued. (For
instructions on how to discontinue RF power delivery, see the section, Turning the RF
Power Delivery “OFF” on page 6-19.

POWER Display

This display shows (in W) RF power delivered to the Catheter. The value may fluctuate
slightly due to changes in tissue impedance.

6-14

Controls and Displays

TEMPERATURE Display

The readings on this display depends on the current control mode of the Controller
(Power Control and Temperature Control), the operational mode, and the type of catheter
connected. Table 6-1 summarizes the readings on the display under specified operating
conditions.

Catheter Type Control Mode TEMPERATURE Display Readings

Table 6-1: TEMPERATURE Display Readings

Catheter(T°) Temperature

Control Mode

Catheter(T°) Power Control

Mode

• At initial power on, display reading is 30°C.

• In READY mode, display shows the temperature

setpoint.

• In ON, CALIBRATE, or DONE operational

modes, display indicates measured catheter tip
temperature.

• If the measured temperature is outside the range
of 31°C to 43°C, the Controller does not deliver
RF power.

• In ON operational mode:

− If the temperature is within 20°C – 120° C

range, the measured temperature displays.

− If the measured temperature is below 20°C, the

message “LO” displays.

− If the measured temperature is above

120°C, the message “HI” displays.

• In READY mode, display reading is 85°C.

• In ON, CALIBRATE, or DONE operational

modes, display indicates measured catheter tip
temperature.

Catheter(Non-T) N/A

• In ON operational mode:

− If the temperature is within 20°C – 120° C

range, the measured temperature displays.

− If the measured temperature is below 20°C, the

message “LO” displays.

− If the measured temperature is above 120°C,

the message “HI” displays.

• Display shows three dashes (---)

6-15

Operator’s Manual

IMPEDANCE Display

This display shows measured impedance. The displayed readings may fluctuate slightly
due to variation in the stability of electrode/tissue contact as the heart beats. If the
measured value demonstrates a significant fluctuation, the Catheter should be
repositioned. Alternatively, slight pressure on the Catheter shaft may minimize Catheter
motion. Table 6-2 summarizes the readings on the display by impedance range.

Table 6-2: Impedance Display Readings

Impedance

Values

Typical Impedance

80 to 150

Low Impedance

Ω

1

< 50 Ω

< 25 Ω

High Impedance

2

> 300 Ω

Operating Condition Controller Activity Display

Reading

Normal operating
condition

Normal RF power
delivery

Display shows
measured
impedance

If accessing up to 50 W
of RF power

If accessing up to 100 W
of RF power

N/A Controller automatically

Controller automatically
shuts off RF power

Controller automatically
shuts off RF power

shuts off RF power

Display flashes
“LO”

Display flashes
“LO”

Display flashes
between
measured
impedance and
“HI”

1. Low impedance limit depends on type of catheter used in the ablation procedure.

2. High Impedance indicates abnormal operation. This condition also may occur if > 1 A is detected by the XP
APM from either DIP Electrode. Refer to the following procedure, Correcting a High Impedance Condition.

6-16

Controls and Displays

Correcting a High Impedance Condition

If a high impedance value is detected during RF power delivery, follow these steps:

1. Ensure that the connection between the Catheter and XP APM is correct and secure.

2. Ensure that the connect ion between each DIP Electrode and XP APM is correct and

secure.

3. Ensure that each DIP Electrode is properly applied.

4. If an improper cable connection is not the cause of the high impedance value, then a

build-up of coagulum on the Catheter tip may be the cause, and RF power output
should be discontinued.

5. To discontinue RF power delivery, refer to the instructions in section, Turning the

RF Power Delivery “OFF” on page 6-19.

TIME Display

This display shows the user-selected value and elapsed time as follows:

• When the RF POWER CONTROL Button is pressed or the Footswitch is depressed,

this display changes from the user-selected time limit to 0 seconds and begins to
count up to the user-selected value.

• When the preset duration has elapsed, the RF power automatically shuts “OFF.” The

user-selected value remains flashing on the TIME Display.

• If the RF POWER CONTROL Button is pressed during delivery of RF power or the

Footswitch is released, the RF power output immediately turns “OFF.” The actual
elapsed time in seconds remains flashing on the TIME Display.

COUNTER Display

This display increases by 1 count with each RF power delivery. This value resets to zero
at any time when the Controller is in the READY mode.

CONTROL Display

This display indicates the Controller’s current control mode (Power Control or
Temperature Control). The green LEDs indicate when the Controller is either in the
Power Control or Temperature Control modes, respectively.

6-17

Directions for Use

The Steerable Ablation Catheter is usually inserted into a vein or artery and is then
positioned into the appropriate chamber of the heart under fluoroscopic guidance. A
transseptal approach may be used. Precise placement of the catheter prior to ablat ion is
accompanied by endocardial mapping using the tip and/or ring electrodes. Once
appropriate positioning has been achieved, RF power is delivered via the EPT-1000 XP
Cardiac Ablation Controller resulting in the ablation of the targeted cardiac tissue.
Temperature can be monitored during the ablation procedure through the use of an EPT
temperature sensing catheter.

1. Pri or to insertion of the St eerable Ablation Catheter, prepare the ent ry site according

to standard aseptic technique practices.

2. Insert the catheter percutaneously into the appropriate artery or vein by the Seldinger

technique using an 8 French hemostatic introducer sheath.

3. Once inside the vessel, the catheter tip can be deflected as necessary to facilitate

advancement into the selected heart chamber. The degree of tip deflection is
controlled by the Steering Lever on the catheter handle. If the Steering Lever is
pushed forward from its neutral position, the tip curves proportionately up to a
maximum of 270 degrees in one direction depending upon the curve option selected.
Pulling the Steering Lever back causes the tip to deflect in the opposite direction. To
prevent over stressing the tip, the Steering Lever movement is limited by the handle
design.

Operator’s Manual

TM

4. When crossing the aortic valve with the ablation catheter, it is recommended that the

catheter tip be deflected to resemble a “pigtail” curve to avoid damage to the valve
leaflets.

5. The catheter curve can be straightened completely and deflected in the opposite

direction against cardiac tissue, facilitating stability during ablation.

6. The adjustable Tension Control Lever may be tightened to retain the tip in the

desired curvature or to increase steering resistance. The catheter is shipped with the
Tension Control Lever in the “(-)” position, which is the minimum tension
adjustment. In this position, the catheter steers freely and does not hold a preset
curve. Rotation of the Tension Control Wheel in the clockwise direction increase
tension. In the “(+)” position, maximum tension is achieved. The catheter should not
be steered in the maximum “(+)” position.

7. Connect the XP APM to the ISOLATED PATIENT CONNECTOR located on the

Controller’s front panel using the attached patient cable. Be sure to carefully follow
the instructions in the Operator’s Manual to connect the XP APM.

6-18

Controls and Displays

8. Connect the Steerable Ablation Catheter to the XP APM by plugging the Quick

Connect Instrument Cable.

9. When the ablation site has been accessed and the tip of the catheter is in contact

against the endocardial surface, intracardiac electrogram signals may be obtained.
Unipolar electrograms can be obtained between the distal tip electrode and any
commercially available low impedance ECG electrode. Bipolar electrogram
recordings can be recorded between the distal tip electrode and any ring electrode or
between any two ring electrodes.

10. When the arrhythmogenic site has been located, the same catheter can be used

therapeutically in the “Ablate” mode to deliver RF energy. RF power is delivered to
the tissue via the distal tip (ablation) electrode which results in thermal necrosis
(ablation) of the arrhythmogenic tissue.

11. The Thermistor Steerable Ablation Catheter differs from the Steerable Ablation

Catheter in that the distal tip electrode incorporates a th ermistor temp erature sensing
component and has associated electrical leads designed to monitor and/or control
temperature at the endocardial surface during the ablation procedure.

Turning the RF Power Delivery “OFF”

RF power delivery ceases by user intervention or certain operating conditions listing in
the next section, Possible Causes of RF Power Delivery Interruption.

To discontinue RF power delivery during operation (RF Power Done mode), the user may
either:

• Press the RF POWER CONTROL Button or

• Release the Footswitch.

Possible Causes of RF Power Delivery Interruption

RF power delivery can cease due to other operating conditions other than user
intervention. RF power ceases when:

• User-selected time limit has been reached.

• XP APM detects greater than 1 A in either of the two DIP Electrodes.

• Impedance is less than 50 Ω when accessing up to 50 W of RF power.

• Impedance is less than 25 Ω when accessing up to 100 W of RF power.

• Impedance is greater than 300 Ω.

• Temperature exceeds setpoint by 5o C for greater than four seconds (Controller in

Temperature Control mode).

• Temperature exceeds 85o C for greater than one second (Controller in Power Control

or Temperature Control mode with a Catheter(T°) connected).

6-19

Operator’s Manual

• Temperature is less than 20o C for greater than one second.

• Temperature exceeds temperature setpoint in Power Control mode (e.g., If

temperature is set at 60o C and measured temperature exceeds 60o C, RF power shuts
off).

• Upper temperature limit is exceeded twice during a single RF power delivery in

Power Control mode.

• System operation errors are detected.

Display Readings During Interruption of RF Pow er Del ivery

When RF power delivery ceases for any reason other than an out-of-range impedance
value or an error, the last value appearing on each display remains flashing and the RF
POWER CONTROL Light turns “OFF.”

If RF power delivery ceases due to an out-of-range impedance value, the l ast measured
impedance value remains flashing on the IMPEDANCE Display, alternating with the
appropriate “HI” or “LO” message.

If RF power delivery ceases due to an error, the last measured impedance value remains
flashing on the IMPEDANCE Display, alternating with the appropriate error code. (See
Table 8-3 for a listing of error codes.)

In any of the above cases, when either the RF POWER CONTROL Button or the
Footswitch is depressed again, the flashing display values change immediately to the
previous user-selected values and the RF POWER CONTROL Light begins flashing.
This signals that the Controller is ready for additional RF power deliveries. This is true
unless RF power delivery, while in the Power Control mode, is interrupted for exceeding
the upper temperature limit a second time. In this case, the set power is 50% of the value
of RF power which causes the upper temperature limit to be exceeded.

6-20

7. Service and Maintenance

The Controller requires no routine service or maintenance. If the Controller fails to
operate when plugged into a proper AC power receptacle and the power switch is t urned
on, check the fuse (refer to Replacing the Fuses in this chapter).

The Controller contains no user-serviceable parts; disassembly and attempted repair by
unqualified personnel may create a hazardous condition and voids the warranty.

% Call EPT for Service

Number: 408.895.3500).

!

Precaution

in personal injury and/or damage to the Controller.

Cleaning/Disinfecting

The outer surfaces of the Controller and its accessories may be cleaned with a mild soapy
solution. If disinfecting is required, isopropyl alcohol may be used to clean the outer
surfaces.

!

Precaution

or abrasive cleaners.

Replacing the Fuses

Replacing the Main Fuse

1. Before replaci ng a fuse in the Controller, disconnect the mains power cord from t he

Controller.

Do not remove the cover of the Controller. Removing the cover may result

Do not immerse the Controller or its accessories in any liquid. Avoid caustic

If a second failure occurs, notify EPT for service (Telephone

2. Repl ace the fuse with another of the same type and rating. Refer to the fuse label on

the rear panel (see Figure 5-10).

3. Pull the fuse holder out of the power entry module.

4. Use a slotted screwdriver to assist in removing the fuse holder.

5. Insert the new fuse in the fuse holder and reinsert it in the power input module.

"

When replacing the fuse holder, ensure the fuse holder is inserted in the

Note

correct orientation for the operational voltage level.

7-1

Operator’s Manual

Auxiliary Power Outlet Fuses

1. Before replaci ng a fuse in the Controller, disconnect the mains power cord from t he

Controller.

2. Repl ace the fuse with another of the same type and rating. Refer to the fuse label on

the rear panel (see Figure 5-10).

3. Use a slotted screwdriver to rotate the fuse holder counter-clockwise 1/8th of a turn.

The fuse holder “pops” out approximately 6 mm (1/4-inch).

4. Remove the fuse holder and the fuse.

5. Insert the new fuse in the fuse holder and reinsert it into the housing.

% Call EPT for Service

please contact EPT for instructions on returning the Controller to EP
Technologies for repair (Telephone Number: 408.895.3500).

If there appears to be a problem with the Controller,

7-2

8. Product Specifications

General Specifications

Table 8-1 lists the specifications for the System (Controller and XP APM).

Table 8-1: System Specifications

Description Specification

Power Specifications

Line Power 100 - 120 VAC (Model #800XP)
Current Rating

Fuse Rating 3 A, 50/60 Hz (100 - 120 VAC)
Auxiliary Power 100 - 120 VAC (Model #800XP)
Current Rating

Fuse Rating 1 A, 50/60 Hz (100 - 120 VAC)
Power Length Cord 10 ft

Footswitch

Cable Length 10 ft, Connector (to Controller): Polarized

Patient Cable to High Power
Automatic Personality Module

Length
Connector

High Power Automatic Personality Module

Dimensions

Height

Width

Depth

Weight

10 ft
“Multi-pin” Polarized Connector

1.8” (4.6 cm)

5.9” (15.0 cm)

3.1” (7.9 cm)

2.2 lb (1.0 kg)

8-1

Operator’s Manual

Table 8-1: System Specifications, Continued

Description Specification

High Power Automatic Personality Module, Continued

Recorder Connectors Quick Connect Connector
Catheter Connectors Quick Connect Connector
Indifferent Electrode Connectors Standard male 2-pin for commercial pads
Recorder Filters

Low Pass Filters Referenced to the INDIFFERENT ELECTRODE

Low Frequency Cutoff

7 kHz, -3dB at 7 kHz ± 2 kHz

High Power Disconnect Mechanism RF output ceases to the patient if more than

1 A flows in either INDIFFERENT
ELECTRODE.

Controller

RF Power Outputs

• 50 W maximum into a minimum impedance of
50 Ω, within a 1 A current limit

• 100 W maximum into a minimum impedance
of 25 Ω, within a 2 A current limit

Maximum RF power output based on catheter
type used and control mode.

Impedance

• Measures 50 Ω and above, if accessing up to
50 W of RF power

• Measures 25 Ω and above, if accessing up to
100 W of RF power

• Measures up to 999 Ω (Controller
automatically shuts off RF power at 300 Ω)

• Displays “LO” or “HI” outside the 25 Ω to
300 Ω range

8-2

Controls and Displays

Controller, Continued

Temperature

Table 8-1: System Specifications, Continued

Description Specification

With Catheter(T°) Connected and
Controller in Temperature Control Mode

With Catheter(T°) Connected and
Controller in Power Control Mode

With Catheter(Non-T) Connected Controller displays “---”
Normal Operating Condition:

With Controller in the Temperature
Control or Power Control Modes

Outside of Normal Operating Range Controller displays “LO” or “HI”

Dimensions

Height
Width
Depth
Weight

Allows selection of desired catheter tip
temperature (temperature setpoint) within the
range of 30° to 80°C.

Allows selection of upper temperature limit or
maximum temperature at which the Controller
continues to deliver the setpower.

Controller measures 20° to 120°C

8” (20 cm)
13” (33 cm)
21” (53 cm)
23 lb. (10.4 kg)

Time 0 to 120 seconds in increments of 1

second.

Counter 0 to 99 RF power deliveries

Low-Frequency Leakage (50/60 Hz);
Source Current, Patient Leads, All Outputs
Tied Together

Normal Polarity, Intact Chassis
Ground

Normal Polarity, Ground Open
Reverse Polarity, Ground Open
Sink Current, at 120 V Applied, All

Inputs
Chassis Source Current, Ground Open

<10 µA

<10 µA
<10 µA
<10 µA

<100 µA

8-3

Operator’s Manual

Table 8-1: System Specifications, Continued

Description Specification

Back Panel Analog Outputs Standard BNC connections to output

signals representing RF power,
impedance, and tip temperature.

Calibration Mode

Power Output 0 - 1 volt corresponds to 0 - 100 W,

continuous square wave

Impedance

Temperature

0 - 1 volt corresponds to 0 - 300 Ω,
continuous
square wave

0 - 1 volt corresponds to 20 - 120°C,
continuous square wave

8-4

Controls and Displays

Environmental Specifications

Table 8-2 lists the environmental specifications for the System.

Table 8-2: Environmental Specifications

Description Specification

Storage

Temperature

-40°C to 70°C
The unit should be gradually returned to the
operating temperature range before use and

stabilized for one hour before operation.
Relative Humidity 10% to 100%, non-condensing
Atmospheric pressure 500 to 1060 millibar

Operating

Temperature

10°C to 40°C
Relative humidity 30% to 75%, non condensing
Atmospheric pressure 700 to 1060 millibar

8-5

Power Delivery

(

)

As an enhanced patient safety feature, the output voltage and current of the System has
been limited. Under normal circumstances (normal patient impedances), the maximum
output power of the System is either 50 or 100 W, depending on catheter type and control
mode. In the event of unusually high or low tissue impedance, the System limits the
maximum power. A graph which depicts the maximum output power of the System as a
function of tissue impedance is shown in Figure 8-1.

Operator’s Manual

"

Only the maximum power is affected. If the power setting is less than the

Note

maximum power available, the System delivers the set power value.

Figure 8-1: Output Pow er vs. Tissue Impedance

100W, 2A

S/W v2.01 (50 Watt)

P

(Watts)

100

90

80

70

60

50

40

30

20

10

20 40 60 80 100 120 140 160 180 200 220 240 260 280 300 320 340 360

Z

Ohms

8-6

Controls and Displays

Error Codes

Table 8-3 defines the error codes for the EP Technologies Cardiac Ablation System.

Code Description

E01 Apparent power (Vrms * Irms) not greater or equal to real power
E02 Apparent power (Vrms * Irms) measured greater than the setpoint

Table 8-3: Error Codes

E03
E04

E05

E06 System Operation Error
E07 An attempt to enter RF Power On mode with a measured temperature

E08 Upper temperature limit (cutoff) exceeded for more than 4.0 seconds.
E09 Upper temperature limit (cutoff) exceeded for the second time.

E01-E03 Error Codes

If error codes E01-E03 are observed, it is recommended that the ablation be attempted
again.

% Call EPT for Service

(Telephone Number: 408.895.3500).

Limit exceeded: V 〉 Vmax or I 〉 Imax or P 〉 Pmax
Temperature is greater than setpoint by at least 5°C for greater than

four seconds
Temperature greater than 85°C or less than 20°C for greater than

second

outside the range of 31oC to 43oC.

If the error code displays again, notify EPT for service

E06 Error Code

If an E06 error code message occurs, turn the Controller “OFF.” Wait approximately five
seconds before turning the Controller “ON.”

% Call EPT for Service

procedure, or if the E06 error code message occurs again following successful
completion of the self-test procedure, notify EPT for service (Telephone Number:

408.895.3500).

If the Controller does not successfully pass the self-test

8-7

Figure 8-2: Labeling Symbols

Operator’s Manual

Power ON Power OFF

Increase Decrease Protective

Variability Clock:

Non-Ionizing

Radiation

Time Switch:

Timer

Loudspeaker Fuse Counter

Temperature at

Distal Electrode

Degree C

Earth Ground

Dangerous

Voltage

Alternating

Current

Defibrillator-Proof

Type Equipment

Attention, Consult

Accompanying

Documents

000

M

Calibration Clear Indifferent

Explosion

Hazard

(Dispersive)

Patch Electrode

Equipotentiality

Radio Frequency

Power (On/Off)

AP

8-8

9. Limited Warranty and Disclaimer

Limited Warranties

Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design
and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties
not expressly set forth herein, whether expressed or implied by operation of law or otherwise,
including, but not limited to, any implied warranties of merchantability or fitness. Handling,
storage, cleaning and storage, cleaning and sterilization of this instrument as well as other factors
relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond BSC's
control directly affect the instrument and the results obtained from its use. BSC's obligation
under this warranty is limited to the repair or replacement of this instrument and BSC shall not
be liable for any incidental or consequential loss, damage, or expense directly arising from the
use of this instrument. BSC neither assumes, not authorizes any other person to assume for it, any
other or additional liability or responsibility in connection with this instrument. BSC assumes no
liability with respect to instruments reused, reprocessed or resterilized and makes no warranties,
expressed or implied, including but not limited to merchantability or fitness for intended use,
with respect to such instrument.

Disclaimer and Exclusion of Other Warranties

There are no warranties of any kind which extend beyond the description of the
warranties above. EPT disclaims and excludes all warranties, whether expressed or
implied, of merchantability of fitness for a particular use or purpose.

Limitation of Liability for Damages

In any claim or lawsuit for damages arising from alleged breach of warranty, breach of
contract, negligence, product liability or any other legal or equitable theory, the buyer
specifically agrees that EPT shall not be liable for damages for loss of profits or revenues,
loss of use of the product, loss of facilities or services, any downtime costs, or for claims
of buyer’s customers for any such damages. EPT’s sole liability for damages shall be
limited to the cost to buyer of the specified goods sold by EPT to buyer which give rise to
the claim for liability.

The buyer’s use of this product shall be deemed acceptance of the terms and conditions of
these limited warranties, exclusions, disclaimers and limitations of liability for money
damages.

U.S.5195968; U.S.5254088; U.S.5257451; U.S.5336182;. U.S.5363861; U.S.5364351; U.S.5363874; U.S.5273535; U.S.5358478;
U.S.5395327, U.S.5456682; U.S.4566682; U.S.5531686; U.S.5524337; U.S.5309910; U.S.5313943; U.S.5398683; U.S.5471982;
U.S.5549108; U.S.5489275; U.S.5328467; other U.S. patents pending; foreign counterparts also pending.

EP TECHNOLOGIES, INC.

2710 Orchard Parkway

San Jose, CA 95134

9-1

Index

ablation procedures

temperature control, 6-10
temperature sensing catheter, 6-18
warnings, 3-1

accessories

footswitch, 1-1, 5-16
XP APM, 1-1

accessory atrioventricular conduction

pathways

indications for use, 2-1
adverse reactions, 3-4
analog outputs

description, 5-14
atrial flutter

indications for use, 2-1
audio control. See volume control knob
auxiliary power outlet

description, 5-15
AV block

indications for use, 2-1
AV nodal reentrant tachycardia

indications for use, 2-1
calibrating

analog outputs, 6-8
calibration panel

button, 5-11

illustration, 5-12
catheter

maximum power output, 5-3

naming conventions, v

Catheter(T°)

temperature selection, 6-10, 6-11

catheter tip temperature

selection, 6-10

connecting

DIP electrodes, 6-3
footswitch, 6-5
power cord, 6-1
quick connect instrument cable, 6-3
recorder equipment, 6-2
XP APM patient cable, 6-1

XP APM/EGM interconnect cable, 6-2
contraindications, 2-1
control modes

power control, 1-3

power delivery protocol, 1-3

selection, 6-9

temperature control, 1-3
control panel

button, 5-3

display, 5-2, 5-10

illustration, 5-2

indicator LEDs, 5-2

readings, 6-17
controller

naming conventions, v

repackaging, 4-1

self-test, 6-5

turn-on, 6-5

unpacking, 4-1

1

controller in other operating modes

control panel, 5-2, 5-10

Catheter(T°) connected, 6-7

controller in power control mode

Catheter(Non-T) connected, 6-9
Catheter(T°) connected, 6-7, 6-9

controller in temperature control mode

Catheter(T°) connected, 6-6, 6-9

counter panel

clear button, 5-10
clearing the counter, 6-12
display readings, 6-17
illustration, 5-10

DIP electrodes

connecting, 6-3
special considerations, 6-4

EMI

illustration, 5-1

impedance panel, 5-7

isolated patient connector, 5-12

mains display, 5-12

power panel, 5-4

RF power control panel, 5-10

temperature panel, 5-5

time panel, 5-9
fuse holders

description, 5-14
fuses

location of, 5-13

replacing, 7-1
ground stud

description, 5-15

effects, 3-3

error codes

correction, E01-E03, 8-7
correction, E06, 8-7
description, 8-7

features

actual outputs, 1-2
continuous unmodulated RF, 1-2
safety, 1-2
user-selectable parameters, 1-2

footswitch

cable connector, 5-14
connecting, 6-5
description, 5-16

front panel

impedance

correcting abnormal condition, 6-17
impedance panel

display, 5-7

illustration, 5-8

readings, 6-16
implantable cardioverter/defibrillators

warnings, 3-1
indications, 2-1
installation

diagram, 1-4

instructions, 6-1
isolated patient connector

description, 5-12
labeling symbols

calibration panel, 5-11

types of, 8-8

10-2

mains display

serial port, 5-15

description, 5-12

mains fuse holder

description, 5-14
naming conventions, v
pacemakers

warnings, 3-1
power control mode

compatibility, 1-3
power cord

description, 5-14
power delivery protocol, 1-3
power panel

display, 5-4

illustration, 5-4

power increase button, 5-5

volume control knob, 5-15
repackaging the system, 4-1
RF power control panel

button/light, 5-10

illustration, 5-11

status, 6-14
RF power delivery

causes of interruption, 6-19

control display, 6-17

counter display, 6-17

impedance display readings, 6-16

temperature display readings, 6-15

time display, 6-17

turning off RF power, 6-19

turning on RF power, 6-14

power switch

description, 5-13

location of, 6-6
precautions, 3-2
ready mode

description, 6-6
rear panel

analog outputs, 5-14

auxiliary power outlet, 5-15

footswitch cable connector, 5-14

fuse holders, 5-14

ground stud, 5-15

illustration, 5-13

mains fuse holder, 5-14

power cord, 5-14

RF power level

selection, 6-9
safety features, 1-2
selecting

catheter tip temperature, 6-10
control modes, 6-9
RF power level, 6-9
temperature setpoint, 6-10, 6-11
time control, 6-12

serial port

description, 5-15

specifications

analog outputs, 5-12
controller, 8-2
environmental, 8-5

power switch, 5-13

labeling symbols, 8-8

10-3

power delivery, 8-6

illustration, 5-5

system, 8-1
XP APM, 8-1

standards

ANSI/AAMI Standard HF-18, 1-1, 3-3
IEC-601, 5-14, 6-3, 6-8

steerable ablation catheter

use of, 6-18
warnings, 3-1

system

cleaning, 7-1
components, 4-1
description, 1-1
directions for use, 6-18
disinfecting, 7-1
fuse replacement, 7-1

readings, 5-6
temperature increase button, 5-7

time control

selection, 6-12

time panel

display, 5-9
illustration, 5-9
readings, 6-17
time buttons, 5-9

transaortic approach

warnings, 3-1

unpacking the system, 4-1
volume control knob

adjusting volume, 6-13
description, 5-15

maintenance, 7-1
naming conventions, v
repackaging, 4-1
specifications, 8-1
unpacking, 4-1
warranty, 9-1

temperature control mode

compatibility, 1-3

temperature display readings

Catheter(Non-T) connected, 6-7

temperature panel

display readings

Catheter(Non-T) connected, 5-6
Catheter(T°) connected,

temperature panel

warnings, 3-1
warranty, 9-1
XP APM

cable configuration, 1-5
connections, 5-16
description, 5-16
illustration, 5-17
naming conventions, v

5-6

display, 5-5

10-4

i