Ampere Generator IFU ENG

1
Ampere™ Generator INSTRUCTIONS FOR USE

INTERNATIONAL EDITION
Software Version 1.0
© Copyright 2015
WARNING: The use of this device in conjunction with a radio frequency ablation St. Jude Medical
catheter, as a part of the diagnosis and treatment of cardiac arrhythmias, Unless otherwise noted, ™ indicates that the name is a
may pose an increased risk of adverse events such as cardiac perforation, trademark of, or licensed to, St. Jude Medical or one of its
myocardial infarction, air embolism, and hematoma requiring surgical subsidiaries. ST. JUDE MEDICAL and the nine-squares
symbol are trademarks and services marks of St. Jude
repair and/or blood transfusion. Medical, Inc. and its related companies. © 2015 St. Jude
Medical, Inc. All Rights Reserved.
St. Jude Medical

One St. Jude Medical Drive
St. Paul, MN
55117-9913 USA
+1 855 478 5833
+1 651 756 5833
sjm.com
EC REP
St. Jude Medical

Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
Australian Sponsor:
St. Jude Medical Australia Pty Limited
17 Orion Rd.,
Rev. C 100081509-en
Lane Cove NSW 2066 2015-02
AUSTRALIA
+61 (02) 9936 1200
Ampere™ Generator Instructions for Use
2 International Edition Rev. C 100081509-en
Symbol Description Symbol Description
Date of Manufacture
Do not use if package is damaged.
Lot number
Package contains 1 item.
Catalog number
Defibrillator-proof type CF applied part
Serial number
Defibrillator-proof type BF applied part

Not for direct patient contact
Power switch
Refer to the instructions for use
AC Power
Consult the Instruction for Use
Power Plug
Dispose of hardware in accordance with

local law
Equipotential jack
Warning General
Serious injury can occur if care is not
taken during use of the system.
On carton: Transport/storage
temperature limitation
Caution
Humidity limitation Notified body CE Mark
Authorized representative in the

EC REP European community
Weight
Input Voltage, Input Frequency and

Replacement fuse information
Keep dry
Software
Manufacturer
In Metro Mark - Brazil
International Edition Rev. C 100081509-en 3
Symbol Description Symbol Description
Electrophysiology (EP) Recording

System Connection
Intertek Safety Agency
Certification
Mark Pump Connection
GenConnect cable connector
Remote Connection
Fiber optic cable connector
Dispersive patch cable connector

Remote Control
Ablation catheter cable connector Remote
Generator Accessories
Ablate
Rated Voltage
Rated Current
Menu
Footswitch
Preset
Generator
Up Button
Generator Kit
Down Button Generator and Remote Control
Non-ionizing electromagnetic radiation

Standby Button
IP68 Footswitch enclosure is dust tight and

protected against submersion in water
Electrogram Cable Connection
Neutral Electrode (Floating Ground)
Footswitch Connection
Fiber Cord Assembly Remote
USB Connection
This Page Intentionally Left Blank

Table of Contents
Chapter 1: Introduction . . . . . . . . . . . . . . . . 7 Chapter 5: Footswitch and Remote Control. . 39

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Overview . . . . . . . . . . . . . . . . . . . . ... ... .... ... .... ... 39
Precaution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Footswitch. . . . . . . . . . . . . . . . . . . ... ... .... ... .... ... 39
Indications For Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Remote Control . . . . . . . . . . . . . . . ... ... .... ... .... ... 40
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Features. . . . . . . . . . . . . . . . . ... ... .... ... .... ... 40
System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Remote Control Feet . . . . . . . . ... ... .... ... .... ... 40
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Remote Control Connections . . ... ... .... ... .... ... 41
User Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Rear Panel Connections. . . . . . ... ... .... ... .... ... 41
Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
System Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Chapter 6: Messages . . . . . . . . . . . . . . . . . . 43
Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Warnings, Precautions, and Adverse Reactions . . . . . . . . . . . . . 10
Appendix A: Ablation Parameters Examples . . 49

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Overview . . . . . . ... .... ... .... ... ... .... ... .... ... 49
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Example 1 . ... .... ... .... ... ... .... ... .... ... 49
Potential Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . 13
Example 2 . ... .... ... .... ... ... .... ... .... ... 50
Example 3 . ... .... ... .... ... ... .... ... .... ... 50
Chapter 2: Display, Controls, and Connections15 Example 4 . ... .... ... .... ... ... .... ... .... ... 51
Front Panel Controls . . . . . . . . . . . . . ... .... ... ... .... . . 15 Example 5 . ... .... ... .... ... ... .... ... .... ... 51
Display Panel . . . . . . . . . . . . . . . . . . ... .... ... ... .... . . 16
Appendix B: Technical Specifications . . . . . . 53

Connection Icons . . . . . . . . . . . . . . . ... .... ... ... .... . . 17
Rear Panel Connections. . . . . . . . . . . ... .... ... ... .... . . 18
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . ... .... ... 53
Power Specifications . . . . . . . . . . . . . . . . . . ... .... ... 53
Chapter 3: Operational Sequence. . . . . . . . . 19 Generator Output Specifications . . . . . . . . . . ... .... ... 53
Setup . . . . . . . . . . . . . . . . . . . . . . . ... .... ... ... .... . . 19 Physical Characteristics. . . . . . . . . . . . . . . . ... .... ... 54
Basic Operation . . . . . . . . . . . . . . . . ... .... ... ... .... . . 22 Environmental Specifications . . . . . . . . . . . . ... .... ... 54
Set Menu Parameters . . . . . . . . . . . . ... .... ... ... .... . . 24 Electromagnetic Emissions Declaration . . . . . ... .... ... 54
Access the Menu . . . . . . . . . . . . ... .... ... ... .... . . 24 Electromagnetic Immunity Declaration I . . . . ... .... ... 55
Ablation Parameters . . . . . . . . . ... .... ... ... .... . . 25 Electromagnetic Immunity Declaration II. . . . ... .... ... 56
Pump Parameters . . . . . . . . . . . ... .... ... ... .... . . 27 Separation Distances. . . . . . . . . . . . . . . . . . ... .... ... 57
Auto Flow . . . . . . . . . . . . . . . . . ... .... ... ... .... . . 28
Appendix C: Maintenance . . . . . . . . . . . . . . 59
Ablation Results and Diagnostics ... .... ... ... .... . . 29
Presets . . . . . . . . . . . . . . . . . . . . . . ... .... ... ... .... . . 35
Define a Preset . . . . . . . . . . . . . ... .... ... ... .... . . 35 SERVICE AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . 59
Service and Maintenance for Cool Point™ Irrigation Pump . 59
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Chapter 4: System Setup Diagrams . . . . . . . 37 Cleaning/Replacing the Ampere™ Generator Air Filter . . . . 59
Cool Point™ Irrigation Pump Setup . . . . . . . . . . . . . . . . . . . . . 37 Replacing the Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 No User-Serviceable Components . . . . . . . . . . . . . . . . . . . 59
Setup the Ampere™ Generator with the Cool Point™ Irrigation Disclaimers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Software Licensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Prime the Tubing and Catheter . . . . . . . . . . . . . . . . . . . . . 37
Appendix D: Graphs . . . . . . . . . . . . . . . . . . 61
Adjust Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Ampere™ Generator Setup with Cool Point™ Irrigation Pump
Output Power vs. Load Resistance (Set) vs. (Measured) . . . . . . . 61
and Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Output Power vs. Load Resistance . . . . . . . . . . . . . . . . . . . . . . 62
Maximum Output Voltage Peak Value (Set) vs Output Voltage Peak
Value (Measured) vs. Load Resistance . . . . . . . . . . . . . . . . . . . 63

Introduction Chapter 1
Preface
The use of all components and accessories of the Ampere™ Generator is described in this manual. The ablation catheter description
can be found in a separate instruction for use manual available with the catheter. This manual provides a description of the Ampere™
Generator, its controls and displays, and a sequence for its operation. This Ampere™ Generator can operate with/without the Cool
Point™ Irrigation pump. Other important information has also been supplied for the user’s convenience.
Precaution
DO NOT attempt to operate the Ampere™ Generator before thoroughly reading this Instructions for Use. The Ampere™ Generator
Instructions for Use should be read, understood, and followed carefully. For future reference, keep this manual in a convenient, readily
accessible place.
Indications For Use
The Ampere™ Generator is intended for use with an EP ablation catheter in creating endocardial lesions during cardiac ablation
procedures to treat cardiac arrhythmias.
Contraindications
The use of this device is contraindicated in patients with active systemic infection.
8 System Description International Edition Rev. C 100081509-en
System Description
Overview
The Ampere™ Generator generates radiofrequency (RF) current, at 485 KHz, to be used during RF catheter ablation procedures of
the heart. The Ampere™ Generator operates in conjunction with an external Disposable Indifferent Patch (DIP) electrode (such as the
1149C-LP by 3M™ or equivalent) and a compatible ablation catheter with an associated cable. The Ampere™ Generator delivers RF
power in a unipolar mode between the ablation catheter's distal electrode and the DIP electrode. For more information regarding the
ablation catheter, refer to its instruction manual.
The Ampere™ Generator features a color LCD screen and easy-to-use controls for setting the desired ablation parameters and for
monitoring ablation progress. The generator can be controlled from the front panel of the main unit or by an optional remote control
unit connected via fiber optic cables. Additional accessories to the generator include an optional footswitch the operator can use to
turn on or off RF delivery. When connected with a compatible St. Jude Medical Cool Point™ irrigation pump, the Ampere™ Generator
provides additional pump control options for use with an irrigated ablation catheter. The Ampere™ Generator is designed to be used
with ablation catheters having integrated temperature sensors, and can measure temperature from a thermistor or up to 2
thermocouples. The Ampere™ Generator provides for connection to an electrophysiologic recording system and the EnSite™
Velocity™ cardiac mapping system.
User Features
The Ampere™ Generator continuously and automatically monitors electrical impedance between the ablation catheter and DIP
electrode at 485 KHz and displays the impedance on the LCD screen. Likewise, temperature from the catheter's temperature sensor is
also continuously and automatically monitored and displayed. RF parameters of power output, temperature, duration, and an
impedance limit are controlled from the front panel using up/down buttons. Frequently-used RF parameters can be programmed into
one of 4 presets also accessible from the front panel. Additional display and ablation control options are accessed through a menu and
turn knob control. RF energy can be turned on or off from a single push-button. A standby button is also available for emergency cutoff
of RF energy. Displays and controls on the main unit are identical on the optional remote control such that changes made to settings
on either the main unit or the remote control are reflected on both.
TempGuard™ Feature
The Ampere™ Generator features a user selectable temperature control algorithm, referred to as the TempGuard™ feature . When the
TempGuard™ feature is selected (through the Ablation Parameters menu), the generator operates in temperature control mode, and
power output from the generator is automatically modulated so that the temperature measured from the catheter remains at or below
the user set temperature. In temperature control mode, additional options are available to control the initial response time of the
TempGuard™ feature. Note that if insufficient power is selected while in temperature control mode, the user set temperature may not
be achieved.
When the TempGuard™ feature is turned off, the generator operates in power control mode. In this mode, the user set power is output
by the generator within a user settable ramp-up time, and then maintains that power. In power control mode, a user set cutoff
temperature can be applied such that RF will automatically terminate if the catheter temperature exceeds the user set temperature.
Impedance Control
An impedance limit on the main display can be set using the up/down arrows, where RF will automatically stop if the measured
impedance exceeds the limit. Additionally, an optional delta impedance cutoff can be selected. This delta impedance cutoff will
automatically stop RF delivery if impedance changes by a user selected amount over a time window of 1 to 10 seconds.
Cool Point™ Irrigation Pump Integration

When used with an irrigated catheter and a Cool Point™ Irrigation Pump, the Ampere™ Generator automatically communicates with
the pump and allows changing of pump parameters from the generator (through the Pump Parameters menu). The Ampere™ Generator
can also be set to automatically change the irrigation rate during ablation if either the power or temperature reach a user defined level.
International Edition Rev. C 100081509-en System Hardware 9
Customizable Information Displays

Various additional options are also available to the user from the menu, including statistics on power, temperature, and impedance from
previous ablation applications, display of additional information during ablation applications, and language, audio volume, and screen
brightness control.
Safety Features
The Ampere™ Generator has many safety features and includes a separate standby button on the front panel to disable RF delivery;
automatic RF shutoff if the impedance < 50 ohms or > 300 ohms or greater than the user set impedance limit; and automatic RF shutoff
if the catheter temperature > 80 °C or if the catheter temperature exceeds the user set temperature by more than 5 °C for more than 3
seconds.
System Hardware
Components
■ Ampere™ Generator
■ Footswitch
Cables
■ Country-specific power cords
■ Equipotential Cable
■ 4 Lead EGM Cable
■ Serial DB9 Cable
■ 1641 Cable - Catheter Extension Cable
■ Disposable Indifferent Patch (DIP) (x2)
■ GenConnect Cable
Accessories
This accessory is available for use with the Ampere™ Generator:
■ Remote Control with power cords, equipotential cable, and fiber optic connecting cables
10 Warnings, Precautions, and Adverse Reactions International Edition Rev. C 100081509-en
Warnings, Precautions, and Adverse Reactions
Definitions
WARNING: A warning contains instructions for avoiding hazardous situations that could cause significant injury to a patient or
operator.
CAUTION: A caution contains instructions for avoiding hazards that could adversely affect system components or system
performance.
NOTE: A note contains specific information relative to the subject at hand.
Warnings
WARNING: Cardiac ablation procedures should be performed only by physicians thoroughly trained in the techniques of
radiofrequency catheter ablation in a fully-equipped electrophysiology laboratory.
WARNING: Catheter ablation procedures present the potential for significant x-ray exposure, which can result in acute radiation
injury as well as an 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 have been taken to
minimize this exposure. Careful consideration must therefore be given for use of the device in pregnant women. The
long-term risk of protracted fluoroscopy has not been established; therefore, careful consideration must be given for the
use of the device.
WARNING: Pacemakers and implantable cardioverter/defibrillators can adversely be affected by Radiofrequency (RF) signals. It is
important to a) have temporary external sources of pacing and defibrillation available during ablation, b) deactivate
ICD’s as they could discharge and injure the patient or even damage the ICD’s during the ablation procedure, c) exercise
extreme caution during ablation when in close proximity to atrial or ventricular permanent pacing leads, and d) perform
complete pacing system analysis on all patients after ablation.
WARNING: Ablation within the coronary arterial vasculature has been associated with myocardial infarction and death.
WARNING: Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for
clinical manifestations of infarction and stroke.
WARNING: The long-term risk of lesions created by RF ablation has not been established. In particular, any long-term effects of
lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
WARNING: When using an EP recording system, the equipment must be front-end isolated or have an isolated patient cable.
WARNING: Failure of the Ampere™ Generator could result in an unintended power output increase. In case of system malfunction,
attempt to stop RF delivery by a) using the front control panel’s Standby button, b) releasing the footswitch, or c) turning
the rocker switch on the rear panel to the off position. If none of the previous attempts turns off the power, disconnect
the power cord.
WARNING: The Ampere™ Generator back panel connectors are NOT isolated. Never connect them directly to a patient. Always plug
external devices into an isolation transformer. Do not touch any connectors or equipment affixed to these connectors and
the patient at the same time.
WARNING: The Ampere™ Generator is not suitable for use within Oxygen Rich Environments or in the presence of flammable
gases, including flammable anesthetic mixtures with air or with oxygen or with nitrous oxide.
WARNING: The Ampere™ Generator should not be used adjacent to or stacked with other equipment.
WARNING: Two Dispersive Pad electrodes must be used when power levels exceed 50 Watts to minimize the potential of skin burns.
International Edition Rev. C 100081509-en Warnings, Precautions, and Adverse Reactions 11
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
Precautions
CAUTION: While using an irrigated catheter, the temperature displayed on the Ampere™ Generator is the temperature of the cooled
electrode at the tip of the catheter—not the tissue temperature.
CAUTION: Always verify that the tubing and catheter have been properly cleared of air prior to inserting the catheter into the
vasculature since entrapped air bubbles may cause emboli. Also, inspect IV tubing for sufficient continuous flow prior
to its use as non-continuous flow may lead to coagulation within and around the distal electrode resulting in blockage of
irrigation ports.
CAUTION: Peri-procedural anticoagulation therapy is recommended for patients undergoing left-sided and transeptal cardiac
procedures and should be considered for selected patients undergoing right-sided procedures.
CAUTION: The catheter impedance display of the Ampere™ Generator 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 should be evaluated and cleaned (if necessary) to eliminate any coagulum.
CAUTION: Do not immerse cable connectors in fluids; electrical performance could be adversely affected.
CAUTION: Adequate filtering must be used to allow continuous monitoring of the surface electrocardiogram (ECG) during
radiofrequency power applications. Monitoring systems incorporating high-frequency current-limiting devices are
recommended.
CAUTION: Desired ablation parameters must be set by the user; otherwise, the default values will be used.
CAUTION: Choose the lowest possible output power for the intended purpose.
CAUTION: Read and follow the DIP electrode manufacturer’s instructions for use.
CAUTION: Standard grounding procedures should be followed if electrosurgical instruments are used.
CAUTION: The Ampere™ Generator 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. This can be achieved by placing a non-
conductive material between the patient and the grounded metal surfaces. DIP electrode attachments are to be as close
to the operating field as possible.
CAUTION: Position connecting cables in such a manner that contact with patient or other leads is avoided.
CAUTION: Accessory equipment connected to the analog and digital interfaces must comply with the respective IEC standards (IEC
60950 for data-processing equipment and IEC 60601-1 for medical equipment). Additional equipment connected to the
signal input or output connections comprise a medical system and therefore, must comply with the requirements of IEC
60601-1-1 or 60601-1:2005.
CAUTION: 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 the power before checking for obvious
defects or misapplication.
CAUTION: Use non-flammable agents for cleaning and disinfecting.
CAUTION: Placement must allow adequate airflow around the unit for cooling.
CAUTION: Regularly inspect and test reusable cables and accessories.
CAUTION: Do not connect items which are not specified as part of system.
CAUTION: This equipment generates, uses, and can radiate radio-frequency energy and, if not installed and used in accordance with
the instructions may be interfered with by other equipment, even if that other equipment complies with CISPR emission
requirements or may cause harmful interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful interference to devices—
which can be determined by turning the equipment off and on—the user is encouraged to correct the interference by one
or more of the following measures:
1. Reorient or relocate the receiving device.
2. Increase the separation between the equipment.
3. Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.
4. Consult the manufacturer for help.
CAUTION: Follow the system installation to achieve optimal use.
CAUTION: When used in conjunction with Cool Point™ Irrigation Pump:

1. Refer to the Cool Point™ Irrigation Pump operator manual to troubleshoot the Cool Point™ Irrigation Pump.
2. The Cool Point™ Irrigation Pump tubing set is required for use.
3. If the communication cable used between the Cool Point™ Irrigation Pump and the Ampere™ Generator becomes
loose or disconnected, cease ablating until the cables are reconnected and secured.
4. Sterile extension IV tubing may be used with the Cool Point™ Irrigation Pump tubing set.
NOTE: This device and accessories should be recycled according to local and national laws after useful life.
NOTE: This equipment has been tested and found to comply with the limits for medical devices in IEC 60601-1-2. These limits
are designed to provide reasonable protection against harmful interference in a typical medical installation.
International Edition Rev. C 100081509-en Warnings, Precautions, and Adverse Reactions 13
Potential Adverse Reactions

Adverse events (in alphabetical order) that may be associated with catheterization and/or cardiac ablation include:
Air embolism Arrhythmia

Arterial/venous thrombosis Arterial spasm
AV Fistula Back pain
Blood loss requiring transfusion Cardiac perforation
Cardiac tamponade Chest pain
Death Groin hematoma
Groin pain Hemothorax
Hypotension Infection
Myocardial infarction Peri-cardial effusion
Phrenic nerve damage Pneumothorax
Pseudoaneurysm Skin burns caused by electrical current
Stroke Thrombotic events
Transient ischemic attack Unintended complete heart block requiring pacemaker
insertion
Unintended sinus node dysfunction requiring pacemaker Valvular damage
insertion
Vascular trauma Vasovagal reaction

Display, Controls, and Chapter 2

Connections
Front Panel Controls
1
2
3
9 4
5
8 7 6
Figure 1. Front Panel Controls
Callout Name Description

1 RF energy delivery • Press to begin delivery of RF energy. Press again to stop RF energy delivery.
Button
2 Menu Button • Displays/hides the Menu.
3 Menu Knob • Rotate the knob to navigate through the menu options.
• Press the knob to select a menu option.
4 Preset Button • Displays the Preset menu (4 assignable presets and default settings).
5 Standby Button • Red light is on while in standby (Standby message displays on-screen).
• Press to toggle On/Off Standby.
• Both the main and Remote unit Standby buttons must be Off to disengage Standby.
6 EGM Connector • For connecting to an EP recording system to display the intracardiac signal.
7 Indifferent Electrode • For connecting the Ampere™ Generator to the Disposable Indifferent Patches.
Connectors (2)
8 Catheter Extension • For connecting the catheter to the Generator.
Connector
9 Arrow Buttons • Press up (increase) or down (decrease) arrows to adjust parameter settings:
• Power (Watts), Temperature (°C), Impedance (Ω), Time (Seconds)
16 Display Panel International Edition Rev. C 100081509-en
Display Panel
Therapy data display, parameter adjustments, and generator setup are made through the display panel.
3 4 5 6
Figure 2. Display Panel

1 Real-time Display • Displays Power, Temperature, Impedance, and Time values as therapy is being
delivered. Displays Temperature and Impedance when RF energy is not being
delivered.
2 Display • Menu display area and therapy feedback.
3 User Set Power • Watts of power to be delivered to the catheter location.
• Arrows increase/decrease power threshold in 1 Watt increments.
4 User Set • Temperature to be reached at the catheter sensor location.
Temperature • Arrows increase/decrease temperature threshold in 1°C increments.
5 User Set • Impedance between the ablation electrode and the DIP electrode(s). If impedance goes
Impedance above set limit, RF energy delivery stops.
• Arrows increase/decrease impedance threshold in 1Ω increments.
6 User Set Time • Time elapsed from when the RF energy delivery button was pressed -- RF energy
delivery stops when the set time is reached.
• Arrows increase/decrease time duration in 1 second increments.
International Edition Rev. C 100081509-en Connection Icons 17
Connection Icons
The Connection Icons indicate the state of connected accessories:
Figure 3. Connection Icons
Icon Name State Description

TempGuard™ Gray • The TempGuard™ feature is not enabled.
Feature White • The TempGuard™ feature is enabled and ready.
Green • The TempGuard™ feature is active.
DIP X2 Gray • Programmed RF energy delivery power is ≤ 50 Watts — only one Disposable
Indifferent Patch is required.
Yellow • Programmed RF energy delivery power is > 50 Watts — two Disposable
Indifferent Patches are required.
Catheter Gray • Catheter is not connected.
Green • Catheter is connected.
Remote Gray • Remote control is not connected.
Control Green • Remote control is connected and communicating with the Ampere™
Generator.
Footswitch Gray • Footswitch is not connected.
Green • Footswitch is connected and communicating with the Ampere™ Generator.
Pump Gray • Pump is not connected.

White • Pump is connected and ready.
Green • Pump is running.
18 Rear Panel Connections International Edition Rev. C 100081509-en
Rear Panel Connections
1 6
7 11
2
8
3
4 9 10
Figure 4. Rear Panel Connections
1 Footswitch Connector Connects to the footswitch.

2 Equipotential Ground Connects the Ampere™ Generator to the hospital equalization connection
Connector point.
3 Main Power Switch “I” position is on.
“O” position is off.
4 Power Cord Connector AC power cord plug in.
5 Fiber Optic Connector Single Fiber Optic port to connect to the (optional) Remote Control. Leave
plug in place when not using this port.
6 Dual Fiber Optic Connector Dual fiber optic port to connect to the (optional) Remote Control.
7 Fiber Optic Transceiver Fiber optic port for future use.
Connector
8 USB Port USB memory stick connection.
9 DB 15 Serial Port (female) Connection for Cool Point™ Irrigation Pump interface
10 DB9 Serial Port (female) Connection for EP recording system interface
11 GenConnect Connects the ablation catheter to the EnSite™ Velocity™ Cardiac Mapping
System Amplifier for isolation of the location signal.
Operational Sequence Chapter 3
Setup
Action Notes
Do not position the Ampere™ System equipment so that it is
difficult to disconnect the system from the mains supply.
Connect the Ampere™ Generator power cord plug (rear
panel) into a properly-grounded AC electrical outlet. To ensure
proper grounding, the power cord plug must be installed in an
AC electrical wall outlet designed for “Hospital Grade” or
“Hospital Only.” Never use an outlet without a grounding
connection.
Use an EGM cable to connect the EGM output of the

Ampere™ Generator to an ECG junction box for recording
intracardiac signals.
NOTE: The Ampere™ Generator Cardiac Ablation

System may only be connected to
recording systems providing patient
electrical isolation in accordance with IEC-
60601-1.
Install the connector from the DIP Electrode into the indifferent
electrode connector on the front panel of the Ampere™
Generator. Gently push the DIP electrode fitting straight in
until it is firmly in place. To unplug, grasp the DIP electrode
fitting and gently pull it out of the receptacle.
WARNING: Use two DIP electrodes if power greater than 50W

is anticipated to be needed.
20 Setup International Edition Rev. C 100081509-en
Action Notes
Connect the Ampere™ Generator to the Cool Point™
Irrigation Pump (Optional) through the interface cable; refer to
the section “Cool Point™ Irrigation Pump Setup” on page 37.
Connect the Ampere™ Generator to a recording system using

a serial DB9 cable.
Connect the Ampere™ Generator to the EnSite™ Velocity™

Cardiac Mapping System using the GenConnect cable.
NOTE: This connection required for correct location on

the EnSite™ Velocity™ Cardiac Mapping System.
For use with the VeriSense™ System, this
connection is NOT used; see “VeriSense™
System Setup” on page 39.
International Edition Rev. C 100081509-en Setup 21
Action Notes
Connect the Footswitch.
NOTE: Optional connection. See “Footswitch and Remote

Control” on page 39 for Footswitch connection
details.
Connect the Remote Control.

• Remote Control connection requires one single fiber optic
cable and one dual fiber optic cable.
NOTE: Optional connection. See “Footswitch and Remote

Control” on page 39 for Remote Control
connection details.
22 Basic Operation International Edition Rev. C 100081509-en
Basic Operation
Step Action Notes

1 Turn on the Ampere™ Generator. Wait until the Ampere™ Generator displays the main
screen:
NOTE: When the Ampere™ Generator powers on,
the settings at the bottom of the screen
(Power, Temperature, Impedance, Time)
return to the defaults, as shown. Also, all
menu parameters (as shown in “Set Menu
Parameters” on page 24) reset to the
defaults.
2 Connect a catheter extension cable to the yellow

connector on the front of the Ampere™ Generator.
• Align the connectors' index keys and insert until the
connector clicks into place.
• To remove, first pull back on the locking collar of the
catheter extension cable, then pull on the cable. 

3 Connect the catheter extension cable to an ablation

catheter; the “Catheter not connected” message is
removed.
NOTE: Refer to the catheter IFU for settings and

purging irrigated catheters if applicable.
NOTE: See “System Setup Diagrams” on page 37

for information on pump setup and
operation.
4 Press the Arrow buttons to adjust the corresponding

settings.
International Edition Rev. C 100081509-en Basic Operation 23
Step Action Notes

5 Press the Ablation button to deliver RF energy.
• RF energy delivery will stop if the user-set duration is
reached or if the RF delivery button is pressed again.
Alternatively, press and hold the Footswitch to deliver
RF.
• The Footswitch delivers RF energy while it is held
down or until the user-defined time expires.
NOTE: Press the Standby button to suspend all
Ampere™ Generator activity and RF
delivery.
Both the main unit and the Remote’s
Standby buttons must be Off to disengage
standby mode.
During RF delivery, the user-configured information
displays in the middle of the screen (see “Display
Options” on page 31 on how to change the information
that displays during RF delivery).
Figure 5. Screen displaying “Ablation Data” during RF

delivery.
6 After RF delivery ends, the center of the screen
displays the average and maximum power,
temperature, and impedance attained during that
session, as well as the duration of RF energy delivery
in seconds.
Figure 6. Post-RF Delivery display.

24 Set Menu Parameters International Edition Rev. C 100081509-en
Set Menu Parameters
NOTE: When the Ampere™ Generator restarts, all menu parameters shown in this section reset to the defaults. Be sure not to
power off and restart the Ampere™ Generator after you set the menu parameters or you will need to reset the parameters
again after restart.
Access the Menu

Use the menu system to set various system parameters:
Step Action Notes

1 Press the Menu button.
2 Rotate the knob to highlight the desired menu option.
3 Press the knob to select the highlighted menu option.
4 Use this procedure to navigate all of the Menu system’s options.

5 Press the Menu button again to exit.
International Edition Rev. C 100081509-en Set Menu Parameters 25
Ablation Parameters
Figure 7. Ablation Parameters Screen
Menu Option Selection Description
Ablation Ablation
Parameters
TempGuard™ OFF When the TempGuard™ feature is turned off, the
generator operates in power control mode. In this mode,
the user set power is reached by the generator within
the adjustable time period (see below), and then
maintains that power. Also, a user-set cutoff
temperature can be set in Temperature Cutoff (see
below) so that ablation will automatically terminate if the
catheter temperature exceeds the cutoff temperature.
ON When the TempGuard™ feature is turned on, the
generator operates in temperature control mode, and
power output from the generator is automatically
modulated so that the temperature measured from the
catheter remains at or below the user set temperature.
NOTE: If insufficient power is set, the user set

temperature may not be achieved.
Temperature OFF When Temperature Cutoff is Off, measured temperature
Cutoff is displayed but does not cause ablation to automatically
terminate unless the measured temperature exceeds 80
°C.
ON Available only if the TempGuard™ feature is Off. When
Temperature Cutoff is On, ablation is automatically
terminated if the measured temperature exceeds the
user set temperature.
Ablation Ramp-up Time 2 seconds • The number of seconds the system takes to reach
Parameters desired user-selected power setting.
• In temperature control mode and if the selected
6 seconds
temperature is reached before full power is applied,
10 seconds power output from the generator is automatically
modulated so that the temperature measured from the
catheter remains at or below the user set temperature.
Auto • In temperature control mode, the Auto setting uses an
algorithm to automatically increase power based on
the difference between the measured temperature and
the user-set temperature. The actual ramp time will
depend on this temperature difference and the user
set power.
NOTE: If insufficient power is set, the user set

temperature may not be achieved.
Delta Impedance Cutoff
Disable Disables Impedance Cutoff feature.
Enable Delta Delta Impedance cutoff automatically stops ablation if
Impedance impedance changes by the selected amount (1-50) over
• 1-50 Ω the specified Delta Time window of None, 1-10 sec.
Delta Time • None: When Delta Time is "None," RF energy delivery
• None will automatically stop if there is a nearly
• 1-10 seconds instantaneous impedance change greater than or
equal to the Delta Impedance value (1-50 Ω, above).
• 1-10: 1-10 seconds, in 1 second increments.
Pump Parameters
Figure 8. Pump Parameters
Pre 1-3 sec Tip Cool Time is the amount of time in seconds that irrigation is
Tip Cool Time at the high flow rate before and after an RF application.
Post 1-3 sec
Pump Low 2-5 Flow Rate is the amount of saline irrigation in ml/min at the
Parameters ml/minute basal rate (low) or when RF is being applied (high).
Flow Rate
High 6-40
ml/minute
Auto Flow
Figure 9. Auto Flow Screen (Power Enable shown)
Disable Disable Disables the AutoFlow feature.

Below 6-40 ml/minute For Power Enable, if the power delivered is below the Set
Power Point, the irrigation rate during RF delivery is the value in
Set Point 1-100 Watts
Enable the "Below" field. If the power delivered is above the Set
Above 6-40 ml/minute Point, the irrigation rate is the value in the "Above" field.
Auto Flow
Below 6-40 ml/minute For Temperature Enable, if the temperature delivered is
below the Set Point, the irrigation rate during RF delivery
Temperature Set Point 15-80° C
is the value in the "Below" field. If the temperature
Enable
Above 6-40 ml/minute delivered is above the Set Point, the irrigation rate is the
value in the "Above" field.
Ablation Results and Diagnostics
Figure 10. Ablation Results Screen
Ablation Results Display Displays Baseline, Minimum, Maximum, and Average for
Power, Temperature, and Impedance parameters.
1 2 2 1
• The Ablation Results Display screen displays information about the most recent
999 ablation records.
• Click |< or >| (#1) to move to the oldest or newest record
• Click < or > (#2) to move one record back or forward.
• If 999 records exist, a message displays, and the next ablation session will
overwrite the oldest record.
• Select Copy to USB to save the most recent 999 records to a USB drive (see
below). Saving records to USB will not erase those records from the system.
• Select Clear (see below) to delete all records.
Ablation Results Copy to USB Copies the ablation results to the USB drive inserted into the
USB connection on the rear of the Amplifier (not the Remote).
See “Rear Panel Connections” on page 18.
Clear Erases all Ablation Results records.
Ablation Diagnostics Display Displays the Ablation Counter and Total Time results.
Clear Erases all Diagnostics results.
Figure 11. The Ablation Diagnostics Screen

Display Options
Figure 12. Display Options Screen
Menu Option Selection Display Results
Display Determines the type of information to display in the center area of the screen.
Options • The selected information displays while RF is being delivered; when RF terminates, the screen
displays the Average/Maximum data for the session.
No Display No data displays in the middle of the screen.
Ablation Counter Number of Ablations Performed
Pump Data Flow Rate and Dispensed Volume

Menu Option Selection Display Results
Display Ablation Data Baseline and change from baseline (Delta) for Impedance and
Options Temperature
Ablation Counter and Data Displays all Ablation and Pump data
System Configuration
Figure 13. System Configuration Screen
Menu Options Selection Description
System Configuration Configuration Language Change the display and Menu system language
(requires system restart).
Audio Audio prompt volume control (except for system
warning prompts).
Brightness Screen brightness control.
Tools Restore Default Settings Restores the Ampere™ Generator to the original
factory settings.
Engineering Logs Copies the Engineering log files for
troubleshooting system issues to a USB memory
stick connected to the rear panel.
Set date & time Set system date and time (requires system
restart).
About
Figure 14. The About Screen
Menu Option Description
About Displays the system Software Version, Model Number, and Region
information.
International Edition Rev. C 100081509-en Presets 35
Presets
Define a Preset
You can define up to four custom presets, which hold parameters for Power, Temperature, Impedance, and Time.
Step Action Notes

1 Press and hold the Presets button until the presets
menu displays.
2 Rotate the knob to select a preset number
3 Use the arrow buttons to adjust the parameters.
4 Press the Presets button to save the preset.

• See “Recall a Preset” on page 36 to use a defined
preset.
36 Presets International Edition Rev. C 100081509-en
Recall a Preset
After you define a preset with custom settings (see “Define a Preset” on page 35), you can recall that preset at any time.
Step Action Notes

1 Press the Presets button.
2 Rotate the knob to select a preset number
3 Press the knob to select the preset.
4 The selected presets are loaded.

System Setup Diagrams Chapter 4
Cool Point™ Irrigation Pump Setup
Overview
This section describes how to setup the Cool Point™ Irrigation Pump. For more detailed instructions, see the Cool Point™ Irrigation
Pump Instructions for Use, the Cool Point™ Tubing Set Instructions for Use, and the irrigated catheter Instructions for Use.
CAUTION: Prior to insertion of the catheter into the patient, purge all the air through the IV tubing and the catheter lumen. Entrapped
air bubbles may cause emboli. Patient should be closely monitored during the post-ablation period for clinical
manifestations of infarction and stroke.
Setup the Ampere™ Generator with the Cool Point™ Irrigation Pump
1. Attach pump tubing to the saline bag.
2. Fill and vent the infusion set.
3. Feed tubing through the pump as shown by the Cool Point™ Irrigation Pump Instructions for Use.
4. Attach the irrigating catheter to the tubing. (Do not insert the catheter into the patient.) Use sterile extension tubing for more
sterile length.
5. Setup the Ampere™ Generator with the CoolPoint™ Irrigation Pump according to the diagram “Ampere™ Generator Setup
with Cool Point™ Irrigation Pump and Remote Control” on page 38.
Prime the Tubing and Catheter

NOTE: Refer to the Cool Point™ Tubing Set Instructions for Use and the Irrigated catheter Instructions for Use for full
instructions.
Adjust Parameters
1. Turn on the power to the pump.
2. The Pump icon displays green, indicating that the pump is connected and communicating with the Ampere™ Generator:
Figure 15. Pump Icon

3. Adjust the Pump and Auto Flow parameters (pages 27-28).
38 Cool Point™ Irrigation Pump Setup International Edition Rev. C 100081509-en
Ampere™ Generator Setup with Cool Point™ Irrigation Pump and Remote Control
NOTE: Refer to the chapter “Footswitch and Remote Control” on page 39 for detailed Footswitch and Remote Control
connections.
International Edition Rev. C 100081509-en VeriSense™ System Setup 39
VeriSense™ System Setup
Overview
This diagram describes how to setup the Ampere™ Generator for use with the VeriSense™ System. For more detailed instructions,
see the VeriSense™ System Instructions for Use.
40 VeriSense™ System Setup International Edition Rev. C 100081509-en
Footswitch and Remote Chapter 5

Control
Overview
This chapter describes the remote control the optional footswitch.
Footswitch
The optional Footswitch is used to start and stop RF energy delivery. When the Footswitch is pressed and held down, RF energy is
delivered until the Footswitch is released or the ablation time has elapsed. The system then displays the average Power, Temperature,
and Impedance values and elapsed Time for the session. If the Footswitch is pressed and held down again, the system will start RF
energy delivery.
NOTE: If the footswitch is activated or deactivated it has priority over the main Ampere™ Generator controls and the remote
control.
The footswitch connects to port #1 on the rear panel of the Ampere™ Generator (see “Rear Panel Connections” on page 41).
■ The supplied footswitch has a cable length of 2.5m. Footswitches with other cable lengths can be ordered through SJM. See the
IFU cover for contact information.
Figure 16. The Ampere™ Generator footswitch.

40 Remote Control International Edition Rev. C 100081509-en
Remote Control
Features
The Remote Control can control and operate the Ampere™ Generator remotely via a single fiber optic cable for control of the Standby
Button, and a dual fiber optic cable for control of software functions. It has an identical front panel display and controls as that of the
Ampere™ Generator’s front panel. Changes to settings made on the Ampere™ Generator or the Remote Control will be updated on
both units.
Select and adjust all settings and presets just as from the main unit’s front panel (e.g. Power, Temperature, Impedance, and Time).
NOTE: Refer to Chapter 2, “Display, Controls, and Connections” on page 15 for a full description of the Ampere™ Generator’s
front panel display and controls.
Figure 17. Ampere™ Generator Remote Control
Remote Control Feet

The Remote Control has extendable feet located on the underside of the unit. To extend, pull the feet out from the body until they click
into place.
Extend the feet out until they click into place.

Figure 18. Remote Control with Feet extended
International Edition Rev. C 100081509-en Remote Control 41
Remote Control Connections

Connect the Remote Control to the Ampere™ Generator rear panel connections shown below.
1 2 3
5 6
Figure 19. Remote Control rear panel connections
1 Equipotential Ground Connects the Ampere Remote Control to the hospital equalization connection
Connector point.
2 Fiber Optic Connector Connects to the Ampere™ Generator Fiber Optic connector #3 for control of
the Standby Button.
3 Dual Fiber Optic Connector Connects to the Ampere™ Generator Dual Fiber Optic connector #4 for control
of software functions.
4 USB Connector For firmware upgrades only (not for copying Ablation data or Engineering logs).
5 Power Cord Connector AC power cord plug in.
6 Remote Control Power Controls power to the Remote Control only.
Switch “I” position is on.
“O” position is off.
Rear Panel Connections

Connect the Footswitch and the Remote Control to these connections on the rear panel of the
Ampere™ Generator: 3
1 4
1 Footswitch Connector Connects to the footswitch.
2 Equipotential Ground Connects the Ampere™ Generator
Connector equipotential ground to the hospital 2
equalization connection point.
3 Fiber Optic Connector Single Fiber Optic port to connect to the
(optional) Remote Control.
4 Dual Fiber Optic Dual Fiber Optic connector to connect to the
Connector (optional) Remote Control.
NOTE: This illustration shows only the Footswitch and Remote Control connections on
the Ampere™ Generator rear panel. To see all connections, refer to “Rear Panel
Connections” on page 18.
Figure 20. Rear Panel Connections

42 Remote Control International Edition Rev. C 100081509-en

Messages Chapter 6
Overview
This chapter documents the messages that the Ampere™ Generator displays and the resolutions to those conditions.
NOTE: Press the Menu Knob or any Arrow Button to dismiss alert messages.
System Messages
Table 1. Ampere ™ Generator System Messages
Message Additional Information Recommended Actions
Catheter not connected. A compatible catheter and/or connection • Connect a compatible ablation catheter
cable was not detected. and cable to the generator.
Startup failed. Button A button on the Ampere™ Generator is held • Restart the generator without holding
pressed during startup. down during generator power-up. down any buttons on the Ampere™
Restart. Generator.
Footswitch in pressed The footswitch activator is held down when • Unplug the footswitch, check that the
state. the footswitch is being connected to the footswitch pedal is not held down, and
Check footswitch and generator. reconnect the footswitch to the
reconnect. generator.
Startup failed. A button on the Remote Control is held down • Restart the generator without holding
Remote control button in during generator power-up. down any buttons on the Remote
pressed state. Control.
Restart.
Previous parameters not The file that contains the Preset settings is • Reprogram the preset parameters (see
saved properly. Restored corrupted and could not be loaded. The “Presets” on page 35).
to default settings. presets reverted to the default settings.
Measured temperature The catheter temperature exceeds the user • Increase the user set temperature.
higher than programmed set temperature. • Wait until the catheter temperature
limit. cools.
• If the TempGuard™ feature is ON, select
a slower Ramp Time or AUTO Ramp
Time.
Measured temperature The catheter temperature is less than 15 °C. • Check that a compatible ablation
too low for ablation. catheter and cable are being used with
Check catheter and the Ampere™ Generator.
cable. • For irrigated ablation catheters, check
that the irrigation saline is at room
temperature.
44 Overview International Edition Rev. C 100081509-en

Measured temperature The catheter temperature is either < 15 °C or • Wait until the catheter temperature
out of range. > 80 °C. cools.
• If the TempGuard™ feature is ON, select
a slower Ramp Time or AUTO Ramp
Time.
• Check that a compatible ablation
catheter and cable are being used with
the Ampere™ Generator.
• For irrigated ablation catheters,
additionally check that the irrigation
saline is at room temperature.
Measured temperature When the TempGuard™ feature is OFF and • Turn Temp Cutoff OFF.
higher than programmed Temp Cutoff is ON, the catheter temperature • Turn the TempGuard™ feature ON and
limit. has exceeded the user set temperature. ablate in temperature control mode.
• Increase the user set temperature
• Wait until the catheter temperature
cools.
Impedance out of range The measured impedance is < 50Ω or > 300 • Check that a compatible ablation
Ω. catheter and cable are being used with
• Check DIP electrode placement on the
patient.
• Check that the catheter is in contact with
the patient.
Measured impedance During an RF application, the measured • Increase the user set impedance limit
higher than programmed impedance exceeds the user set impedance • Check DIP electrode placement on the
limit. limit. patient.
• Check that the catheter is in contact with
the patient.
• Check for coagulum formation on the
catheter ablation electrode.
Measured impedance too The measured impedance is < 50Ω. • Check that a compatible ablation
low to continue ablation. catheter and cable are being used with
• Check DIP electrode placement on the
patient.
Delta Impedance Cutoff During ablation and if the Impedance Cutoff • Disable the impedance cutoff or change
reached. feature is enabled, a change in the the user set delta impedance or delta
impedance over the user set delta time has time values. (See “Delta Impedance
exceeded the user set delta impedance. Cutoff” on page 26.)
Power exceeded The measured power is 10% greater than the • If the TempGuard™ feature is ON, select
maximum limit. maximum allowable user set power for the a slower Ramp Time or AUTO Ramp
catheter. Time.
Unable to deliver During ablation, the actual power output is • Restart the Ampere™ Generator. If not
requested power. Consult lower than what the generator algorithms are resolved, call SJM Technical Support.
IFU. requesting, and ablation stops.
International Edition Rev. C 100081509-en Overview 45

Measured power higher The measured power is greater than the user • If the TempGuard™ feature is ON, select
than programmed limit. set power for more than 1 second. a slower Ramp Time or AUTO Ramp
Time.
Unable to deliver If the user set power >50 watts and the • Decrease the user set power below 50
requested power due to measured impedance >200 Ω, the Ampere™ watts.
impedance increase. Generator will not be able to reach • Check DIP electrode placement on the
programmed power. Note that ablation will patient.
not stop.
Pump not at low flow. Cool Point™ pump flow is stopped during • If using an irrigated ablation catheter,
ablation. stop ablation and remove and inspect
the catheter ablation electrode. Restart
pump flow before reintroducing the
ablation catheter.
• Refer to the Cool Point™ pump IFU.
Pump not connected. During ablation, the Cool Point™ pump has • If using an irrigated ablation catheter,
been disconnected from the generator. stop ablation and remove and inspect
the catheter ablation electrode. Check
the communication cable between the
pump and the Ampere™ Generator and
restart the pump.
Pump priming. Cool Point™ pump is performing the fluid • Wait until the pump has completed fluid
priming process and ablation cannot priming.
proceed. • Command the pump to halt fluid priming.
Pump stopped. Cool Point™ pump has stopped while • Remove the ablation catheter from the
ablation is ongoing. patient and troubleshoot the pump.
Pump communication For more information, refer to the Cool • Check the communication cable
error. Point™ pump IFU. between the pump and the Ampere™
Generator and restart the pump.
Pump Door open. For more information, refer to the Cool • Refer to the Cool Point™ pump IFU.
Point™ pump IFU.
Pump pressure sensor
not connected.
Pump occlusion detected.
Pump bubble detected.
Pump bubble detector
failure.
Pump startup failure.
Pump button stuck.
Pump speed failure.
USB not detected, verify Data copy to a USB connected thumb drive • Insert a USB thumb drive before copying
USB drive inserted. was started, but no drive was detected. data from the generator.

Copy Unsuccessful. An error occurred while copying data to the • Reseat the USB thumb drive and re-
thumb drive. initiate the data copy.
• Replace the USB thumb drive with a
different thumb drive and re-initiate the
data copy.
Standby: Press button to The Standby button on the main unit or the • Press the Standby button to clear the
resume. Remote was pressed, stopping ablation. message.
• Both the main unit and the Remote’s
Standby buttons must be “off” to
disengage Standby.
Ablation terminated due During ablation, an error was detected with • Check that the Remote Control unit has
to remote control the Remote Control. power.
disconnect. • Check that the fiber optic cables to the
remote control are connected.
Restart the generator for When changing the language on the • Select "YES" to load the language
language change to take generator, the generator must be restarted in change, then restart the generator.
effect. order for changes to take effect. • Select "NO" to abort the language
change.
Restart the generator for When changing the time on the generator, • Select "YES" to load the time change,
time change to take the generator must be restarted in order for then restart the generator.
effect. changes to take effect. • Select "NO" to abort the time change.
Maximum number of The Ampere™ Generator can hold data for • Copy the ablation session records to a
session records reached. 100 ablation session records and will USB thumb drive to save existing
The next ablation record overwrite the oldest record when full. records.
will overwrite oldest data. • Clear all existing ablation session
Save data and clear if records.
desired. • Clear the message by pressing any
button and continue. The message will
re-appear after each ablation session
until Ablation Results are cleared. See
"Ablation Results > Clear" in the Menu
Options.
Internal chassis Internal temperature sensors are detecting • Stop using the generator, but leave the
temperature too high. that the system is overheating. generator on to cool; wait for the alarm
Check fan or relocate to resolve before further ablation.
generator to ensure • Check for ventilation obstructions or
adequate airflow. external heat source.
System cooling. Do not Internal temperature sensors are detecting • Stop using the generator, but leave the
turn off generator until this that the system is overheating. generator on to cool; wait for the alarm
message disappears. to resolve before further ablation.
• Check for ventilation obstructions or
external heat source.
Software versions of Software version can be found in the “About” • Upgrade the software such that the
generator and remote menu. software versions on the generator and
control do not match. remote controls match. Call SJM
Contact SJM technical Technical Support for more information.
support.

Generator malfunction. Indicates a system error. • Restart the Ampere™ Generator. If not
Contact SJM Technical resolved, call SJM Technical Support.
Support.

Ablation Parameters Appendix A

Examples
Overview
Example 1
Ablation Parameters • The TempGuard™ feature feature is ON.
• Ramp Time is AUTO.
NOTE: Temperature Cutoff is not available when the TempGuard™ feature is ON.
Key Attributes • With the TempGuard™ feature on, the generator is operating in temperature control
mode.
• In temperature control mode, the generator uses an algorithm to automatically modulate
RF energy output to maintain the user set temperature.
• The delivered power will not exceed the user set power.
• Ramp Time determines how fast power increases when RF energy comes on.
Description In temperature control mode, the generator uses an algorithm to automatically modulate
RF energy output to maintain the user set temperature. With Ramp Time set to AUTO, this
algorithm also determines the rate of increase in RF energy output when RF energy
comes on.
• If the measured temperature is close to the user set temperature, RF energy output will
change gradually to maintain the measured temperature close to the user set
temperature.
• If the measured temperature is not close to the user set temperature, RF energy output
will change rapidly to keep the measured temperature at or below the user set
temperature.
• Regardless of the measured or user set temperatures, RF power will not exceed the
user set power.
Clinical Example The physician wishes to maintain a particular temperature during RF energy delivery but
does not want power to exceed a particular limit.
Example 2
Ablation Parameters • The TempGuard™ feature is ON.
• Ramp Time is 2, 6, or 10 seconds.
NOTE: Temperature Cutoff is not available when the TempGuard™ feature is ON.
Key Attributes • With the TempGuard™ feature on, the generator is operating in temperature control
mode.
• In temperature control mode, the generator uses an algorithm to automatically modulate
RF energy output to maintain the user set temperature.
• The delivered power will not exceed the user set power.
Description If the user set temperature is high and the user set power is low, when RF energy comes
on, the measured temperature will not immediately reach the user set temperature.
Under these conditions, it will take either 2, 6, or 10 sec to reach the user set power
(depending on the ramp time setting).
• After this ramp time, if the measured temperature stays well below the user set
temperature, the power output will remain at the user set power.
• At any time during RF energy delivery including the ramp time, if the measured
temperature approaches the user set temperature, RF energy will be automatically
modulated to maintain the user set temperature.
Clinical Example The physician wishes to maintain a particular temperature during RF energy delivery but
does not want power to exceed a particular limit. Additionally, the physician wishes RF
energy to approach the set power quickly (Ramp Time = 2 sec) or more gradually (Ramp
Time = 10 sec).
Example 3
Ablation Parameters • The TempGuard™ feature is OFF.
• Temperature Cutoff is OFF.
Key Attributes • With the TempGuard™ feature off, the generator is operating in power control mode.
• In power control mode, the RF energy output goes to the user set power level and is not
automatically modulated.
• With the Temperature Cutoff off, the measured temperature is only displayed. RF energy
output will be automatically stopped if the measured temperature exceeds 80 °C. The
user must change generator settings manually if a target temperature is desired.
Description • When RF energy comes on, it will take either 2, 6, or 10 sec to reach the user set power
(depending on the ramp time setting). After this ramp time, the power output will remain
at the user set power. The measured temperature is displayed but does not control RF
energy delivery. If the user wishes to maintain a specific target temperature, RF power
output must be manually adjusted.
Clinical Example The physician wishes to deliver RF energy at a constant power level and wishes to
manually adjust that power level to maintain a particular temperature. Additionally, the
physician wishes RF energy to reach the set power quickly (Ramp Time = 2 sec) or more
gradually (Ramp Time = 10 sec).
Example 4
Ablation Parameters • The TempGuard™ feature is OFF.
• Temperature Cutoff is ON.
Key Attributes • With the TempGuard™ feature off, the generator is operating in power control mode.
• In power control mode, the RF energy output goes to the user set power level and is not
• With the Temperature Cutoff on, RF energy delivery will automatically be stopped if the
measured temperature reaches or exceeds the user set temperature.
Description • When RF energy comes on, it will take either 2, 6, or 10 sec to reach the user set power
(depending on the ramp time setting). After this ramp time, the power output will remain
at the user set power. If the measured temperature reaches the user set temperature,
RF energy delivery will automatically be stopped, but RF energy will not otherwise be
Clinical Example The physician wishes to deliver RF energy at a constant power level but does not want
the measured temperature to exceed a specific level. Additionally, the physician wishes
RF energy to reach the set power quickly (Ramp Time = 2 sec) or more gradually (Ramp
Time = 10 sec).
Example 5
Ablation Parameters • Impedance Cutoff is Enabled with Delta Time and Delta Impedance values selected
Key Attributes • Impedance cutoff monitors the impedance for short-term changes.
• RF energy delivery is automatically stopped if the impedance changes by at least the
Delta Impedance value during the Delta Time window.
Description • If the Impedance Cutoff is enabled, Delta Time specifies a window of time that
impedance is monitored during RF delivery. For example, if Delta Time is 3 sec, the
most recent 3 sec of impedance values are monitored. RF energy delivery will be
automatically stopped if impedance changes by at least the Delta Impedance value
within the Delta Time window.
Clinical Example The physician wishes to monitor for a sudden change in impedance during RF delivery.
The change in impedance must be at least 10 ohms and must happen over 2 seconds or
faster. With Impedance Cutoff enabled, the Delta Impedance would be set to 10 ohms,
and the Delta Time would be set to 2 sec.

Technical Specifications Appendix B
Specifications
Power Specifications
Supply Voltage 100-240VAC, 50/60 Hz
Current Rating Generator
2.4 A typical at 100 VAC, full load
1.2 A typical at 240 VAC, full load
Remote
.20 A typical at 100 VAC, full load
.12 A typical at 240 VAC, full load
Fuse Rating F1 & F2:
5.2 x 20mm
3A, 250V
Medium Acting
Operating Duration Monitor: Continues until start button or footswitch is activated.
NOTE: Pressing the Standby Button (on main unit or Remote Control)
enters standby mode, which disables all output until the button is
released. Both the main unit’s and the Remote Control’s Standby
button must be released to terminate standby mode.
Ablation: Continues from 1-999 seconds
Safety Class Class I. Type CF according to IEC 60601-1
Operating Frequency 485 kHz
Operating Parameters Values are digitally displayed on the Ampere™ Generator front panel.
Generator Output Specifications

PARAMETER Units Power Up Default Operating Range Adjustment Steps Accuracy
RF Output Power Watts 30 1-100 1 Watt  20% (1-4W)

 10% (5-100W)
Temperature C Varies (based on 15-80 1C  3C
catheter)
Impedance Ohms 150 50-300 1Ω  10% @ 100 Ω
Time Seconds 120 1-999 1 second +/- 1 second
54 Specifications International Edition Rev. C 100081509-en
Physical Characteristics
Operating Modes Temperature Control Mode
Power Control Mode
Input/Output Socket for the catheter
Socket for the footswitch
Serial interface (DB9 EP Recording System interface)
Serial interface (DB15 Pump interface)
Fiber Optic Connectors (Remote Control Interface)
Dimensions Generator: 266.7mm H x 360.68mm W x 363.22mm D
(10.5" H x 14.2" W x14.3" D)
Remote: 121.92mm H x 355.6 W x 208.28 D

(4.8" H x 14.0" W x 8.2" D)
Weight Generator: 22.0 lbs
Remote: 6.5 lbs
Environmental Specifications
Storage Temperature: -25oC to +60oC
Relative humidity: 20% to 90%, non-condensing
Altitude range shall be: 0m to 7620m
Operation Temperature: 10oC to 35oC
Relative humidity: 20% to 90%, non-condensing
The operating ambient altitude range shall be: 0m to
3000m (9843’)
Electromagnetic Emissions Declaration

The Ampere ™ Generator is intended for use in the electromagnetic environment specified below. The
customer or the user of the Ampere ™ Generator should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF emissions Group 1 The Ampere ™ Generator uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class A The Ampere ™ Generator is suitable for use in all

CISPR 11 establishments other than domestic and those directly connected
to the public low-voltage power supply network that supplies buildings used
for domestic purposes.
Harmonic emissions Not Applicable

IEC 61000-3-2
Voltage fluctuations/ Not Applicable

flicker emissions
IEC 61000-3-3
International Edition Rev. C 100081509-en Specifications 55
Electromagnetic Immunity Declaration I

The Ampere ™ Generator is intended for use in the electromagnetic environment specified below. The
customer or the user of the Ampere ™ Generator should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic

discharge (ESD) tile. If floors are covered with synthetic
material the relative humidity should be at
EN61000-4-2 (IEC 1000-4-2) ±8 kV air ±8 kV air
least 30%.
Electrical fast ±2 kV for power supply lines ±2 kV Mains power quality should be that of a
transient/burst typical commercial or hospital environment.
EN61000-4-4 (IEC 1000-4-4) ±1 kV for input/output lines ±1 kV
Surge ±1 kV differential mode ±1 kV Mains power quality should be that of a

EN61000-4-5 (IEC 1000-4-5) ±2 kV common mode typical commercial or hospital environment.
±2 kV
Voltage dips, short <5% UT >95% dip in VNOM for 0.5 Mains power quality should be that of a
interruptions and voltage >95% dip in UT line cycle typical commercial or hospital environment. If
variations on power supply the user of the Ampere™ Generator requires
for 0.5 cycle
input lines. continued operation during power mains
IEC 61000-4-11 interruptions, it is recommended that the
40% UT 60% dip in VNOM for 5 line Ampere ™ Generator be powered from an
60% dip in UT cycles uninterruptible power supply.
for 5 cycles
30% dip in VNOM

70% UT
30% dip in UT for 25 line cycles
for 25 cycles
<5% UT >95% of VNOM

>95% dip in UT for 5 sec
for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be

(50/60 Hz) at levels characteristic of a typical location in
a typical commercial or hospital environment.
magnetic field
IEC 61000-4-8
Note UT is the a.c. mains voltage prior to application of the test level.
Electromagnetic Immunity Declaration II

The Ampere ™ Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Ampere ™
Generator should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance
Portable and mobile RF communications equipment should

be used no closer to any part of the Ampere ™ Generator,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance

Conducted RF 3 Vrms 3 Vrms
IEC 61000-4-6 150kHz to 80 MHz V1 = 3
3.5
d [ ] P
V1
Radiated RF 3 V/m 3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz E1 = 3
d  1.2 P
3.5
d [ ] P 80 MHz to 800 MHz
E1
d  1.2 P
7
d [ ] P 800 MHz to 2.5 GHz
E1
d  2.3 P
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m)
Field strengths from fixed RF transmitters, as determined

by an electromagnetic site survey,a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked

with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
Cool Point ™ Irrigation Pump is used exceeds the applicable RF compliance level above, the Cool Point ™ Irrigation Pump should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the Cool Point ™ Irrigation Pump.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m.
International Edition Rev. C 100081509-en Specifications 57
Separation Distances
Recommended separation distances between portable and mobile RF communications equipment and the Ampere ™ Generator
The Ampere ™ Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the Ampere ™ Generator can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Ampere ™ Generator as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum output power Separation distance according to frequency of transmitter

of transmitter m
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
3.5 3.5 7
d = ------- P d = ------- P d = ------- P
V1 E1 E1
0.01 .117 .117 .233
.10 .369 .369 .737
1 1.167 1.167 2.33
10 3.69 3.69 7.37
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacture.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.

Maintenance Appendix C
SERVICE AND MAINTENANCE
If the Ampere™ Generator fails to operate when plugged into a proper AC power receptacle and the power switch is turned ON, check
the fuse. If a second failure occurs, notify St. Jude Medical for service (see the front cover of this IFU for contact information).
PRECAUTION: DO NOT remove the cover of the Ampere™ Generator. Removing the cover may result in personal injury and/or
damage to the Ampere™ Generator.
Service and Maintenance for Cool Point™ Irrigation Pump

Refer to the Cool Point™ Irrigation Pump Instructions for Use for service, maintenance, and warranty of the pump.
Cleaning
As needed, all surfaces of the Ampere™ System should be cleaned with a dry, lint free cloth gently applied. Where necessary, alcohol
may be applied on such a cloth to remove grease and stains. Avoid caustic or abrasive cleaners. If disinfection is required, use isopropyl
alcohol to clean the outer surfaces.
Cleaning/Replacing the Ampere™ Generator Air Filter

1. The bottom cover contains air filters that should be cleaned as needed. The recommended inspection time is every 3 months.
2. Use a Torx T10 screwdriver to remove the fastener holding the filter grill in place to gain access to the filters and wash in warm
water.
3. Allow the filters to dry before reinserting back into the Ampere™ Generator.
Replacing the Fuses

1. Disconnect the main power cord from the Ampere™ Generator.
2. Replace the fuse with a fuse of equal value as indicated in “Fuse Rating” on page 53.
If there appears to be a problem with the Ampere™ Generator, please contact St. Jude Medical (see the front cover of this IFU for
contact information) for instructions on returning the Ampere™ Generator for service.
No User-Serviceable Components
There are no user-serviceable components within the products. Do not attempt to perform any repair work or attempt to open the RF
Ablation device or footswitch enclosures. This limited warranty is null and void if the product is misused, abused, modified, or
tampered with in any way. Disassembly and attempted repair by unqualified personnel may create a hazardous condition.
60 Software Licensing International Edition Rev. C 100081509-en
Disclaimers
SJM’s catheter products are designed as single-use devices and are not intended for reuse. Furthermore, the authorized uses and
approved methods of use of each of our catheter products and RF Ablation devices are set forth in the related Instructions for Use that
accompany each of our catheter products and RF Ablation devices. SJM disclaims any responsibility and liability for the use of its
catheter products and RF Ablation Devices in a manner that has not been authorized or approved.
SJM HEREBY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OR WARRANTY OF QUALITY,
OTHER THAN AS EXPRESSLY SET FORTH HEREIN OR IN THE PRODUCT LABELING, INCLUDING THE APPLICABLE
USER DIRECTIONS/INFORMATION. SJM WILL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL,
CONSEQUENTIAL, OR OTHER DAMAGES OF ANY TYPE ARISING OUT OF THE USE OF THE PRODUCT BY THE
CUSTOMER. IN NO EVENT SHALL SJM’S LIABILITY EXCEED THE PURCHASE PRICE PAID FOR THE DEFECTIVE
PRODUCT. Furthermore, this limited warranty shall not apply to, and SJM shall not be responsible for, any loss arising in connection
with the purchase or use of any SJM product that has been repaired by anyone other than SJM or altered in any way that might, in
SJM’s sole judgment, affect its stability or reliability, or that has been subject to misuse, negligence, or accident, or that has been used
otherwise than in accordance with the directions/instructions for use furnished by SJM. This is a limited warranty and is exclusive and
in lieu of all other warranties, express or implied, and of all other obligations or liabilities on SJM’s part and SJM neither assumes nor
authorizes any representative or other person to assume for it any other liability in connection with SJM’s products. The foregoing
shall not relieve SJM from strict tort liability, if otherwise applicable under governing law, for damages for personal injury
caused by a product defect that made the product unreasonably dangerous at the time it was sold or placed.
Software Licensing
The Ampere™ Generator includes the Xerces XML library developed by The Apache Software Foundation (http://www.apache.org/).
Portions of the Xerces XML library were originally based on software copyright (c) 1999, IBM Corporation., http://www.ibm.com.
Copyright 2013 St. Jude Medical
Xerces is licensed under the Apache License, Version 2.0 (the "License"); you may not use this file except in compliance with the
License.
You may obtain a copy of the License at http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed
to in writing, software distributed under the License is distributed on an "AS IS" BASIS, WITHOUT WARRANTIES OR
CONDITIONS OF ANY KIND, either express or implied. See the License for the specific language governing permissions and
limitations under the License.
Ampere™ Generator software is based in part on the work of the Qwt project (http://qwt.sf.net)
For GPLv2, LGPLv2.1, and GPLv3 licensed code used on the Ampere™ Generator the End User may receive a copy of the source
code on media via postal service by submitting a written request to: opensourcerequest@sjm.com. Alternatively, the End User can
mail a written request to:
St. Jude Medical Inc.

Attn: Computer Systems Development and Tools Department
One St. Jude Medical Drive
St. Paul, MN 55117
The request should include the version number of the Ampere™ Generator, End User name, company name (if applicable), return
mailing address, and email address. Certain source distributions require a fee for physical media; in such case, the End User will be
sent details on the cost and payment procedure via email. The request must be sent within three (3) years of the date of St. Jude Medical
Inc.'s last delivery of the Ampere™ Generator, or in the case of code licensed under the GPLv3, the End User may send a request for
as long as St. Jude Medical Inc. offers spare parts or technical support for the Ampere™ Generator.
Graphs Appendix D
Output Power vs. Load Resistance (Set) vs. (Measured)
Diagram shows power output setting versus actual measured power output at load resistance of 50 to 300 ohms.
Figure 21. Output Power vs. Load Resistance (SET) vs. (Measured) Graph
62 Output Power vs. Load Resistance International Edition Rev. C 100081509-en
Output Power vs. Load Resistance
Diagrams show power output at 100% and 50% settings at load resistance of 50 to 300 ohms.
Figure 22. Output Power vs. Load Resistance Graph

International Edition Rev. C 100081509-en Maximum Output Voltage Peak Value (Set) vs Output Voltage Peak Value 63
Maximum Output Voltage Peak Value (Set) vs Output Voltage Peak Value
(Measured) vs. Load Resistance
Diagram shows maximum possible peak output voltage versus the output control setting.
Figure 23. Maximum Output Voltage Peak Value (Set) vs Output Voltage Peak Value (Measured) vs. Load Resistance Graph
64 Maximum Output Voltage Peak Value (Set) vs Output Voltage Peak Value International Edition Rev. C 100081509-en

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1

Ampere™ Generator INSTRUCTIONS FOR USE

Software Version 1.0

St. Jude Medical

St. Jude Medical

Symbol Description Symbol Description

Defibrillator-proof type CF applied part

Defibrillator-proof type BF applied part

Dispose of hardware in accordance with

Humidity limitation Notified body CE Mark

Authorized representative in the

Input Voltage, Input Frequency and

Symbol Description Symbol Description

Electrophysiology (EP) Recording

GenConnect cable connector

Dispersive patch cable connector

Ablation catheter cable connector Remote

Down Button Generator and Remote Control

Non-ionizing electromagnetic radiation

IP68 Footswitch enclosure is dust tight and

Neutral Electrode (Floating Ground)

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Chapter 1: Introduction . . . . . . . . . . . . . . . . 7 Chapter 5: Footswitch and Remote Control. . 39

Appendix A: Ablation Parameters Examples . . 49

Appendix B: Technical Specifications . . . . . . 53

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Indications For Use

Cool Point™ Irrigation Pump Integration

Customizable Information Displays

Warnings, Precautions, and Adverse Reactions

NOTE: A note contains specific information relative to the subject at hand.

CAUTION: Use non-flammable agents for cleaning and disinfecting.

CAUTION: Regularly inspect and test reusable cables and accessories.

CAUTION: Follow the system installation to achieve optimal use.

CAUTION: When used in conjunction with Cool Point™ Irrigation Pump:

Potential Adverse Reactions

Air embolism Arrhythmia

This Page Intentionally Left Blank

Display, Controls, and Chapter 2

Front Panel Controls

Callout Name Description

Callout Name Description

The Connection Icons indicate the state of connected accessories:

Figure 3. Connection Icons

Icon Name State Description

Pump Gray • Pump is not connected.

Rear Panel Connections

Figure 4. Rear Panel Connections

Callout Name Description

1 Footswitch Connector Connects to the footswitch.

Operational Sequence Chapter 3

Use an EGM cable to connect the EGM output of the

NOTE: The Ampere™ Generator Cardiac Ablation

WARNING: Use two DIP electrodes if power greater than 50W

Connect the Ampere™ Generator to a recording system using

Connect the Ampere™ Generator to the EnSite™ Velocity™

NOTE: This connection required for correct location on

NOTE: Optional connection. See “Footswitch and Remote

Connect the Remote Control.

NOTE: Optional connection. See “Footswitch and Remote

Step Action Notes

2 Connect a catheter extension cable to the yellow

3 Connect the catheter extension cable to an ablation

NOTE: Refer to the catheter IFU for settings and