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Ampere™ Generator Instructions for Use
International Edition Rev. A 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 4
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.
