OPERATION
• WARNING: Pacemakers, implantable cardioverter/defibrillators, and leads can be adversely affected
by radiofrequency energy. It is important to refer to the manufacturer's instruction for use prior to
performing ablation procedures.
• WARNING: The impedance display of the RF Generator should be continuously monitored during RF
power delivery. If a sudden rise in impedance is noted, RF power delivery should be discontinued.
• WARNING: Failure of the RF Generator could result in an unintended increase of output power.
• WARNING: The risk of igniting flammable gases or other materials is inherent in the application of RF power
and precautions must be taken accordingly. Some materials, for example cotton, wool and gauze, when
saturated with oxygen may be ignited by sparks produced in normal use of the HF surgical equipment.
Note: Boston Scientific relies on the physician to determine, assess and communicate to the individual patient
all foreseeable risks of the cardiac ablation procedure.
This section provides basic operation instructions for the Maestro 4000™ Cardiac Ablation System.
Start-Up
Turn the RF Generator ON by toggling the Mains Power Switch on the front panel to the "I" position.
If a Remote is connected to the RF Generator:
• Turn the Remote ON by toggling its Mains Power Switch to the "I" position.
• Press the Generator Remote button to activate the Remote Control Panel.
The RF Generator and Remote (if applicable) will initiate a self-test.
• "SELF TEST" appears on the alphanumeric display, a continuous audio tone is generated for
approximately two seconds, and all front panel displays/indicators are lit.
• The Pod and a Catheter must be connected to complete the self-test.
• If no System malfunction is detected, the RF Control Button will flash to indicate the RF Generator has
entered STANDBY state.
• If a System malfunction is detected, the RF Generator or Remote (if applicable) will not operate. The
red SYSTEM FAULT indicator will be lit. The displays for Power, Temp, Impedance and Time will all
read 888.
Standby State
STANDBY state initiates automatically after System start-up and whenever Deliver state is terminated. Power,
Temperature, Impedance, and Time settings may be viewed and adjusted in this state.
When STANDBY state is initiated after System start-up:
• The default settings shown in Table 2 will appear in the Power, Temperature, Impedance, and Time
displays.
Table 2. Default Setting for Power, Temperature, Impedance, Time
Catheter Type
Standard, High-Power,
Closed-Irrigation
Open-Irrigated
• Measured impedance and temperature values appear in the alphanumeric display.
• Ablation count and total time (also in the alphanumeric display) will be reset to zero.
Maestro 4000™ Cardiac Ablation System Operator's Manual, Global
Power
Temperature
0 Watts
30 °C
0 Watts
50 °C
Impedance
Time
300Ω
0 Sec
250Ω
0 Sec
17
Black (K) ∆E ≤5.0