Description
The Rotablator Rotational Angioplasty System is a catheter-based angioplasty
device utilizing a diamond-coated elliptical burr at the tip of a flexible drive
shaft. Tracking coaxially over a guide wire and rotating at up to 190,000 RPM,
the burr ablates plaque into fine particles that are disposed of by the body’s
reticuloendothelial system. The three main components included in the system
are the guide wire, control console system, and the advancer/catheter.
The Rotablator Console monitors and controls the rotational speed of the burr
and provides the operator with performance information throughout the
procedure. In the control console, the gas is filtered and then regulated by a
fixed-pressure regulator. The resultant pressure is gated by a pilot-actuated
valve, and gas flow is automatically adjusted by a proportional pneumatic valve
in order to maintain proper Rotablator System operating speed. The gas then
enters the gas turbine, and after expanding in the turbine, is exhausted at the
bottom of the Rotablator Rotational Angioplasty System advancer. Compressed
gas is also supplied to the foot pedal through a triple hose. When the foot pedal
is depressed, the gas is returned to the console, where it activates the pilot
valve, permitting flow of regulated compressed gas to the Rotablator Rotational
Angioplasty System advancer via the front panel turbine connector. With this
pilot valve arrangement, the gas flow to the Rotablator Rotational Angioplasty
System advancer cannot be throttled by using the foot pedal.
Intended Use
The Rotablator Console is intended for use with the Rotablator Rotational
Angioplasty System. Refer to guide wire and advancer package inserts for
specific information on the use of these components.
Restrictions, Warnings and Precautions
Restrictions
Caution: Federal (USA) law restricts this device to sale by or on the
order of a physician. For coronary use, federal (USA) law further
restricts this device to a physician trained and/or experienced in coronary
balloon angioplasty. Governing law outside the USA restricts this device to sale
by or on the order of a physician.
Warnings
• Never use oxygen as the propellant for the Rotablator Rotational
Angioplasty System. Never connect the regulator to an oxygen cylinder.
Oxygen combined with oil or other combustibles in the system can result in
an explosion.
• The use of accessories, transducers and cables other than those specified,
with the exception of transducers and cables sold by the manufacturer of the
Rotablator System as replacement parts for internal components, may result
in increased emissions or decreased immunity of the Rotablator System.
• The Rotablator System should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the Rotablator
System should be observed to verify normal operation in the configuration
in which it will be used.
• This device is not to be used in the presence of flammable anesthetics.
• If a hissing noise is detected from the console, check to make sure that the
pressure of the gas supplied to the air or nitrogen connector does not exceed
758.4 kPa (110 psi). The console is equipped with a pressure relief valve to
protect against excessive inlet pressure. Do NOT operate the Rotablator
Console with gas pressures in excess of 758.4 kPa (110 psi), as a gas hose
may burst.
• If patient defibrillation becomes necessary, the physician should take the
appropriate measures to protect himself against electrocution from the
defibrillator.
• Do not modify or repair. Modification or repair of the instrument by a
person other than an authorized Boston Scientific representative may
compromise the integrity of the device and/or lead to device failure
which, in turn, may result in patient injury or death. Boston Scientific
assumes no liability with respect to any instrument which has been
modified or repaired by a person other than an authorized Boston
Scientific representative and makes no warranties, express or implied,
including but not limited to merchantability or fitness for a particular
purpose, with respect to such instruments. If repair is needed, call your
Boston Scientific representative.
Precautions
• Care must be taken not to spill saline or other fluids on the console. Saline
spilled in the console may result in corrosion or electrical hazard.
• User should take precautions when using the console in conjunction with
other medical electrical equipment, as electromagnetic interference between
the equipment may affect the performance of the console or other devices.
The console complies with IEC 60601-1-2 regulations for radiation of and
immunity from electromagnetic energy.
• The Rotablator Console needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC information
provided in Appendix D.
• Portable and mobile RF communications equipment can affect the
Rotablator Console.
Description of the Rotablator Console
Figure 1
Control Console Front Panel
The symbols used on the console are listed in Appendix A. The main features
and functions of the console shown in Figure 1 are described below.
Front Panel
• Power Switch: Power is supplied to the console when the switch is in the
depressed position. The push button power switch is located in the lower
right corner of the front panel. The green light to the left of the switch
illuminates to indicate that the power has been turned on.
• Turbine Pressure Control Knob: The knob located above the power
switch is used to adjust the gas pressure to the turbine and consequently, the
rotational speed. Turning the knob clockwise increases the turbine pressure
(speed) as indicated on the turbine pressure gauge. Counterclockwise
rotation decreases the turbine pressure (speed).
• Turbine Pressure Gauge: Located above the turbine pressure control knob,
the pressure gauge displays the pressure of the compressed gas being
supplied to the advancer gas turbine. Generally the greater the gas pressure
to the gas turbine, the higher the rotational speed. The pressure should not
be allowed to exceed 482.6 kPa (70 psi) during normal operation. Flow
restrictions have been incorporated into the pneumatic system to prevent the
delivery of excessive energy to the advancer. For additional information on
operating range, accuracy and precision, see Table 1.
• Rotational Speed Display (Tachometer): The rotational speed display
located in the upper left corner of the console indicates the speed in RPM of
the burr and gas turbine. When the gas turbine is not operating, the display
is blank. When the foot pedal is depressed, the rotational speed is shown on
the rotational speed display. For additional information on operating range,
accuracy and precision, see Table 1.
• STALL Light: The STALL light is located directly below the rotational
speed display, and is visible only when illuminated. If the rotational speed of
an advancer falls below 15,000 RPM for more than 0.5 second, the red
STALL light is illuminated and delivery of compressed gas to the advancer
is discontinued. A stall condition may also be detected if the fiber optic
connection is not properly engaged. Stall detection is a safety feature
designed to discontinue delivery of compressed gas to the advancer in the
event of excessive mechanical loading or incorrect connection of the fiber
optic. Releasing the foot pedal will clear the stall condition and extinguish
the STALL light.
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Rotablator™ Rotational Angioplasty System