Rotablator Console User manual

Console
Consola Console Konsole Console Console
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Gebrauchsanweisung
Mode d’emploi
Istruzioni per l’uso
Gebruiksaanwijzing
Kontakt den nærmeste Boston Scientific kundeserviceafdeling, hvis en dansk kopi af brugsanvisningerne ønskes. Spørg efter reservedel nr.: 90185046-02 Rev. B
ЕрйкпйнщнЮуфе ме фп гсбцеЯп еохрзсЭфзузт фзт Boston Scientific бн пй ПдзгЯет ЧсЮузт брбйфеЯфбй нб еЯнбй уфб ЕллзнйкЬ. ЖзфЮуфе фпн бсйимь бнфбллбкфйкпэ: 90185046-03 Rev. B
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Kontakta Boston Scientific kundtjänst om ni behöver ett exemplar av en svensk bruksanvisning. Fråga efter del nummer: 90185046-05 Rev. B
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Directions for Use
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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
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