Rotapro: Rotational Atherectomy System Console

CV 03
ROTAPRO™
Operator's Manual �� 2

Rotational Atherectomy System Console
Black (K) ∆E ≤5.0

Boston Scientific (Spiral Bound Manual Template, 5.5in x 8.5in Global), DFU, MB, ROTAPRO Console, Global, 50480266-01B_pretrans
Table of Contents
Description.......................................................................................................................................................................................................... 3
Intended Use....................................................................................................................................................................................................... 3
Restrictions, Warnings and Precautions........................................................................................................................................... 3
How Supplied...................................................................................................................................................................................................... 3
Handling and Storage...................................................................................................................................................................................... 4
Description of the ROTAPRO™ Console.................................................................................................................................................... 4

Figure 1. Console Front Panel.................................................................................................................................................................. 4
FRONT PANEL/SCREEN DISPLAY.................................................................................................................................................................. 4
Table 1. Indicator Display Images........................................................................................................................................................... 4
Table 2. Numeric Display Features......................................................................................................................................................... 5
REAR PANEL..................................................................................................................................................................................................... 5
Assembly and Setup of the ROTAPRO Console.................................................................................................................................... 5

Console Placement.......................................................................................................................................................................................... 5
Figure 2. Console System......................................................................................................................................................................... 6
Figure 3. MNPT Coupling......................................................................................................................................................................... 7
CLEANING AND DISINFECTION INSTRUCTIONS............................................................................................................................................. 8

Cleaning Instructions...................................................................................................................................................................................... 8
Disinfection Instructions................................................................................................................................................................................. 8
SHUT DOWN AND DISPOSAL INSTRUCTIONS................................................................................................................................................. 8
References........................................................................................................................................................................................................... 8
APPENDIX A - SYMBOL TRANSLATION KEY.................................................................................................................................................... 9

Appendix B - Service and Maintenance Information.................................................................................................................... 10

TECHNICAL SPECIFICATIONS...................................................................................................................................................................... 10
QUARTERLY INSPECTIONS.......................................................................................................................................................................... 10
IEC 62353 RECURRENT TESTING................................................................................................................................................................. 10
SERVICE INFORMATION............................................................................................................................................................................... 10
Figure 4. Fuse Replacement.................................................................................................................................................................. 11
CONTACT INFORMATION ............................................................................................................................................................................ 11
Appendix C - Running the System From Low Pressure (House) Lines..................................................................................... 11
APPENDIX D - TROUBLESHOOTING................................................................................................................................................................. 12
Appendix E - Electronic and Electromagnetic Guidance........................................................................................................... 12

EMC WARNINGS............................................................................................................................................................................................ 13
Warranty........................................................................................................................................................................................................... 13

ROTAPRO™
Rotational Atherectomy System
Description
The ROTAPRO Rotational Atherectomy 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 guidewire 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 guidewire, console, and the advancer/catheter.
The ROTAPRO Console monitors and controls the rotational speed of the burr and provides the operator with performance
information throughout the procedure. In the console, the gas is filtered and then regulated by a fixed-pressure regulator. The
resultant pressure is gated by a solenoid valve, and gas flow is automatically adjusted by a proportional pneumatic valve in
order to maintain proper ROTAPRO System operating speed. The gas then enters the ROTAPRO Advancer gas turbine, and after
expanding in the turbine, is exhausted at the bottom of the ROTAPRO Advancer.
Intended Use
The ROTAPRO Console is intended for use with the ROTAPRO Rotational Atherectomy System. Refer to guidewire 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. Rotational atherectomy should be
performed only by physicians trained in percutaneous interventional procedures.
Warnings
• Never use oxygen as the propellant for the ROTAPRO Rotational Atherectomy 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, other than those specified, with the exception of those sold by the manufacturer of the ROTAPRO System
as replacement parts for internal components, may result in increased emissions or decreased immunity of the ROTAPRO System.
• The ROTAPRO System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is
necessary, the ROTAPRO 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 ROTAPRO 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 themselves
against electrocution from the defibrillator.
• Do not modify or repair beyond replacement of fuses as described in Service Information. 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.
• Following any change in console set-up or configuration, the ROTAPRO System should be observed to verify normal
operation in the configuration in which it will be used.
• If the ROTAPRO System shows evidence of mechanical failure at any time prior to or during the Atherectomy procedure,
immediately discontinue use of the device and contact your Boston Scientific Representative for evaluation. Do NOT
attempt to use a damaged ROTAPRO System; use may result in device malfunction and/or patient injury.
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 ROTAPRO Console requires special precautions regarding Electromagnetic Compatibility (EMC) and needs to be
installed and put into service according to the EMC information provided in Appendix D.
• Portable and mobile RF (Radio Frequency) communications equipment can affect the ROTAPRO Console.
How Supplied
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.

Handling and Storage
Temperature: -30 °C to +60 °C
Humidity: 10% to 95% non-condensing
Description of the ROTAPRO™ Console
Rotational Speed Display
Indicator Display Area
Event Timer
Procedure Timer
Timer Reset Button

RPM Adjustment Knob
Advancer Fiber Optic Connector
Advancer Electrical Connector
Advancer Gas Line Connector
Figure 1. 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/SCREEN DISPLAY
• Timer Reset Button: Pushing and releasing the reset button, located next to the Speed Control Knob, resets the event and
procedure timers both to 0:00.
• Advancer Gas Line Connector: The gas line connector receives the Advancer hybrid harness gas hose and supplies filtered,
regulated compressed gas to the advancer when rotation is activated via the advancer knob button or momentary switch.
• Advancer Fiber Optic Connector: The female connector receives the mating male duplex connector from the advancer hybrid
harness fiber optic tachometer cable. The orientation of the cable to the female connector is not important. The fiber optic
tachometer cable carries light pulses which the console uses to determine the rotational speed of the gas turbine and burr.
• Advancer Electrical Connector: The female connector supplies electrical power to the Advancer through the hybrid
harness multi-pin male connector. To connect to the console, orient the Advancer Power Connector with white chevrons
facing toward the front panel LCD display, or upward when console is vertically pole mounted.
• RPM Adjustment Knob: The knob located between the display and advancer connection ports is used to adjust the gas
pressure to the turbine and consequently, the rotational speed. Turning the knob clockwise increases the turbine pressure
(speed), and counterclockwise rotation decreases the turbine pressure (speed).
• Rotational Speed Display (Tachometer): The rotational speed is displayed on the screen in units of kRPM. See Table 2 for
additional information on operating range, accuracy, and precision.
• Event Timer: The event timer records the duration of rotation from activation to deactivation for each run. The event timer
automatically resets to 0:00 each time rotation is activated. See Table 2 for additional information on operating range,
accuracy, and precision.
• Procedure Timer: The procedure time is the sum of the individual event times and indicates the total cumulative time the
burr has been spinning in Normal Mode during the procedure. See Table 2 for additional information on operating range,
accuracy, and precision.
Table 1. Indicator Display Images
Indicator Indicator Name Description

5+ kRPM A yellow triangular outline will appear when rotational speed drops
Deceleration more than 5 kRPM below the free lumen platform speed. Free lumen
platform speed is achieved approximately 1 second after each
instance rotation is activated or the speed control knob is adjusted.
10+ kRPM A solid yellow triangle will appear when rotational speed drops more
Deceleration than 10 kRPM below the free lumen platform speed. Free lumen
platform speed is achieved approximately 1 second after each
instance rotation is activated or the speed control knob is adjusted.
Black (K) ∆E ≤5.0 / CMYK Image

Indicator Indicator Name Description
Check Pressure A yellow CHECK PRESSURE indication will appear when pressure is
not supplied to the console. If the indicator appears, verify the gas
supply hose is connected to the console and gas supply, the gas
supply valve is fully open, and the supply pressure to the console is
within the range of 620.5 kPa to 758.4 kPa (90 psi to 110 psi).
Stall A red STALL indication appears and delivery of compressed gas to the
advancer discontinues when the rotational speed falls to 15 kRPM
or below for approximately 1/2 second. 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
momentary button in Dynaglide™ Mode or activating rotation in Normal
Mode via the knob button will extinguish the STALL indication. Note:
When a STALL condition occurs, dashes will appear in the Rotational
Speed Display.
Dynaglide A green DYNAGLIDE indication will appear when Dynaglide Mode

is selected via the DYNA button on the advancer. Dynaglide Mode
provides controlled low speed rotation (approximately 60 kRPM to
90 kRPM) for use during intraprocedure exchange of the ROTAPRO™
Advancer or catheter.
Table 2. Numeric Display Features
Note: Operating ranges apply to the display, refer to the Advancer Directions for Use for recommended treatment ranges.
Display Operating Range Accuracy Precision
Rotational Speed Display 0 RPM-250,000 RPM ± 3000 RPM 1,000 RPM
Event Timer 00:00-59:59 ± 3.6 seconds 1 second
Procedure Timer 00:00-59:59 ± 3.6 seconds 1 second
REAR PANEL
• Power Switch: Power is supplied to the console when the rocker-style switch is depressed in the (“line” symbol) position.
The rocker switch is located adjacent to the power line cord entry module. The FRONT PANEL display illuminates to indicate
that the power has been turned on.
• Power Cord: This cable plugs into a conventional 100-120 V~ or 220-240 V~ receptacle (as indicated on the name plate
located on the rear of the console) and provides power to the console. The ground wire of the power cord is internally
connected to the console chassis.
• Fuses: The fuses protect the console’s electrical components in the event of a serious electrical fault. If a fuse should fail,
refer to Appendix B for replacement instructions.
• Potential Equalization Connector: Located adjacent to the compressed gas inlet, the potential equalization connector is
provided to allow potential equalization between various hospital electrical instruments.
• Compressed Gas Inlet: This male connector mates to the corresponding connector on the supply line from the compressed
gas source. Pressure at this inlet should always be between 620.5 kPa and 758.4 kPa (90 psi and 110 psi) with a minimum
flow capacity of 140 l/min (5 standard cubic feet per minute [scfm]). Pressure will be reduced by the console to operating
limits. An internal pressure-relief valve protects against input pressures in excess of 792.9 kPa (115 psi) and creates a loud
hissing noise in the console when the pressure exceeds 792.9 kPa (115 psi).
Assembly and Setup of the ROTAPRO Console

The recommended console system, illustrated in Figure 2, consists of an air or nitrogen pressure regulator mounted on a
compressed gas cylinder, connected to the ROTAPRO Console via a supply hose (provided with the console). Gas cylinders must
be properly secured per standard procedures.
Note: It may also be possible to operate this system from a hospital (house) gas system, as discussed in Appendix C.
Console Placement
The console attaches vertically to a standard five-wheel rolling intravenous (IV) pole or rests horizontally on a table or hard, flat
surface. To avoid risk of tipping, do not use the console in the vertical orientation without being secured to an IV pole.
Use the IV pole screw clamp to attach the console to a standard IV pole with five wheels and a 20 inch diameter base making sure
to attach the console to the IV pole at a distance not greater than 60 in (153.0 cm) from the floor to the top edge of the console.
CMYK Image / Black (K) ∆E ≤5.0

Supply
Hose
Gas
Source
ROTAPRO
Pole Mount Clamp
Console
Advancer Fiber
Optic Connector
Power
Cord
Saline Infusion
Catheter
Port
Advancer Gas Line

Connector
Hybrid Advancer Electrical

ROTAPRO Harness Connector
Advancer
Figure 2. Console System
To put the ROTAPRO™ Console into service, proceed as follows:
WARNING
NEVER use oxygen as the propellant for the ROTAPRO Rotational Atherectomy System. NEVER connect the regulator to an oxygen
cylinder. Oxygen combined with oil or other combustibles in the system can result in an explosion.
WARNING
This device is not to be used in the presence of flammable anesthetics.
1. Procure a compressed gas cylinder containing either compressed air or nitrogen.

A cylinder capacity of at least 2250 l (79.46 standard cubic feet) is recommended, and will provide approximately 20 minutes
of service with the ROTAPRO Rotational Atherectomy System advancer running at full speed. Larger cylinders may be used.
A fully charged spare cylinder should always be available.
2. Secure the compressed gas cylinder in accordance with manufacturer and hospital procedures.
3. Obtain a cylinder regulator (relieving type is recommended) capable of delivering at least 140 l/min (5 scfm) at 620.5 kPa -
758.4 kPa (90 psi - 110 psi).
Make certain that the cylinder regulator fitting is compatible with the gas cylinder being used.
4. Connect the supply hose gas coupling (provided with the ROTAPRO Console) to the outlet port of the cylinder regulator.
Unless local government regulations require otherwise, the gas coupling is configured with 1/4 in MNPT (Male National
Pipe Thread) threads (see Figure 3). Verify the type of gas coupling provided with the ROTAPRO Console prior to procuring a
cylinder regulator.
If necessary, use suitable adapters to make the connection. In some countries, the regulator end of the gas supply hose has
a permanently attached warning tag to remind users not to connect it to oxygen sources. Do NOT remove this tag.
5. Remove the cylinder cap and attach the regulator, tightening the cylinder fitting firmly.
The regulator should be adjusted so that the outlet pressure is in the range 620.5 kPa - 758.4 kPa
(90 psi - 110 psi).
6. Connect the supply hose to the inlet connector on the back of the console.
In most countries, the inlet connector is marked AIR OR NITROGEN.

¼ in MNPT Coupling
Figure 3. MNPT Coupling
7. Connect the power cord to a properly rated hospital grade grounded receptacle (as indicated on the label located on the
rear of the console). Do not position console to make it difficult to disconnect the console from the supply mains.
WARNING
To avoid risk of electric shock, this equipment must only be connected to a supply mains with a protective earth ground.
8. Open the compressed gas cylinder valve, or line valve if running on house air (see Appendix C), to supply compressed gas
to the console.
Note that the cylinder regulator gauge indicates the pressure of the gas remaining in the cylinder. The regulator should be
adjusted so that it never supplies more than 758.4 kPa (110 psi) to the console, and no less than 620.5 kPa (90 psi). Do not
initiate the procedure if less than 3,447 kPa (500 psi) of gas remains in the tank.
WARNING
If a hissing noise is detected from the console, check to make sure that the gas pressure supplied to the air or nitrogen connector
does not exceed 758.4 kPaz (110 psi). The console is equipped with a pressure relief valve to protect against excessive inlet
pressure. Do NOT operate the ROTAPRO™ Console with gas pressures in excess of 758.4 kPa (110 psi), as a compressed gas
hose may burst.
9. Splash
The ROTAPRO Console is designed to be placed outside of the sterile field. Care should be taken to protect the console from
splash and ingress of liquids which may cause damage to internal components.
10. Ventilation
The ROTAPRO Console uses natural convection cooling to maintain the proper operating temperature for internal
components. Cooling vent is located on the rear of the console enclosure. In order to ensure proper ventilation of the
console, it must be mounted on an IV pole (per instructions), or placed on a hard, flat surface with a minimum of 2.5 cm (1 in)
clearance maintained at the rear of the enclosure. Do not set on drapes or bedding.
11. Push the console power switch and confirm that the screen illuminates indicating power is on.
The ROTAPRO Console is now ready for use.
12. Disconnecting cables.
Do not use excessive force when disconnecting the advancer harness or power cord.

CLEANING AND DISINFECTION INSTRUCTIONS
Caution:
• To avoid the potential for electric shock, turn the power switch off and disconnect the power cord from the hospital’s
electrical outlet before cleaning and disinfecting the console. The power cord and gas supply hose may remain connected
to the back of the console.
• To avoid damage to the console:
- Do not allow fluids to enter the enclosure or any connectors.
- Do not immerse the console enclosure into fluids.
- Do not use solvents or abrasive cleaners.
- Do not spray directly on to the console.
The console has been tested and demonstrated to be compatible with the following cleaning and disinfection solutions:
• 70% Isopropyl Alcohol (IPA)
• Bleach (0.5% to 1% Sodium Hypochlorite)
• Super Sani-Cloth™ Germicidal Wipes
Cleaning Instructions
1. Use Super Sani-Cloth Germicidal Wipes, or a pre-saturated wipe containing one of the following:
a. 70% IPA
b. Bleach (0.5% to 1% Sodium Hypochlorite)
Or, prepare a clean wipe by soaking with solution (a or b above). Wring excess solution ensuring the wipe remains
saturated but not dripping.
2. Wipe each panel (front, sides, top and bottom) of the console for a minimum of one minute until all visible soil is removed.
• While wiping, give particular attention to crevices and hard to clean areas.
• Replace soiled wipes as needed and use additional wipes to ensure that all surfaces are uniformly cleaned.
3. Use a clean, lint-free cloth/wipe dampened with water to wipe all accessible surfaces of the device a minimum of two times
to remove residual solution. Use additional clean, dampened cloths/wipes as needed.
4. Thoroughly dry all surfaces of the console with a clean, lint-free cloth/wipe.
5. Repeat steps 1 through 4 once. Use a soft-bristled brush, as necessary.
6. Visually inspect the console for the absence or presence of remaining soil in a well-lit area with an unaided eye. While
inspecting, give particular attention to verifying soil has been removed from the
hard-to-clean areas. If soil is present, then repeat the cleaning steps until all visible soil is removed.
Disinfection Instructions
1. Use Super Sani-Cloth Germicidal Wipes, or a pre-saturated wipe containing one of the following:
a. 70% IPA
b. Bleach (0.5% to 1% Sodium Hypochlorite)
Or, prepare a clean wipe by soaking with solution (a or b above). Wring excess solution ensuring the gauze/wipe remains
saturated but not dripping.
2. Thoroughly wipe each panel (front, sides, top and bottom) of the console and allow the surfaces to remain visibly wet for a
minimum of two minutes if using Super Sani-Cloth Germicidal Wipes (minimum of ten minutes for other wipes).
• Thoroughly wipe crevices and hard to disinfect areas.
• Use additional wipes as necessary to ensure surfaces remain wet.
3. Use a clean, lint-free cloth/wipe dampened with water to wipe all accessible surfaces of the device a minimum of two times
to remove residual solution. Use additional clean, dampened, lint-free cloths/wipes as needed.
4. Thoroughly dry all surfaces of the console with a clean, lint-free cloth/wipe.
SHUT DOWN AND DISPOSAL INSTRUCTIONS

1. Shut Down Procedure
To power off the ROTAPRO™ Console, first depress the console power switch to the (“circle” symbol) position. Finally, fully
close the gas supply valve.
2. Disposal
The user should follow local and national regulations for disposal of electronics when disposing of this unit. The console
contains no batteries.
References
For coronary use, please refer to the ROTAPRO Rotational Atherectomy System physician training program course materials for
a listing of publications, or contact your Boston Scientific Representative.

APPENDIX A - SYMBOL TRANSLATION KEY
The symbols shown below may be present when required by specific safety testing agencies such as Underwriters Laboratories
(UL), Canadian Standards Association (CSA), etc.
ROTAPRO Rotational
Device Identification Contents
Atherectomy System
Timer Reset Button GTIN Global Trade Item Number
Speed Adjust Date of Manufacture
Advancer Fiber Optic Connector REF Catalog Number
Advancer Electrical Connector SN Serial Number
Advancer Gas Line Connector NON Non Sterile

STERILE
00 %
Type CF Applied Part Humidity Limitation
00 %
0000 °C
Power Off 0000 °C
Temperature Limitation
Power On Recyclable Package
2X Fuse Do not use if package is damaged.
T 1A 250X
Alternating Current Legal Manufacturer
Dangerous Voltage CE Marking
Air or Nitrogen EC REP EU Authorized Representative
Equipotentiality AUS Australian Sponsor Address
Follow Instructions
ARG Argentina Local Contact
for Use
Separate Collection BRA Brazil Local Contact
Caution / Attention TUR Turkey Local Contact
UL Certification
CMYK Image / Black (K) ∆E ≤5.0

Appendix B - Service and Maintenance Information
TECHNICAL SPECIFICATIONS
Electrical Specifications: Input Voltage: 100 V - 240 V~
Frequency: 50 Hz - 60 Hz
Power: 70 VA Continuous Operation
Fuses: 2xT1.0AH, 250V~, 5x20 mm time-lag, high breaking capacity.
Protection Against Ingress Vertical pole mounted use orientation: IPX1

from Liquid: Horizontal on table use orientation: IPX0
Pneumatic Specifications: Input Gas: Compressed Air or Nitrogen

Pressure: 620.5 kPa - 758.4 kPa (90 psi - 110 psi)
Flow: Minimum, 140 l/min (5 scfm) at rated pressure.
Operating Conditions: Ventilation: Minimum 2.5 cm (1 in) clearance on all sides, with console
on a hard flat surface.
Temperature: +10 ºC to +40 ºC

Altitude: </= 4000 meters above sea level.
Storage Conditions: Temperature: -30 ºC to +60 ºC

Safety Agency Registration: UL LLC Classified to ANSI/AAMI ES60601-1:2005/(R)2012, CSA CAN/CSA-C22.2

No. 60601-1:14; ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10), CAN/CSAC22.2
No. 60601-1:14 No. 601.1. Class I Medical Device. Type CF Applied Part.
QUARTERLY INSPECTIONS
These inspections should be performed once per quarter by an operator familiar with the ROTAPRO™ System. If console fails any
of the inspections listed below, contact your Boston Scientific Representative.
1. Check the physical condition of the power cable, strain relief, and plug.
Make sure that there are no frayed ends on the power cable connector, the strain relief is attached, the plug has no
bent prongs, and the ground prong in the plug is present and secure. Verify that there are no unacceptable scratches or
punctures on the exterior of the AC cord set.
2. Check for loose or missing screws, sharp edges, or loose connectors.
By hand, check the console pneumatic connectors and verify that they are not loose. Verify that all screws are in place on
pole clamp and seam between front and rear panels. With console disconnected from power cord, gas supply hose, and IV
pole, hold console in both hands and gently shake in two different directions to verify that there is no loose hardware inside
the console.
3. Perform an external visual inspection for mechanical damage.
Verify that there are no unacceptable chips, dents, scratches, or marks on the console enclosure. Verify that the knob is
secured properly and not loose. Make sure that the pneumatic connectors are in working order, not stuck open, and are
tight against the console.
4. Check the operation of the CHECK PRESSURE indication feature.
With the gas supply hose disconnected, verify the CHECK PRESSURE indication appears on the screen. Supply gas pressure
in the range of 620.5 to 758.4 kPa (90 to 110 psi), and verify the CHECK PRESSURE indicator disappears from the screen.
IEC 62353 RECURRENT TESTING
National regulations may require that the user, manufacturer, or manufacturer representative periodically perform and document
testing of the device. If such testing is required in your country, follow the testing interval and extent of testing as regulated in
your country. If you do not know the national regulations in your country, please contact your Boston Scientific Representative.
If IEC 62353 is a required standard by national regulations but no specific testing or interval is specified, it is recommended to
perform testing using the direct method as specified in IEC 62353 at an interval of every 24 months or as per local regulations.
IEC 62353 Test Limit
Protective Earth Resistance < 300mΩ (when measured with power cord attached)
Earth Leakage Current < 5 mA
Touch Current < 100 μA
If the ROTAPRO Console exceeds the limits described in table above, immediately discontinue use of the console and contact
your Boston Scientific Representative.
SERVICE INFORMATION
Fuse: In the event of a fuse failure, replacement fuses should be ordered from Boston Scientific. Turn off the power and unplug
the line cord from the power outlet. The power cord may also be unplugged from the rear of the console to improve fuse access.
Using a tool such as a screwdriver, remove the fuse drawer by depressing both locking tabs. See Figure 4.
10

Power Switch
Fuse Drawer Fuse Drawer

Locking Tab Locking Tab
Fuse Drawer
Power Cord
Receptacle
Figure 4. Fuse Replacement
Replace both fuses at the same time by inserting replacement fuses into the drawer. Reinsert the fuse drawer until the locking
tabs snap into place. Reconnect the power cord and restore power to the console. If a fuse fails again, disconnect all power to
the console and contact your Boston Scientific Representative.
All other service must be performed by Boston Scientific Corporation personnel. Field repair, other than the console’s external
fuse replacement, voids all warranties and may not be performed without express authorization from Customer Service.
CONTACT INFORMATION
The Boston Scientific phone numbers listed below are not intended to assist with any medical emergencies. Use these contacts
only for assistance for technical issues involving the operation of the ROTAPRO™ Console.
Before contacting the Boston Scientific Technical Service Department:
• Obtain the ROTAPRO Console serial number
• Obtain details of the event or problem
Next, call, email, or fax the Technical Assistance Center according to your geographic region.
Region Telephone Number Email
AMEA (Asia, Middle East, Africa) +65-6418-8878 [email protected]
Europe (see below for individual countries) +31-45-546-7707 [email protected]
France +33-139-304-971 [email protected]
Italy +39-022-698-3218 [email protected]
Spain +34-917-619-999 [email protected]
Germany +49-815-126-86118 [email protected]
United Kingdom +44-1442-411-686 [email protected]
Japan 81-44-287-7660 [email protected]
United States 1-800-949-6708 [email protected]
Argentina (+54)1157772692 [email protected]
Brazil (+55)1155459063 [email protected]
Colombia (+57)16295045 [email protected]
México (+52)15559924100 [email protected]
Appendix C - Running the System From Low Pressure (House) Lines

The ROTAPRO Rotational Atherectomy System is designed to be operated from compressed gas cylinders via a cylinder regulator.
However, if a house air or nitrogen system is available, the console can be supplied directly from a house system, eliminating the
need for a cylinder and cylinder regulator. The requirements are as follows:
1. The compressed gas must be air or nitrogen only.
2. The gas must be clean, dry, and oil free.
3. The gas pressure must be between 620.5 kPa (90 psi) and 758.4 kPa (110 psi) at the inlet to the console. It is recommended to
use a low pressure regulator at the gas supply, and is required if the supply pressure at any time exceeds 758.4 kPa (110 psi).
4. The system must be capable of supplying gas at a rate of 140 l/min (5 scfm) or more.
An adapter fitting is available for the ROTAPRO Console. This fitting has a female quick-connect on one end and 1/4 in MNPT threads
on the other. The 1/4 in MNPT end is a standard 1/4 in pipe male fitting and will readily fit most gas handling equipment (see Figure 3).
11

APPENDIX D - TROUBLESHOOTING
Console Does Not Power On - In the event the console screen does not illuminate when the power switch is depressed in the
(“line” symbol) position, check the power cord connection to the console and to the properly rated hospital grade grounded
receptacle. If the screen still does not illuminate, check for fuse failure per the SERVICE INFORMATION section. If the fuses do not
appear to have failed, or fuse replacement does not resolve the issue, contact your Boston Scientific Representative.
Note: Some power cords, such as those provided to the United Kingdom, have a fuse in the power cord plug that connects to
the mains power receptacle. If the power cord fuse has failed, contact your Boston Scientific Representative for a replacement.
CHECK PRESSURE Indicator Remains When Console Is Connected to Gas Pressure Source - Check the connection of the gas
supply hose to the console and to the gas supply. If a pressure reducing regulator is used, check the connection of the regulator
to the pressure source. Verify all shutoff valves are in the open position, and the regulator output is set to the range of 620.5 kPa to
758.4 kPa (90 psi-110 psi). If the CHECK PRESSURE indicator remains on the screen, contact your Boston Scientific Representative.
Console Display Orientation Incorrect - If the console display orientation does not match the orientation the console is placed in,
cycle the power switch off and back on with the console in the desired orientation. If the screen orientation does not change to
match the console orientation, change the console orientation if possible. If the console screen orientation cannot be adjusted
with the text in a legible orientation, do not begin or continue the procedure and contact your Boston Scientific Representative.
Appendix E - Electronic and Electromagnetic Guidance
Guidance and manufacturer’s declaration - electronic emissions
The ROTAPRO System is intended for use in the electromagnetic environment specified below. The customer or the user of
™
the ROTAPRO System should assure that it is used in such an environment.
Emission Test Compliance Electromagnetic Environment - Guidance

RF emissions Group 1 The ROTAPRO System uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions Class A The ROTAPRO System is suitable for use in all establishments
CISPR 11 other than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings used
Harmonic emissions Class A for domestic purposes.
IEC 61000-3-2
Voltage fluctuations / flicker emissions Complies

IEC 61000-3-3
Guidance and manufacturer’s declaration - electromagnetic immunity
The ROTAPRO System is intended for use in the electromagnetic environment specified below. The customer or the user of
Immunity Test Compliance Level Electromagnetic Environment - Guidance
Electrostatic discharge ± 8 kV contact Floors should be wood, concrete or ceramic tile.

(ESD) ± 2 kV, ± 4 kV, ± 8 kV, and ± 15 kV Air If floors are covered with synthetic material, the
IEC 61000-4-2 relative humidity should be at least 30%.
Electrical fast transient ± 2 kV for power supply lines Mains power quality should be that of a typical
/ burst ± 1 kV for input / output lines commercial or hospital environment.
IEC 61000-4-4
Surge ± 0.5 kV, ±1 kV Line-to-Line Mains power quality should be that of a typical
IEC 61000-4-5 ± 0.5 kV, ±1 kV, ± 2 kV Line-to-Ground commercial or hospital environment.
Voltage Dips 0% UT for 0.5 cycle at 0°, 45°, 90°, 135°, Mains power quality should be that of a typical
IEC 61000-4-11 180°, 225°, 270°, and 315° commercial or hospital environment. If the user
of the ROTAPRO System requires continued
0% UT for 1 cycle and 70% UT for 25/30 operation during power mains interruptions, it
cycles at 0° is recommended that the ROTAPRO System be
powered from an uninterruptible power supply
Voltage Interruptions 0% UT for 250/300 cycles or a battery.
IEC 61000-4-11
Power frequency (50/60 Hz) 30 A/m Power frequency magnetic fields should be at
magnetic field IEC 61000-4-8 levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
12

Guidance and manufacturer’s declaration - electromagnetic immunity
The ROTAPRO™ System is intended for use in the electromagnetic environment specified below. The customer or the user of
Immunity Test Compliance Level Electromagnetic Environment - Guidance
Conducted RF 3 Vrms See Warning below for separation of portable RF
IEC 61000-4-6 150 kHz to 80 MHz communications equipment.
6 Vrms in ISM bands from
0.15 MHz to 80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 MHz to 2.7 GHz
Proximity fields from RF wireless 380 - 390 MHz: 27 V/m

communication equipment 430 - 470 MHz: 28 V/m
704 - 787 MHz: 9 V/m
800 - 960 MHz: 28 V/m
1700 - 1900 MHz: 28 V/m
2400 - 2570 MHz: 28 V/m
5100 - 5800 MHz: 9 V/m
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.
EMC WARNINGS
WARNING
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are
operating normally.
WARNING
Use only those accessories intended to be used with the ROTAPRO System.
WARNING
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
WARNING
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the ROTAPRO System, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Warranty
Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this
instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or
implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness
for a particular purpose. Handling, storage, cleaning and sterilization of this instrument as well as other factors relating to the
patient, diagnosis, treatment, surgical procedures and other matters beyond BSC’s control directly affect the instrument and
the results obtained from its use. BSC’s obligation under this warranty is limited to the repair or replacement of this instrument
and BSC shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the
use of this instrument. BSC neither assumes, nor authorizes any other person to assume for it, any other or additional liability or
responsibility in connection with this instrument.
Super Sani-Cloth is a registered trademark of Professional Disposable International, Inc.
13

Brazil
BRA
Local Contact
Para informações de contato da
Boston Scientific do Brasil Ltda,
por favor, acesse o link
www.bostonscientific.com/bra
Turkey
TUR
Local Contact
Boston Scientific Tıp Gereçleri Ltd. Şti.
Küçük Çamlıca Mahallesi
Oymak Çıkmazı Sok. No:1 Üsküdar 34696, İstanbul, Türkiye
Tel +90 216 544 47 00
Faks +90 216 544 47 01
EU Authorized
EC REP
Representative
Boston Scientific Limited
Ballybrit Business Park
Galway
IRELAND
Australian
AUS
Sponsor Address
Boston Scientific (Australia) Pty Ltd

PO Box 332
BOTANY
NSW 1455
Australia
Free Phone 1800 676 133
Free Fax 1800 836 666
Argentina
ARG
Local Contact
Para obtener información de
contacto de Boston Scientific
Argentina SA, por favor, acceda al
link www.bostonscientific.com/arg
Legal
Manufacturer
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
USA
USA Customer Service 888-272-1001
Do not use if package

is damaged.
Recyclable
Package
0344
© 2018 Boston Scientific Corporation or 2018-01
its affiliates. All rights reserved. 50480266-01

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CV 03

Operator's Manual ���������������������������������� 2

Black (K) ∆E ≤5.0

Restrictions, Warnings and Precautions........................................................................................................................................... 3

Description of the ROTAPRO™ Console.................................................................................................................................................... 4

Assembly and Setup of the ROTAPRO Console.................................................................................................................................... 5

CLEANING AND DISINFECTION INSTRUCTIONS............................................................................................................................................. 8

SHUT DOWN AND DISPOSAL INSTRUCTIONS................................................................................................................................................. 8

APPENDIX A - SYMBOL TRANSLATION KEY.................................................................................................................................................... 9

Appendix B - Service and Maintenance Information.................................................................................................................... 10

Appendix C - Running the System From Low Pressure (House) Lines..................................................................................... 11

Appendix E - Electronic and Electromagnetic Guidance........................................................................................................... 12

Black (K) ∆E ≤5.0

Restrictions, Warnings and Precautions

Black (K) ∆E ≤5.0

Description of the ROTAPRO™ Console

Rotational Speed Display

Indicator Display Area

Timer Reset Button

Figure 1. Console Front Panel

Table 1. Indicator Display Images

Indicator Indicator Name Description

Black (K) ∆E ≤5.0 / CMYK Image

Dynaglide A green DYNAGLIDE indication will appear when Dynaglide Mode

Table 2. Numeric Display Features

Display Operating Range Accuracy Precision

Rotational Speed Display 0 RPM-250,000 RPM ± 3000 RPM 1,000 RPM

Procedure Timer 00:00-59:59 ± 3.6 seconds 1 second

Assembly and Setup of the ROTAPRO Console

CMYK Image / Black (K) ∆E ≤5.0

Advancer Gas Line

Hybrid Advancer Electrical

Figure 2. Console System

To put the ROTAPRO™ Console into service, proceed as follows:

1. Procure a compressed gas cylinder containing either compressed air or nitrogen.

Black (K) ∆E ≤5.0

Figure 3. MNPT Coupling

Black (K) ∆E ≤5.0

SHUT DOWN AND DISPOSAL INSTRUCTIONS

Black (K) ∆E ≤5.0

Timer Reset Button GTIN Global Trade Item Number

Speed Adjust Date of Manufacture

Advancer Fiber Optic Connector REF Catalog Number

Advancer Electrical Connector SN Serial Number

Advancer Gas Line Connector NON Non Sterile

Power On Recyclable Package

Alternating Current Legal Manufacturer

Dangerous Voltage CE Marking

Air or Nitrogen EC REP EU Authorized Representative

Equipotentiality AUS Australian Sponsor Address

Separate Collection BRA Brazil Local Contact

Caution / Attention TUR Turkey Local Contact

CMYK Image / Black (K) ∆E ≤5.0

Electrical Specifications: Input Voltage: 100 V - 240 V~

Power: 70 VA Continuous Operation

Fuses: 2xT1.0AH, 250V~, 5x20 mm time-lag, high breaking capacity.

Protection Against Ingress Vertical pole mounted use orientation: IPX1

Operator's Manual �� 2