SET UP CONSOLE, FOOT PEDAL AND
CONNECT ADVANCER TO CONSOLE
n CONNECT SALINE TO ADVANCER
ADVANCE THE ROTAWIRE GUIDEWIRE
BEYOND THE LESION
LOCK ADVANCER KNOB FORWARD AND INSERT
BURR THROUGH SHEATH
RELEASE AND PULL BACK ADVANCER KNOB
WHEN BURR IS PROXIMAL TO THE LESION
PROCEED WITH ROTATIONAL ATHERECTOMY
REMOVE BURR IN DYNAGLIDE MODE
This checklist is not intended to replace the Directions for Use.
Please refer to the Rotablator™ System DFU in the product
package for complete Directions for Use.
for Peripheral Rotablator™
Rotational Atherectomy System
• One burr approach is common
• P laque modification vs. de-bulking
(≈ 70% native vessel)
• Adjunctive pharmaceuticals per hospital protocol
• Target free lumen speed of ~160,000 RPM
• Limit RPM drop to under 5,000 RPM
• 15-30 second runs (average)
• Limit total burr time to under 5 minutes
ROTABLATOR™ ROTATIONAL ATHERECTOMY SYSTEM
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the
complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and
Rotalink Plus INTENDED USE/INDICATIONS FOR USE: The Rotablator Rotational Atherectomy System is intended for
percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for
endovascular procedures. RotaWire: INDICATIONS FOR USE/INTENDED USE:These guidewires are intended for use with the
Rotablator Rotational Atherectomy System. Lubricant INDICATIONS FOR USE: Rotaglide lubricant is intended for use with the
Rotablator atherectomy system, for the purpose of increasing the lubricity of the system. CONTRAINDICATIONS AND
RESTRICTIONS: Contraindications: 1. Occlusions through which a guidewire will not pass. 2. Use in coronary arteries. 3. Long (≥
20 cm) total occlusions. 4. Angiographic evidence of thrombus prior to treatment with the Rotablator Rotational Atherectomy System.
Such patients may be treated with thrombolytics (e.g., Urokinase). When the thrombus has been resolved for two to four weeks, the
lesion may be treated with the Rotablator Rotational Atherectomy System.5. Angiographic evidence of significant dissection at the
treatment site. The patient may be treated conservatively for approximately four weeks to permit the dissection to heal before
treating the lesion with the Rotablator Rotational Atherectomy System. Lubricant CONTRAINDICATIONS: Rotaglide™ lubricant
is contraindicated in patients with known allergies to the lubricant ingredients: olive oil, egg yolk phospholipids, glycerin, sodium
deoxycholate, L-histidine, disodium EDTA, sodium hydroxide, and water. Restrictions • Federal (USA) law restricts the use of this
system to physicians who are credentialed in peripheral angioplasty and who have attended the Rotablator System Physician
Training Program. WARNINGS: • The risks of Rotational Atherectomy can be reduced if the device and associated accessories are
used in the appropriate patient population by a physician who has had adequate training.• If the Peripheral RotaLink Plus shows
evidence of mechanical failure at any time prior to or during the angioplasty procedure, immediately discontinue use of the device
and return it to Customer Service for evaluation. Do NOT attempt to use a damaged Peripheral RotaLink Plus; use may result in
device malfunction and/or patient injury.• Never operate the Peripheral RotaLink Plus without saline infusion. Flowing saline is
essential for cooling and lubricating the working parts of the advancer. Operation of the advancer without proper saline infusion may
result in permanent damage to the advancer.• Never operate the Peripheral RotaLink Plus with the Rotablator Rotational
Atherectomy System in Dynaglide™ mode or operate the guidewire brake defeat button unless you have a firm grip on the guidewire
using the wireClip™ Torquer. The wireClip Torquer may be held with the fingers or inserted completely into the docking port after the
brake button is depressed. Defeating the brake, or operating the Peripheral RotaLink Plus with the Rotablator Rotational Atherectomy
System in Dynaglide mode, without securing the guidewire may result in rotation and entanglement of the guidewire.• During setup
of the Peripheral RotaLink Plus never grip or pull on the flexible shaft.• The burr at the distal tip of the Peripheral RotaLink Plus is
capable of rotating at very high speeds. Do NOT allow parts of the body or clothing to come in contact with the burr. Contact may
result in physical injury or entanglement. • Never advance the rotating burr to the point of contact with the guidewire spring tip.
Such contact could result in distal detachment and embolization of the tip.• If the Peripheral RotaLink Plus stops and the red STALL
light on the console illuminates, retract the burr and immediately discontinue treatment. Check the advancer for proper connection to
the console. If the connections are correct, use fluoroscopy to analyze the situation. Never force the system when rotational or
translational resistance occurs, as vessel perforation may occur.• Never advance the rotating burr by advancing the sheath.
Guidewire buckling may occur and perforation or vascular trauma may result. Always advance the rotating burr by using the advancer
knob.• If resistance is encountered, retract the burr and stop treatment immediately. Use fluoroscopy to analyze the situation. Never
force the Peripheral RotaLink Plus when rotational or translational resistance occurs, as vessel perforation, vessel trauma or
embolism due to burr detachment or fractured wire may occur and in rare instances may result in surgical intervention and death.
• The use of Rotablator Rotational Atherectomy System for in-stent restenosis might lead to damage of stent components and/or
Peripheral RotaLink Plus, which may lead to patient injury. • Always keep the burr advancing or retracting while it is rotating.
Maintaining the burr in one location while it is rotating may lead to excessive tissue removal or damage to the Peripheral RotaLink
Plus or entrapment of the Peripheral RotaLink Plus. It is best to advance and retreat the burr no more than 3 cm at a time in a smooth
pecking motion, being careful to engage the lesion only minimally when resistance is met. Do not allow the individual burr run time
to exceed 30 seconds with total rotational procedure time not to exceed five minutes. RotaWire WARNINGS: Use extreme caution
and careful judgment in patients for whom anticoagulation is not indicated. Console WARNINGS: • Never use oxygen as the
propellant for the Rotablator Rotational Atherectomy System. • 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. • This device is not to be
used in the presence of flammable anesthetics. • Do NOT operate the Rotablator Console with gas pressures in excess of 758.4 kPa
(110 psi). • Do not modify or repair. Lubricant WARNINGS: Discard vial if there are particulates in the emulsion or if an oiling-out
of emulsion has occurred. PRECAUTIONS: • Percutaneous rotational angioplasty with the Rotablator Rotational Atherectomy
System should only be carried out at medical facilities where prompt treatment can be immediately performed in the event of a
potentially injurious or serious complication. • Appropriate drug therapy including (but not limited to) anticoagulant and vasodilator
therapy must be provided to the patient during all phases of patient care. • When the Peripheral RotaWire™ Guidewires and/or
Peripheral RotaLink Plus are in the body, they should only be manipulated while they are under fluoroscopic observation with
radiographic equipment that provides high resolution images. • Use only normal saline as the infusate. Never inject contrast agent,
or any other substance that is not approved as part of the Rotablator Rotational Atherectomy System, into the infusion port or saline
infusion bag as this may cause permanent damage to the Peripheral RotaLink Plus. Console PRECAUTIONS: •User should take
precautions when using the console in conjunction with other medical electrical equipment. • 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
in the DFU. ADVERSE EVENTS: Potential adverse reactions which may result from the use of this device include but are not
limited to: • Additional intervention • Allergic reaction • Amputation • Death • Embolism • Hematoma/Hemorrhage
• Hemodynamic changes • Hemoglobinuria • Infection • Restenosis • Stroke • Slow, no flow, abrupt vessel closure • Surgery
including arterial bypass • Thrombosis and vessel occlusion • Vessel trauma (dissection, perforation, psudoaneurysm, arteriovenous
fistula) There may also be complications associated with distortion, kinks, and fracture of the guidewire and physical deterioration or
malfunction of the device, which can lead to patient injury or death.
Rotablator, RotaLink, RotaWire, DynaGlide, RotaGlide and WireClip are registered or unregistered trademarks of
Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners.
300 Boston Scientific Way
Marlborough, MA 01752-1234
To order product or for more information
contact customer service at 1.888.272.1001.
© 2016 Boston Scientific Corporation
or its affiliates. All rights reserved.
Rotational Atherectomy System
PERIPHERAL ROTABLATOR™ Rotational Atherectomy System
• Plug in console and turn on power switch.
• Lock advancer knob 2 – 3 cm forward before
advancing into guide sheath or introducer sheath.
Advancer burr stops, stalls, or does not reach
desired platform speed
• Advance burr forward while holding the wire — do
not activate burr in guide sheath or introducer sheath.
Outside the body:
• When burr is proximal to the lesion, relieve any
forward tension on drive shaft by unlocking advancer
knob and pulling it back. Ensure the distal tip of the
Peripheral RotaWire is far enough beyond the lesion
to avoid contact with the rotating burr.
• Check all air lines and tubing to ensure they are kink
free and connections are tight.
• Connect air supply hose to compressed air or nitrogen
(min 500 PSI in tank per procedure; 90 – 110 PSI
flowing to console).
• Connect DynaGlide™ Foot Pedal hoses — green and
blue to back of the console, pink to the front.
• Connect Peripheral RotaLink™ Plus fiber-optic cables
and air line to front of console.
• Add Peripheral RotaGlide™ Lubricant and optional
adjunctive pharmaceuticals (per hospital protocol) to
1 liter bag of sterile saline, then connect to Peripheral
RotaLink™ Plus infusion port and pressurize to
• Select sheath that will accommodate the largest burr
size to be utilized (~70% of native vessel).
Introducer/Guide Sheath Selection & Sizing
Introducer/Guide Sheath Size*
• Advance the Peripheral RotaWire™ Guidewire beyond
lesion and backload burr, stopping proximal to the sheath.
• Connect WireClip™ Torquer to the end of the wire.
Test system outside body with foot pedal activated
• Drip — check drip from catheter sheath tip and
• Rotation — set burr speed to desired RPM level.
• Advancer — check free movement of advancer knob.
• Wire — check that wire is visible out of the advancer,
torquer clip is attached, and tug on wire while rotating
to ensure brake is activated.
* For a given French size guide sheath or introducer sheath, the internal lumen and
hemostasis valve will vary from manufacturer to manufacturer. When using an
introducer for the first time, it should be tested with the largest Peripheral RotaLinkTM
Plus burr intended to be used with it.
• With 15-30 second runs, advance burr in a smooth
pecking motion until all the way through the lesion.
Limit total burr time to under 5 minutes.
• Limit RPM drop to under 5,000 of platform speed
• Press DynaGlide button on foot pedal (green light will
appear on console).
• Press brake defeat on advancer while holding
• Check air source pressure (90-110 PSI) and air source
volume (>500 PSI).
• Ensure DynaGlide mode is turned off.
• Check saline connection and make sure drip increases
when burr is activated.
• Check for kinks in the drive shaft and guidewire.
• Confirm that burr is not in contact with the drapes
or hemostasis valve.
Inside the body:
• If the burr has lodged in the lesion, cease use and
carefully attempt to remove the device. Never attempt
to start the burr spinning if it has stalled within the
• Check that the hemostasis valve is not overly
tightened to avoid crimping the catheter.
• Evaluate the introducer or guide sheath for kinks.
• Press foot pedal for low-speed rotation in
• Determine if the saline flush was infusing during
testing; if not, the motor drive may be affected.
• Retract Peripheral RotaLink Plus Catheter while
assistant simultaneously holds WireClip Torquer
and advances the Peripheral RotaWire Guidewire to
• If the burr is 1.25 mm or 1.50 mm, the burr could be
lodged within the sheath. Pull the burr control knob
completely forward to dislodge the burr. Leave the
burr control knob completely forward and re-advance
the burr to the lesion.
• Press DynaGlide button to reactivate normal mode
after removing catheter.
• Peripheral RotaWire Guidewire is a 0.009” wire with
a 0.014” tip, 330 cm in length.
• The white substance on the Peripheral RotaWire
is a lubricant called Hystrene™. This should not be
removed from the guidewire.
• Peripheral RotaGlide Lubricant contains egg yolks
and olive oil, therefore it is contraindicated for
patients who are allergic to these substances.
• Rotablator System customer complaints should
be forwarded to the Complaint Call Center
Console emits a hissing noise
• Check air source pressure (90 - 110 PSI).
• Check all air lines and tubing to ensure they are kink
free and connections are tight.
• Advancer may be defective (replace).
Regulator/Air supply hissing
• Tighten the regulator connection to the air supply until
hissing stops. If hissing does not stop, replace the
Teflon™ Tape around the fitting.
• Check the Rotablator Device quick disconnect in the
regulator for leaking. If air leak is unresolved after
tightening, remove the connector and replace the