rotablator_system_reference_guide_april_2014.pdf
Page 1
™
Reference Guide
Please consult device DFU for full Operating Instructions
Technical Assistance: 1.800.949.6708
System
Set-Up
Page 2
System
Set-Up
System Set-Up
• Connect foot pedal to console (3 connections) A
• Connect air hose to air supply
• Connect air supply to console B
• Open gas tank to pressurize system
• Check gauges to ensure proper system pressure
(min 500 psi in the tank / 90 –110 psi to the console)
A
A
Console Front
B
Console Back
Console Back
Page 3
System Set-Up
Pre-Procedure System Test
Test system outside body with foot pedal activated
D
Drip: Verify irrigation at distal tip
of burr catheter
R
Rotation: Set burr speed to desired
RPM level
A
Advancement: Confirm advancer knob and
burr move freely
W
Wire: Verify brake is holding guidewire while
burr is spinning and wire clip is affixed
System
Overview
Page 4
System
Overview
Foot Pedal
System Overview
Dynaglide button
On/Off pedal
Console
Rotational speed
display (tachometer)
Procedure timer
Reset button
Turbine pressure gauge
(delivered to advancer)
Air Supply
Dynaglide™ indicator
Monitors gas
delivered to console
Monitors gas
contained in tank
Turbine pressure
control knob
(adjusts RPM)
Event timer
Advancer fiber optic
tachometer connector
Power switch
Dynaglide connector
Advancer turbine
(pneumatic) connector
Power indicator
Dynaglide connectors
Page 5
Drive shaft sheath
System Overview
Rotablator Advancer
Drive shaft connector
Advancer knob
tion
osi
Brake defeat button
p
tion
rac
Ret
Saline infusion port
Fiber optic cable
Guidewire
Compressed gas
connector
WireClip™ torquer
Page 6
System Overview
Burr Sizes
A wide selection of burr sizes provides flexibility
to treat any size occlusion (0.35 mm to 2.5 mm).
1.5 mm
1.75 mm
1.25 mm
2.0 mm
(Also available in 2.15, 2.25, 2.38, and 2.50 mm)
Page 7
System Overview
Wires
Floppy
• 325 cm total length
• Flexible and torqueable
• Reduced guidewire bias
Extra Support
• 325 cm total length
• More supportive
guidewire characteristics
0.005"
0.014"
Maximum
Spring Tip
Diameter
2.2 cm
13 cm
0.0077"
0.009"
0.005"
0.014"
Maximum
Spring Tip
Diameter
2.8 cm
5 cm
0.009"
Page 8
System Overview
Rotaglide™ Lubricant*
• Inject one 20 cc vial into 1000 cc saline flush bag
• Reduces friction and improves tactile feel
• Reduces sudden drops in RPMs caused by lesion feedback
• Reduces heat generation
• Contraindicated if patient is allergic to eggs or olive oil
• Does not require refrigeration
*Ingredients: Olive oil, egg yolk, phopholipids, sodium deoxycholate, L-histidine, disodium EDTA, sodium hydroxide, water
Page 9
Guide sizes are based on larger lumen catheters.
Guide Catheter Selection & Sizing
Burr
(mm)
Diameter
(Inches)
Minimum Recommended
Guide Catheter Internal
Diameter (Inches)
Recommended
Guide Catheter
(French)
1.25
0.049
0.060
‡
6.0
1.50
0.059
0.063
6.0
1.75
0.069
0.073
7.0
2.00
0.079
0.083
8.0
2.15
0.085
0.089
8.0
2.25
0.089
0.093
9.0
2.38
0.094
0.098
9.0
2.50
0.098
0.102
10.0
*,†
* Inside guide catheter diameter and french size may differ among manufacturers. Ensure guide is compatible with the largest burr
intended to be used.
† Sheath size is the determinant of the minimum ID on the 1.25 mm burr.
‡ Add 0.004" to burr diameter to calculate minimum ID needed
Recommended Guide Catheter Curves
Right: FR4, Multipurpose
Left: Q-Curve™, CLS™, Left Back-Up
(Guide catheters with side holes can help to improve flow.)
Recommended Burr Speed
Small Burrs (1.25 mm–2.0 mm): 160,000–180,000 RPM
Large Burrs (≥ 2.15 mm): 140,000–160,000 RPM
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Atherectomy
Procedure
Atherectomy Procedure
Burr Positioning
• Lock advancer knob 2 – 3 cm forward and advance
into guide catheter
• When the burr is 1–2 cm proximal to the lesion,
relieve any forward tension on the drive shaft by
unlocking advancer knob and pulling it back
Ablation
• Advance burr in a smooth back and forth pecking motion until all the way through the lesion
• Maintain RPMs within 5,000 of platform speed
– Limit runs to < 30 seconds with rest periods in between
• Upsize burr in 0.25 mm increments if necessary
• Total rotational procedure time should not exceed five minutes
• Finish with one polishing run
– No RPM drop
– Should be little to no resistance
Page 11
Atherectomy Procedure (continued)
Burr Removal
• Press Dynaglide™ button on foot pedal (Dynaglide indicator
on console will light)
• Press brake defeat on advancer while holding WireClip™ Torquer
• Press foot pedal for low-speed rotation in Dynaglide mode
• Retract Rotablator Catheter while assistant holds WireClip Torquer
and advances guidewire simultaneously to maintain guidewire position
• Press Dynaglide button to reactivate normal mode after catheter is
removed from patient
Burr Upsizing
• Utilize IVUS to properly assess reference vessel diameter
• Step up burr sizes in next catheter size increments (0.25 mm increments)
– Ensure guide catheter accommodates burr size
Atherectomy
Procedure
Page 12
Atherectomy Procedure (continued)
Rotalink™ Advancer / Burr Connection–Key Steps*
• Loosen advancer knob, slide forward exposing drive
shaft connection–tighten knob. Slide back copper sheath
and align catheter drive shaft and advancer drive shaft.
• Position inner-drive shaft into spoon of burr catheter
Snap interlocks together
• Slide copper sheath over interlock connection,
feeling a snap as it locks
• Test for successful connection by tugging
Loosen advancer knob (retract while holding catheter)
Push catheter body into advancer firmly until it snaps
into place
* Never operate the Advancer without saline infusion. Flowing saline is essential for cooling and lubricating working parts of the advancer.
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Troubleshooting
Burr stops, stalls, or does not reach desired platform speed – Inside the body
–– Check that the hemostasis valve is not overly tightened to avoid crimping catheter
–– Evaluate the guide catheter for kinks
–– Determine if the saline flush was infusing during testing; if not, the motor drive could be affected
–– If the burr is a 1.25 mm or 1.5 mm, the burr could be lodged within the sheath. Push advancer control
knob completely forward to dislodge. Leave the burr control knob completely forward and re-advance the
burr to the lesion.
–– If the burr has lodged in the lesion, cease rotational atherectomy and carefully attempt to remove
the device. Never attempt to start the burr spinning if it has stalled within the lesion.
-- Don’t pull on the catheter
-- Administer nitro
-- Wait 30 seconds, try dislodging the burr again
-- Use buddy wire and balloon to help expand
-- Use Dynaglide™ Foot Pedal for quick burp
Rotablator system customer complaints should be forwarded to the Complaint Call Center (1.800.811.3211)
TroubleShooting
Page 14
TroubleShooting
Troubleshooting (continued)
Burr stops, stalls, or does not reach desired platform speed – Outside the body
–– Check pressure coming from air source (90–110 psi)
–– Check volume of air supply in tank (>500 psi)
–– Check all lines and tubing to ensure they are kink free and connections are tight
–– 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
–– Confirm that burr is not in contact with drapes or the hemostasis valve
–– Check that guidewire is kink free
Burr becomes detached
–– Do not turn on the air turbine
–– C
arefully advance the non-rotating drive shaft and retract the burr and guidewire until the distal tip
of the drive shaft and proximal tip of the burr are in contact
–– W
ithdraw the drive shaft, burr, and guidewire as a unit with tension applied on the guidewire to keep
the burr adjacent to the distal end of the drive shaft
–– Inject IV nitroglycerin to relieve any spasm
Page 15
Troubleshooting (continued)
Blank RPM display during procedure
–– Check to see that the foot pedal is fully depressed
Burr spins after foot pedal is released
–– Turn down the rotational speed on the console to the burr exchange speed (60,000 to 90,000 RPM)
–– R
etract the burr from the artery using the burr exchange technique, discontinue use of the Rotablator
system and contact customer service
Regulator / Air supply emits a hissing noise
–– C
heck dual-gauge regulator connection to air supply and tighten connection until hissing stops;
if hissing persists, replace the Teflon™ tape around the fitting
–– C
heck the Rotablator device quick disconnect in the regulator for leaking; if air leak persists, remove the connector and replace the Teflon tape
Console emits a hissing noise
–– Dual-guage regulator setting should be between 90 –100 psi
–– Ensure all air hoses are tightly connected and not kinked
–– Advancer may be defective (replace advancer)
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Troubleshooting (continued)
Console stall light comes on
––
––
––
––
––
––
As a safety feature, system automatically stalls when the RPM drops below 15,000 for 1.5 seconds or more
Release the foot pedal to clear the stall condition
Examine the air hose for kinking
Check advancer connections and then depress the foot pedal to continue
Ensure console is plugged in, correctly set-up and connected
Double check airflow regulator to secure tank connections and quantity of pressure output tank
The advancer was running, but now is not
––
––
––
––
Check all connections
Check air source–make sure it is on and delivering 90 –110 psi
Check for possible lack of saline which can cause “burn out”
A new advancer may be needed if no saline drip through the advancer
There is blood in the sheath
–– Discontinue treatment; verify that the saline infusion is properly connected, pressurized, and flowing
–– If the device is properly connected and blood continues to flow up the sheath, replace the
RotaLink™ Catheter with a new device
Page 17
Frequently Asked Questions
Can I use house air as opposed to the air tank?
–– Yes. Ensure that house air is delivering 90 –110 psi to the console.
What is a Rota Cocktail?
–– P
harmacological agents such as nitroglycerine, verapamil, heparine, etc. have been used routinely with
the flush solution. Boston Scientific does not prescribe the contents of the Rota cocktail.
Why is there a white substance on the guidewire?
–– T
his is a lubricant called Hystrene™ to facilitate initial burr passage over a dry wire; do not wipe this compound off the guidewire
What clearance is needed for burrs through guide catheters (See System Overview: Guide
Catheter Selection & Sizing)
–– 0.004" required. Add 0.004" to burr diameter to calculate minimum ID needed
FAQs
Page 18
FAQs
Frequently Asked Questions (continued)
How do I order an Airgas Regulator?
–– Part #H80215901-011
Need brass fitting–Rectus Type 21 Adapter
–– A
ffixes directly to Airgas regulator or house air line
–– Provided with Airgas regulator ordered from Boston Scientific
Who do we contact for physician proctoring?
–– Contact your Boston Scientific sales representative
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RotaWire™ Guide Wire
Model/Description
Length
Tip Length
Flexibility
Spring Tip
Diameter
Maximum
Diameter
Quantity
H802 23239-001 2
RotaWire Extra Support Guide Wire
with WireClip™ Torquer
330 cm
2.8 cm
Stiff
0.009 in
0.014 in
Box of 5
H802 22824-002 2
RotaWire Floppy Guide Wire
with WireClip Torquer
330 cm
2.2 cm
Flexible
0.009 in
0.014 in
Box of 5
Burr Size
Length
Maximum
Diameter
Order Number
RotaLink™ System Catheter and Burr
Order Number
H802 22782-001A 0
Model/Description
Rotablator RotaLink Advancer (separate from catheter and burr)
H802 22768-002 0
RotaLink Exchangeable Burr Catheter
1.25 mm
135 cm
0.58 in
H802 22768-003 0
RotaLink Exchangeable Burr Catheter
1.50 mm
135 cm
0.58 in
H802 22768-004 0
RotaLink Exchangeable Burr Catheter
1.75 mm
135 cm
0.58 in
H802 22768-005 0
RotaLink Exchangeable Burr Catheter
2.00 mm
135 cm
0.58 in
H802 22768-015 0
RotaLink Exchangeable Burr Catheter
2.15 mm
135 cm
0.58 in
H802 22768-006 0
RotaLink Exchangeable Burr Catheter
2.25 mm
135 cm
0.58 in
H802 22768-016 0
RotaLink Exchangeable Burr Catheter
2.38 mm
135 cm
0.58 in
H802 22768-007 0
RotaLink Exchangeable Burr Catheter
2.50 mm
135 cm
0.58 in
UPN
Codes
Page 20
UPN
Codes
RotaLink™ Plus Pre-Connected Exchangeable Rotational Atherectomy System
Model/Description
Burr Size
Length
Maximum
Diameter
H749 23631-002 0
RotaLink Pre-connected Exchangeable Burr Catheter and Advancing Device
1.25 mm
135 cm
0.58 in
H749 23631-003 0
RotaLink Pre-connected Exchangeable Burr Catheter and Advancing Device
1.50 mm
135 cm
0.58 in
H749 23631-004 0
RotaLink Pre-connected Exchangeable Burr Catheter and Advancing Device
1.75 mm
135 cm
0.58 in
H749 23631-005 0
RotaLink Pre-connected Exchangeable Burr Catheter and Advancing Device
2.00 mm
135 cm
0.58 in
H749 23631-015 0
RotaLink Pre-connected Exchangeable Burr Catheter and Advancing Device
2.15 mm
135 cm
0.58 in
H749 23631-006 0
RotaLink Pre-connected Exchangeable Burr Catheter and Advancing Device
2.25 mm
135 cm
0.58 in
H749 23631-016 0
RotaLink Pre-connected Exchangeable Burr Catheter and Advancing Device
2.38 mm
135 cm
0.58 in
H749 23631-007 0
RotaLink Pre-connected Exchangeable Burr Catheter and Advancing Device
2.50 mm
135 cm
0.58 in
Order Number
Console
Order Number
Model/Description
Voltage
™
H802 22020-039 1
System Console, RC5000 Rotablator Console, SERV
115 VAC
H802 22020-039L
Refurbished Rotablator Console
115 VAC
Page 21
Accessories
Order Number
H802 21600-003 1
Model/Description
Replacement Braided Air Supply Hose (20 feet)
™
Quantity
Single
H802 22436-002 1
Dynaglide Foot Pedal
Single
H802 22151-001 1
Power Cord — North America
Single
H802 15901-01 1
Byrne Regulator
Single
H802 22196-003 2
™
WireClip Torquer
Box of 5
Rotaglide™ Lubricant
Order Number
H749 23548-001 62
Model/Description
Quantity
Rotaglide Lubricant Mixture 20 cc vials
Box of 6
The C-code used for this product is C1724, Catheter, transluminal atherectomy, rotational. C-codes are used for hospital outpatient device
reporting for Medicare and some private payers.
Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice.
For Technical Assistance contact: 1.800.949.6708
Page 22
Rotablator, Dynaglide, Rotalink, Rotaglide, Q-Curve, CLS, and WireClip are registered or
unregistered trademarks of Boston Scientific Corporation. All other trademarks are property
of their respective owners.
Rotablator Rotational Atherectomy System
Prior to use, please see the complete “Directions for Use” for more information on Indications,
Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.
Intended Use/Indications for Use: Percutaneous rotational coronary angioplasty with the
Rotablator Rotational Atherectomy System, as a sole therapy or with adjunctive balloon
angioplasty, is indicated in patients with coronary artery disease who are acceptable
candidates for coronary artery bypass graft surgery and who meet one of the following
selection criteria:
• Single vessel atherosclerotic coronary artery disease with a stenosis that can be passed
with a guidewire
• Multiple vessel coronary artery disease that in the physician’s judgment does not pose
undue risk to the patient
• Certain patients who have had prior percutaneous transluminal coronary angioplasty (PTCA),
and who have a restenosis of the native vessel or,
• Native vessel atherosclerotic coronary artery disease that is less than 25 mm in length.
Contraindications and Restrictions
Contraindications:
1. Occlusions through which a guidewire will not pass.
2. Last remaining vessel with compromised left ventricular function.
3. Saphenous vein grafts.
4. Angiographic evidence of thrombus prior to treatment with the Rotablator 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 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 System.
Restrictions: Federal (USA) law restricts the use of this system to physicians who are
credentialed in 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. The use of Rotablator for in-stent restenosis might lead to damage of stent components
and/or Rotablator System, which may lead to patient injury.
Precautions: Treating certain types and/or locations of lesions or patients with certain
conditions is inherently riskier, regardless of the therapeutic device being used. For many
of these applications, relatively few cases have been carried out using the Rotablator System.
Physicians should be aware of the higher risk when treating such patients and the lack
of scientific evidence for treatment in the following applications:
1. Patients who are not candidates for coronary artery bypass surgery
2. P
atients with severe, diffuse three-vessel disease (multiple diseased vessels should be
treated in separate sessions)
3. Patients with unprotected left main coronary artery disease
4. Patients with ejection fraction less than 30%
5. L
esions longer than 25 mm
6. Angulated (≥ 45°) lesions. There has been limited experience with the brachial approach.
Adverse Events: Potential adverse reactions which may result from the use of this device
include but are not limited to: • Angina or unstable angina • Arrhythmias • Bailout stenting
• Cardiac perforation • Cardiac tamponade
• Conduction block • Coronary artery spasm
• Death • Drug reactions, allergic reaction
to contrast medium • Embolism (coronary,
cerebral, peripheral) • Hemorrhage or
hematoma • Infection, local infection,
systemic infection • Myocardial ischemia
• Myocardial infarction (Q-wave and non
Q-Wave) • Pericardial effusion • Pulmonary
edema/cardiogenic shock • Slow flow,
no flow, abrupt vessel closure • Stroke
• Vascular thrombus • Vessel trauma
Boston Scientific Corporation
(dissection, perforation, rupture or injury)
One Boston Scientific Place
There may also be complications associated
Natick, MA 01760-1537
with distortion, kinks, and fracture of the
www.bostonscientific.com
guidewire and physical deterioration or malfunction.
Caution: Federal Law (USA) restricts this device
to sale by or on the order of a physician.
To order product or for more
information, contact customer
service at 1.888.272.1001
© 2014 Boston Scientific Corporation
or its affiliates. All rights reserved.
IC-193906-AA APR2014