Boston Scientific

Rotablator Rotational Angioplasty System

Rotablator System Reference Guide April 2014

Reference Guide

22 Pages

File Type: PDF

File Size: 1.69 MB

File Name: rotablator_system_reference_guide_april_2014.pdf

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Page 1

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Reference Guide Please consult device DFU for full Operating Instructions

Technical Assistance: 1.800.949.6708 System Set-Up

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)

Console Front

Console Back

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

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

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

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)

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"

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

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

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

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

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.

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

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 –– Carefully 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 –– Withdraw 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

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) –– Retract 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 –– Check dual-gauge regulator connection to air supply and tighten connection until hissing stops; if hissing persists, replace the Teflon™ tape around the fitting –– Check 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)

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

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? –– Pharmacological 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? –– This 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

Frequently Asked Questions (continued) How do I order an Airgas Regulator? –– Part #H80215901-011

Need brass fitting–Rectus Type 21 Adapter –– Affixes 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

RotaWire™ Guide Wire Order Number

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

RotaLink™ System Catheter and Burr Order Number

Model/Description

H802 22782-001A 0

Rotablator RotaLink Advancer (separate from catheter and burr)

H802 22768-002 0