2
Burr (mm) Diameter (cm) Minimum Recommended Guide Catheter Internal Diameter (cm) Recommended Guide Catheter (French) *, 1.25 0.13 0.15 6.0 1.50 0.15 0.16 6.0 1.75 0.18 0.19 7.0 2.00 0.20 0.21 8.0 2.15 0.22 0.23 8.0 2.25 0.23 0.24 9.0 2.38 0.24 0.25 9.0 2.50 0.25 0.26 10.0 Select a guide catheter with an inner diameter of at least 0.1 mm (0.004 in) greater than the largest burr being used in the procedure. System Set-Up Connect foot pedal to console • Connect air hose to air supply • Connect air supply to console Open gas tank to pressurize system (min 34,4 bars in the tank / 6,2 - 7,6 bars to the console) Rotablation flushing cocktail Rotablation cocktail with verapamil, nitrates and heparin in saline (5 mg/5 mg/5,000 U in 500 ml of saline) 1 Component Set-Up Attach advancer to the console (3 connections: Turbine, flushing and optical fibers) Attach saline infusion port to IV pressure bag (inflate to ~200 mmHG) • Open irrigation line • Backload burr catheter onto guidewire • Connect wire clip torquer Watch the infographics animation on Guidelines for Rotational atherectomy Guide Catheter Selection & Sizing 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 and verify Dynaglyde speed 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 GUIDE CATHETER SELECTION 1 Most procedures can be performed with a 6 FR GC which can accommodate burrs up to 1.5 mm. A single curve that gives strong support is recommended. Right: FR4; Multipurpose Left: Q Curve®, CLS™ * 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. 0.004” (0.10 mm) to burr diameter to calculate minimum ID needed 1 Barbato E et al. European expert consensus on rotational atherectomy. Eurointervention, 2015; 11:30-36 PROCEDURAL RECOMMENDATIONS ABLATION SPEED: Between 135,000 and 180,000 RPM to reduce risk of complications RUN TIME: Short duration: individual runs should be no longer than 30 secs DECELERATION: should be < 5,000 RPM ROTABLATOR Rotational Atherectomy System Guide sizes are based on larger lumen catheters.

FV5 BC00317 Console Setup Instructions Guide for ESM · Rotablation fl ushing cocktail • Rotablation cocktail with verapamil, nitrates and heparin in saline (5 mg/5 mg/5,000 U

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Page 1: FV5 BC00317 Console Setup Instructions Guide for ESM · Rotablation fl ushing cocktail • Rotablation cocktail with verapamil, nitrates and heparin in saline (5 mg/5 mg/5,000 U

Burr (mm)

Diameter (cm)

Minimum Recommended Guide Catheter Internal Diameter (cm)

Recommended Guide Catheter (French)*,†

1.25 0.13 0.15‡ 6.0

1.50 0.15 0.16 6.0

1.75 0.18 0.19 7.0

2.00 0.20 0.21 8.0

2.15 0.22 0.23 8.0

2.25 0.23 0.24 9.0

2.38 0.24 0.25 9.0

2.50 0.25 0.26 10.0 Select a guide catheter with an inner diameter of at least 0.1 mm (0.004 in) greater than the

largest burr being used in the procedure.

System Set-Up

• Connect foot pedal to console • Connect air hose to air supply• Connect air supply to console• Open gas tank to pressurize system

(min 34,4 bars in the tank / 6,2 - 7,6 bars to the console)

Rotablation fl ushing cocktail

• Rotablation cocktail with verapamil, nitrates and heparin in saline (5 mg/5 mg/5,000 U in 500 ml of saline)1

Component Set-Up

• Attach advancer to the console (3 connections: Turbine, fl ushing and optical fi bers)

• Attach saline infusion port to IV pressure bag (infl ate to ~200 mmHG)• Open irrigation line• Backload burr catheter onto guidewire• Connect wire clip torquer

Watch the infographics animation onGuidelines for Rotational atherectomy

Guide Catheter Selection & Sizing

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 and verify Dynaglyde speed

A Advancement: Confi rm advancer knob and burr move freely

W Wire: Verify brake is holding guidewire while burr is spinning and wire clip is affi xed

GUIDE CATHETER SELECTION1 Most procedures can be performed with a 6 FR GC which can accommodate burrs up to 1.5 mm. A single curve that gives strong support is recommended.Right: FR4; Multipurpose Left: Q Curve®, CLS™

* 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.‡ 0.004” (0.10 mm) to burr diameter to calculate minimum ID needed

1 Barbato E et al. European expert consensus on rotational atherectomy. Eurointervention, 2015; 11:30-36

PROCEDURAL RECOMMENDATIONS

ABLATION SPEED: Between 135,000 and 180,000 RPM to reduce risk of complicationsRUN TIME: Short duration: individual runs should be no longer than 30 secsDECELERATION: should be < 5,000 RPM

ROTABLATOR™ Rotational Atherectomy System

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LMLeft Main

Page 2: FV5 BC00317 Console Setup Instructions Guide for ESM · Rotablation fl ushing cocktail • Rotablation cocktail with verapamil, nitrates and heparin in saline (5 mg/5 mg/5,000 U

All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.Information for the use only in countries with applicable health authority product registrations. Not intended for use or distribution in France, Japan and the USA.

IC-184801-AD-EU JAN 2017 © 2017 Boston Scientific Corporation or its affiliates. All rights reserved.

www.bostonscientifi c.eu

© 2017 Boston Scientifi c Corporationor its affi liates. All rights reserved.

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