ROTAPRO Console Guide

Components

™

Rotational Speed Display (Tachometer)

Set Up

Components

ROTAPRO Console

Event Timer Procedure Timer Reset Button

Troubleshooting

Turbine Pressure Control Knob (Adjusts RPM)

Advancer Connections Compressed Gas Connector Electrical Connector

Burr & Catheter Sizing

Fiber Optic Connector

Ordering Information

Console Back Power ON/OFF Power Cord Connector Gas Line Connector

ROTAPRO Advancer

Advancer Controls

™

Dynaglide™ Mode On/Off Button Dynaglide Momentary On Button

Advancer Knob On/Off Button • Press and release to activate • Press and hold 4 seconds to cancel

Advancer Knob On/Off Button

Advancer Body

Dynaglide™ On/Off Button • Press and release to activate Brake Defeat Button

Drive Shaft Connector

Catheter Connector Latch Catheter Body

Brake Defeat Button • Press and hold to release brake while using Dynaglide

Drive Shaft Sheath

Dynaglide Momentary On Button • Press and hold to activate

Components

Overview

Set Up

1

Console Set Up Gas Source

2

Advancer Set Up

3

Pre-Procedure Test D.R.A.W

Ordering Information

Burr & Catheter Sizing

Troubleshooting

Set Up

Hose Supply

ROTAPRO™ Advancer

Advancer Connections

Console Set Up

1

Advancer Set Up

2

1 Connect air hose to air supply and

1 Select appropriate burr size and

back of the console

ROTAWIRE™ (Extra Support or Floppy)

2 Connect power cord

2 Load advancer/burr catheter system

onto the ROTAWIRE

3 Open compressed air valve to supply

compressed gas to the console

Pole Mount Clamp Power Switch

3 Attach WireClip™ Torquer

4 Push the console power switch

4 Connect fiber optic, electrical, and

gas line cables to console

5 Check gauges to ensure proper

system pressure

5 Connect saline infusion bag to

infusion port

Power Cord Gas Supply Hose

Dual Stage Regulator • Monitors gas delivered to console (6,2 - 7,6 bar) • Monitors gas contained in tank (minimum 34,4 bar per case)

Pole Mounted Orientation • Standard IV pole (2.5 cm diameter) with five wheels and a 51 cm diameter base • Height not greater than 60 in (153.0 cm) from the floor to the top edge of the console

A

B

C

Advancer Connections: A Fiber Optic Connector B Electrical Connector C Gas Line Connector

Components

3

D

Drip – Saline drip from bottom of advancer and catheter*

R

Rotate – Burr is rotating and RPMs are stable**

A

Advancer – Free movement of advancer knob

Set Up

Test system outside body

W Wire – Wire is visible and brake is functioning

* Never operate the ROTAPRO™ Advancer without saline infusion. Flowing saline is essential for cooling and lubricating the working parts of the advancer. Operating the advancer without proper saline infusion may result in permanent damage to the ROTAPRO Advancer. **Do not allow the burr to remain in one location while rotating at high speeds, as this may lead to wear of the guidewire (for instance, the burr may cut the ROTAWIRE ™ when rotating in the same position on the wire for extended periods of time). Gently advance or retract the burr while it is in a high-speed rotary motion.

Ordering Information

Burr & Catheter Sizing

Troubleshooting

Troubleshooting

Pre-Procedure Test – D.R.A.W.

Common Troubleshooting FAQs

Check Pressure Indicator

• Check Pressure Indicator • Stall Indicator • Deceleration Indicator • Advancer Knob On/Off Advancer Doesn’t Respond • Dynaglide™ Button Doesn’t Respond • Burr Doesn’t Stop When On/Off Button is Pressed • Unable to Reach Desired Speed

What is it? A yellow CHECK PRESSURE indication that appears when pressure is not supplied to the console.

Why is it there? Troubleshooting feature in the absence of the legacy console gauge to help identify issues with pressure.

What should you do? • Verify the gas supply hose connection to the console and to the gas supply. • Verify the gas supply valve is fully open. • Ensure adequate air supply of at least min 34,4 bar in the tank / 6,2 - 7,6 bar to the console. NOTE: Console has 2.1 bar trigger limit. Indicator is not designed to signal that supplied pressure to the console is within the DFU range of 620.5 kPa to 758.4 kPa (6,2 - 7,6 bar) to the console.

Stall Indicator

Deceleration Indicator

What is it?

What is it?

A safety feature that automatically stops burr rotation when the speed drops below 15,000 RPM for a ½ second or more.

Safety feature that warns user of significant drops in burr rotational speed.

Why is it there? Signal that user is engaging the lesion with too much force and ensure the burr is not lodged.

What should you do? • Pull back and re-platform proximal to the lesion. Actuating the advancer start/stop button should regain the RPM display. If system still displays a STALL condition: • If the advancer was running prior to stall, ensure saline flow. If there is no flow then advancer “burn out” may have occurred, which happens quickly. • Ensure ALL connections are secure: electrical, fiber optic, and air. • Ensure air supply is adequate. If system still displays a STALL condition: • Replace advancer and burr catheter • Resistance is likely in the advancer/ burr catheter

Why is it there? Ensure proper procedural technique is used.

What should you do? • Before starting ablation, allow approximately 1 second of rotation in the free lumen to set platform speed for each instance rotation is activated or the speed control knob is adjusted. • Failure to wait 1 second before engaging lesion may result in an incorrect baseline of speed. Therefore, the deceleration feature may remain on during the procedure. • To reset deceleration indicators, retract to the free lumen and deactivate rotation. Reactivate rotation and allow 1 second before engaging the lesion to baseline speed.

Issue: Advancer Knob On/Off Button Doesn’t Respond

Issue: Dynaglide Momentary Button Doesn’t Respond ™

What should you do?

What should you do?

Test button to ensure it is functioning properly:

Test button to ensure it is functioning properly:

• Activation/Deactivation of rotation is achieved upon release of the button. • Holding button down for 4 seconds voids activation.

• Press Dynaglide On/Off button and ensure Dynaglide mode is activated on the console and the green LED light on the advancer is on.

• ½ second minimum press is required to protect against unintentional activation.

• Press and hold down the Dynaglide momentary button. Rotation is deactivated upon release.

Check for possible causes:

Check for possible causes:

• Check if Dynaglide™ mode is engaged. On/Off button is inactive in Dynaglide mode.

• Check if Dynaglide mode is engaged. Momentary button is inactive in normal mode.

• Verify there is no stall or low pressure indicator on console.

• Verify there is no stall or low pressure indicator on console.

• Ensure ALL connections are secure: electrical, fiber optic, and air.

• Ensure ALL connections are secure: electrical, fiber optic, and air.

• Ensure air supply is adequate.

• Ensure air supply is adequate.

If button still doesn’t respond:

If button still doesn’t respond:

• Replace advancer and burr catheter

• Replace advancer and burr catheter

Issue: Burr Doesn’t Stop When On/Off Button is Pressed

Issue: Unable to Reach Desired Speed

What should you do? • Turn speed down to Dyna speeds (60 –80K) and retract the burr from the artery using the same technique as the burr exchange procedure. • If the RPM adjustment knob does not decrease burr rotational speed, power down the console using the power switch on the back of the console. Remove the burr catheter without rotation. • Unplugging any of the connections will also stop rotation.

What should you do? • Platform speed is automatically set at approximately 160K RPM (±15K RPM). Check for potential causes: • Low initial speeds are often a sign of excess resistance in the advancer, burr, or wire. Common causes include: • Kink in wire or burr catheter • Tortuous anatomy • Wire friction • Hemostasis valve too tight • Incorrect handshake connection • Check air source, ensure it is on and delivering 6,2 - 7,6 bar to the console • Check for kinks in air hoses

Components

Burr & Catheter Sizing

Set Up

Guide sizes are based on larger lumen catheters. Diameter (Inches)

Minimum Recommended Guide Catheter Internal Diameter (Inches)*

Recommended Guide Catheter†,‡

Recommended Burr Speed

1.25

0.049

0.060

6F

160,000 – 180,000

1.50

0.059

0.063

6F

160,000 – 180,000

1.75

0.069

0.073

7F

160,000 – 180,000

2.00

0.079

0.083

8F

160,000 – 180,000

2.15

0.085

0.089

8F

140,000 – 160,000

2.25

0.089

0.093

9F

140,000 – 160,000

2.38

0.094

0.098

9F

140,000 – 160,000

2.50

0.098

0.102

10F

140,000 – 160,000

* Add 0.004" to burr diameter to calculate minimum ID needed. † 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.

Troubleshooting Burr & Catheter Sizing Ordering Information

Burr (mm)

Recommended Guide Catheter Curves Right: FR4, Multipurpose Left: Q-CURVE™, CLS™, Left Back-Up (Guide catheters with side holes can help to improve flow.)

Burr & Catheter Sizing

1.5 mm 1.25 mm

1.75 mm 2.0 mm

Components

Ordering Information Model/Description

GTIN

Ref/Catalog Number

08714729975076

H749 3930901 0

1.25 mm

08714729893356

H749 39300125 0

1.5 mm

08714729893363

H749 39300150 0

1.75 mm

08714729893370

H749 39300175 0

2.0 mm

08714729893387

H749 39300200 0

2.15 mm

08714729893394

H749 39300215 0

2.25 mm

08714729893400

H749 39300225 0

2.38 mm

08714729893417

H749 39300238 0

2.5 mm

08714729893424

H749 39300250 0

ROTAWIRE Floppy Guidewire with WireClip Torquer

08714729195566

H802 22824002 2

ROTAWIRE Extra Support Guidewire with WireClip Torquer

08714729195573

H802 23239001 2

1.25 mm

08714729185864

H802 22768002 0

1.50 mm

08714729185857

H802 22768003 0

1.75 mm

08714729185840

H802 22768004 0

2.00 mm

08714729126881

H802 22768005 0

2.25 mm

08714729185819

H802 22768006 0

2.50 mm

08714729185796

H802 22768007 0

2.15 mm

08714729185826

H802 22768015 0

2.38 mm

08714729185802

H802 22768016 0

ROTAGO™ Cart

08714729974307

H749 3936901 0

Power Cord, Type E/F

08714729975366

H749 3936803 0

Power Cord, Type G

08714729975465

H749 3936813 0

Power Cord, Type H

08714729975434

H749 3936810 0

Power Cord, Type J

08714729975380

H749 3936805 0

Power Cord, Type K

08714729975410

H749 3936808 0

ROTAPRO ™ System Console ROTAPRO Console Kit Assy UL/CSA

Set Up

ROTAPRO Pre-Connected Burr and Advancing Device

Troubleshooting

ROTAWIRE™ Guidewire

Ordering Information

Burr & Catheter Sizing

ROTALINK™ Exchangeable Burr Catheter

Accessories

Ordering Information

ROTAPRO Gas Hose, Braided, Clear 20' WireClip Torquer – Box of 5

N/A

H749 3937301 0

08714729195535

H802 22196003 2

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 labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information contained herein is for use or distribution outside the US, France, and Japan only. All trademarks are the property of their respective owners. IC-566001-AB-AUG2018. CreativeServices.

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