45MHz Rotational Imaging Catheter

REVOLUTION

ENGLISH

	One Way Luer
	Proximal Shaft		Monorail
	109 cm		23mm
	3.5F	3.2F	RO
	Telescoping Section	Usable Length	Marker
	Pullback Length	Usable Length
Fig. 1	Pullback Length	135 cm
Fig. 1	150 mm	135 cm
	150 mm
CAUTION:	WARNINGS:

1.U.S. Federal Law restricts this device to sale by or on the order of a physician.

2.Prior to use, read this entire Instructions For Use.

INTENDED USE:

The Revolution® catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

DESCRIPTION:

The Revolution 45MHz rotational IVUS imaging catheter consists of two main assemblies; the imaging core and the catheter body. The catheter body comprises of three sections; distal section w/ .014" compatible F/X port, proximal section (single lumen), telescope section.

The distal section and proximal (single lumen) sections comprise the "working length" of the catheter, the telescoping section remains outside of the guiding catheter. The telescoping shaft (section) allows the imaging core to be advanced and retracted for up to 150 mm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the guidewire exit port to the proximal end of the window portion of the distal section.

The imaging core is composed of a hi-torque, flexible, rotating drive cable with a distal outward looking 45MHz ultrasonic transducer. An electromechanical connector interface at the proximal end makes the connection to the patient interface module (PIM). The PIM-catheter interface consists of an integrated mechanical drive assembly and electrical connection.

A flushing port with a one-way valve (Fig. 1) is used to displace the air initially present within the catheter. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way valve helps retain saline in the catheter during use.

The catheter body has a distal guidewire lumen with a proximal exit port located 2 cm from the distal end (Fig 1). A radiopaque (RO) marker is embedded in the catheter body at 0.5 cm from the tip. In addition, an insertion depth indicator is located on the catheter body at 100 cm, corresponding to femoral insertions.

The catheter is for use with the In-Vision Gold imaging system with software V5.0 or higher or the Volcano s5 and Volcano s5i imaging system. Consult your System Operator’s Manual.

CONTRAINDICATIONS:

This device is not currently indicated for use in cerebral or peripheral vessels. Use of IVUS Imaging Catheters is contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include: bateremia or sepsis, major coagulation system abnormalities, patients disqualified for CABG surgery, patients disqualified for PTCA, severe hemodynamic instability or shock, patients diagnosed with coronary artery spasm, and total occlusion.

ADVERSE EFFECTS:

Bleeding at the entry puncture site, injury to the vascular wall, thrombosis of the vessel, and peripheral embolization has occurred with the use of percutaneous intravascular catheter devices.

Use of the Revolution catheters is restricted to specialists who are familiar with, and have been trained to perform, the procedures for which this device is intended.

DO NOT advance the catheter if resistance is encountered. The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.

Care should be taken when utilizing devices that comprise a short monorail; in such instances advancement of the device distal to a deployed stent can result in exposure of the guidewire to the stent struts.

In instances where the device has crossed a deployed stent, care should be taken when retracting the device to ensure that entanglement does not occur. Fluoroscopy should be used to monitor guidewire position with the respect to the imaging catheter and the stent; at no time should the imaging catheter be retracted if there is evidence of guidewire prolapse or if significant resistance to withdrawal is experienced. If either of these events occur, advance the imaging catheter distal of the stent and then carefully remove the whole system under the guidance of fluoroscopy.

Care should be taken when re-advancing a guide wire after stent deployment. A guide wire may exit between stent struts when re-crossing a stent that is not fully apposed to the vessel wall. Subsequent advancement of the catheter could cause entanglement between the catheter and the stent. Care should be taken to slowly remove the catheter from a stented vessel.

PRECAUTIONS:

The Revolution device is a delicate scientific instrument and should be treated as such. Always observe the following precautions:

Contents supplied STERILE using an EtO (ethylene oxide) process. Do not use if sterile barrier is damaged. If damage is found call your Volcano Corporation representative.

To maintain optimal patient safety, inspect the product prior to use. Do not use if saline leaks from any location other than the vent port in the monorail section.

For single use only. Do not re-use, reprocess or re-sterilize. Re-use, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness or death.

Re-use, reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patients.

The catheter has no user serviceable parts. Do not attempt to repair or to alter any component of the catheter assembly.

Do not attempt to connect the catheter to electronic equipment other than the designated systems.

Never attempt to attach or detach the catheter while the PIM motor is running. To do so may damage the connector.

Avoid any sharp bends, pinching, or crushing of the catheter.

Do not kink or sharply bend the catheter at any time. This can cause drive cable failure. An insertion angle greater than 45º is considered excessive.

Turn the PIM "OFF" before withdrawing the imaging catheter.