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iLAB™ featuring
ULTRA ICE™ PLUS Catheter

Indications, Safety and Warnings

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Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

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. Information not intended for use or distribution in France.

iLAB Ultrasound Imaging System

Indications for System Use

The ILAB™ Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy. Refer to the Catheter Directions for Use provided with all Boston Scientific Ultrasound Imaging Catheters to determine compatibility with the ILAB System. All Ultrasound Imaging Catheters will be referred to as Imaging Catheters throughout the remainder of this user’s guide. The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to Imaging Catheter Directions for Use, packaged with each catheter.

Contraindications for System Use

Use of the Imaging Catheter is contraindicated where introduction of any catheter would constitute a threat to patient safety. This instrument is contraindicated for fetal imaging. The contraindications include the following patient characteristics: General: bacteremia or sepsis, major coagulation system abnormalities, unsuitability for coronary artery bypass surgery, unsuitability for balloon angioplasty (PTCA), total occlusion, severe hemodynamic instability or shock, coronary artery spasm, myocardial infarction, intra-arterial or intra-ventricle thrombosis, life-threatening rhythmic disorders, mechanical heart valves that would be crossed by the imaging catheter

Indications for Auto Pullback Use

Automatic Pullback is indicated when the following occurs: the physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator. The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed. Two-dimensional, longitudinal reconstruction of the anatomy is desired.

Contraindications for Auto Pullback Use

Use of the Automatic Pullback is contraindicated where introduction of any catheter would constitute a threat to patient safety. For further information, please consult the Imaging Catheter Directions for Use packaged with each Imaging Catheter.

WARNINGS, CAUTIONS, AND PRECAUTIONS LISTS

Inappropriate use of the ILAB System may lead to patient illness, injury, or death. Please read this User’s Guide and the package inserts for the Imaging Catheters carefully and completely before attempting to use the System. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Other than the fuses on the AC Power Isolation Transformer, the ILAB System enclosures contain no operator-serviceable components. Refer servicing to Boston Scientific-authorized personnel only. Possible explosion hazard if used in the presence of flammable anesthetics. Use only Imaging Catheters that are specifically approved for the ILAB System. For instructions on proper disposal methods for the following consumable items, please refer to the Directions for Use packaged with the item: Disposable Sled, Motordrive Sterile Bag, Imaging Catheter (and packaged accessories), Tableside Controller Drape. Care should also be exercised in adjusting all settings to avoid obscuring low-level signals that may have diagnostic value. Improper settings can seriously degrade image quality. Do not attempt to autoclave, immerse, or sterilize the Motordrive Unit. The user has the ultimate responsibility for any use of these measurements in the direction of interventions.

Cautions List

Ensure that the Imaging Catheter is carefully inserted through the opening in the Motordrive Sterile Bag, without catching any part of the Bag between the Imaging Catheter and the Motordrive. Do not attempt to manually move the Motordrive in the Sled once it is installed in a Sled without first depressing the Release Lever. The AC Power Isolation Transformer is intended to be used only with ILAB System equipment. Always begin powering off the system by first using the Control Panel and then turning off the main AC power switch. For more information, refer to "Powering Down the ILAB System" in the chapter, Using the ILAB System in the User’s Guide.

Precautions List

Verify that both latches on the Sled are fully engaged with the Motordrive. Observe the precautions provided from the manufacturer of the media regarding handling, labeling, and storage. If the ILAB System does not produce a usable image when connected to a Catheter Simulator, please contact your Boston Scientific representative for technical assistance.

NOTE: Medical electrical equipment requires special precautions regarding EMC. This equipment needs to be installed and put into service according to the EMC information contained within the accompanying documents. Due to the unique nature of archived (DICOM) files on CD, DVD or Removable Hard Drive media should be labeled, handled, and stored according to individual manufacturer's recommendations to avoid data loss or corruption over time.

Potential System Usage Complications

The following complications may occur as a consequence of intravascular or intracardiac imaging: abrupt closure, angina, cardiac arrhythmias including but not limited to: ventricular tachycardia, ventricular fibrillation, and complete heart block, catheter/guidewire/pressure wire entrapment, embolism, Emergent Coronary Artery Bypass Graft (CABG) surgery, infection, myocardial infarction, myocardial ischemia, myocardial perforation, stent strut damage, stroke (including Cerebral Vascular Accident and Transient Ischemic Attack), thrombus formation, total occlusion, valvular injury, vessel dissection, injury, or perforation, vessel spasm.

For further information, please consult the Catheter Directions for Use packaged with each Imaging Catheter.

(Rev B)

ULTRA ICE PLUS Ultrasound Imaging Catheter

INTENDED USE/INDICATIONS FOR USE

ULTRA ICE PLUS Catheter: This rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures. MDU5 PLUS Sterile Bag: The MDU5 PLUS Sterile Bag is intended to cover the motordrive during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.

CONTRAINDICATIONS

This product is contraindicated in the presence of conditions which create unacceptable risk during catheterization. This device is not intended to be used in the coronary arteries. This device is not intended for fetal use.

WARNINGS

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. If resistance is met upon withdrawal of the catheter, verify resistance using fluoroscopy, then remove the entire system simultaneously. When utilizing a steerable guide sheath, it is not recommended to articulate the sheath tip beyond 55 degrees. Utilizing a fixed curve guide sheath with an angle greater than 55 degrees is not recommended. A guide sheath with an inner diameter less than 2.84 mm must never be utilized. When utilizing the ICE catheter, it is not recommended to place the transducer assembly within the curve of the guide sheath while imaging.

PRECAUTIONS

Contents supplied STERILE using a gamma radiation (Cobalt 60) process. Do not use if sterile barrier is damaged. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization 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. Reuse, reprocessing or resterilization 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. This device should be used by physicians thoroughly trained in the techniques of invasive cardiology and in the specific approach to be used. After the procedure, inspect the catheter carefully for any damage which may have occurred during use. The catheter has no user serviceable parts. Do not attempt to repair or to alter any component of the catheter assembly as provided. 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 motor is running. Throughout the procedure anticoagulant therapy is recommended for patients undergoing left-sided and transseptal cardiac procedures and should be considered for selected patients undergoing right-sided procedures. Avoid any sharp bends, pinching or crushing of the catheter. Do not kink or sharply bend the catheter at any time. An insertion angle greater than 45° is considered excessive. Turn the MDU5 PLUS “OFF” before withdrawing the imaging catheter, or when advancing the catheter in the body. Prior to utilizing the ICE catheter, verify there are not kinks in either the ICE catheter or guide sheath.

COMPLICATIONS

The risks and discomforts involved in imaging cardiac structures include those associated with similar types of diagnostic procedures in the heart. However, any of these risks or discomforts may occur with greater frequency or severity than previously reported. Additionally, these complications may necessitate additional medical treatment including surgical intervention. Abnormal heart rhythms, cardiac wall injury including perforation, damage to cardiac valvular structures, death, endocarditis, hematoma, hypotension/hypertension, infection/discomfort, myocardial infarction, stroke/embolism, thrombosis, vascular wall injury including perforation. As with all procedures that utilize the Seldinger Technique for introducing a catheter into an artery, the following complications have been reported: infection and pain in the region of the insertion site, hemorrhage, arteriovenous fistula.

(Rev A)

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