iLAB™ featuring
ULTRA ICE™ PLUS Catheter

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.

90960359 (Rev AB)

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.Content

INTENDED USE/INDICATIONS FOR USE

Ultra ICE™ Plus 9 MHz IntraCardiac Echo Catheter
The Ultra ICE Plus rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.
MDU5 PLUS™ Sterile Bag Sterile Bag for MDU5 PLUS Motordrive Unit
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

Ultra ICE™ Plus 9 MHz IntraCardiac Echo Catheter
This product is contraindicated in the presence of conditions which create unacceptable risk during catheterization. This device is not to be used in the coronary arteries. This device is not intended for fetal use.
MDU5 PLUS™ Sterile Bag Sterile Bag for MDU5 PLUS Motordrive Unit
No additional information is required for the section in the BSD.

WARNINGS

Ultra ICE™ Plus 9 MHz IntraCardiac Echo Catheter

• 
  When utilizing a steerable guide sheath, it is not recommended to articulate the sheath tip beyond 55 degrees. Over articulation may result in separation and/or embolization of device components that could lead to vessel obstruction or necessitate percutaneous or surgical intervention. In rare cases, stroke or death could result.
• Utilizing a fixed curve guide sheath with an angle greater than 55 degrees is not recommended. This could result in separation and/or embolization of device components that could lead to vessel obstruction or necessitate percutaneous or surgical intervention. In rare cases, stroke or death could result.
• A guide sheath with an inner diameter less than 2.84 mm must never be utilized. Utilization of such a guide sheath could cause separation and/or embolization of device components that could lead to vessel obstruction or necessitate percutaneous or surgical intervention. In rare cases, stroke or death could result.
• When utilizing the catheter, it is not recommended to place the transducer assembly within the curve of the guide sheath while imaging. This could result in separation and/or embolization of device components that could lead to vessel obstruction or necessitate percutaneous or surgical intervention. In rare cases, stroke or death could result.

MDU5 PLUS™ Sterile Bag Sterile Bag for MDU5 PLUS Motordrive Unit

No additional information is required for the section in the BSD.

PRECAUTIONS

Ultra ICE™ Plus 9 MHz IntraCardiac Echo Catheter

• Do not kink or sharply bend the catheter at any time. This can cause drive cable failure. 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.

MDU5 PLUS™ Sterile Bag Sterile Bag for MDU5 PLUS Motordrive Unit

No additional information is required for the section in the BSD.

POTENTIAL ADVERSE EVENTS

Ultra ICE™ Plus 9 MHz IntraCardiac Echo Catheter

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.

• Allergic reaction to contrast media, anesthetic or medications
• Arrhythmia
• Cardiac tamponade and pericardial effusion
• Cardiac trauma
• Cerebrovascular accident and transient ischemic attack
• Death
• Device Entrapment requiring surgical intervention
• Embolism (air, foreign body, tissue or thrombus)
• Hematoma
• Hemorrhage
• Hypotension/Hypertension
• Infection
• Myocardial infarction
• Radiation injury
• Thrombosis including deep vein thrombosis and pulmonary embolism
• Vessel trauma including perforation and arteriovenous fistula

MDU5 PLUS™ Sterile Bag Sterile Bag for MDU5 PLUS Motordrive Unit

No additional information is required for the section in the BSD.

91161596 AC.5