Reprocessed 3D Imaging Catheter
Contents
1. SMI 420 303 Rev C 7 Do not use excessive force to advance or withdraw the catheter when resistance is encountered 8 Discontinue the procedure and determine the cause of resistance before proceeding if strong resistance is encountered during articulation of the catheter 9 Perforation of the vasculature or cardiac structures is an inherent risk of any catheter placement 10 Do not immerse or allow any fluid or moisture between the catheter connector and ultrasound catheter the device may not function properly 11 Regular visual inspection of the catheter connector is recommended Replace a damaged catheter connector immediately 12 Ensure the two articulation knobs are in the neutral position and the brake is released before advancing or withdrawing the diagnostic ultrasound catheter 13 Excessive bending or kinking of the catheter may damage internal wires and or distal tip articulating capabilities POTENTIAL ADVERSE EVENTS The following potential risks may be associated with 3D Imaging Catheters The frequency and severity of these adverse events can vary and may necessitate additional medical intervention including surgery Several major adverse events have been documented for cardiac catheterization procedures including the following 1 Death Stroke Cardiac tamponade Myocardial infarction Pulmonary embolism Air embolism AV fistula Femoral artery or vein injury Hemothorax Perforation Dissection Pneumothorax2. N lt INSTRUCTIONS FOR USE STERILMED Lo Reprocessed 3D Imaging Catheter Control SMI 420 303 Rev C Reprocessed by Sterilmed Inc 11400 73 Avenue North Maple Grove MN 55369 Toll Free 1 888 541 0078 Fax 763 488 3350 www steriilmed com Caution Federal law restricts this device to sale by or on the order of a physician INDICATIONS FOR USE The Reprocessed SOUNDSTAR 3D and SOUNDSTAR eco Diagnostic Ultrasound Catheters hereinafter 3D and eco Diagnostic Ultrasound Catheter are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart The 3D and eco Diagnostic Ultrasound Catheters provide location information when used with the CARTO XP Version 9 0 or higher and CARTO 3 version 1 1 and higher EP Navigation System The Original Equipment Manufacturer OEM provided an Instructions for Use IFU document as well as a Compatibility Matrix Insert for the systems compatibility with the original device The health institution who wishes the device to be reprocessed should retain this original document DEVICE DESCRIPTION The Sterilmed Reprocessed 3D and eco Diagnostic Ultrasound Catheters are designed to provide two dimensional imaging using an ultrasound ultrasonic phased array transducer and three dimensional location information using a location sensor Both the ultrasound transducer and locat
3. Pseudoaneurysm Thrombosis Valve or structural cardiac damage oe oa eS eS PRP PP BWN FP CO _ _ lt lt _ INSTRUCTIONS FOR USE STERILMED x Reprocessed 3D Imaging Catheter Control SMI 420 303 Rev C GENERAL INSTRUCTIONS AND INFORMATION Verify product receipt and ensure that owner s name is appropriate on the label Inspect package and product for signs of damage or sterility compromise Use of this reprocessed device should be limited to those physicians trained in use of this device and associated equipment If additional reprocessing of the product is desired wipe the device with a moist sponge to remove any visible blood or tissue package product label as biohazard and ship product back to Sterilmed DIRECTIONS FOR USE 1 Remove the catheter from the sterile packaging using proper sterile technique 2 Check the device for any signs of damage and do not use catheter if damaged in any way 3 Manipulate the steering control knobs to verify proper flexion of the catheter tip and place them in the neutral position 4 Place the sterile sheath over the interconnect tab so it is fully seated onto the handle 5 Mate the catheter connector with the steering handle making certain that the connector is locked in place 6 Place the sterile sheath over the catheter connector in a manner which will allow the distal portion to be outside the sterile field 7 Connect the end of the catheter connecto
4. c thrombus Presence of class IV angina or heart failure Deep vein thrombosis Significant peripheral vascular disease gt OQ00 2 Warning This device is not intended for a Use inthe coronary vessels b Insertion into the arterial system c Fetal or pediatric uses WARNINGS AND PRECAUTIONS 1 The user of the device should have adequate training and a thorough understanding of the use and applications of these devices as well as cardiac imaging procedures All mapping procedures must be performed in fully equipped EP labs 2 For ultrasound purposes the Reprocessed 3D and eco Diagnostic Ultrasound Catheters are identical to the AcuNav 10F Catheter Refer to the AcuNav Ultrasound Catheter User Manual supplied by the OEM 3 Inspect the packaging and the imaging catheter prior to use If sterility appears compromised or the package product appears damaged do not use 4 The device should only be used by physicians trained in cardiac catheterization and preferably in the placement and use of intracardiac imaging devices and the interpretation of the resulting ultrasound images 5 Do not attempt to connect and operate the device before completely reading and understanding the instructions for use and system manual 6 Carefully manipulate the catheter in order to avoid cardiac damage perforation or tamponade _ _ lt lt _ INSTRUCTIONS FOR USE STERILMED x Reprocessed 3D Imaging Catheter Control
5. d at www sterilmed com Further questions or concerns by the health practitioner can be addressed directly by contacting your Sterilmed Customer Service Associate and or the Sterilmed Quality Department at 1 888 541 0078 LY D INSTRUCTIONS FOR USE STERILMED x Reprocessed 3D Imaging Catheter Control SMI 420 303 Rev C Explanation of Symbols Single patient use only Consult instructions for use Use by date OEM Catalog number Sterilized using ethylene oxide Do not use if package is damaged Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner NOTE Please refer to the package and labeling for applicable symbols
6. ion sensor are at the distal tip of the device and may be positioned within the target area by a steering mechanism which rotates the catheter tip and allows for variable deflection The 3D and eco Diagnostic Ultrasound Catheters feature a hand piece a flexible shaft and a distal tip section containing the ultrasound transducer and location sensor The 3D and eco Diagnostic Ultrasound Catheter 3D location sensor provides location information to the CARTO XP and CARTO 3 EP Navigation Systems The 3D and eco Diagnostic Ultrasound Catheters have a 10 French diameter and a 90 cm insertion length The 3D and eco Diagnostic Ultrasound Catheters have been cleaned evaluated for continued integrity and sterilized following a prior use Devices are tracked throughout the reprocessing steps to monitor and ensure they do not exceed the specified number of reprocessing cycles ee lt lt _ INSTRUCTIONS FOR USE STERILMED ho Reprocessed 3D Imaging Catheter Control SMI 420 303 Rev C This device is provided STERILE This device has been reprocessed for a single use If the device is to be used again it must undergo reprocessing prior to use CONTRAINDICATIONS 1 This device is contraindicated in cases where vascular access is inadequate or in the presence of conditions which create an unacceptable risk during cardiac catheterization such as Sepsis Major coagulation abnormalities Presence of any right sided intracardia
7. r to the ultrasound system using the appropriate SwiftLink Catheter connector and verify that the imaging screen appears 8 Use the hypertonic catheter connector to connect the 3D and eco Diagnostic Ultrasound Catheter to the mapping system if used 9 When the 3D and eco Diagnostic Ultrasound Catheter is used in conjunction with the CARTO XP and CARTO 3 mapping system connect the catheter to the Patient Interface Unit PIU using a sterile extension cable not provided by Sterilmed Inc Caution Quick connection or disconnection of the 3D and eco Diagnostic Ultrasound Catheters may result in catheter damage potentially causing procedural delay 10 Connect the reference patch such as REFSTAR with QWIKPATCH to the appropriate operating system 11 For use of the 3D and eco Diagnostic Ultrasound Catheter in mapping procedures an additional external reference patch not provided by Sterilmed Inc is required for location reference position purposes Connect the external reference patch not provided by Sterilmed Inc following the appropriate mapping system documentation ee lt lt _ INSTRUCTIONS FOR USE STERILMED wa Reprocessed 3D Imaging Catheter Control SMI 420 303 Rev C 12 Create a vascular access with an appropriate introducer sheath 13 Advance the catheter into the vasculature though the introducer sheath under fluoroscopic guidance 14 Manipulate steering knobs to direct the tran
8. sducer inside the cardiac anatomy 15 Release the tension control knob and return the steering knobs to the neutral position prior to withdrawal of the catheter INTERFERING SUBSTANCES OR DEVICES Immediately discontinue the use of the 3D and eco Diagnostic Ultrasound Catheter if it interferes with the function of the patient s pacemaker METHODS TO TEST REPROCESSED DEVICES Devices have been tested to demonstrate biocompatibility following reprocessing as well as achievement of sterility Validated methods are used for cleaning packaging and routine sterilization Inspection and pre release testing are used to ensure appropriate device integrity and function of each device prior to release of product for reuse Sterilization This product and its packaging have been sterilized with ethylene oxide gas EO Even though the product is processed in compliance with all applicable laws and regulations relating to EO exposure Proposition 65 a State of California voter initiative requires the following notice Warning This product and its packaging have been sterilized with ethylene oxide The packaging may expose you to ethylene oxide a chemical known to the State of California to cause cancer or birth defects or other reproductive harm SoundStar REFSTAR QWIKPATCH and CARTO are trademarks of Biosense Webster Inc AcuNav and SwiftLink are trademarks of Siemens Medical Solutions USA Inc Instructions for Use can be foun
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