Related Manuals for St. Jude Medical Tendril MRI LPA1200M
Summary of Contents for St. Jude Medical Tendril MRI LPA1200M
- Page 1 Tendril MRI™ Model LPA1200M User's Manual Active Fixation Bipolar Steroid-Eluting Endocardial Pacing Lead...
- Page 2 Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related...
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Page 3: Intended Use/Indications
The St. Jude Medical™ MR Conditional lead is part of the St. Jude Medical MR Conditional pacing system. Patients with an implanted St. Jude Medical™ MR Conditional pacing system can have an MRI scan if the conditions for use, as described in the MRI Procedure Information document, are met. -
Page 4: Package Contents
permanently damage the pulse generator. Testing has demonstrated that the St. Jude Medical™ MR Conditional pacing system is conditionally safe for use in the MRI environment when used according to the instructions in the MRI Procedure Information document. The St. Jude Medical MR Conditional pacing system includes a St. -
Page 5: Outer Package
Figure 1. Lead Accessories Vein lifter Clip-on tool Storage The lead should be stored at room temperature. Permitted storage temperatures are between -5°C (23°F) and +50°C (122°F). Outer Package The lead is delivered in a cardboard package. The package label contains valuable descriptive information, including model designation, serial number, and the "... -
Page 6: Potential Adverse Events
The package contents have been sterilized with ethylene oxide before shipment. This lead is for single use only and is not intended to be resterilized. If the sterile package has been compromised, contact St. Jude Medical. Potential Adverse Events Potential complications associated with the use of the lead are the same as with the use of any lead and listed in the following table. -
Page 7: Select And Access A Vein
Adjacent to the Sternoclavicular Joint. PACE 16 (I): 445-457, 1993.Jacobs, D.M., Fink, A.S., Miller, R.P., et al.: Anatomical and Morphological Evaluation of Pacemaker Lead Compression. PACE 16 (I): 434-444, 1993. For additional information, contact your St. Jude Medical Sales Representative. -
Page 8: Test The Mechanical Operation Of The Helix With The Fixation Tool
Figure 5. Insert the stylet into the fixation tool Test the Mechanical Operation of the Helix with the Fixation Tool Before implanting the lead, the mechanical operation of the helix should be tested. With both thumbscrews secured and with the fixation tool in one hand, hold the lead stationary with the other hand. Use the thumb and forefinger to rotate only the gray portion of the tool clockwise (in the direction of the arrow on the tool marked "FIXATE"). -
Page 9: Position The Lead
Test the Mechanical Operation of the Helix with the Clip-On Tool For information on using the clip-on tool, see Secure the Tip with the Clip-On Tool (page 8). Using the Vein Lifter A vein lifter is supplied to facilitate the introduction of the lead into a free-standing vein. Insert the tip of the vein lifter into the vein incision and gently lift it while introducing the lead underneath, into the vein. -
Page 10: Ventricular Lead Placement
Figure 9. Atrial lead placement With the clip-on tool or the fixation tool, extend the helix so that the lead is fixed to the atrial wall. Retract the entire stylet from the lead with a smooth and steady motion. Check that the lead is properly anchored by introducing more of it into the heart until the loop that forms either lies on the bottom of the atrium, or is about to enter the inferior vena cava or the right ventricle. -
Page 11: Secure The Tip With The Fixation Tool
Figure 11. Open the clip-on tool Insert lead into notch Figure 12. Extend the helix by rotating the clip-on tool clockwise Secure the Tip with the Fixation Tool As an alternative to the clip-on tool, the fixation tool may be used to extend or retract the helix. After the fixation site has been selected, hold the lead body stationary in one hand and turn the distal (gray) section of the fixation tool clockwise (in the direction marked "FIXATE"). -
Page 12: Secure The Lead
Figure 13. Extension and retraction of the helix Helix fully extended Helix fully retracted Marker ring Electrically active helix Once fixation is verified, loosen the proximal thumbscrew on the fixation tool and carefully withdraw the stylet under fluoroscopic observation. The lead tip should remain in position. Exercise caution during stylet retraction to avoid dislodging the lead. Retraction of the J-shaped stylet may be more difficult than retraction of a straight stylet. -
Page 13: Connection To The Device
If the lead or any portion of it is extracted, handle it according to local regulations. Clean the explanted device with disinfectant and return it to St. Jude Medical for investigation and safe disposal. For safety reasons, we recommend that all used leads be enclosed in a protective cover. -
Page 14: Technical Support
Please complete an Out of Service/Explant/Patient Death form and return it to St. Jude Medical with the explanted device. Whenever possible, send along a printout of the programmed settings of the device. Technical Support St. Jude Medical maintains 24-hour phone lines for technical questions and support: 1 818 362 6822 ... -
Page 15: Stylet Color Codes
Use by Affixed in accordance with European Council Directive 90/385/EEC and 1999/5/EC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of these Directives. Device has been demonstrated to pose no known hazards in a specified MRI environment with... - Page 16 MR environment and conditions specified for MR Conditional use: • Magnet strength: 1.5 Tesla • Scan regions: Whole body • SAR (specific absorption rate) ¢4 W/kg For a complete set of conditions and environments, see the MRI Procedure Information document.
- Page 20 +32 2 774 68 11 Manufacturing Site: Manufacturing Site: St. Jude Medical Puerto Rico LLC St. Jude Medical Operations (M) Sdn. Bhd. Lot A Interior - #2 Rd Km. 67.5 Plot 102, Lebuhraya Kampung Jawa, Santana Industrial Park Bayan Lepas Industrial Zone...