Summary of Contents for Abbott Agilis HisPro DS3H010-38
- Page 1 Agilis HisPro™ Steerable Catheter With Electrodes Model DS3H010-38 Instructions for Use...
- Page 2 WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. ™ Indicates a trademark of the Abbott group of companies. ‡...
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Page 3: Indications For Use
Effective Length Outer Diameter Inner Diameter DS3H010-38 38cm 10.5Fr The catheter is compatible with the following Abbott Medical recording and pacing systems: Table 2. Device Compatibility System Device Connect via Supreme Electrophysiology Cable (401980, 401981, WorkMate Claris™ Recording System 401982, or 401983) Supreme Electrophysiology Cable (401980, 401981, Merlin™... - Page 4 The package contents have been sterilized with ethylene oxide before shipment. The package contents are for single use only and are not intended to be resterilized. If the sterile package has been compromised, do not use. Contact Abbott Medical. ...
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Page 5: Storage And Handling
Storage and Handling Handle with care. Items should be stored at temperatures between -20ºC (-4ºF) and 50ºC (122ºF). Store in a well-ventilated area under conditions that protect items from extreme humidity. In addition, cartons containing these items should be protected from water and should not be crushed. - Page 6 Use the valve bypass tool to open the hemostasis valve and advance the lead and stylet to the distal tip of the catheter. Use fluoroscopy to confirm the position of the lead within the catheter. Aspirate for the presence of air and flush the catheter through the stopcock. Close the stopcock. Finding the Target Location Connect the WorkMate Claris™...
- Page 7 Partially retract the catheter to prevent lead dislodgement. NOTE: Ensure lead suture sleeve is positioned and slid as far proximal as possible on the lead. Turn the deflection knob counterclockwise to the neutral position. Position the lead within the channel on the deflection knob. Secure the lead with thumb.
- Page 8 Guide the rest of the lead into the Slitter tool thumbpad groove and secure it with thumb. CAUTION: Lead must be fully seated within the Slitter tool lead retention channel and thumbpad groove. CAUTION: Thumb position should not extend above thumbpad. •...
- Page 9 10. Slit the catheter. Ensure the exposed portion of Catheter shaft is straight, without significant curvature. Ensure both arms are extended. Hold the Slitter tool in a stable fixed position. CAUTION: Do not advance or rotate Slitter tool. Steadily pull the catheter through the Slitter tool in one continuous, axial motion, avoiding rotation.
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Page 10: Technical Support
Technical Support Abbott Medical maintains 24-hour phone lines for technical questions and support: 1 818 362 6822 1 800 722 3774 (toll-free within North America) + 46 8 474 4147 (Sweden) + 61 2 9936 1200 (Australia) ... -
Page 11: Limited Warranty And Disclaimer
Product’s “Instructions for Use” published by Abbott) due to a defect in materials or workmanship, Abbott will provide a credit for the purchase of an equivalent or functionally equivalent replacement Abbott product in an amount not to exceed the lesser of the net invoiced price of the original Abbott product or the replacement Abbott product. - Page 14 St. Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court Sylmar, CA 91342 USA +1 818 362 6822 2020-06 ARTEN600080436 B...