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Limited Warranty and Disclaimer 

Limited Warranty and Disclaimer – AGILIS HisPRO CATHETER 
The purchaser (you) must comply with the terms and conditions in this document for this Limited Warranty to apply. Abbott Medical  
(“Abbott”) hereby warrants that if this Abbott product (the “Product”) fails to perform within written operating specifications (when 
used as intended under normal surgical conditions and in conformance with the instructions for its use and maintenance contained 
in the 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. In addition to the other terms, limitations and 
exclusions in this Limited Warranty, the following conditions must be met in order for this Limited Warranty to apply: 
1.

 

The Product was designed and distributed by Abbott.  

2.

 

The Product must be returned for analysis to Abbott, 15900 Valley View Court, Sylmar, California 91342 within forty-five (45) 
days of its use in the applicable patient procedure along with written documentation evidencing the procedure date and a 
description of the reasons for return. Upon return, the Product becomes the property of Abbott. 

3.

 

The Product has not been mishandled, improperly stored, reprocessed or altered in any way or used in any way that is not in 
conformance with the Product’s authorized uses and approved methods of use as set forth in the Product’s “Instructions for 
Use” published by Abbott. 

4.

 

The Product was used before the 'USE BEFORE' date marked on the packaging of the Product. 

Abbott will analyze the returned Product and determine whether it qualifies for coverage under this Limited Warranty. No 
representation or warranty is made that an Abbott product will not fail. THIS LIMITED WARRANTY IS IN LIEU OF, AND ABBOTT 
HEREBY DISCLAIMS AND EXCLUDES, ALL OTHER WARRANTIES, REPRESENTATIONS OR CONDITIONS, WHETHER EXPRESS 
OR IMPLIED BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF 
MERCHANTABILITY, NON-INFRINGEMENT, COURSE OF DEALING, QUIET ENJOYMENT, OR FITNESS FOR A PARTICULAR 
PURPOSE. 
Abbott disclaims responsibility for any medical complication, including death, resulting from the use of its products. Except for the 
replacement credit as expressly provided by this Limited Warranty, ABBOTT IS NOT RESPONSIBLE FOR ANY INDIRECT, SPECIAL, 
COVER, PUNITIVE, CONSEQUENTIAL, INCIDENTAL, OR OTHER DAMAGES DIRECTLY OR INDIRECTLY ARISING FROM THE USE 
OF OR RELATED TO THE PRODUCT AND WHETHER BASED ON ANY DEFECT, FAILURE, OR MALFUNCTION OF THE PRODUCT 
REGARDLESS OF WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE. ABBOTT’S SOLE 
LIABILITY AND PURCHASER’S SOLE REMEDY RELATED TO THE PRODUCT IS LIMITED TO THE REPLACEMENT CREDIT AS 
DESCRIBED IN THIS LIMITED WARRANTY. Some jurisdictions do not allow the exclusion or limitation of consequential damages 
however, so the above limitations or exclusions may not apply to you. 
THE ABOVE DISCLAIMERS AND LIMITATIONS SHALL BE CONSTRUED TO COMPLY WITH APPLICABLE LAW AND THIS LIMITED 
WARRANTY SHALL BE REFORMED ACCORDINGLY AS NECESSARY TO COMPLY WITH APPLICABLE LAWS OF THE COUNTRY 
WHERE THE PRODUCT IS USED. 
 

Summary of Contents for Agilis HisPro DS3H010-38

Page 1: ...Agilis HisPro Steerable Catheter With Electrodes Model DS3H010 38 Instructions for Use...

Page 2: ...e 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 Indicates a...

Page 3: ...Pacing System Analyzer PSA Supreme Electrophysiology Cable 401980 401981 401982 or 401983 Adapter Pins Refer to the Merlin PSA Help Manual for a complete list of cables required to connect the PSA to...

Page 4: ...catheter may result in damage Handle with care Do not immerse the handle or cable connector in fluids electrical performance could be affected Do not expose to organic solvents Precautions to prevent...

Page 5: ...ckwise see figure below Do not use if the catheter is damaged 6 Turn the deflection knob counterclockwise to the neutral position Note After the catheter has been deflected the catheter shaft may not...

Page 6: ...ignals Anchoring the Lead 1 After finding the target location advance and anchor the lead helix into the target location 2 Attach electrical connectors to the lead 3 Confirm placement of the lead via...

Page 7: ...ction knob Secure the lead with thumb 6 Align the Slitter tool lead stabilization channel with the lead cup and secure the lead in the lead stabilization channel CAUTION Inaccurate alignment or exerti...

Page 8: ...e lead fully seated in the lead retention channel Lead not seated fully in the retention channel 9 Ensure the Slitter tool reference line is parallel with the catheter shaft see figure below Figure 2...

Page 9: ...f the Catheter shaft should have minimal curvature The Catheter should be slit using an axial motion avoiding rotation 11 Carefully remove the lead from the Slitter tool 12 Confirm placement of the le...

Page 10: ...symbols may be found on the product or product label For harmonized symbols refer to the Universal Symbols Glossary at https medical abbott manuals Symbol Description Outer dimension Inner dimension A...

Page 11: ...of use as set forth in the Product s Instructions for Use published by Abbott 4 The Product was used before the USE BEFORE date marked on the packaging of the Product Abbott will analyze the returned...

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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...

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