CardioFocus HeartLight X3 Manual De Instrucciones página 17

33. Post-ablation mapping may be performed at the discretion of the physician.
34. If the Endoscope will be reprocessed, remove Endoscope from the Balloon Catheter. Follow the Endoscope
Cleaning & Sterilization instructions for the Endoscope.
• straighten the Balloon Catheter
• uncouple the luer from the Endoscope fitting at the back end of the Balloon Catheter handle
• gently pull the Endoscope out of the Balloon Catheter
• coil the Endoscope into a loop no smaller than 15cm (6") diameter
35. Disconnect the Catheter from the Console and remove from the sterile field.
8. Specifications
Outer Balloon Catheter diameter
Recommended Introducer sheath
Storage Parameters
9. Storage
Store in a cool dry place. Recommended storage temperature is from 5 to 30
10. Disposal
Used products are contaminated and must be handled and disposed as contaminated hospital waste according
to local and national regulations and hospital guidelines. Remember to remove the endoscope from the Balloon
Catheter for reprocessing prior to disposal.
11. Limited Warranty
LIMITED WARRANTY: The purchaser must comply with the terms and conditions in this document for this
Limited Warranty to apply.
CARDIOFOCUS WARRANTS THAT THE PRODUCT(S) HAS (HAVE) BEEN MANUFACTURED AND
RELEASED FOR USE IN ACCORDANCE WITH ITS SPECIFICATIONS AND TESTED USING ITS
ESTABLISHED TEST METHODS.
CARDIOFOCUS DOES NOT WARRANT THE SUITABILITY OF A DEVICE FOR ANY SPECIFIC PATIENT,
SINCE FITNESS FOR USE IS A MEDICAL DECISION.
CARDIOFOCUS WILL NOT BE RESPONSIBLE FOR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL,
DIRECT, INDIRECT, OR OTHER LIABILITIES, LOSSES, DAMAGES, OR COSTS PURSUANT TO OR AS A
RESULT OF THIS WARRANTY.
THIS WARRANTY REPRESENTS THE ENTIRE OBLIGATION OF CARDIOFOCUS AND IS MADE IN LIEU OF
ANY OTHER WARRANTIES WHETHER EXPRESSED OR IMPLIED, INCLUDING MERCHANTABILITY.
THE REMEDIES SET FORTH IN THIS WARRANTY WILL BE THE ONLY REMEDIES AVAILABLE TO ANY
PERSON. NO PERSON HAS ANY AUTHORITY TO BIND CARDIOFOCUS TO ANY WARRANTY OR
REPRESENTATION EXCEPT THOSE SPECIFICALLY CONTAINED HEREIN.
WITHOUT LIMITING THE FOREGOING, CARDIOFOCUS OR ITS AFFILIATED COMPANIES, SHALL NOT BE
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
4 mm (12 Fr)
≥ 12F ID 180 deflectable sheath
◦
75cm usable length; ≤94cm overall length
Greater than 0°C (32°F)
° °
C (41 – 86 F).
ECN-4541
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