General Warning - Medtronic ARCTIC FRONT 2AF231 Manual Del Usuario

14.Position the catheter at the ostium of the next target pulmonary vein using the guide wire
and/or deflection capabilities. Inflate the balloon and verify the balloon position before
proceeding with the next cryoablation treatment.
15.Determine effective ablation of the cardiac tissue by assessing electrical isolation of the
pulmonary vein from the left atrium (entrance and exit block) after the cryoablation
treatments have been completed.
16.After all treatments are completed, and after the balloon is deflated, its length is
maximized and it is tightly wrapped, retract the catheter into the sheath.
17.Remove the catheter from the patient.
7 Specifications
Catheter shaft size
Recommended introducer sheath
Inflated balloon diameter
Shaft length (with balloon inflated)
Number of thermocouples
Environmental parameters
Storage
Operation
8 Medtronic limited warranty
For complete limited warranty information see Medtronic limited warranty on page 7.
9 Service
Medtronic employs highly trained representatives and engineers located throughout the
world to serve you and, upon request, to provide training to qualified hospital personnel in
the use of Medtronic products. Medtronic also maintains a professional staff to provide
technical consultation to product users. For more information, contact your local Medtronic
representative, or call or write Medtronic at the appropriate telephone number or address
listed on the back cover.
10 Medtronic limited warranty
The following Limited Warranty applies to customers within the United States only:
A. This Limited Warranty provides the following assurance to the purchaser of a Medtronic
catheter, hereafter referred to as Product:
(1) Should the Product fail to function within normal tolerances due to a defect in
materials or workmanship on or before its "Use By" or "Use Before" date, Medtronic
will at its option: (a) issue a credit to the purchaser equal to the Purchase Price, as
defined in Subsection A(2), against the purchase of the replacement product or (b)
provide a functionally comparable replacement product at no charge.
(2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the
original, or current functionally comparable, or replacement product.
B. To qualify for this Limited Warranty, these conditions must be met:
(1) The Product must be used on or before its "Use By" or "Use Before" date.
(2) The Product must be returned to Medtronic within 60 days and shall be the property
of Medtronic.
(3) The Product must not have been used for any other patient.
(4) The Product must be used in accordance with the labeling and not altered or
subjected to misuse, abuse, accident, or improper handling.
C. This Limited Warranty is limited to its express terms. In particular:
(1) Except as expressly provided by this Limited Warranty, MEDTRONIC IS NOT
RESPONSIBLE FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL
DAMAGES BASED ON ANY DEFECT, FAILURE, OR MALFUNCTION OF THE
Product, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT,
OR OTHERWISE.
(2) This Limited Warranty is made only to the purchaser of the Product. AS TO ALL
OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE WHETHER
ARISING FROM STATUTE, COMMON LAW, CUSTOM, OR OTHERWISE. NO
EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND
BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY
SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.
(3) The exclusions and limitations set out above are not intended to, and should not be
construed so as to, contravene mandatory provisions of applicable law. If any part
or term of this Limited Warranty is held to be illegal, unenforceable, or in conflict with
applicable law by a court of competent jurisdiction, the validity of the remaining
portions of the Limited Warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this Limited Warranty did not contain the
particular part or term held to be invalid. This Limited Warranty gives the purchaser
specific legal rights. The purchaser may also have other rights which vary from state
to state.
(4) No person has any authority to bind Medtronic to any representation, condition, or
warranty except this Limited Warranty.
This Limited Warranty is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis,
MN 55432-5604. It applies only in the United States. Areas outside the United States should
contact their local Medtronic representative for exact terms of the Limited Warranty.

General warning

Medtronic catheters are used in the extremely hostile environment of the human body.
Catheters may be easily damaged by improper handling or use due to their unavoidably
fragile character, which is dictated by the unusual requirements of their application.
Consequently, no representation or warranty is made that failure or cessation of function of
the catheter will not occur, or that the body will not react adversely to the catheter, or that
medical complications will not follow.
Medtronic ® Limited Warranty
The following Limited Warranty applies to customers outside the United States only:
A. This LIMITED WARRANTY provides the following assurance to the purchaser of a
Medtronic catheter, hereafter referred to as Product, that should the Product fail to
function to specification, Medtronic will issue a credit, equal to the original purchase price
(but not to exceed the value of the replacement product), against the purchase of any
Medtronic replacement product used for that patient.
B. To qualify for the LIMITED WARRANTY, these conditions must be met:
(1) The Product must be used on or before its "Use By" or "Use Before" date.
(2) The Product must be returned to Medtronic within 60 days and shall be the property
of Medtronic.
(3) The Product must not have been used for any other patient.
(4) The Product must be used in accordance with the labeling and not altered or
subjected to misuse, abuse, accident, or improper handling.
C. This LIMITED WARRANTY is limited to its express terms. In particular, Medtronic is not
responsible for any incidental or consequential damages based on any use, defect, or
failure of the Product, whether the claim is based on warranty, contract, tort, or otherwise.
D. The exclusions and limitations set out above are not intended to, and should not be
construed so as to, contravene mandatory provisions of applicable law. If any part or
term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be
illegal, unenforceable, or in conflict with applicable law, the validity of the remaining
portions of the LIMITED WARRANTY shall not be affected, and all rights and obligations
shall be construed and enforced as if this LIMITED WARRANTY did not contain the
particular part or term held to be invalid.
3.99 mm (10.5 Fr)
12 Fr FlexCath Steerable Sheath
2AF231 - 23 mm
2AF281 - 28 mm
100 cm
1
Greater than 0 °C (32 °F)
15 °C to 30 °C (60 °F to 86 °F) at altitudes less
than 2400 meters (8000 feet) above sea level
Arctic Front Technical Manual English 7