St. Jude Medical PACEL 401761 Instrucciones De Uso página 3

CAUTION: AVOID INSERTION OF A REDUNDANT LENGTH OF CATHETER AS THIS CAN RESULT IN LOOPING
OR KNOTTING (SEE PRECAUTIONS).
11 . Advance the pacing catheter until an ST segment elevation is observed, indicating contact with the endocardium .
Connect the pacing catheter to an isolated external pacemaker: the distal (-) electrode connector pin (black) is connected
to the negative terminal of the pacemaker and the proximal (+) electrode connector pin (red) is connected to the positive
terminal .
12 . If you need to extend the distance between a SJM Pacel™ Flow Directed Pacing Catheter and the external pacemaker, a
SJM™ Bipolar Pacing Cable may be used .
Note: Ensure that the SJM Pacel™ Flow Directed Pacing Catheter's connectors are fully inserted into the
connector block of the SJM Patient Cable. If the connectors are not fully inserted, an electrical connection will
not be made with the pacing device, and the pacing cables will not transmit an electrical current.
12 .1 The connector block's security pins (thumbwheels) should be opened completely prior to inserting the catheter's
connectors .
12 .2 When attaching the catheter to the pacing cable, align the rectangular sections of the catheter's connectors with
the inputs on the pacing cable's connector block in order to enable full insertion of the connectors . Connect the
distal (-) electrode connector pin (black) to the negative input of the connector block and the proximal (+) electrode
connector pin (red) to the positive input of the connector block . Ensure that the catheter's connectors are fully
inserted into the connector block of the pacing cable . Some resistance will be encountered after the cylindrical
section of the connector is inserted into the connector block .
Note: The connector must be inserted until it cannot be pushed in any farther . Refer to Diagram 1 below .
Connector Block
Thumbwheel
+
CORRECT
12 .3 Confirm that the catheter's connectors are fully inserted before tightening the thumbwheels . Particular attention
must be paid during this step because it is possible to tighten the pins without establishing a secure connection .
12 .4 Close the thumbwheels .
Note: Refer to the SJM™ Bipolar Pacing Cable Instructions for Use Manual for further information .
13 . Adjust the pulse generator and the position of the catheter as required to establish stable pacing as recommended by
the pacemaker manufacturer .
14 . With catheter advanced, break handle of introducer sheath and peel sheath apart while withdrawing from the vessel .
Take care NOT to withdraw the catheter .
CAUTION: THE NEED FOR SYMMETRICAL PEELING OF THE SHEATH CANNOT BE OVEREMPHASIZED. IF
CATHETER WITHDRAWAL IS DIFFICULT WHEN THE SHEATH IS PEELED, COMPLETELY WITHDRAW THE
SHEATH FROM THE INTRODUCTION SITE WHILE HOLDING THE CATHETER IN POSITION. THEN PEEL THE
SHEATH SYMMETRICALLY FROM THE CATHETER BY GRASPING BOTH HANDLE HALVES.
15 . Aseptically secure the catheter at the point of insertion to prevent catheter migration, possible tip dislodgement, and loss
of capture . The catheter stability and tip location may be verified radiographically .
SHELF LIFE
Storage beyond the indicated package expiration may result in balloon deterioration . Resterilization will not extend shelf life .
PACKAGING
The packaging protects the catheter from physical damage and from exposure to the atmosphere . Keep the catheter inside
the shelf box until use . Store in a cool, dark, dry place .
USA ONLY - LIMITED WARRANTY AND DISCLAIMER
St . Jude Medical ("SJM") hereby warrants that if any SJM product fails to perform within normal tolerances for a patient due to a
defect in materials or workmanship, SJM will provide, at no charge, a replacement SJM product for the patient' s use . This
limited warranty applies only if each of the following conditions are met .
1 . The product was packaged and labeled by SJM .
2 . The failed product must be returned to SJM and becomes the property of SJM .
3 . The product has not been mishandled, reprocessed or altered in any way .
4 . The product was used before the "USE BY" date marked on the packaging of the product .
STATE OF CALIFORNIA (USA) ONLY:
WARNING: This product and its packaging have been sterilized with ethylene oxide . The packaging may expose you to ethylene
oxide, a chemical known to the State of California to cause cancer or birth defects or other reproductive harm .
Connector Pin
–
+ –
INCORRECT
DIAGRAM 1
No representation or warranty is made that a SJM product will not fail . SJM disclaims responsibility for any medical
complications, including death, resulting from the use of its products . Except as expressly provided by this limited warranty,
SJM IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY
DEFECT, FAILURE, OR MALFUNCTION OF ITS PRODUCTS, WHETHER THE CLAIM IS BASED ON WARRANTY,
CONTRACT, TORT, OR OTHERWISE . Some states do not allow the exclusion or limitation of incidental or consequential
damages however, so the above limitation or exclusion may not apply to you .
Except as expressly provided by the limited warranty, SJM MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING,
BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR
PURPOSE .
AUSTRALIA ONLY - LIMITED WARRANTY AND DISCLAIMER
This warranty is given by St . Jude Medical (SJM) . To make inquiries regarding this warranty, use the contact information for
either the manufacturer or Australian Sponsor located on the back cover .
Our goods come with guarantees that cannot be excluded under the Australian Consumer Law . You are entitled to a
replacement or refund for a major failure and compensation for any other reasonably foreseeable loss or damage . You are also
entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a
major failure .
The benefits to you given by this warranty are in addition to your other rights and remedies under the Australian Consumer
Law .
SJM warrants to the buyer that the goods, for a period equal to the validated shelf life of the goods (the "Warranty Period"),
shall meet the product specifications established by the manufacturer when used in accordance with the manufacturer's
instructions for use and shall be free from defects in materials and workmanship . Unless otherwise obligated by law or
mandatory consumer guarantees, under this warranty SJM will, at its option, replace or repair the goods at its factory, if the
buyer, at the buyer's expense, returns the goods within the Warranty Period to SJM to the address below and after SJM
confirms that the goods are defective .
St Jude Medical
Roseville Distribution Center
Attn: Postmarket Surveillance
2305 Walnut Street
Roseville, MN 55113
Tel .: (651) 756-2000
To the maximum extent permitted by law, if a mandatory term is implied by law or a mandatory consumer guarantee applies to
the goods, and the goods are not of a kind ordinarily acquired for personal, domestic or household use or consumption, SJM's
liability for the breach of the term or guarantee is limited to, at SJM's option, either replacement or repair of the goods or
payment of the costs of replacing or repairing the goods .
EXCEPT FOR MANDATORY TERMS IMPLIED BY LAW, MANDATORY CONSUMER GUARANTEES, OR AS EXPRESSLY
PROVIDED IN THIS WARRANTY, ST . JUDE MEDICAL DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY
KIND, EXPRESS OR IMPLIED .
See the Terms and Conditions of Sale for further information .
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