Johnson & Johnson Biosense Webster THERMOCOOL SMARTTOUCH Mode D'emploi page 7

THERMOCOOL SMARTTOUCH™ Bi-Directional
Navigation Catheter
Caution: Federal (USA) law restricts this device to sale by or on
the order of a physician.
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STERILE. Sterilized using ethylene oxide.
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For single use only.
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Do not resterilize.
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Do not use if the package is open or damaged.
Device Description
The Biosense Webster THERMOCOOL SMARTTOUCH™ Bi-Directional
Navigation Catheter is a multi-electrode luminal catheter with a deflectable tip
designed to facilitate electrophysiological mapping of the heart and to transmit
radiofrequency (RF) current to the catheter tip electrode for ablation purposes.
The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the
catheter is used in conjunction with an RF generator and a dispersive pad
(indifferent electrode). The catheter has force-sensing technology that provides
a real-time measurement of contact force between the catheter tip and the heart
wall.
The catheter has a high-torque shaft with a bi-directional deflectable tip section
containing an array of electrodes which includes a 3.5 mm tip dome. All of the
electrodes may be used for recording and stimulation purposes. The tip
electrode serves to deliver RF current from the RF generator to the desired
ablation site. The tip electrode and ring electrodes are made from a noble metal.
The catheter incorporates a thermocouple temperature sensor that is embedded
in the 3.5 mm tip electrode. A Rocker Lever is used to deflect the tip. The high-
torque shaft also allows the plane of the curved tip to be rotated to facilitate
accurate positioning of the catheter tip at the desired site. Additionally, a variety
of curve types are available in symmetric or asymmetric combinations, providing
two 180° opposed, single planed curves. Currently, the available curves for the
THERMOCOOL SMARTTOUCH™ Bi-Directional Navigation Catheters include
DD, FF, JJ, DF and FJ.
At the proximal end of the catheter, a saline input port with a standard luer fitting
terminates from the open lumen. This saline port serves to permit the injection of
normal saline to irrigate the tip electrode. During ablation, heparinized normal
saline is passed through the internal lumen of the catheter and through the tip
electrode, to irrigate and cool the ablation site as well as the electrode tip.
An irrigation pump should be used to control the saline irrigation. The catheter
interfaces with standard recording equipment and a compatible RF Generator
via accessory extension cables with the appropriate connectors.
This catheter features a location sensor embedded in the tip section that
transmits location and contact force information to the CARTO™ 3 Navigation
System. An appropriate reference device is required for location reference
position purposes. For use in mapping procedures and for information on
appropriate reference devices, and for further description of the operation of the
CARTO™ 3 System, refer to the User Manual for your CARTO™ 3 Navigation
System.
Indications and Use
The Biosense Webster THERMOCOOL SMARTTOUCH™ Bi-Directional
Navigation Catheter and related accessories are indicated for catheter-based
cardiac electrophysiological mapping (stimulating and recording) and, when used
in conjunction with a radiofrequency generator, for cardiac ablation.
The THERMOCOOL SMARTTOUCH™ Bi-Directional Navigation Catheter
provides a real-time measurement of contact force between the catheter tip and
heart wall, as well as location information when used with CARTO™ 3
Navigation System.
Contraindications
Do not use this device:
1. If the patient has had a ventriculotomy or atriotomy within the preceding
eight weeks because the recent surgery may increase the risk of perforation.
2. In the patient with a myxoma or an intracardiac thrombus as the catheter
could precipitate an embolus.
3. In patients with prosthetic valves as the catheter may damage the
prosthesis.
4. In the coronary vasculature due to risk of damage to the coronary arteries.
5. In patients with an active systemic infection because this may increase the
risk of cardiac infection.
6. Via the transseptal approach in a patient with an interatrial baffle or patch
because the opening could persist and produce an iatrogenic atrial shunt.
7. Via the retrograde trans-aortic approach in patients who have had aortic
valve replacement.
8. With a long sheath or short introducer < 8.5 F in order to avoid damage to
the catheter shaft.
Warnings and precautions
1. Do not use excessive force to advance or withdraw the catheter when
resistance is encountered during catheter manipulation through the sheath.
2. Do not manually pre-shape the distal shaft of the catheter by applying
external forces intended to bend or affect the intended shape or curve of the
catheter.
3. The contact force reading is for information only and is not intended to
replace standard handling precautions.
4. The catheter must be warmed up as specified prior to use. If the catheter
has not reached a steady state condition, there is potential for a zero-offset
drift to occur which could result in an inaccurate contact force reading.
5. Always zero the contact force reading following insertion into the patient or
when moving the catheter from one chamber of the heart to another. Ensure
the catheter is not in contact with heart tissue prior to zeroing. Refer to the
User Manual for your CARTO™ 3 System for instructions on how to zero the
contact force reading.
6. The contact force reading might become inaccurate if the contact force
sensor (located between the first and second ring electrode) comes into
close proximity with a ferrous material, such as the braided shaft of another
catheter. If extreme fluctuations in force are observed, ensure the catheter's
contact force sensor is not in close proximity with another catheter's shaft,
check zero on the catheter and, if necessary, remove and inspect the
catheter.
7. To ensure proper operation of the contact force sensor, the first two ring
electrodes of the catheter tip must protrude from the distal tip of the guiding
sheath.
8. When applying high lateral force during mapping and RF application, the
user should monitor the contact force Dashboard and vector display on the
CARTO™ 3 screen to ensure that contact force measurements remain
within the accurate range. Refer to the Error Messages and Alerts section of
the CARTO™ 3 System Instructions for Use for System-related alert
messages and indications related to inaccurate force readings.
M-5276-684K
WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada.
English
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Release Date: 11/1/2019