Johnson & Johnson Biosense Webster THERMOCOOL SMARTTOUCH Mode D'emploi page 9

39. The catheter is sterilized with ethylene oxide gas and should be used by the
"Use By" date on the device package. Do not use the catheter if past the
"Use By" date.
40. The Biosense Webster THERMOCOOL SMARTTOUCH™ Bi-Directional
Navigation Catheter is intended for single patient use only.
41. This device is packaged and sterilized for single use only. Do not reuse,
reprocess or resterilize. Reuse, reprocessing, or resterilization may
compromise the structural integrity of the device and/or lead to device failure
that in turn may result in patient injury, illness or death. Also, reprocessing or
resterilization of single use devices may create a risk of contamination
and/or cause patient infection or cross-infection, including, but not limited to,
the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness, or death of the
patient.
42. Do not use near MRI equipment since movement or heating of the catheter
may occur and the image on the display may become distorted.
43. Use both fluoroscopy and electrogram data to monitor catheter
advancement and reduce risk of tissue injury.
44. The Biosense Webster THERMOCOOL SMARTTOUCH™ Bi-Directional
Navigation Catheter used in conjunction with a RF generator is capable of
delivering significant electrical power. Patient or operator injury can result
from improper handling of the catheter and indifferent electrode, particularly
when operating the catheter. During energy delivery, the patient should not
be allowed to come in contact with grounded metal surfaces. If during
ablation, temperature does not rise, discontinue delivery of energy and
check set-up.
45. The risk of igniting flammable gases or other materials is inherent in
electrosurgery. Precautions must be taken to restrict flammable materials
from the electrosurgical suite.
46. Electromagnetic interference (EMI) produced by the Biosense Webster
THERMOCOOL SMARTTOUCH™ Bi-Directional Navigation Catheter, when
used in conjunction with an RF generator during normal operation, may
adversely affect the performance of other equipment.
47. Electrodes and probes for monitoring and stimulating devices can provide
paths for high frequency current. The risk of burns can be reduced but not
eliminated by placing the electrodes and probes as far away as possible
from the ablation site and the indifferent electrode. Protective impedances
may reduce the risk of burns, and permit continuous monitoring of the
electrocardiogram during energy delivery.
48. The temperature sensor measures electrode tip temperature, not tissue
temperature. The temperature displayed on the RF generator is for the
cooled electrode only and does not represent tissue temperature. If the RF
generator does not display temperature, verify that the appropriate cable is
plugged into the RF generator. If temperature still is not displayed, there
may be a malfunction in the temperature sensing system that must be
corrected prior to applying RF power.
49. The temperature measurement accuracy of the Biosense Webster
THERMOCOOL SMARTTOUCH™ Bi-Directional Navigation Catheter, as
with any temperature measurement electrophysiology catheter, is largely
determined by the temperature accuracy specification of the RF generator
used. Please consult the user manual for the RF generator to be used for
the temperature accuracy specification.
50. Before use, check irrigation ports are patent by infusing heparinized normal
saline through the catheter and tubing.
51. Regularly inspect and test reusable cables and accessories.
RF Ablation
For RF ablation the catheter is connected to the CARTO™ 3 System PIU, which
connects to the RF generator. For setup procedures refer to the User Manual for
your CARTO™ 3 Navigation System. For proper RF generator interface, use
only a Biosense Webster or compatible interface cable. To complete the
electrical circuit, an indifferent electrode must be connected to the indifferent
electrode input on the RF generator. Verify that circuit impedance prior to RF
ablation is within expected parameters. Verify that the RF generator displays a
temperature not above 37°C after the catheter is inserted into the patient and
before applying RF power.
RF Generator Operation
Refer to the applicable RF generator manual for proper connection of the
catheter to the generator and for detailed instructions as to generator operation
for RF ablation.
RF ablation application parameters will vary depending on the ablation site, the
specific conditions present in each procedure and the RF generator control
circuitry. Based on data obtained from prior animal and clinical studies,
recommended RF application parameters are provided below in the "Directions
for Use" and in Table 1. Always monitor temperature and impedance rise when
using the THERMOCOOL SMARTTOUCH™ Bi-Directional Navigation Catheter.
How Supplied
The THERMOCOOL SMARTTOUCH™ Bi-Directional Navigation Catheter is
•
supplied STERILE (EtO).
•
The catheter has a 7.5 F shaft with 8 F ring electrodes and a usable length
of 115 cm.
Currently, the available curves for the THERMOCOOL SMARTTOUCH™ Bi-
•
Directional Navigation Catheters include DD, FF, JJ, DF, and FJ (Figure 1).
•
Additional catheter accessory devices are provided separately.
Packaging
The THERMOCOOL SMARTTOUCH™ Bi-Directional Navigation Catheter is
supplied STERILE. The catheter is secured in a two-piece thermoform tray and
placed into a Tyvek/Nylon film pouch, sealed, and placed in a box. Both the
pouch and thermoform tray are sterile unless the package is damaged or
opened.
Storage
Store in a cool, dry, dark place. Storage temperature should be between 5 and
25°C (41 and 77°F).
Sterilization/"Use By" Date
This catheter has been sterilized with ethylene oxide gas. Product and package
testing have been conducted to support the "Use By" date printed on the product
labels. DO NOT USE after the "Use By" date.
Disposal
Recycle components, or dispose of the product and its residual elements or
waste items in accordance with local laws and regulations.
Directions for Use
Please refer to the User Manuals for the CARTO™ 3 System, irrigation pump
and RF Generator for instructions on connecting and operating these systems in
conjunction with the THERMOCOOL SMARTTOUCH™ Bi-Directional Navigation
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.
Figure 1
English
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Release Date: 11/1/2019