English
6 M-5276-692A
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.
19. Do not use near MRI equipment since movement or heating of the catheter
may occur and the image on the display may become distorted.
20. Use both fluoroscopy and electrogram data to monitor catheter
advancement and reduce risk of tissue injury.
21. The Biosense Webster T
HERMO
C
OOL
®
S
MART
T
OUCH
™
Diagnostic/Ablation
Deflectable Tip 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.
22. 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.
23. Electromagnetic interference (EMI) produced by the
Biosense Webster T
HERMO
C
OOL
®
S
MART
T
OUCH
™
Diagnostic/Ablation
Deflectable Tip Catheter, when used in conjunction with an RF generator
during normal operation, may adversely affect the performance of other
equipment.
24. 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.
25. 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.
26. The temperature measurement accuracy of the
Biosense Webster T
HERMO
C
OOL
®
S
MART
T
OUCH
™
Diagnostic/Ablation
Deflectable Tip 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.
27. Before use, check irrigation ports are patent by infusing heparinized normal
saline through the catheter and tubing.
28. Regularly inspect and test reusable cables and accessories.
RF Ablation
For RF ablation the catheter is connected to the C
ARTO
®
3 System Patient
Interface Unit (PIU), which connects to the RF generator. For setup procedures
refer to the User Manual for your C
ARTO
®
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 Biosense Webster T
HERMO
C
OOL
®
S
MART
T
OUCH
™
Diagnostic/Ablation
Deflectable Tip Catheter.
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.
Storage
Biosense Webster
T
HERMO
C
OOL
®
S
MART
T
OUCH
™
Diagnostic/Ablation
Deflectable Tip catheter must be stored in a cool, dry place. Storage temperature
should be between 5 and 25° C (41 and 77° F).
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 C
ARTO
®
3 System, irrigation pump and
RF generator for instructions on connecting and operating these systems in
conjunction with the Biosense Webster T
HERMO
C
OOL
®
S
MART
T
OUCH
™
Diagnostic/Ablation Deflectable Tip Catheter. Use appropriate Biosense Webster
accessory cables to connect the
Biosense Webster T
HERMO
C
OOL
®
S
MART
T
OUCH
™
Diagnostic/Ablation
Deflectable Tip Catheter to the appropriate accessory equipment.
1.
Using aseptic technique, remove the catheter from the package and place
in a sterile work area. Inspect the catheter carefully for electrode integrity
and overall condition.
2.
Create a vascular access in a large central vessel using aseptic techniques.
3.
In order to prevent damage to the catheter tip, use the insertion tube
supplied with the catheter to advance or retract the catheter through the
hemostasis valve of the sheath. After insertion, slide the insertion tube back
toward the handle.
4.
To verify compatibility between the sheath and catheter, advance the
catheter through sheath prior to insertion. The P
REFACE
®
Sheath, or an
8.5 F sheath, is recommended.
5.
The catheter is connected to the recording equipment and/or the RF
generator through the C
ARTO
®
3 System using the appropriate interface
cables. Connect the catheter to the Patient Interface Unit (PIU) via the
appropriate Biosense Webster cable. Connect the PIU to the generator via
the appropriate Biosense Webster cable. Connect the PIU to the
appropriate recording and mapping systems, including the C
ARTO
®
3
Navigation System, with appropriate interface cables. Use only
Biosense Webster interface cables. Connect the irrigation pump tubing to
the Luer fitting of the catheter. A 3-way stopcock may also be used.
Connect the irrigation pump to a room temperature, heparinized (1 u
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.
