English
8
M-5276-784B
not increase power before checking for obvious defects or misapplication of
the indifferent electrode or other electrical leads.
38.
Read and follow the indifferent electrode manufacturer’s instructions for use;
the use of indifferent electrodes that meet or exceed ANSI/AAMI
requirements (
AAMI IEC 60601
-2-2
), is recommended.
39.
The Biosense Webster T
HERMO
C
OOL
S
MART
T
OUCH
®
SF Uni-Directional
Navigation
Catheter is intended for use with compatible RF generators,
a
compatible irrigation pump,
C
ARTO
®
3 System and Biosense Webster
cables, and other appropriate interface cabl
es and connectors.
Use of a
compatible irrigation pump is recommended to assure proper irrigation flow
rate
.
40.
The Biosense Webster T
HERMO
C
OOL
S
MART
T
OUCH
®
SF Uni-Directional
Navigation
Catheter has been shown to create larger lesions than standard
non-irrigated
RF ablation catheters. Care should be taken when ablating
near structures such as the sino-
atrial and atrioventricular nodes.
41.
The sterile packaging and catheter should be inspected prior to use. Do not
use if the packaging or catheter appears damaged.
42.
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.
43.
The Biosense Webster T
HERMO
C
OOL
S
MART
T
OUCH
®
SF Uni-Directional
Navigation
Catheter is intended for single patient use only.
44.
Do not use near MRI equipment since movement or heating of the catheter
may occur and the image on the display may become distorted.
45.
Use both fluoroscopy and electrogram data to monitor catheter
advancement and reduce risk
of tissue injury.
46.
The Biosense Webster T
HERMO
C
OOL
S
MART
T
OUCH
®
SF Uni-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.
47.
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.
48.
Electromagnetic interference (EMI) produced by the
Biosense Webster
T
HERMO
C
OOL
S
MART
T
OUCH
®
SF Uni-Directional Navigation
Catheter, when
used in conjunction with an RF generator during normal operation, may
adversely affect the performance of other equipment.
49.
Electrodes and probes for monitoring and stimulating devices can provide
paths for high frequency current. The risk of burns can be reduc
ed 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 en
ergy delivery.
50.
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.
51.
The temperature measurement accuracy of the Biosense Webster
T
HERMO
C
OOL
S
MART
T
OUCH
®
SF Uni-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.
52.
Before use, check irrigation ports are patent by infusing heparinized normal
saline through the catheter and tubing.
53.
Regularly inspect and test reusa
ble cables and accessories.
54.
When ablating near adjacent anatomical structures, take precautions to
minimize collateral damage to the
adjacent structures.
55.
When ablating near the esophagus (along the posterior wall of the left
atrium), take precautions to av
oid injuring the esophagus, including
appropriately reducing RF power.
56.
When ablating near the phrenic nerve, take precautions to avoid injuring the
phrenic nerve, including appropriately reducing RF power and pacing to
identify the proximity of the nerve.
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 wit
hin 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
®
SF Uni-Directional
Navigation
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.
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.
Storage
Store in a cool, dry, dark 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.
