English
6 M-5276-658A
may reduce the risk of burns, and permit continuous monitoring of the
electrocardiogram during energy delivery.
44. 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.
45. The temperature measurement accuracy of the
Biosense Webster T
HERMO
C
OOL
®
SF 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.
46. Before use, check irrigation ports are patent by infusing heparinized normal
saline through the catheter and tubing.
47. Regularly inspect and test reusable cables and accessories.
RF Ablation
For RF ablation, the catheter must be connected to the appropriate input
connector(s) on the RF generator. For proper interface use only
Biosense Webster or compatible interface cables. 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 operation of the RF
generator.
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
T
HERMO
C
OOL
®
SF
Diagnostic/Ablation Deflectable Tip Catheter.
How Supplied
•
The T
HERMO
C
OOL
®
SF
Diagnostic/Ablation Deflectable Tip Catheter is supplied
Sterile (EtO) unless the package is damaged or opened.
•
Currently, the available curves for the T
HERMO
C
OOL
®
SF
Diagnostic/Ablation
Deflectable Tip Catheters
include BB, DD, FF, JJ, BD, FJ, DJ, BF, and DF.
•
Additional catheter accessory devices are provided separately.
Storage
The T
HERMO
C
OOL
®
SF
Diagnostic/Ablation Deflectable Tip catheter must be
stored in a cool, dry place. Storage temperature should be between 5 and 25
o
C
(41 and 77
o
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.
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.
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 irrigation pump, RF generator and the
irrigation tubing for instructions on connecting and operating these systems in
conjunction with the T
HERMO
C
OOL
®
SF
Diagnostic/Ablation Deflectable Tip
Catheter. Use appropriate Biosense Webster accessory cables to connect the
T
HERMO
C
OOL
®
SF
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.
To verify compatibility between the sheath and catheter, advance the
catheter through sheath prior to insertion.
4.
Connect the catheter to the recording equipment and/or the RF generator
using the appropriate Biosense Webster cable. To complete the electrical
circuit, connect an indifferent electrode to the indifferent electrode input on
the generator.
5.
Connect the irrigation tubing to a room temperature, heparinized (1 u
heparin/ml) normal saline bag using standard safe hospital practices. Open
the stopcock on the end of the irrigation tubing and fill the irrigation tubing
as slowly as possible. Remove any trapped air and then close the stopcock.
6.
Load the irrigation tubing into the irrigation pump. Open the stopcock and
flush the irrigation tubing per the irrigation pump instructions until the air is
expelled through the open end of the tubing.
7.
Connect the stopcock on the end of the irrigation tubing to the luer fitting of
the T
HERMO
C
OOL
®
SF
Diagnostic/Ablation Deflectable Tip Catheter.
8.
Flush the catheter and tubing per standard technique to ensure purging of
trapped air bubbles and to verify that the irrigation holes are patent.
9.
Start continuous irrigation at a flow rate of 2 ml/min.
10. Insert
the
T
HERMO
C
OOL
®
SF
Diagnostic/Ablation Catheter via the entrance
site, using a guiding sheath with a minimum size of 8 F. Advance the
catheter to the area under investigation. Use both fluoroscopy and
electrograms to aid in proper positioning.
11. Deflection of the Catheters:
Use the Rocker Lever to deflect the catheter tip (Figure 1). When the lever
is pulled back from neutral, the tip will deflect relative to the direction of
rotation. The amount of deflection is relative to the amount of lever rotation.
When the lever is pushed forward, the tip will deflect in the opposite
direction. To straighten the tip, return the Rocker Lever to neutral position.
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.
