Directions For Use - Johnson & Johnson Biosense Webster THERMOCOOL SMARTTOUCH SF Mode D'emploi

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.
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 C
RF Generator for instructions on connecting and operating these systems in
conjunction with the T
Catheter. Use appropriate Biosense Webster accessory cables to connect the
T C S
HERMO OOL MART
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. Any sheath < 8.5 French is
contraindicated.
5. The catheter is connected to the recording equipment and/or the RF
generator through the C
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
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 IU heparin/ml) normal saline bag
using standard safe hospital practices. To complete the electrical circuit,
connect an indifferent electrode to the indifferent electrode input on the
generator.
6. Flush the catheter and tubing per standard technique to ensure purging of
trapped air bubbles and to verify that the irrigation holes are patent.
7. Start continuous irrigation at a flow rate of 2 ml/min.
8. Insert the T
HERMO
Catheter via the entrance site using the insertion tube and an appropriately
sized introducer sheath. Advance the catheter to the area under
investigation.
9. Verify that the "TCool SF" option is selected on the RF generator. When this
option is chosen, the generator defaults to the safety parameters
established for the Biosense Webster T
Catheter.
10. Use both fluoroscopy and electrograms to aid in proper positioning.
11. In order to achieve optimal force reading accuracy and stability, allow the
catheter to warm up for 2 minutes after connection to the C
prior to use of the force feedback feature.
12. Zero the contact force reading following insertion into the patient. The tip
electrode and all four ring electrodes must be outside of the sheath so that
the force sensor is inside the body. Ensure the catheter tip is not in contact
with tissue by evaluating the location on fluoroscopy and the C
System, the EGM amplitude, and catheter movement. Variations in the force
reading at the same rate as the cardiac or respiration cycle may indicate
contact with cardiac structures. Once these markers indicate the tip is not in
contact, the reading can be zeroed. Refer to the User Manual for your
®
C 3 System for instructions on how to zero the contact force reading.
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13. Zero the contact force reading when moving the catheter from one chamber
of the heart to another or upon re-insertion.
14. Use the Rocker Lever to deflect the catheter tip (Figure 2). 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.
The handle has an adjustable friction control that allows the operator to
use the Rocker Lever and deflecting tip in a "free" state or adjust the
friction to where the Rocker Lever and tip curve are "locked" in place
(Figure 3). This knob is located on the opposite side of the Rocker Lever.
Out of the package, the knob will be in the "off" position, which allows the
freest movement for the lever and deflecting tip. The amount of friction
increases as the Friction Control Knob is rotated clockwise until it reaches
the fully "on" position. Clockwise rotation from the "off" position increases
the friction within the Deflection Mechanism. Counter-Clockwise rotation
from the "on" position decreases the friction within the Deflection
Mechanism.
M-5276-785B
C S
HERMO OOL MART
®
T SF Bi-Directional Navigation Catheter to the
OUCH
®
3 System using the appropriate interface
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C S T
OOL MART OUCH
Figure 2
®
3 System, irrigation pump and
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®
T SF Bi-Directional Navigation
OUCH
®
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®
SF Bi-Directional Navigation
C S
HERMO OOL MART
English
3 Navigation
®
T SF
OUCH
®
3 System,
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®
3
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