Endosense TactiCath, Инструкция по эксплуатации

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d) To avoid thromboemboli, intravenous heparin should be used when
entering the left heart during ablation, and many physicians prescribe
acetylsalicylic acid (ASA), less often warfarin, for about 3 months
afterward. No consensus yet exists about the need for short-term
anticoagulation after ablation.
e) When using the Endosense TactiCath
®
Diagnostic/Ablation
Deflectable Tip Catheter with conventional EP lab system (using
fluoroscopy to determine catheter tip location), or with a
3D navigational system, careful catheter manipulation must be
performed in order to avoid cardiac damage, perforation, or
tamponade. Do not use excessive force to advance or withdraw the
catheter when resistance is encountered. The firmness of the tip
dictates that care shall be taken to prevent perforation of the heart.
f) Always pull the thumbknob back to straighten the catheter tip before
insertion or withdrawal of the catheter.
g) Always maintain a constant saline infusion flow to prevent
coagulation within the lumen of the catheter.
h) The preferred way of accessing the left side of the heart is using a
septal puncture. Accessing the left side of the heart in a retrograde
way through the Aorta, might require excessive forces to pass the
aortic valve, resulting in potential damage to the steering and/or
irrigation channel of the TactiCath
®
catheter.
i) When radiofrequency current is interrupted for either a temperature
or an impedance rise (the set limit is exceeded), this is potentially
caused by coagulum formation at the catheter’s tip. In this case, the
catheter should be removed, and the tip cleaned of coagulum. When
cleaning the tip electrode, be careful not to twist the tip electrode with
respect to the catheter shaft; twisting may damage the tip electrode
bond and loosen the tip electrode. Make sure the irrigation holes are
not occluded prior to re-use.
j) Apparent low power output, high impedance reading or failure of the
equipment to function correctly at normal settings may indicate faulty
application of the indifferent electrode(s) or failure of an electrical
lead. Do not increase power before checking for obvious defects or
misapplication.
k) Read and follow the indifferent electrode manufacturer's instructions
for use; the use of indifferent electrodes, which meet or exceed
ANSI/AAMI requirements (HF18), is recommended.
l) The Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip
Catheter is intended for use with the Endosense Splitter only which
is compatible with Stockert EP-Shuttle RF Generator (see TactiCath
®
System User Manual).
m) Care should be taken when ablating near structures such as the
sino-atrial and AV nodes.
n) The sterile packaging and catheter should be inspected prior to use.
o) The Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip
Catheter is intended for single use only.
p) Do not resterilize and reuse.
q) The Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip
Catheter used in conjunction with a radiofrequency 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 device. During
energy delivery, the patient should not be allowed to come in contact
with grounded metal surfaces.
r) The risk of igniting flammable gases or other materials is inherent in
electrosurgery.
s) Precautions must be taken to restrict flammable materials from the
electrosurgical site.
t) Electromagnetic interference (EMI) produced by the Endosense
TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter when used
in conjunction with a radiofrequency generator during normal
operation may adversely affect the performance of other equipment.
u) 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.
v) The temperature sensor measures electrode tip temperature, not
tissue temperature. The temperature displayed on the generator is
for the cooled electrode only and does not represent tissue
temperature. If the generator does not display temperature, verify
that the appropriate cable is plugged into the generator. If
temperature still is not displayed, there may be a malfunction in the
temperature sensing system which must be corrected prior to
applying radiofrequency power.
w) Before use, check that irrigation ports are fully functional by infusing
saline through the catheter.
x) Regularly inspect and test cables and accessories.
6 RADIOFREQUENCY ABLATION
For radiofrequency ablation, the catheter must be connected to the
appropriate input connectors at the Endosense Splitter which is connected
to the radiofrequency generator. For proper radiofrequency generator
interface, use only an Endosense Splitter (see TactiCath
®
System User
Manual).
To complete the electrical circuit, an indifferent pad must be connected to
the reference electrode input on the generator. Circuit impedance prior to
radiofrequency ablation should be approximately 100 Ohms. Verify that
the generator displays a temperature near body temperature after the
catheter is inserted into the patient and before applying radiofrequency
power.
7 GENERATOR OPERATION
Refer to the Endosense TactiCath
®
System User Manual as well as to the
applicable radiofrequency generator manual for proper connection of the
catheter to the generator and for detailed instructions as to generator
operation for radiofrequency ablation.
Radiofrequency ablation application parameters will vary depending on
the ablation site, the specific conditions present in each procedure and the
radiofrequency generator control circuitry. Based on data obtained from
prior animal and clinical studies, recommended RF application parameters
are provided below.
Always monitor temperature and impedance rise when using the
Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter.
8 STERILIZATION/"USE BY" DATE
This catheter has been sterilized with ethylene oxide gas. Do not use the
catheter if the package is open or damaged. Use the catheter prior to the
“Use by” date shown on the package label.
9 SUGGESTED INSTRUCTIONS FOR USE
Please refer to both these Instructions for Use and the TactiCath
®
System
User Manual when using the TactiCath
®
Diagnostic/Ablation Deflectable
Tip Catheter in conjunction with the TactiCath
®
Equipment.
9.1 Preparing the catheter for use
1. Remove the catheter from the package and place it in a sterile work
area.
2. Create a vascular access in a large central vessel using aseptic
techniques.
3. Connect the catheter to the Endosense Splitter.
4. Connect the Endosense Splitter to the radiofrequency generator.
5. Connect the irrigation input of the catheter to the tubing set
appropriate to the irrigation pump applied.
6. Purge the irrigation tube at high flow rate to ensure that no air resides
in the tubing system of the catheter. Check the purging success by
immersing the catheter tip into a sterile liquid and observe bubbles
while purging. Make sure that no bubbles are coming out the catheter
while purging.
7. Ensure a minimum flow of 2 ml/min throughout the entire procedure to
prevent clotting and/or occlusion of the irrigation holes at the
catheter’s tip.