Endosense TactiCath User manual

Endosense TactiCath
®
Catheter Instructions for Use
PR-000 985_J
Date 07/2009 1/43
Instructions for use
Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter
English Page 3
Mode d'emploi
Endosense TactiCath
®
Cathéter de diagnostic/ablation à extrémité orientable
Français Page 7
Gebrauchsanweisung
Endosense TactiCath
®
Steuerbarer Diagnostik-/Ablationskatheter
Deutsch Seite 11
Istruzioni per l’uso
Endosense TactiCath
®
Catetere diagnostico/per ablazione con punta direzionabile
Italiano Pagina 15
Instrucciones de uso
Endosense TactiCath
®
Catéter para diagnóstico/ablación con punta dirigible
Español Página 19
Instruções de utilização
Endosense TactiCath
®
Cateter de ponta dirigível para diagnóstico/ablação
Português Página 23
Gebruiksaanwijzing
Endosense TactiCath
®
Diagnose/Ablatie Katheter met buigbare tip
Nederlands Pagina 27
Brugervejledning
Endosense TactiCath
®
Diagnostisk/ablationskateter med fleksibel spids
Dansk Side 31
Bruksanvisning
Endosense TactiCath
®
Diagnostik-/ablationskateter med böjbar spets
Svenska Sida 35
Návod k použití
Endosense TactiCath
®
Diagnosticko- ablační katetr s ohebným hrotem
Česky Strana 39
0050

Endosense TactiCath
®
Catheter Instructions for Use
PR-000 985_J 2/43
For single use only Refer to accompanying instructions for use
Ne pas réutiliser Se reporter au mode d’emploi accompagnant le produit
Nur zum Einmalgebrauch Siehe beiliegende Gebrauchsanweisung
Monouso Fare riferimento alle istruzioni allegate per l’uso
Para un solo uso Consultar las instrucciones de uso adjuntas
Utilizar apenas uma vez Consulte as instruções de utilização inclusas
Enkel voor eenmalig gebruik Zie bijgevoegde gebruiksaanwijzing
Kun til engangsbrug Se de vedlagte brugsanvisninger
Endast för engångsbruk Se bifogad bruksanvisning
Pouze k jednorázovému použití Další informace najdete v návodu k použití
Use by Serial number
Utiliser avant Numéro de série
Verwendbar bis Seriennummer
Usare entro Numero di serie
Fecha de caducidad Número de serie
Usar até Número de série
Gebruiken vóór Serienummer
Anvendes før Serie nummer
Används före Serienummer
Použijte do Sériové číslo
Sterilized using ethylene oxide Catalog Number
Stérilisé à l'oxyde d'éthylène Numéro de référence
Mit Ethylenoxid sterilisiert Katalognummer
Sterilizzato con ossido di etilene Numero di catalogo
Esterilizado con óxido de etileno Número de catálogo
Esterilizado por óxido de etileno Número de Referência
Gesteriliseerd met ethyleenoxide Catalogusnummer
Steriliseret med ethylenoxid Katalog nummer
Steriliserad med etylenoxid Katalognummer
Sterilizováno etylenoxidem Katalogové čislo

English
PR-000 985_J 3/43
Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter
CAUTION
•
••
•Sterile. Sterilized with ethylene oxide gas.
•
••
•For single use only.
•
••
•Do not use if the package is open or damaged.
•
••
•Do not attempt to operate the device prior to completely reading
and understanding the applicable instructions for use.
1 CATHETER DESCRIPTION
The Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter
designed for cardiology application is an 8.5 F introducer compatible
multi-electrode luminal catheter with a deflectable tip designed to facilitate
electrophysiological mapping of the heart and to transmit radiofrequency
(RF) current to the catheter tip electrode for intracardial ablation purposes.
For ablation the catheter is used in conjunction with a radiofrequency
generator and a dispersive pad (indifferent patch electrode).
The catheter has a high-torque shaft with a deflectable tip section with
four platinum-iridium electrodes. All of the electrodes may be used for
recording and stimulation purposes. The tip electrode is used to deliver
radiofrequency current from the radiofrequency generator to the desired
ablation site. The tip electrode and ring electrodes are made of platinum-
iridium. The catheter incorporates a thermocouple temperature sensor
which is embedded in the 3.5 mm tip electrode. Tip deflection is controlled
at the proximal end by a handpiece in which a piston slides; a thumbknob
on the piston controls piston travel. When the thumbknob is pushed
forward the tip is deflected (curved). When the thumbknob is pulled back
the tip straightens. The shape of the curve depends on the deflectable tip
length (currently available: 65 mm). The high-torque shaft also allows the
plane of the curved tip to be rotated to facilitate accurate positioning of the
catheter tip at the desired site.
At the proximal end of the catheter lead-out a saline port with a standard
Luer fitting terminates from the open lumen. This saline port is used to
permit the delivery of isotonic saline solution to irrigate the tip electrode.
During ablation normal saline is passed through the 0.7 mm diameter
lumen of the catheter and through the tip electrode, to irrigate and cool
both the catheter tip and the ablation site.
The catheter interfaces with standard recording equipment and a
compatible radiofrequency generator via accessory Endosense Splitter
with the appropriate connectors.
The distal force sensing technology called Touch+
®
is also an integral part
of Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter.
For use in conjunction with force sensing refer to the TactiCath
®
System
User Manual.
2 INDICATIONS
The Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter
is indicated for use in cardiac electrophysiological mapping (stimulation
and recording) and, when used in conjunction with a radiofrequency
generator, for cardiac ablation in the right atrium (RA) and in the left
atrium (LA), such as:
•
••
•Interruption of accessory atrioventricular (AV) conduction
pathways associated with tachycardia, called the Wolff-
Parkinson-White syndrome (WPW);
•
••
•Treatment of AV nodal re-entrant tachycardia (AVNRT);
•
••
•Creation of complete AV nodal block in patients with a difficult to
control ventricular response to an atrial arrhythmia;
•
••
•Creation of a RA isthmus line for patients with isthmus
dependent atrial flutter;
•
••
•Atrial fibrillation.
3 CONTRAINDICATIONS
•
••
•The catheter must not be used for radiofrequency ablation if the patient
has intracardiac mural thrombus or has had a ventriculotomy or
atriotomy within the preceding four weeks.
•
••
•The catheter may not be appropriate for patients with prosthetic valves
and must not be used in the coronary vasculature.
•
••
•A relative contraindication for catheter ablation procedures is active
systemic infection.
•
••
•The transseptal approach is contraindicated in patients with left atrial
thrombus or myxoma, or interatrial baffle or patch.
4 WARNINGS
a) The temperature sensor located within the electrode will not reflect
either electrode tissue interface or tissue temperature due to the
cooling effects of the saline irrigation of the electrode. The
temperature displayed on the generator is the temperature of the
cooled electrode, not tissue temperature. The temperature sensor is
used to verify that the irrigation flow rate is adequate. Before
initiating the application of radiofrequency current, a decrease in
electrode temperature confirms the onset of saline irrigation of the
ablation electrode. Recording temperature from the electrode during
the application of radiofrequency current ensures that the irrigation
flow rate is being maintained.
b) Patients undergoing septal accessory pathway ablation are at risk for
complete AV block which requires the implantation of a permanent
pacemaker. Permanent pacing may be required in patients who
experience inadvertent complete AV block as a result of
radiofrequency ablation.
c) Implantable pacemakers and implantable cardioverter/defibrillator
(ICDs) may be adversely affected by radiofrequency current. It is
important to:
•
••
•Have temporary external sources of pacing and
defibrillation available during ablation.
•
••
•Temporarily reprogram the pacing system to minimum
output to minimize risk of inappropriate pacing.
•
••
•Exercise extreme caution during ablation when in close
proximity to atrial or ventricular permanent leads.
•
••
•Program the ICD to the OFF mode during the ablation
procedure.
•
••
•Perform complete implantable device analysis on all
patients after ablation.
d) The combination of intracoronary placement of the ablation catheter
and radiofrequency energy application has been associated with
myocardial infarction.
e) Significant x-ray exposure can result in acute radiation injury as well
as increased risk for somatic and genetic effects, to both patients
and laboratory staff. Therefore catheter ablation should only be
performed after adequate attention has been given to the potential
radiation exposure associated with the procedure, and steps taken to
minimize this exposure. Careful consideration must therefore be
given for the use of the device in pregnant women.
f) Do not expose catheter to organic solvents such as alcohol.
g) Do not resterilize/reuse the catheter.
h) Do not immerse proximal handle or cable connector in fluids;
electrical performance could be affected.
i) Do not scrub or twist the distal tip electrode during cleaning.
j) Inspect saline irrigation for air bubbles prior to its use in the
procedure. Air bubbles in the saline irrigation may cause emboli.
5 PRECAUTIONS
a) Do not attempt to operate the Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter or the radiofrequency
generator prior to completely reading and understanding the
applicable instructions for use.
b) Cardiac ablation procedures must be performed by appropriately
trained personnel in a fully-equipped electrophysiology laboratory.
c) The long-term risks of protracted fluoroscopy and creation of
radiofrequency induced lesions have not been established. Careful
consideration must therefore be given for the use of the device in
prepubescent children. Furthermore, the risk/benefit in asymptomatic
patients has not been studied.

English
PR-000 985_J 4/43
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.