AtriCure nContact EPi-Sense Mode D'emploi page 2

IFU for EPi-Sense Guided Coagulation System with VisiTrax
®
INSTRUCTIONS FOR USE
Product Description
Components of the Guided Coagulation System:
®
(1) EPi-Sense Guided Coagulation System with VisiTrax
multiple formats include:
o CDK-1411 Coagulation Device, 1cm
o CDK-1413 Coagulation Device, 3cm
ACCESSORIES PROVIDED SEPARATELY:
(2) CS-3000 RF Generator plus accessories, Non-Sterile, Reusable (under separate IFU)
(3) CSK-2030 Sensing Cable, Non-Sterile, Reusable (under separate IFU)
(4) CSK-2000 RF Cable, Sterile, Single Use (under separate IFU)
(5) nContact Cannula – multiple formats, Sterile, Single Use (under separate IFUs)
(6) Valleylab PolyHesive Patient Return Electrode (REF E7506)
®
The EPi-Sense Guided Coagulation Devices with VisiTrax
PVC.
Product Features
Fig. 1. General Coagulation Device Key Features
(1) Handle; (2) Vacuum Port; (3) Guide Wire Exit Port; (4) RF Connection; (5) Perfusion Port;
(6) Stopcock; (7) Graduated Fitting to Vacuum Tubing; (8) Strain Relief; (9) Main Body; (10) Distal
Shell; (11) Coagulation Electrode and Sensing Electrodes; (12) Guide Tube Opening; (13)
Insulative Covering; (14) Vacuum Lumen; (15) Locator Arrows (1cm spacing)
Fig. 2. Generator Key Features
(1) CSK-2030 Cable Connection (2) Indifferent, Dispersive Electrode Connection
(3) Footswitch Connection (4) Diagnostic Device Connection (5) Power Adjustment
(6) Time Adjustments (7) Mode button (8) RF ON/OFF Button (9) Standby Mode LED
(10) Error LED (11) RF LED
Indications
®
The EPi-Sense Guided Coagulation System with VisiTrax
of cardiac tissue using radiofrequency (RF) energy during cardiac surgery for the treatment
of arrhythmias including Atrial Fibrillation (AFIB) or Atrial Flutter (AFL).
Contraindications
Patients with presence of left atrial thrombus, a systemic infection, active endocarditis, or another
infection local to the surgical site at the time of surgery. Patients with Barrett's Esophagus.
Warnings:
➢ Care should be taken to ensure that the device is not in contact with tissue that is not going
to be coagulated (e.g. vascular and nerve tissue), in order to avoid inadvertent tissue damage.
➢ To avoid unintentional coagulation, always ensure the device or device combined with optional
guidewire is oriented toward the desired coagulation location.
➢ Avoid contact with other surgical instruments, scopes, staples, or other objects while
coagulating. Inadvertent contact with objects while coagulating could lead to conduction of RF
energy or heat and unintentional coagulation of tissues in contact with those objects.
➢ The device is provided sterile and is intended for single patient use only. Do not reprocess or
reuse. Reuse can cause damage to device, patient injury, and/or the communication of
infectious disease(s) from one patient to another.
➢ Do not scrape or scratch off the gold surface of the sensing electrodes when cleaning the RF
coagulation electrode to avoid an adverse reaction due to copper exposure to the patient.
➢ To avoid unintentional coagulation, care should be taken to ensure overlapping structures are
separated and thermally isolated when anatomy allows.
➢ Inspect all devices and packaging prior to use. If any breach of the packaging is found the
sterility of the product cannot be ensured which poses a risk of patient injury. Do not use
product if breach is found.
➢ The risk of igniting flammable gases or other materials is inherent in the application of RF
energy. Precautions must be taken to restrict flammable materials from the area where tissue
coagulation is performed.
➢ Care should be taken to ensure device is not moved during RF power delivery. Device
movement may cause loss of suction and tissue tear and/or unintentional coagulation.
➢ Care should be taken to ensure no vessels (or other structures) are restricted during
device manipulation. Vessel restriction could cause hemodynamic instabilities or patient
harm.
➢ Care should be taken to confirm device placement before power application to avoid
collateral tissue damage.
➢ Care should be taken to fill cannula with saline during ablation to avoid collateral tissue
damage.
➢ Care should be taken to ensure device is perfused during ablation to avoid unintentional
tissue damage.
➢ Physicians should consider a comprehensive anti-coagulation protocol including pre-
operative, intra-operative and post-operative anti-coagulation management to prevent
potential thromboemboli.
➢ Physicians should consider placing an esophageal temperature probe prior to
coagulating tissue to monitor esophageal temperature throughout the procedure to
prevent collateral tissue damage. Throughout the procedure ensure the probe is located
directly behind the ablation probe to ensure an accurate reading.
➢ Physicians should consider post-operative anti-inflammatory medication to decrease the
potential for post-operative pericarditis.
®
Device (sterile, for single-use only) –
®
o CDK-1412 Coagulation Device, 2cm
®
are not made with natural rubber or
®
is intended for the coagulation
Precautions:
➢ The coils on the distal end of the device must be kept clean of coagulum during surgery to avoid
loss of power. Do not clean coagulum off the electrode of the device with an abrasive cleaner or
electrosurgical tip cleaner. The electrodes could be damaged resulting in device failure.
➢ Implantable cardioverter/defibrillators can also be adversely affected by RF signals.
➢ Interference produced by the operation of high-frequency surgical equipment may adversely
affect the operation of other electronic medical equipment such as monitors and imaging
systems. This can be minimized or resolved by rearranging monitoring device cables so they
do not overlap the Coagulation System cables.
➢ The use and proper placement of an Indifferent Electrode is a key element in the safe and
effective use of electrosurgery, particularly in the prevention of patient burns. Ensure entire area
of electrode is reliably attached to the patient's body.
➢ While the distal portion of the device is designed to be malleable to conform to the anatomy of
the area to be coagulated, excessive manipulation, torqueing, rough shaping, or forcing the
movement of the device may damage or deform the distal end and cause potential patient
harm. This may also cause the sensing electrodes to become detached and or break off the
device.
➢ Care should be taken when handling the distal end of the device near the electrode with
surgical instruments – do not squeeze or clamp the electrode. Do not cut or tear silicone.
➢ The coagulation device is only compatible with the nContact generator, cables, and
Use of another manufacturer's accessories may cause damage to the
accessories.
device and/or injury to the patient.
➢ Coagulation devices have been tested and have pre-set power and time settings for
optimal coagulation. Changing these settings may cause coagulation dimension to vary
from the values given in this document.
➢ Care should be taken to ensure the path to position the device is large enough to advance
the device easily – forcing the device may damage the device, cause tissue damage or
patient harm.
➢ Care should be taken to ensure device is not twisted or over manipulated during
procedure. Twisting/torqueing/over manipulating device can cause damage to the device,
the lumen to collapse, fracture of electrodes or vacuum lumen spring, separation of
electrodes from device, kinking of PEEK guide tube, loss of suction, disconnection of
perfusion/IV tubing, kinked perfusion/IV tubing, or patient harm.
➢ Connection of multiple devices to one vacuum unit may reduce vacuum functionality.
➢ Care should be taken to ensure optional guidewire stays on the sterile field during
manipulation.
➢ Care should be taken to visualize the devices and/or guidewire components when in the body,
during introduction and/or removal from the Cannula.
components prior to insertion and removal in order to avoid inadvertent tissue damage with the
devices and or guidewire.
➢ Before coagulation of tissue, ensure guidewire and/or scope are not between tissue and
coagulation device electrode.
➢ If a guidewire is used with guided device, ensure that insulative covering is intact along the
exposed Guidewire.
➢ The coagulation devices should be used by physicians trained in the techniques of
minimally invasive endoscopic surgical procedures and in the specific approach to be
used.
➢ If using a TEE probe, care should be taken to withdraw the TEE probe prior to ablation to
avoid compressing the esophagus against the left atrium during ablation.
➢ If the device is used near a pacemaker, a potential hazard exists due to possible
interference with the action of the pacemaker and potential damage to the pacemaker. A
pacemaker in a patient undergoing any surgery with RF energy must be turned off before
applying RF energy.
Additional warnings and precautions can be found in the nContact Coagulation System
Radiofrequency (RF) Generator Unit Model CS-3000 Operators Manual (LBL-2123).
Potential Complications of the Coagulation Procedure
• Infection
• Cardiac tamponade
• Pulmonary vein stenosis
• Vessel injury
• Pericardial effusion
• Tissue perforation
• Excessive bleeding
• Phrenic nerve injury
• Left atrial rupture
Required Equipment/Supplies
• Only Use 0.9% Normal Saline Solution (250 mL bag recommended)
• Sterile Perfusion/IV Tubing Set (10 Drops/mL)
• Sterile Vacuum Tubing Set
• Vacuum regulated to -400 mmHg (-533 mbar; -15.75 inHg; -40 cmHg; -7.73 psi; -400
torr; -53 kPa)
Recommended Optional Equipment/Supplies
• .035" 100cm "J" Guide Wire
• nContact Cannula Kit (multiple formats)
• Sterile Water (For cannula flooding only)
• nContact Stylet Kit (multiple formats)
• nContact Sensing Cable Assembly Kit (non-sterile) – CSK-2030 or CSK-2010
• Endoscope - see nContact Cannula IFU scope recommendations
• Temporary external electrogram recording device that meets the following
specifications; Complies with IEC 60601-1 and system accepts shielded 2mm pin
connectors
Device Set Up
1. Place the indifferent, dispersive (return) electrode on patient, per Fig. 3 and connect
cable to front of generator (Fig. 2, #2). Ensure entire area of electrode is reliably
attached to the patient's body.
Fig. 3. Placement of Indifferent, Dispersive Electrode
2. Place generator footswitch near the surgeon and connect the footswitch cable to front of
generator. Refer to Fig. 2, #3.
3. Inspect all trays, cartons and packaging to ensure there has been no package damage,
which may result in product contamination. If package damage is discovered, do not use –
replace the product.
a) Outside the sterile field, remove the device and cable from cartons.
b) Inside the sterile field, remove device from the tray and place near patient.
i. Remove the device from the tray by releasing the tabs.
ii. Remove the Tuohy Borst fitting from the tray and attach to guide wire exit
port on the handle.
English
LBL-1819-EU Rev. G
Always fully retract devices and
• Esophageal Fistula
• Myocardial infarction
• New arrhythmias
• Thromboembolic complication
• Neurologic complication
• Death
• Complete heart block requiring
permanent pacemaker implantation
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