AtriCure nContact EPi-Sense Mode D'emploi page 4

IFU for EPi-Sense Guided Coagulation System with VisiTrax
®
8. Connect power cable to generator back panel connector (Fig. 9, #2) then power on the
generator via the Power ON/OFF rocker switch (Fig. 9, #1). Refer to the Operator Manual for
complete generator instructions.
Fig. 9. Generator Back Panel Key Features
Manipulation of Guided Coagulation Device Over Accessory Guide Wire
1. Insert the rigid end of the accessory guide wire into the guide tube in the distal end of the
guided coagulation device, ensuring that the floppy end of the guide wire is at the distal
end of the coagulation device (Fig. 10).
Fig. 10. Accessory Guide Wire and Distal End of Coagulation Device
2. Secure the rigid end of the accessory guide wire with a Tuohy Borst or stopcock such
that the floppy end of the guide wire is in the desired position relative to the distal end of
the coagulation device.
3. Advance the guided coagulation device through the cannula until positioned at desired
coagulation location.
Manipulation of Guided Coagulation Device Over Guidewire
1. Prepare distal end of device by pre-shaping to give distal tip a slight upward bend as
shown in Fig. 11 below.
Fig. 11 Pre-shaped Distal End Configuration
2. Place guide wire in desired coagulation location.
3. If attached, remove torquer from end of guide wire.
4. Carefully feed one end of the guidewire into the guide tube in the distal end of guided
coagulation device (Fig.10, #1).
5. Slide guided coagulation device until guide wire protrudes from handle of guided
coagulation device. If available, attach torquer to the end of guide wire protruding from
handle of device.
6. Advance the guided coagulation device along the guide wire until positioned at desired
coagulation location using guidewire to assist in placement.
a) Use locator arrows (Fig.10, #2) to visualize the direction and location of the
coagulation electrode during positioning.
b) Hold device on desired location until vacuum is engaged.
Tissue Coagulation
1. Ensure all steps of device set-up are performed.
2. Select the power mode of operation on the generator.
3. Place device in desired location by direct visualization. Engage vacuum by turning the
stopcock.
4. Ensure contact between the electrode and cardiac tissue by;
i.Using locator arrows (Fig 10, #2) to visualize the direction and location of the
coagulation electrode
ii.Reference dots designate the exposed ablative area of the coagulation coil.
iii.Direct visualization of the device against cardiac tissue after initiation of vacuum;
iv. Visual observation of saline perfusion from the unpressurized saline bag at a rate
of approximately 1 drop per second through the drip chamber while vacuum is
initiated.
5. Use the sensing electrodes as a secondary aid to confirm contact with cardiac tissue.
a) Pre-Coagulation with the vacuum engaged: check ECG recorder to visualize
cardiac tissue waveforms.
6. Fill cannula with approximately 10 to 20 mL of room temperature saline or sterile water. Saline
or sterile water may be administered via the cannula stopcock or directly through the cannula.
See Cannula IFU for stopcock set-up.
7. Initiate power by pressing and releasing the footswitch or RF ON/OFF button on generator
front panel. An audible signal will sound at the beginning of the RF cycle.
8. Coagulate tissue for pre-determined cycle.
Device Code and Power
Size Watts
CDK-1411, 1cm 10*
CDK-1412, 2cm 25*
CDK-1413, 3cm 30*
*Automatic cycles have been pre-determined for optimal tissue coagulation.
®
3 cm Device
2
Average Lesion Dimensions
Time Depth Length Width
Sec mm mm Mm
120* 7 18 10
60* 6 28 9
90* 7 35 10
9. When the generator completes a cycle, RF energy turns off automatically, and an
audible completion beep sounds for 1 second.
10. Suction saline or sterile water from pericardial space using cannula suction to improve
visibility. Reference Cannula IFU for suction set-up.
11. After the cycle is complete, disengage vacuum from the distal end of the device by
turning the stopcock lever.
12. Remove the distal end of coagulation device from tissue and observe completeness
of lesion.
13. Place device electrode in next desired location using guide wire if desired.
a) After reactivating the vacuum, ensure perfusion flow is functioning by observing
drops in IV tubing drip chamber.
14. Check for cardiac signals from the sensing electrodes.
15. Repeat steps 3-11 from above as needed until desired lesions have been completed.
16. At completion of procedure, remove device from tissue, disconnect all cables and tubes and
discard device, tubing sets, and cable following local governing ordinances and recycling
plans for disposal or recycling of device components.
CAUTION: Positioning and manipulation of the coagulation device without a
guide wire inserted into the guide tube may cause the guide tube to kink.
CAUTION: To avoid interruption of vacuum or perfusion flow, do not leave
device tubing clamped during coagulation of tissue.
CAUTION: Large blood clots and tissue particles may clog vacuum lumen and
impair suction.
CAUTION: To avoid tissue damage: Do not move the device if vacuum is
engaged.
CAUTION: Bending device without guidewire in guide tube may kink the guide
tube. Avoid inserting guidewire into a kinked guide tube.
CAUTION: Do not torque guided coagulation device if distal end is curved as
damage to device may occur and the electrodes may separate and/or break off
from the device.
CAUTION:
pinching/entrapping tissue with other devices, such as the optional nContact
Cannula.
CAUTION: 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 use tools on the electrode coil, place tools on silicone only as the electrodes
may separate and/or break off from the device.
CAUTION: Ensure device is properly connected – switching connections may
cause inadequate tissue contact and reduced functionality.
CAUTION: Temporarily unused active electrodes should be stored in a location
isolated from the patient.
Maintenance and Troubleshooting
(See nContact Coagulation System Radiofrequency (RF) Generator Unit Model CS-3000
Operators Manual for additional system maintenance and trouble shooting)
Situation
Device is not receiving
perfusion flow
Device is connected but
does not register pre-set
power and time
1
Device does not engage
with tissue
Generator shuts down
during cycle due to high
impedance (High
impedance warning will be
indicated on Generator)
No signals are registering
on sensing equipment
monitors
Unable to remove device
from guidewire
Generator does not
activate cycle (High
impedance warning will be
indicated on Generator as
"OC" which means Open
Circuit)
Guidewire will not insert
into device
Device will not advance along
Volume
Guidewire or through optional
3
mm
nContact Cannula
803
1085
1691
English
Visualize the distal end of the device, to ensure it is not
Troubleshooting
Action(s)
• Check perfusion connections on device handle
• Check perfusion line connection at IV saline bag
• Ensure perfusion line is fully open
• Ensure saline bag is not empty
• Ensure that
device perfusion line/IV tubing are not
clamped/obstructed/kinked
• Check all connections to the generator and to Cable CSK-2030
• Check the connection of the patient return electrode to the
patient
• Check the cable connection at the handle of the device, the
arrows on the cable should be aligned with the arrow on the
handle. If both arrows are not aligned, disconnect cable and
rotate blue end 180° until aligned then reconnect.
• Check vacuum connections on device handle
• Ensure stopcock lever is in correct position
• Check vacuum line connection at trap and vacuum unit and
ensure other lines are not open
• Check vacuum pressure – should be approximately -400 mmHg
• Ensure that device and vacuum unit lines are not
clamped/obstructed/kinked
• Check that perfusion set-up is per IFU
• Ensure that device distal end is shaped to conform to tissue
• Check that device is still engaged with tissue (see above if not)
• Check for excessive material (e.g. fat, tissue) on device
electrode, remove material as required
• Check all cable connections, including indifferent electrode
connection
• Re-start coagulation
• Check all cable connections. Ensure the cables and shrouded
pins are connected per figures 6 and 7.
• Ensure the shrouded pin numbers match the sensing electrodes
on the sensing equipment.
• Remove torquer from end of guidewire
• Flush "Guide Wire Exit" port on the handle with saline
• Ensure generator is plugged in and turned on
• Check all cable connections; check indifferent electrode
connection for correct position and that it is adhered to the
patient
• Ensure device electrode is in direct contact with desired tissue
• Check for material on device electrode, remove material as
required
• Check footswitch connection
• Ensure that generator is in "Power Control Mode"
• Ensure that Time is not set to "zero"
• Refer to generator Operator Manual LBL-2123
• Ensure guide wire is being inserted into guide tube opening
• Ensure recommended guidewire is being used
• Ensure guide tube opening is not blocked
• Ensure device is not kinked
• Ensure guide tube is not kinked
• Flush "Guide Wire Exit" port on the handle with saline
• Lubricate lumen of nContact Cannula with sterile water or sterile saline
LBL-1819-EU Rev. G
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