AtriCure nContact EPi-Sense Mode D'emploi page 3

IFU for EPi-Sense Guided Coagulation System with VisiTrax
®
Fig. 4. Coagulation Device in Tray
1
2
(1) Handle; (2) Stopcock; (3) Tabs; (4) Tuohy Borst fitting; (5) Distal End
CAUTION: Using excess force to remove the device from the tray may result in
damage to the device.
4. Prepare the Vacuum
a) Attach one end of the sterile vacuum tubing to the graduated fitting where indicated on
device handle by the vacuum symbol ('VAC') and the other to the vacuum trap (Fig 5 &
6). Use the stopcock to apply and release the vacuum to the distal assembly.
b) Ensure the vacuum unit pressure is set to -400 mmHg.
CAUTION: Do not exceed -550 mmHg for vacuum use – exceeding this pressure may
reduce suction capabilities, reduce tissue contact or cause tissue damage.
Fig. 5. Coagulation Device Setup
(1) Perfusion Port (2) Line to Saline Bag (3) RF Cable CSK-2000 (4) Guide
wire Exit (5) Stopcock (6) Stepped Luer to Vacuum tube
5. Prepare the 0.9% Normal Saline Bag
a) Place unpressurized saline IV bag at patient height or above.
b) Connect perfusion tubing to female Luer connection where indicated on device handle
by the perfusion "droplet" symbol, Fig. 5, #1. Verify IV line is fully open.
c) Insert IV tubing set into 0.9% normal saline bag.
d) Turn on vacuum pressure and prime device by engaging the suction with a sterile
surface (gloved hand).
i. Ensure perfusion flow is functioning by observing drops in IV tubing drip
chamber. Make sure the device is primed by observing perfusion at distal
end of coagulation device before starting operation of device. Ensure IV line
is fully open.
CAUTION: Verify that IV line is fully open. Do not pressurize saline bag; that is, do
not use an infusion pump for delivery or a pressure bag. Pressurizing saline or partially
open perfusion tubing can vary perfusion rate causing loss of suction and the
coagulation dimensions to vary from values listed, and cause tissue perforations from
excess heating.
CAUTION: Ensure device is primed prior to first RF power delivery.
CAUTION: Use ONLY 0.9% normal saline.
CAUTION: Ensure perfusion/IV tubing is connected to the handle at the "droplet" symbol
– do not connect perfusion tubing to stopcock or "Guide Wire Exit".
6. Connect RF cable CSK-2000 to device handle where indicated by the 'RF' symbol - blue
connection to blue connection, Fig. 5, #3 & Fig.6, #4.
CAUTION: Ensure arrows on cable and handle are aligned and cable is completely connected.
Device will not register on generator if cable is incorrectly connected.
CAUTION: Cables to surgical electrodes should be positioned to prevent contact with patient or
other leads.
a) If using the CSK-2030: Connect the black end of the Sensing Cable CSK-2030
to the generator front panel connector (Fig. 2, & Fig 6, #1).
b) Connect the black end of the RF cable CSK-2000 to the black Bessel receptacle
of the Sensing Cable CSK-2030 (Fig. 6, #3).
Fig. 6. Sensing System Connection using CSK-2030 new style
Sensing System Connection using CSK-2030 old style
®
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4 5
English
A
1
Equipment
(A) Generator CS-3000
(B) Sensing Cable CSK-2030
(C) RF Cable CSK-2000
(D) Device CDK-14XX
c) If using the CSK-2010: Connect the black end of the CSK-2000 cable to the
coagulation device connetion on the generator front panel (Figure 6B, #1)
d) Connect the grey end of the CSK-2010 sensing cable to the diagnostic device
connection on the generator front panel (Figure 6B, #3)
Fig. 6B. CSK-2010 Sensing System Connection
Equipment
(A) Generator CS-3000;
(B) Sensing Cable CSK-2010;
(C) RF Cable CSK-2000;
(D) Device CDK-14XX
7. When connecting the shrouded pins from Cable CSK-2030 (Fig 6, #2) to the ECG recorder
equipment refer to Fig 7 below.
Fig. 7. Sensing Electrode Locations (1cm and 3cm models)
1 2
(1) Distal #1 Sensing Electrode = CSK-2030 Shrouded Pin #1
(2) Distal #2 Sensing Electrode = CSK-2030 Shrouded Pin #2
(3) Proximal #3 Sensing Electrode = CSK-2030 Shrouded Pin #3
(4) Proximal #4 Sensing Electrode = CSK-2030 Shrouded Pin #4
(5) Coagulation Electrode
(6) Reference Dots
Sensing Electrode Location (1cm model)
3
(1) Distal #1 Sensing Electrode = CSK-2030 Shrouded Pin #1
(2) Distal #2 Sensing Electrode = CSK-2030 Shrouded Pin #2
(3) Coagulation Electrode
CAUTION: Ensure inputs from the ECG recorder are isolated from earth ground, if not there
is an increased possibility of fibrillation.
Fig 8. Sensing Electrode Spacing in mm
LBL-1819-EU Rev. G
2
3
B
4
D
Connections
(1) CSK-2030 to CS-3000
(2) CSK-2030 to Sensing Equipment
(3) CSK-2000 to CSK-2030
(4) CSK-2000 to CDK-14XX
Connections
(1) CSK-2000 to CS-3000
(2) CSK-2010 to Sensing
(3) CSK-2010 to CSK-3000
(4) CSK-2000 to CDK-14XX
5 3 4
1 2
1 cm Device
2 cm Device
C
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