Generator Operating Modes; System Components Supplied With The Generator; Components Not Supplied With The Generator; Cs-3000 Rf Generator User Interface - nContact CS-3000 Mode D'emploi

CS-3000 RF Generator Unit Operator Manual
Figure 2. Voltage versus Impedance Load
Maximum Voltage RMS - CS-3000
200
180
160
140
120
100
80
60
40
20
0
0 200 400 600
Figure 3. Delivered Power versus Set Power
Delivered Power vs. Device Setting - 275 ohm load
100.00
90.00
80.00
70.00
60.00
50.00
40.00
30.00
20.00
10.00
0.00
0 10 20 30

Generator Operating Modes

1. Standby mode – The generator is idle; no energy is delivered, no measurements are
performed. The software version is identified.
2. Ready Power Control mode – The generator detects the type of coagulation device
connected and determines initial Power and Time set points accordingly. These preset
Power and Time levels can be adjusted by the operator.
3. RF ON Power Control mode – The generator transmits a constant Power level until
the elapsed Time equals the set point or an error is detected.
4. Diagnostic Evaluation Mode – RF energy is NOT transmitted to the coagulation device
during this mode. Measurements of resistivity are taken from electrodes on a separate
accessory device (not yet available) to indicate the extent of coagulation necrosis.

System Components Supplied with the Generator

Components provided with the nContact Model CS-3000 RF Generator Unit include:
o 1 US Line power cable (US version only)
o 1 EU Line power cable (EU version only)
o 1 UK Line power cable (EU version only)
o 1 Footswitch (pedal)
o 2 Operator Manuals
o 2 Fuses – LittelFuse 2183-15, Time Delay (Slo -Blo), Rated at 3.15A, 250VAC

Components Not Supplied with the Generator

Accessories provided separately by AtriCure, Inc. for use with the CS-3000 RF Generator
Unit and complying with the limits for medical devices to the IEC 60601-1 standards include:
o Numeris® Tethered Coagulation Devices (Single Use, Sterile) – Packaged Kit Models
that may be used with the RF Generator are: CSK-021 (CS-1201); CSK-022 (CS-
1202); CSK-023 (CS-1203); CSK-025 (CS-1205). Refer to device Instructions for Use
(IFU) for operation and disposal.
o EPi-Sense® Coagulation Devices with sensing capabilities (Single Use, Sterile) –
Packaged Kit Models that may be used with the RF Generator are: CDK-1411, CDK-
1412, CDK-1413. Refer to device Instructions for Use (IFU) for operation and
disposal.
o RF Coagulation Cable (Single Use, Sterile) – Model CS-2000 Refer to CSK-2000
cable Instructions for Use (IFU) for operation and disposal.
• Note: Packaged Kit Model CSK-2000 contains the Model CS-2000 Cable
o Sensing Cable Assembly (Multiple Use, Non-Sterile) – Model CS-2030 Refer to CSK-
2030 cable Instructions for Use (IFU) for operation.
• Note: Packaged Kit Model CSK-2030 contains the Model CS-2030 Cable
AtriCure, Inc.
Voltage RMS
800 1000 1200 1400 1600
Impedance - Ohms
40 50 60 70 80
Device Setting
Delivered Power
2021/09
o Or Sensing Cable (Multiple Use, Non-Sterile) – Model CS-2010 Refer to CSK-2010
Cable Instructions for Use (IFU) for operation.
Note: Packaged Kit Model CSK-2010 contains the Model CS-2010 Cable
•
Accessories required for use with the Model CS-3000 RF Generator unit but not provided
with CS-3000 RF Generator but with Coagulation Devices include:
o Patient Return Electrode (e.g. Indifferent, Dispersive Electrode), surface area of 21
square inches (136cm

CS-3000 RF Generator User Interface

Figure 4. Generator Front Panel – Key Features
1800 2000
The front panel of the generator provides connections for the Coagulation Device Cable
CSK-2000 (9), the Indifferent, Electrode (10), a Footswitch (11), and connector for CSK-
2010 Sensing Cable (12) . The Front Panel incorporates pushbuttons to set Power (2),
Set Time (3), change the operating Mode (4), and turn the RF energy transmission on
and off (1). The graphical display (5) shows the Operating Mode, Power, Time,
Impedance, and Percent Change in Impedance during Power Control Mode. LEDs
indicate when the generator is in Standby Mode (6), if an Error (7) has been detected,
or when RF energy is transmitted (8).
Front Control Panel
Power is displayed in Watts (W). In Power Control mode, the Power Set point is the power
level that will be transmitted to the coagulation device. The power set point is determined by
90 100
the specific coagulation device and will automatically register once the coagulation device is
connected. Refer to the Instructions For Use of the devices for the pre-set power and time.
The maximum power allowed depends on the connected coagulation device. Power delivery
may be adjusted while RF is activated by depressing the Power up or down pushbuttons to
set the power in 1-Watt increments.
NOTE: If a coagulation device is not connected or identified, then Power will be set to
4 W and the maximum power will be limited to 50 W.
The actual Power transmitted through the coagulation device replaces the set point in the
graphic display once RF energy is activated. In Power Control mode, the Actual Power is
adjusted to the set point but is also controlled to account for tissue response that is detected
by changes in impedance.
Impedance (resistance between the coagulation device and the indifferent, dispersive
electrode) is measured by the generator and displayed in ohms (Ω). A bar graph shows the
change in impedance between the initiation of RF energy (baseline) and throughout tissue
coagulation (test). As conductivity decreases, impedance increases. During coagulation of
tissue, when the temperature of the tissue increases above 100oC causing tissue
desiccation, the impedance increases markedly. This creates an insulating barrier. The
generator rapidly decreases Power if the impedance increases rapidly and terminates RF
energy transmission if the impedance increases above 500Ω.
Time is preset when a coagulation device is connected and identified by the generator. The
Time set point determines the duration of energy delivery unless an error is detected or the
operator manually terminates the transmission of RF energy. Using the up and down
arrows, Time is set in 1 second increments between 0 and 150 seconds.
Elapsed time of the energy delivery replaces the Time Set value on the graphic display once
RF energy is activated.
The Error LED Indicator illuminates when the system encounters an internal condition
precluding operation of the generator. This may include a self-test failure, an incorrect
connection or setting, excess heating warning, or a fault in the system. The generator will
not deliver power when the Error LED is illuminated (see Chapter 6: Troubleshooting).
English
LBL-2123 Rev. G
2 ).
Power Set (2)
Actual Power (5)
Impedance (5)
Time Set (3)
Elapsed Time (5)
Error Indicator (7)
Page 8 / 92