Generatoroperatingmodes; Systemcomponentssuppliedwiththegenerator; Componentsnotsuppliedwiththegenerator; Cs-3000 Rfgeneratoruserinterface - nContact CS-3000 Manual Del Usuario

CS-3000 RF Generator Unit Operator Manual
Figure 3. Delivered Power versus Set Power
Delivered Power vs. Device Setting - 275 ohm load
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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:
Line power cable
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Footswitch (pedal)
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Operator Manual
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2 Fuses – LittleFuse 2183-15, Time Delay (Slo -Blo), Rated at 3.15A, 250VAC
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Components Not Supplied with the Generator
Accessories provided separately by nContact Surgical, 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:
Coagulation Devices (Single Use, Sterile) – Packaged Kit Models that may be
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used with the RF Generator are: CSK-021 (CS-1201); CSK-022 (CS-1202);
CSK-023 (CS-1203); CSK-025 (CS-1205); CSK-121 (CS-1211); CSK-122 (CS-
1212); CSK-123 (CS-1213); CSK-125 (CS-1215). Refer to device Instructions
for Use (IFU) for operation and disposal.
Coagulation Devices with sensing capabilities (Single Use, Sterile) – Packaged Kit
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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.
RF Coagulation Cable (Single Use, Sterile) – Model CS-2000 Refer to CSK-2000
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cable Instructions for Use (IFU) for operation and disposal.
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Note: Packaged Kit Model CSK-2000 contains the Model CS-2000 Cable
Sensing Cable Assembly (Multiple Use, Non Sterile) – Model CS-2030 Refer to CSK-
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2030 cable Instructions for Use (IFU) for operation.
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Note: Packaged Kit Model CSK-2030 contains the Model CS-2030 Cable
Or Sensing Cable (Multiple Use, Non Sterile) – Model CS-2010 Refer to CSK-2010
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Cable Instructions for Use (IFU) for operation.
Note: Packaged Kit Model CSK-2010 contains the Model CS-2010 Cable
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Accessories required for use with the Model CS-3000 RF Generator unit but not provided
by nContact include:
Patient Return Electrode (e.g. Indifferent, Dispersive Electrode), surface area of
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21 square inches (136cm
Reference Number E7506.
nContact Surgical, Inc.
All manuals and user guides at all-guides.com
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Device Setting
Delivered Power
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), equivalent to Covidien Valleylab Polyhesive
CS-3000 RF Generator User Interface
Figure 4. Generator Front Panel – Key Features
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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 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 100
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.
During Standby Mode, the graphic display shows the nContact logo and indicates the
software version for the RF generator.
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).
The Mode button is used to adjust the operating mode between Standby, Power Control, and
Diagnostic Evaluation. Pressing the Mode button during the application of RF energy will be
ignored by the system.
The RF ON/OFF button works in parallel with the Footswitch (see Footswitch description).
During Power Control Mode, the RF ON/OFF button controls the operation of the RF
generator by initiating or terminating RF energy.
LBL-2123 Rev. E
Power Set (2)
Actual Power (5)
Impedance (5)
Time Set (3)
Elapsed Time (5)
Message (5)
Error Indicator (7)
Mode Button (4)
RF ON/OFF Button (1)
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C causing
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