Chapter3:Cleaning; Chapter4:Technicalspecifications Andsafetyinspection; Devicespecifications; Environmentalspecifications - nContact CS-3000 Manual Del Usuario

CS-3000 RF Generator Unit Operator Manual
5. Press the Mode button to perform a self-test and check system functionality before
transitioning to Power Control mode. Subsequent depressing of the Mode button
will toggle between Power Control and Diagnostic Evaluation modes.
NOTE: If an Error is detected, the red Error LED will illuminate and a Message will display
in the Graphic Display. Cycle the CS-3000 main power off and on so the RF Generator
passes through self-test. (see Chapter 6: Troubleshooting).
CS-3000 Operation in Power Control Mode
When the RF Generator enters Power Control mode, the initial Power is set to 4 W and
Time is set to 0 until a Coagulation Device is connected via the RF coagulation cable to the
receptacle in the generator.
Connect a coagulation device to the appropriate receptacle (blue) of the cable then connect
the cable (black) to the receptacle on the RF generator so the pre-set Power and Time values
are displayed. Refer to the instruction for use of the coagulation devices for the appropriate
pre-set power and time settings.
1. The Power level is automatically pre-set by the manufacturer at the recommended
level for the connected coagulation device; however, the Power level may be adjusted
by the user to a different setting, if desired.
2. The Time set point is automatically pre-set by the manufacturer for the connected
coagulation device at the recommended treatment duration setting, however, the
Time set point may be adjusted by the user to a different duration if desired.
3. Connect the indifferent, dispersive electrode to the appropriate receptacle on the RF
generator.
4. Make sure the indifferent, dispersive electrode is adequately attached to the patient's
back or thigh.
5. Insert the footswitch connector into the receptacle on the front panel.
6. Prepare the patient for electrosurgery following standard protocol.
7. Position the coagulation device. Depress and release the footswitch once or press
the RF ON/OFF button on the front panel. The CS-3000 operates as an "Intermittent"
generator so depressing and releasing the footswitch once will turn the generator
ON. Standing on the footswitch may cause unwanted termination of the RF
Generator.
8. Once the RF ON/OFF button or the footswitch is depressed and released, the
generator enters the RF ON State and transmits RF energy to the coagulation device.
If the generator needs to be terminated during operation, the RF ON/OFF button or
the footswitch may be depressed and released again. The CS-3000 is an
"Intermittent" generator so depressing and releasing the footswitch once will turn the
generator OFF. Standing on the footswitch may cause unwanted initiation of the RF
Generator.
9. Proper placement of the coagulation device and appropriate generator settings are
essential to electrocoagulation. Monitor the Impedance measurements on the front
panel graphic display to assist in the coagulation process.
10. At any point in the procedure, the setting for the Power delivery may be adjusted.
Time may only be adjusted while RF energy is not transmitted.
11. The generator automatically stops delivering energy once it has Timed out
(completed the pre-set cycle) and enters Ready state. To stop the RF delivery before
the cycle duration expires, depress and release the footswitch, or the RF ON/OFF
button on the front panel. When the generator is re-started, the unit re- sets to the
previous set Time and Power settings.
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CAUTION: Depress and release the footswitch once to turn the RF Generator ON or
OFF. Do not stand on the footswitch because it may cause unwanted activation or
termination.
NOTE: If the coagulation device must be repositioned, depress and release the
footswitch or RF ON/OFF button to terminate energy delivery. To restart the generator,
depress and release the footswitch or the RF ON/OFF button again.
NOTE: If the impedance rises above 500Ω, the generator stops delivering RF and
transitions back to Ready state.
Chapter 3 Cleaning
NOTE: Do not spray or pour liquids directly on the unit.
NOTE: The unit and/or accessories cannot be sterilized.
WARNING: Ensure Isopropyl Alcohol (IPA) is completely dry before operating the
unit.
CAUTION: Avoid caustic or abrasive cleaners
Guidelines
The following guidelines are recommended for cleaning the unit. It is the user's
responsibility to qualify any deviations from these processing methods.
1. Disconnect the unit or cart from the outlet before cleaning.
2. If the unit and/or accessories are contaminated with blood or other body fluids, they
shall be cleaned before the contamination can dry (within two hours of
contamination).
3. The outer surfaces of the unit and/or accessories shall be cleaned with 70% -90%
Isopropyl alcohol (IPA) wipes for a minimum of two minutes. Do not allow fluids to
enter the chassis.
4. Pay attention to all areas where fluids or soil may gather, such as under/ around the
handles or any tight crevices/ grooves.
5. Dry the unit and/or accessories with a dry, white lint-free cloth.
6. Conduct a final confirmation of the cleaning process by visually inspecting the white
cloth for remaining soil.
7. If soil remains on the white cloth, repeat steps 3 through 6.
8. After cleaning is complete, turn the unit on to perform Power On Self-Test (POST). If
any errors are received, contact AtriCure to begin return process.
nContact Surgical, Inc.
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Chapter 4 Technical Specifications and Safety Inspection
Device Specifications
Environmental Specifications
Periodic Inspections
Periodic safety inspections of the generator and attached accessories should be performed
by persons who, based on their training, knowledge, and practical experience, are capable
of adequately testing and assessing the safety and functionality of the generator.
Visual Inspection
Operating Test
Chapter 5 Product Specifications
Operational Conditions & Front Panel Displays
1. Class I Equipment
2. Defibrillation Proof Type CF Applied Part. The recovery time for the CS-3000 RF
Generator to be fully operational after exposure to defibrillation voltages is 5
seconds.
3. Generator meets IPX1 Requirements for protection against fluid ingress
4. Not Suitable for Flammable Anesthetics
5. Intermittent Operation – The Duty Cycle for Transmitting RF Energy at Maximum
Power (100 Watts, +/-20%) is 150 Seconds ON and 10 Seconds OFF.
6. Uses LittleFuse 2183.15, Time Delay (Slo Blo) Fuse Rated at 3.15 A, 250VAC.
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CAUTION: Only replace fuses with the LittleFuse 2183.15, Time Delay (Slo Blo)
Fuse Rated at 3.15 A, 250VAC
Operating Conditions
Temperature
Humidity
Atmospheric pressure
Storage & Shipping Conditions
Temperature
Humidity
Atmospheric pressure
NOTE: Gradually return the RF Generator to operational conditions after storage or
shipping, and stabilize for one hour before use.
1. Instruction manual present.
2. Labels, cautions, or warnings placed correctly and in all required locations.
3.
No apparent external mechanical damage to the generator, connectors,
accessories, or wiring.
1. Self-test diagnostic upon start-up, includes self-calibration of measurement circuitry.
2. Footswitch operation.
3. Front control panel; keys and displays.
WARNING: If testing reveals a defect that could harm the patient, employees, or third
parties, the generator should not be used until it has been properly repaired or serviced.
The operator must immediately notify the appropriate authorities of the defect.
Figure 8. RF Generator Front Panel Display at "Power On"
Turning POWER ON to the generator transitions the generator to "Standby" mode.
Figure 9. RF Generator Front Panel Display at "Standby Mode"
Entering STANDBY MODE activates the "Standby" LED ("Error" LED and "RF
ON/OFF" LEDs remain off). The nContact logo & "software version" are displayed.
LBL-2123 Rev. E
10°C to 40°C
30 % RH to 75 % RH, non-condensing.
700 to 1060 millibar
-40°C to 60°C
10 % RH to 95 % RH, non-condensing
500 to 1060 millibar
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