CS-3000 RF Generator Unit Operator Manual
AtriCure, Inc.
IFU-0022.A
2021/04
Page 9 / 12
1.
The Power level is automatically pre-set by the manufacturer at the recom-
mended 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 coag-
ulation 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 set-
tings are essential to electrocoagulation. Monitor the Impedance measure-
ments 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 deliv-
ery 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.
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 oper
-
ating 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.
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.
Chapter 4 Technical Specifications and Safety Inspection
Device Specifications
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 Maxi-
mum Power (100 Watts, +/-20%) is 150 Seconds ON and 10 Seconds OFF.
6. Uses LittelFuse 2183.15, Time Delay (Slo Blo) Fuse Rated at 3.15 A, 250VAC.
CAUTION
: Only replace fuses with the LittleFuse 2183.15, Time Delay (Slo
Blo) Fuse Rated at 3.15 A, 250VAC
Environmental Specifications
Operating Conditions
Temperature
10°C to 40°C, 50°F to 104°F
Humidity
30 % RH to 75 % RH, non-condensing
Atmospheric pressure
700 to 1060 millibar
Storage & Shipping Conditions
Temperature
-34°C to 60°C, -30°F to 140°F
Humidity
30% RH to 85% RF, non-condensing
Atmospheric pressure
500 to 1060 millibar
NOTE:
Gradually return the RF Generator to operational conditions after storage
or shipping and stabilize for one hour before use.
Periodic Inspections
Periodic safety inspections of the generator and attached accessories should be
performed by persons who, based on their training, knowledge, and practical expe-
rience, are capable of adequately testing and assessing the safety and functionality
of the generator.
Visual Inspection
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.
Operating Test
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, employ-
ees, or third parties, the generator should not be used until it has been properly
repaired or serviced. The operator must immediately notify the appropriate author-
ities of the defect.
