nContact Model CS-3000 Operator Manual Rev B

CS-3000 RF Generator Unit Operator Manual

LBL-2123 Rev B compliance with the requirements of industry standard IEC 60601-1-1. If in doubt, consult the technical service at nContact Surgical, Inc. o While the distal portion of the Coagulation Device is designed to be malleable to conform to the anatomy of the area to be coagulated, excessive or rough shaping of the device may damage its internal components. Care should be taken when handling the distal end of the device near the electrode with surgical instruments – do not squeeze or clamp the electrode. o Inspect the Coagulation Device, RF Coagulation Cable, and packaging before use. If any breach of the packaging is found, the sterility of the product cannot be guaranteed, and the product should not be used. o Ensure complete separation of the Indifferent, Dispersive Electrode and EKG electrodes to prevent interference with patient monitoring equipment. Needle monitoring electrodes are not recommended. Monitoring systems incorporating high frequency current-limiting devices are recommended.

Preface The nContact Surgical, Inc. Model CS – 3000 Radiofrequency Generator Unit is used to transmit radiofrequency (RF) energy for localized tissue heating resulting in tissue coagulation. The unit operates in Power Control and Diagnostic Evaluation modes and is designed specifically for use with nContact coagulation devices and accessories.

Contraindications o The use of the nContact Model CS – 3000 RF Generator Unit, Coagulation Device and accessories is contraindicated when, in the judgment of the physician, surgical electrocoagulation procedures using RF energy would be contrary to the best interests of the patient. o Use in the presence of internal or external pacemakers or internal cardioverter / defibrillators (ICDs) and monitoring equipment may require special considerations.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Y Warnings o Carefully read all instructions before use. o Use of radiofrequency energy in patients with internal or external pacemakers or ICDs and monitoring equipment may require special consideration. The attending Cardiologist and/or the pacemaker/ICD manufacturer should be consulted before electrocoagulation surgery. o Hazardous electrical output. This equipment is for use only by qualified medical personnel trained in the use of electrocoagulation surgery. Failure of the highfrequency surgical equipment could result in unintended increase of output power. o Electric shock hazard. Do not remove the cover of the nContact RF Generator Unit Model CS-3000. There are no user-serviceable parts inside the generator. Refer servicing to qualified personnel only (see information contained in “Customer Service / Equipment Servicing”). o Interference produced by the operation of high-frequency surgical equipment may adversely influence the operation of other electronic medical equipment such as monitors and imaging systems. o Never increase Power beyond what is minimally required without first inspecting the integrity and contact of the coagulating device. o Care should be taken to ensure that the device is not in contact with tissue that is not going to be coagulated (e.g. vascular and nerve tissue), to avoid inadvertent tissue damage. o Avoid contact between the Coagulation Device and other surgical instruments, staples or other objects while coagulating. Inadvertent contact with objects while coagulating could lead to conduction of RF energy or heat and unintentional coagulation of tissues in contact with those objects. o Burns to the physician’s hands are possible if an RF activated device electrode comes into contact with a metal instrument or surface. o The Coagulation Devices and RF Coagulation Cable are provided sterile and are intended for single patient use only. Do not reprocess or reuse. Reuse can cause patient injury and the transmission of infectious disease(s) from one patient to another. o The coils on the distal end of the Coagulation Device must be kept clean of coagulum during surgery to avoid loss of power. Do not clean coagulum off the electrode of the device with an abrasive cleaner or electrosurgical tip cleaner. The electrodes could be damaged, resulting in device failure. o The use and proper placement of an Indifferent Electrode is a key element in the safe and effective use of electrosurgery, particularly in the prevention of patient burns.

The Model CS-3000 RF Generator is intended for use in the electromagnetic environment specified below. The user should assure that the CS-3000 is used in such an environment Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions Group 2 The CS-3000 RF Generator intentionally CISPR 11 transmits RF energy as its intended function. Nearby electronic equipment may be affected. RF Emissions Class A The CS-3000 RF Generator is suitable for use in CISPR 11 all establishments other than domestic and Harmonic Emissions Not Applicable those directly connected to public low-voltage power supply network that supplies buildings IEC 61000-3-2 Voltage Fluctuations/ Not Applicable used for domestic purposes. Flicker Emissions IEC 61000-3-3

Y Precautions o Radiofrequency surgery uses high-frequency energy output. Do not perform procedures if flammable or explosive media are present. Non-flammable agents should be used for cleaning and disinfection. o Make sure the patient is not in contact to earthed metal during the operation of the CS-3000 RF Generator. Always use appropriate insulation between the patient and metal surfaces that may connect to earthed ground. Follow the manufacturer’s directions for the placement of the indifferent, dispersive electrode and for proper insulation between the patient and any metallic surfaces. o Maintain safe handling techniques during electrocoagulation due to electric fields and hot metallic surfaces. o Do not touch the electrode surface of the Coagulation Device and the Indifferent, Dispersive Electrode at the same time, especially when operating the Model CS-3000 RF Generator. Superficial skin burns could occur. o This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful interference. This equipment generates, uses, and can radiate RF energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the operator is encouraged to correct the interference by:  Relocating or moving the equipment  Increase the separation distance between the equipment  Connect the equipment into different outlets  Consult nContact Surgical, Inc. representatives for help o The Coagulation Device, RF Generator, Cables and Accessories have been tested as a system. Use of another manufacturer’s accessories may cause damage to the equipment or injury to the patient. o The use of accessory equipment not listed in this operator’s manual as complying with the equivalent safety requirements of this CS-3000 RF Generator may lead to a reduced level of safety. Accessory equipment connected to the CS-3000 RF Generator must be in compliance with IEC-60601-1 requirements. Anyone who connects additional equipment to the CS-3000 RF Generator is responsible for

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CS-3000 RF Generator Unit Operator Manual

LBL-2123 Rev B

Guidance & Manufacturer’s Declaration– Electromagnetic Immunity Immunity Test

IEC 60601 Test Level

Electrostatic Discharge (ESD) IEC 61000-4-2

+/- 6kV Contact for conductive parts

Electrical Fast Transient / Burst IEC 61000-4-4 Surge IEC 61000-4-4

Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

+/- 8kV air Discharge for insulated parts

Electromagnetic Environment -Guidance

6 kV CD

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

8 kV AD

+/- 2kV for Power Supply Lines +/- 1kV for Input/Output Lines +/- 1kV line(s) to line(s) line(s) to earth

Compliance Level

+/- 2kV for Power Supply Lines +/- 1kV for Input/Output Lines

+/- 2kV

+/- 1 kV DM +/- 2 kV CM

<5% Vt (>95% dip in Vt for .5 cycle)

<5% Vt (>95% dip in Vt for .5 cycle)

40% Vt (60% dip in Vt for 5 cycles)

40% Vt (60% dip in Vt for 5 cycles)

70% Vt (30% dip in Vt for 25 cycles)

70% Vt (30% dip in Vt for 25 cycles)

<5% Vt (95% dip in Vt for 5 sec)

<5% Vt (95% dip in Vt for 5 sec)

3 A/m

3 A/m

Power Frequency (50/60 Hz) Magnetic field IEC 61000-4-8

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the CS-3000 RF Generator requires continued operation during power mains interruptions, it is recommended that the CS-3000 RF Generator be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: Vt is the ac mains voltage prior to application of the test level.

Portable and mobile RF communications equipment should be used no closer to any part of the CS-3000 RF Generator including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance (d): Conducted RF IEC 61000-4-6

3 Vrms

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 Vrms

3 V/m

d = 1.2√P d = 1.2√P - 80 MHz to 800 MHz d = 2.3√P - 800MHz to 2.5 GHz where ‘P’ is the maximum output power rating of the transmitter in watts (W) according to the Transmitter Manufacturer and ‘d’ is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic a site survey , should be less than the compliance b level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CS-3000 RF Generator is used exceeds the applicable RF compliance level above, the CS-3000 RF Generator should be observed to verify normal operation. If abnormal performance is observed, additional measure may be necessary, such as re-orienting or relocating the CS-3000, RF Generator. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

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CS-3000 RF Generator Unit Operator Manual

LBL-2123 Rev B

Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the CS-3000 RF Generator

Chapter 1 Introduction Overview

The CS-3000 RF Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CS3000 RF Generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CS-3000 RF Generator as recommended below, according to the maximum output power of the communications equipment. Separation Distance According to Frequency of Transmitter Rated (m) Maximum 80 MHz to 800 Output Power 150 kHz to 80 MHz 800 MHz to 2.5 GHz MHz of Transmitter d = 1.2√P d = 2.3√P (W) d = 1.2√P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance ‘d’ in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where ‘P’ is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

The nContact Model CS-3000 RF Generator Unit transmits a high-frequency alternating current through a coagulation device to coagulate soft tissue. The RF current induces ionic agitation in the tissue causing molecular friction and producing heat. Thus the heat is generated in the tissue and not in the device. As the temperature in the tissue increases, tissue coagulation occurs leading to cell necrosis. The tissue temperature and volume of coagulated tissue are affected by the amount of Power delivered, the surface area of coagulation device contacting the tissue, and the duration of energy delivery. The generator operates in either the Power Control or Diagnostic Evaluation mode. When operating in Power Control mode, set the desired duration and Power level. The generator will transmit Power at the set point for the Time set by the operator. Power may be adjusted manually throughout the treatment to tailor the coagulation process but caution should be used when deviating from the recommended, pre-set power settings.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Product Description The nContact Model CS-3000 RF Generator Unit is an electrosurgical generator that transmits RF current at a frequency of 480 kHz. The generator transmits up to 100 watts (W) of Power (+/- 20%), depending on the coagulation device connected. While the RF Energy is delivered, Power, Impedance, and Time are continually measured and updated on the generator display. Figure 1 shows the Power versus Impedance curves at set power levels of 100 Watts and 50 Watts. The RF Generator operates between 30 and 500 ohms. The RF Generator produces constant power along the operational impedance range. Figure 2 shows the relationship between Voltage and Impedance. Figure 3 shows the relationship between Set Power and Delivered Power at an impedance of 275 ohms.

Power & Voltage Output Diagrams Figure 1. Power Output versus Impedance Load

Glossary of Terms Surgical procedures in which high-frequency electric current is used to coagulate tissues.

Coagulation Electrode

The metal conductor in the coagulation device used to transmit RF energy to tissue.

Indifferent, Dispersive Electrode

Commonly referred to as the “return electrode” or “patient electrode” or “ground pad.” Large surface area ground used to complete the circuit of the electrical current. Usually placed on the patient’s back or thigh, the Indifferent, Dispersive Electrode is connected to the generator at the Indifferent Connector.

CS-3000 Power Curves 100

100 W Power 50W Power

80

Power - Watts

Electrocoagulation

60

40

Symbols and Icons Manufacturer Vacuum

RF

20

Radiofrequency

Keep Upright

Perfusion

Equipotentiality Connection Indifferent, Dispersive Electrode

Defibrillation Proof Type CF Applied Part Attention, Consult Accompanying Documents

Caution: Electrical Shock Hazard

Footswitch Connection

W

Watts

Non-ionizing Radiation



Time

Ω

Ohms

Lot Number

s

Seconds

0 0

200

400

600

800

1000

1200

1400

Alarm Volume Control

Alternating Current

Neutral Electrode Isolated from Earth

1800

2000

Figure 2. Voltage versus Impedance Load Maximum Voltage RMS - CS-3000 200 180 160

Serial Number

1600

Impedance - Ohms

Voltage - RMS

VAC

Catalog Number

Voltage RMS

140 120 100 80

 + -

Control Buttons to Increase Power or Time Control Buttons to Decrease Power or Time Protective Earth Terminal

0

AC Power Switch OFF

l

AC Power Switch ON

OC

Measurement Out of Range

40 20

Separate Collection for Electrical Equipment per WEEE Directive

CE Mark and Identification number of Notified body

Authorized Representative

Dangerous Voltage

nContact Surgical, Inc.

60

0 0

200

400

600

800

1000

1200

1400

1600

1800

Impedance - Ohms

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2000

CS-3000 RF Generator Unit Operator Manual

LBL-2123 Rev B

Figure 3. Delivered Power versus Set Power

CS-3000 RF Generator User Interface

Delivered Power vs. Device Setting - 275 ohm load

Figure 4. Generator Front Panel – Key Features

100.00 90.00 80.00

Delivered Power

70.00 60.00 50.00 40.00 30.00 20.00 10.00 0.00 0

10

20

30

40

50

60

70

80

90

100

Device Setting Delivered Power

Generator Operating Modes 1. 2.

3. 4.

Standby mode – The generator is idle; no energy is delivered, no measurements are performed. The software version is identified. 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. 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. 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 Line power cable o Footswitch (pedal) o Operator Manual o 2 Fuses – LittleFuse 2183-15, Time Delay (Slo -Blo), Rated at 3.15A, 250VAC

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: o 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); CSK-121 (CS-1211); CSK-122 (CS1212); CSK-123 (CS-1213); CSK-125 (CS-1215). Refer to device Instructions for Use (IFU) for operation and disposal. o Coagulation Devices with sensing capabilities (Single Use, Sterile) – Packaged Kit Models that may be used with the RF Generator are: CDK-1411, CDK-1412, CDK1413. 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. o

 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-2030 cable Instructions for Use (IFU) for operation.

 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 Cable Instructions for Use (IFU) for operation. o 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 by nContact include: o Patient Return Electrode (e.g. Indifferent, Dispersive Electrode), surface area of 21 square inches (136cm2), equivalent to Covidien Valleylab Polyhesive Reference Number E7506. o

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 Set (2) 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.

Actual Power (5) 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 (5) 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 Set (3) 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 (5) Elapsed time of the energy delivery replaces the Time Set value on the graphic display once RF energy is activated.

Message (5) During Standby Mode, the graphic display shows the nContact logo and indicates the software version for the RF generator.

Error Indicator (7) 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).

Mode Button (4) 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.

RF ON/OFF Button (1) 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.

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CS-3000 RF Generator Unit Operator Manual RF ON/OFF Indicator (8) The RF ON/OFF indicator lights up when RF energy is being transmitted. RF energy transmission includes the periodic delivery of energy to measure impedance, even when the RF generator has not been activated. However, when RF energy is being transmitted at the power capable of causing coagulation, the RF ON/OFF indicator light is constantly illuminated.

LBL-2123 Rev B Figure 6B. CDK Type Devices, CSK-2000, CSK-2010 Cable and RF Generator Setup

Connections Front Panel Connectors The Footswitch, RF Coagulation Cable for the Device, Indifferent, Dispersive Electrode and Diagnostic Port for Sensing Cable CSK-2010 connectors allow interfacing with accessory devices.

Footswitch (11) Depress the footswitch to begin delivering RF energy. To terminate the energy delivery and reset the Time during operation, depress the footswitch again.

Indifferent, Dispersive Electrode (10) The indifferent, dispersive electrode provides a path for the electrical current through the patient and back to the generator. It is important to properly attach the indifferent, dispersive electrode to the patient per manufacturer’s instructions (see “Setup and Operation”). The indifferent, dispersive electrode is for single use only.

Sensing Cable Connection (12) The Sensing Cable Interface (Generator ‘diagnostic’ port) allows the connection of the sensing electrodes from the EPi-Sense device to the external EP Sensing (EKG) equipment, with the use of the CSK-2010 cable.

Y CAUTION: Ensure that the EP Sensing (EKG) equipment comply with IEC 60601-225 for protection from high frequency surgical interference.

RF Coagulation Cable for the Device (9) nContact Surgical manufactures the coagulation devices and RF coagulation cable for exclusive use with the Model CS-3000 RF Generator Unit. Refer to the two Figures (5 & 6) below, for the appropriate setup.

Back Panel Connectors Figure 7. Generator Back Panel – Key Features

CSK Type Devices, CSK-2000 Cable and RF Generator Setup Refer to the drawing below for the appropriate setup of the CSK devices with the CSK2000 cable and the CS-3000 generator.

Figure 5. CSK Type Devices, CSK-2000 Cable and RF Generator Setup

Power Switch (13) Switch that powers the generator on and off.

AC Power Connector (14) Connector for the AC line power cable.

Grounding Stud (15) Used as a ground equalization for safety and testing.

Serial Data Connector (16) CDK Type Devices, CSK-2030 or CSK-2010, CSK-2000 Cable and RF Generator Setup

Serial communication connector to a host computer for data display and archival purposes.

Alarm Volume Control (17)

Refer to the drawing below for the appropriate setup of the CDK devices with the CSK2000 cable, CSK-2030 or CSK-2010 cable and the CS-3000 generator.

Figure 6A. CDK Type Devices, CSK-2000, CSK-2030 Cable and RF Generator Setup

Knob for modifying the volume of the generator alarm. Rotate the knob clockwise to increase the volume.

Chapter 2 Setup and Operation Generator Setup and Operation Preparing the Patient – Attaching the Indifferent, Dispersive Electrode Prepare the patient for electrosurgery following standard protocol. Ensure patient’s entire body, including extremities, is insulated against contact with grounded metal parts. Closely follow instructions for the coagulation device and manufacturer directions for the indifferent, dispersive electrode. o

Y CAUTION: Failure to achieve good skin contact by the entire adhesive surface of the indifferent, dispersive electrode could result in a patient burn or poor electrical performance from the coagulation device. Note: Patient Return Electrode (e.g. Indifferent, Dispersive Electrode), surface area of 21 square inches (136cm2), equivalent to Covidien Valleylab Polyhesive Reference Number E7506 is recommended.

Setting up the CS-3000 RF Generator 1. 2. 3. 4. Note: Pin Call out for CSK-2010 and CSK-2030 are the same D1 = Distal Electrode 1 = Shrouded Pin #1; P1 = Proximal Electrode 1 = Shrouded Pin #3; D2 = Distal Electrode 2 = Shrouded Pin #2; P2 = Proximal Electrode 2 = Shrouded Pin #4

nContact Surgical, Inc.

Connect the supplied power cord into back mains receptacle of the CS-3000 RF Generator. Plug the CS-3000 RF Generator power cord into an outlet. On the back of the CS-3000, activate the mains switch and turn the RF Generator on. Turning on the generator (switch on rear of generator) causes the system to enter Standby mode where no measurements or settings are possible. The nContact logo and the software version number are displayed in the message window; the Standby LED is illuminated.

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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).

LBL-2123 Rev B

Y

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 Humidity Atmospheric pressure

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 resets to the previous set Time and Power settings.

10C to 40C 30 % RH to 75 % RH, non-condensing. 700 to 1060 millibar

Storage & Shipping Conditions Temperature Humidity Atmospheric pressure

-40C to 60C 10 % RH to 95 % RH, non-condensing 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 experience, are capable of adequately testing and assessing the safety and functionality of the generator.

Visual Inspection 1. 2. 3.

Instruction manual present. Labels, cautions, or warnings placed correctly and in all required locations. No apparent external mechanical damage to the generator, connectors, accessories, or wiring.

Operating Test 1. 2. 3.

Self-test diagnostic upon start-up, includes self-calibration of measurement circuitry. Footswitch operation. 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.

Chapter 5 Product Specifications Operational Conditions & Front Panel Displays Figure 8. RF Generator Front Panel Display at “Power On”

Y 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 Disconnect the unit from the wall plug before cleaning. Wipe the exterior surfaces of the generator and the footswitch with 70–90% isopropyl alcohol. Allow the surfaces to dry thoroughly before connecting the power supply to a wall outlet or powering on the unit.

Turning POWER ON to the generator transitions the generator to “Standby” mode.

Figure 9. RF Generator Front Panel Display at “Standby Mode”

Y CAUTION: o o o o o

Do not use steam or heat sterilization Do not soak in glutaraldehyde or other disinfectant Do not immerse in any liquid Do not place drinks or other liquids on generator since spilling liquid can cause electrical shock or damage to the unit Do not allow any liquid to pass into any electrical connections or the interior of the generator

Chapter 4 Technical Specifications and Safety Inspection Device Specifications 1. 2. 3. 4. 5. 6.

Class I Equipment 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. Generator meets IPX1 Requirements for protection against fluid ingress Not Suitable for Flammable Anesthetics Intermittent Operation – The Duty Cycle for Transmitting RF Energy at Maximum Power (100 Watts, +/-20%) is 150 Seconds ON and 10 Seconds OFF. Uses LittleFuse 2183.15, Time Delay (Slo Blo) Fuse Rated at 3.15 A, 250VAC.

nContact Surgical, Inc.

Entering STANDBY MODE activates the “Standby” LED (“Error” LED and “RF ON/OFF” LEDs remain off). The nContact logo & “software version” are displayed.

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CS-3000 RF Generator Unit Operator Manual Figure 10. RF Generator Front Panel Display Entering “Power Control Mode”

From Standby, when the user presses the “MODE” button, the generator passes a self-test. If the self-diagnostic tests don’t detect an Error code, the generator then enters POWER CONTROL MODE (in this mode, the RF ON/OFF LED is blinking). As displayed in the drawing above, the impedance measurement is Open Circuit (OC) because the device and the indifferent electrode is not connected. The generator Power is set to 4 W and Time is set to 0.

Figure 11. RF Generator Front Panel Display in “Power Control Ready State”

LBL-2123 Rev B Figure 13. Front Panel Display in “RF ON” with Resistivity Active

POWER CONTROL RF ON with Resistivity Active, Device & Indifferent, Dispersive Electrode Attached “RF ON/OFF” is transmitted to the device and the “RF ON/OFF” LED is activated. Measured impedance is displayed (120) but not graphed. Resistivity is measured and graphed (“Test”) against the “Baseline” value (300 Ω/cm). Percent change in resistivity is displayed on the right (e.g.  20%) Power transmitted at 50 W Time (33 sec) counts up to set point

Figure 14. RF Generator Cycle Complete, Returns to Power Control “Ready” State

From POWER CONTROL MODE the generator enters a Ready State. Note: An indifferent electrode and coagulation device are connected to the generator and placed on the patient. “RF ON/OFF” LED is not activated, but will be blinking. When the user attaches a device, the generator detects device type and presets information. Refer to the Instructions for Use of the coagulation devices for the pre-set power and time.

Figure 12. Sample Display in “RF ON” State with a Device Attached

When the RF cycle is complete upon reaching preset time, generator returns to the POWER CONTROL MODE Ready State. “RF ON/OFF” terminates when Time equals set point, and LED turns off. “Time Limit” message is displayed in the upper right. Parameters display for 3 seconds, then reset to preset values. Final Impedance is measured (80 Ω) and displayed in lower left and is graphed against the “baseline” value (100 Ω). Final Percent change in impedance is displayed ( 20%). Final Power transmitted shown (50W). Time at Termination of RF energy is displayed (90 s).

POWER CONTROL RF ON State for Devices In this mode, the user presses “RF ON/OFF” to activate and transmit RF energy to the coagulation device. The “RF ON/OFF” LED is activated. Power is preset for the coagulation devices. The cycle Time (e.g. 56 s) is displayed in lower right corner and counts up to the set value. Impedance is measured and the value displayed in the lower left (e.g. 105 Ω). Impedance is graphed (in the right “Test” bar) against the baseline value measured at initiation of RF. The baseline value is also displayed above the graph and in the left “Baseline” bar. The percent change in impedance from baseline is displayed on the right (e.g. 25%) with an arrow ( or) to indicate whether the change in value was an increase or a decrease. During RF application, an audible tone will sound every second for a 200 millisecond pulse.

nContact Surgical, Inc.

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CS-3000 RF Generator Unit Operator Manual

LBL-2123 Rev B Warning and Fault States – Error Conditions

Figure 15. User Terminates Energy Cycle – Generator Returns to “User Request” State

When user presses RF ON/OFF button to terminate RF transmission, generator returns to the POWER CONTROL MODE User Request State and “RF ON/OFF” LED turns off. “User Request” message is displayed in the upper right. Both device and indifferent, dispersive electrode remain connected. Parameters display for 3 seconds then reset to preset values. Final Impedance measured (90 Ω) is displayed and graphed against baseline value (100 Ω). Final Percent change in impedance is displayed (e.g.  10%). Final Power transmitted is shown on the left (50 W). Time at User Termination of RF energy is displayed (41 s).

Figure 17. ERROR “Imp Limit” – Impedance Exceeds Threshold

This error (warning) occurs when Impedance exceeds the threshold limit, causing termination of RF energy transmission. “Imp Limit” message displays in upper right and Error LED illuminates. For warnings, parameters display for 3 seconds or until the warning is corrected. Once the warning is corrected then the parameters reset to the preset values. Final Impedance (765 Ω) is displayed and graphed against the baseline (100 Ω). Final Percent change in impedance is displayed ( 665%). Final Power transmitted shown (50 W). Time at User Termination of RF energy (34 s) displayed. When this warning occurs, an audible tone will sound three times for 1.5 seconds with 450 milliseconds between tones.

Figure 16. Generator Enters “Diagnostic Evaluation Mode” Figure 18. ERROR “RF Eff Limit” – System Error

To enter the Diagnostic Mode from the POWER CONTROL - Ready State, user presses the MODE button. RF energy is inactive and the “RF ON/OFF” LED is off. User connects an accessory device (not yet available), presses “RF ON/OFF” to set the baseline resistivity value. Measured resistivity (300 Ω/cm) is displayed and graphed against baseline (250 Ω/cm). Final Percent change in resistivity is displayed ( 20% indicating an increase).

nContact Surgical, Inc.

This error (fault) occurs when there is a conflict with hardware or software, causing termination of RF energy transmission. All faults that are not recoverable will be displayed with the appropriate message and will require cycling of the main power switch so the generator passes through self-test. “RF Eff Limit” message is displayed and the Error LED illuminates. (Eff = Efficiency). Parameters display until the generator is Powered OFF, then Powered ON so that the generator performs its start-up diagnostic self tests. Final Impedance (90 Ω) displays and is graphed against baseline (100 Ω). Final Percent change in impedance is displayed (e.g.  10%). Final Power transmitted is shown (50 W). Time at User Termination of RF energy (22 s) is displayed. When this fault occurs, an audible tone will sound continuously until the generator is turned off.

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CS-3000 RF Generator Unit Operator Manual

LBL-2123 Rev B

Chapter 6 Troubleshooting The following flowchart illustrates a user decision tree to assist in operation of the generator and troubleshooting.

Figure 19. Generator Modes, States and Operational Flow

WARNING: Do not open the back panel of the RF Generator. This may cause serious injury and damage to the unit. It will void the warranty. When problems cannot be resolved by the directions in this troubleshooting section, contact nContact Surgical, Inc. for additional service and repair information Table 1 provides a list of symptoms which may occur during routine operation of the RF Generator. If you encounter a problem that is not listed here, contact nContact Surgical, Inc.

Table 1 – List of Troubleshooting Symptoms & Actions Symptom

Action

No displays or indicators when the RF Generator is turned on

 Be sure the generator is plugged into a working electrical outlet.  Check power switch on back of generator.  Unplug and check the fuse on the rear panel. Fuses should only be replaced with LittleFuse 2183.15, Time Delay (Slo Blo) rated at 3.15A, 250VAC.

IMP LIMIT warning, indicating impedance out of range

nContact Surgical, Inc.

Symptom

Action

Error LED indicator illuminates and one of the following Fault messages appears in Message window: RF EFF LIMIT ROM CRC FAILURE RAM FAILURE TIMER FAILURE +48 VOLT SUPPLY FAIL -12 VOLT SUPPLY FAIL +12 VOLT SUPPLY FAIL +5 VOLT SUPPLY FAIL IMPEDANCE TEST FAIL RF POWER TOO HIGH WHEN OFF RF POWER TOO HIGH WHEN ON RESISTIVITY FAILED MEASURED POWER CALCULATED POWER FAN FAULT GROUND FLOAT ON A/D CAL VOLTAGE ON A/D AMBIENT TEMP FAIL

 Power unit OFF, then Power ON again.  Allow generator to run through normal start-up self-diagnostics.  If generator returns to Error state and the problem persists, contact your nContact Surgical, Inc. representative.

Error LED indicator shows a button is stuck and one of the following Fault messages appears: RF ON BUTTON STUCK MODE BUTTON STUCK POWER/TEMP UP BUTTON STUCK POWER/TEMP DOWN BUTTON STUCK TIME UP BUTTON STUCK TIME DOWN BUTTON STUCK RF power does not turn on when footswitch is depressed

 Depress and release the indicated button to determine if the button remains stuck.  Power unit OFF, then Power ON again.  Allow generator to run through normal start-up self-diagnostics.  If generator returns to Error state and the problem persists, contact your nContact Surgical, Inc. representative.

 Verify the footswitch is connected to the front panel of the generator  Ensure Time is not set to 0.  Ensure IMP LIMIT error is not detected impedance should be within 30 – 500Ω.  Ensure a coagulation device is connected to the generator  Ensure the indifferent, dispersive electrode is attached to the patient and connected to the generator  Check the footswitch by unplugging its cable from the generator, placing a thumb over the foot pedal connector then depressing the pedal. If the footswitch is functioning properly, air should be expelled through the connector as the footswitch is depressed.

RF interferes with ultrasound and other equipment

 Ensure the cables from the electrodes do not cross the cables from the ultrasound probe or other equipment.  Changing settings on the ultrasound may alleviate image interference.

Impedance is greater than 500 Ω at the beginning of RF power delivery

 Ensure the indifferent, dispersive electrode is properly attached.  Check all connections.  Clean off any coagulum from the coagulation device.  Ensure device is properly placed on tissue site.

Impedance is less than 30 Ω at the beginning of RF power delivery

o Reposition the coagulating device

 Check connections to coagulation device and indifferent, dispersive electrode.  Ensure device is properly placed on tissue site.  Check position of indifferent, dispersive electrode on patient’s back or thigh.  If problem persists, replace the coagulation device and indifferent, dispersive electrode.

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CS-3000 RF Generator Unit Operator Manual

LBL-2123 Rev B

Chapter 7 Customer Service / Equipment Servicing/ Warranty nContact Surgical, Inc. is dedicated to providing service and support to its customers. If there are any questions concerning the use of the nContact Coagulation system, please contact Customer Service at: M Manufacturer: United States: nContact Surgical, Inc. 1001 Aviation Parkway, Suite 400 Morrisville, North Carolina 27560 USA Telephone: +1-919-466-9810 Fax: +1-919-466-9811

Authorized European Representative: Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands 31-0-70-345-8570

LIMITED WARRANTY This Limited Warranty applies to the nContact RF Generator. If the RF Generator is used properly (in accordance with the supplied Operator’s Manual), but proves to be defective through no fault of the purchaser or user, it will be repaired or replaced free of charge or its purchase price refunded, at nContact’s discretion. nContact’s obligation to repair or replace the RF Generator, or refund the purchase price, shall expire 12 months from the receipt of the product by the purchaser from nContact [or its authorized representative]. The term “purchaser” as used herein refers to any individual or entity that purchases the nContact product from nContact Surgical Inc. or its authorized representatives. The purchaser’s sole and exclusive remedy against nContact and nContact’s sole and exclusive liability under this Limited Warranty shall be the repair or replacement of the RF Generator or refund of its purchase price in accordance herewith. The RF Generator has no user-serviceable parts. If servicing is required, the RF Generator must be returned to nContact Surgical, Inc., and may only be returned with the prior approval of nContact. Such approval must reference a Returned Goods Authorization (RGA) number issued by nContact Customer Service. Shipping and transportation costs, if any, incurred in connection with the return of the RF Generator to nContact shall be the responsibility of the purchaser. If the RF Generator is determined by nContact to be defective under this Limited Warranty, shipping and transportation costs will be reimbursed by nContact to the purchaser. Any attempt to service, repair, modify or alter the RF Generator, or to use the RF Generator other than in accordance with the supplied Operator Manual and in the manner and medical procedures set forth in the Operator Manual, will void this Limited Warranty. DISCLAIMER: EXCEPT AS SET FORTH ABOVE, nCONTACT SURGICAL, INC. MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESSED OR IMPLIED, WITH REGARD TO THE RF GENERATOR OR ACCESSORIES, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY, QUALITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE. nCONTACT SHALL NOT BE LIABLE FOR THE COST OR PROCUREMENT OF SUBSTITUTE GOODS BY THE PURCHASER OR FOR ANY SPECIAL, INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE OR EXPENSE DIRECTLY OR INDIRECTLY ARISING FROM USE OF THE RF GENERATOR OR ACCESSORIES OR ANY DEFECT THEREOF. nCONTACT HAS NO CONTROL OVER THE CONDITIONS OR THE MANNER IN WHICH THE PRODUCT IS USED; THEREFORE, IN ADDITION TO VOIDING THE LIMITED WARRANTY ABOVE, nCONTACT DISCLAIMS ANY LIABILITY WHATSOEVER ARISING FROM FAILURE TO OPERATE THE RF GENERATOR ACCORDING TO THE SUPPLIED OPERATOR MANUAL OR IN THE MANNER AND MEDICAL PROCEDURES SET FORTH THEREIN, OR IN THE EVENT OF ANY UNAUTHORIZED SERVICE, REPAIR, MODIFICATION OR ALTERATION OF THE RF GENERATOR, OR UNDER ANY OTHER CONDITIONS OR CIRCUMSTANCES OUTSIDE THE CONTROL OF nCONTACT. nCONTACT NEITHER ASSUMES, NOR AUTHORIZES ANY OTHER PERSON TO ASSUME FOR IT, ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THE PRODUCT.

nContact Surgical, Inc.

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