Coblator II System (RF80000E) Users Manual Rev A July 2010

ii COBLATOR® II (RF8000E) SYSTEM User’s Manual

2 COBLATOR® II (RF8000E) SYSTEM User’s Manual

COBLATOR® II (RF80000E) SYSTEM 3 User’s Manual

High frequency surgical unit with respect to electrical shock, fire and mechanical hazards only in accordance with: UL 60601-1/CAN/CSA C22.2 No. 601.1, IEC/EN 60601-2-2.

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This equipment has been tested and found to comply with the limits for medical devices to IEC/EN 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. If this equipment does cause harmful interference to other devices, which can be verified by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving device, • Increase the separation between the affected equipment and the Controller, • Connect the affected equipment to an outlet or circuit different from that to which the Controller is connected, or • Consult the manufacturer or field service technician for help.

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COBLATOR® II (RF80000E) SYSTEM 5 User’s Manual

Description, Indications for Use, and Contraindications... 7 Description... 7 Indications for Use... 7 Contraindications... 7 System Overview... 8 Connection Diagram... 8 Principle of Operation... 9 Warnings, Precautions, and Adverse Events... 10 Warnings... 10 Precautions... 10 Adverse events... 12 Controls, Indicators, and Alarms... 12 Controls & Indicators... 12 Alarms... 13 Diagram of Controls, Indicators, and Alarms... 14 Unpacking, Assembly, and System Check... 15 Unpacking... 15 Assembly and System Check... 15 Instructions for Use... 16 Operator Training Requirements... 16 General System Operation... 16 Voltage Outputs... 17 System Preparation and Care... 18 System Preparation... 18 Wand Selection... 19 System Shut Down... 19 System Storage and Transport... 19 Equipment Disposal... 19

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Table of Contents

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Cleaning and Disinfection... 20 Controller, Flow Control Valve Unit, and Flow Control Cable... 20 Foot Control... 20 Wand... 20 Maintenance and Troubleshooting... 21 Maintenance... 21 Fuse Replacement... 21 Troubleshooting Guide... 21 Product Specifications... 23 Technical Specifications... 23 Controller Output Graphs... 24 Electromagnetic Environment Specifications... 27 Controller Classification and Safety Verification... 31 Classification... 31 Safety Verification... 31 Customer Service... 32 Warranty Information... 32 Product Complaints... 28 Symbols Key... 33

COBLATOR® II (RF80000E) SYSTEM 7 User’s Manual

Description The Coblator®­ II (RF8000E) is a bipolar, radiofrequency (RF) electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The System consists of the following components: 1) an electrosurgical radiofrequency controller; 2) a reusable, non-sterile Power Cord; 3) a reusable, non-sterile Foot Control; 4) a reusable, non-sterile Flow Control Valve Unit; 5) a reusable, non-sterile Flow Control Cable; 6) a single use, disposable, sterile Wand The Controller is the power source that delivers radiofrequency (RF) energy to the treatment site via the Wand. The sterile disposable Wand device is available in various single or multi-tip configurations and is supplied separately.

Indications for Use The Coblator II (RF8000E) is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.

Contraindications The Coblator II (RF8000E) is contraindicated in any procedures where a conductive solution is not used. The Coblator II (RF8000E) is also contraindicated for patients who have cardiac pacemakers or other electronic implants. Please refer to the Wand Instructions for Use for a more comprehensive list of contraindications regarding specific procedures.

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Description, Indications for Use, and Contraindications

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System Overview Connection Diagram

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15

6

5

4 3

12

13

10

11 14

1. 2. 3. 4. 5. 6. 7. 8.

Controller Power Cord Foot Control Ablate Pedal Coagulation Pedal Coblate Set Point Adjustment Button Controller Connectore Handle

09. Shaft 10. Return Electrode 11. Active Electrode Tip 12. Suction Tube (Optional on Wand Style) 13. Irrigant Tube (Optional on Wand Style) 14. Wand 15. Flow Control Cable 16. Flow Control Valve Unit

COBLATOR® II (RF80000E) SYSTEM 9 User’s Manual

The Coblator II (RF8000E) System Controller is designed to deliver RF energy to the electrode elements located at the distal end of the sterile single-use Wands. Current flows between the active electrode element and the return electrode element, providing a localized energy field. The result of this arrangement is controlled energy delivery with minimal collateral tissue damage. The Coblator II (RF8000E) System works by passing RF energy through a conductive solution (such as normal saline) in close proximity to or in contact with the tissue to be treated. The conductive solution forms a thin layer between the active and return electrode elements. In the Coblate mode, when sufficient energy is applied, the conductive solution is converted into a vapor layer (plasma) containing energized charged particles. When the highenergy charged particles come in contact with tissue, they cause its disintegration through molecular dissociation. This mode of operation results in relatively low treatment site temperatures when compared to conventional electrosurgical systems, thus yielding limited collateral thermal damage to the surrounding untreated tissue. The function of the device is different when a lower voltage is applied between the active electrode(s) and the target tissue. In this case, the electrical field is below the threshold required to create a plasma layer and resistive tissue heating occurs. This mode is useful when a greater thermal effect is needed, i.e. for coagulation of blood vessel or other vascular tissues. The appropriate voltage setting will depend on the design of Wand used, tissue type, and desired tissue effect. In contrast, monopolar systems only have an active electrode on the device tip. The current path travels from the active electrode through the patient’s body to a return pad affixed to the patient’s body. This results in significantly more energy passing through the patient’s body and through the surrounding tissue.

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Principle of Operation

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Warnings, Precautions, and Adverse Events The following is a list of Warnings and Precautions that apply to the general operation of the Coblator II (RF8000E). For specific warnings and precautions, please refer to the Wand and the Patient Cable Instructions for Use.

WARNINGS • Failure to follow all applicable instructions may result in serious surgical consequences. • Explosion Hazard: The following substances will contribute to increased fire and explosion hazards in the operating room: flammable substances (such as alcohol-based skin prepping agents and tinctures), flammable anesthetics, naturally occurring flammable gases which may accumulate in body cavities such as the bowel, oxygen enriched atmospheres, and oxidizing agents such as nitrous oxide (N2O) atmospheres. • Fire Hazard: DO NOT place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). • Electrosurgical accessories, which are activated or hot from use, can cause a fire. • Accessory tips may remain hot enough to cause burns after the electrosurgical current is deactivated. • Inadvertent activation or movement of Wands outside the field of vision may result in injury to the patient. • Localized burns to the patient or physician may result from electrosurgical current carried through other instruments and conductive objects. • Electrosurgical current may be generated in conductive objects by direct contact with the active electrode or by the active or return electrode being in close proximity to a conductive object. • If excessive heating or physical forces cause damage to the Wand tip, foreign body fragments may result, possibly requiring extended surgery for removal. • DO NOT use the Coblator II (RF8000E) System with non-conductive media (e.g. sterile water, dextrose, air, gas, glycine, etc.). Use only conductive media such as normal saline or Ringer’s lactate. • Electric Shock Hazard: DO NOT connect wet accessories to the Controller.

PRECAUTIONS • Prior to initial use, ensure that all package inserts, warnings, precautions, and Instructions for Use are read and understood. • Safe and effective electrosurgery is dependent not only on equipment design, but also, to a large extent, on factors under the user’s control. Only persons having adequate training and familiarity with orthopedic, arthroscopic, spinal and neurosurgical surgeries should perform procedures with the Coblator II (RF8000E). • Consult medical literature relative to techniques, complications, and hazards prior to performance of any procedure. • Evaluate patients for predisposing medical problems that may be aggravated by the stress of surgery. • A thorough understanding of the principles and techniques involved in electrosurgical procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device and other medical instruments. Ensure that insulation or Controller grounding is not compromised. • When instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure. • When not in use, remove the Wand from the surgical site and place outside of the operative field away from metallic objects. Wands should remain separated from other electrosurgical equipment to avoid inadvertent electrical coupling between devices. Otherwise, inadvertent activation may cause injury to patient and/or user or equipment damage.

COBLATOR® II (RF80000E) SYSTEM 11 User’s Manual

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• DO NOT wrap Wand cables around metal objects. Wrapping cords around metal objects may induce currents that could lead to shocks, fires, or injury to the patient or surgical personnel. • Use caution when using Wand tips to probe or manipulate tissue. Forceful contact between Wand tips and tissue or other instruments may result in damage to the instrument. • DO NOT allow fluid to contact any electrical connectors on the Wands, Controller, or Cables during use. • Maintain the lowest power setting necessary to achieve the desired tissue effect. • DO NOT allow patient contact with grounded metal objects, such as a surgical table frame or an instrument table, to avoid risk of shock. Grounding pads should not be used. • DO NOT contact metal objects with an activated Wand. • Observe fire precautions at all times. Sparking and heating associated with electrosurgery may be an ignition source. • DO NOT use flammable agents for cleaning and disinfection of the Controller or Cables. • As with other electrosurgical units, electrodes and Cables can provide paths for high frequency current. Position the cables to avoid contact with the patient or other electrical leads. • High frequency (HF) electrosurgical equipment such as the Coblator II (RF8000E) System may adversely affect the operation of other electronic equipment. • Electrodes should remain separated from other electrosurgical equipment to avoid inadvertent electrical coupling between devices. • Monitoring electrodes should be positioned as far as possible from the surgical electrodes when HF surgical equipment and physiological monitoring equipment are used simultaneously on a patient. Needle Monitoring electrodes are not recommended. • Monitoring equipment incorporating high frequency current-limiting devices is recommended. • DO NOT remove the cover of the Controller. Refer servicing to qualified personnel. • DO NOT obstruct the exhaust fan (located at rear of Controller). • DO NOT touch the Controller’s fan and/or speaker while touching the patient. • Before each use, check that all Controller indicator lights and audio signals are functional. Make sure that the power cable plug is properly connected to the Controller receptacle. • To avoid risk of fire, only replace the Controller fuses with the same type and rating. • Controller failure could result in an unintended increase in output power. • The Coblator II (RF8000E) System is designed to be operated exclusively as a unit. Only use accessories provided by ArthroCare • The Coblator II (RF8000E) System should not be used adjacent to or stacked with other equipment. If the system is used adjacent to or stacked with other equipment, the system should be verified that it is operating in its intended configuration. • DO NOT use other ArthroCare Foot Controls. Use only the Foot Control provided with the Coblator II (RF8000E) System. • When endoscopes are used with endoscopically-used accessories, the patient leakage currents may be additive. • The Controller may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the Controller or shielding the location. • The controller is not intended to be used with a neutral electrode. • DO NOT reuse ArthroCare PlasmaWands that have been designed for single use to avoid failure or unanticipated performance.

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• If a Power Cord other than the ArthroCare Power Cord is used, please ensure the Power Cord complies with the voltage and current rating listing on the back panel of the Controller. Failure to do so may alter the performance of the Controller.

ADVERSE EVENTS As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur.

Controls, Indicators, and Alarms Controls & Indicators The Controller incorporates the following controls and indicators: 1. On/Off Switch This toggle switch turns the AC power on and off. When the Controller is powered on, green numbers will be visible in the Coblate and Coagulation Level Display Windows. These displays may remain active for up to 5 seconds following power turn-off. 2. Coagulation Level Adjustment Increment and Decrement Arrow buttons control the coagulation output voltage. Refer to the Instructions for Use section of this manual for the corresponding voltage levels for each setting. 3a. Coagulation Level Display This display indicates the output level for coagulation mode. A nominal setting will automatically be displayed when the System is powered up with a Wand attached or when a new Wand is connected. Prior to connection of a Wand, this display will show 0. 3b. Coagulation Activation Indicator A blue indicator will illuminate when the Foot Control Coagulation Pedal is depressed with a Wand attached. 4a. Coblate Level Display This display indicates the output level for Coblate mode. A nominal setting will automatically be displayed when the System is powered up with a Wand attached or when a new Wand is connected. Prior to connection of a Wand or the Patient Cable, this display will show 0. 4b. Coblate Activation Indicator A yellow indicator will illuminate when the Foot Control Ablation Pedal is depressed with a Wand attached. 5. Coblate Set Point Adjustment Increment and Decrement Arrow buttons control the Coblate output voltage. This output level can also be adjusted from the Ablate Set Point Adjustment function on the Foot Control. Refer to the Instructions for Use section of this manual for the corresponding voltage levels for each setting. 6. Wand Connected Indicator When the Wand is properly connected, the green Wand Connected Indicator light will illuminate. 7. Foot Control Connected Indicator When a Foot Control or Hand Switch is properly connected, the Foot Control / Hand Switch Connected Indicator will illuminate green.

COBLATOR® II (RF80000E) SYSTEM 13 User’s Manual

Alarms 1. Intermittent dual tone: 2. Intermittent monotone:

current limit alarm or overload connection fault alarm (Wand)

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8. Flow Control Activation Indicator When a Foot Control is properly connected, the Foot Control Connected Indicator will illuminate green. 9. Warning Indicator This red indicator illuminates when a Controller-specific failure or malfunction occurs. 10. Flow Control Cable Receptacle The Flow Control Cable plugs into the black-ringed receptacle located on the front of the Controller. 11. Foot Control Receptacle The Foot Control plugs into the gray receptacle located on the front of the Controller. 12. Wand Cable Receptacle The Wand Cable plugs into the blue-ringed receptacle located on the front of the Controller. 13. Symbol for Defibrillator-Proof Type BF Equipment This equipment provides a degree of protection against electric shock to TYPE BF applied parts as defined in IEC/EN 60601-1, it also has an F type applied part capable of withstanding the effects of defibrillator discharge. 14. Tone Volume Control The Tone Volume Control regulates tone volume. To increase volume, turn the knob clockwise. To reduce volume, turn the knob counterclockwise. 15. Non-Ionizing Radiation Symbol This symbol indicates that this equipment intentionally emits RF energy during activation. 16. Fuse Rating Symbol This symbol indicates that only fuses with the appropriate rating should be used. Check the Controller back label for the appropriate fuse rating. See Maintenance and Troubleshooting section for fuse replacement instructions. 17. Power Cord Receptacle / Fuse Holder The Controller power cord plugs into this receptacle. The fuse holder is behind the receptacle. 18. Equipotential Ground Symbol This symbol identifies the conductor that is used to bond the equipment to earth ground. 19. CE Mark - European Certification Symbol This indicates compliance with the European Commission Medical Device Directive (93/42/EEC). 20. UL Classified Mark The UL Classified Mark indicates compliance with applicable Safety Standards for the United States and Canada by Underwriters Laboratories, Inc. (UL). 21. Attention Symbol This symbol alerts the user to read and understand this manual and accompanying instructions before operating the equipment. 22. No Disposal Symbol This symbol indicates that this equipment should not be discarded in any waste container.

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Diagram of Controls, Indicators, and Alarms

240V - T4A 250V

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COBLATOR® II (RF80000E) SYSTEM 15 User’s Manual

Unpacking Verify that all items have been received and are not damaged. Damage should be reported at once to the Customer Service Department. Save all containers and packaging material; they will be required if it is necessary to return the equipment.

Assembly and System Check 1. Connect the Power Cord to the receptacle on the rear panel of the Controller. Connect the other end of the Power Cord to the electrical outlet. If it is necessary to use a Power Cord other than the one supplied with the System, the additional Power Cord should comply with appropriate electrical standards and be suitable for hospital use. 2. Turn the On/Off Switch on the front panel of the Controller to the ‘On’ (I) position. The Coblate and Coagulation Level Displays should indicate a setting of ‘0’. All other indicator lights should be off. 3. Attach the Foot Control to the gray receptacle on the front of the Controller. The Foot Control Connected Indicator light on the front panel of the Controller should illuminate. 4. Depress the Ablate function on the Foot Control. The red Warning Indicator light on the front panel of the Controller should illuminate and the Controller should emit an intermittent monotone alarm. The yellow Coblate Activation Indicator on the front panel should be off. If the Controller does not function as described above, please contact Customer Service immediately.

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Unpacking, Assembly, and System Check

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Instructions for Use Operator Training Requirements The operator should be experienced in electrosurgical techniques. It is recommended that the user remain current with advances in otorhinolaryngology (ENT) procedures. Additional training on the use of the Coblator II (RF8000E) System from an ArthroCare representative is recommended.

General System Operation

Wands are activated using the Foot Control. The Foot Control a has three functions as described below: Coblate/Ablate Activation Pressing the Coblate/Ablate Activation function operates the Controller’s normal Coblate mode and will activate the Wand(s).

Coagulation Activation Pressing the coagulation function will activate the Controller’s coagulation mode.

Coblate Set Point Adjustment Pressing the Coblate Set Point Adjustment function will adjust the Coblate voltage level on the Controller. Each time the Coblate Set Point Adjustment function is pressed, the Coblate voltage level increases by one level up to the maximum set point for each Wand style. Once the maximum level for the connected Wand has been reached, the System will cycle back to set point one.

COBLATOR® II (RF80000E) SYSTEM 17 User’s Manual

The Coblate and Coagulation voltage level settings are indicated by a single digit LED output display on the front panel of the Controller. This display corresponds to the output voltage as follows: Coblate Mode Display 1 2 3 4 5 6 7 8 9

Output Voltage (Vrms ±10%) 100 127.5 155 182.5 210 237.5 265 290 300

Coagulation Mode Display 1 2 3 4 5 6 7 8 9

Output Voltage (Vrms ±10%) 65 70 75 81 87 93 100 108 115

When the Controller is first powered on with no Wand attached, the display digit ‘0’ appears on both front panel displays as a default setting. If a Wand is attached at or after power-up, the unit will adjust the outputs to nominal settings. These settings will usually provide the best effect in most situations. Once a Wand has been properly connected, the voltage level can be increased or decreased by pressing the Coblate level adjustment or the coagulation level adjustment buttons located on the front panel. Coblate level can also be adjusted by pressing the Ablate set point adjustment function on the Foot Control. Both the Coblate and Coagulation levels may be adjusted to levels throughout the appropriate range, depending on the maximum voltage permitted by the particular Wand in use.

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Voltage Outputs

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System Preparation and Care System Preparation 1. Prior to each use, inspect the Coblator II (RF8000E) System for possible damage to the Controller Casing, Flow Control Valve Unit, and cables. 2. Insert the receptacle end of the Power Cord into the Power Cord Receptacle located at the rear of the Controller. Insert the plug end of the Power Cord into an appropriately grounded electrical outlet. Position the Controller so that the exhaust fan located in the rear of the Controller is unobstructed and directed away from the patient. 3. Press the On/Off Switch on the front panel of the Controller to the ‘On’ (I) position. The Coblate and Coagulation Level Displays should indicate a setting of ‘0’. All other indicator lights should be off. 4. Connect the Foot Control to the gray Foot Control Receptacle on the front of the Controller. The Foot Control Connected Indicator (green) on the Controller front panel will illuminate. 5. Plug the Wand cable into the blue Wand Cable Receptacle on the front of the Controller. Refer to each Wand Instructions for Use for specific instructions regarding surgical preparation and procedures. 6. For surgical applications that require automated delivery of conductive media (e.g. saline, Ringer’s lactate) to the treatment site, attach the Flow Control Valve Unit to an IV pole by placing the rear clamp onto the shaft of the pole. Secure the unit to the pole by turning the knob clockwise. NOTE: The fluid source must be higher than the patient for proper operation (1 meter / 3 feet recommended). 7. Make sure the Flow Control Cable connectors are completely dry before use. Connect one end of the Flow Control Cable into the black Flow Control Receptacle on the front of the Controller and the other end into the receptacle on the rear of the Flow Control Valve Unit. The ends of the Flow Control Cable are interchangeable. 8. Hang a bag of fluid (saline or Lactated Ringers) on the IV pole and spike the bag with the supplied tubing attached to the Wand. Be sure to close the roller clamp completely before spiking the bag. 9. Press the Flow Activation Switch located on the front of the Flow Control Valve Unit to ‘On’ position to manually activate the system. The green light on the front of the Flow Control Valve Unit will illuminate indicating that the Flow Control Valve Unit is activated. Load the tubing into the pinch valve located on the front of the Flow Control Valve Unit. This is facilitated by stretching the section of IV tubing to be pinched by the valve. If present, open the Stopcock on the irrigant tubing lead of the Wand. Irrigant will flow to the Wand and thereby prime the irrigant line assembly. Set the drip rate with the roller clamp on the IV administration set to achieve the desired flow rate for the Wand being used. 10. Open the roller clamp on the tubing. Fluid will flow to the Wand and thereby prime the tubing assembly. Set the drip rate with the roller clamp on the IV administration set to achieve the desired flow rate for the Wand being used.

COBLATOR® II (RF80000E) SYSTEM 19 User’s Manual

11. Return the Flow Activation Switch located on the front of the Flow Control Valve Unit to the ‘AUTO’ position to manually de-activate the system and stop fluid flow. NOTE: When sufficient conductive media is present between the active and return Wand portions at the coagulation site, the conductive media flow may be turned off at the user’s discretion via a switch on the Controller front panel. However, conductive media will always flow to the treatment site during Coblate 12. Set Coblate and Coagulation Settings to the appropriate level required to obtain desired effects.

Wand Selection Select the Wand type most appropriate for the procedure. The Controller will preset nominal and maximum Coblate and Coagulation voltages for each Wand style to ensure a safe and effective operation. In order to adjust the voltage setting, the Wand must be connected to the Controller.

System Shut Down 1. Verify that the roller clamp on the wand tubing is closed to is restrict flow. Remove the tubing from the Flow Control Valve Unit by depressing the activation switch to the ‘ON’ position and pull it off the valve. The tubing can then be removed from the bag of fluid. 2. Turn the power switch to the ‘OFF’ position. After a brief (less than 5 seconds) delay, all lights on the Controller will go off. 3. Remove the Wand from the Controller. 4. Dispose of the Wand and associated tubing.

System Storage and Transport All Coblator II (RF8000E) System components may be safely stored and transported at an ambient temperature range of -40°C (-40° F) to +70°C (158° F). The relative humidity should be between 10 and 85%.

Equipment Disposal The Coblator II (RF8000E) System contains electronic printed circuit assemblies and should not be disposed in any waste container. It should be disposed of in accordance with any applicable national or institutional policies relating to obsolete electronic equipment. Contact ArthroCare for return of the Coblator II (RF8000E) System for proper disposal. Dispose the Wand according to normal institutional practices for potentially contaminated items.

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System Preparation and Care (Cont.)