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COBLATOR
®
II (RF80000E) SYSTEM
3
User's Manual
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:
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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Related Manuals for ArthroCare COBLATOR II
Summary of Contents for ArthroCare COBLATOR II
- Page 1 COBLATOR ® II (RF80000E) SYSTEM User’s Manual 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.
- Page 2 4 COBLATOR ® II (RF8000E) SYSTEM User’s Manual...
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Page 3: Table Of Contents
COBLATOR ® II (RF80000E) SYSTEM User’s Manual Table of Contents ¡ ¢ £ ¤ ¥ ¦ § ¥ ¨ © © ¥ £ § ¥ ¨ © ¢ ¨ ¤ ¢ ¡ © ¨ © § ¤ ¥ © ¥ £... - Page 4 6 COBLATOR ® II (RF8000E) SYSTEM User’s Manual ¡ © ¥ © & © ¥ ¢ ¥ © ¡ £ § ¥ ¨ © ..........................20 Controller, Flow Control Valve Unit, and Flow Control Cable ..................20 Foot Control ................................20 Wand..................................
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Page 5: Description
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. -
Page 6: Connection Diagram
8 COBLATOR ® II (RF8000E) SYSTEM User’s Manual System Overview Connection Diagram 1. Controller 09. Shaft 2. Power Cord 10. Return Electrode 3. Foot Control 11. Active Electrode Tip 4. Ablate Pedal 12. Suction Tube (Optional on Wand Style) 5. Coagulation Pedal 13. - Page 7 User’s Manual Principle of Operation 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.
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Page 8: Warnings
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. - Page 9 ArthroCare Foot Controls. Use only the Foot Control provided with the Coblator II (RF8000E) System. necessary to take mitigation measures, such as reorienting or relocating the Controller or shielding the location.
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Page 10: Adverse Events
12 COBLATOR ® II (RF8000E) SYSTEM User’s Manual 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 &... -
Page 11: Alarms
COBLATOR ® II (RF80000E) SYSTEM User’s Manual 8. Flow Control Activation Indicator When Flow Control Valve Unit is activated (valve open), the green Flow Control Activation Indicator will illuminate. 9. Warning Indicator This red indicator illuminates when a Controller-specific failure or malfunction occurs. 10. -
Page 12: Diagram Of Controls, Indicators, And Alarms
14 COBLATOR ® II (RF8000E) SYSTEM User’s Manual Diagram of Controls, Indicators, and Alarms 240V - T4A 250V... -
Page 13: Unpacking
COBLATOR ® II (RF80000E) SYSTEM User’s Manual Unpacking, Assembly, and System Check 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. -
Page 14: Operator Training Requirements
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. -
Page 15: Voltage Outputs
COBLATOR ® II (RF80000E) SYSTEM User’s Manual Voltage Outputs 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 Coagulation Mode Display... -
Page 16: System Preparation
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. -
Page 17: Wand Selection
-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. -
Page 18: Controller, Flow Control Valve Unit, And Flow Control Cable
20 COBLATOR ® II (RF8000E) SYSTEM User’s Manual Cleaning and Disinfection Controller, Flow Control Valve Unit, and Flow Control Cable sterilize or immerse in liquid. Wipe clean with a soft cloth and mild detergent as needed. Foot Control sterilize. Clean with detergents and disinfectants according to standard practices. Disinfect with liquid chemical disinfectants such as chlorine solutions, iodophors, glutaraldehydes and hydrogen peroxides. -
Page 19: Maintenance
Controller and contact Customer Service. Troubleshooting Guide If you are experiencing problems with the Coblator II (RF8000E) System, you may want to use the following troubleshooting guide to help identify or eliminate the problem before contacting Customer Service: ¢... - Page 20 ¡ This is a safety feature of the Coblator II (RF8000E) and may occur if the Wand is activated for an extended period of time without contacting tissue. To reset the unit, lift your foot off the foot pedal if the System is connected to the Foot Control.
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Page 21: Technical Specifications
COBLATOR ® II (RF80000E) SYSTEM User’s Manual Product Specifications Technical Specifications ¨ © § ¤ ¨ ¡ ¤ Input Power Requirements Voltage ..............100-120, 220-240 VAC Frequency. -
Page 22: Controller Output Graphs
24 COBLATOR ® II (RF8000E) SYSTEM User’s Manual Controller Output Graphs Output power at each set point with 250 Ohms load (per IEC/EN 60601-2-2, subclause 6.8.3) is given in the graphs below: Set Point Output Power vs. Set Point at 250 Ohms Resistive Load, Coblate Set Point Output Power vs. - Page 23 COBLATOR ® II (RF80000E) SYSTEM User’s Manual The output power (at full and half settings) versus load resistance (per IEC/EN 60601-2-2, subclause 6.8.3) is given in the graphs belows: Full Power Half Power Load Resistance, Ohms Output Power vs. Load Resistance, Coblate Full Power Half Power Load Resistance, Ohms...
- Page 24 26 COBLATOR ® II (RF8000E) SYSTEM User’s Manual The open circuit voltage for each set point is given in the graphs below: Set Point Open Circuit Voltage Measurements, Coblate Set Point Open Circuit Voltage Measurements, Coagulation...
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Page 25: Electromagnetic Environment Specifications
¢ The Coblator II (RF8000E) System is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the Coblator II (RF8000E) System should assure that it is used in such an environment. Emission Compliance... - Page 26 § The Coblator II (RF8000E) System is intended for use in the electromagnetic environment specified below. The customer or the user of the Coblator II (RF8000E) System should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level...
- Page 27 § The Coblator II (RF8000E) System is intended for use in the electromagnetic environment specified below. The customer or the user of the Coblator II (RF8000E) System should assure that it is used in such an environment. Immunity IEC 60601...
- Page 28 § ¡ The Coblator II (RF8000E) System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Coblator II (RF8000E) System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Coblator II (RF8000E) System as recommended below, according to the maximum output power of the communications equipment.
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Page 29: Classification
........non patient applied parts If the System fails to meet the following specifications, please contact ArthroCare Customer Service for a return merchandise authorization. -
Page 30: Warranty Information
Customer Service Warranty Information The Coblator II (RF8000E) System Controller, Foot Control, Flow Control Valve Unit, and Flow Control Valve Interface Cable are warranted for one year from the date of shipment to the original purchaser. Any component of the System, which develops defects resulting from defective material or workmanship during these time periods will be replaced or repaired without charge. - Page 31 U.S. Patents: 5,679,281; 5,697,536; 5,697,882; 5,697,909; 5,871,469; 5,891,095; 5,683,366; 6,053,172; 6,063,079; 6,086,585; 6,109, 268; 6,159,208; 6,024,733; 6,117,109; 6,159,194; 6,149,620; 6,142,992; 5,683,366; 6,105,581; 6.045,532; 6,149,992; 5,681,882, 5,843,109; 6,113,597. Additional patents issued and pending. ArthroCare and Coblator are registered trademarks of ArthroCare Corporation.
- Page 32 34 COBLATOR ® II (RF8000E) SYSTEM User’s Manual...
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