ArthroCare COBLATOR II User manual

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

4COBLATOR®II (RF8000E) SYSTEM
User’s Manual

5
COBLATOR®II (RF80000E) SYSTEM
User’s Manual
ENGLISH
Table of Contents
                                                 
. . . . . . . . . . . . . . . . . . . . . . 7
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
             
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Connection Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
                   
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
                                    
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
                            
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Controls & Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Diagram of Controls, Indicators, and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
                              
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Assembly and System Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
                 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Operator Training Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
General System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Voltage Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
                       
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Wand Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
System Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
System Storage and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Equipment Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

6COBLATOR®II (RF8000E) SYSTEM
User’s Manual
                      
.............................................................................................................................. 20
Controller, Flow Control Valve Unit, and Flow Control Cable ..................................................................................... 20
Foot Control............................................................................................................................................................... 20
Wand.......................................................................................................................................................................... 20
!              "             
............................................................................................................. 21
Maintenance .............................................................................................................................................................. 21
Fuse Replacement..................................................................................................................................................... 21
Troubleshooting Guide............................................................................................................................................... 21
                   
.................................................................................................................................... 23
Technical Specifications............................................................................................................................................. 23
Controller Output Graphs........................................................................................................................................... 24
Electromagnetic Environment Specifications ............................................................................................................. 27
                                #           
................................................................................. 31
Classification.............................................................................................................................................................. 31
Safety Verification ...................................................................................................................................................... 31
             
.............................................................................................................................................. 32
Warranty Information.................................................................................................................................................. 32
Product Complaints.................................................................................................................................................... 28
       $  
........................................................................................................................................................ 33

7
COBLATOR®II (RF80000E) SYSTEM
User’s Manual
ENGLISH
Description, Indications for Use, and
Contraindications
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.

8COBLATOR®II (RF8000E) SYSTEM
User’s Manual
6
5
3
4
16
15
10
11
14
13
12
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. Irrigant Tube (Optional on Wand Style)
6. Coblate Set Point Adjustment Button 14. Wand
7. Controller Connectore 15. Flow Control Cable
8. Handle 16. Flow Control Valve Unit
System Overview
Connection Diagram

9
COBLATOR®II (RF80000E) SYSTEM
User’s Manual
ENGLISH
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. 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 high-
energy 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.

10 COBLATOR®II (RF8000E) SYSTEM
User’s Manual
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
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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.
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  %  "
place active accessories near or in contact with flammable materials (such as gauze or
surgical drapes).
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instruments and conductive objects.
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the active or return electrode being in close proximity to a conductive object.
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possibly requiring extended surgery for removal.
 
  %  "
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.
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connect wet accessories to the Controller.
PRECAUTIONS
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understood.
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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).
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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.
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compatibility prior to initiation of the procedure.
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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.

11
COBLATOR®II (RF80000E) SYSTEM
User’s Manual
ENGLISH
 
  %  "
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.
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or other instruments may result in damage to the instrument.
 
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allow fluid to contact any electrical connectors on the Wands, Controller, or Cables during use.
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 
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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.

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contact metal objects with an activated Wand.
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source.
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use flammable agents for cleaning and disinfection of the Controller or Cables.
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the cables to avoid contact with the patient or other electrical leads.
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the operation of other electronic equipment.
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between devices.
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equipment and physiological monitoring equipment are used simultaneously on a patient. Needle Monitoring
electrodes are not recommended.
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remove the cover of the Controller. Refer servicing to qualified personnel.
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obstruct the exhaust fan (located at rear of Controller).
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touch the Controller’s fan and/or speaker while touching the patient.
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power cable plug is properly connected to the Controller receptacle.
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provided by ArthroCare
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is used adjacent to or stacked with other equipment, the system should be verified that it is operating in its intended
configuration.
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use other ArthroCare Foot Controls. Use only the Foot Control provided with the Coblator II
(RF8000E) System.
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necessary to take mitigation measures, such as reorienting or relocating the Controller or shielding the location.
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reuse ArthroCare PlasmaWands that have been designed for single use to avoid failure or
unanticipated performance.

12 COBLATOR®II (RF8000E) SYSTEM
User’s Manual
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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, 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 is properly connected, the Foot Control Connected Indicator will illuminate green.