COBLATOR® II (RF80000E) SYSTEM 3

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.
4 COBLATOR® II (RF8000E) SYSTEM
User’s Manual
 COBLATOR® II (RF80000E) SYSTEM 5
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
6 COBLATOR® 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
 COBLATOR® II (RF80000E) SYSTEM 7
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.
8 COBLATOR® II (RF8000E) SYSTEM
User’s Manual

System Overview

Connection Diagram

16

15

4 5

12

10
13

11

14

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

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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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‡ $ FFHVVRU\WLSVPD\UHPDLQKRWHQRXJKWRFDXVHEXUQVDIWHUWKHHOHFWURVXUJLFDOFXUUHQWLVGHDFWLYDWHG
‡ ,QDGYHUWHQWDFWLYDWLRQRUPRYHPHQWRI:DQGVRXWVLGHWKHILHOGRIYLVLRQPD\UHVXOWLQLQMXU\WRWKHSDWLHQW
‡ / RFDOL]HGEXUQVWRWKHSDWLHQWRUSK\VLFLDQPD\UHVXOWIURPHOHFWURVXUJLFDOFXUUHQWFDUULHGWKURXJKRWKHU
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.
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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.
 COBLATOR® II (RF80000E) SYSTEM 11
User’s Manual

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

ENGLISH
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. 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.

Alarms
1. Intermittent dual tone: current limit alarm or overload
2. Intermittent monotone: connection fault alarm (Wand cable)
14 COBLATOR® II (RF8000E) SYSTEM
User’s Manual

Diagram of Controls, Indicators, and Alarms

240V - T4A 250V

22
 COBLATOR® II (RF80000E) SYSTEM 15
User’s Manual

ENGLISH
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.

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.
16 COBLATOR® II (RF8000E) SYSTEM
User’s Manual

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:
    
&    
       

Pressing the Coblate/Ablate Activation function operates the Controller’s normal Coblate mode and
will activate the Wand(s).
               

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

    

       '    


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

ENGLISH
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 Output Voltage Display Output Voltage
(Vrms ±10%) (Vrms ±10%)
1 100 1 65
2 127.5 2 70
3 155 3 75
4 182.5 4 81
5 210 5 87
6 237.5 6 93
7 265 7 100
8 290 8 108
9 300 9 115

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.
18 COBLATOR® II (RF8000E) SYSTEM
User’s Manual

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.
%  "  (

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

ENGLISH
System Preparation and Care (Cont.)
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.
%  "  (

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.
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. Follow
manufacturer guidelines for concentration and length of exposure.

Wand
 )
      
 
   %  "  


 
    *

 

The Wand is supplied sterile. The Wand is intended

 

 

       
                   
    

    
  '  
  

 )
   
+   

  
   
            
  
        



Please refer to the

Instructions for Use associated with each Wand type for specific information concerning Wand use.
 COBLATOR® II (RF80000E) SYSTEM 21
User’s Manual

ENGLISH
Maintenance and Troubleshooting

Maintenance
Other than fuse replacement, the Controller has no user-serviceable parts. It is designed to provide consistent
output levels and is calibrated by clock crystals, voltage references, and fixed resistors. There are NO internal
adjustments in the instrument and, due to the integrated calibration methods, no annual maintenance check is
required. There is NO software incorporated in the Coblator II (RF8000E) System Controller. If any component
malfunctions, call Customer Service for a return authorization. A service manual is available upon request.

Fuse Replacement
The fuse holder is located on the back of the Controller. To replace a fuse, turn off the power to the Controller
and unplug the power cord from the power outlet at the rear of the Controller. After waiting at least 10 seconds for
internal circuitry to discharge, use a screwdriver or similar tool to remove the fuse holder by depressing the locking
tabs. Replace both fuses with ArthroCare part number 08549 for systems rated for 100-120VAC operation, or with
ArthroCare part number 08548 for systems rated for 220-240VAC operation. Replace both fuses with the same type
and rating as specified on the rear panel of the Controller. Reinsert the fuse holder until the locking tabs snap into
place. Reconnect the power cord and restore power to the Controller. If a fuse fails again, disconnect all power to
the 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:
‡ 
  )
 
  
     
    
 
  
         
 


Check that the Power Cord is properly connected to the Controller and plugged into an appropriately grounded
outlet. If the unit is plugged in properly, check if the fuses have blown. To change the fuses, follow the
instructions for Fuse Replacement.
‡
)


-           
 
             
         

Check that the Foot Control is properly connected to the Controller and that the cord is not nicked, cut or frayed.
Do not use the Foot Control if the cord has been damaged.
‡ *UHHQ:DQG&RQQHFWHG,QGLFDWRUOLJKWGRHVQRWLOOXPLQDWHZKHQD:DQGLVFRQQHFWHG
)
  
      


Make sure that the Wand is properly connected to the Controller. If the problem persists, first change the Wand.
If the Wand indicator light is still not illuminated, please return the System for service.
22 COBLATOR® II (RF8000E) SYSTEM
User’s Manual

Maintenance and Troubleshooting (Cont.)

‡ 1RWKLQJKDSSHQVZKHQRQHRIWKHGHYLFHDFWLYDWLRQIXQFWLRQVRQWKH)RRW&RQWUROLV
)

 
 


Verify that the correct Foot Control pedal has been depressed. Verify that both the Foot Control Connected
Indicator light and the Wand Connected Indicator light are illuminated when the Foot Control is depressed. Check
if the voltage level has been adjusted to a level appropriate for operation (usually 1 or greater). Confirm that the
Wand tip and shaft are covered by a conductive irrigant. Make sure that the Wand is properly connected to the
Controller. If the problem persists, first replace the Wand. If the System still fails to operate, return for service.
‡ 7KH:DQGGRHVQRWDFWLYDWHDQLQWHUPLWWHQWPRQRWRQHDODUPVRXQGVDQGDUHGZDUQLQJ
)
          


This generally indicates a connection problem. It is possible that the Wand is not properly connected to the
Controller. Check all connections. If the alarm continues to sound when the Foot Control is depressed, first
replace the Wand. Return the System for service if the problem continues.
‡ $GXDOWRQHDODUPVRXQGVDQGDUHGZDUQLQJOLJKWLOOXPLQDWHVZKHQWKH:DQGLV
)
    


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. Make sure that the Wand is in good contact with the target tissue, and depress
the Foot Control again. If the alarm continues to sound, first replace the Wand. If the problem persists, return
the System for service.
‡ $JUHHQ)ORZ&RQWURO$FWLYDWLRQ,QGLFDWRULVEOLQNLQJLQWHUPLWWHQWO\ZKHQWKH)RRW
)
     
                
   
 
 


If Foot Control Coagulation, Ablation pedals are depressed while Flow Control Valve Unit is damaged or not
connected to the Controller, the green Flow Control Activation Indicator will blink intermittently. Check for damage
to the Flow Control Cable and for proper connection between the Controller and the Flow Control Valve. If the
problem persists, return the System for service.
 COBLATOR® II (RF80000E) SYSTEM 23
User’s Manual

ENGLISH
Product Specifications

Technical Specifications
      


Input Power Requirements

Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100-120, 220-240 VAC
Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 / 60 Hz
RMS Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 / 4 Amps
Fuse Rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100-120 VAC: T8Amps 250V
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .220-240 VAC: T4Amps 250V
        


Fundamental Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 kHz

Voltage Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-300 Vrms @100 kHz
Max. Output Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . :#ȍ

Operating Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10° C to 40° C

      
  
   

Weight (max). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . <10 kg

Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 cm (5.25 inches.)
Width. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 cm (1.4 ft.)
Length. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 cm (1.45 ft.)
-         

Foot Control Cable Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.7 m (15.5 ft.)

#
-           
    
   

Weight (max). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1kg (2.2 lbs.)

Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.9 cm (3.5 inches)
Width. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.8 cm (4.3 inches)
Length. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 cm (8.7 inches)
-            

Overall Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.5 m (14.7 ft.)

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:
Power Watts (rms)

Set Point
Output Power vs. Set Point at 250 Ohms Resistive Load, Coblate
Power Watts (rms)

Set Point

Output Power vs. Set Point at 250 Ohms Resistive Load, Coagulation
 COBLATOR® II (RF80000E) SYSTEM 25
User’s Manual

ENGLISH
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

Power Watts (rms)

Load Resistance, Ohms

Output Power vs. Load Resistance, Coblate

Full Power Half Power

Power Watts (rms)

Load Resistance, Ohms

Output Power vs. Load Resistance, Coagulation

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

The open circuit voltage for each set point is given in the graphs below:
Open Circuit Voltage (V rms)

Set Point
Open Circuit Voltage Measurements, Coblate
Open Circuit Voltage (V rms)

Set Point
Open Circuit Voltage Measurements, Coagulation
 COBLATOR® II (RF80000E) SYSTEM 27
User’s Manual

ENGLISH
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 Electromagnetic Environment -
Guidance
RF Emissions CISPR 11 Group 1 The Coblator II (RF8000E) System
uses RF energy only for its internal
function. Therefore, its RF emis-
sions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF Emissions CISPR 11 Class A The Coblator II (RF8000E) System
Harmonic Emissions IEC 61000-3-2 Class A is suitable for use in all establish-
ments other than domestic and those
Voltage Fluctuations/Flicker Complies
directly connected to the public
Emissions IEC 61000-3-3
low-voltage power network that sup-
plies buildings used for domestic
purposes.
28 COBLATOR® II (RF8000E) SYSTEM
User’s Manual


 
     
        

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 Compliance Level Electromagnetic
Environment - Guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood,
discharge (ESD) ± 8 kV air ± 8 kV air concrete or ceramic tile.
IEC 61000-4-2 If floors are covered with
synthetic material, the rela-
tive humidity should be at
least 30 %.
Electrical fast ± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should
transient/burst ± 1 kV for input/output lines ± 1 kV for input/output lines be that of a typical com-
IEC 61000-4-4 mercial or hospital environ-
ment.
Surge IEC ± 1 kV line(s) to line(s) ±1 kV line(s) to line(s) Mains power quality should
61000-4-5 ± 2 kV line(s) to earth ± 2 kV line(s) to earth be that of a typical com-
mercial or hospital environ-
ment.
Voltage dips, <5 % T . <5 % T . Mains power quality should
short interrup- (>95 % dip in T) for 0,5 cycle
. (>95 % dip in T) for 0,5 cycle . be that of a typical commer-
tions and volt- cial or hospital environment.
40 % T 40 % T
age variations If the user of the Coblator II
. .

(60 % dip in T) for 5 cycles (60 % dip in T) for 5 cycles

on power supply (RF8000E) System requires
. .

input lines IEC 70 % T. 70 % T . continued operation during

61000-4-11 (30 % dip in T) for 25 cycles
. (30 % dip in T) for 25 cycles . power mains interruptions,
it is recommended that
<5 % T <5 % T
the Coblator II (RF8000E)
. .

(>95 % dip in T) for 5 s (>95 % dip in T) for 5 s

System be powered from
. .

an uninterruptible power
supply or a battery.
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 Hz) mag- fields should be at levels
netic field IEC characteristic of a typical
61000-4-8 location in a typical com-
mercial or hospital environ-
ment.
NOTE T is the a.c. mains voltage prior to application of the test level.
.
 COBLATOR® II (RF80000E) SYSTEM 29
User’s Manual

ENGLISH

 
     
        

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 Compliance Electromagnetic
Test Test Level Level Environment - Guidance
Portable and mobile RF communications equipment should be used
no closer to any part of the Coblator II (RF8000E) System, including
cables, than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted 3 Vrms 150 3V
G ¥
RF IEC kHz to 80
/

61000-4-6 MHz G ¥ / 80 MHz to 800 MHz

Radiated 3 V/m 80 G ¥ / 800 MHz to 2,5 GHz
RF IEC MHz to 2,5 3 V/m
Where is the maximum output power rating of the transmitter in
61000-4-3 GHz
/

watts (W) according to the transmitter manufacturer and d is the rec-

ommended separateion distance in meters (m).
Field strengths from fixed RF transmitters as determined by an elec-
tromagnetic site surveya, should be less than the compliance level in
each frequency range.b

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 Coblator II (RF8000E) System is
used exceeds the applicable RF compliance level above, the Coblator II (RF8000E) System should be observed to
verify normal operation. IF abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the Coblator II (RF8000E) System.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
30 COBLATOR® II (RF8000E) SYSTEM
User’s Manual


0
   


        
 1
 

     
 !    
0 -

 
            2    
  
         3 0 - 4 5 5 5  6  


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.
Rated Maximum Separation Distance According to Frequency of Transmitter (m)
Output Power of
Transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
G 9¥ / G (¥ / G (¥ /

0,01 0,12 0,12 0,23

0,1 0,37 0,37 0,74
1 1,2 1,2 2,3
10 3,7 3,7 7,4
100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance in 7

metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where is the /

maximum output power rating the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.
 COBLATOR® II (RF80000E) SYSTEM 31
User’s Manual

ENGLISH
Controller Classification and Safety Verification

Classification
According to IEC/EN 60601-2-2, Specification for High Frequency Surgical Equipment, the Controller is classified as
follows:

‡ 7
 \SHRISURWHFWLRQDJDLQVWHOHFWULFDOVKRFN
Class I equipment.
‡ '
 HJUHHRISURWHFWLRQDJDLQVWHOHFWULFDOVKRFN
Defibrillation proof, type BF (Isolating/floating).
‡ '
 HJUHHRISURWHFWLRQDJDLQVWKDUPIXOLQJUHVVRIZDWHU
- Controller meets requirements of IEC/EN 60601-2-2, subclause 44.6.
- Foot Control meets requirements of IEC/EN 60601-2-2, subclause 44.6, watertight construction (IPX8).
‡ (
 TXLSPHQWQRWVXLWDEOHIRUXVHLQWKHSUHVHQFHRIDIODPPDEOHDQHVWKHWLFPL[WXUH
‡ 0
 RGHRIRSHUDWLRQFDSDEOHRIFRQWLQXRXVRSHUDWLRQ

Safety Verification
The Coblator II (RF8000E) System meets the requirements of UL 60601-1, IEC/EN 60601-1, IEC/EN 60601-1-2,
IEC/EN 60601-2-2, CSA C22.2 No. 601.1, IEC/EN 60601-2-18. It is recommended that the biomedical engineering
department test the System to ensure that it meets the following leakage levels.

‡ / HDNDJHFXUUHQW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ”—$DW9$&+]
isolated patient connections
‡ / HDNDJHFXUUHQW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ”—$DW9$&+]
non patient applied parts

If the System fails to meet the following specifications, please contact ArthroCare Customer Service for a return
merchandise authorization.
32 COBLATOR® II (RF8000E) SYSTEM
User’s Manual

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.

Product Complaints
All questions or concerns related to the quality, reliability and/or durability of this product should be directed to
Customer Service or an authorized ArthroCare representative. Please contact Customer Service or an authorized
ArthroCare representative for a return authorization.
!      


ArthroCare Corporation
7000 West William Cannon Drive
Austin, TX 78735 U.S.A.
Toll Free: (800) 797-6520 (Customer Service)
www.arthrocare.com
      *
     
0
 

   

ArthroCare UK Ltd.
St. James Business Park
9 Grimbald Crag Court
Knaresborough, North Yorkshire
HG5 8QB, United Kingdom
Tel: +44 (0) 1423 888806
 COBLATOR® II (RF80000E) SYSTEM 33
User’s Manual

ENGLISH
Symbols Key
Caution, Consult accompanying documents/Caution
Date of Manufacture
Coagulation
Coblate/Ablate
Wand Connected
Foot Control/Hand Switch Connected
Defibrillator-Proof Type BF Equipment
Fuse Rating
Non-Ionizing Radiation
Tone Volume Control
Fragile, Handle with Care
Temperature Limitations
Keep Dry
Equipotential Ground
Manufacturer
EC REP Authorized representative in the European Community
Humidity Range: 10% - 85% R.H. Non-condensing
Coblate Set Point Adjustment
AC Voltage
Irrigant Delivery
Do not dispose in waste container
CE mark and Identification number of Notified Body. The product meets the essential requirements of
Medical Device Directive (93/42/EEC).
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
 
"
      
 % "          3 0 - 4 5 5 5  6  


is covered by the following 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.
34 COBLATOR® II (RF8000E) SYSTEM
User’s Manual