Quantum and Quantum 2 System (RF12000) Users Manual Rev D March 2014

2 ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System User’s Manual

ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System 3 User’s Manual

High frequency surgical unit with respect to electrical shock, fire and mechanical hazards only in accordance with: IEC/EN 60601-1/CAN/CSA C22.2 No. 601.1, IEC/EN 60601-1-2, IEC/EN 60601-1-4, IEC/EN 60601-2-2, and IEC/ EN 60601-2-18.

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This equipment has been tested and found to comply with the limits for medical devices to IEC/EN 60601-1-2:2001. 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.

4 ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System User’s Manual

ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) 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 ... 11 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 Environmental Requirements ... 19 Equipment Disposal... 19

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Table of Contents

6 ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System User’s Manual

Cleaning and Sterilization... 20 Controller and Foot Control ... 20 Reusable Patient Cable... 20 Wand... 21 Maintenance and Troubleshooting... 22 Maintenance ... 22 Fuse Replacement... 22 Troubleshooting Guide... 22 Error messages... 24 Product Specifications... 25 Technical Specifications ... 25 Controller Output Graphs... 26 Controller Classification and Safety Verification... 29 Classification... 29 Safety Verification... 29 Parts List... 30 Customer Service... 30 Warranty Information... 30 Product Complaints... 30 Symbols Key... 31

ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System 7 User’s Manual

Description The ArthroCare® Quantum™ System (Model RF 12000) and ArthroCare® Quantum™ 2 System (Model RF 12000) are a bipolar, radiofrequency (RF) electrosurgical system designed for use in arthroscopic and orthopedic procedures. Each System consists of the following components: 1) a bipolar radiofrequency Controller; 2) a reusable, non-sterile Power Cord; 3) a reusable, non-sterile Foot Control; 3a) a reusable, non-sterile wireless Foot Control (optional); 4) a reusable, non-sterile Patient Cable (optional); and 5) a disposable, sterile ArthroWand®. An optional reusable non-sterile Hand Control is also available for use with the System. The Controller is the voltage source that delivers RF energy to the treatment site via a reusable Patient Cable and sterile Wand, or an integrated Cable Wand (ICW), or a sterile Wand/Cable combination. The reusable Patient Cable (optional) is supplied non-sterile and is designed for sterilization prior to use. The sterile disposable Wand is available in various single or multi-electrode configurations and is supplied separately. The Controller is activated by either a reusable Foot Control, or an optional reusable Hand Control, or Wand with Integrated Finger Switches.

Indications for Use The ArthroCare Quantum (RF 12000) System and ArthroCare Quantum 2 System (RF 12000) are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

Contraindications The ArthroCare Quantum (RF 12000) System and ArthroCare Quantum 2 System (RF 12000) are contraindicated in any procedures where a conductive solution is not used. The System is also contraindicated for patients who have cardiac pacemakers or other electronic implants without specific instructions from the manufacturer of the cardiac pacemaker or implant. Please refer to the Wand Instructions for Use for a more comprehensive list of contraindications regarding specific procedures. The controller is not intended to be used with a neutral electrode.

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Description, Indications for Use, and Contraindications

8 ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System User’s Manual

System Overview Connection Diagram

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6 4 9a 9c 3

9b

8 14

11

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1. Controller 2. Power Cord 3. Foot Control 4. Ablation Pedal 5. Coagulation Pedal 6. Set Point Adjustment Button 7. Foot Control Connector 8. Patient Cable (optional) 9a. Patient Cable Connector 9b Cable Connector with Gray Plug 9c. Cable Connector with Black Plug

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12 13

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10. Integrated Cable Wand (ICW) 11. Shaft (Wand) 12. Return Electrode (Wand) 13. Active Electrode Tip (Wand) 14. Irrigation Tube (optional on Wand Style) 15. Wand 16. Handle (Wand) 17. Suction Tube (optional on Wand Style) 18. Integrated Finger Switch Wand 19. Wireless Foot Control transmitter 20. Wireless Foot Control receiver

ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System 9 User’s Manual

The ArthroCare Quantum (RF 12000) Controller and ArthroCare Quantum 2 System (RF 12000) are 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 elements and the return electrode element, both elements or poles located on the Wand itself in a bipolar configuration, providing a localized energy field. The result of this arrangement is controlled energy delivery with minimal collateral tissue damage. The ArthroCare Quantum (RF 12000) System and ArthroCare Quantum 2 System (RF 12000) work by passing RF energy through a conductive solution (such as normal saline or Ringer’s lactate) 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 ablation 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 and monopolar RF systems, thus yielding limited collateral thermal damage to the surrounding untreated tissue. The system can also function when a lower voltage is applied between the active and return electrodes. 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. The appropriate voltage setting will depend on the design of the Wand used, tissue type, and desired tissue effect.

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Principle of Operation

10 ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) 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 ArthroCare Quantum (RF 12000) System and ArthroCare Quantum 2 System (RF 12000). For specific warnings and precautions, please refer to the Wand and the Patient Cable Instructions for Use.

WARNINGS • T  he Quantum (RF 12000) System and Quantum 2 System (RF 12000) are intended for use by healthcare professionals only. The Quantum (RF 12000) System and Quantum 2 System (RF 12000) 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 Quantum (RF 12000) System or Quantum 2 System (RF 12000) or shielding the location. • 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 ArthroCare Quantum (RF 12000) System or ArthroCare Quantum 2 System (RF 12000) 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. • Controller failure could result in an unintended increase in output power.

PRECAUTIONS • P  rior 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 surgery should perform procedures with the ArthroCare Quantum (RF 12000) System or ArthroCare Quantum 2 System (RF 12000). • 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.

ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System 11 User’s Manual

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

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• W  hen not in use, remove the Wand from the surgical site and place away from metallic objects. Wands should remain separated from other electrosurgical equipment to avoid inadvertent electrical coupling between devices. Inadvertent activation may cause injury to patient and/or user or equipment damage. • DO NOT wrap Patient Cable 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 use the Wand as a lever to enlarge surgical site or gain access to tissue. • DO NOT allow fluid to contact any electrical connectors on the Wands, Controller, or Cables during use. • Maintain the lowest Controller Set Point necessary to achieve the desired tissue effect. • Confirm proper activation of the Wand if a Controller Set Point is chosen outside of the selected, default settings. • DO NOT allow patient contact with grounded conductive 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 ArthroCare Quantum (RF 12000) System or ArthroCare Quantum 2 System (RF 12000) 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. 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. • The ArthroCare Quantum (RF 12000) System and ArthroCare Quantum 2 System (RF 12000) are designed to be operated exclusively as a unit. Only use accessories provided by ArthroCare. • ArthroCare fully warrants the safety and efficacy of our devices when used as intended for indications for which they are approved. ArthroCare cannot verify the safety of single use Wands that have been reprocessed or reused. • The Quantum (RF 12000) System and Quantum 2 System (RF 12000) is certified to IEC60601-1-2, class A, and 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 Quantum (RF 12000) System and Quantum 2 System (RF 12000) or the optional wireless Foot Control (P/N H4001-XX). • When endoscopes are used with endoscopically-used accessories, the patient leakage currents may be additive. • DO NOT use controller if the alarms during system check are not audible. • 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.

12 ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System User’s Manual

Controls, Indicators, and Alarms Controls & Indicators The Quantum (RF 12000) Controller and Quantum 2 System (RF 12000) incorporates the following controls and indicators: FRONT PANEL 1. On/Off Switch This switch turns the AC power on and off. When the switch is on,the LCD display on the Controller will be active. This display may remain active for up to 5 seconds following power turn-off. 2. Warning Indicator A red indicator illuminates and an audible signal alarms when a Controller-specific failure or malfunction occurs. 3. Foot Control / Hand Control /Wireless Foot Control Connected Indicator A green Foot Control / Hand Control Connector Indicator will illuminate when a Foot Control or Reusable Hand Control is properly connected. 4. Coagulation Activation Indicator A blue indicator will illuminate when the Foot Control or Hand Control or Wand finger switch Coagulation function is depressed with a Wand attached. 5. Wand Connected Indicator A green Wand Connector Indicator will illuminate when the Patient Cable and the Wand are properly connected. 6. Coagulation Set Point Adjustment Increment and Decrement Arrow buttons control the Coagulation Set Point. Refer to the Instructions for Use section of this manual for the corresponding voltage levels for each setting. 7. Ablation Set Point Adjustment Increment and Decrement Arrow buttons control the Ablation Set Point. The Ablation output adjustment is only enabled on wands where this feature is allowed. The Ablation output level can also be adjusted from the Ablation Set Point Adjustment function on the Foot Control or the Hand Control or the Wand’s integrated finger switch. Refer to the Instructions for Use section of this manual for the corresponding voltage levels for each setting. 8. LCD Display Window This display indicates the output level for ablation and coagulation. Nominal settings will automatically be displayed when the System is powered up with a Wand attached or when a new Wand is connected. When the Controller is turned on, and prior to connection of a Wand, this display will show “Connect Wand”. 9. Ablation Activation Indicator A yellow indicator will illuminate when the Foot Control or Hand Control or Wand finger switch Ablation function is depressed with a Wand attached. 10. Plasma Mode Indicator The Plasma Mode Active Indicator will illuminate when the Ablation output is active and the Quantum (RF 12000) and Quantum 2 (RF 12000) detects that the wand is actively cutting or resecting tissue. 11. Foot Control / Hand Control Receptacle The Foot Control / Hand Control / Wireless Foot Control Receiver plugs into the tan receptacle located on the front of the Controller. 12. 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.

ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System 13 User’s Manual

BACK PANEL 16. Tone Volume Control The Tone Volume Control regulates tone volume. To increase volume, turn the knob clockwise. To reduce volume, turn the knob counterclockwise. 17. Non-Ionizing Radiation Symbol This symbol indicates that this equipment intentionally emits RF energy during activation. 18. 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. 19. Power Cord Receptacle / Fuse Holder The Controller Power Cord plugs into this receptacle. The fuse holder is behind the receptacle. 20. Equipotential Ground Symbol This symbol identifies the conductor that is used to bond the equipment to earth ground. 21. TÜV Nord Classified Mark The TÜV Nord Classified Mark indicates compliance with applicable international IEC 60601 series safety standards. 22. Attention Symbol This symbol alerts the user to read and understand this manual and accompanying instructions before operating the equipment. 23. No Disposal Symbol This symbol indicates that this equipment should not be discarded in any waste container. 24. Serial Communication Port This port allows the Quantum (RF 12000) System and Quantum 2 (RF 12000) to communicate to remote accessory devices, such as arthroscopy pumps, that use the RS-232 serial communication protocol. 25. CE Mark - European Certification Symbol This indicates compliance with the European Commission Medical Device Directive (93/42/EEC). 26. UL Classified Mark The UL Classified Mark indicates compliance with applicable Safety Standards for the United States and Canada by Underwriters Laboratories, Inc. (UL).

Alarms 1. Intermittent dual tone: power limit alarm or overload 2. Intermittent monotone: connection fault alarm (Patient Cable, Wand, Cable Wand, Over Temperature Condition, Over Power Condition)

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13. Black Cable Receptacle The Cable Receptacle with the black ring will accept cable wands with black mating end. 14. Tan Cable Receptacle The Cable Receptacle with the tan ring will accept the reusable Patient Cable and cable wands with gray mating end. 15. Sliding Door This door slides left and right and allows access to either the Black Cable Receptacle or the Tan Cable Receptacle.

14 ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System User’s Manual

Diagram of Controls, Indicators, and Alarms

ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) 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 alternate 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’ position. The system should go through a Power On Self Test routine, and the ArthroCare logo and software version number should be displayed. During this sequence, verify that the displays and indicator lights are properly working and that the warning alarm is audible. The Display should indicate “Connect Wand”. If the display indicates “PRESS ANY BUTTON”, press the yellow or blue set point adjustment keys on the front of the controller or press the foot pedal adjustment button to return controller to standby mode. 3. Attach the Foot Control or Hand Control or Wireless Foot Control Receiver to the tan receptacle on the front of the Controller. The Foot Control / Hand Control / Wireless Foot Control Connected Indicator on the front panel of the Controller should illuminate. 4. Depress the Ablation function on the Foot Control or the Hand Control. The red Warning Indicator on the front panel of the Controller should illuminate and the Controller should emit an intermittent monotone alarm. The yellow Ablation Activation Indicator on the front panel should be off. CAUTION: DO NOT use controller if the alarms during system check are not audible. NOTE: Use only the Foot Control authorized by ArthroCare for use with Quantum (RF 12000) System. 5. Attach Patient Cable and Wand or Integrated Cable Wand to appropriate cable receptacle (tan receptacle for tan connector Wands and black receptacle for black connector Wands).The green Wand Indicator should illuminate. See System Preparation and Care section of this manual for additional information. CAUTION: DO NOT contact metal objects with an activated Wand. CAUTION: DO NOT place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). CAUTION: Electrosurgical accessories, which are activated or hot from use, can cause a fire. CAUTION: Accessory tips may remain hot enough to cause burns after the electrosurgical current is deactivated.  CAUTION: Localized burns to the patient or physician may result from electrosurgical current carried through other instruments and conductive objects. 6. Taking care not to touch the Wand end, depress the Ablation (yellow) pedal of the Foot Control or button on the Hand Control or Wand’s integrated finger switch. The yellow Ablation Activation Indicator should illuminate. If the Controller does not function as described above, please contact Customer Service immediately.

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Unpacking, Assembly, and System Check

16 ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) 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 orthopedic procedures. Additional training on the use of the ArthroCare Quantum (RF 12000) System and ArthroCare Quantum 2 (RF 12000) from an ArthroCare representative is recommended.

General System Operation Wands are activated using either the Foot Control or the Hand Control or the Wand’s integrated finger switch. Depending on the type of Wand that is connected, the RF will either be activated continuously as long as any of these switches are pressed, or the RF delivery will be limited to a predetermined time interval. The Quantum (RF 12000) System and Quantum 2 (RF 12000) automatically detects Wands that include this feature. When this type of Wand is detected, the system activates the Timer icon on the LCD display to indicate to the operator that the RF delivery time will be automatically limited. Refer to the Wand IFU for further information. The Foot Control, the Hand Control, and the Wand’s integrated finger switch have three functions (ablation, coagulation, and ablation set point adjustment) as described below: Ablation Activation Pressing the Ablation Activation function operates the Controller’s normal ablation mode and will activate the Wand. Coagulation Activation Pressing the coagulation function will activate the Controller’s preset coagulation mode and will activate the Wand for hemostasis of blood vessels. Ablation Set Point Adjustment Pressing the Ablation Set Point Adjustment function will adjust the Ablation voltage level on the Controller. Each time the Ablation Set Point Adjustment function is pressed, the Ablation 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 1. Timer Icon A Wand that limits the RF delivery time to a predetermined value has been connected to the system. NOTE: The Foot Control, the reusable Hand Control, and the Wand with Integrated Finger Switches may be used in the same procedure but cannot be used simultaneously.

Quantum 2 (RF 12000) System Some Wands include an integrated thermocouple that allows the temperature of the irrigating fluid to be monitored during use. These Wands are only to be used with the Quantum 2 (RF 12000) System. The Quantum System automatically detects Wands that include this function and enables the temperature display. When these Wands are used, the operator can select a temperature alarm set point by using the COAG adjustment buttons when the system is in the standby mode. During use, if the measured temperature exceeds this set point, an audible and a visual alarm are activated to alert the operator. Refer to the Wand IFU for more information on this feature. Wands with the Ambient™ feature are not compatible with other controllers including Quantum (RF 12000) controllers. Temperature Monitor Display A Wand that includes the temperature monitor feature has been connected to the Quantum 2 (RF 12000) System. An audible and a visual alarm are activated if the measured irrigation temperature exceeds the alarm set point.

ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System 17 User’s Manual

The voltage outputs correspond to the Ablate or Coag Set Points as listed in the Table below. Depending on the particular Patient Cable in use, the display corresponds to the output voltage in open circuit as follows: Tan Patient Cable Receptacle Display Output Voltage (Vrms ±10%) 1 100 2 126 3 154 4 180 5 207 6 234 7 260 8 287 9 314 10 Not Allowed Coag 0 0 Coag 1 65 Coag 2 100

Black Patient Cable Receptacle Display Output Voltage (Vrms ±10%) 1 100 2 126 3 154 4 180 5 207 6 234 7 260 8 287 9 314 10 320 Coag 0 0 Coag 1 65 Coag 2 100

When the Controller is first powered on with no Wand attached, after the self tests are completed, a “Connect Wand” message will be displayed on the controller front panel. If a Wand is attached at power-up, the Controller will display “Press any key”. After a wand is connected or a key pressed, the output levels will be set automatically by the system to the default values for the particular Wand. These settings will usually provide the best effect in most situations. Press any key on the controller front panel or the set point adjustment button on the Foot Control or Hand Control or the Wand’s integrated finger switch to adjust the display to the nominal settings. NOTE: If a Set Point is selected outside of the default range (between the initial Set Point and maximum Set Point), proper activation of the Wand should be confirmed. Once a Wand has been properly connected, the Ablation or Coagulation voltage level can be increased or decreased by pressing the voltage level adjustment button located on the front panel. Ablation level can also be adjusted by pressing the Ablation set point adjustment function on the Foot Control or the Hand Control or the Wand’s integrated finger switch. The ablation setting levels may be adjusted to levels throughout the appropriate range, depending on the maximum voltage permitted by the particular Wand in use. In general, the higher set point values will result in more aggressive tissue ablation, low set point values (e.g. 1 or 2) will result in the Wand maintaining a resistive heating mode. Wands also have adjustable coagulation functionality which can be adjusted using coagulation set point buttons on the controller front panel. Nominal coag is “1” and enhanced coag is “2”.

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Voltage Outputs

18 ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System User’s Manual

System Preparation and Care System Preparation 1. Prior to each use, inspect the ArthroCare Quantum (RF 12000) System or ArthroCare Quantum 2 (RF12000) System for possible damage to the Controller Casing 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 system should go through a Power On Self Test routine, and the ArthroCare logo and software version number should be displayed. During this sequence, verify that the displays and indicator lights are properly working and that the warning alarm is audible. The LCD should indicate “Connect Wand”. 4. Connect the Foot Control or the reusable Hand Control or wireless Foot Control Receiver to the Foot Control / Hand Control Receptacle on the front of the Controller. The Foot Control / Hand Control Connected Indicator (green) on the Controller front panel will illuminate. 5. a. If using the reusable Patient Cable, ensure that the Patient Cable has been cleaned and sterilized and that the connectors are DRY before use. Slide the sliding door to the right and connect the Patient Cable to the tan Receptacle on the front of the Controller. Connect the appropriate Wand to the other end of the Patient Cable. NOTE: If sliding door has been removed, contact Customer Service. b. If using an ICW with gray mating or tan end, slide the sliding door to the right and connect the ICW to the Tan Receptacle (27 pin) on the Controller. c. If using an ICW with black mating end, slide the door to the left and connect the ICW to the Black Cable Receptacle (18 pin) on the front of the Controller. NOTE: Refer to each Wand Instructions for Use for specific instructions regarding surgical preparation and procedures. 6. Set appropriate Set Point Display required to obtain desired effects.

ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System 19 User’s Manual

Select the Wand type most appropriate for the procedure. The Quantum (RF 12000) Controller and Quantum 2 (RF 12000) Controller will default to a recommended ablation set point and coagulation set point for each Wand style to serve as a guide for safe and effective operation. NOTE: Initial and maximum Set Points are suggested settings. Proper activation of the Wand should always be confirmed. In order to adjust the ablation set points, the Wand and Patient Cable must be connected to the Controller.

System Shut Down 1. Turn the power switch to the ‘OFF’ ( 0 ) position. After a brief (less than 4 seconds) delay, all lights on the Controller and the Set Point Display will go off. 2. Disconnect the suction tubing if appropriate. 3. If using the reusable Patient Cable, remove the Wand from the Patient Cable and disconnect the Patient Cable from the Controller. Dispose of the Wand and prepare the Patient Cable for sterilization and further use. 4. If using the ArthroWand with Integrated Cable, disconnect the Wand cable connector from the Controller. Do not attempt to separate the ArthroWand from the Cable component. Discard the Wand with Integrated Cable.

System Environmental Requirements All ArthroCare Quantum (RF 12000) System and ArthroCare Quantum 2 (RF 12000) components may be safely stored and transported at an ambient temperature range of -40°C (-40° F) to +70°C (158° F) and atmospheric pressure of 500 hPa (7.2 psi) to 1060 hPa (15.3 psi). The relative humidity should be between 10 and 85%. The ArthroCare Quantum (RF 12000) and ArthroCare Quantum 2 (RF 12000) may be safely operated at an ambient temperature range of +10° C (+50° F) to +40° C (104° F), atmospheric pressure of 700 hPa (10.1 psi) to 1060 hPa (15.3 psi) and relative humidity of 10% to 85%.

Equipment Disposal The ArthroCare Quantum (RF 12000) System and ArthroCare Quantum 2 (RF 12000) contains electronic printed circuit board 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 Quantum (RF 12000) and ArthroCare Quantum 2 (RF 12000) Controller for proper disposal. Dispose of the Wand and the Patient Cable according to normal institutional practices for potentially contaminated items.

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Wand Selection

20 ArthroCare® Quantum™ (RF 12000) System and ArthroCare® Quantum™ 2 (RF 12000) System User’s Manual

Cleaning and Sterilization Surface Cleaning of Controller and Foot Control DO NOT sterilize or immerse in liquid. Wipe clean with a soft cloth and mild detergent as needed. Clean with detergents according to standard practices. Follow manufacturer guidelines for concentration and length of exposure.

Cleaning and Sterilization of Patient Cable The Patient Cable is supplied NON-STERILE. It is reusable if cleaned and sterilized prior to each use. Ensure that a validated and approved steam sterilization process is used during the sterilization process. Surface Cleaning and Disinfection • Before cleaning, secure the protective caps over the Patient Cable connectors to protect them from possible damage. The protective caps should fit snugly over the Patient Cable connector. If the protective caps are loose, check to see if the silicone o-ring is positioned within the groove on the cable connector. Replacement o-rings are available through ArthroCare. The Patient Cable should then be wiped down with a mild, disinfecting detergent solution using a soft brush or sponge to remove any gross contaminants from the Patient Cable. The Patient Cable can be rinsed under running water to remove any cleaning residue. The Patient Cable should not be immersed in water or any other solution. Remove the protective caps from the Patient Cable connectors and inspect the Patient Cable for any damage such as cuts or nicks. Damaged Patient Cable should not be reused. Sterilize the clean Patient Cable by following one of the recommended sterilization methods: Pre-Vacuum Steam Sterilization If the pre-vacuum steam sterilizer has a prefixed cycle, use the “Hard Goods” cycle. If it does not have a prefixed cycle, the following parameters are recommended: • Set temperature at 270-272°F (132-133°C); • Set exposure time for 10 minutes for wrapped Patient Cables; • Set exposure time for 4 minutes for unwrapped Patient Cables; • Set drying time for 5 minutes minimum. Gravity Displacement Steam Sterilization The following parameters are recommended for gravity displacement steam sterilization: • Set temperature at 270-272°F (132-133°C); • Set exposure time to 15 minutes for wrapped or unwrapped Cables; • Set drying time for 8 minutes minimum. Or • Set temperature at 250-254°F (121-123°C); • Set exposure time to 30 minutes for wrapped or unwrapped cables; • Set drying time for 8 minutes.