Quantum Service Manual Rev A Jan 2008

2 ArthroCare® Quantum™ (RF 12000) System Service Manual

ArthroCare® Quantum™ (RF 12000) System 3 Service Manual

TABLE OF CONTENTS Introduction... 5 Functional Description of the Quantum System...7 Board Level Description...9 Main Board...10 Display Board with LCD Display...11 Medical Grade Power Supply...11 Front Panel Overlay...11 Block Diagram for Quantum Controller...13 Inside view of the Quantum Controller...15 System Maintenance and Troubleshooting Guide...16 Maintenance...16 Troubleshooting Guide...16 Technical Specifications...19 Controller Functional Specifications...19 Environmental...19 Dimensions and Weight...19 Controller Measuring Function...19 Safety...19 Warnings, Precautions, and Adverse Events...20 Warnings...20 Precautions...20 Adverse Events...21 Output Test Procedures...22 Output Test for the ArthoCare Quantum Controller...22 Output voltage for Quantum Controller in Ablation and Coagulation Modes...23 Output Test Using an Electrosurgical Analyzer...23 Power Output for Quantum System in Ablation and Coagulation Modes...24 Customer Service...25 Warranty Information...25 Product Complaints...25 Symbols Key...26

4 ArthroCare® Quantum™ (RF 12000) System Service Manual

ArthroCare® Quantum™ (RF 12000) System 5 Service Manual

Introduction

The ArthroCare® Quantum™ (RF 12000) System is a bipolar, radiofrequency (RF) electrosurgical system designed for use in arthroscopic and orthopedic procedures. The 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®.

The Quantum (RF 12000) Controller consists of four main components: the Main Board, Display Board with LCD Display, Medical Grade Power Supply and Front Panel Overlay. This manual will cover each of these components as well as provide the necessary information on calibrating, troubleshooting and performing routine maintenance for the Controller. Observe all warnings and precautions noted in this manual as well as in the Quantum (RF 12000) System User’s Manual. Failure to do so may result in complications with the equipment, or safety hazards to the user or patient. WARNING: All service must be performed by an Authorized Repair Facility. All service or repair questions should be directed to the ArthoCare Customer Service Department.

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ArthroCare® Quantum™ (RF 12000) System 7 Service Manual

Functional Description of the Quantum System

The Quantum (RF 12000) Controller is designed to deliver RF energy to the electrode elements located at the distal end of the sterile single-use ArthroWands. Current flows from the active wand element to the integrated return Wand element, providing a localized energy field. The result of this arrangement is controlled energy delivery with minimal collateral tissue damage. 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 electrode(s). 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 Wand used, tissue type, and desired tissue effect. The Quantum (RF 12000) System provides two output connectors:

• The Cable Receptacle with the tan ring will accept the reusable Patient Cable (27 pin) with a disposable sterile Wand, making it compatible with the ArthroCare System 2000, or Integrated Cable Wand (ICW) with gray mating end. • The Cable Receptacle with the black ring delivers higher power and will accept ICW with black mating end.

A single digit LED output display on the front panel of the Controller indicates the ablation voltage level settings. The table below shows relations between the open circuit output voltage and LED display in ablation and coagulation modes. In coagulation mode, the LED display shows “C”. The Quantum (RF 12000) Controller has a fixed coagulation voltage. Display 0 1 2 3 4 5 6 7 8 9 10 Coag 0 Coag 1 Coag 2

Output voltage at tan receptacle (Vrms ± 10%) 0 100 126 154 180 207 234 260 287 314 NA 0 65 100

Output voltage at black receptacle (Vrms ±10%) 0 100 126 154 180 207 234 260 287 314 320 0 65 100

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ArthroCare® Quantum™ (RF 12000) System 9 Service Manual

Board Level Description

The Quantum (RF 12000) Controller consists of four main components: Main Board, Display Board with LCD Display, Medical Grade Power Supply and the Front Panel Overlay. This section will describe in detail the function of each of these components.

Main Board:

• Provides primary power supply and patient isolation

• Generates a regulated power output of 70-330 Vrms (± 10%) at 100khz.

• Supports the system microcontroller (MCU) that sets the system clock, controls the peripheral components (Front Panel Overlay, Display, Sound, Foot Control, etc.), identifies high power mode and sets the default and maximum value for the type of Wand that is connected. • Over temperature sensing circuitry • Safety alarm circuitry

Display Board with LCD Display: • Provides interface to the LCD Display.

• Provides LED indicators for Foot Control pedal, Wand, coagulation and alarm. • Provides interface to Front Panel Overlay

Medical Grade Power Supply:

• Generates a regulated 12 VDC power output to supply the control circuitry

Front Panel Overlay:

• Houses the Up and Down arrow keys as well as the ablation indicator (Coblation Logo).

10 ArthroCare® Quantum™ (RF 12000) System Service Manual

Main Board

The Main Board produces the 70-320 Vrms (±10%) at 100kHz signal that drives the electrodes at the distal end of the ArthroWands. The nominal Raw + 320 VDC is generated from the 120 VAC or 240 VAC line voltages using automatic line voltage switching (AVS) circuit built around U26. The circuit functions in two ways based on the AC input voltage. For 85 to 149 VAC, the circuit functions as a doubler. At 180 to 249 VAC, the circuit performs as a full-wave bridge rectifier. The patient isolation barrier is created with the following components:

• T1, T2, T3, T4 and T5 current sensing transformers monitor current flowing through the four electrodes and integrated return respectively.

• U1 and U5 digital isolators provide isolation and interface to the Wand via the Handpiece & Cable Unit. These isolators along with the AD converter, U7 determine what type of Wand is connected, the position of the RF control switches and send this information to the MCU via the SPI interface. • U3 temperature monitor measures the temperature of TC enabled Wands and sends this information to the MCU with the SPI interface. • U13 digital isolator isolation to the RS-232 communication port.

• The AD converter, U7 determines if the high power ICW is connected to the Controller. • U12 and U4 provide the isolated +12 V to the RS-232 and Wand recognition circuits.

The nominal Raw + VDC drives a phase-modulated full-bridge switch-mode regulator which is used to provide the necessary voltage output to the Wands. This circuit consists of four MOSFETs (Q14, Q15, Q16, and Q17) configured as a full bridge. Their phase of conduction or overlay is controlled by a phase shift resonant controller (U27). The MCU controls the on/off switching of this circuit by enabling the DC_EN which activates the “over current shutdown” (CS) on U27 via Q12. The output from this full bridge switch mode regulator (+MOD) is applied to the 100kHz inverter circuitry consisting of Q7, Q8, Q9, and Q10. The output from this inverter circuitry drives the output board via T6.

MCU - The MCU provides all necessary clock frequencies used throughout the system including the 100kHz sync signal. The MCU is also responsible for the control of the LCD display and indicator lights on the Display Board, the Up/Down arrow keys on the Front Panel Overlay, and the interface for the Foot Control. The MCU controls the different safety monitoring circuits in the system. This includes the output current limit circuit, over temperature sensing circuit, and detection of the Wand or Foot Control circuit. A variety of different audio tones are associated with these safetymonitoring circuits as well as with the normal operations of the system.

ArthroCare® Quantum™ (RF 12000) System 11 Service Manual

The following table describes each type of audio tone in detail. It includes the type of tone, description, and frequency of the tone.

Type

Description

Set Point tone

Tone when setting voltage level

Interlock tone

Tone when Foot Control pedal is pressed and either Wand or Patient Cable is not connected

Ablation tone Alarm tone

Coagulation tone

Frequency

Tone for normal operation

Continuous tone @ 620Hz

Tone for current limit

Alternating tone 200ms @ 620Hz and 1240Hz

Tone when in Coagulation mode

Single tone, 200ms @ 620Hz

Intermittent tone 200ms @2480 Hz Continuous tone @ 1240Hz

Medical Grade Power Supply

The Medical Grade Power Supply is an off-the-shelf SMPS that converts the 100-240 VAC supply voltage to a regulated 12 VDC output that is used to power the system control circuitry.

Display Board

The Display Board supports the LCD display and the indicator lights for the Foot Control, Wand, ablation, coagulation, and alarm. U1 is the port expander that provides the interface for Up and Down keys as well as the driving capability for the indicator lights for the Foot Control, Wand, ablation (Coblation Swirl Logo), coagulation and alarm. U5 provides the control voltages required to activate the LCD display.

Front Panel Overlay

The Front Panel Overlay is a membrane panel that contains Up and Down arrow keys as well as the indicator lights.

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ArthroCare® Quantum™ (RF 12000) System 13 Service Manual

Block Diagram for Quantum (RF12000) Controller

Power Switch Power Entry Module

Main Board RF Output Stage - 4 kV Isolation

120/240 VAC 50/60 Hz

DC Power Supply

RF Isolation Transformer and Relays

Vmod (20-70VDC)

12 VDC

Bipolar Supply

Bipolar Return

Patient Contacting Parts

Temperature/Probe ID Sense 4 k V Isolation Rectifier and DC-DC SMPS

MCU and Control Logic Control Signals

5 VDC ISO AD Converter

SETPOINT COAG

4kV Isolation

CUT 12/12 VDC Converter

DIG ISO

12/12 VDC Converter

TC PROBE ID1

SPI Digital Isolators

I2C AND 5 VDC Supply RS-232 Display Board and LCD

PROBE ID2

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ArthroCare® Quantum™ (RF 12000) System 15 Service Manual

Inside view of the Quantum (RF 12000) Controller MEDICAL GRADE POWER SUPPLY

COOLING FAN

POWER INLET MODULE

SPEAKER

MAIN BOARD

Front View

FOOTSWITCH CONNECTOR

FRONT PANEL OVERLAY DISPLAY BOARD WITH LCD DISPLAY

18 PIN CONNECTOR 27 PIN CONNECTOR

POWER SWITCH

VOLUME ADJUST KNOB Back View

EQUIPOTENTIAL LUG

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System Maintenance and Troubleshooting Guide Maintenance

The Quantum (RF 12000) Controller has been designed to function with minimal periodic maintenance, inspection, or internal system calibration. Cleaning of the outside surfaces of the Quantum (RF 12000) Controller is recommended in accordance with standard hospital practice. Periodic cleaning of the outside surfaces may be accomplished by using a nonabrasive cleaning detergent. Also, periodic cleaning and inspection of the Power Cord should be performed.

Troubleshooting Guide

This section is designed to aid the trained service technician/engineer in troubleshooting the Quantum (RF 12000) Controller. This section is only designed to troubleshoot to board level.

WARNING: Only trained qualified technicians should perform any repairs on the Quantum (RF 12000) System. Please contact the ArthroCare Corporation Customer Service Department before attempting any repairs on the Quantum (RF 12000) System.

Error Symptom

Corrective Action

Controller does not power up after the power switch is pressed.

1. Power Cord – Check that the Power Cord is plugged in properly to the Controller and into the appropriate outlet. If necessary, replace the Power Cord. 2. In-line fuses – Check that the in-line fuses, located in the rear of the instrument, are not blown. If they are blown, replace with the appropriate value fuse as per the User’s Manual. 3. Main Board – Possible defective Main Board. Replace Main Board.

Green wand LED does not illuminate when a Wand with the Patient Cable or ICW is connected to the UUT.

1. Patient Cable – Check that the Patient Cable is connected correctly. 2. Wand – Possible Wand failure. Change Wand.

3. Patient Cable – Possible defective Patient Cable. Replace Patient Cable. 4. LED – Possible defective LED. Replace Overlay.

ArthroCare® Quantum™ (RF 12000) System 17 Service Manual

Troubleshooting Guide Cont’d Error Symptom

Corrective Action

Green Foot Control LED does not illuminate.

1. Foot Control Connector – Check that the Foot Control is properly connected to the Controller.

2. Foot Control – Possible defective Foot Control. Replace Foot Control.

3. LED – Possible defective LED. Replace Overlay. No Output

1. Foot Control and/or Patient Cable – Check all connections for the Foot Control, Patient Cable and Wand. 2. Wand – Possible Wand failure. Replace Wand. 3. Patient Cable – Possible Patient Cable failure. Replace Patient Cable. 4. Internal Harness Cable – Check that the main harness cable from the Output Board to the front panel Patient Cable connector is connected properly. 5. Main Board – Possible Main Board failure. Replace Main Board.

6. Voltage level set at zero – Make sure that the voltage level is set at a number ≥ 1. Intermittent monotone alarm and the red LED illuminates when Wand is activated

1. Connections – Check all connections to the instrument. Make sure that the activated Wand with the Patient Cable or ICW are seated properly.

2. Wand – Possible Wand failure. Replace Wand. 3. Main Board – Possible Main Board failure. Replace Main Board.

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Troubleshooting Guide Cont’d Error Symptom

Corrective Action

Dual tone alarm and the red LED illuminates when Wand is activated.

1. Safety feature - The warning light of the Quantum (RF 12000) Controller is illuminated when the Wand is activated. The Quantum (RF 12000) Controller is designed to signal this type of alarm when the Wand is activated for an extended period of time without touching tissue. If this occurs, release Foot Control to reset the unit.

2. Wand – Possible Wand failure. Replace Wand.

3. Patient Cable – Possible Patient Cable failure. Replace Patient Cable. Flashing display and indicator lights.

1. Main Board – Main Board failure. Replace Main Board.

ArthroCare® Quantum™ (RF 12000) System 19 Service Manual

Technical Specifications Controller Functional Specifications

Input Voltage...100-120/220-240 V~ Input Frequency...50/60Hz RMS Current...8 / 4 A Maximum Output Power...400W @ 217 Ω Output Frequency...100kHz Output Voltage Range...0-320 Vrms @ 100kHz +/-10%

Environmental

Operating temperature range...10 °C to 40 °C Storage/Transportation temperature range...-40 °C to 70 °C Humidity range...10% to 85% non-condensing Pressure range...500 to 1060 kPa

Dimensions and Weight

Controller: Weight (max)...< 5 kg (< 11 lbs) Height...10.2 cm (4.0 inches) Width...40.6 cm (16.0 inches) Length...40.9 cm (16.1 inches)

Controller Measuring Function

Temperature range...20 to 60°C Temperature resolution...1°C Calibrated accuracy...±3°C

Safety

The Quantum (RF 12000) Controller meets the requirements of IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-4, IEC/EN 60601-2-2, and CSA 22.2 No. 601.1.IEC/EN 60601-2-18. All units are tested to verify that they meet these requirements. These standards include, but are not limited to the following: • Class Type

Class I, Type BF

• Leakage current, non-patient applied parts

≤ 500 µA at 100-120/220-240 V~, 50/60 Hz

• Leakage current, isolated patient connections • Power cord resistance to chassis

≤ 100 µA at 100-120/220-240 V~, 50/60 Hz

≤ 100 mΩ

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Warnings, Precautions, and Adverse Events

The following is a list of Warnings and Precautions that apply to the general operation of the Quantum (RF 12000) System. For specific warnings and precautions, please refer to the Wand and the Patient Cable Instructions for Use.

Warnings

• The RF 12000 System is intended for use by healthcare professionals only. The RF 12000 System 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 RF 12000 System 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 Wand or by the active or return wand 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 Quantum (RF 12000) System with non-conductive media (e.g. sterile water, dextrose, air, gas, glycine, etc.). Use only conductive media such as normal saline or Ringer’s lactate. • Electric Shock Hazard: DO NOT connect wet accessories to the Controller. • Controller failure could result in an unintended increase in output power.

Precautions

• Prior to initial use, ensure that all package inserts, warnings, precautions, and Instructions for Use are read and understood. • Safe and effective electrosurgery is dependent not only on equipment design, but also, to a large extent, on factors under the user’s control. Only persons having adequate training should perform procedures with the Quantum (RF 12000) System. • 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.