ArthroCare Quantum RF 12000 User manual

1
ArthroCare®Quantum™ (RF 12000) System
Service Manual
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.
High frequency surgical unit with respect to electrical shock, fire and mechanical hazards only in accordance with:
IEC/EN 60601-1/CAN/CSAC22.2 No. 601.1, and IEC/EN 60601-2-2.

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

3
ArthroCare®Quantum™ (RF 12000) System
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 ElectrosurgicalAnalyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Power Output for Quantum System in Ablation and Coagulation Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Customer Service ...........................................................................25
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Product Complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Symbols Key ...............................................................................26

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

5
ArthroCare®Quantum™ (RF 12000) System
Service Manual
Introduction
TheArthroCare®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, sterileArthroWand®.
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 theArthoCare Customer Service Department.

6ArthroCare®Quantum™ (RF 12000) System
Service Manual

7
ArthroCare®Quantum™ (RF 12000) System
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-useArthroWands. 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.
Asingle 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 Output voltage at tan receptacle Output voltage at black receptacle
(Vrms ± 10%) (Vrms ±10%)
0 0 0
1100 100
2 126 126
3 154 154
4 180 180
5 207 207
6234 234
7260 260
8 287 287
9 314 314
10 NA 320
Coag 0 0 0
Coag 1 65 65
Coag 2 100 100

8ArthroCare®Quantum™ (RF 12000) System
Service Manual

9
ArthroCare®Quantum™ (RF 12000) System
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).

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 theAC 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 theAD 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.
•TheAD 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. Avariety of different audio tones are associated with these safety-
monitoring circuits as well as with the normal operations of the system.
10 ArthroCare®Quantum™ (RF 12000) System
Service Manual