Related Manuals for ArthroCare Quantum RF 12000
Summary of Contents for ArthroCare Quantum RF 12000
- Page 1 ® ArthroCare Quantum™ (RF 12000) System and ® Quantum™ 2 (RF 12000) System ArthroCare User’s Manual...
- Page 2 ® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare...
- Page 3 ® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare...
- Page 4 ® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare 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.
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Page 5: Table Of Contents
® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare Table of Contents Description, Indications for Use, and Contraindication ............7 Description ..........................7 Indications for Use ........................7 Contraindications ......................... 7 System Overview ........................8 Connection Diagram ........................ - Page 6 ® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare Cleaning and Sterilization ......................20 Controller and Foot Control ......................20 Reuseable Patient Cable ......................20 Wand ............................21 Maintenance and Troubleshooting ..................22 Maintenance ..........................
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Page 7: Description, Indications For Use, And Contraindication
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. -
Page 8: System Overview
® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare System Overview Connection Diagram 1. Controller Integrated Cable Wand (ICW) 2. Power Cord Shaft (Wand) 3. Foot Control Return Electrode (Wand) 4. Ablation Pedal 13. -
Page 9: Principle Of Operation
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. -
Page 10: Warnings, Precautions, And Adverse Events
ArthroCare 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. -
Page 11: Adverse Events
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. -
Page 12: Controls, Indicators, And Alarms
® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare Controls, Indicators, and Alarms Controls & Indicators The Quantum (RF 12000) Controller and Quantum 2 System (RF 12000) incorporates the following controls and indicators:... -
Page 13: Alarms
® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare 14. Tan Cable Receptacle The Cable Receptacle with the tan ring will accept the reusable Patient Cable and cable wands with gray mating end. -
Page 14: Diagram Of Controls, Indicators, And Alarms
® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare Diagram of Controls, Indicators, and Alarms... -
Page 15: Unpacking, Assembly, And System Check
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. -
Page 16: Instructions For Use
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. -
Page 17: Voltage Outputs
® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare Voltage Outputs 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... -
Page 18: System Preparation And Care
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. -
Page 19: Wand Selection
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%. -
Page 20: Cleaning And Sterilization
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. -
Page 21: Wand
® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare Cleaning and Sterilization (Cont.) CAUTION: The recommended sterilization parameters are only valid with sterilization equipment that is properly maintained and calibrated. CAUTION: To ensure adequate sterilization, make sure that the protective caps do not cover the cable connectors during sterilization. -
Page 22: Maintenance And Troubleshooting
Controller and contact Customer Service. Troubleshooting Guide If you are experiencing problems with the ArthroCare Quantum (RF 12000) System or ArthroCare Quantum 2 (RF 12000) System, you may want to use the following troubleshooting guide to help identify or eliminate the problem before contacting Customer Service: ... - Page 23 A dual tone alarm sounds and a red warning light illuminates when the Wand is activated. This is a safety feature of the ArthroCare Quantum (RF 12000) System and ArthroCare Quantum 2 (RF 12000) System and may occur if the Wand is activated for an extended period of time without contacting tissue.
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Page 24: Error Messages
® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare Error Messages Fault/Error Fault Description LCD Message Error Both CUT/COAG buttons pressed E1: Cut and Coag simultaneously simultaneously activated Error Wand disconnected while RF active... -
Page 25: Product Specifications
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 (ArthroCare Quantum 2 System only) Temperature range……………………………………………………………………..20 to 60°C Temperature resolution…………………………………………………………………………1°C Calibrated accuracy……………………………………………………………………………±3°C Foot Control and Hand Control Cable Length …………………………………………………………….4.7 m (15 ft.) -
Page 26: Controller Output Graphs
® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare Controller Output Graphs The Output Power at each specified set point is shown for the tan patient cable receptacle of the instrument in the graph below. The used load was 248 Ohms for all set points, except set point nine, where the resistance used was 219 Ohms (per IEC/EN 60601-2-2, subclause 6.8.3). - Page 27 ® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare 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 below: Half Power...
- Page 28 ® Quantum™ (RF 12000) System and ArthroCare User‟s Manual ® Quantum™ 2 (RF 12000) System ArthroCare C - 1 C - 2 Set Point Output Voltage vs. Set Point, Tan and Black Patient Cable Receptacle...
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Page 29: Controller Classification And Safety Verification
Leakage current……………………………………………..100A at 100-120/220-240 V~, 50/60 Hz isolated patient connections Leakage current…………………………………………….500A at 100-120/220-240 V~, 50/60 Hz non patient applied parts If the System fails to meet the specifications listed above, please contact ArthroCare Customer Service for a return merchandise authorization. -
Page 30: Parts List
Customer Service Warranty Information The ArthroCare Quantum (RF 12000) Controller, ArthroCare Quantum 2 (RF 12000) Controller, and Foot Control are warranted for one year and the warranty for the reusable Patient Cable extends for a period of 90 days 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. -
Page 31: Symbols Key
CAUTION: Federal (U.S.A) law restricts this device to sale by or on the order of a physician. Rx only The ArthroCare Quantum System and ArthroCare Quantum 2 System are covered by the following U.S. Patents: 5,697,909; 5,697,281; 5,697,536; 5,697,882; 5,683,366; 5,681,282; 5,766,153; 5,810,764;... - Page 32 ©2009-2010 Copyright ArthroCare Corporation. All rights reserved. No part of this manual may be reproduced in any form, or by any electronic or mechanical means, without permission in writing from ArthroCare Corporation. P/N 18838 Rev. G Aug 2010...
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