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ArthroCare

Quantum

™ (RF 12000) System and

ArthroCare

Quantum™ 2 (RF 12000) System

User’s Manual

Содержание Quantum RF 12000

Страница 1: ...ArthroCare Quantum RF 12000 System and ArthroCare Quantum 2 RF 12000 System User s Manual ...

Страница 2: ...ArthroCare Quantum RF 12000 System and 2 ArthroCare Quantum 2 RF 12000 System User s Manual ...

Страница 3: ...ArthroCare Quantum RF 12000 System and 3 ArthroCare Quantum 2 RF 12000 System User s Manual ...

Страница 4: ...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 fro...

Страница 5: ... Adverse Events 10 Warning 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 P...

Страница 6: ...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 ...

Страница 7: ...able 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...

Страница 8: ...tion Pedal 13 Active Electrode Tip Wand 5 Coagulation Pedal 14 Irrigation Tube optional on Wand Style 6 Set Point Adjustment Button 15 Wand 7 Foot Control Connector 16 Handle Wand 8 Patient Cable optional 17 Suction Tube optional on Wand Style 9a Patient Cable Connector 18 Integrated Finger Switch Wand 9b Cable Connector with Gray Plug 19 Wireless Foot Control transmitter 9c Cable Connector with B...

Страница 9: ...eated 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 oper...

Страница 10: ...turn 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 med...

Страница 11: ...ended 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 func...

Страница 12: ...t 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 d...

Страница 13: ...ceptacle 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 ...

Страница 14: ...ArthroCare Quantum RF 12000 System and 14 ArthroCare Quantum 2 RF 12000 System User s Manual Diagram of Controls Indicators and Alarms ...

Страница 15: ...ess 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 ...

Страница 16: ...ate 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...

Страница 17: ...est 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 ...

Страница 18: ... 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 steriliz...

Страница 19: ... 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 hP...

Страница 20: ...own 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 a...

Страница 21: ... do not cover the cable connectors during sterilization CAUTION Make sure Cable is thoroughly DRY before use Wet Cable may damage the Cable and Controller Wand The Wand is supplied sterile The Wand is intended for single use only DO NOT clean resterilize or reuse the Wand as this may result in product malfunction failure or patient injury which may also expose the patient to the risk of transmitte...

Страница 22: ...ystem does not power up after the power switch is pressed 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 System powers up and controller is unresponsive There are some controller self tests that are pe...

Страница 23: ...arning light illuminates This generally indicates a connection problem Either the Wand is not fully seated in the Patient Cable or the Patient Cable is not properly connected to the Controller Check all connections If the alarm continues to sound when the Foot Control or the Hand Control button or Wand s integrated finger switch is depressed first replace the Patient Cable and then the Wand Return...

Страница 24: ...ed wand detected E7 Wand error Error Controller powered on with re used wand E8 Wand error Fault Integrity of stored program compromised calculated CRC differs from loaded value F1 Hardware failure Fault Integrity of RAM space compromised RAM test failed No LCD message can be displayed Fault COP watchdog timer not strobed F3 Hardware failure Fault Output of the DC DC converter out of specification...

Страница 25: ...put Power Fundamental Frequency 100 kHz Voltage Range 0 320 Vrms 100 kHz Max Output Power 400 W 217 Operating Temperature 10 C to 40 C Controller Dimensions 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 ...

Страница 26: ...00 250 300 350 400 C 1 C 2 1 2 3 4 5 6 7 8 9 Set Point Output Power Wrms Output Power vs Set Point at 248 Ohms Resistive Load Tan Patient Cable Receptacle The Output Power at each specified set point is shown for the black patient cable receptacle of the instrument in the graph below The load used was 200 Ohms for all set points except set point nine where the resistance used was 217 Ohms per IEC ...

Страница 27: ... Receptacle Note at 50 Ohms full power setting of the black patient cable receptacle the current limiting circuit of the instrument suppressed the output and thus the output power registered a low value The following plot illustrates the relationship between instrument set points and output RMS voltage 0 50 0 100 150 200 250 300 350 400 0 200 400 600 800 1000 1200 Load Resistance Ohms Power Wrms H...

Страница 28: ...2000 System and 28 ArthroCare Quantum 2 RF 12000 System User s Manual 0 50 100 150 200 250 300 350 C 1 C 2 1 2 3 4 5 6 7 8 9 10 Set Point Output Voltage Vrms Output Voltage vs Set Point Tan and Black Patient Cable Receptacle ...

Страница 29: ...44 6 watertight construction IPX8 Equipment not suitable for use in the presence of a flammable anesthetic mixture Mode of operation capable of continuous operation Safety Verification The ArthroCare Quantum RF 12000 System and ArthroCare Quantum 2 RF 12000 meet the requirements of IEC EN 60601 1 IEC EN 60601 1 2 IEC EN 60601 1 4 IEC EN 60601 2 2 CSA 22 2 No 601 1 and IEC EN 60601 2 18 It is recom...

Страница 30: ...riginal 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 C...

Страница 31: ...ste container Timer Temperature measurement in degrees Celsius Humidity Range 10 85 R H Non condensing CE mark and Identification number of Notified Body The product meets the essential requirements of Medical Device Directive 93 42 EEC Rx only CAUTION Federal U S A law restricts this device to sale by or on the order of a physician The ArthroCare Quantum System and ArthroCare Quantum 2 System are...

Страница 32: ...t 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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