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Summary of Contents for Arthrex AR-9600
- Page 1 O.P.E.S ORTHOPAEDIC PROCEDURE ELECTROSURGICAL SYSTEM USER’S GUIDE User ’s Guide • O.P.E.S. Electrosurgical Generator...
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Page 2: Equipment Covered In This Manual
18 Yeates Close Thame OX9 3AR UK Made in USA Printed in USA MC-55-065-001 Rev. 5 AR9600 UG ©2005 Arthrex, Inc. All rights reserved. Contents of this publication may not be reproduced without the written permission of Arthrex, Inc. Arthrex, Inc. -
Page 3: Conventions Used In This Guide
Prior to use in a surgical procedure, carefully unpack and inspect the components for any sign of damage, which may have occurred during shipping. If shipping damage is suspected, notify Arthrex or any authorized Arthrex distributor immediately. Any such damage could compromise patient safety. -
Page 4: Table Of Contents
Checking Bipolar Mode (with bipolar footswitch) ............3-3 Checking Monopolar Mode (with monopolar footswitch) ........3-3 Checking Monopolar Mode (with handswitch) ............3-3 Performance Checks.......................3-3 Using the Arthrex O.P.E.S. Electrosurgical Generator .............4-1 Inspecting the Generator and Accessories ..............4-2 Setup Safety........................4-2 Setting Up ........................4-3 Preparing for Monopolar Surgery..................4-4... - Page 5 Maintaining the Arthrex O.P.E.S. Electrosurgical Generator ...........5-1 Cleaning ..........................5-2 Periodic Inspection......................5-2 Fuse Replacement ......................5-2 Troubleshooting........................6-1 Error Codes and Audio Tones .................6-2 Repair Policy and Procedures .....................7-1 Responsibility of the Manufacturer..................7-2 Returning the Generator for Service ................7-2 Step 1 – Obtain a Returned Authorization Number ..........7-2 Step 2 –...
- Page 6 Figure A – 4 Output power versus impedance for Blend mode, set at Maximum....A-6 Figure A – 5 Output power vs impedance for Pinpoint mode..........A-7 Figure A – 6 Output power vs impedance for Spray mode ..........A-7 Figure A – 7 Output power vs impedance for Bipolar mode ..........A-8 Arthrex, Inc.
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Page 7: Introducing The Arthrex O.p.e.s. Electrosurgical Generator
INTRODUCING THE ARTHREX O.P.E.S. ELECTROSURGICAL GENERATOR This section includes the following information: ● ● Key Features ● ● Components and Accessories ● ● Safety CAUTIONS: Read all warnings, cautions, and instructions provided with this generator before using. Read the instructions, warnings, and cautions provided with electrosurgical accessories before using. -
Page 8: Key Features
• Blend with 10 Settings The Blend mode is a combination of Cutting and Hemostasis. The Arthrex O.P.E.S. Electrosurgical Generator gives the surgeon freedom to adjust the desired level of blend. A setting of 1 is minimal hemostasis with maximum cutting effect. A setting of 10 is maximum hemostasis with minimal cutting effect. -
Page 9: Components And Accessories
The use of digital technology improves the sensing rate used by the generator compared to other electrosurgical generators on the market today. COMPONENTS AND ACCESSORIES You should receive the following components with your generator: • Arthrex O.P.E.S. Electrosurgical Generator • Hospital-grade power cord (110 VAC and 220 VAC) • User’s Guide • Service Guide... -
Page 10: Safety
To promote the safe use of the Arthrex O.P.E.S. Electrosurgical Generator, this section presents the warnings and cautions that appear throughout this user’s guide. It is important that you read, understand, and follow the instructions in these warnings and cautions so that you can operate this equipment with maximum safety. - Page 11 • In addition, place patient return electrodes according to the manufacturer’s instructions. Potential for alternate site burns increases if the return electrode is compromised. Arthrex recommends the use of split return electrodes and generators with a contact quality monitoring system.
- Page 12 If required by local codes, connect the generator to the hospital equalization connector with an equipotential cable. Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator. Arthrex, Inc.
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Page 13: Controls, Indicators, And Receptacles
CONTROLS, INDICATORS, AND RECEPTACLES This section describes: ● ● The Front and Rear Panels ● ● Controls, Indicators, Receptacles, and Ports User ’s Guide • O.P.E.S. Electrosurgical Generator... -
Page 14: Front Panel
FRONT PANEL Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel Arthrex, Inc. -
Page 15: Symbols On The Front Panel
Symbols on the Front Panel SYMBOLS DESCRIPTION Cut Controls Cut Mode Blend Mode Coag Controls Pinpoint Mode Spray Mode Bipolar Controls Bipolar Mode Indicators Split Return Electrode Solid Return Electrode Regulatory Symbology Read instructions before use. Defibrillator Proof Type CF Equipment RF Isolated –... -
Page 16: Preset Controls
10 user-defined presets. Press Blinks in the lower right corner of and hold the Set button for three the Preset display to indicate that seconds to save the settings. the current setting is not one of the user-defined presets. Arthrex, Inc. -
Page 17: Cut And Blend Controls
Cut and Blend Controls Figure 2 – 3 Controls for the Cut and Blend modes Blend Amount Control Buttons Cut Power Display (watts) Cut Power Control Buttons Increases or decreases the Indicates the power set for Increases or decreases the Cut or amount of blend (Level 1-10) the Cut / Blend mode. -
Page 18: Coag Controls
Illuminates when Coag mode is activated. Pinpoint Mode Indicator Indicates when the Pinpoint mode is selected. Pinpoint and Spray Mode Selector Toggles between Pinpoint mode and Spray mode. Spray Mode Indicator Indicates when the Spray mode is selected. Arthrex, Inc. -
Page 19: Bipolar Controls
Bipolar Controls Figure 2 – 5 Controls for the Bipolar mode Bipolar Power Display (watts) Indicates the power set for the Bipolar Power Control Buttons Bipolar mode. Increases or decreases the Bipolar Displays error code in the event power output in increments of 1 to of an error. -
Page 20: Indicators
Monopolar Footswitch Indicator Bipolar Footswitch Indicator Illuminates when monopolar Illuminates when bipolar footswitch control is plugged footswitch control is plugged in and available. in and available. Arthrex, Inc. -
Page 21: Power Switch And Receptacles
Power Switch and Receptacles Figure 2 – 7 Location of the unit power switch and front panel receptacles Power On/Off Switch Return Electrode Turns the unit on or off. Receptacle Accepts a standard return electrode plug. Monopolar Handswitching Receptacle Bipolar Receptacle Accepts standard 3-pin handpieces. -
Page 22: Rear Panel
Symbols on the Rear Panel SYMBOLS DESCRIPTION Equipotential Ground Stud Non-ionizing Radiation Volume Control Danger - Explosion Risk If Used With Flammable Anesthetics. Fuse Enclosed Relay Connector Monopolar Footswitch Input Jack Bipolar Footswitch Input Jack Read Instructions Before Use 2-10 Arthrex, Inc. -
Page 23: Getting Started
GETTING STARTED This section includes the following information: ● ● Initial Inspection ● ● Installation ● ● Function Checks ● ● Performance Checks User ’s Guide • O.P.E.S. Electrosurgical Generator... -
Page 24: Initial Inspection
INSTALLATION Place the Arthrex O.P.E.S. Electrosurgical Generator on any flat surface with a tilt angle not more than 10˚. The unit relies on natural convection cooling. Do not block its bottom or rear vents. Ensure that air flows freely on all sides of the unit. -
Page 25: Confirming Modes
Confirming Modes Confirm that you can select each mode and adjust the power up and down. Checking Bipolar Mode (with bipolar footswitch) 1. Plug in the Bipolar footswitch.Verify that the Bipolar footswitch indicator illuminates. 2. Press the pedal on the bipolar footswitch.Verify that the Bipolar mode activation indicator illuminates and that the system generates the Bipolar activation tone. - Page 26 Arthrex, Inc.
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Page 27: Using The Arthrex O.p.e.s. Electrosurgical Generator
USING THE ARTHREX O.P.E.S. ELECTROSURGICAL GENERATOR This section contains the following procedures: ● ● ● ● Inspecting the Generator and Accessories Memory Presets and Factory Settings ● ● ● ● Setup Safety Blend Controls ● ● ● ● Setting Up Activating the Unit ●... -
Page 28: Inspecting The Generator And Accessories
INSPECTING THE GENERATOR AND ACCESSORIES Before each use of the Arthrex O.P.E.S. Electrosurgical Generator, verify that the unit and all accessories are in good working order: • Inspect for damage to the Electrosurgical Generator and all its connections. • Verify that the appropriate accessories and adapters are present. -
Page 29: Setting Up
CAUTIONS: Do not stack equipment on top of the generator or place the generator on top of electrical equipment. These configurations are unstable and/or do not allow adequate cooling. Provide as much distance as possible between the electrosurgical generator and other electronic equipment (such as monitors). -
Page 30: Preparing For Monopolar Surgery
PREPARING FOR MONOPOLAR SURGERY Monopolar surgery requires a return electrode. Applying the Return Electrode To maximize patient safety, Arthrex recommends using a split return electrode and a generator with a contact quality monitoring system (Bovie NEM™). NOTICE: The Bovie NEM™ system requires that you use a split return electrode. -
Page 31: Preparing For Bipolar Surgery
PREPARING FOR BIPOLAR SURGERY 1. Connect a Bipolar cable to the Bipolar receptacle on the front of the unit. 2. Connect a forceps instrument to the bipolar cable. 3. Connect the bipolar footswitch to the bipolar footswitch connecting socket located on the rear of the unit. To activate the Bipolar mode, depress the pedal on the bipolar footswitch. -
Page 32: Setting Your Presets
45 watts CUT II 110 watts PINPOINT 50 watts 50 watts Blend 30% 120 watts PINPOINT 50 watts 50 watts Blend 30% 140 watts PINPOINT 50 watts 50 watts Blend 30% 160 watts PINPOINT 50 watts 50 watts Arthrex, Inc. -
Page 33: Blend Controls
BLEND CONTROLS In reference to Sections 2 and 4 of the User’s Manual, this addendum elaborates on the functionality of the O.P.E.S.unit’s Blend controls. Blend settings can be adjusted to a desired amount of hemostasis (Level 1 - 10). The following describes how to adjust the Blend setting: Ascending illuminated bars indicate increased hemostasis. -
Page 34: Memory Feature (Last Used Preset)
Preset number 2. The next time the unit is switched on, the number 2 Preset will be displayed and available when the unit is activated. The number 2 Preset will now be the last saved Preset settings for Preset 2. Arthrex, Inc. -
Page 35: Activating The Unit
Do not wrap the accessory cords or patient return electrode cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team. Danger: Fire / Explosion Hazard - Do not use the Arthrex O.P.E.S. Electrosurgical Generator in the presence of flammable anesthetics. - Page 36 Inadvertent contact with the patient may result in burns. 1. U.S. Department of Health and Human Services. National Institute for Occupational Safety and Health (NIOSH). Control of Smoke from Laser / Electric Surgical Procedures. HAZARD CONTROLS, Publication No. 96-128, September, 1996.) 4-10 Arthrex, Inc.
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Page 37: Maintaining The Arthrex O.p.e.s. Electrosurgical Generator
MAINTAINING THE ARTHREX O.P.E.S. ELECTROSURGICAL GENERATOR This section covers the following topics: ● ● Cleaning ● ● Periodic Inspection ● ● Fuse Replacement User ’s Guide • O.P.E.S. Electrosurgical Generator... -
Page 38: Cleaning
Follow the procedures approved by your institution or use a validated infection control procedure. Do not allow fluids to enter the chassis. Do not sterilize the generator. PERIODIC INSPECTION Every six months, visually inspect the Arthrex O.P.E.S. Electrosurgical Generator for signs of wear or damage. In particular, look for any of the following problems: • Damage to the power cord •... -
Page 39: Troubleshooting
TROUBLESHOOTING This section includes Error Code Descriptions and actions to take to resolve them. User ’s Guide • O.P.E.S. Electrosurgical Generator... -
Page 40: Error Codes And Audio Tones
Error Codes and Audio Tones The Arthrex O.P.E.S. Electrosurgical Generator includes automatic self-diagnostics. If the diagnostics detect an error, the system displays an error code, sounds an audible tone, and deactivates the unit output power. Most error codes result from faults in acces- sories attached to the unit. -
Page 41: Repair Policy And Procedures
REPAIR POLICY AND PROCEDURES Refer to this section for information on: ● ● Responsibility of the Manufacturer ● ● Returning the Generator for Service User ’s Guide • O.P.E.S. Electrosurgical Generator... -
Page 42: Responsibility Of The Manufacturer
Returned Authorization Number. Then, clean the Generator and package securely to ensure proper protection of the unit. So as to aid in the processing of the unit, please be sure to include a reference to the Arthrex Return Authorization Number on the outside of the box and ship directly to Arthrex. -
Page 43: Technical Specifications
TECHNICAL SPECIFICATIONS All specifications are nominal and subject to change without notice. A specification referred to as “typical” is within ± 20% of a stated value at room temperature (25° C / 77° F) and a nominal input power voltage. User ’s Guide •... -
Page 44: Performance Characteristics
Generator should fit on all standard Carts for monopolar generators. The device should be stored and used in a room temperature of approximately 77 F/25 -34˚ to 65˚ C (-29˚ to 149˚ F) Ambient temperature range Relative humidity 0% to 75%, non-condensing Atmospheric pressure 500 hPa to 1060 hPa Arthrex, Inc. -
Page 45: Audio Volume
Audio Volume The audio levels stated below are for activation tones (cut, coag, and bipolar) and alarm tones (return electrode and system alarms) at a distance of one meter. Alarm tones meet the requirements for IEC 60601-2-2. Activation Tone Volume (adjustable) 45 to 65 dB Cut I: 610 Hz Frequency... -
Page 46: High Frequency (Rf) Leakage Current
The Arthrex O.P.E.S. Electrosurgical Generator complies with the appropriate IEC 60601-1-2 and IEC 60601-2-2 specifications regarding electromagnetic compatibility. Voltage Transients (Emergency Generator Mains Transfer) The Arthrex O.P.E.S. Electrosurgical Generator operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source. OUTPUT CHARACTERISTICS Maximum Output for Monopolar and Bipolar Modes Power readouts agree with actual power into rated load to within 20% or 5 watts, whichever is greater. -
Page 47: Output Power Curves
OUTPUT POWER CURVES The curves that follow depict the changes for each mode at specific power settings. Figure A – 1 Output power vs impedance for Cut I mode Figure A – 2 Output power vs impedance for Cut II mode User ’s Guide •... -
Page 48: Figure A - 3 Output Power Versus Impedance For Blend Mode, Set At Minimum
Figure A – 3 Output power versus impedance for Blend mode, set at Minimum Figure A – 4 Output power versus impedance for Blend mode, set at Maximum Arthrex, Inc. -
Page 49: Figure A - 5 Output Power Vs Impedance For Pinpoint Mode
Figure A – 5 Output power vs impedance for Pinpoint mode Pinpoint Coag 1000 1500 2000 2500 3000 120W Load Resistance [Ohms] Figure A – 6 Output power vs impedance for Spray mode User ’s Guide • O.P.E.S. Electrosurgical Generator... -
Page 50: Figure A - 7 Output Power Vs Impedance For Bipolar Mode
Figure A – 7 Output power vs impedance for Bipolar mode Arthrex, Inc. -
Page 51: Warranty
WARRANTY Limited Warranty. For the applicable periods as listed below, after delivery of the Equipment and subject to the terms hereof, Arthrex warrants the Equipment to be free from manufacturers’ defects in material and craftsmanship under normal use and service. - Page 52 Arthrex, F.O.B. Arthrex’s facility. If Arthrex determines that any product or service is not defective or that Arthrex is not liable for the defect, the Customer will be notified;...
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