HELIX AR ABC Operators Manual Rev L

LIMITED WARRANTY For a period of two years following the date of shipment, CONMED Corporation warrants the CONMED HelixAR™ ABC® Electrosurgical Generator with Argon Beam Coagulation (HelixAR ABC System) against any defects in material or workmanship and will repair or replace (at CONMED’s discretion) the same without charge, provided the maintenance as specified in this manual has been performed using replacement parts approved by CONMED. This warranty is void if the product is used in a manner or for purposes other than intended. ©2017 CONMED Corporation 525 French Road Utica, NY 13502-5994 USA For Technical Service, to set up a Service Request or to Order Repair Parts: Phone: 727-399-5597 or 1-800-552-0138 Ext. 3 Fax: 727-399-5269 Email: [email protected] http://www.conmed.com/conmed-service.php Or contact your CONMED representative. For Customer Service, Return Authorization or to Order Disposables: Phone: 1-800-448-6506 or 315-797-8375 Fax: 315-735-6235 Or Contact Your CONMED Representative. European Authorized Representative MDSS GmbH Schiffgraben 41 D-30175 Hannover Germany

The revision level of this manual is specified by the highest revision letter found on either the inside front cover or enclosed errata pages (if any). Manual Number: 60-8801-ENG Rev. L Unit Serial Number: __________________

Quick-Reference Guide Generator Setup 1. For first-time use, connect the pressure lines to the argon tanks. 2. Open the valve on the gas cylinder. 3. Verify that the Argon Tank Indicator gauge either shows green or amber. 4. Set the argon gas selector knob for the tank that will be used first. 5. Plug the HelixAR ABC System into a wall outlet. 6. Connect footswitches, if appropriate. 7. Place the Dispersive Electrode on the patient and plug it into the Generator. 8. Connect the appropriate accessories (the Monopolar Footswitch always goes in Receptacle 1). 9. For Argon Handpieces, the gas connection should be finger-tight. If a three-prong connection is present, connect to the Monopolar 2/Argon Handpiece Receptacle. 10. For Monopolar or Bipolar Handpieces, connect to the Monopolar 1/Foot Control Receptacle and Bipolar Accessory Receptacle, respectively. 11. Turn on the power. 12. Verify that adequate cylinder pressure is indicated on the right front panel under ABC. 13. If using a Dual-Foil Pad (recommended), ensure that the green light on the Pad Indicator is flashing green and the Contact Quality Bar is showing green bars after the electrode is properly connected. 14. If using a single foil pad, ensure that the green light on the Pad Indicator is steady green after the electrode is properly connected. Standard Electrosurgery 1. For Monopolar Cut and Coag, select the appropriate specialty mode (General, Fluids or Lap). 2. Select Monopolar Cut Mode (Pure or Blend 1-3). I. Set the power. 3. Select Monopolar Coag Mode (Spray, Pinpoint or Standard). I. Set the power. 4. Select Bipolar (Micro or Macro). I. Set the power.

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Argon Beam Coagulation (ABC) 1. Select the appropriate mode (Lap, Open, ABC®Flex or Manual). 2. Lap Mode is the default mode. I. Used for endoscopic and laparoscopic procedures. II. Max gas flow is 4 L/min. III. Manually set the power and flow rate settings independently. Select Open Mode. I. For open procedures. II. Max gas flow is 10 L/min. III. Gas flow rate adjusts automatically with the power setting up to the max flow rate. Select ABC®Flex Mode. I. For ABC®Flex procedures. II. Max gas flow is 2 L/min. III. Manually set the power and flow rate settings independently. Select Manual Mode. I. Manually set the power and flow rate settings independently. 3. Set the power and gas flow. 4. Press Purge. Remote Power Control (The surgeon can change power from the surgical field when selected.) 1. Press the Remote Power Button on the front panel. 2. Double-click the Cut, Coag or ABC Button on the Handpiece. 3. Increase power by pressing the Cut Button. 4. Decrease power by pressing the Coag Button. 5. The surgeon can either double-click to exit, or it will time out after a few seconds. Pulse Cut 1. Press the Yellow Pulse Button below the Cut LCD screen. 2. Select Pure or Blend 1-3. 3. Adjust the power. 4. Power values displayed are the average and peak power at rated load. Pulse Coag 1. Press the Blue Pulse Button below the Coag LCD screen. 2. Select Spray, Standard or Pinpoint. 3. Adjust the power. 4. Power values displayed are the average and peak power at rated load. Pulse ABC 1. Press the blue Pulse Button below the ABC LCD screen. 2. Select Single Shot, 200 ms, 400 ms or 600 ms duty cycle. 3. Adjust the power and gas flow.

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Argon Dissect 1. Ensure that the Dissecting Electrode is attached to the appropriate ABC Handpieces when using this mode. 2. Press the yellow Argon Button below the Argon LCD screen. 3. Select Dissect Pure, Dissect Low, Dissect Med or Dissect High. 4. Adjust the power and gas flow. Program Mode (Press the Program Button to save the active settings, to recall the previously saved program or to delete the previously saved program.) 1. To save the active settings: I. Press the left middle circular button on the left screen to select “Save the active settings” and press OK. II. Use the OK and arrow keys to select and enter the desired information. III. Press the Program Button and follow the prompts to confirm the selection on the left screen. 2. To recall the previously saved program: I. Press the left middle circular button on the left screen to select “Recall a saved program” and press OK. II. Scroll through the saved program and select the desired program by pressing OK. 3. To replace an existing program: I. Press the left middle circular button on the left screen to select “Replace an existing program” and press OK. II. Scroll through the saved programs and select the desired program to replace. III. Confirm selection on the left screen. 4. To delete a previously saved program: I. Press the left middle circular button on the left screen to select “Delete a saved program” and press OK. II. Scroll through the saved program and select the program to delete by pressing OK. III. Confirm the selection on the left screen. Refer to the rest of the Operator’s Manual for complete instructions.

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Table of Contents Quick-Reference Guide... 3 Section 1

General Information... 9

1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 1.3 1.3.1 1.3.2 1.3.3 1.3.4 1.3.5 1.3.6 1.3.7 1.4 1.4.1 1.4.1.1 1.4.1.2 1.4.1.3 1.4.1.4 1.4.1.5 1.4.1.6 1.4.1.7 1.4.2 1.4.2.1 1.4.2.2 1.4.2.3 1.4.2.4 1.4.2.5 1.4.2.6 1.5 1.6

Figure 1.1 Major System Components... 11 Basic System Operation... 12 Cautions for Equipment Preparation... 13 Accessory Compatibility and Use... 13 Equipment Clearance... 13 Equipment Cleaning... 14 Transportation, Storage and Shipment... 14 Interference... 14 Warnings for Patient Preparation... 14 Fire Hazards... 14 Dispersive Electrodes... 14 Monitoring Electrodes... 15 Interference... 16 Implants and other Items on Patients... 16 Transportation... 16 Clinical Use... 16 Warnings and Cautions for Use... 17 Warnings... 17 Dual or Simultaneous Activation... 17 Dispersive Electrodes and Other Accessories... 17 Operating Conditions... 17 Argon Gas... 18 Argon Beam Coagulation Mode... 18 General Modes, Flow Rates and Duty Cycles... 19 Output Voltage and Electric Shock... 19 Cautions... 19 Operator Qualifications... 20 Dispersive Electrodes and Other Accessories... 20 Smoke Evacuation... 20 General Modes, Flow Rates and Duty Cycles... 20 Output Voltage and Electric Shock... 20 Dual or Simultaneous Activation... 20 Warnings for Testing or Servicing... 21 Recommendations for Preventative Maintenance... 21

Section 2

Controls, Displays and Connectors... 23

2.1

User Interface... 24 Figure 2.1 User Interface... 24 Output Panel... 26

2.2 2.3 2.4 2.5

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Figure 2.2 Output Panel... 26 Rear Panel... 27 Figure 2.3 Rear Panel... 27 Mobile Pedestal (Cart)... 28 Figure 2.4 Mobile Pedestal... 28 Explanation of Symbols... 29

Section 3

Set Up for Use... 31 Table 3.1 Default mode for the HelixAR Electrosurgical System... 36

Section 4

Operation... 37

4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.2 4.2.1 4.2.2 4.2.3

Operating Modes and Descriptions... 38 Monopolar Cut Modes... 38 Monopolar Coagulation Modes... 38 Specialty Modes... 39 Bipolar Coagulation... 39 Argon Beam Coagulation (ABC)... 39 Shut Down Procedure... 40 Maintenance... 40 General Maintenance Information... 40 Exterior Cleaning... 40 Periodic Inspection... 40

4.2.4 4.2.4.1 4.2.4.2 4.2.4.3

4.2.4.6 4.2.4.7 4.2.5 4.3 4.3.1 4.3.1.1 4.3.1.2 4.3.2 4.3.3 4.4

Periodic Preventative Maintenance (PM)... 41 Chassis Ground Integrity... 42 Displays, Alarms and Commands... 42 Output Power... 42 Table 4.2.1 Monopolar RF Output Power Accuracy... 42 Table 4.2.2 Bipolar RF Output Power Accuracy... 42 RF Leakage Measurement... 43 Table 4.2.3 Allowable RF Leakage Current to Ground... 43 Table 4.2.4 Allowable RF Leakage - Inactive Monopolar Outputs... 44 Table 4.2.5 Allowable RF Leakage - Inactive Biopolar Outputs... 45 Mains Frequency Leakage Measurement... 45 Table 4.2.6 Mains Frequency Allowable Leakage - Chassis and Bipolar Outputs... 45 Table 4.2.7 Mains Frequency Allowable Leakage - Monopolar Outputs... 46 Automatic Return Monitor (ARM) Check... 46 Output Coupling Capacitor Check... 47 Battery Replacement... 47 Basic Troubleshooting... 48 Dispersive Electrode Fault... 48 Single-Foil Dispersive Electrode Alert... 48 Dual-Foil Dispersive Electrode Alert... 48 Accessory Fault Tone... 48 Faults... 48 Environmental Protection... 49

Section 5

Installation... 51

5.1 5.2 5.2.1 5.3 5.3.1 5.3.2

Initial Unpacking and Inspection... 52 Installation Steps... 52 Wireless Footswitch Installation Instructions for the HelixAR System . . 52 Preliminary Checks... 54 Preliminary Functional Testing... 54 Preliminary Performance Testing... 55

4.2.4.4

4.2.4.5

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Section 6

Specifications... 57

6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11

Input Power:... 58 Mains Internal Over-Current Protection... 58 Mains Frequency Leakage... 58 Regulatory Compliance... 58 Operation... 58 Power Display Accuracy... 58 Line Regulation... 58 Environmental... 58 Contact Quality Monitor... 58 Other Specifications... 59 Electromagnetic Compatibility... 59 6.11.1 EN/IEC 60601-1-2 Table 1... 59 6.11.2 EN/IEC 60601-1-2 Table 2... 60 6.11.3 EN/IEC 60601-1-2 Table 3... 61

6.12 6.12.1 6.12.2

6.13

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6.11.4 EN/IEC 60601-1-2 Table 4... 62 Output Characteristics... 63 Operating Modes and Nominal Output Parameters... 63 Output Characteristic Curves... 64 Figure 6.1 Output Power vs. Power Setting... 66 Figure 6.2 Maximum Peak Voltage vs. Power Setting in General Specialty Mode... 66 Figure 6.3 Maximum Peak Voltage vs. Power Setting in Lap Specialty Mode... 66 Figure 6.4 Load Regulation, ABC – Open... 66 Figure 6.5 Load Regulation, ABC – ABC®Flex... 66 Figure 6.6 Load Regulation, Monopolar Pure Cut – General... 67 Figure 6.7 Load Regulation, Monopolar Pure Cut – Lap... 67 Figure 6.8 Load Regulation, Monopolar Blend 1 – General... 68 Figure 6.9 Load Regulation, Monopolar Blend 1 – Lap... 68 Figure 6.10 Load Regulation, Monopolar Blend 2 – General... 69 Figure 6.11 Load Regulation, Monopolar Blend 2 – Lap... 69 Figure 6.12 Load Regulation, Monopolar Blend 3 – General... 70 Figure 6.13 Load Regulation, Monopolar Blend 3 – Lap... 70 Figure 6.14 Load Regulation, Monopolar Pinpoint Coag – General... 71 Figure 6.15 Load Regulation, Monopolar Pinpoint Coag – Lap... 71 Figure 6.16 Load Regulation, Monopolar Standard Coag – General . . . 72 Figure 6.17 Load Regulation, Monopolar Standard Coag – Lap... 72 Figure 6.18 Load Regulation, Monopolar Spray Coag – General... 73 Figure 6.19 Load Regulation, Monopolar Spray Coag – Lap... 73 Figure 6.20 Load Regulation, Monopolar Argon Dissect Pure... 74 Figure 6.21 Load Regulation, Monopolar Argon Dissect Low... 74 Figure 6.22 Load Regulation, Monopolar Argon Dissect Med... 75 Figure 6.23 Load Regulation, Monopolar Argon Dissect High... 75 Figure 6.24 Load Regulation, Bipolar Micro... 76 Figure 6.25 Load Regulation, Bipolar Macro... 76 Accessory Compatibility... 77

HelixAR Electrosurgical Generator with Argon Beam Coagulation (ABC)

Section 1 GENERAL INFORMATION

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Section 1 GENERAL INFORMATION Foreword This Operator’s Manual provides the user with setup and operating instructions for the HelixAR Electrosurgical Generator with Argon Beam Coagulation (HelixAR ABC System). The HelixAR ABC System is designed for use by medical professionals familiar with the required techniques and instructions for use of the equipment. It is recommended that personnel study this manual before attempting to operate this equipment. Technical specifications, performance characteristics and user maintenance instructions are also included in this Operator’s Manual. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product or included in this Operator’s Manual. CAUTION: Federal law (USA) restricts this device to be sold by or on the order of a physician.

Introduction The CONMED HelixAR ABC System is a state-of-the-art, radio frequency-isolated electrosurgical generator. It is designed for enhanced control of bleeding and for the electrosurgical destruction of the tissue in multispecialty procedures in the operating room or endoscopy suite. The CONMED HelixAR ABC System combines conventional electrosurgical features (Monopolar Cut, Monopolar Coagulation and Bipolar) with Argon Beam Coagulation in a full-capability, mobile electrosurgical system.

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This equipment, in conjunction with connected accessories, is intended to produce high-frequency electrical energy for the controlled destruction of tissue. Safe and effective electrosurgery is dependent, not only on equipment design, but also on factors under the control of the operator. It is important that the instructions supplied with this equipment be read, understood and followed in order to ensure the safe and effective use of this equipment. Intended Use/Indications for Use The CONMED HelixAR ABC System is intended to deliver argon gas, as well as a high-frequency electrical current for the cutting and/or coagulation of tissue.

HelixAR Electrosurgical Generator with Argon Beam Coagulation (ABC) Major System Components

NOTE: For the Generator to operate as intended, it must be secured on the Cart.

The HelixAR ABC System consists of two major sub-assemblies integrated into one system (see Figure 1.1):

NOTE: For assembly and initial setup, refer to Section 5.

1. The Generator Assembly

WARNING: Any tampering with or modification to this device is strictly prohibited.

2. The Mobile Pedestal (Cart) The Generator Assembly houses the power supplies, power amplifiers, control circuits, logic and microprocessor circuits, and low-pressure pneumatic devices for the argon gas delivery system. The Generator Assembly also contains the User Interface Panel and the Output Receptacle Bar for connecting accessories. The Mobile Pedestal provides a base, as well as houses the high-pressure pneumatics for the Generator Assembly.

Figure 1.1 Major System Components

Generator

Mobile Pedestal (Cart)

Back

Front

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Section 1 GENERAL INFORMATION 1.1 Basic System Operation

Features of the HelixAR ABC System include:

The HelixAR ABC System offers clinical functionality in four different electrosurgical modes: Monopolar Coagulation, Monopolar Cut, Bipolar Coagulation and Argon Beam Coagulation.

• Dynamic response technology that delivers optimal clinical effects in Monopolar Cut, Monopolar Coag and Bipolar Coag operational modes through the continuous control of current and voltage.

The HelixAR ABC System is compatible with all CONMED ABC Handpieces described in the Electrosurgery Product Catalog.

• An option to restore the ESU to the last settings used.

The HelixAR ABC System provides a broad range of capabilities in a single electrosurgical generator. This electrosurgical unit (ESU) fulfills the operational and safety needs of the operating room by providing: • Three Monopolar Cutting Modes: Pure, Blend and Pulse. • Four Monopolar Coagulation Modes: Standard, Spray, Pinpoint and Pulse. • Two Bipolar Modes: Micro and Macro. • Three Argon Modes: Continuous, Pulse and Argon Dissect. • Four Argon Flow Control Modes: Open, Lap (laparoscopic/endoscopic), ABC®Flex and Manual. • Radio frequency-isolated and independent outputs. • The proven Automatic Return Monitor (ARM®) contact quality monitoring system. • Continuous microprocessor safety monitoring.

• User-programmable settings where individual settings can be stored based on procedure or different users. • The ability to change power settings from the control panel while the ESU is activated. • An adapter portal for different types of footswitched accessories. One combination Monopolar Handswitched/Footswitched Receptacle for 3 mm, Bovie #12 and banana plugs. One combination Monopolar Handswitched/ Argon Handswitched Receptacle. • A separate Bipolar Receptacle for both handswitched and footswitched forceps. • Channeled accessory receptacles that direct plugs into position for easy attachment. • A compartment for seamless integration of the AER DEFENSE™ Smoke Evacuation system. • A stacking adapter to allow Modular integration of the CONMED System 5000™ ESU. • Wireless footswitches to allow control of Monopolar Cut/Coag and Argon Beam Coagulation Modes. Additional details about controls, displays and connectors of the HelixAR ABC System are described in Section 2.

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HelixAR Electrosurgical Generator with Argon Beam Coagulation (ABC)

1.2 Cautions for Equipment Preparation

• Prior to initial use, performance of the device should be tested. See Section 5 for additional installation details.

The CONMED HelixAR ABC System is intended to be used by licensed practitioners as a general-purpose electrosurgical generator, used in conjunction with an electrosurgical handpiece, for delivery of radio-frequency electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.

• Potentially hazardous conditions may exist when accessories of similar connector types are combined. Be certain accessories are appropriate for the type of generator output used. Use only CONMED Footswitches as described in Section 6.13, or footswitches specifically marked as compatible with the HelixAR ABC System in the latest Product Catalog.

1.2.1 Accessory Compatibility and Use • Use only accessories that meet the requirements of Section 6. Refer to the latest CONMED Product Catalog for compatible accessories. Use of other accessories may result in increased emissions or decreased immunity of the ESU. • Reusable accessory cables should be periodically tested for function and safety in accordance with the original manufacturer’s instructions for use. • Visually inspect all accessories before each use to verify the integrity of insulation and the absence of obvious defects. In particular, electrode cables and endoscopic accessories should be checked for damage to the insulation. • Unused accessories should be stowed in a safe, electrically insulated place, such as a non-conductive holster that is isolated from the patient. CONMED recommends accessories not be connected to the Generator Assembly unless needed.

• Confirm bipolar leads are connected only to the bipolar receptacles. Connecting bipolar accessories to monopolar outputs may result in patient injury. • Electrosurgical equipment that is known to be defective should not be used. 1.2.2 Equipment Clearance • Do not place containers with liquid on top of the ESU. Wipe spilled liquids off the ESU immediately. To preclude inadvertent entry of liquids, do not operate this ESU except in its normal position. • Do not stack other devices or equipment on top of or adjacent to the HelixAR ABC System unless the proper stacking adapter is employed. • For cooling, 2 in clearance (5cm) is required on each side and the back of the ESU.

• Never connect more than one accessory at a time to any one receptacle. • Use the power cord provided with the unit. Replacement power cords may be obtained from CONMED. Use only a hospital-grade, three-prong power cord rated to meet the specifications in Section 6-and all of the requirements for safe grounding of the ESU. The user should verify that the power receptacle with which this ESU is used is properly grounded, correctly polarized and of the proper frequency per Section 6. Do not use ground “cheater plugs” or extension cords. • Confirm all accessories are properly connected to the appropriate receptacles before powering the ESU.

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Section 1 GENERAL INFORMATION 1.2.3 Equipment Cleaning • The following cleaning agents can be used to clean the exterior of the ESU and footswitches: oo Mild detergents, such as Windex® or Formula 409® oo 70% isopropyl alcohol oo 5% sodium hypochlorite (Clorox®) • Do not reuse disposable (single-use) accessories. The ability to effectively clean and re-sterilize single-use devices has not been established, and subsequent re-use may adversely affect the performance, safety and/ or sterility of the accessory. 1.2.4 Transportation, Storage and Shipment • Prior to shipment or storage, the ESU should be enclosed and sealed in a polyethylene bag and placed in its original carton using original packaging materials. • Do not use cords as handles, as damage to the insulation, increased risk of burns or other injury may result. 1.2.5 Interference • Interference may occur between the radio-frequency signals of the HelixAR ABC System and ground-referenced ESUs that are used simultaneously with it. Do not use ground-referenced ESUs with the HelixAR ABC System.

1.3 Warnings for Patient Preparation 1.3.1 Fire Hazards • Flammable agents used for cleaning or disinfecting the surgical area, such as solvents of adhesives, should be allowed to evaporate before the highfrequency surgical equipment is used. Only nonflammable agents should be used for cleaning and disinfection. • There is a risk of pooling of flammable solutions in body depressions, such as the umbilicus and in body cavities, such as the vagina. Any fluid pooled in these areas should be removed before the high-frequency surgical equipment is used. Only nonflammable agents should be used for cleaning and disinfection. • Due to the danger of ignition of endogenous gases, the bowels should be purged and filled with nonflammable gas prior to abdominal surgery. • To avoid the risk of tracheal fires, never use electrosurgery devices to enter the trachea during tracheotomy procedures. • The use of flammable anesthetics or oxidizing gases, such as nitrous oxide (N2O) and oxygen, should be avoided unless these agents are evacuated if a surgical procedure is carried out in the region of the thorax or the head. • Exercise care when moving the ESU to avoid electrostatic charge buildup in the presence of flammable materials, as there is a risk of igniting these materials if a spark should occur. 1.3.2 Dispersive Electrodes • This ESU is equipped with the ARM, which monitors the quality of the Dispersive Electrode connection. When a correctly functioning SingleFoil Dispersive Electrode is connected to the ESU, the ARM verifies the connections between the ESU, the Dispersive Electrode cable and the Dispersive Electrode. It does not verify that a Single-Foil Dispersive Electrode is in contact with the patient. When using a Dual-Foil Dispersive Electrode, the ARM confirms the total resistance is within the preset safety range. • Use only Dual-Foil Dispersive Electrodes that are compatible with the ARM contact quality monitor.

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HelixAR Electrosurgical Generator with Argon Beam Coagulation (ABC) • Proper application on the patient and visual inspection of the Dispersive Electrode is required for safe operation. CONMED recommends using Dispersive Electrodes manufactured by CONMED. • The use and proper placement of a Dispersive Electrode on a patient is a key element in safe and effective electrosurgery. Follow the manufacturer’s directions and recommended practices for the preparation, placement, use, surveillance and removal of the Dispersive Electrode supplied for use with this ESU. • Apply the Dispersive Electrode over a well-vascularized muscle mass that is thoroughly clean and dry. Clean the site and clip hair as necessary (per hospital policy) to provide an adequate electrical connection. Avoid placement over scar tissue, bony prominences or other areas where pressure points on small areas might develop. • The entire area of the Dispersive Electrode should be placed so that the entire conductive area is in firm contact with an area of the patient’s body that has a good blood supply and is as close to the operative site as possible. In general, electrosurgical current paths should be as short as possible and should run either longitudinally or in a diagonal direction to the body, not laterally and under no circumstances lateral to the thorax. • Dispersive Electrodes and probes of monitoring, stimulating and imaging devices can provide paths for highfrequency currents even if they are battery-powered, insulated or isolated at 50/60 Hz. The risk of burns can be reduced but not eliminated by placing the probes as far away as possible from the electrosurgical site and the Dispersive Electrode. Protective impedances incorporated in the monitoring leads may further reduce the risk of these burns.

• Heat applied by thermal blankets or other sources is cumulative with the heat produced at the Dispersive Electrode (caused by electrosurgical currents). Choosing a Dispersive Electrode site that is remote from other heat sources may minimize the risk of patient injury. • To minimize the possibility of cardiac pacemaker interference, place the Dispersive Electrode such that the electrosurgical current path does not intersect the path of the pacemaker or leads. NOTE: Federal law (USA) requires that all healthcare facilities must report to the manufacturer of a medical device any death or serious injury or illness to a patient related to the use of a medical device. Serious injuries or illness involving the use of a medical device must be reported to the manufacturer of the device (or to the FDA if the manufacturer of the device is not known) within 10 working days of the incident. Summary reports of such injuries must also be submitted directly to the FDA twice a year. Patient deaths related to the use of a medical device must be reported to the manufacturer and the FDA. For further information, please contact the Complaints Department of CONMED at 1-800-448-6506. • Dual-Foil Dispersive Electrodes are always recommended as they enable the ARM feedback capability of the Generator. 1.3.3 Monitoring Electrodes • When high-frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient, all monitoring electrodes should be placed as far as possible from the surgical site and Dispersive Electrode. • Needle monitoring electrodes are not recommended. • Monitoring systems incorporating high-frequency, current-limiting devices are recommended whenever possible. • The active electrode should not be used in the vicinity of electrocardiograph electrodes.

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Section 1 GENERAL INFORMATION 1.3.4 Interference • Electrosurgery, by nature, produces significant levels of electromagnetic interference (EMI) when the ESU is activated. This EMI may damage or impair the function of other electronic equipment in the operating room, especially equipment that makes contact with the patient. Adverse effects can only be mitigated by use of equipment specifically designed to tolerate electrosurgical interference. • Other equipment in the operating room, including portable or mobile communications equipment, may produce EMI, which can affect the function of the ESU. Adverse effects can only be mitigated by use of equipment with EMI characteristics proven to be below recognized limits. In the event of suspected interference from other equipment, discontinue use of the ESU until the problem can be remedied. 1.3.5 Implants and other Items on Patients • The patient should not be allowed to come into contact with metal items that are grounded or have an appreciable capacitance to earth. Examples of this would be operating tables, supports, etc. • Jewelry and other metallic items can cause localized burns if they make contact with grounded items and should be removed from the patient prior to the use of electrosurgery. • Skin-to-skin contacts, such as between the arm and body of a patient or between the legs and thighs, should be avoided by the insertion of dry gauze.

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• The use of electrosurgery on patients with cardiac pacemakers, AICDs, neurostimulators or other active implants is potentially hazardous. The implant may be irreparably damaged and/or the high-frequency energy of the electrosurgical output may interfere with the function of the implant. Ventricular fibrillation may occur. Precautions should be taken to ensure the patient’s well-being is maintained in the event of such interaction. The manufacturers of the implants should be consulted for advice before operating on a patient with an implant. These precautions also apply to operating room personnel with similar implants. 1.3.6 Transportation • When transporting the device, push the system only with the designated features provided for transportation, such as the handle on the Cart. 1.3.7 Clinical Use • Do not use monopolar electrosurgery on small appendages, as in circumcision or finger surgery, as it can cause thrombosis and other unintended injury to tissue proximal to the surgical site. Should the surgeon decide the bipolar electrosurgical technique is acceptable for circumcision, do not apply the bipolar electrosurgical current directly to circumcision clamps.

HelixAR Electrosurgical Generator with Argon Beam Coagulation (ABC)

1.4 Warnings and Cautions for Use 1.4.1 Warnings 1.4.1.1 Dual or Simultaneous Activation • Simultaneous activation can be used in Pure Cut, Blend 1-3, Standard Coag and Spray Coag Monopolar Modes; in General and Lap Modes, non-pulsed. Caution should be used as the output from either active electrode may change as a result of starting or ending activation of a second output. Power sharing is unlikely to be equal due to differences in electrode materials, proximity to tissue and accessory cord arrangement. Due to these dynamic differences, the power delivered through one accessory during dual activation may vary from 0% to 100% of the dial setting. It is preferred to use a second electrosurgical generator to perform simultaneous operations. • When the Generator is operated in the Dual Activation Mode, the radiofrequency leakage may increase, thereby increasing the potential for an alternate path burn to the patient. • All electrosurgical outputs operate with non-simultaneous, discrete output, i.e., “first come, first served,” except when the unit is operating in Dual Activation Mode. 1.4.1.2 Dispersive Electrodes and Other Accessories • A return electrode (also known as a Dispersive Electrode) must be used in Monopolar Mode to return the current to the Generator. • Do not depend solely on the Contact Quality Bar for confirmation of good return electrode application. Due to interaction between the return electrode site conditions and the contact area, visual confirmation of contact is mandatory.

• Ensure the footswitches are not inadvertently depressed in order to prevent accessories from being unintentionally activated. Place footswitches in locations that necessitate deliberate action in order to activate the footswitch. Use caution when selecting the correct footswitch to activate. 1.4.1.3 Operating Conditions • To prevent possible overheating and damage to the Generator, do not obstruct the air vents. • Grounding reliability can only be achieved when the CONMED HelixAR ABC System is connected to a threeprong, hospital-grade receptacle. • Ensure the power switch in the rear of the unit is always accessible. • The operator of this device must be aware of the power settings on the display. • It is recommended to use two separate generators as opposed to using simultaneous activation of the monopolar accessories using a single generator. • Do not place the distal tip of the argon gas next to suction/irrigation device. • Do not use the device if the display is illegible. • It is recommended that electronic insufflators with non-defeatable audible and visual over-pressurization warning signals be used during all laparoscopic procedures.

WARNING: Ensure that electrodes are properly secured and not loose in the accessory. Check for poor electrical connection, poor fit, or visibly exposed metal of the electrode where it connects with the accessory handle. WARNING: To avoid the risk of accidental activation or activating the wrong mode, ensure that the footswitches and handswitching accessories are not inadvertently depressed. Place footswitches in locations that necessitate deliberate action in order to activate the footswitch. Use caution when selecting the correct footswitch to activate. WARNING: To avoid the risk of accidental activation of the wrong mode, confirm the desired mode is selected prior to use. Properly position the unit to assure the operator or their support personnel can readily verify the settings.

• Any tampering with or modification to this device is strictly prohibited. • Failure to replace the fuses with the components specified in Section 6.2 may result in risk of fire or smoke.

• Verify that the electrode is fully and securely seated in the handpiece before use.

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Section 1 GENERAL INFORMATION 1.4.1.4 Argon Gas WARNING: To reduce the risk of embolism, minimize the exposure of unsealed tissue to Argon gas flow without a beam.

• High-purity, medical-grade (99.998% minimum purity) argon gas must be used with the CONMED HelixAR ABC System when using ABC Mode. • Always verify that argon gas is contained in the cylinder you are connecting. The line connections are compatible with argon gas cylinders, as well as with several other types of gas cylinders (e.g., Freon™, helium, krypton, neon, nitrogen, xenon). • Introduction of argon gas to an insufflated cavity can increase insufflation pressures if not closely monitored. Increased pressures have been associated with gas emboli. Active venting is necessary to prevent over-insufflation. Continually monitor intra-abdominal pressure. • Avoid directing the beam straight into large, open blood vessels at high gas flow rates to prevent the formation of emboli.

1.4.1.5 Argon Beam Coagulation Mode • When using ABC Mode with the HelixAR System for open and laparoscopic surgery, use only CONMED ABC accessories specifically designed for open and laparoscopic procedures, respectively. • When using ABC Mode with the HelixAR System for GI surgery, use only CONMED ABC accessories specifically designed for GI procedures. • Keep the probe tip at least 3 mm (0.12 in) away from the tissue, or per accessory instructions, and at a 45-60° angle during Argon Beam Coagulation. Be sure to use the lowest gas flow necessary for the desired coagulation effect. To reduce the possibility of gas embolism, move the probe away from tissue between activations. • Avoid high-power and long-duration applications of the argon beam to tissues sensitive to depth of penetration, such as vessels covered by thin membranes. Unwarranted tissue damage may result. • Argon Beam Coagulation is used solely for coagulating; its only effects are fulguration and thermal coagulation, and it will not cut or vaporize even when the beam is continuously applied to the most delicate tissue. • With Argon Beam Coagulation, risk of gas embolism rises when there is insufficient radio-frequency output power to produce rapid hemostasis on the target tissue. • Extended use of Argon Beam Coagulation on the digestive tract (e.g., stomach, intestine and bowel) may lead to post-operative complications such as perforation and tissue rupture. Avoid applying energy to a localized area for durations in excess of one second.

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HelixAR Electrosurgical Generator with Argon Beam Coagulation (ABC) • The tip of the nozzle must be within 1 cm (0.4 in) or less of the tissue surface to initiate the beam. If the beam does not initiate immediately, replace the accessory. The tip of the nozzle must not contact tissue or be used for tissue exploration. If the nozzle tip glows red, the tip is either too close to the tissue or the power is set too high. • Exposed edges of large, open vessels should be coapted before application of the argon beam. The coaptation pressure should continue to be applied after cessation of argon beam application to ensure effective hemostasis. • Argon Dissect should only be used with the Argon Dissecting Electrode accessory attached to the compatible ABC Handpieces. Not doing so may result in excessive argon flow, potentially causing an embolism. • Pure Argon Dissect and Low Argon Dissect will create minimal or no eschar. • Pulse ABC will result in minimal coagulation and should not be directed into an open vessel.

• 1.4.1.7 Output Voltage and Electric Shock • Failure of the CONMED HelixAR ABC System could result in an unintended increase in output power. • To avoid the risk of electrical shock, never make contact with the chassis and the patient simultaneously. • The risks of neuromuscular stimulation increases with Coagulation Modes, such as Spray Coag and ABC. Precautions should be taken to ensure the patient’s well-being is maintained in the event of noticeable stimulation. 1.4.2 Cautions Safe and effective electrosurgery is dependent, not only on equipment design, but also on factors under the control of the operator. It is important the instructions supplied with this equipment be read, understood and followed in order to ensure safe and effective use of the equipment. The HelixAR ABC System is capable of causing physiological effects, including burns to the patient or operator. Observe all caution and warning symbols.

1.4.1.6 General Modes, Flow Rates and Duty Cycles • Only use Lap Mode for laparoscopic surgery. Do not select the Open, ABC®Flex or Manual Modes. The Lap Mode limits the maximum argon flow rate to 4 slpm. • Use only ABC®Flex Mode for GI surgery. Do not select the Open, Lap or Manual Modes. The ABC®Flex Mode limits the maximum flow rate to 2 slpm. • The operator of this device must ensure that the desired mode is selected prior to activation. • As the clinical use of electrosurgical units is intermittent in nature, with duty cycles on the order of 10%, this ESU is not designed to operate for extended periods of continuous output.

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Section 1 GENERAL INFORMATION 1.4.2.1 Operator Qualifications WARNING: To prevent injuries and/or damage to the System, do not attempt repair. Maintenance should be performed only by qualified service personnel. WARNING: Use of incorrect fuses or shorting IEC bars can cause electrical safety hazard. WARNING: Failure to replace the fuses with the components specified in Section 6.2 may result in risk of fire or smoke. WARNING: As the clinical use of electrosurgical units is intermittent in nature with duty cycles on the order of 10%, this ESU is not designed to operate for extended periods of continuous output.

• Only properly qualified and trained operators should perform electrosurgery. The operator and his/her support personnel must be diligent in assuring the ESU is properly configured and proper settings are used. The ESU must be in a location that assures the operator or his/her support personnel can readily verify the settings. 1.4.2.2 Dispersive Electrodes and Other Accessories • Apparent low power output or failure of the electrosurgical equipment to provide the expected effect at otherwise normal settings may indicate faulty application of the Dispersive Electrode, failure of an electrical lead or excessive accumulation of tissue on the active electrode. Do not increase power output before checking for obvious defects or misapplication of the Dispersive Electrode. Check for effective contact of the Dispersive Electrode to the patient anytime the patient is moved after initial application of the Dispersive Electrode. • In the event the system resets due to a power interruption or low voltage, check the contact of the Dispersive Electrode prior to resuming electrosurgery. • If a Dispersive Electrode or ARM alert is sounded intraoperatively, physically confirm proper Dispersive Electrode attachment to the patient and confirm the Dispersive Electrode Status Indicator is within the acceptable contact quality range when using a Dual Pad. Smooth the Dispersive Electrode surface with a hand to ensure electrode contact with the patient’s skin. Replace the Dispersive Electrode if necessary. • The cables to the surgical electrodes (Active, Bipolar or Dispersive Electrodes) should be positioned in such a way that contact with the patient or other leads is avoided. • The operating room staff should never contact electrosurgical electrodes (either active or dispersive) while the radio-frequency output of the ESU is energized. • The electrodes of recently activated accessories may be hot enough to burn the patient or ignite surgical drapes or other flammable material.

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• Temporarily unused active electrodes should be stored in an electrically insulated location, such as a holster. The unused active electrode should never be placed on the patient. • When using compatible Argon Handpieces, an alert will sound if the system detects occlusion in the argon flow. 1.4.2.3 Smoke Evacuation • Studies have shown the smoke generated during electrosurgical procedures may be harmful to surgical personnel. These studies recommend using a surgical mask and adequate ventilation of the smoke using a surgical smoke evacuator. 1.4.2.4 General Modes, Flow Rates and Duty Cycles • Confirm the desired electrosurgical mode is selected prior to use to ensure output characteristics are suitable for the intended procedure. • The output power selected should be as low as possible and activation times should be as short as possible for the intended purpose. • The clinical use of electrosurgery is intermittent in nature. This ESU should not be activated continuously for extended periods of time. • Do not ignore unexpected tones. Check to determine the cause of the tone to avoid potential injury. 1.4.2.5 Output Voltage and Electric Shock • Avoid output power settings that may result in output voltages that exceed the rating of the attached accessory. See Sections 6.13 for additional details. 1.4.2.6 Dual or Simultaneous Activation • Simultaneous activation can be used in both Standard and Spray Monopolar Coagulation Modes. Caution should be used, as the output from either active electrode may change as a result of activation of a second output or ending activation of an output.