System 5000 Operators Manual Rev W 2013

LIMITED WARRANTY For a period of two years following the date of delivery, CONMED Corporation warrants the CONMED System 2450™ Electrosurgical Generator against any defects in material or workmanship and will repair or replace (at CONMED’s option) the same without charge, provided that routine 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.

© 2013 CONMED Corporation

525 French Road Utica, New York 13502-5994 USA

U.S. Patent Numbers 6,830,569 - 6,875,210 - 6,948,503 - D55224 and other patents pending. For Technical Service or Return Authorization Phone: 303-699-7600 / 1-800-552-0138 Extension 5274 Fax 303-699-1628 For Customer Service or to order parts phone: 1-800-448-6506 / 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 60-8016-ENG Rev. W Unit Serial Number_________________________________

TM

Table of Contents & List of Illustrations Section

1.0 1.1

Title

Page

General Information... 1-1

Cautions... 1-2

1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.1.5.1 1.1.5.2 1.1.5.3 1.1.5.4

Cautions For Equipment Preparation... 1-2 Cautions For Patient Preparation... 1-2 Cautions For Use... 1-4 Cautions For Testing or Servicing... 1-6 Electromagnetic Compatibility... 1-6 EN/IEC 60601-1-2 Table 201... 1-7 EN/IEC 60601-1-2 Table 202... 1-7 EN/IEC 60601-1-2 Table 204... 1-8 EN/IEC 60601-1-2 Table 206... 1-9

1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 1.2.6 1.2.7 1.2.8 1.2.9 1.2.10 1.2.11

Mains Overcurrent Protection... 1-9 Mains Frequency Leakage... 1-9 Regulatory Compliance... 1-9 Operation... 1-10 Power Display Accuracy... 1-10 Line Regulation... 1-10 Environmental... 1-10 Contact Quality Monitor... 1-10 Audio Specifications... 1-10 Other Specifications... 1-11 Operating Modes and Nominal Output Parameters... 1-11

1.2

Specifications... 1-9

1.3

Explanation of Symbols... 1-12

1.4

Output Characteristic Curves... 1-14

2.1 2.2

Initial Inspection... 2-1 Installation... 2-1

2.3

Preliminary Checks... 2-1

2.4

Controls, Displays and Connectors... 2-3

2.5 2.6

Set Up For Use... 2-7 Operation... 2-10

1.3.1 1.3.2 1.3.3 1.3.4

2.0 2.2.1 2.3.1 2.3.2 2.4.1 2.4.2 2.4.3 2.4.4

Control Panel... 1-12 Interior... 1-12 Output/Control Panel... 1-12 Rear Panel... 1-13

Installation and Operation... 2-1

Installation Of Fuses... 2-1 Preliminary Functional Testing... 2-1 Preliminary Performance Testing ... 2-3 Control Panel... 2-3 Output Panel... 2-5 Rear Panel... 2-6 Accessory Compatibility... 2-7

Section

Title

Page

2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.6.6 2.6.6.1 2.6.6.2 2.6.7 2.6.7.1 2.6.8

General... 2-10 Monopolar Pulse Cut... 2-10 Monopolar Pulse Coag... 2-11 Fluids Specialty Mode... 2-11 Lap Specialty Mode... 2-11 Programming... 2-11 Storing Programs... 2-11 Using Programs... 2-11 Remote Power Control ... 2-11 Changing Monopolar Power Remotely... 2-11 Shut Down Procedure... 2-12

2.7.1 2.7.2 2.7.3 2.7.4

General Maintenance Information... 2-12 Cleaning... 2-12 Periodic Inspection... 2-12 Periodic Performance Testing... 2-12

2.7

2.8

2.8.1 2.8.1.1 2.8.1.2 2.8.2 2.8.3 2.8.4

2.9

User Maintenance... 2-12

In Case of Difficulty... 2-12

Dispersive Electrode Alarm... 2-12 Single Dispersive Electrode Alarm... 2-12 Dual Dispersive Electrode Alarm... 2-13 Acc Codes... 2-13 Err Codes... 2-13 If All Else Fails... 2-13

Environmental Protection... 2-13

Figure/Title

Page

Figure 1.1 Figure 1.2 Figure 1.3 Figure 1.4 Figure 1.5 Figure 1.6 Figure 1.7 Figure 1.8 Figure 1.9 Figure 1.10 Figure 1.11 Figure 1.12 Figure 1.13 Figure 2.1 Figure 2.2 Figure 2.3 Figure 2.4 Figure 2.5

Output Power vs. Power Setting... 1-14 Display vs. Open Circuit Peak Voltage... 1-14 Load Regulation, Monopolar Pure Cut... 1-15 Load Regulation, Monopolar Blend 1... 1-15 Load Regulation, Monopolar Blend 2... 1-16 Load Regulation, Monopolar Blend 3... 1-16 Load Regulation, Monopolar Pinpoint Coag... 1-17 Load Regulation, Monopolar Standard Coag... 1-17 Load Regulation, Monopolar Spray Coag... 1-18 Load Regulation, Bipolar Micro... 1-18 Load Regulation, Bipolar Macro... 1-19 Load Regulation, Lap Spray... 1-19 Load Regulation, Lap Standard... 1-20 Control Panel... 2-4 Output Panel... 2-6 Rear Panel... 2-7 Accessory Schematics... 2-14 Accessory Connections... 2-14

TM

General Information Section 1.0

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. This manual provides the set up and operating instructions for the System 5000™ Electrosurgical Unit (ESU). Electrosurgery can be dangerous to patients, staff and other equipment if misused. Please understand and follow the warnings and cautions that are included in this manual. Technical specifications, performance characteristic curves and user maintenance instructions are also included. The System 5000™ provides a broad range of capabilities in a single, general-purpose electrosurgical generator. This rugged ESU fulfills the operational and safety needs of the modern operating room by providing:

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Continuous microprocessor safety monitoring.

Features include: •

Dynamic Response Technology delivers optimal clinical effects in all operational modes through the continuous synchronization of current and voltage.

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Bipolar Output Meter provides visual and audible feedback to surgeon during tubal ligations, vasectomies, and other procedures.

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ReadiPlug™ universal accessory receptacle eliminates the need for foot-controlled adapters.

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Four monopolar cutting modes: Pure, Blend 1, Blend 2 and Blend 3.

Nine programmable memory settings provide set-up convenience.

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Three monopolar coagulation modes: Spray, Standard and Pinpoint.

Automatic programming restores the ESU to the last settings used.

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Two bipolar modes: Micro and Macro

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Two specialty modes and a general surgery mode:

Remote Power Control (PC) allows power setting changes using standard hand-controlled pencils.

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Independent power setting available for all modes.

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General Mode provides full power performance for open surgical procedures.

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Fluids Specialty Mode provides immediate energy delivery for procedures performed in a fluid medium.

Ability to change power settings from the control panel while the ESU is activated.

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Laparoscopic Specialty Mode provides optimal safety by limiting output voltage and minimizing the potential harmful effects of capacitive coupling.

Two handswitched receptacles and a separate footswitched receptacle enable multiple accessory connections.

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Simultaneous activation in non-contact monopolar coagulation modes.

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Channeled accessory receptacles direct plugs into position, making attachments less cumbersome.

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Pulse Cut Mode provides precise modulated energy delivery for critical dissection.

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Pulse Coagulation Mode provides a modulated waveform for unsurpassed precision and control.

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Illuminated receptacles for greater visibility.

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Integrated operating room control system capability.

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Radio Frequency (RF) isolated and independent outputs.

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Integrated interface for activation of smoke evacuators and similar devices.

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The proven Automatic Return Monitor (A.R.M.™) contact quality monitoring system.

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1.1

Cautions

This equipment, in conjunction with connected accessories, is intended to produce highfrequency 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 safe and effective use of the equipment. 1.1.1 •

Cautions For Equipment Preparation

Use only accessories that comply with the relevant regulatory standards for your location and meet the requirements of Section 1.2, Section 1.4, and Figure 2.4. Use of other accessories may result in increased emissions or decreased immunity of the ESU.

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Reusable accessory cables should be periodically function and safety tested in accordance with the original manufacturer’s instructions.

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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.

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The System 5000™ is equipped to connect three monopolar accessories at one time for the convenience of the surgical staff. Unused accessories should be stowed in a safe, electrically insulated place such as a nonconductive holster, isolated from the patient. CONMED recommends accessories not be connected unless needed.

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Never connect more than one accessory at a time to any one receptacle, not including the dispersive electrode receptacle when the appropriate CONMED adapter is used.

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Use only a hospital grade, 3-prong, power cord rated to meet the specifications in Section 1.2 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 1.2. Do not use ground cheater plugs or extension cords. Failure to

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adhere to this warning may cause increased leakage currents. •

Do not place liquid containers 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.

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Do not stack other devices or equipment on top of or adjacent to the System 5000™. The CONMED Stacking Adapter (Cat. No. 60-8030001) allows two System 2500™ or System 5000™ units to be stacked in a safe manner.

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Confirm all accessories are properly connected to the appropriate receptacles before powering the ESU.

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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 Electrosurgery footswitches. Confirm bipolar leads are connected only to the bipolar receptacles. Connecting bipolar accessories to monopolar outputs may result in patient injury.

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Do not reuse disposable (single use) accessories.

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Do not use cords as handles as damage to the insulation and increased risk of burns or other injury may result.

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A failure in the ESU could cause an unintended increase in output power. Verify that the ESU is functioning correctly prior to use.

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Prior to use, verify that devices connected to the Activation Relay Connector function properly in a manner that is synchronized with ESU power delivery.

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Equipment connected to the Serial Interface Connector must be approved by CONMED and must be connected in accordance with instructions accompanying the equipment. Verify proper operation prior to ESU use.

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Disconnecting the power cord provides the primary means of isolating this device from Mains power. Position this device to allow quick disconnection of the power cord.

1.1.2 •

Cautions For Patient Preparation

Electrosurgery should NEVER be performed in the presence of flammable anesthetics, flammable prep solutions or drapes, oxidizing

gases such as Nitrous Oxide (N2O) or in oxygen-enriched environments. The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be eliminated by device design. Precautions must be taken to restrict flammable materials and substances from the electrosurgical site. They may be present in the form of an anesthetic, life support, skin preparation agent, produced by natural processes within body cavities or originate in surgical drapes, tracheal tubes or other materials. 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. Due to the danger of ignition of endogenous gases, the bowel should be purged and filled with nonflammable gas prior to abdominal surgery. To avoid the risk of tracheal fires, never use electrosurgery to enter the trachea during tracheotomy procedures. •

The System 5000™ mobile pedestal is made of nonconductive plastic, that can hold a static charge. It should not be used in a flammable environment, as described above.

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Only non-flammable agents should be used for cleaning and disinfection wherever possible.

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Exercise care when relocating 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.

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This ESU is equipped with the Automatic Return Monitor (A.R.M.™), which monitors the quality of the dispersive electrode connection. When a correctly functioning single dispersive electrode is connected to the ESU, A.R.M.™ verifies the connections between the ESU, the dispersive electrode cable and the dispersive electrode. It DOES NOT verify that a single dispersive electrode is in contact with the patient. When using a dual dispersive electrode, A.R.M.™ confirms the total resistance is within the preset safety range. Proper application and visual inspection of the dispersive electrode is required for safe operation.

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The use and proper placement of a dispersive electrode is a key element in safe and effec-

tive electrosurgery. Follow manufacturer’s directions and recommended practices for the preparation, placement, use, surveillance and removal of any dispersive electrode supplied for use with this electrosurgical unit. •

Apply the dispersive electrode over a wellvascularized muscle mass that is thoroughly clean and dry. Clean and clip site, as necessary, to provide adequate electrical connection and per hospital policy. Avoid placement over scar tissue, bony prominences or other areas where pressure points on small areas might develop.

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Because of the risk of burns, needles should never be used as a dispersive electrode for electrosurgery. 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.

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Dispersive electrodes and probes of monitoring, stimulating and imaging devices can provide paths for high frequency 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. Needles should not be used as monitoring electrodes during electrosurgical procedures.

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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.

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The active electrode should not be used in the vicinity of electrocardiograph electrodes.

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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

1-3

electrode site that is remote from other heat sources may minimize risk of a patient injury. •

Electrosurgery, by its 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. Cables subject to flexing should be inspected frequently for shielding integrity.

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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 below recognized limits. In the event of suspected interference from other equipment, discontinue use of the ESU until the problem can be remedied.

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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.

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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 use of electrosurgery.

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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 or neuromuscular stimulation 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.

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1-4

To minimize the possibility of cardiac pacemaker interference, place the dispersive elec-

trode such that the electrosurgical current path does not intersect the path of the pacemaker or leads. 1.1.3

Cautions For Use

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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 safe and effective use of the equipment. Only properly qualified and trained operators should perform electrosurgery. The operator and their support personnel must be diligent in assuring that the ESU is properly configured and that proper settings are used. The ESU must be located to assure the operator or their support personnel can readily verify the settings. The System 5000 is capable of causing physiological effects, including burns to the patient or operator.

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PLEASE NOTE: Federal law (U.S.A.) requires that all health care 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 Regulatory Affairs Department of CONMED Electrosurgery at 800-552-0138, 303-699-7600 or FAX 303-699-9854.

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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 that the bipolar electrosurgical technique is acceptable for circumcision, do not apply the bipolar electrosurgical current directly to circumcision clamps.

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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 disper-

sive 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. •

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•

•

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Studies have shown that 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 or other means. In the event that 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 A.R.M.™ alarm is sounded intraoperatively, physically confirm proper dispersive electrode attachment to the patient and confirm that the display falls within the set range. Smooth the dispersive electrode surface with hand to ensure electrode contact to patient skin. Replace the dispersive electrode if necessary. Some equipment and/or techniques fall outside the intended use of standard electrosurgery dispersive electrodes, such as application of high current, long activation times, or use of conductive fluid (e.g. tissue ablation, joint ablation, etc.) In these non-traditional conditions, there is a risk that excessive heat may build up in standard dispersive electrodes and may pose a risk to the patient. 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. Power sharing is unlikely to be equal because of differences in electrode to tissue distance and other factors. This unequal power sharing can be enough to stop power delivery to one electrode if the second electrode is close to tissue and the first electrode is somewhat above the tissue. The motion or deactivation of one electrode can cause the other electrode to start delivering power when it had been too far away from tissue to arc before the first electrode change.

Simultaneous activation can also increase leakage currents, which can be hazardous to the patient. It is recommended that a second electrosurgical generator be used when it is necessary to perform simultaneous operation. •

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.

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Confirm the desired specialty mode is selected prior to use to ensure output characteristics are suitable for the intended procedure.

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Confirm the desired bipolar mode is selected prior to use to ensure output characteristics are suitable for the intended procedure.

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The output power selected should be as low as possible and activation times should be as short as possible for the intended purpose.

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The clinical use of electrosurgery is intermittent in nature. This ESU should not be activated continuously for extended periods of time.

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When uncertain of the proper setting for the power level in a given procedure, start with a low setting and increase as required.

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Confirm that Pulse Cut Mode is properly selected prior to activation to ensure that improper application does not result in patient injury. Set the monopolar coag power to 0 when using Pulse Cut to ensure that an accidental activation of coag does not cause patient injury. Listen for the distinct Pulse Cut Activation Tone during activation to confirm that Pulse Cut is indeed active.

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Observe all caution and warning symbols printed on the ESU.

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The operating room staff should never contact electrosurgical electrodes (either active or dispersive) while the RF output of the ESU is energized.

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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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Do not ignore unexpected tones. Check to determine the cause of the tone, otherwise injury can occur.

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The Active Electrode is capable of delivering either Cut or Coag effects - use caution when selecting the proper activation request switch.

1-5

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Temporarily unused active electrodes should be stored in an electrically insulated holster. The unused active electrode should never be placed on the patient. This is especially important for laparoscopic procedures.

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Ensure that 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.

1.1.4 •

Service should not be attempted without reference to the System 5000™ service manual (Catalog Number 60-8017-ENG), provided by ConMed. The Service Manual provides the Preventative Maintenance (PM) requirements, calibration instructions, circuit diagrams, and circuit components listing necessary for performing service on the System 5000. This electrosurgical unit should be tested by a Hospital Qualified Biomedical Technician on a periodic basis to ensure proper and safe operation. It is recommended that examination of the ESU be performed at least yearly.

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When the ESU is integrated in a system, such as an Operating Room Control Center through the Serial Interface Connector, the organization responsible for system integration must ensure safety by evaluating the system using IEC 60601-1: 2005 as a basis.

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No modification to this equipment is allowed.

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There are no user serviceable parts in this equipment. Improper servicing of the equipment could result in improper operation and present a risk of electric shock

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Refer all servicing to a Hospital Qualified Biomedical Technician. Your CONMED sales representative will be happy to assist you in getting your equipment serviced. High voltages are developed within the ESU that are accessible when the top cover is removed. These voltages are potentially dangerous and should be treated with extreme caution.

• The high voltage DC power supply in this ESU is equipped with a bleeder resistor to dissipate the charge on the filter capacitor.

1-6

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Never remove or install any parts with the power cord connected to AC mains.

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Avoid contact with the output leads when the ESU is activated. Periodically inspect the test leads used for the output connections for obvious defects.

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Although this ESU will withstand momentary short circuits on the output, prolonged short circuits may damage the ESU. Shortcircuiting the output should be avoided since it is neither necessary nor desirable.

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Since 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. When testing, it is recommended that duty cycles be limited to 10 seconds activation with delays of 30 seconds between activations.

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Activating the System 5000™ in other than its normal operating position impairs the heat dissipation capability of the heat sink.

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Ensure that the two top cover screws are tightened and always perform a power-up check to confirm a normal power-up sequence before returning the ESU to service.

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Improperly connecting test equipment can cause electric shock and destruction of equipment.

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Turn unit off and wait until storage capacitors have discharged before connecting test equipment.

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Loss of power supply isolation can cause electrical shock. When servicing the high voltage power supply, assume internal isolation is compromised until verified otherwise.

Cautions For Testing or Servicing

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However, it takes several seconds after power is removed to bleed the charge down to a safe level. It is recommended that the ESU be isolated from the mains by removing the power cord connection to the power plug and allowing at least thirty (30) seconds be elapse before touching or attempting to perform any maintenance involving the power supply or power amplifier.

1.1.5

Electromagnetic Compatibility

Following are guidance and manufacturer’s declarations regarding electromagnetic compatibility for the System 5000™.

1.1.5.1 EN/IEC 60601-1-2 Table 201 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The System 5000™ Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the System 5000 Electrosurgical Unit should assure that it is used in such an environment.

Emissions test

Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Group 2

The System 5000 Electrosurgical Unit must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

The System 5000 Electrosurgical Unit is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/Flicker emissions IEC 61000-3-3

Complies

1.1.5.2 EN/IEC 60601-1-2 Table 202 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The System 5000™ Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the System 5000 Electrosurgical Unit should assure that it is used in such an environment.

Immunity Test

IEC60601 test level

Compliance level

Electromagnetic environment - guidance

Electromagnetic discharge (ESD)

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/ burst

±2 kV for power supply lines

±2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-4

±1 kV for input/ output lines

±1 kV for input/ output lines

Surge

±1 kV differential mode

±1 kV differential mode

±2 kV common mode

±2 kV common mode

<5 % UT (>95 % dip in UT) for 0.5 cycle

<5 % UT (>95 % dip in UT) for 0.5 cycle

40 % UT (60 % dip in UT) for 5 cycles

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

IEC 61000-4-2

IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the System 5000 Electrosurgical Unit requires continued operation during power mains interruptions, it is recommended that the System 5000 Electrosurgical Unit be powered from an uninterruptible power supply or a battery.

<5 % UT <5 % UT (>95 % dip in UT) (>95 % dip in UT) for 5 sec for 5 sec Power frequency (50/60 Hz) magnetic field

3 A/m

3 A/m

IEC 61000-4-8

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

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1.1.5.3 EN/IEC 60601-1-2 Table 204 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The System 5000™ Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the System 5000 Electrosurgical Unit should assure that it is used in such an environment.

Immunity Test

IEC60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the System 5000™ Electrosurgical Unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

d = 1.2√P

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the System 5000™ Electrosurgical Unit is used exceeds the applicable RF compliance level above, the System 5000™ Electrosurgical Unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the System 5000™ Electrosurgical Unit.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [v1] V/m.

1-8

1.1.5.4 EN/IEC 60601-1-2 Table 206 Recommended separation distances between portable and mobile RF communications equipment and the System 5000™ Electrosurgical Unit The System 5000™ Electrosurgical Unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the System 5000™ Electrosurgical Unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System 5000™ Electrosurgical Unit as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2√P

d = 1.2√P

d = 2.3√P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

(W)

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

1.2

Specifications

Input Power: 600 watts maximum Model

Mains Voltage VRMS

Frequency

Mains Current ARMS

Fuses*

Hz

Nominal

60-8005-001

50/60

115

104

127

5.3

T6.3A

60-8005-002

50/60

100

90

110

6.2

T8.0A

60-8005-003

50/60

230

198

253

2.7

T3.15A

Minimum Maximum

Maximum

*Fuses are Type T, High Breaking 1.2.1

Mains Overcurrent Protection

Two fuses for each ESU with ratings as noted in the table above. 1.2.2

Mains Frequency Leakage

Designed to comply with IEC60601-1: 2005. Patient connections to Neutral: Less than 10 μA. Chassis to Neutral: Less than 25 μA (120V), Less than 45 μA (240V). 1.2.3

Regulatory Compliance

Designed to comply with Medical Electrical Equipment Standards (IEC 60601-1: 2005 and related standards). Manufactured in an ISO 13485 Registered Facility.

1-9

Type of protection against electric shock: IEC Class 1. Degree of protection against electric shock: Type CF, Defibrillator Proof. Non-Ionizing Radiation. 1.2.4

Operation

Mode of operation: Intermittent 10 Sec on/30 Sec off. 1.2.5

Power Display Accuracy

The greater of ±10% of display or ±3 watts at rated load. 1.2.6

Line Regulation

Power Change <1%/V for the range of line voltages specified. 1.2.7

Environmental

Operating Conditions: 10°C to 30°C, 95% RH Non-condensing maximum at altitudes between 60 meters below and 3000 meters above mean sea level. Degree of protection against Ingress of Water: IPX1 (Protection against vertically falling water drops). Mounting Restriction: 2-inch (5cm) clearance required on each side, back and above the ESU for cooling. Cooling: Natural convection, conduction, radiation and temperature controlled fan. Storage Conditions: -34°C (-29° F) to 65°C (149° F), 95% RH Non-condensing maximum, at altitudes from –60 to +4500 meters above mean sea level when sealed in original poly bag, packing material and shipping carton.

Transportation Conditions: -34°C (-29° F) to 65°C (149° F), 95% RH Non-condensing maximum. Prior to shipment or storage, the ESU should be enclosed and sealed in a polyethylene bag and placed in original carton using original packaging materials. RF Leakage: <100 mA per IEC60601-2-2: 2009, 201.8.7.3.101b. 1.2.8

Contact Quality Monitor

Single dispersive electrode: Two wire continuity detector, typical trip threshold is 10 ohms Dual dispersive electrode: Two wire resistance monitor, typical acceptance range 10 to 150 ohms, trip threshold typically 30% higher than initial activation, visual indication of patient resistance changes. 1.2.9

Audio Specifications

Cut = 520 Hz Coag = 440 Hz Bipolar = 440 Hz Acc Fault = 847 Hz (pulsating) Dispersive Electrode Alarm = 847 Hz (pulsating) Err Fault = 847 Hz (pulsating) Increase Power Level = 379 Hz Decrease Power Level = 343 Hz Enter Cut Remote Power Control = 440 Hz followed by 574 Hz

1-10

Enter Coag Remote Power Control = 440 Hz followed by 515 Hz Bipolar Output Tone = 215 Hz Pulse Cut Activation Tone = 520 Hz with periodic short pulses at 481 Hz during output power pulses Pulse Coag Activation Tone = 440 Hz with periodic short pulses at 384 Hz (All tones are 45 dbA minimum except Alarms, which are 65 dbA minimum) 1.2.10 Other Specifications Power Cord: All units supplied with an IEC-320 250V 10A 65°C mains inlet connector. Power cords can be ordered from CONMED Electrosurgery or obtained from other sources if the following specifications are met: Region

Specification

Description

Standard

USA, Canada

Any UL, CSA manufacturer

SJT or better

250VAC, minimum 16AWG, 3 Conductor, maxi- UL817 mum length 20 feet (6m)

Europe

Any HAR cord manufacturer

<HAR>H05WF3G1.0

Copper 1.0mm2 minimum cross sectional area, maximum length 20 feet or 6.0m

IEC60799

Weight: 21.5 lb. (9.75 Kg) Height: 5.5 inches (14 cm); Width: 13.5 inches (35 cm); Depth: 21.5 inches (48 cm) including handle SPECIFICATIONS SUBJECT TO CHANGE WITHOUT NOTICE 1.2.11 Operating Modes and Nominal Output Parameters Max Power (watts)

Rated Load (ohms)

Typical Crest Factor

Max Open Circuit Voltage (Peak)

Carrier Freq. (KHz)*

Pulse Repetition Freq. (KHz)

Pure Cut

300

500

1.4 - 1.7

720

391

N/A

Blend 1

200

500

1.5 – 1.9

820

391

20.0

Blend 2

200

500

1.8 – 2.4

980

391

20.0

Blend 3

200

500

2.4 – 2.9

1230

391

20.0

Pinpoint Coag

120

500

3.7 - 4.6

1720

391

20.0

Standard Coag

120

500

5.6 – 6.6

2740

562

39.0

Spray Coag

80

500

7.1 – 9.7

5220

562

19.5

Micro Coag

50

50

1.5 – 1.9

160

391

N/A

Macro Coag

90

300

1.6 - 2.0

540

391

N/A

Mode Monopolar

Bipolar

*Measured in the open circuit condition. •

Activation of Pulse Cut will make the selected cut mode, Pure Cut, Blend 1, Blend 2, or Blend 3 active for 70 milliseconds every 600 milliseconds.

•

Activation of Pulse Coag will make the selected coag mode, either Standard or Spray, active for 2.5 milliseconds every 5 milliseconds. Displayed power setting will represent the average power being delivered which is approximately half the power delivered during the pulses.

•

LAP Specialty Mode output parameters match general operation parameters except the maximum voltage is limited to less than 2700 Volts peak.

•

FLUIDS Specialty Mode output parameters match general operation parameters with an initial energy boost upon activation to initiate an arc.

1-11

1.3

Explanation of Symbols

1.3.1

Control Panel

Single Dispersive electrode Status/Alarm Indicator for single monopolar dispersive electrodes.

Note: International System 5000™ units use symbols on the Control Panel. Some symbols are replaced by words on the domestic (U.S.) units. These words are indicated by bold text in the symbol description.

Dual Dispersive electrode Status/Alarm Indicator for dual monopolar dispersive electrodes.

Pure Cut waveform with minimum thermal damage and hemostasis.

Bipolar Output Current ndicator Pulse Mode

Blend 1 waveform with moderate hemostasis.

Remote Power Control Key: Press to enable or disable Remote Power Control.

Blend 2 waveform with medium hemostasis.

Program

Blend 3 waveform with maximum hemostasis.

Program Store Key

Pinpoint Monopolar Coagulation. Selection Scroll Button

Standard Monopolar Coagulation. Spray Monopolar Coagulation.

1.3.2

Protective Earth (Inlet Connector)

Micro Bipolar Coagulation

High Voltage Circuitry

Macro Bipolar Coagulation 1.3.3 General Setup

Fluids Specialty Mode

Interior

Output/Control Panel Dispersive Electrode – Connection for monopolar dispersive electrode. ReadiPlug™ Universal Accessory Receptacle

Lap Specialty Mode

1-12

Hand-controlled Monopolar Output: Connection for handcontrolled monopolar accessories.

Do not operate in oxygen enriched environments.

Bipolar Output: Connection for bipolar accessories.

Bipolar Footswitch Connector.

Caution: High voltage output.

Activation relay connector.

Type CF: Patient connections are isolated from earth and resist the effects of defibrillator discharge. RF Isolated: Patient connections are isolated from earth at high frequency. Caution Power on: connected to the mains. Power off: disconnected from the mains. Refer to Instruction Manual/ Booklet (for critical safety instruction) The color of the symbol is blue. 1.3.4

Rear Panel Enclosure resists entry of vertically falling water. This equipment intentionally supplies non-ionizing RF energy for physiological effect.

Monopolar Footswitch Connector.

Equipotential Ground Terminal. Replace fuse only with type and rating as shown. Caution - High Voltage Inside - Refer servicing to qualified personnel. Serial Interface Connector. Volume control: Bipolar Activation tone. Volume control: Activation tone. Volume increase/decrease. Medical Electrical Equipment: With respect to electric shock, fire and mechanical hazards only in accordance with IEC/ AAMI ES60601-1 / CAN/ CSA-C22.2 No. 60601-1 (2008) Consult accompanying documents prior to placing equipment in service.

Explosion risk if used in the presence of flammable anesthetics.

1-13

1.4

Output Characteristic Curves

Power Output (Watts to Rated Load)

Figure 1.1 illustrates output power delivered to rated load for all available modes. Figure 1.2 illustrates the maximum peak voltage available at a given power setting and output mode. Section 1.2 specifies rated loads and maximum power for each mode, while figures 1.3 – 1.11 illustrate output power delivered to a range of load resistances for each mode.

Displayed Setting

Figure 1.1 Output Power vs. Power Setting

5000

Output Voltage (Peak)

4000 3000 2000 1000 0 0

100

200

Power Setting

Figure 1.2 Display vs. Open Circuit Peak Voltage

1-14

300

Output Power (Watts)

Load Resistance (Ohms)

Output Power (Watts)

Figure 1.3 Load Regulation, Monopolar Pure Cut

Load Resistance (Ohms)

Figure 1.4 Load Regulation, Monopolar Blend 1

1-15

Output Power (Watts)

Load Resistance (Ohms)

Output Power (Watts)

Figure 1.5 Load Regulation, Monopolar Blend 2

Load Resistance (Ohms)

Figure 1.6 Load Regulation, Monopolar Blend 3

1-16