Conmed 5000 User manual

Operator’s Manual

E L E C T R O S U R G I C A L U N I T

LIMITED WARRANTY

For a period of two years following the date of delivery,

CONMED Corporation warrants the CONMED System

5000™ 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.

525 French Road

Utica, New York 13502 U.S.A.

U.S. Patent Nos. 4,961,739 - 5,152,762 - 5,626,575-

6,830,569 - 6,835,082 - 6,875,210 - 6,939,347 -

D477,082 - D477,408.

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. N 11/07

Unit Serial Number_________________________________

Table of Contents

& List of Illustrations

Section Title Page

1.0 General Information .........................................................................1-1

1.1 Cautions ...................................................................................................... 1-1

1.1.1 Cautions For Equipment Preparation ................................................................................1-2

1.1.2 Cautions For Patient Preparation .......................................................................................

1.1.3 Cautions For Use ..............................................................................................................

1.1.4 Cautions For Testing or Servicing .....................................................................................1-5

1.1.5 Electromagnetic Compatibility ..........................................................................................

1.1.5.1 EN/IEC 60601-1-2 Table 201 ...........................................................................................

1.1.5.2 EN/IEC 60601-1-2 Table 202 ...........................................................................................

1.1.5.3 EN/IEC 60601-1-2 Table 204 ...........................................................................................

1.1.5.4 EN/IEC 60601-1-2 Table 206 ...........................................................................................

1.2 Specifications .............................................................................................. 1-9

1.2.1 Mains Overcurrent Protection ...........................................................................................1-9

1.2.2 Mains Frequency Leakage .................................................................................................1-9

1.2.3 Regulatory Compliance ...................................................................................................

1.2.4 Operation ........................................................................................................................

1.2.5 Power Display Accuracy ..................................................................................................

1.2.6 Line Regulation ..............................................................................................................1-10

1.2.7 Environmental .................................................................................................................

1.2.8 Contact Quality Monitor .................................................................................................

1.2.9 Audio Specifications ........................................................................................................

1.2.10 Other Specifications ........................................................................................................

1.2.11 Operating Modes and Nominal Output Parameters .........................................................1-11

1.3 Explanation of Symbols ............................................................................. 1-12

1.3.1 Control Panel ..................................................................................................................1-12

1.3.2 Interior ............................................................................................................................

1.3.3 Output/Control Panel ......................................................................................................1-12

1.3.4 Rear Panel .......................................................................................................................1-13

1.4 Output Characteristic Curves .................................................................... 1-14

2.0 Installation and Operation ................................................................ 2-1

2.1 Initial Inspection ......................................................................................... 2-1

2.2 Installation .................................................................................................. 2-1

2.2.1 Installation Of Fuses .........................................................................................................2-1

2.3 Preliminary Checks .....................................................................................2-1

2.3.1 Preliminary Functional Testing ..........................................................................................2-1

2.3.2 Preliminary Performance Testing ......................................................................................

2.4 Controls, Displays and Connectors .............................................................2-3

2.4.1 Control Panel ....................................................................................................................2-3

2.4.2 Output Panel .....................................................................................................................

2.4.3 Rear Panel .........................................................................................................................

2.5 Set Up For Use ........................................................................................... 2-7

2.6 Oper

2.6.1 General ...........................................................................................................................2-10

2.6.2 Monopolar Pulse Cut ......................................................................................................2-10

ation .................................................................................................. 2-10

1-2 1-4

1-6 1-6 1-7 1-8 1-9

1-10 1-10 1-10

1-10 1-10 1-10 1-11

1-12

2-3

2-5 2-6

Section Title Page

2.6.3 Monopolar Pulse Coag ....................................................................................................2-11

2.6.4 Fluids Specialty Mode .....................................................................................................

2.6.5 Lap Specialty Mode .........................................................................................................

2.6.6 Programming ..................................................................................................................

2.6.6.1 Storing Programs ............................................................................................................

2.6.6.2 Using Programs ..............................................................................................................

2.6.7 Remote Power Control

2.6.7.1 Changing Monopolar Power Remotely ...........................................................................

..................................................................................................2-11

2-11 2-11 2-11 2-11 2-11

2-12

2.7 User Maintenance ..................................................................................... 2-12

2.7.1 General Maintenance Information ................................................................................... 2-12

2.7.2 Cleaning ..........................................................................................................................

2.7.3 Periodic Inspection ..........................................................................................................

2.7.4 Periodic Performance Testing ..........................................................................................

2-12 2-12 2-12

2.8 In Case of Difficulty .................................................................................. 2-12

2.8.1 Dispersive Electrode Alarm .............................................................................................2-12

2.8.1.1 Single Dispersive Electrode Alarm ...................................................................................

2.8.1.2 Dual Dispersive Electrode Alarm ....................................................................................

2.8.2 Acc Codes .......................................................................................................................

2.8.3 Err Codes ........................................................................................................................

2.8.4 If All Else Fails ................................................................................................................

2-12 2-13 2-13 2-13 2-13

2.9 Environmental Protection .........................................................................2-13

Figure/Title Page

Figure 1.1 Output Power vs. Power Setting ........................................................................................1-14

Figure 1.2 Display vs. Open Circuit Peak Voltage ...............................................................................

Figure 1.3 Load Regulation, Monopolar Pure Cut .............................................................................

Figure 1.4 Load Regulation, Monopolar Blend 1 ...............................................................................

Figure 1.5 Load Regulation, Monopolar Blend 2 ...............................................................................

Figure 1.6 Load Regulation, Monopolar Blend 3 ...............................................................................

Figure 1.7 Load Regulation, Monopolar Pinpoint Coag .....................................................................

Figure 1.8 Load Regulation, Monopolar Standard Coag ....................................................................

Figure 1.9 Load Regulation, Monopolar Spray Coag .........................................................................

Figure 1.10 Load Regulation, Bipolar Micro ......................................................................................

Figure 1.11 Load Regulation, Bipolar Macro .....................................................................................

Figure 1.12 Load Regulation, Lap Spray ............................................................................................

Figure 1.13 Load Regulation, Lap Standard .......................................................................................

Figure 2.1 Control Panel .......................................................................................................................

Figure 2.2 Output Panel .......................................................................................................................

Figure 2.3 Rear Panel ...........................................................................................................................

Figure 2.4 Accessory Schematics .........................................................................................................

Figure 2.5 Accessory Connections ......................................................................................................

1-14 1-15 1-15 1-16 1-16 1-17 1-17 1-18 1-18 1-19 1-19 1-20

2-4 2-6

2-7 2-14 2-14

General Information

Section 1.0

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 mis used. 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:

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

• Three monopolar coagulation modes: Spray, Standard and Pinpoint.

• Two bipolar modes: Micro and Macro

• Two specialty modes and a general surgery mode:

• General Mode provides full power perfor mance for open surgical procedures.

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

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

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

• Pulse Coagulation Mode provides a modulated waveform for unsurpassed precision and con trol.

• Radio Frequency (RF) isolated and indepen dent outputs.

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

• Continuous microprocessor safety monitoring.

Features include:

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

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

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

• Nine programmable memory settings provide set-up convenience.

• Automatic programming restores the ESU to the last settings used.

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

• Independent power setting available for all modes.

• Ability to change power settings from the con trol panel while the ESU is activated.

• Two handswitched receptacles and a separate footswitched receptacle enable multiple acces sory connections.

• Simultaneous activation in non-contact monopolar coagulation modes.

• Channeled accessory receptacles direct plugs into position, making attachments less cum bersome.

• Illuminated receptacles for greater visibility.

• Integrated operating room control system capability.

• Integrated interface for activation of smoke evacuators and similar devices.

1.1 Cautions

This equipment, in conjunction with connected accessories, is intended to produce high-frequency electrical energy for the controlled destruction of tissue.

1-1

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 rel evant 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.

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

• Visually inspect all accessories before each use to verify the integrity of insulation and the absence of obvious defects. In particular, elec trode cables and endoscopic accessories should be checked for damage to the insulation.

• 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, electri cally insulated place such as a non-conductive holster, isolated from the patient. CONMED recommends accessories not be connected unless needed.

• 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.

• 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, cor rectly polarized and of the proper frequency per Section 1.2. Do not use ground cheater plugs or extension cords.

• 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.

• Do not stack other devices or equipment on top of or adjacent to the System 5000™. The CONMED Stacking Adapter (Cat. No.

60-8030-001) allows two System 2500™ or System 5000™ units to be stacked in a safe manner.

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

• 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.

• Do not reuse disposable (single use) accesso ries.

• Do not use cords as handles as damage to the

insulation and increased risk of burns or other injury may result.

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

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

• 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.

1.1.2 Cautions For Patient Preparation

• Electrosurgery should NEVER be performed in the presence of flammable anesthetics, flammable prep solutions or drapes, oxidiz ing gases such as Nitrous Oxide (N oxygen-enriched environments. The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be elim inated 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,

O) or in

1-2

such as the vagina. Any fluid pooled in these areas should be removed before the high fre quency 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 tra cheotomy 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.

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

• Exercise care when relocating the ESU to avoid electrostatic charge buildup in the pres ence of flammable materials, as there is a risk of igniting these materials if a spark should occur.

• This ESU is equipped with the Automatic Return Monitor (A.R.M.™), which monitors the quality of the dispersive electrode con nection. 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 disper sive 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 opera tion.

• 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 well-vas cularized 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 tis sue, bony prominences or other areas where pressure points on small areas might develop.

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

electrosurgery. The entire area of the disper sive 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 tho rax.

• Dispersive electrodes and probes of monitor ing, 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 elec trode. 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.

• 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 disper sive 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.

• Heat applied by thermal blankets or other sources is cumulative with the heat pro duced at the dispersive electrode (caused by electrosurgical currents). Choosing a disper sive electrode site that is remote from other heat sources may minimize risk of a patient injury.

• Electrosurgery, by its nature produces signifi cant 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 interfer

1-3

ence. Cables subject to flexing should be inspected frequently for shielding integrity.

• Other equipment in the operating room, including portable or mobile communica tions equipment, may produce EMI, which can affect the function of the ESU. Adverse effects can only be mitigated by use of equip ment with EMI characteristics proven below recognized limits. In the event of suspected interference from other equipment, discon tinue use of the ESU until the problem can be remedied.

• The patient should not be allowed to come into contact with metal items that are ground ed 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 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.

• The use of electrosurgery on patients with cardiac pacemakers, AICDs, neurostimulators or other active implants is potentially hazard ous. The implant may be irreparably dam aged and/or the high frequency energy of the electrosurgical output may interfere with the function of the implant. Ventricular fibrilla tion may occur. Precautions should be taken to ensure the patient’s well-being is main tained in the event of such interaction. The manufacturers of the implants should be con sulted for advice before operating on a patient with an implant. These precautions also apply to operating room personnel with similar implants.

• To minimize the possibility of cardiac pace maker interference, place the dispersive elec trode such that the electrosurgical current path does not intersect the path of the pace maker or leads.

1.1.3 Cautions For Use

• 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 quali fied and trained operators should perform electrosurgery. The operator and their sup port 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.

• 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 inci dent. 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 manu facturer and the FDA. For further informa tion, please contact the Regulatory Affairs Department of CONMED Electrosurgery at 800-552-0138, 303-699-7600 or FAX 303699-9854.

• Do not use monopolar electrosurgery on small appendages, as in circumcision or finger sur gery, 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 accept able for circumcision, do not apply the bipolar electrosurgical current directly to circumcision clamps.

• 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 misap plication 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 elec trode.

1-4

• Studies have shown that smoke generated during electrosurgical procedures may be harmful to surgical personnel. These studies recom mend using a surgical mask and adequate ven tilation 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 with in the set range. Smooth the dispersive elec trode surface with hand to ensure electrode contact to patient skin. Replace the dispersive electrode if necessary.

• 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 end ing 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.

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

• Confirm the desired bipolar 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 intermit tent in nature. This ESU should not be acti vated continuously for extended periods of time.

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

• 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 con firm that Pulse Cut is indeed active.

• Observe all caution and warning symbols printed on the ESU.

• The operating room staff should never contact electrosurgical electrodes (either active or dis persive) while the RF 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.

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

• 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.

• Ensure that the footswitches are not inadver tently depressed in order to prevent acces sories from being unintentionally activated. Place footswitches in locations that necessi tate deliberate action in order to activate the footswitch. Use caution when selecting the correct footswitch to activate.

1.1.4 Cautions For Testing or Servicing

• Service should not be attempted without refer ence to the System 5000™ service manual (Catalog Number 60-8017-ENG).

1-5

• 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 examina

tion of the ESU be performed at least yearly.

• 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 dan gerous and should be treated with extreme caution.

• The high voltage DC power supply in the System 5000™ is equipped with a bleeder resistor to dissipate the charge on the filter capacitor. However, it takes several seconds after power is removed to bleed that charge down to a safe level. It is recommended that at least thirty (30) seconds be allowed to elapse before touching or attempting to per

form any maintenance involving the power supply or power amplifier.

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

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

• Although this ESU will withstand momentary short circuits on the output, prolonged short circuits may damage the ESU. Short-circuit

ing the output should be avoided since it is neither necessary nor desirable.

• 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 continu

ous output. When testing, it is recommended that duty cycles be limited to 10 seconds

activation with delays of 30 seconds between activations.

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

• Ensure that the two top cover screws are tight

ened and always perform a power-up check to confirm a normal power-up sequence before returning the ESU to service.

• Improperly connecting test equipment can cause electric shock and destruction of equip

ment.

• Turn unit off and wait until storage capacitors have discharged before connecting test equip

ment.

• Loss of power supply isolation can cause elec

trical shock. When servicing the high voltage power supply, assume internal isolation is compromised until verified otherwise.

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

Harmonic emissions IEC 61000-3-2

Voltage fluctuations/ Flicker emissions IEC 61000-3-3

Group 2 The System 5000 Electrosurgical Unit must emit electromagnetic

energy in order to perform its intended function. Nearby elec tronic equipment may be affected.

Class A The System 5000 Electrosurgical Unit is suitable for use in all

establishments, other than domestic establishments and those

Class A

Complies

directly connected to the public low-voltage power supply net work that supplies buildings used for domestic purposes.

1-6

1.1.5.2 EN/IEC 60601-1-2 Table 202

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Immunity Test IEC60601 test

level

Electromagnetic discharge (ESD)

IEC 61000-4-2

Electrical fast transient/ burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short inter ruptions and voltage variations on power sup ply input lines

IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

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

±6 kV contact

±8 kV air

±2 kV for power supply lines

±1 kV for input/ output lines

±1 kV differential mode

±2 kV common mode

<5 % UT (>95 % dip in UT)

for 0.5 cycle

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

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

<5 % UT (>95 % dip in UT) for 5 sec

3 A/m 3 A/m Power frequency magnetic fields should be at

Compliance level

±6 kV contact

±8 kV air

±2 kV for power supply lines

±1 kV for input/ output lines

±1 kV differential mode

±2 kV common mode

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

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

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

<5 % UT (>95 % dip in UT) for 5 sec

Electromagnetic environment - guidance

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

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

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

Mains power quality should be that of a typi cal 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 sup ply or a battery.

levels characteristic of a typical location in a typical commercial or hospital environment.

1-7

1.1.5.3 EN/IEC 60601-1-2 Table 204

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

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

Radiated RF IEC 61000-4-3

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.

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) tele phones 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.

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

3 Vrms

3 V/m

d = 1.2√P

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 tance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

d is the recommended separation dis-

should be less than the

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