VIO dV User Manual V 3.3.x Rev A

USER MANUAL VIO®dV

Registered trademarks of Erbe Elektromedizin GmbH: autoCUT®, BiCision®, BiClamp®, CleverCap®, endoCUT®, endoCOAG®, Erbe®, erbe power your performance.®, ERBECRYO®, ERBEJET®, ERBOKRYO®, FiAPC®, forcedCOAG®, HYBRIDknife®, KYRON®, NESSY®, NESSY ŭ®, PLURA®, preciseAPC®, Preflow®, pulsedAPC®, ReMode®, softCOAG®, sprayCOAG®, swiftCOAG®, thermoSEAL®, twinCOAG®, VIO®.

For USA only: Caution: Federal law (USA) restricts this device to sale, distribution, or use by or on the order of a physician. MEDICAL - APPLIED CURRENT/ENERGY EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH AAMI ES60601-1 (2005) + AMD 1 (2012) CSA-C22.2 No. 60601-1 (2014) ANSI/AAMI/IEC 60601-2-2:2017 CSA-C22.2 No. 60601-2-2:19 19NA

UL has classified the high frequency surgical unit VIO with the following assortment of high frequency surgical accessories: • 20193-084 split neutral electrode • 20190-109 hand switching ESU pencil • 20195-501 bipolar forceps, premium • 20196-053 connecting cable for electro surgery

CE0124

Art. No. 10140-620 All rights to this User Manual, in particular rights of duplication, dissemination and translation, are reserved. No part of this User Manual may be reproduced in any form (by photocopying, microfilming or other methods) or processed, duplicated or disseminated by the use of electronic systems without the written consent of Erbe Elektromedizin GmbH. The information contained in this User Manual can be changed or expanded without prior notice and without obligation on the part of Erbe Elektromedizin GmbH. The illustrations in this User Manual may differ in some details from your product. Printed by Erbe Elektromedizin Printed in Germany Copyright © Erbe Elektromedizin GmbH, Tübingen 2020

Table of Contents

Table of Contents 1

Safety Instructions... 9

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Normal use... 9 Intended use... 9 Safety notations... 9 Meaning of the note... 9 Who must read this User Manual?... 10 Compliance with safety information... 10 Structure of safety instructions... 10 Operating errors and incorrect installation by persons without training... 10 Risks due to the environment... 11 Electric shock... 12 Fire / explosion... 13 Burns... 14 Inadvertent tissue damage... 18 Risks due to incorrect use of the neutral electrode... 19 Defective unit... 21 Interference caused by the unit... 21 Damage to the unit and accessories... 23 Notes... 23

2

Safety Features... 25 NESSY... 25 What NESSY setting is active? What neutral electrode do I have to connect?... 26 Incorrect neutral electrode connected... 27 No neutral electrode connected... 28 Setting: Dual Pad... 28 Setting: Single Pad... 29 Setting: Either Way, single surface neutral electrode connected... 29 Setting: Either Way, dual surface neutral electrode connected... 30 Short circuit in the connecting cord or in the clip of a dual surface neutral electrode with the setting Either Way... 31 Monitoring the direction of application of the contact surfaces in the case of dual surface neutral electrodes... 32 Automatic monitoring of the HF output parameters electrical voltage and power... 33 Automatic monitoring of the Activation Time Limit... 33 Protection from operating errors... 34 Startup Tests... 34

3

Operating principle of the VIO dV... 35 Constant voltage regulation as opposed to constant power regulation... 35

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Table of Contents

4

Accessories... 37 Introduction...37 Examples of accessories for VIO dV...38 Check compatibility of instrument and CUT / COAG mode...39 Check compatibility of the neutral electrode...41 Compatible footswitches...41

5

Description of the Controls... 43 Controls on the front panel and control panel...43 Description of a display...46 Controls on the back...47

Working with the electrosurgical unit... 49 Grounding the unit, connecting footswitches, establishing a power connection...49 Switching on the unit, performance test...49 Connecting the neutral electrode...49 Checking the neutral electrode connection...50 What neutral electrode features that are related to safety are monitored?...51 Connecting instruments...51 Calling up settings used in the previous surgical procedure using Recall...52 Setting the unit without using the Recall button...53 Select the mode, effect and power limit...53 Activating using the footswitch...56 Activating using the fingerswitch...58 Calling up the help menu...60 VIO dV signal tones...61 Modifying the volume on the unit...61

7

Description of receptacle hardware... 63 Monopolar receptacle...63 Bipolar receptacle...63 Neutral electrode receptacle...64

8

Monopolar modes... 65 AUTO CUT...65 DRY CUT...66 SWIFT COAG...68 FORCED COAG...69 CLASSIC COAG...71

9

Bipolar modes... 73 BIPOLAR CUT...73 BIPOLAR SOFT COAG...74 BIPOLAR SOFT COAG with AUTO STOP...76 BiClamp...78

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6

Table of Contents

10 Installation... 81 Installing the unit... 81 Ambient conditions... 81 Electrical installation... 82 Installing the back of the electrosurgical unit... 84

11 Information on electromagnetic compatibility (EMC)... 85 Guidelines for avoiding, recognizing and rectifying unwanted electromagnetic effects on other equipment or systems, which are the result of operating the VIO system... 85

12 Cleaning and disinfection... 91 Wipe disinfection... 91 Instructions for cleaning and disinfection... 91 Safety Instructions... 91

13 Error messages... 93 14 General Technical Data... 95 15 Maintenance, Customer Service, Warranty, Disposal... 97

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Maintenance... 97 Warranty... 97 Disposal... 98

16 Symbols... 99

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Table of Contents

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1 • Safety Instructions

Chapter 1 Safety Instructions Normal use The VIO dV must be used with appropriate accessories. The VIO dV may only be operated in rooms used for medical purposes. The VIO dV may only be used by persons who have been trained on how to use the device or device combinations properly in accordance with the corresponding User Manual.

Intended use The Erbe VIO dV electrosurgical unit is intended to deliver High Frequency (HF) current for the cutting and/or coagulation of tissue.

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Safety notations

DANGER indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTICE indicates a potentially hazardous situation which, if not avoided, may result in property damage.

Meaning of the note "Note:" Refers a) to manufacturer's information that relates directly or indirectly to the safety of people or protection of property. The information does not relate directly to a risk or dangerous situation. Refers b) to manufacturer's information that is important or useful for operating or servicing the unit.

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1 • Safety Instructions

Who must read this User Manual? Knowledge of the User Manual is absolutely essential for correct operation of the unit. The User Manual must therefore be read by everyone who works with the equipment. Anyone who prepares, sets, disassembles, cleans and disinfects the unit must also read the User Manual. Please pay particular attention to the safety instructions in each chapter.

Compliance with safety information Working with medical equipment is associated with certain risks to patients, medical personnel and the environment. Risks cannot be entirely eliminated by design measures alone. Safety does not depend solely on the equipment. Safety depends to a large extent on the training of medical personnel and correct operation of the equipment. The safety instructions in this chapter must be read, understood and applied by everyone who is working with the equipment.

Structure of safety instructions

• Operating errors and incorrect installation by persons without training • Risks due to the environment • Electric shock • Fire / explosion • Burns • Inadvertent tissue damage • Risks due to incorrect use of the neutral electrode • Defective unit • Interference caused by the unit • Damage to the unit and accessories • Notes

Operating errors and incorrect installation by persons without training

WARNING Operating errors and incorrect installation by persons without training Persons without training can operate or install the unit incorrectly. Risk of injury or death for patients and medical staff! Risk of damage to property. Ö The equipment may only be used and installed by persons who have been trained on how to use and install it properly according to this User Manual.

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The safety instructions are structured according to the following risks:

1 • Safety Instructions

Ö Training may only be carried out by persons who are suitable on the basis of their knowledge and practical experience. Ö In the event of uncertainties or if you have any questions, please contact Technical Service. You will find the addresses in the address list at the end of this User Manual.

Risks due to the environment

NOTICE Interference with the unit from portable and mobile HF telecommunications equipment (e.g. mobile phones, WLAN equipment) Electromagnetic waves emitted by portable and mobile HF telecommunications equipment may affect the unit. The unit may fail or not perform properly. Ö When using portable and mobile HF telecommunications devices, including their accessories, there must be a distance of at least 30 cm between them and the device and its cords.

NOTICE

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Unsuitable temperature or level of humidity during operation If you operate the equipment at an unsuitable temperature or level of humidity, it may sustain damage, fail, or not perform properly. Ö Operate the equipment at a suitable temperature and level of humidity. You will find the tolerances for temperature and humidity in the Technical Data. Ö If other ambient conditions must be observed for operation of the equipment, you will also find them in the Technical Data.

NOTICE Unsuitable temperature or humidity in transit or storage If you transport or store the equipment at an unsuitable temperature or level of humidity, it may sustain damage and fail. Ö Transport and store the equipment at a suitable temperature and level of humidity. You will find the tolerances for temperature and humidity in the Technical Data. Ö If other ambient conditions must be observed for transport and storage of the equipment, you will also find them in the Technical Data.

NOTICE Insufficient acclimatization time, unsuitable temperature during acclimatization If the device was stored or transported below or above a certain temperature, it will take a certain time and temperature to acclimatize. If you do not observe the rules, the device can sustain damage and fail. Ö Acclimatize the device according to the rules in the Technical Data.

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1 • Safety Instructions

NOTICE Overheating of the device due to poor ventilation If ventilation is poor, the device can overheat, sustain damage, and fail. Ö Install the device in such a way that the circulation of air around the housing is not obstructed.

NOTICE Penetration of liquid into the device The housing is not absolutely watertight. If liquid penetrates, the device can sustain damage and fail. Ö Make sure no liquid can penetrate the device. Ö Do not place vessels containing liquids on top of the device.

Electric shock

WARNING

Ö Connect the unit to a properly installed grounded power outlet. Ö Only connect the unit to a power supply network with proper grounding. Ö Only use the provided power cord. The power cord must bear the applicable national test symbol. Ö Check the power cord for damage. You must not use a damaged power cord. Ö The supply voltage must match the voltage specified on the unit's rating plate. Ö Do not use multiple power outlets. Ö Do not use extension cords.

WARNING Incorrect line fuse, defective device Risk of electric shock to the patient and medical personnel! Risk of damage to property. Ö Blown line fuses may only be replaced by a competent technician. Only replacement fuses that have the same rating as the one specified on the unit’s rating plate may be used. Ö When a fuse has been changed, the function of the unit must be verified. If the unit does not function properly or if there are any concerns, please contact Technical Service. You will find the addresses in the address list at the end of this User Manual.

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Defective grounded power outlet, power supply network without proper grounding, inferior-quality power cord, incorrect line voltage, multiple power outlets, extension cords Risk of electric shock and other injuries to the patient and medical personnel! Risk of damage to property.

1 • Safety Instructions

WARNING Connection of unit and power supply during cleaning and disinfection Risk of electric shock to the medical personnel! Ö Switch off the unit. Unplug the power cord of the unit.

Fire / explosion In electrosurgery electric sparks and arcs occur at the instrument. Flammable gases, vapors, and liquids can be set alight or caused to explode.

DANGER Flammable anesthetics Risk of explosion to the patient and medical personnel! Risk of damage to property. Ö Do not use flammable anesthetics when an operation is being performed on the head or thorax. Ö If use is unavoidable, you must extract the anesthetics before performing electrosurgery.

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WARNING Flammable gas mixture in TUR (Transurethral Resection) and TCR (Transcervical Endometrial Resection) Hydrogen and oxygen can ascend into the roof of the bladder, the upper part of the prostate, and the upper part of the uterus. If you resect into this gas mixture, it could combust. Risk of combustion to the patient! Ö Allow the gas mixture to escape through the resectoscope sheath. Ö Do not resect into the gas mixture.

DANGER Flammable endogenous gases in the gastrointestinal tract Risk of explosion to the patient! Ö Extract the gases before performing electrosurgery or irrigate with CO2.

DANGER Combustion-supporting gases, e.g. oxygen, nitrous oxide The gases can accumulate in materials like cotton wool or gauze. The materials become highly flammable. Risk of fire to the patient and medical personnel! Risk of damage to property. Ö Do not use combustion-supporting gases when an operation is being performed on the head or thorax. Ö If use is unavoidable, you must extract the combustion-supporting gases before performing electrosurgery. Ö Remove any jeopardized (e.g. cotton wool or gauze) materials before performing electrosurgery.

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1 • Safety Instructions

Ö Check the oxygen-carrying tubes and connections for leaks. Ö Check the endotracheal tubes and their cuffs for leaks.

WARNING Active or hot instruments in contact with combustible materials Materials like gauze, swabs, and cloths can catch fire. Risk of fire to the patient and medical personnel! Risk of damage to property. Ö Do not bring active or hot instruments into contact with combustible materials. Ö Put instruments down in a safe place: sterile, dry, non-conductive, and easy to see. Instruments that have been put down must not come into contact with the patient, medical personnel, or combustible materials.

WARNING Flammable detergents and disinfectants, flammable solvents in adhesives used on the patient and on the device Risk of fire and explosion to the patient and medical personnel! Risk of damage to property. Ö Use products that are not flammable.

Ö Allow the products to evaporate completely before switching on the device. Ö Check whether flammable liquids have accumulated under the patient, in body recesses such as the navel, or in body cavities such as the vagina. Remove any liquids before performing electrosurgery.

WARNING Ignition of anesthetics, skin cleansers, and disinfectants in potentially explosive atmospheres If you place the device in a potentially explosive atmosphere, anesthetics, skin cleansers, and disinfectants can ignite. Risk of fire and explosion to the patient and medical personnel! Risk of damage to property. Ö Do not place the device in potentially explosive atmospheres.

Burns

WARNING Damaged device, damaged accessories, modified device, and modified accessories Risk of burns and injury to the patient and medical personnel! Risk of damage to property. Ö Check the device and accessories for damage every time before using them (e.g. footswitch, cords of instruments and the neutral electrode).

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If the use of flammable products is unavoidable, proceed as follows:

1 • Safety Instructions

Ö You must not use damaged equipment or damaged accessories. Replace defective accessories. Ö If the device is damaged, please contact Technical Service. Ö For your safety and that of the patient: Never attempt to perform repairs or make modifications yourself. Any modification will invalidate liability on the part of Erbe Elektromedizin GmbH.

WARNING HF leakage current flows through metal parts The patient must not have contact with electrically conductive objects. That includes metal parts of the operating table, for example. HF current can be discharged through points of contact accidentally (HF leakage current). Risk of burns to the patient! Ö Position the patient on dry, antistatic drapes. Ö If the drapes can become wet during the operation due to sweat, blood, irrigation liquid, urine, etc., lay a waterproof plastic sheet under the drapes.

WARNING HF leakage current flows through monitoring electrodes HF current can be discharged through points of contact between the skin and monitoring electrodes accidentally (HF leakage current).

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Risk of burns to the patient! Ö Position monitoring electrodes as far away as possible from the surgical field (area where electrosurgical instruments are used). Ö Do not use needle electrodes for monitoring during electrosurgery. Ö Where possible, use monitoring electrodes that contain devices to limit high-frequency current.

WARNING HF leakage current flows through skin-to-skin points of contact HF current can be discharged through skin-to-skin points of contact accidentally (HF leakage current). Risk of burns to the patient! Ö Prevent skin-to-skin points of contact. For example, lay dry gauze between the patient's arms and body.

WARNING Unintentional activation of the instrument Risk of burns to the patient and medical personnel! Ö Put instruments down in a safe place: sterile, dry, non-conductive, and easy to see. Instruments that have been put down must not come into contact with the patient, medical personnel, or combustible materials. Ö Instruments that have been put down must not come into contact with the patient, not even indirectly. An instrument can come into contact with the patient indirectly through electrically conductive objects or wet drapes, for example.

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1 • Safety Instructions

CAUTION Hot instruments Even non-active instruments that are still hot can burn the patient or medical personnel. Ö Put instruments down in a safe place: sterile, dry, non-conductive, and easy to see. Instruments that have been put down must not come into contact with the patient, medical personnel, or combustible materials. Ö Instruments that have been put down must not come into contact with the patient, not even indirectly. An instrument can come into contact with the patient indirectly through electrically conductive objects or wet drapes, for example.

WARNING Unintentional activation of the instrument during an endoscopic application If the instrument is activated and remains activated during an endoscopic application, the patient can suffer burns when the instrument is removed. All points that come into contact with the active part of the instrument are at risk. The cause of unintentional activation can be a fault in the footswitch or device for example. You will recognize unintentional activation from the continuous activation signal, even though you have released the footswitch. Ö Turn off the power switch on the electrosurgical unit immediately. Only then should the instrument be removed from the patient’s body.

WARNING Capacitive coupling between the cords of two instruments When one instrument is activated, current can be transferred to the cord of another instrument (capacitive coupling). The patient can suffer burns if the non-active but still live instrument has direct or indirect contact with the patient. Risk of burns to the patient! Ö Lay the cords of instruments in such a way that they are as far apart as possible. Ö Put instruments down in a safe place: sterile, dry, non-conductive, and easy to see. Ö Instruments that have been put down must not come into contact with the patient, medical personnel, or combustible materials. Ö Instruments that have been put down must not come into contact with the patient, not even indirectly. An instrument can come into contact with the patient indirectly through electrically conductive objects or wet drapes, for example.

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Risk of burns to the patient!

1 • Safety Instructions

WARNING Activation Time too long, effects too high The longer the Activation Time of the unit and the higher the effect, the greater the risk of accidental tissue damage. Risk of accidental tissue damage to the patient! Ö Activate the unit for as short a time as possible relative to the required surgical effect. Ö The temperature at the neutral electrode site increases during long and continuous activations; therefore, ensure that the cooling phases between activations are sufficient. Ö Set effect as low as possible relative to the required surgical effect. Ö If you are unable to achieve a surgical effect with an ActivationTime / effect level that is sufficient judging from experience, this can be due to a problem with the electrosurgical unit or accessories: Ö Check the instrument for soiling with insulating tissue remnants. Ö Check the neutral electrode to make sure it is secure. Ö Check the connectors on all cords to make sure they are secure.

WARNING

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Activation of the unit with no knowledge of active settings If the user does not understand the active settings of the unit, he can cause the patient accidental tissue damage. Ö Check the active settings on the display of the unit, after: switching on the unit, pressing the Recall button, and connecting an instrument.

WARNING The user was not informed of a change in Activation Time Limit Risk of accidental tissue damage to the patient! Ö All users must be informed of any change in Activation Time Limit, before the user works with the modified Activation Time Limit for the first time. Ö The temperature at the neutral electrode site increases during long and continuous activations; therefore, ensure that the cooling phases between activations are sufficient.

WARNING Tissue structures / vessels with a cross-section that is small or becoming smaller If monopolar HF current flows through parts of the body with a relatively small cross-section, there is a risk of unintentional coagulation for the patient! Ö If possible, use the bipolar coagulation technique.

WARNING Activation signal not audible You do not hear the signal when the electrosurgical unit is activated. Risk of burns to the patient and medical personnel! Ö Adjust the activation signal so that it is clearly audible.

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1 • Safety Instructions

WARNING Undesirable contact between the active instrument and metal objects in the patient's body Contact with metal hemostats, etc. Risk of burns to the patient! Ö Do not touch metal objects (e.g. implants) in the patient's body with the active instrument.

CAUTION A hand-held metal instrument is touched with the active instrument (electrode) Risk of hand burns! Ö Such practice is not recommended. The risk of burns cannot be ruled out.

CAUTION HF leakage current flows through the skin of medical personnel Risk of burns to the patient and medical personnel! Ö Do not come in contact with the patient while the surgeon is using an active electrosurgical instrument on the patient.

WARNING Safety margin between the active instrument and sensitive tissue structures too narrow Adjacent structures can be damaged by the thermal effect of electrosurgery. Ö Ensure that there is a sufficient safety margin between the active instrument and sensitive tissue structures (e.g. nerves, muscles).

CAUTION Electrically conductive implants can redirect or concentrate current flow. Risk of burns for the patient and possible damage to the implant. Ö In the case of patients wearing electrically conductive implants, consult the manufacturer of the implant or the relevant specialist department of your hospital prior to surgery. Ö Position the return electrode so that the implant is not located between the active electrode (monopolar instrument) and the return electrode.

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Inadvertent tissue damage

1 • Safety Instructions

Risks due to incorrect use of the neutral electrode

CAUTION Non-compatible or single surface neutral electrode When applying a non-compatible neutral electrode, it should be expected that monitoring the contact between neutral electrode and skin is faulty. When applying a single surface neutral electrode, the contact between neutral electrode and skin is not monitored. If contact between neutral electrode and skin is inadequate, the unit does not emit any visual and acoustic signal. Risk of burns for the patient under the neutral electrode! Ö Check in the accompanying papers of the manufacturer whether the neutral electrode is suitable for the VIO device used. Ö Use only suitable neutral electrodes. Ö Check in the accompanying papers of the manufacturer whether the neutral electrode cable is suitable for the neutral electrode used. Ö Use only suitable neutral electrode cables. Ö When applying a single surface neutral electrode: Regularly check the neutral electrode for good skin contact.

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WARNING Positioning the neutral electrode above the heart Risk of cardiac arrhythmia for the patient due to function-related currents from neutral electrode monitoring! Ö Do not position the neutral electrode over the heart or in the region of the heart.

CAUTION Incorrect application of the neutral electrode Risk of burns to the patient! Ö Apply the entire contact surface of the neutral electrode to a muscular part of the body with good blood circulation. Ö Apply the neutral electrode as close as possible to the surgical site. Ö Insert the contact tab of the neutral electrode completely into the connecting clamp. The contact tab must not touch the patient's skin. Ö Align the long edge of the neutral electrode (1) towards the operating field. The current should flow from the instrument to the long edge of the neutral electrode. See Fig. 1-1. Ö Check the neutral electrode regularly for good contact with the patient's skin. Ö Check the neutral electrode especially when the patient has been repositioned and after surgical steps where the device was activated frequently and for a long time.

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1 • Safety Instructions

Fig. 1-1

CAUTION Short circuit in the connecting cord or in the clip of a dual surface neutral electrode With the NESSY setting Either Way setup and a short circuit in the connecting cord or in the clip of a dual surface neutral electrode the device can no longer monitor the contact with the patient's skin or the application direction of the contact surface. You will not receive a warning if the electrode becomes detached from the skin. You will not receive a warning if the application direction of the neutral electrode is incorrect. Risk of burns to the patient! Ö To rule out the possibility of a short circuit in the connecting cord and the clip before use, you can test the connecting cord. (See chapter Safety Features.) Note: Erbe recommends using a dual surface neutral electrode with the setting Dual Pad. By combining the neutral electrode and unit settings in this way, maximum safety is ensured for monitoring of the neutral electrode (see chapter Safety Features). If there is a short circuit in the connecting cord, a warning tone and the message "Check neutral electrode contact" are triggered when a monopolar mode is activated.

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1 • Safety Instructions

Defective unit

WARNING Undesirable rise in output level due to failure of electrosurgical unit Risk of accidental tissue damage to the patient! Ö The device shuts off independently. Ö To guard against a possible failure of the electrosurgical unit, have the device checked for safety at least once a year.

WARNING Technical safety checks not being done Risk of injury or death for patients and medical staff! Risk of damage to property. Ö Have the device checked for safety at least once a year. Ö You must not use a device that is not safe.

WARNING Failure of display elements If display elements fail, you can no longer operate the device safely. Risk of injury or death for patients and medical staff!

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Ö You must not use the unit.

Interference caused by the unit

WARNING Interference with cardiac pacemakers, internal defibrillators, or other active implants Activation of the electrosurgical unit may affect the performance of active implants or damage them. Risk of injury or death for patients! Ö In the case of patients having active implants, consult the manufacturer of the implant or the competent department of your hospital prior to performing surgery. Ö Do not position the neutral electrode near cardiac pacemakers, internal defibrillators, or other active implants.

NOTICE Interference with electronic equipment due to the electrosurgical unit The activated electrosurgical unit can affect the performance of electronic equipment by causing interference. The equipment may fail or not perform properly. Ö Position the electrosurgical unit, the cords of the instruments, and the cord of the neutral electrode as far away as possible from electronic equipment. Ö Position the cords as far away as possible from the cords of electronic equipment.

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