VIO3 User Manual V1.0x March 2016

Table of Contents

Table of Contents Safety Instructions... 9 Intended use... 9 Intended purpose... 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... 11 Risks due to the environment... 11 Electric shock... 12 Fire / explosion... 13 Burns... 15 Risks due to incorrect use of the return electrode... 19 Defective unit... 21 Interference caused by the unit... 21 Damage to the unit and accessories... 22 Notes... 23

2

Safety Features... 25 NESSY... 25 VIO 3 detects no return electrode... 27 Split return electrode connected... 28 Non-split return electrode connected... 31 Neonatal monitoring... 32 Automatic monitoring of the HF output parameters electrical voltage and power... 32 Automatic monitoring of the maximum activation time... 32 Protection from operating errors... 33

80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

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3

Accessories... 35 Introduction... 35 VIO 3 example accessories... 36 Use of APC instruments... 38 Check compatibility of instrument and CUT / COAG mode with the help of the Upmax display... 38 Check compatibility of the return electrode... 40 Compatible footswitches... 40

4

Description of the Controls... 41 Controls on the front panel... 41 VIO 3 main screen... 43 Controls on the back... 46

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Table of Contents

Working with VIO 3... 47 Make power connection...47 Switching on, self-test...47 Selecting the program...48 Connecting return electrode, applying it on the patient...49 Check return electrode...49 Connecting the first instrument...50 Connecting a second instrument...52 Meaning of the instrument symbols in different displays...53 Connecting an instrument which is not stored in the program...54 Checking program settings...54 Changing mode and effect...55 Assigning activation type...57 Activating VIO 3...58 Subprograms, changing between subprograms...60 Functions in the “Menu” screen...61 Overwriting a modified program or saving as a new program...64

6

Editing mode... 67 Authorized persons...67 Editing options...67 Renaming, adding and deleting elements...67 Creating a new program with two subprograms...70

7

Description of receptacle hardware... 75 Individual socket configuration...75 Purchasing further receptacles...75 Monopolar socket MO 3-pin; 9/5...75 Monopolar socket MO 3-pin; Bovie...75 Bipolar socket BI 2-pin 22–28; 8/4...76 Multifunction socket MF...76 MF-U socket...76 return electrode socket NE 6; 2-pin...77

8

Monopolar CUT modes... 79 autoCUT...79 highCUT...81 dryCUT®...83 endoCUT® I...85 endoCUT® Q...87

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Monopolar COAG modes... 89 softCOAG®...89 forcedCOAG®...91 swiftCOAG®...93 sprayCOAG®...95 preciseSECT...97 twinCOAG®...99

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Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

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Table of Contents

10 Bipolar CUT modes... 101 autoCUT bipolar... 101 highCUT bipolar... 103

11 Bipolar COAG modes... 105 softCOAG® bipolar... 105 forcedCOAG® bipolar... 108 thermoSEAL®... 110

forcedAPC... 113 preciseAPC®... 115 pulsedAPC®... 117

13 Argon-supported modes (only available with the APC module) . . 119 autoCUT... 119 highCUT... 121 dryCUT®... 123 softCOAG®... 125 forcedCOAG®... 127 swiftCOAG®... 129 preciseSECT... 131 twinCOAG®... 133

14 Installation... 135 80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

12 APC modes (only available with the APC module)... 113

Ambient conditions... 135 Electrical installation... 136 Installation of the rear of the VIO 3... 138 Installation of the VIO 3 on an overhead suspension arm system... 139 Installation of the VIO 3 on an Erbe equipment cart... 139

15 Cleaning and Disinfection... 141 Safety Instructions... 141 Wipe disinfection... 142 Instructions for cleaning and disinfection... 142

16 Messages... 143 17 General Technical Data... 149 18 Information on electromagnetic compatibility (EMC)... 151 Guidelines for avoiding, recognizing and rectifying unwanted electromagnetic effects on other equipment or systems, which are the result of operating the VIO system... 151

19 WiFi explanations... 155 Explanation on compliance with FCC Rules... 155 Explanation on compliance with IC Rules... 155

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1 • Safety Instructions

Chapter 1 Safety Instructions

The VIO 3 can be combined with suitable Erbe units and modules (e.g. APC 3) and accessories. The VIO 3 may only be used in rooms used for medical purposes. The VIO 3 may only be used by medical professionals who have been trained in the use of the unit or combination of units on the basis of the User Manual.

Intended use The VIO 3 is an electrosurgical unit for cutting and coagulation, as well as for vessel sealing. Thanks to its performance features, it offers universal applications.

Safety notations

DANGER 80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

Normal use

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.

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 The safety instructions are structured according to the following risks: • Operating errors and incorrect installation by persons without training • Risks due to the environment • Electric shock • Fire / explosion • Burns • Risks due to incorrect use of the return electrode • Defective unit • Interference caused by the unit • Damage to the unit and accessories • Notes

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80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

Compliance with safety information

1 • Safety Instructions

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.

 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.  Training may only be carried out by persons who are suitable on the basis of their knowledge and practical experience.  In the event of uncertainties or if you have any questions, please contact Erbe Elektromedizin. 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 by portable and mobile HF communication devices (e.g. mobile phones, WLAN equipment) Electromagnetic waves emitted by portable and mobile HF communication devices can effect the unit. The unit may fail or not perform properly. 80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

Risk of injury or death for patients and medical staff! Risk of damage to property.

 Please see the table "Recommended separation distances between portable and mobile HF communications equipment and the equipment" at the end of this User Manual.

NOTICE 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.  Operate the equipment at a suitable temperature and level of humidity. You will find the tolerances for temperature and humidity in the Technical Data.  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.  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.  If other ambient conditions must be observed for transport and storage of the equipment, you will also find them in the Technical Data.

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1 • Safety Instructions

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.  Acclimatize the device according to the rules in the Technical Data.

Overheating of the device due to poor ventilation If ventilation is poor, the device can overheat, sustain damage, and fail.  Install the device in such a way that there is an unobstructed circulation of air around the housing. Installation in confined wall recesses is prohibited.

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

Electric shock

WARNING 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.  Connect the unit / the equipment cart to a properly installed grounded power outlet.  Only connect the unit to a power supply network with proper grounding.  Only use the Erbe power cord or an equivalent power cord for this purpose. The power cord must bear the applicable national test symbol.  Check the power cord for damage. You must not use a damaged power cord.  The supply voltage must match the voltage specified on the unit's rating plate.  Do not use multiple power outlets.  Do not use extension cords.

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80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

NOTICE

1 • Safety Instructions

WARNING Incorrect line fuse, defective device Risk of electric shock to the patient and medical personnel! Risk of damage to property.  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.

WARNING Connection of unit / equipment cart and power supply during cleaning and disinfection Risk of electric shock to the medical personnel!  Switch off the device. Unplug the power cord of the device/equipment cart.

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 80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

 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 Erbe.

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

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!  Allow the gas mixture to escape through the resectoscope sheath.  Do not resect into the gas mixture.

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

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1 • Safety Instructions

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.  Do not use combustion-supporting gases when an operation is being performed on the head or thorax.

 Remove any jeopardized (e.g. cotton wool or gauze) materials before performing electrosurgery.  Check the oxygen-carrying tubes and connections for leaks.  Check the endotracheal tubes and their cuffs for leaks.  Before using argon plasma coagulation (APC) in the tracheobronchial system it is absolutely essential that you observe the specific safety information and instructions in the User Manual for the argon plasma unit!

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.  Do not bring active or hot instruments into contact with combustible materials.  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 / equipment cart Risk of fire and explosion to the patient and medical personnel! Risk of damage to property.  Use products that are not flammable. If the use of flammable products is unavoidable, proceed as follows:  Allow the products to evaporate completely before switching on the device.  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.

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80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

 If use is unavoidable, you must extract the combustion-supporting gases before performing electrosurgery.

1 • Safety Instructions

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.

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.  Check the device and accessories for damage every time before using them (e.g. footswitch, cords of instruments and the return electrode, equipment cart).  You must not use damaged equipment or damaged accessories. Replace defective accessories.  If the equipment or equipment cart is damaged, please contact our customer service.

80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

 Do not place the device in potentially explosive atmospheres.

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

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1 • Safety Instructions

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!  Prevent skin-to-skin points of contact. For example, lay dry gauze between the patient's arms and body.

Unintentional activation of the instrument Risk of burns to the patient and medical personnel!  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.  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.

CAUTION Hot instruments Even non-active instruments that are still hot can burn the patient or medical personnel.  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.  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. Risk of burns to the patient!  Turn off the power switch on the electrosurgical unit immediately. Only then should the instrument be removed from the patient’s body.

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80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

WARNING

1 • Safety Instructions

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!

 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.  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 Activation time too long, effects too high The longer the activation time of the unit and the higher the effect, the higher the risk of accidental tissue damage. Risk of accidental tissue damage to the patient!  Activate the unit for as short a time as possible relative to the required surgical effect. 80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

 Lay the cords of instruments in such a way that they are as far apart as possible.

 The temperature at the return electrode site increases during long and continuous activations; therefore, ensure that the cooling phases between activations are sufficient.  Set the effect as low as possible relative to the required surgical effect. However, an effect level that is too low can be dangerous, e.g. gas embolisms in connection with the APC (Argon Plasma Coagulation), because the plasma does not ignite at an effect level that is too low.  If you are unable to achieve a surgical effect with an activation time / effect level that is normally sufficient judging from experience, this can be due to a problem with the electrosurgical unit or accessories:  Check the instrument for soiling with insulating tissue remnants.  Check the return electrode to make sure it is secure.  Check the connectors on all cords to make sure they are secure.

WARNING 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.  Check the active settings on the display of the unit, after: switching on the unit, connecting up an instrument, and changing the program.

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1 • Safety Instructions

WARNING The user was not informed of a change in maximum activation time Risk of accidental tissue damage to the patient!  All users must be informed in good time of any change in maximum activation time. That is, before the user works with the modified maximum activation time for the first time.

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!  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!  Adjust the activation signal so that it is clearly audible.

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!  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!  Such practice is not recommended. The risk of burns cannot be ruled out.

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80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

 The temperature at the return electrode site increases during long and continuous activations; therefore, ensure that the cooling phases between activations are sufficient.

1 • Safety Instructions

CAUTION The interconnections of the VIO 3 carry HF voltage when they are activated. If you touch the interconnections during activation, you can suffer burns.  You may only remove the cap (1) (fig. below) if you install the VIO 3 on an APC 3.

Fig. 1-1

Risks due to incorrect use of the return electrode

CAUTION 80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

 Keep the cap in a safe place. If you disconnect the VIO 3 from the APC 3, you must replace the cap on the interconnections.

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

WARNING Positioning the return electrode above the heart Risk of ventricular fibrillation and cardiac arrest for the patient!  Do not position the return electrode over the heart or in the region of the heart.

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1 • Safety Instructions

CAUTION Incorrect application of the neutral electrode Risk of burns to the patient!  Apply the entire contact surface of the neutral electrode to a muscular part of the body with good blood circulation.  Apply the neutral electrode as close as possible to the surgical site.

 Align the long edge of the return electrode (1) towards the surgical field. The current should flow from the instrument towards the long edge of the return electrode. See Fig. 1-2.  Check the neutral electrode regularly for good contact with the patient's skin.  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.

80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

 Insert the contact tab of the neutral electrode completely into the connecting clamp. The contact tab must not touch the patient's skin.

1

1

Fig. 1-2

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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!  The device shuts off independently.

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

80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

 To guard against a possible failure of the electrosurgical unit, have the device checked for safety at least once a year.

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!  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.  Do not position the return 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.  Position the electrosurgical unit, the cords of the instruments, and the cord of the return electrode as far away as possible from electronic equipment.  Position the cords as far away as possible from the cords of electronic equipment.

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1 • Safety Instructions

WARNING Low-frequency currents stimulate nerves and muscles (Neuromuscular Stimulation) Low-frequency currents arise either due to low-frequency power sources or partial rectification of the HF current. Spasms or muscle contractions can occur. Risk of injury to the patient.

NOTICE Use of non-approved internal cables by Technical Service This can result in the increased emission of electromagnetic waves or reduce the immunity of the device. The unit may fail or not perform properly.  Technical Service may only use the internal cables that are listed in the service manual for the device.

NOTICE Stacked devices If you stack the device next to other equipment or with other equipment, the devices can affect each other. The unit may fail or not perform properly.  The device may only be stacked next to or with VIO series units.  If it is necessary to operate the device near other equipment or stacked together with other equipment, check whether the devices are affecting each other: Are the devices behaving unusually? Do errors occur?

Damage to the unit and accessories

NOTICE Alcohol-based spray disinfectant for fast disinfection In the case of elastic molded parts and paint surfaces, there is a risk of formation of cracks. Propanol and ethanol will attack the surfaces.  Do not use these substances.

NOTICE Alternate use of disinfectant solutions based on different active ingredients A color reaction may occur with plastics.  Do not use these substances alternately.

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80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

 Set effect as low as possible relative to the required surgical effect.

1 • Safety Instructions

CAUTION Electric load on instrument too high The instrument can be damaged. If the damaged area comes into contact with tissue, it can lead to unintentional coagulation.  Determine the electrical capacity of the instrument. It is either printed on the instrument or can be found in the user manual. Compare the electrical capacity of the instrument with the maximum HF peak voltage of the required mode.

CAUTION Very long activation cycles without cooling phases The electrosurgical unit is designed and tested for a relative activation time of 25% (in accordance with IEC 60601-2-2). If you undertake long activation phases without the appropriate cooling breaks, gradual heating under the return electrode may occur, or the unit may sustain damage. Risk of burns to the patient!  Keep to a 25% relative activation time (see also Technical Data, Operating Mode) if you operate the unit over a prolonged period.

Notes Grounding

Note: If necessary, the equipment can be connected to the external grounding system of the room with the grounding pin on the back of the unit and/or Cart using a connecting cable designed for this purpose. Affects of low frequency leakage currents due to a defective grounding system within the room may be eliminated through external grounding.

Use of a defibrillator

Note: All HF receptacles and the return electrode receptacle (applied parts) meet Type CF requirements and are protected against the effects of defibrillator discharge.

Using a smoke evacuator

Note: In order to evacuate the smoke that develops during electrosurgical procedures, Erbe recommends using a smoke evacuator.

80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

 Instructions are available in the "Accessories" chapter.

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2 • Safety Features

Chapter 2 Safety Features

What is NESSY?

Should you wish to activate the unit’s monopolar mode, you have to connect a return electrode and apply it on the patient. The unit is equipped with a Neutral Electrode Safety System (NESSY), which monitors the return electrode, warns of critical situations, and thus prevents burns. Observe the unit’s optical and acoustic warning signals. Observe the error and advisory messages from return electrode monitoring.

Safety when connecting a split or non-split return electrode

You can connect a split or a non-split return electrode to the VIO 3. Erbe recommends connecting a split return electrode, as it offers enhanced safety with regard to burns. When connecting a split return electrode, three safety-relevant properties are monitored: • the connection to the VIO 3 • the contact to the patient’s skin • the application direction of the return electrode (NESSY symmetry monitoring) When connecting a non-split return electrode, only one safety-relevant property is monitored:

80114-601 03.16

Dok.-Nr.: D110127, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: JDE/10.05.16, Ausdruck nicht maßstäblich und kein Original.

NESSY

• the connection to the VIO 3

Preferred return electrode type

In the VIO 3 Protected settings, you or an authorized person can set whether you wish to work with a split or non-split return electrode. If you connect the preferred type of return electrode, you do not need to register the return electrode on the VIO 3. If you connect another type of return electrode, VIO 3 asks you: Which return electrode type have you just connected? You then have to make the decision between a split or a non-split return electrode.

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