ESG-100 ELECTROSURGICAL UNIT Instructions for Use Dec 2018

Olympus ESG-100

EN

Instructions for Use

Contents 1

Important information 1.1

Intended use

1.2

Applicability of endoscopic treatment

1.3

Instructions for use

1.4

User qualification

1.5

Environment of use

1.6

Electrosurgical unit compatibility

1.7

Repair and modification

1.8

Signal words

1.9

Danger, warnings and cautions

1.10 Reporting serious incidents

2

General description

3

Inspection prior to use

4

Symbols, definitions and functions 4.1

Symbols and descriptions 4.1.1 Front panel 4.1.2 Rear panel 4.1.3 Packaging

4.2

Front panel 4.2.1 Buttons / Switches 4.2.2 Indicators 4.2.3 Displays 4.2.4 Connectors

4.3

5

6

Rear panel

Accessories 5.1

Footswitch

5.2

P-cord

5.3

A-cord

5.4

Peristaltic pump unit AFU-100 and communication cable

Installation and commissioning 6.1

Installation of equipment

6.2

Connection to an AC mains power supply

6.3

Equipotential bonding

6.4

Connection of footswitch

6.5

Connection to the peristaltic pump unit AFU-100

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Operation 7.1

Power supply

7.2

Acoustic signals and tone volume adjustments

7.3

Neutral electrode (for monopolar treatment only) 7.3.1 Split type neutral electrode 7.3.2 Non-split neutral electrode 7.3.3 Connection of the neutral electrode

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9

7.4

Connection of instruments

7.5

Mode selection

7.6

Output power setting

7.7

Activation of selected mode

7.8

Performing the electrosurgical intervention

7.9

Procedure after use

Cleaning, storage and disposal 8.1

Cleaning

8.2

Storage

8.3

Disposal of the unit

Troubleshooting 9.1

Footswitch operation

9.2

Neutral electrode operation

9.3

Error codes and measures

9.4

Periodic safety checks

9.5

Returning the electrosurgical unit for repair

10

Service operation mode

11

System chart

12

Specifications 12.1 Mode characteristics 12.2 Output characteristics 12.3 Technical data

13

4

Electromagnetic compatibility

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1

Important information

1.1

Intended use

Instructions for Use

The ESG-100 is an electrosurgical unit for tissue coagulation and cutting in general and endoscopic surgery in conjunction with designated electrosurgical accessories, endoscopes applicable for electrosurgery, light sources and ancillary equipment. Contraindications: Electrosurgical interventions are contraindicated if, in the judgment of the physician, tissue coagulation and cutting could have a negative effect on the state of the patient. Electrosurgical tissue coagulation and cutting may be contraindicated for patients with cardiac pacemakers, a weakened immune system or blood coagulation disorders.

1.2

Applicability of endoscopic treatment If there is an official standard on the applicability of endoscopic treatment as defined by a national or local medical administration, or other institution, such as an academic society, follow that standard when performing the procedure. Before performing any endoscopic treatment, study the properties, purposes, effects and possible risks thoroughly (nature, extent, probability and imminence) associated with the planned treatment and any alternative therapeutic method that can be performed. Carry out endoscopic treatment only when its benefits outweigh its risks. Fully explain to the patient the possible benefits and risks of endoscopic treatment as well as those of any therapeutic method(s) that can be performed instead of endoscopy, and perform endoscopic treatment only after patient consent is granted. During endoscopic treatment, continue to evaluate the potential benefits and risks, and stop the treatment if the risks become greater than the possible benefits to the patient.

1.3

Instructions for use These instructions for use contain essential information on using this electrosurgical unit safely and effectively. Before use, thoroughly review these instructions for use and the instructions for use of all equipment which will be used during the procedure. Use the equipment as instructed. Keep this and all related instructions for use in a safe, accessible location. If you have any questions or comments about any information in these instructions for use, please contact Olympus or your distributor.

1.4

User qualification If there is an official standard that defines the qualifications required for medical personnel using electrosurgical generators as defined by a national or local medical administration or other institution, such as an academic society, follow this standard. If there is no such standard, the user must be a physician or medical personnel under supervision of a physician and must have received appropriate training in using this electrosurgical unit. These instructions for use, therefore, do not explain or discuss endoscopic or electrosurgical procedures. In addition, the user must undergo an instruction / training for the use of this unit. The instruction / training will be provided by authorised representatives of Olympus or your distributor during installation and commissioning. Federal Law of the USA restricts this device to use by, or on the order of, a physician.

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Instructions for Use

1.5

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Olympus ESG-100

Environment of use This product is only intended to be used in hospitals and medical rooms or equivalent with appropriate specialized equipment.

1.6

Electrosurgical unit compatibility Refer to chapter 11 (System chart) to confirm that this electrosurgical unit is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and / or equipment damage.

1.7

Repair and modification This electrosurgical generator does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or user injury and / or equipment damage may result. Repairs must only be carried out by Olympus or a firm authorised by Olympus. Some problems that appear to be malfunctions may be corrected by referring to chapter 9 (Troubleshooting). If the problem cannot be resolved using the information in chapter 9, contact Olympus or your distributor. Do not service or maintain any part of the product while in use with a patient.

1.8

Signal words The following signal words are used throughout these instructions for use: 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. It may also be used to alert against unsafe practices or potential equipment damage.

NOTE

Indicates additional helpful information.

d

1.9

Danger, warnings and cautions High frequency leakage current or spark discharge may cause user and / or patient burns. Always prepare for an emergency operation in case of unintentional patient burn, bleeding and perforation. Follow the dangers, warnings and cautions given below when handling this electrosurgical unit. This information is to be supplemented by the dangers, warnings and cautions given in each chapter.

User-related error prevention WARNING

Improper use

The safety and effectiveness of electrosurgical interventions depends not only on the design of the equipment used, but also to a major extent on factors which are under the

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Instructions for Use

control of the user. It is therefore extremely important to read, understand and follow the instructions supplied with the electrosurgical unit and the accessories in order to ensure safety and effectiveness. Always use the electrosurgical unit as outlined in these instructions for use. Improper use will not only impede functions and prevent optimum performance, but may cause equipment damage and / or complications. Before each use, always inspect the equipment as outlined in these instructions for use.

Environmental conditions CAUTION

Interference of the unit with other equipment

Be sure that this electrosurgical unit is not used adjacent to or stacked with other equipment (other than the components of this electrosurgical unit or system) to avoid electromagnetic interference. Before use, thoroughly confirm the compatibility of all equipment. To ensure electrical safety, the electrosurgical unit should not be used in conjunction with: 

Electrical equipment whose safety against leakage current is not guaranteed.



Electrosurgical equipment whose safety in combined use is not guaranteed.

The electrosurgical unit complies with the electromagnetic compatibility (EMC) standard. Nevertheless, when the electrosurgical unit is active it may disturb neighboring electronic equipment. If an auxiliary computer system is in use together with the electrosurgical unit and endoscopic imaging techniques, the image on the monitor might freeze or blackout. Follow the instructions in chapter 13 (Electromagnetic compatibility) regarding electromagnetic ambient conditions. Never loop the cords (active cord, bipolar cord, neutral electrode cord) or bundle cords together with cords belonging to other medical equipment. The high frequency signals or spark discharge noise generated by the unit may interfere with the operation of other medical equipment. Do not use the electrosurgical unit in a location exposed to strong electromagnetic radiation (microwave or short-wave medical treatment equipment, Magnetic Resonance Imaging, radio or mobile phone equipment). Electrosurgical unit malfunction can occur. CAUTION

Unsuitable temperature and humidity

The electrosurgical unit should only be used under the conditions as described in chapter 12.3 (Technical data). Use under other conditions may impede normal performance and / or result in equipment damage.

Accessories WARNING

Mechanical stress

Do not apply excessive bending, straining, or squeezing force to any cords. It may cause malfunction. CAUTION

Non-compatible accessories and accessory damage

The electrosurgical unit shall only be used with compatible accessories. When connecting accessories (cords, electrodes, instruments) avoid output settings where the maximum output voltage of the electrosurgical unit may exceed the rated accessory voltage (refer to chapters 12.1, Mode characteristics, 12.2 Output characteristics, and the instructions for use of the accessory). W7092100_03

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Refer to chapter 12.3 (Technical data) for a list of compatible neutral electrodes. Before use, the electrosurgical unit and accessories must be examined for damage. All communication cables and its plugs must be free of scratches and cracks. Cables and accessories with damaged insulation or connections must not be used.

Electric shock WARNING

Grounding failure

To prevent the risk of electric shock, the housing of the electrosurgical unit must be grounded. Always connect the power cord plug to a properly grounded wall outlet. Do not use a 3-pin / 2-pin adapter, as it can impair safe operation of the unit. WARNING

User shock

To prevent user shock, malfunction and damage of the electrosurgical unit, keep liquids away from all electrical equipment. If liquid gets on or into the electrosurgical unit, terminate operation immediately and contact Olympus or your distributor. CAUTION

Injury during servicing

When the housing is opened, there is a danger of electric shock. The unit must only be serviced by authorised technicians.

Burns WARNING

Patient and / or user

The maximum output voltage characteristics of the electrosurgical unit are shown in the diagrams in chapter 12.2 (Output characteristics). When setting the power level, first set it to a low level and increase it gradually. If the output is initially set to a high level, the electrode’s insulation may be damaged and cause user and / or patient burns. Furthermore, it is recommended that you perform basic testings before using the electrosurgical unit. If the instructions for use of the endoscopic instrument to be used stipulate a rated voltage, the output should be set so that it does not exceed that voltage. Contact with the tip of the electrodes may cause burns when the electrosurgical unit is active. During operation, temporarily unused electrodes should be stored in an electrically insulated container. Unused electrodes should never be placed on the patient. Otherwise, it may cause patient and / or user burns. To prevent patient burns, the electrosurgical unit and ancillary cords should not come in contact with the patient or metal parts of the operating table. Furthermore, the patient should also be kept away from metallic parts of the operating table or other devices. If the electrosurgical unit is used in conjunction with another electrosurgical unit, never use both electrosurgical units simultaneously. Keep the electrosurgical instrument connected to the not-used electrosurgical unit away from the target area while the other electrosurgical unit is in operation. Do not activate output of both units simultaneously. Patient or user injury may occur due to the concentration of electric current. To prevent patient burns, the patient’s skin surfaces should not touch each other (e.g. bare arm and side of chest) or any metal items in the procedure room. Remove any 8

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metallic items from the patient (wristwatches, jewelry, etc.) before starting the procedure. To prevent patient burns during endoscopic treatment, the patient’s clothes must be dry. During endoscopic treatment be sure that the distal end of the endoscope and / or instruments do / does not contact bridging fluids surrounding the target tissue. Electric current may flow to the surrounding tissue via the fluids and cause burns. The endoscopic treatment performed should not include an operation in which part of the treated tissue (polyp head, etc.) or part of the endoscope distal end or endotherapy instrument is in contact with or close to surrounding tissue during high frequency exposure. Otherwise, current flows to the tissue through the part of the treated tissue, the metallic parts at the endoscope’s distal end or endotherapy instrument and may cause burns. When using an electrocardiograph or other physiological monitoring equipment simultaneously with the electrosurgical unit on a patient, any monitoring electrodes should be placed as far away as possible from the electrodes used with the electrosurgical unit. If placed too close, high frequency signals or spark discharge noise from the electrosurgical unit may interfere with the operation of an electrocardiograph or other physiological monitoring equipment. Needle monitoring electrodes should not be used, as they may cause patient burns. Physiological monitoring equipment incorporating high frequency current limiting devices is recommended. To prevent burns, the user and assistant should wear chemical-resistant gloves during the procedure. CAUTION

High frequency leakage current

Wherever possible, the patient should not be able to come into contact with electrically conductive components that are grounded. Route all connecting cables so that they are not in direct contact with the patient or other cables. Capacitive coupling may occur.

Potential hazards for the heart DANGER

Shock hazards to the heart

To prevent shock hazards, never apply the electrosurgical unit to the heart in combination with type B or BF applied parts. When using the electrosurgical unit on or in the vicinity of the heart, be sure to use it with the minimum necessary output. Spark discharge during operation may affect the heart. DANGER

Pacemaker / Defibrillator malfunction

The high frequency equipment, when applied to a patient with a cardiac pacemaker, an implanted cardioverter defibrillator (ICD) or other implanted electronic devices (IED), may cause malfunctioning or failure of the implanted electronic device and may seriously affect the patient. Always confirm that it is safe to proceed with a cardiologist or the manufacturer of the implanted electronic device before proceeding. If monopolar modes of the electrosurgical unit are used, position the neutral electrode so that the current pathway does not pass through or near the implanted electronic device and its lead system. The risk of malfunction or failure of an implanted electronic device is reduced by the use of a bipolar mode. A risk does exist, however, if the application is in close proximity to the implanted electronic device. WARNING W7092100_03

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Instructions for Use

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Always keep a defibrillator ready in case of a cardiac emergency. During operation of the defibrillator, remove the endoscope from the patient.

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Fire / Explosion DANGER

Ignitable anaesthetics / fire supporting gases

The risk of flammable gases or other materials being ignited exists with any surgical application of electrical energy. Precautionary measures must be taken to keep flammable materials and substances away from the site of intervention (do not use flammable anaesthetics, nitrous oxide or oxygen). Otherwise, explosion or fire may result and cause serious injuries. This electrosurgical unit is not explosion-proof. Do not use the unit within an explosion zone. WARNING

Ignitable gas in the gastro-intestinal tract

If the intestines contain a flammable gas, replace this gas with air or a non-flammable gas before performing the operation, to minimize the risk of fire or explosion. WARNING

Ignitable cleaning- and disinfection agents

Flammable agents used for cleaning and disinfection must be allowed to evaporate before the electrosurgical unit is used. Also ensure that flammable solutions are neither on the patient’s skin (e.g. under neutral electrode) nor in the patient’s body cavity when the electrosurgical unit is used. Non-flammable agents should be used for cleaning and disinfection wherever possible. WARNING

Ignitable materials

If absorbent cotton or gauze is used during the procedure, it can be ignited by a spark generated in the normal operation of the equipment. When performing electrosurgery, arcs occur which could lead to burning or deflagration of combustible gases. WARNING

Risk of fire

Disconnect the power plug before changing the fuses! Replace fuses as marked. The fuses must only be replaced by authorised technicians.

Procedural hazards and complications DANGER

Procedural hazards and complications

The safety of electrosurgery will be greatly enhanced by a thorough knowledge of the medical literature on the subject. Study of specific information on the hazards and complications of the procedure in question is especially recommended. To respond to possible patient bleeding, prepare at least one of the following three haemostatic procedures: coagulation, clipping or local injection. To prepare for possible accidents, emergency equipment for life-saving, intubation and appropriate pharmaceuticals should be located in or near the procedure room. Use physiological monitoring equipment throughout the entire procedure, for continuous observation of the patient’s condition. For procedures where the high frequency current could flow through parts of the body with a relatively small cross-sectional area, use of a bipolar mode may be desirable to avoid accidental coagulation. The electrosurgical unit should not be used for performing circumcisions.

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WARNING

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Olympus ESG-100

Safety measures for personnel during procedure

Studies have shown that smoke generated during electrosurgical procedures can be irritating and potentially harmful to surgical personnel. These studies recommend the use of surgical masks and adequate ventilation of smoke by the use of surgical smoke evacuators or other means. WARNING

Output performance

If the electrosurgical unit fails and the output is stopped during treatment, it may be impossible to continue treatment due to adhesion of mucous tissue to the instrument or other accident. Should any abnormal output be suspected during operation, immediately terminate the use of the equipment by releasing the footswitch. If the footswitch does not react, switch off the electrosurgical unit. Otherwise, malfunction of the equipment may cause an unintended increase in output. During endoscopic treatment never grasp the target tissue with non-insulated grasping forceps. Non-insulated grasping forceps will disperse the electric current and normal operation may be impeded. WARNING

Unintentional electrical stimulation of nerves and muscles

Low frequency electrical currents can stimulate nerves and muscles. Low frequency electrical currents may be generated by a partial rectification of the high frequency electrical current, in particular when there is a spark discharge to the tissue or to another metallic object. This may cause violent spasms or muscle contractions. Use the lowest appropriate power level and cut level (e.g. Cut 1 instead of Cut 2). CAUTION

Unit defect

To prevent electrosurgical unit damage, never short-circuit electrodes (accessories, neutral electrodes). In the event of a defect or malfunction in the unit, an undesirably high output power may be emitted.

1.10 Reporting serious incidents If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority.

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General description The ESG-100 electrosurgical unit enables the user to perform common monopolar and bipolar applications. Both can be operated in cutting and coagulation modes. The electrosurgical unit is equipped with a user friendly display that allows the user to select from a list of optimized modes. All settings are saved automatically and are at the user’s disposition when switching on the electrosurgical unit the next time or when the user changes the modes during a procedure. The electrosurgical unit is equipped with a high voltage power supply which allows fast control of the output resulting in safely controlled tissue effects and protection against over- and under-dosage. In addition, the integrated high power cut support (HPCS) is a precondition for optimized cutting procedures without initial delay. Another feature of the electrosurgical unit is the fast spark monitor (FSM). This technology measures the spark intensity in intervals of a few milliseconds when cutting tissue. The fast spark monitor ensures the application of output powers that are as low as possible and as much as necessary to achieve well defined tissue effects. Moreover, the contact quality monitor (CQM) analyses continuously the contact resistance of the neutral electrode, ensuring a safe application and minimizing the risk of thermal injuries to the patient. The contact quality monitor status is continuously displayed by visual indicators. Finally, the leakage protection sensor (LPS) automatically monitors the high frequency leakage current through the patient and produces a visual and acoustic signal if the current is too high.

3

Inspection prior to use Verify that all items shown below are contained in the package. Inspect each item for damage. If the electrosurgical unit is damaged, a component is missing or you have any questions, do not use the electrosurgical unit. Contact Olympus or your distributor immediately.

Electrosurgical unit

Footswitch with cable

Instructions for use

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4

Symbols, definitions and functions

4.1

Symbols and descriptions

4.1.1 Front panel Power on / off

Caution

Toggle between modes Defibrillation proof type CF applied part (cardiac application) Up

Down

Bipolar cutting

Bipolar coagulation

Monopolar cutting

Monopolar coagulation Output insulated from earth (connection for neutral electrode) Footswitch assignment

Neutral electrode – non-split type

Neutral electrode – split type

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4.1.2 Rear panel Manufacturer Date of manufacture Serial number Reference number Indication of the direction of higher volume Loudspeaker Footswitch connection Interface for pump connection Operating instructions Waste electrical and electronic equipment Fuse Non-ionizing electromagnetic radiation CE marking indicating that the device is in conformity with the applicable requirements set out in applicable European Union harmonization legislation Operating instructions

Potential equalization terminal

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4.1.3 Packaging Keep away from rain Fragile; handle with care This way up Temperature storage

limit

during

transport

and

Stacking limit by number (including lowest box) Atmospheric pressure transport and storage

limitation

during

Relative humidity limitation during transport and storage Quantity

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4.2

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Front panel

Level display (21)

Up / down button (6 / 5)

Error indicator (8)

Mode display (22)

Power switch (0)

Toggle button (7)

Bipolar cut mode indicator (9)

Activation indicator bipolar cut (13)

Contact quality monitor indicator for split neutral electrode (20)

Footswitch assignment to bipolar connector indicator (17)

Neutral electrode connector (25)

Bipolar cut select button (1)

Bipolar connector (23) Activation indicator bipolar coagulation (14) Bipolar coagulation mode indicator (10) Bipolar coagulation select button (2)

Contact quality monitor indicator for non-split neutral electrode (19) Monopolar coagulation select button (4) Monopolar coagulation mode indicator (12) Activation indicator monopolar coagulation (16) Footswitch assignment to monopolar connector indicator (18) Monopolar connector (24) Activation indicator monopolar cut (15) Monopolar cut select button (3) Monopolar cut mode indicator (11)

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4.2.1 Buttons / Switches

18

0

Power switch This switch turns on and off the electrosurgical unit.

1

Bipolar cut select button This button is used for the selection of a bipolar cutting mode. The level display (21) shows the selected power level. The mode display (22) shows the selected mode.

2

Bipolar coagulation select button This button is used for the selection of a bipolar coagulation mode. The level display (21) shows the selected power level. The mode display (22) shows the selected mode.

3

Monopolar cut select button This button is used for the selection of a monopolar cutting mode. The level display (21) shows the selected power level. The mode display (22) shows the selected mode.

4

Monopolar coagulation select button This button is used for the selection of a monopolar coagulation mode. The level display (21) shows the selected power level. The mode display (22) shows the selected mode.

6/5

Up / down button These buttons increase / decrease the value displayed at level display (21) during normal operation.

7

Toggle button This button switches to the next mode shown in the mode display (22).

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4.2.2 Indicators 8

Error indicator This indicator illuminates red if any error occurs.

9

Bipolar cut mode indicator This indicator signals a bipolar cutting selection.

10

Bipolar coagulation mode indicator This indicator signals a bipolar coagulation selection.

11

Monopolar cut mode indicator This indicator signals a monopolar cutting selection.

12

Monopolar coagulation mode indicator This indicator signals a monopolar coagulation selection.

13

Activation indicator bipolar cut This indicator signals a bipolar cutting activation.

14

Activation indicator bipolar coagulation This indicator signals a bipolar coagulation activation.

15

Activation indicator monopolar cut This indicator signals a monopolar cutting activation.

16

Activation indicator monopolar coagulation This indicator signals a monopolar coagulation activation.

17

Footswitch assignment to bipolar connector indicator This indicator signals the footswitch assignment to the bipolar connector. When a bipolar cutting or coagulation mode is selected this indicator illuminates and both modes can be activated by the footswitch.

18

Footswitch assignment to monopolar connector indicator This indicator signals the footswitch assignment to monopolar connector. When a monopolar cutting or coagulation mode is selected this indicator illuminates and both modes can be activated by the footswitch.

19

Contact quality monitor indicator for non-split neutral electrode This indicator illuminates green if a non-split neutral electrode is connected.

20

Contact quality monitor indicator for split neutral electrode This indicator illuminates green if a split neutral electrode is connected and the contact resistance is within an acceptable range. The indicator illuminates red if the split neutral electrode is not connected or applied properly (e.g. bad contact quality) or no neutral electrode is connected (in both cases the activation of monopolar output is disabled).

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4.2.3 Displays 21

22

Level display This display shows the currently selected power level. 1 … 120

Power level

Err

Error notice

InF

Information notice

Mode display This display shows the currently selected mode during normal operation. Cut

Cutting mode

PulseCut

Pulsed cutting mode

SoftCoag

Soft coagulation mode

ForcedCoag

Forced coagulation mode

RFCoag

Controlled tissue coagulation with acoustic resistance feedback (radiofrequency coagulation)

RFCoag + RCAP

Deep tissue coagulation with resistance controlled automatic power (radiofrequency coagulation)

Mid.Ped. -> Toggle

Middle pedal of the footswitch is functioning as a toggle pedal if the peristaltic pump unit is disconnected

Mid.Ped. -> Pump

Middle pedal of the footswitch is activating the pump flow with connected peristaltic pump unit

Error: No.

Error notice and related error number

Text / No.

Information notice with related text or number

NOTE

The mode display messages may depend on the language setting of the electrosurgical unit.

4.2.4 Connectors

20

23

Bipolar connector This terminal connects the plug of the bipolar applicator.

24

Monopolar connector This terminal connects the plug of the monopolar applicator.

25

Neutral electrode connector This terminal connects the plug of the neutral electrode.

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4.3

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Rear panel Volume control (31)

Equipotential bonding connector (28)

Type plate (30)

Communication port peristaltic pump unit (27) Footswitch connector (26)

Mains connector with integrated fuses (29)

26

Footswitch connector This terminal connects the footswitch with the electrosurgical unit, so that cutting and coagulation modes can be activated by the footswitch.

27

Communication port for peristaltic pump unit AFU-100 This terminal is used for the communication between the electrosurgical unit and the peristaltic pump unit.

28

Equipotential bonding connector This terminal is used for potential equalization.

29

Mains connector with integrated fuses This terminal serves as a connection to the mains power supply.

30

Type plate The type plate contains specific information about the electrosurgical unit regarding type of device, reference number (REF), line voltage range, output power classification, serial number and the registered office of the manufacturer.

31

Volume control This knob is used for adjusting the output volume.

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