Olympus ESG-400 User manual

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
INSTRUCTIONS FOR USE
ELECTROSURGICAL GENERATOR
ESG-400
WB91051W

Contents
1 Using this document..........................................................................................................5
1.1 User instructions ...............................................................................................................5
1.2 Conventions throughout this document.............................................................................5
1.3 Safety-related information in this document ......................................................................5
2 Safety information..............................................................................................................7
2.1 Intended purpose ..............................................................................................................7
2.2 Contact..............................................................................................................................8
2.3 General safety notes .........................................................................................................8
3 Product description .........................................................................................................16
3.1 Scope of delivery ............................................................................................................16
3.2 Product functions ............................................................................................................16
3.3 Features ..........................................................................................................................17
3.4 Operating elements on the hardware..............................................................................18
3.5 Operating elements of the touchscreen ..........................................................................21
3.6 Double-pedal foot switch.................................................................................................24
3.7 Optional accessories.......................................................................................................25
3.8 Symbols ..........................................................................................................................28
3.9 Warranty..........................................................................................................................29
4 Installation ........................................................................................................................30
4.1 Safety notes for installation .............................................................................................30
4.2 Connection of peripheral equipment ...............................................................................30
4.3 Connection to the mains electricity .................................................................................31
4.4 Automatic mist and smoke evacuation............................................................................32
4.5 Connecting the foot switch ..............................................................................................35
5 Basic settings and menu.................................................................................................37
5.1 Function list .....................................................................................................................37
5.2 Push button hierarchy .....................................................................................................38
5.3 Select procedure.............................................................................................................39
5.4 Assign foot switch and autostart function........................................................................40
5.5 MENU push button..........................................................................................................42
6 Using the ESG-400 with a neutral electrode..................................................................57
6.1 Safety notes for neutral electrode use.............................................................................57
6.2 Correct usage of neutral electrodes................................................................................57
6.3 Conditions of the CQM indicator .....................................................................................59
6.4 Connecting to the electrosurgical generator ...................................................................59
6.5 Verifying the CQM indicator ............................................................................................61
7 Before use.........................................................................................................................62
7.1 Inspection........................................................................................................................62
7.2 Procedure after inspection ..............................................................................................67
7.3 Power settings.................................................................................................................68
7.4 Tissue effects depending on the power level and effect level.........................................75
8 Use.....................................................................................................................................77
8.1 Safety notes for use ........................................................................................................77
8.2 Description of the output sockets ....................................................................................79
8.3 Connecting HF instruments.............................................................................................80

8.4 Switching on the electrosurgical generator .....................................................................80
8.5 Automatic mist and smoke evacuation............................................................................80
8.6 Selecting output settings.................................................................................................81
8.7 HF instrument recognition...............................................................................................83
8.8 Bipolar modes SalineCut and SalineCoag......................................................................86
8.9 Bipolar coagulation mode RFCoag .................................................................................86
8.10 Activating.......................................................................................................................88
8.11 Troubleshooting.............................................................................................................91
9 After use .........................................................................................................................104
9.1 Safety notes for after use ..............................................................................................104
9.2 Disconnecting ...............................................................................................................104
10 Reprocessing ...............................................................................................................105
10.1 Safety notes for reprocessing......................................................................................105
10.2 General information for reprocessing..........................................................................105
10.3 Cleaning......................................................................................................................105
10.4 Disinfection..................................................................................................................106
10.5 Other HF equipment....................................................................................................106
11 Maintenance, repair and shipment.............................................................................107
11.1 Maintenance................................................................................................................107
11.2 Repair..........................................................................................................................107
11.3 Shipment.....................................................................................................................108
12 Storage and disposal...................................................................................................109
12.1 Storage........................................................................................................................109
12.2 Disposal ......................................................................................................................109
13 Ordering information ...................................................................................................110
14 Compatible equipment ................................................................................................111
14.1 System chart ...............................................................................................................111
14.2 Compatible neutral electrodes ....................................................................................113
15 Technical data ..............................................................................................................115
15.1 Specications for the ESG‑400...................................................................................115
15.2 Ambient conditions for operation, storage and transport ............................................115
15.3 Sockets .......................................................................................................................116
15.4 Resistance range for CQM..........................................................................................116
15.5 Specications for cables .............................................................................................116
16 Electromagnetic compatibility....................................................................................117
17 Additional information.................................................................................................120
17.1 Alarm system ..............................................................................................................120
17.2 Tone information .........................................................................................................121
17.3 Mode characteristics according to IEC 60601-2-2 ......................................................123
17.4 Characteristics of High Power Cut Support (HPCS) ...................................................124
17.5 Output characteristic diagrams ...................................................................................124
18 Glossary........................................................................................................................151
19 Index..............................................................................................................................155

5
Using this document
1 Using this document
1.1 User instructions
Before use, thoroughly read these instructions for use and the instructions for use of all
other products that will be used during the procedure.
If the required instructions for use are missing, immediately contact an Olympus
representative.
Keep the instructions for use in a safe, accessible location.
1.2 Conventions throughout this document
This is the safety alert symbol. It is used to alert the user to potential physical injury
hazards. Observe all safety messages that follow this symbol to avoid possible injury.
This symbol indicates additional helpful information.
1.
2.
3.
A numeration indicates a sequence of actions.
●Bullet points indicate individual actions or different options for action.
–
–
–
Dashes indicate the listing of data, options or objects.
1)
2)
3)
Numbers with right parenthesis name elements in illustrations.
[…] Bracketed terms refer to elements in the graphical user interface or keys.
Elements in the graphical user interface can be:
- buttons
- menu items
- dialog elements
1.3 Safety-related information in this document
For safe and efcient use of this product it is important to read the complete instructions for
use. The safety related information of these instructions for use is not only described in this
chapter. All information and instructions in this document are to ensure a safe and efcient
use.
Safety information are described in 3 categories:
‒General safety notes
‒ Specic safety notes
‒Safety messages

6
Using this document
1.3.1 General safety notes
General safety notes are located at the beginning of the instructions for use. They address
safety issues that apply to the general use and handling of the product.
1.3.2 Specic safety notes
Specic safety notes are located at the beginning of a chapter or section. They address
safety issues that are specic to the information and actions described in the chapter or
section.
1.3.3 Safety messages
Safety messages focus on unexpected incidents that can occur during the intended
use. They are placed in the context of such risks and actions. The safety messages are
highlighted by a signal word.
DANGER
Indicates a hazardous situation which, if not avoided, will result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not avoided, can result in death or
serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided, can result in minor or
moderate injury.
NOTICE
Indicates a property damage message.

7
Safety information
2 Safety information
This chapter provides general safety information for using the product. The safety
information includes:
‒Intended purpose
‒Contact and manufacturer information
‒General safety notes
2.1 Intended purpose
Intended use and indications
The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in
open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories
and ancillary equipment.
2.1.1 Relative contraindications
Relative contraindications of electrosurgical interventions:
‒If electrosurgery could have a negative effect on the state of the patient.
‒ Patients with implanted electronic devices (e.g. pacemakers or cardioverter‑debrillators)
‒Patients with a weakened immune system
‒Patients with blood coagulation disorders.
2.1.2 Patient target group
Not dedicated to a specic patient population. Patient target groups are dened by the
individual applicator used with the device.
2.1.3 Intended users
Medical use
Only for use by a qualied physician or medical personnel under the supervision of a
physician.
Only for use in an adequate medical environment.
These instructions for use do not explain or discuss clinical procedures.
Reprocessing
Reprocessing of reusable products may only be performed by qualied hygiene personnel.
Repair
Repair of the product may only be performed by trained qualied servicing personnel that
has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the
safety and performance of the product.
Commissioning
The electrosurgical generator must be properly installed and commissioned by Olympus or
by a person or rm commissioned and authorized by the manufacturer.
2.1.4 Clinical benets
Clinical benets depend on the applied part used with the device.

8
Safety information
2.2 Contact
2.2.1 Manufacturer
Olympus Winter & Ibe GmbH
Kuehnstr. 61
22045 Hamburg
Germany
Country-specic information
Refer to the contact information for customers included in the scope of delivery for country-
specic information.
2.2.2 Incident reporting
If a serious incident occurs with the device, report it to the manufacturer and/or the relevant
national authority according to national legislation.
2.3 General safety notes
Application of high frequency treatment
If there is an ofcial standard on the applicability of high frequency treatment as dened 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 high frequency 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 high frequency treatment only when its benets outweigh its risks. Fully explain to the
patient the possible benets and risks of high frequency treatment as well as those of any
therapeutic method(s) that can be performed instead of electrosurgery, and perform high
frequency treatment only after patient consent is granted. During high frequency treatment,
continue to evaluate the potential benets and risks, and stop the treatment if the risks
become greater than the possible benets to the patient.
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.
Read all instructions for use thoroughly
Before use, read this instructions for use and the instructions for use for all other equipment
which will be used during the procedure.
An insufcient understanding of the safety information in these instructions for use can result
in death, serious injury, or equipment damage.
Troubleshooting
Some problems that appear to be malfunctions may be corrected by referring to section
“8.11 Troubleshooting” on page 91. If the problem cannot be resolved using the
information in this chapter, contact Olympus.
●Do not service or maintain any part of the product while in use with a patient.

9
Safety information
2.3.1 User-related error prevention
WARNING
Improper use
‒The safety and effectiveness of electrosurgical interventions depend not only on the
design of the equipment used, but also to a major extent on factors which are under the
control of the user. It is therefore extremely important to read, understand and follow the
instructions supplied with the electrosurgical generator and the accessories in order to
ensure safety and effectiveness.
‒Always use the electrosurgical generator as outlined in this instruction manual.
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 this instruction manual.
WARNING
Unauthorized repairs and product modication
Unauthorized repairs and product modication can cause injury to the patient and the user.
Repairs must only be performed by qualied servicing personnel that has been authorized
by Olympus. Refer to the section “11.2 Repair” on page 107 for more details.
Do not attempt to repair or modify the product.
CAUTION
Regular safety checks
The electrosurgical generator and the foot switch must undergo a safety check in yearly
intervals in accordance with the national statutory regulations.
2.3.2 Risks regarding environmental conditions
CAUTION
Interference with other equipment
The electrosurgical generator complies with the electromagnetic compatibility (EMC)
standard. Nevertheless, when the electrosurgical generator is active it may disturb
neighboring electronic equipment. If an auxiliary computer system is in use together
with the electrosurgical generator and endoscopic imaging techniques, the image on the
monitor might freeze or blackout. Follow the instructions in chapter “16 Electromagnetic
compatibility” on page 117 regarding electromagnetic ambient conditions.
‒Be sure that this electrosurgical generator is not used adjacent to or stacked with other
equipment (other than the components of this electrosurgical generator or system) to
avoid electromagnetic interference.
‒ Before use, thoroughly conrm the compatibility of all equipment.
‒To ensure electrical safety, the electrosurgical generator 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.
‒Never loop the cables (active cable, bipolar cable, neutral electrode cable) or bundle
cables together with cables belonging to other medical equipment. The high frequency
signals or spark discharge noise generated by the electrosurgical generator may
interfere with the operation of other medical equipment.
‒Do not use the electrosurgical generator in a location exposed to strong electromagnetic
radiation (microwave or short-wave medical treatment equipment, magnetic resonance
imaging, radio or mobile phone equipment). Electrosurgical generator malfunction can
occur.

10
Safety information
NOTICE
Unsuitable temperature and humidity
The electrosurgical generator should only be used under the conditions as described in
section “15.2 Ambient conditions for operation, storage and transport” on page 115. Use
under other conditions may impede normal performance and/or result in equipment damage.
2.3.3 Risks regarding accessories
WARNING
Mechanical stress
Do not apply excessive bending, straining, or squeezing force to any cords. It may cause
malfunction.
WARNING
Non-compatible and damaged accessories
‒The electrosurgical generator shall only be used with compatible accessories.
‒When connecting accessories (cords, electrodes, HF instruments) avoid output settings
where the maximum output voltage of the electrosurgical generator may exceed the
rated accessory voltage (refer to section “7.3 Power settings” on page 68, and the
instruction manual of the accessory).
‒For a list of compatible neutral electrodes refer to section “14.2 Compatible neutral
electrodes” on page 113. For compatible plugs and sockets refer to section “8.2
Description of the output sockets” on page 79.
‒Before use, the electrosurgical generator and accessories must be examined for
damage. All cables and its plugs must be free of scratches and cracks. Cables and
accessories with damaged insulation or connections must not be used.
2.3.4 Risks regarding electric shock
WARNING
Grounding failure
There is a risk of electric shock if the housing of the electrosurgical generator is not
grounded.
‒ Only connect the power cable to a properly grounded xed socket outlet.
‒ Do not use an adapter for an incompatible grounded xed socket outlet as it can impair
safe operation of the electrosurgical generator.
WARNING
User shock
To prevent user shock, malfunction and damage of the electrosurgical generator, keep
liquids away from all electrical equipment. If liquid gets on or into the electrosurgical
generator, terminate operation immediately and contact Olympus.
CAUTION
Injury during servicing
When the housing is opened, there is a danger of electric shock.
The electrosurgical generator must only be serviced by authorized technicians.

11
Safety information
2.3.5 Risks regarding burns
WARNING
Burns to the patient and/or the user
‒The maximum output voltage characteristics of the electrosurgical generator are shown
in the diagrams in section “17.5 Output characteristic diagrams” on page 124. When
setting the power level, rst 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.
However, certain modes may present an unacceptable risk at low output power
settings. For example, with the PulseCut fast mode or PulseCut slow mode, the risk of
an excessive thermal effect rises if the output power setting is too low. Therefore, it is
recommended that you perform basic testing before using the electrosurgical generator.
If the instruction manual of the HF 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
generator is active.
‒During operation, temporarily unused electrodes should be stored in an electrically
insulated container. Unused electrodes or HF instruments should never be placed on the
patient. Otherwise, it may cause patient and/or user burns.
‒To prevent patient burns, the electrosurgical generator 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. Remove any metallic items from the patient (wristwatches, jewelry, etc.) before
starting the procedure.
‒If the electrosurgical generator is used in conjunction with another electrosurgical
generator, never use both generators simultaneously. Keep the HF instrument connected
to the not-used electrosurgical generator away from the target area while the other
generator is in operation. Do not activate output of both generators 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.
‒To prevent patient burns during high frequency treatment, the patient’s clothes must be
dry.
‒During endoscopic treatment be sure that the distal end of the endoscope and/or
HF instruments do/does not contact bridging uids surrounding the target tissue. Electric
current may ow to the surrounding tissue via the uids and cause burns. This does not
apply to instruments intended for use in conjunction with conductive uids.
‒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 ows 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 generator on a patient, any monitoring
electrodes should be placed as far away as possible from the electrodes used with
the electrosurgical generator. If placed too close, high frequency signals or spark
discharge noise from the electrosurgical generator 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
measures is recommended.
‒To prevent burns, the user and assistant should wear surgical gloves during the
procedure.

12
Safety information
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.
2.3.6 Potential hazards to the heart
DANGER
Shock hazards to the heart
To prevent shock hazards, never apply the electrosurgical generator to the heart in
combination with type B or BF applied parts.
When using the electrosurgical generator 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.
WARNING
Cardiac emergency
● Always keep a debrillator ready in case of a cardiac emergency. During operation of
the debrillator, remove the endoscope and/or laparoscope and HF instruments from the
patient.
2.3.7 Risks regarding implants
DANGER
Pacemaker/Debrillator malfunction
The high frequency equipment, when applied to a patient with a cardiac pacemaker, an
implanted cardioverter debrillator (ICD) or other implanted electronic devices (IED), may
cause malfunctioning or failure of the implanted electronic device and may seriously affect
the patient.
‒ Always conrm 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 generator 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.
Other electrically conductive implants
All electrically conductive implants present a hazard due to concentration or re-direction of
HF currents. Qualied advice should be obtained before the electrosurgical procedure.
2.3.8 Risks regarding re and explosion
WARNING
Ignitable gases in the bladder
Electrolysis that occurs during TCR/is (Transcervical endometrial Resection) and TURis
(Transurethral Resection) can produce ammable gases. These gases can ascend into the
upper part of the uterus or bladder and can come in contact with the electrode.

13
Safety information
Activating the HF current while ammable gases are present can cause the gases to ignite
or explode. This can result in uterine or bladder perforation or puncture, exogenous burns or
other injury.
‒Before activating the HF current, use the endoscopic image to make sure that the distal
end of the resectoscope is not located in the ammable gases. The gases are visible as
bubbles in the irrigation uid.
‒Do not activate the HF current while the distal end of the resectoscope is located in the
gases or in their direct vicinity.
‒Before activating the HF current, evacuate or move the gases or allow the gases to
escape from the uterus or bladder as necessary, e.g. by evacuating the gases through
the sheath of the resectoscope.
WARNING
Ignitable anaesthetics and gases
The risk of ammable gases or other materials being ignited exists with any surgical
application of electrical energy.
‒ Precautionary measures must be taken to keep ammable materials and substances
away from the site of intervention (do not use ammable anaesthetics, nitrous oxide or
oxygen). Otherwise, explosion or re may result and cause serious injuries.
‒Do not use the electrosurgical generator within an explosion zone. This electrosurgical
generator is not explosion-proof.
WARNING
Ignitable gas in the gastro-intestinal tract
If the intestines contain a ammable gas, replace this gas with air or a non‑ammable gas
before performing the operation, to minimize the risk of re or explosion.
WARNING
Ignitable cleaning and disinfection agents
‒Flammable agents used for cleaning and disinfection must be allowed to evaporate
before the electrosurgical generator is used. Also ensure that ammable solutions are
neither on the patient’s skin (e.g. under neutral electrode) nor in the patient’s body cavity
when the electrosurgical generator is used.
‒ Non‑ammable 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, sparks occur which could lead to burning or
deagration of combustible materials.
‒ Body hair is ammable. Water soluble surgical lubricating jelly may be used to cover hair
close to the surgical site to decrease ammability.
WARNING
Risk of re
Disconnect the power plug before changing the fuses. Replace fuses as marked. The fuses
must only be replaced by authorized technicians.

14
Safety information
2.3.9 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 specic 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.
‒Always prepare a spare electrosurgical generator or an alternative procedure to avoid
interruption of treatment due to an unexpected electrosurgical generator failure during
treatment.
‒Should any abnormal output be suspected during operation, immediately terminate
the use of the equipment by releasing the foot switch. If the foot switch does not react,
switch off the electrosurgical generator. Otherwise, malfunction of the equipment may
cause an unintended increase in output.
‒Use physiological monitoring equipment throughout the entire procedure, for continuous
observation of the patient’s condition.
‒ For procedures where the high frequency electrical current could ow through parts of
the body with a relatively small cross sectional area, the use of a bipolar mode may be
desirable in order to avoid unwanted tissue damage.
‒It is not recommended to use electrosurgery for circumcisions because of the risk of
thermal injuries. The risk can be reduced if metal parts of any kind (e.g. clamps) and/or
monopolar HF instruments are avoided.
WARNING
Safety measures during the procedure
‒Wear personal protective equipment to guard against dangerous chemicals and
potentially infectious material. During operation, wear appropriate personal protective
equipment, such as eye wear, face mask, moisture-resistant clothing and surgical gloves
that t properly and are long enough so that your skin is not exposed.
‒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 generator fails and the output is stopped during treatment, it
may be impossible to continue treatment due to tissue or coagulum build-up on the
HF instrument or other similar condition.
‒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
Electrical stimulation of nerves and muscles
Nerves and muscles can be stimulated by low frequency electrical currents or intense high
frequency electrical currents. Low frequency electrical currents may be generated by a
partial rectication of intense high frequency electrical current, in particular when there is a
spark discharge to the tissue or to another metallic object. Intense high frequency electrical
currents can occur at the beginning of an electrosurgical cut or when using high output
power settings. This may cause violent spasms or muscle contractions.

15
Safety information
Use the lowest appropriate power level and effect (e.g. effect 1 instead of effect 3). However,
for certain modes a low output power setting may present an unacceptable risk for the
patient. For example, with the PulseCut fast mode or PulseCut slow mode, the risk of an
excessive thermal effect rises if the output power setting is too low.
CAUTION
Generator defect
To prevent electrosurgical generator damage, never short-circuit electrodes (accessories,
neutral electrodes). In the event of a defect or malfunction in the electrosurgical generator,
an undesirably high output power may be emitted.

16
Product description
3 Product description
This chapter provides a general overview of the product and its functions. This includes the
following information:
‒Scope of delivery
‒Product functions and features
‒Operating elements
‒Description of foot switches and optional accessories
‒Explanation of symbols
‒Warranty information
3.1 Scope of delivery
Before use, check that all items are available.
Contact an Olympus representative or an authorized service center if any items are missing
or damaged.
1) Electrosurgical generator ESG-400
2) Double-pedal foot switch WB50402W
3) Instructions for use and Contact information for customers
3.2 Product functions
The electrosurgical generator ESG-400 is designed to be used for the following
electrosurgical applications:
‒Bipolar electrosurgical cutting and coagulation.
‒Monopolar electrosurgical cutting and coagulation, which requires a neutral electrode.
The ESG-400 is equipped with several cutting and coagulation modes. All settings of the
device are done via the touchscreen on the front panel.
The ESG-400 is activated by a compatible foot switch or by a hand switch at the connected
HF instrument. The bipolar coagulation mode BiSoftCoag also provides activation via
Autostart.

17
Product description
The ESG-400 is connected to the local power supply.
The ESG-400 can be mounted on the compatible TC-E400 Energy Cart.
Details on the hardware and software, on the correct handling and use of the device are
described in the following chapters.
3.3 Features
The electrosurgical generator is equipped with the following features:
‒Contact Quality Monitor (CQM)
‒High Power Cut Support (HPCS)
‒Fast Spark Monitor (FSM)
‒Resistance Controlled Automatic Power (RCAP)
‒Automatic end of procedure detection
3.3.1 CQM – Contact Quality Monitoring for the neutral electrode
When using split type neutral electrodes for monopolar electrosurgery, the ESG-400 is able
to detect unintended detachment of the neutral electrode from the patient. The indicator for
the contact quality monitor (CQM) shines green while the contact between the split type
neutral electrode and the skin of the patient is within an acceptable resistance range. If the
contact between the split type neutral electrode and the patient’s skin is insufcient, then an
alarm tone sounds, a warning message is displayed and the CQM indicator shines red.
Using non-split type neutral electrodes is not as safe as using split type ones, because CQM
is not able to detect any detachment of non-split type neutral electrodes from the patient.
For detailed information on the safe and correct use of neutral electrodes refer to chapter “6
Using the ESG-400 with a neutral electrode” on page 57.
3.3.2 HPCS – High Power Cut Support
This feature optimizes the start of the cutting procedure by applying high power to the tissue
to support immediate spark ignition and to reduce the risk of mechanical cutting.
3.3.3 FSM – Fast Spark Monitor
This feature ensures smooth and reproducible cutting although the tissue characteristics are
varying, e.g. in muscle and fat.
3.3.4 RCAP – Resistance Controlled Automatic Power
RCAP is a feature that supports the bipolar mode RFCoag. Deep tissue coagulation without
signicant desiccation is achieved with RCAP.

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Depending on the momentary tissue status, RCAP determines the maximum power uptake
of the tissue and automatically adjusts the electrosurgical generator. For this process the
geometry of the used bipolar applicator and also the individual tissue characteristics, e.g.
blood perfusion, are considered. Therefore, premature tissue desiccation is effectively
avoided and it is not necessary to manually adapt the power settings.
3.3.5 Automatic end of procedure detection
Certain bipolar coagulation modes are supported by an automatic end of procedure
detection. When coagulating tissue the electrical resistance of the tissue increases. Tissue
resistance is continuously measured by the electrosurgical generator so that it is able to
detect when coagulation is completed. As soon as a limited value of tissue resistance is
exceeded, the electrosurgical generator automatically stops the HF output.
Depending on the mode, the end of procedure is indicated by a special end tone.
3.4 Operating elements on the hardware
3.4.1 The front panel
1) Power switch
To switch the electrosurgical generator on and off.
2) *BIPOLAR output socket
To connect a bipolar HF instrument.
3) *MONOPOLAR 2 output socket
To connect a monopolar HF instrument.
4) *MONOPOLAR 1 output socket
To connect a monopolar HF instrument.

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5) Touchscreen
To display the status of connected accessories.
To show and modify settings.
6) FOOT SWITCH push button
To open the “Foot switch screen” to assign one or two foot switch(es) or the autostart
function to a specic output socket.
7) SELECT PROCEDURE push button
To open the “Select Procedure screen” to recall saved settings.
8) MENU push button
To open the “Menu screen” to control several functions (save or delete a procedure,
control the touch tone, output volume and brightness as well as other functions).
9) Contact quality monitor indicator for split type neutral electrode
Indicates the connection status of a split type neutral electrode.
10) Contact quality monitor indicator for non-split type neutral electrode
Indicates the connection status of a non-split type neutral electrode.
11) *Neutral electrode socket
To connect a neutral electrode.
12) *UNIVERSAL socket
To connect the plug of an Olympus HF instrument with HF instrument recognition.
13) UDI (unique device identier)
*Applied part according to standard IEC 60601-1.
For a detailed explanation of the different types of sockets refer to section “8.2 Description
of the output sockets” on page 79 and to chapter “6 Using the ESG-400 with a neutral
electrode” on page 57.

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Product description
3.4.2 The rear panel
1) Volume control
To adjust the volume of the activation tone.
2) Ventilation slots
3) Identication plate
4) Potential equalization connector
To increase electrical safety by potential equalization.
5) Power socket
For connection to the mains electricity.
6) Fuse holder
Compartment for the replaceable fuses.
7) LINK-OUT socket
To connect peripheral equipment via a communication cable with a 14-pin plug.
8) Foot switch sockets
To connect a compatible foot switch.
9) LINK-IN socket
To connect peripheral equipment via a communication cable with a 26-pin plug.
LINK-IN LINK-OUT