Indicates an imminently hazardous situation which, if not avoided, will result in
death or serious injury.
d
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.
NOTE
The user must have received appropriate training in using, servicing,
adjustment, updating and upgrading this electrosurgical generator.
Introduction
The intended use depends on the approval of the country. Refer to the instructions for use of the electrosurgical
unit.
Maintenance instructions
This maintenance manual contains essential information on using and maintaining this electrosurgical
generator safely and effectively. Instructions for the operation of this electrosurgical generator and related
danger, warnings and cautions concerning electrosurgery are beyond the scope of this maintenance manual.
Before using and maintaining, thoroughly review this manual and the instructions for use or maintenance
manuals of all equipment which will be used during maintenance. Use the equipment as instructed. Keep this
manual in a safe, accessible location. If you have any questions or comments about any information in this
maintenance manual, contact Olympus.
Signal words
The following signal words are used throughout this maintenance manual:
ESG-400
INTRODUCTION
User qualifications
The user must have received appropriate training in using this electrosurgical generator. The following
instructions are for use by qualified personnel only. Use of this maintenance manual by other individuals is
prohibited. The training will be provided by authorized representatives of Olympus during installation and
commissioning.
Federal Law of the USA restricts this device to use by, or on the order of, a physician.
7.022.211 / ISSUE 4 2 / 99 Introduction
Precautions
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 maintenance 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 maintenance manual.
WARNING
Annual safety checks / Inspection
The electrosurgical generator and the footswitch must undergo a safety check in yearly intervals
in accordance with the national statutory regulations (refer to chapter 7 “Inspection”).
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 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 “Electromagnetic Compatibility (EMC) information” in the Appendix of the
instruction for use 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 generator should only be used under the conditions as described in chapter
1-3 (Limitations). Use under other conditions may impede normal performance and / or result in
equipment damage.
High frequency leakage current or spark discharge may cause user burns.
Follow the dangers, warnings and cautions given below when handling and servicing this electrosurgical unit.
This information is to be supplemented by the dangers, warnings and cautions given in each chapter.
ESG-400
7.022.211 / ISSUE 4 3 / 99 Introduction
ESG-400
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 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
“Mode characteristics”, “Output characteristics” in the Appendix of the instruction for use, and the
instruction manual of the accessory). For a list of compatible neutral electrodes, refer to
“Specifications” in the Appendix of the instruction for use.
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.
When taking measurements or troubleshooting of the electrosurgical unit, take appropriate
precautions, such as using isolated tools and equipment, using the “one hand rule,” etc.
CAUTION
Injury during servicing
When the housing is opened, there is a danger of electric shock. The unit must only be serviced
by authorized technicians.
Burns
WARNING
User
The maximum output voltage characteristics of the electrosurgical generator are shown in the
diagrams in “Output characteristics” in the Appendix of the instruction for use. 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.
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.
High frequency, high voltage signals that can cause severe burns are present in the
monopolar / bipolar sockets described in this maintenance manual. Take appropriate precautions
when testing and troubleshooting this area of the electrosurgical unit.
7.022.211 / ISSUE 4 4 / 99 Introduction
ESG-400
Fire / Explosion
DANGER
Ignitable anaesthetics / fire supporting gases
The risk of flammable gases or other materials being ignited exists with any contact of electrical
energy. Precautionary measures must be taken to keep flammable materials and substances
away from an active electrosurgical unit (do not use flammable anesthetics, 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 cleaning- and disinfection agents
Flammable agents used for cleaning and disinfection must be allowed to evaporate before the
electrosurgical unit is used and serviced.
Non-flammable agents should be used for cleaning and disinfection wherever possible.
WARNING
Risk of fire
Hazards and complications
WARNING
Contamination
The electrosurgical unit may be contaminated with infections materials; therefore, all surfaces of
the unit’s housing should be cleaned before servicing according to chapter 1-8 (Cleaning).
WARNING
Output performance
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.
WARNING
Service persons
Take additional precautions for service technicians, when using the unit’s service operation
mode (see chapter 15, Service operation mode).
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.
DANGER
Unit defect
Never use the electrosurgical unit if an abnormality is suspected.
Repair and Maintenance
CAUTION
Repair
Repairs must only be carried out by Olympus or a firm authorized by Olympus.
CAUTION
Maintenance
Preventive maintenance (inspection / periodic safety check) must only be carried out by a
qualified person / technician.
OLYMPUS is a registered trademark of the Olympus Corporation.
The company names, product names, and proprietary technical terms in this document are the trademarks or
1-1 Intended Use .................................................................................................................................... 10
5-2 Front panel ....................................................................................................................................... 22
5-5 All screen ......................................................................................................................................... 25
5-6 Set screen ........................................................................................................................................ 26
1-5 Front Panel ....................................................................................................................................... 42
CHAPTER 3: REPAIR SYSTEM ...................................................................................... 43
7.022.211 / ISSUE 4 7 / 99 Content
ESG-400
1 ESG-400 MAIN UNIT .................................................................................................... 44
2-1 Visual inspection of the electrosurgical generator and accessories ................................................ 68
2-2 Verifying the contact quality monitor function .................................................................................. 71
2-3 Checking the DC resistance (according to IEC 60601-2-2) ............................................................. 73
2-4 Checking the earth resistance (according to IEC 60601-1 and IEC 62353) .................................... 73
2-5 Checking the earth leakage current (according to IEC 60601-1) .................................................... 73
2-6 Checking the patient leakage current (according to IEC 60601-1) .................................................. 74
2-7 Checking the current and power consumption and output waveform .............................................. 75
2-8 Checking the high frequency leakage current (according to IEC 60601-2-2) .................................. 77
2-8-1 Measurement of the monopolar high frequency leakage current under loaded condition ...... 77
2-8-2 Measurement of the monopolar high frequency leakage current under unloaded condition .. 79
2-8-3 Measurement of the bipolar high frequency leakage current under loaded condition ............ 81
2-8-4 Measurement of the bipolar high frequency leakage current under unloaded condition ........ 83
2-9 Checking the output power .............................................................................................................. 85
2-10 Checking for certain features and error messages .......................................................................... 85
2-11 Final test ........................................................................................................................................... 86
1-1 Intended Use .................................................................................................................................... 10
5-2 Front panel ....................................................................................................................................... 22
5-5 All screen ......................................................................................................................................... 25
5-6 Set screen ........................................................................................................................................ 26
The ESG-400 is a reusable, non-sterile electrosurgical generator with different mono- and bipolar cutting and
coagulation modes. The maximum output power is 320 W.
On the front side it features a touch screen display that displays the connection status of accessories and
peripherals connected to the electrosurgical generator. It is also used to show and modify the output settings
(e.g. mode, output power, effect) as well as to control other functions (e.g. save settings).
In addition the ESG-400 has a bipolar socket, two monopolar sockets, a neutral electrode socket, and a
universal socket to connect applicators with instrument recognition. The power switch turns the generator on
and off.
Two contact quality indicators (one for split and one for non-split electrodes) are green illuminated if neutral
electrodes are correctly connected. Three additional push buttons allow recalling a previously saved setting
(Select Procedure), to assign the footswitches to specific output sockets (Footswitch), and to control several
other functions (Menu), e.g. select language, touch tone control, output volume, or brightness.
On the rear panel the volume control, a ventilation hole, the equipotential bonding point, the AC power socket,
and two footswitch sockets can be found. Furthermore, for the connection of peripheral equipment 26-pin plugs
respectively 14-pin plugs can be connected to the LINK-IN or to the LINK-OUT socket.
On the bottom panel, a docking socket is featured. It can be used to connect the ESG-400 directly to the
USG-400 and upcoming devices. The ESG-400 is compatible with the new USG-400 ultrasonic generator to
enable the use of combined (US + HF) instruments.
SoftCoag (Coagulation of tissue with little sticking and carbonization; 3 Effects)
ForcedCoag (Fast and effective coagulation; 3 Effects)
SprayCoag (Contact-free surface coagulation with little penetration depth; 3 Effects)
PowerCoag (Fast and effective coagulation with increased dissection capabilities; 3 Effects)
Bipolar Cut:
BipolarCut (All bipolar cutting procedures of tissue structures; 3 Effects)
SalineCut (Cutting in conductive fluid; 3 Effects; only available via UNIVERSAL socket )
Bipolar Coagulation:
BiSoftCoag (Coagulation with little sticking and carbonization; 3 Effects)
AutoCoag (Coagulation with little sticking and carbonization; 3 Effects)
SalineCoag (Coagulation in conductive fluid; 3 Effects; only available via UNIVERSAL socket )
HardCoag (Controlled tissue coagulation; 3 Effects)
RFCoag (Controlled deep tissue coagulation; with and without RCAP) FineCoag (Coagulation of
tissue with little sticking and carbonization; 1 Effect)
The modes have preset power levels that may be customized by the user in a defined range.
2-2 Accessories
Footswitch Double Pedal (WB50402W): It has a blue pedal that is used to activate the selected coagulation
mode and a yellow pedal that is used to activate the selected cutting mode.
Footswitch Single Pedal (optional; WB50403W): It has a blue pedal that is used to activate the selected
coagulation mode
P-Cord (optional; MAJ-814): The P-cord is used to connect a patient plate to the ESG-400.
(1) Use this product under the supervision of a doctor at a medical facility.
(2) Do not use this product in combination with the products other than those designated by Olympus.
(3) This product shoul be used, transported or stored in the following environment.
Power switch
This switch turns the electrosurgical generator on and off.
2.
BIPOLAR socket
This socket connects the plug of a bipolar HF instrument.
3.
MONOPOLAR 2 socket
This socket connects the plug of a monopolar HF instrument.
4.
MONOPOLAR 1 socket
This socket connects the plug of a monopolar HF instrument.
5.
Touch-screen
Displays the connection status of the accessories and peripherals connected to the electrosurgical
generator. It is also used to show and modify the output settings (e.g. mode, output power, effect) as
well as to control other functions (e.g. save procedures, delete procedures).
6.
FOOTSWITCH push button
This button is used to open the “Footswitch screen” to assign one or two footswitch(es) or the autostart
function to a specific output socket.
7.
SELECT PROCEDURE push button
This button is used to open the “Select Procedure screen” to recall saved settings.
8.
MENU push button
This button is used 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).
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 not applied properly (e.g. bad contact quality or partly dislocated) or no neutral electrode is
connected (in both cases the activation of monopolar output is disabled).
10.
Contact quality monitor indicator for non-split neutral electrode
This indicator illuminates green if a non-split neutral electrode is connected.
11.
Neutral electrode socket
This socket connects the plug of a neutral electrode for monopolar application.
12.
UNIVERSAL socket
This socket connects the plug of an Olympus HF instrument with HF instrument recognition.
Footswitch sockets
This socket connects the plug of a single or double pedal footswitch.
2.
Volume control
This knob is used for adjusting the output volume.
3.
Ventilation hole
Holes for air ventilation via a cooling fan; there are also ventilation holes on each side of the
electrosurgical generator.
4.
Equipotential bonding point
To increase electrical safety, this point is used for potential equalization. All equipment housings that
come into contact with the patient are electrically connected in order to prevent low-frequency
electrical currents from endangering the patient in the event of a defect in the conventional protective
conductor system.
5.
AC power socket
This socket serves as a connection to the mains power supply via a power cord
6.
LINK-OUT socket
This socket connects the plug (14-pin) of a cable connected to peripheral equipment.
7.
LINK-IN socket
This socket connects the plug (26-pin) of a cable connected to peripheral equipment.
NOTE
language setting of the electrosurgical generator.
For a detailed explanation of the different types of
sockets, refer to chapter 6 “Connection of neutral
electrode” and chapter 3.7 “Connection of HF
instruments”.
The number shows the selected output power level. If an output power level is set to zero, “--” will be
displayed instead of numbers.
6.
Effect
The number shows the selected effect. For RFCoag mode the RCAP function can be selected instead
of an effect (refer to chapter 5.3, “Output setting”)
1.
Mode button
These buttons allow the mode selection for a corresponding output socket as shown in the title line. If
a selection is already activated, this is indicated by a gray button. If no mode shall be selected, press
the “Off button.”
2.
Return button
Press this button to return to the “Set screen.”
This arm secures the connector of the neutral electrode with the clamp.
2.
Clamp
This clamp connects the neutral electrode to the “P-cord”.
3.
Plug on the electrosurgical generator side
This plug connects the “P-cord” to the electrosurgical generator.
1.
2.
3.
The neutral electrode cable “P-cord” (Olympus REF: MAJ-814) is an optional item for the connection with a
neutral electrode which may be purchased separately.