Indicates an imminently hazardous situation which, if not avoided, will result in
d
Indicates a potentially hazardous situation which, if not avoided, could result in
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
The user must have received appropriate training in using, servicing,
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, cont act O ly mpus.
Signal words
The following signal words are used throughout this maintenance manual:
INTRODUCTION
DANGER
WARNING
CAUTION
NOTE
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.
NOTE
Federal Law of the USA restricts this device to use by, or on the order of, a physician.
death or serious injury.
death or serious injury.
or potential equipment damage.
Indicates additional helpful information.
adjustment, updating and upgrading this electrosurgical generator.
7.022.211 / ISSUE 5 2 / 110 Introduction
ESG-400
User
The safety and effectiveness of electrosurgical interventions depend not only o
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
will not only impede functions and prevent optimum performance, but may cause equipment
damage and
ications. Before each use, always inspect the equipment as outlined in
this
The electrosurgical generator and the footswitch must undergo a safety check in yearly intervals
in accordance with
Environmental
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 s hould not be used in conjunction w
The electrosurgical generator complies with the electromagnetic compatibility (EMC) standard.
Never
equipment. If an auxiliary computer system is in use together with the electrosurgical generator
and endoscopic imaging techniques, the image on the monitor might f
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 cor
with cords belonging to other medical equipment. The high frequency s ignals 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.
The elect rosurgi cal
should only be used under the conditions as described in chapter
1
equipment damage.
Precautions
High frequency leakage c urrent 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.
-related error prevention
WARNING Improper use
n the design of
maintenance manual. Improper use
/ or compl
maintenance manual.
WARNING Annual safety checks / Inspection
the national statutory regulations (refer to chapter 7 “Inspection”).
conditions
CAUTIONInterference of the unit with other equipment
ith:
• Electrical equipment whose safety against leakage current is not guaranteed.
• Electrosurgical equipment whose safety in com bined use is not guaranteed.
theless, when the electrosurgical generator is active it may disturb neighboring electronic
reeze or blackout. Follow
d) or bundle cords together
CAUTION Unsuitable temperature and humidity
generator
-3 (Limitations). Use under other conditions may impede normal performance and / or result in
7.022.211 / ISSUE 5 3 / 110 Introduction
ESG-400
Accessories
Do not apply excessive bending, straining, or squeezing force to any cords. It may cause
malfunction.
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 ins
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
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
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 han
When the housing is opened, there is a danger of electric shock. The unit must only be serviced
by
Burns
The maximum output voltage characteristics of the electrosurgi
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 electro
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 ris k 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
exceed that voltage.
High frequency, high voltage signals that can cause severe burns are present in the
monopolar
when testing and troublesho
WARNING
CAUTION Non-compatible accessories and accessory damage
WARNING Grounding failure
-pin / 2-pin adapter, as it can impair safe operation of the unit.
WARNING User shock
Mechanical stress
truction for use, and the
CAUTIONInjury during servicing
authorized technicians.
WARNING User
cal generator are shown in the
de’s insulation may be damaged and cause user and /
be set so that it does not
/ bipolar sockets descri bed in thi s maintenance manual. Take appropriate precautions
oting this area of the electrosurgical unit.
7.022.211 / ISSUE 5 4 / 110 Introduction
d rule,” etc.
ESG-400
Fire
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
oxygen). Otherwise, explosion or fire may result and cause serious injuries. This electrosurgical
uni
Flammable agents used for cleaning and disinfection must be allowed to evaporate before the
electrosurgical unit is used and servi
Non
Haz
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
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 m
in output.
Take additional precautions for service technicians, when using the unit’s service operation
mode (see chapter 15, Service operation mode).
To prevent electrosurgic
circuit electrodes (accessories, neutral
electrodes).
In the event of a defect or malfunction in the unit, an undesirably high output power may be
emitted.
Repairs must only be carried out by Olympus or a firm authorized by Olympus.
Preventive maintenance (inspection / periodic safety check) must only be carried out by a
qualifie
/ Explosion
DANGER Ignitable anaesthetics / fire supporting gases
anesthetics, nitrous oxide or
t is not explosion-proof. Do not use the unit within an explosion zone.
WARNINGIgnitable cleaning- and disinfection agents
ced.
-flammable agents should be used for cleaning and disinfection wherever possible.
WARNING Risk of fire
Replace fuses as marked. The fuses
authorized technicians.
ards and complications
WARNING Contamination
1-8 (Cleaning).
WARNINGOutput performance
ay cause an unintended increase
WARNING
CAUTION Unit defect
DANGER Unit defect
Never use the electrosurgical unit if an abnorm ali ty is suspe cted.
OLYMPUS is a registered trademark of the Olympus Corporation.
The company names, product names, and proprietary technic al 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 5 7 / 110 Content
ESG-400
1 ESG-400 MAIN UNIT .................................................................................................... 44
2-1 Visual inspection of the electrosurgical generator and accessories ................................................ 76
2-2 Verifying the contact quality monitor function .................................................................................. 80
2-3 Checking the DC resistance (according to IEC 60601-2-2) ............................................................. 82
2-4 Checking the earth resistance (according to IEC 60601-1 and IEC 62353) .................................... 82
2-5 Checking the earth leakage current (according to IEC 60601-1) .................................................... 82
2-6 Checking the patient leakage current (according to IEC 60601-1) .................................................. 83
2-7 Checking the current and power consumption and output waveform .............................................. 84
2-8 Checking the high frequency leakage current (according to IEC 60601-2-2) .................................. 86
2-8-1 Measurement of the monopolar high frequency leakage current under loaded condition ...... 86
2-8-2 Measurement of the monopolar high frequency leakage current under unloaded condition .. 88
2-8-3 Measurement of the bipolar high frequency leakage current under loaded condition ............ 90
2-8-4 Measurement of the bipolar high frequency leakage current under unloaded condition ........ 92
2-9 Checking the output power .............................................................................................................. 94
2-10 Checking for certain features and error messages .......................................................................... 94
2-11 Final test ........................................................................................................................................... 95
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 bipol ar 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 volum e 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.
2-1 Application Modes
Monopolar Cut:
• PureCut (Cutting of varying tissue structures; 3 Effects)
• BlendCut (Cutting of varying tissue structures; 3 Effects)
• PulseCut slow (Intermittent cutting; 3 Effects)
• PulseCut fast (Intermittent cutting; 3 Effects)
Monopolar Coagulation:
• 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)
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.
. It is also used to show and m odify the output settings (e.g. mode, output power, effect) as
This button is used to open the “Footswitch screen” to assign one or two footswitch(es) or the autostart
This button is used to open the “Menu screen” to control several functions (save or delete a procedure,
8.
6.
1.
2.
3.
4.
7.
12.
11.
10.
9.
5.
5-2 Front panel
Power sw itch
1.
This switch turns the electrosurgical generator on and off.
BIPOLAR socket
2.
This socket connects the plug of a bipolar HF instrument (applied part).
MONOPOLAR 2 socket
3.
This socket connects the plug of a monopolar HF instrument ( appl ied p art) .
MONOPOLAR 1 socket
4.
This socket connects the plug of a monopolar HF instrument (applied part).
Touch-screen
5.
Displays the connection status of the accessories and peripherals connected to the electrosurgical
generator
well as to control other functions (e.g. save procedures, delete procedures).
FOOTSWITCH push button
6.
function to a specific output socket.
SELECT PROCEDURE push button
7.
This button is used to open the “Selec t Procedure screen” to recall saved settings.
MENU push button
8.
control the touch tone, output volume and brightness as well as other functions).
Holes for air ventilation via a cooling fan; there are also ventilation holes on each side of the
oint is used for potential equalization. All equipment hous ings that
screen messages may depend on the
For a detailed explanation of the different types of
chapter 6 “Connection of neutral
electrode” and chapter 3.7 “Connection of HF
1.
2.
3.
4.
7.
6.
5.
1.
5-3 Rear panel
Footswitch socket s
1.
This socket connects the
Volume control
2.
This knob is used for adjusting the output volume.
Ventilation hole
3.
plug of a single or double pedal footswitch.
electrosurgical generator.
Equipotential bonding point
4.
To increase electrical safety, this p
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 conventi onal protective
conductor system.
AC power socket
5.
This socket serves as a connection to the mains power supply via a power cord
LINK-OUT socket
6.
This socket connects the plug (14-pin) of a cable connected to peripheral equipment.
LINK-IN socket
7.
This socket connects the plug (26-pin) of a cable connected to peripheral equipment.
NOTE
The touch-
language setting of the electrosurgical generator.
This indicator shows the corresponding output socket where the same symbol is printed on the front
This symbol indicates if the autostart function is assigned to the corresponding output socket. Blank if
1.
1.
2.
3.
4.
5.
8.
6.
11.
7.
9.
10.
5-4 Bottom panel
Docking socket
1.
This socket connects the plug (7-pin) of a docking connector to connect peripheral equipment. For
more details, see chapter 1-6-1.
5-5 All screen
Reference to output sockets indicator
1.
panel.
Output socket name
2.
The name of the corresponding output socket is displ ay ed here.
Autostart indicator
autostart or foots witch is not assigned. Refer to chapter 6.4, “Assign footswitch and autostart function”.
This symbol indicates if communication with peripheral equipment connected to the docking socket is
This symbol indicates if a connected double pedal footswitch is assigned to the corresponding output
socket. Blank if autostart or footswitch is not assigned. Refer to chapter 6.4, “Assign footswitch and
The name of the output mode as selected in the “Mode sc reen” is displayed here. If “Off” is selected,
The number shows the effect as selected in the “Set screen”. For RFCoag mode the RCAP function
Each button covers the entire area including all output socket related information as described above
(3. to 10.). Press the button, to switch to the corresponding “Set screen” to select the mode, power
This symbol indicates if a c onnected single pedal footswitch is assigned to the corresponding output
The name of the instrument or cable will be displayed instead of the output socket name
The name of the output mode as selected in the “Mode screen” is displayed here. Press this button to
1.
5.
2.
2
6.
3.
4.
Procedure name
4.
The name of the selected procedure is displayed here. Blank if no procedure is selected.
Communication indicator
5.
established.
Footswitch indicator (double pedal)
6.
autostart function”.
Output mode
7.
“--“ will be displayed instead of power level and effect.
Output power level
8.
The number shows the output power level as selected in the “Set screen”. If an output power level is
set to zero, “--” will be displayed instead of numbers.
Effect
9.
can be selected instead of an effect (refer to chapter 5.3, “O utput sett ing” ) .
Button area
10.
levels and effects for the corresponding output socket.
Footswitch indicator (single pedal)
11.
socket. Blank if autostart or footswitch is not assigned. Refer to chapter 6.4, “Assign footswitch and
autostart function”.
UNIVERSAL / Instrument name
12.
“UNIVERSAL” if an instrument or cable with instrument recognition is connected to the UNIVERSAL
socket.
5-6 Set screen
Mode button
1.
switch to the “Mode screen”. If “Off” is selected,
“--“ will be displayed instead of power level and effect.
Plus button / Minus button
2.
These buttons increase / decrease the output power level.
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.
Lever-locking arm
1.
This arm secures the connector of the neutral electrode with the clamp.
Clamp
2.
This clamp connects the neutral electrode to the “P-cord”.
This plug connects the “P-cord” to the electrosurgical generator.