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
Page 3
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
Page 4
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.
Page 5
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
Page 8
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.
The recommended combinations of ancillary equipment and accessories that can be used with the
electrosurgical generator are listed in the system chart below. In addition, new products released after the
introduction of this product may also become compatible with this electrosurgical generator. For further details,
contact Olympus.
After cleaning the electrosurgical unit, dry it thoroughly before storage or using
Patient debris and reprocessing chemicals are hazardous. During cleaning
and disinfection, always wear appropriate personal protective equipment, such
perly so that your skin is not exposed. Always
When disconnecting plugs of instruments or power cords, always hold the
Never immerse the electrosurgical unit in water, clean or disinfect by
Do not clean the connectors or the alternating current power inlet. Cleaning
m or corrode the contacts, which could damage the
Do not wipe the external surface with hard or abrasive wiping material. The
The electrosurgical unit m ay be contaminated with infections materials, therefore, before servicing, perform the
following cleaning procedures. For maintenance and storage of other items than those described below, refer to
the respective instructions for use.
8-1 Cleaning
All surfaces of the unit’s housing can be cleaned and disinfected with the cleaning agents and surface
disinfectants normally used for medical equipment (mild cleaning solution, e.g. 70 % isopropyl alcohol). No
liquid must enter the connector or the unit duri ng cleaning.
1) Switch off the electrosurgical unit and disconnect the power cord from the grounded wall outlet.
2) If the equi pm en t and / or accessories are contaminated with blood or other potentially infectious materials,
first wipe off all gross debris using neutral detergent, and then wipe its surface with a lint-free cloth
moistened with a surface disinfectant.
3) To remove dust, dirt and non-patient debris, wipe the electrosurgical unit and footswitch using a soft,
lint-free cloth moistened with 70 % ethyl or isopropyl alcohol.
8 Cleaning, sto rage and disposal
WARNING
CAUTION
it again. If it is used while still wet, there is a risk of electric shock.
as eye wear, face mask, moisture-resistant clothing and chemical-resistant
waterproof gloves that fit pro
remove contaminated protective clothing before leaving the reprocessing area.
plug. Pulling the cable m ay result in damaging of the wires.
immersion, gas sterilization or autoclaving. It may cause equipment damage.
Do not store the electrosurgical unit in a location exposed to direct sunlight,
adiation (e.g. near
wave medical treatment
equipment, magnetic resonance imaging equipment, radio or mobile phones).
8-2 Storage
Before storage of the electrosurgical unit, disconnect the power cord and store it properly according to the
environmental conditi on s descr ibed in cha pter 1.4 (Technical dat a).
CAUTION
x-rays, radioactivity, liquids or strong electromagnetic r
microwave medical treatment equipment, short-
Damage to the electrosurgical unit may result.
8-3 Disposal of the unit
When disposing of this electrosurgical unit, or any of its components (such as fuses), follow all applicable
national and local laws and guidelines.
Waste electrical and electronic equipment
In accordance with European Directive 2002/96/EC on waste electrical and elec tronic equipment (WEE E), the
product must not be disposed of as unsorted municipal waste, but s hould be collected separately.
Refer to Olympus for return and / or collection systems available in your country.
1-5 Front Panel ....................................................................................................................................... 42
Due to the containing embedded PC the Motherboard is the central unit of the ESG-400. The Motherboard
controls the Relay Board, the HVPS Board and the Generator Board. It contains all input and output interfaces
to the user as well as to other medical devices or computers. Additionally func tionali ties off the board are the
low voltage supplies for the complete unit, the mains input including filters and the measuring part of the
voltage line selection circuit for switching between 115 and 230 VAC.
Overview:
• Embedded PC incl. periphery
• Embedded PC with MPC5200 controller (incl. address and data bus, chip selects,
interrupt inputs, I 2C, SPI, in-/output ports, uarts, timer)
• Watchdog circuit
• Chip select decoder
• Hardware reset
• JTAG interface
• Real time clock
• POF interface for the spark monitor
• Digital input and output circuits
• D/A converters for controlling the HVPS
• A/D converters for measuring different signals from Relay, HVPS and Generator, temperatures and
watching on important voltages
Connections/Interfaces:
• To the PCBs Relay, HVPS and Generator
• Push buttons for user inputs on the front panel
• Volumeboard for changing the speaker volume
• Power Indicator shows power-on of the unit on the front
• CQM Indicator shows status of CQM on the front
• Controlling and driving the main housing fan
• Audio circuit incl. D/A converter and amplifier for sound
• Graphic controller with driver and backlight for the front display
• Touch controller for the touch display
• Ethernet controller and connec tor for external connections
• RS-232 with connector for external connections
• USB host with transceiver and connector for external connections
• FlexRay controller, transceiver and connector for external connections
• Connectors for foots witch incl. detection and analysis circuit
• Connectors for handswitches incl. activation detection circuits
• Instrument recognition circuit for instruments connected to the universal socket
• Detection circuit for devices connec ted to the dock ing co nne c tor
The high voltage power supply (HVPS) is a switching mode power supply with series resonance circuit. It
provides a high DC voltage for the HF Generator. It contains:
• voltage line selection circuit, f o r automatic change between 110/230 VAC
• simple rectifier circuit
• PWM driving circuit
• driving circuits including a digital flip-flop stage for complete cycle driving
• power FET half-bridge, a series resonance circuit, output transformer and rectifying stage
• current and voltage monitors
• discharge circuit
1-3 Generator board
The Generator Board generates the HF output energy from a DC input voltage and contains:
• control circuit for generating st art and driv in g puls es of “one cy cle” sin us oscil lato r
• driving stage for power FET, parallel resonance circuit and series resonance circuit
• relays for switching between different transformer windings
• HF output voltage monitor and redundant HF voltage monitor
• HF output current monitor and redundant HF current monitor
• HF output phase monitor
• HF leakage current monitor
• spark monitor (SPM) supply circuit
• spark monitor for detecting positive and negative DC voltage offset
1-4 Relay Board
The Relay board is used to connect the active output socket to the generator board. It contains:
• connectors to every single HF output socket
• relays which are separating the non active output terminals from the active output terminals
• separating relays are forced guided relays with read-back contact in secondary circuit to control the relay
status
• contact quality monitor (CQM)
• transient voltage suppression (TVS) diodes in applied part
(1) In general, the main unit mus t be shipped to a service center in the event of a malfunction.
(2) Indiv id ual units can be replaced.
2 Board Compatibility
The compatibility of boards and components is dependent on the hardware version of the generator. The
hardware version can be indentified by the serial number of the generator.
The serial number starting with 5 numbers, hardware version with WXX and followed by 3 numbers after the
hyphen.
Example: XXXXXWYY-ZZZ, WYY will show the hardware version.
3 Optional Accessories
3-1 WB50402W (Footswitch with two pedals)
Supplied as a spare part subject to repair services in the event of a malfunction.
3-2 WB50403W (Footswitch with one pedal)
Supplied as a spare part subject to repair services in the event of a malfunction.
3-3 MAJ-814 (Neutral electrode cable “P-cord”)
Supplied as a spare part subject to repair services in the event of a malfunction.
4 Precautions on Function and Operation Settings
4-1 General Precautions
Before repair, it is generally advisable to record the function and operation settings as the basis for restoring
these settings after service.
If the original settings cannot be known due to mechanical problems present at the time the unit was accepted
for repair, apply the f actory-set values or the safest settings (such as the lowest output levels). In this case,
inform the user that the settings have been changed.
If the electrosurgical unit has visible damage, do not use the electrosurgical unit and contact the legal
manufacturer. If the unit is not functioning properly, use the information in this chapter to identify and correct the
malfunction. If the problem cannot be resolved by the described remedial action, stop using the electrosurgical
unit and contact the legal manufacturer for repair.
DANGER
CAUTION
CAUTION
Never use the electrosurgical unit if an abnorm ali ty is suspected.
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 qualified person / technician.
Check the following table, to identify or correct failures regarding the neutral elec trode operation.
Contact quality monitor Mode Indication
Bipolar application Standby and activation
Monopolar application
A non-spli t neutral electrode is
connected. Activation is possible.
Contact quality monitor detects
connection of neutral elec trode.
If a split neutral electrode is
connected, it has a short circuit.
Immediately replace the neutral
electrode!
A split neutral electrode is connected.
Activation is possible. Contact quality
monitor detects connectio n of neutral
electrode and contac t to patients’ skin.
During standby: A split or a non-split
neutral electrode is not connected or a
split neutral electrode detaches.
Activation is disabled.
During activation: A split or a non-split
neutral electrode has disconnected or a
split neutral electrode detaches. The activation is stopped.
A neutral electrode is not required. Contact
quality monitor indicator for split neutral
electrode illuminates red.
Contact quality monitor indicator for non-split
neutral electrode illuminates green.
Contact quality monitor indicator for split
neutral electrode illuminates green.
Contact quality monitor indicator for split
neutral electrode illuminates red.
During activation an alarm signal can be
heard and the touch-screen will display an
error window (E202).
Follow the troubleshooting advices in this chapter, to identify or correct failures. The error window is configured
as shown in figure below.
(Example: E002 Short circuit)
NOTE
If an error occurs (see Fig. 4.3.1):
An error window will appear and an alarm signal is audible.
The OK bu
than 4.00-A
A short message with the error code, error title and a description of the remedial action will be displayed.
The error code consists of an error number shown under the “caution” symbol.
Depending on the error priority, the condition of the audible signal and the “caution” symbol are different
(see Table 4.1).
Proceed with the described remedial action.
The error window disappears after a few seconds, if the error is cleared.
If the error window is still displayed, the error is not cleared. Proceed with the next remedial action if
The electrosurgical generator is equipped with an intelligent
multiple variables. Depending on the risk potential, alarms are
classified in “high priority”, “medium priority” and “low priority”
alarms. An alarm of higher priority overrides an existing alarm of
er priority. If more than one alarm situation of equal priority is
NOTE
alarm system which determines alarm conditions on the base of
low
determined, the one that occurred first is displayed only. This
electrosurgical generator complies with the IEC 60601-1-8: 2006.
Situation Possible cause Remedial action
No sound is audible
during activation.
The volume can not
be adjusted via the
volume control within
the “Menu screen” or
at the rear panel.
The electrosurgical
generator does not
respond to footswitch
or handswitch
activation.
The volume is set to an inaudible level
(e.g. due to high environmental noise).
Malfunction of the electrosurgical
generator.
The volume of the error-related audible
signal is not adjustable.
Malfunction of the electrosurgical
generator.
Improper connection of the footswitch to
one of the footswitch sockets on the rear
panel of the electrosurgical generator or
the HF instrument to the output socket.
The footswitch or the handswitch of the
HF instrument and / or the connection
cable are damaged.
Increase the volume either on the touch-screen
within the “Menu screen” or use the volume
control on the rear panel of the electrosurgical
generator.
Stop using the electr o surg ica l gener at or and
press the power switch to turn off the
electrosurgical generator. Contact the legal
manufacturer.
No action required.
Contact the legal manufactur e r.
Check the footswitch and the HF instrum ent f or
correct connection.
Check the footswitch or the handswitch of the
HF instrument and / or the connection cable for
damages and, if necessary, replace the
footswitch, the HF instrument or the connection
cable.
The incorrect footswitch peda l or
handswitch button is pressed.
The electrosurgical generator is not
switched on.
Another footswitch pedal or handswitch
button of the HF instrument is pressed.
The output is activated by the peripheral
equipment.
A window is displayed on the
touch-screen.
The “All screen” or “Set screen is not
displayed on the touch-screen.
The corresponding output mode has
been deactivated in the “Mode screen”
(“Off” is displayed) or the power level has
been set to “--“.
Press the correct footswitch pedal or
handswitch button of the HF instrument.
Switch on the electrosurgical generator with the
power switch.
To activate the intended output, release the
current pressed footswitch pedal or handswitch
button of the HF instrument.
If the output of the peripheral equipment is
activated, the output of the electrosurgical
generator cannot be activated simultaneously.
Stop using the peri phera l equipment.
Press the “OK button” or “Cancel button” to
close the window or wait until the window
disappears automatically after a few seconds.
Return to the “All screen” or “Set screen”.
Select an output mode in the “Mode screen” or
increase the power level via the “Set screen”
(refer to chapter 5.3, “Output setting”).
Malfunction of the electrosurgical
generator.
If the autostart
function is selected,
the electrosurgical
If an error code is displayed, perform the indicated remedial actions below. If the problem cannot be resolved by
the described remedial action, contact the legal manufacturer.
The error messages frequently used are translated in table 4.2.
Description in Error Code Table Actual messages displayed on ESG-400
“Auto-restart”
“Contact OLY” If the problem persists, contact Olympus.
“Release FSW”
“Release HSW”
“Replace Instrument”
“Reconnect Instrument”
“Cable Connection”
“Cable Damage”
Table 4.2: frequently used error messages
Error
no.
E001
NOTE
Error message Possible cause Remedial action
Open circuit
Check if the electrodes of
the instrument have
proper tissue contact.
The ESG-400 will be restarted automatic ally when the error with the message
of “Auto-restart” is occurred.
Electrodes of the HF instrument
may have no proper tissue contact.
Malfunction of the HF instrument
and / or the connection cable.
ESG-400 will automatically restart.
Release the footswitch pedal to continue.
Release the handswitch of the instrumentto contin ue.
If the problem persists, replace the instrument.
Reconnect the instrument to the UNIVERSAL socket.
Check all communication c ables are connectedcorrectly.
Check all cables for damage. If necessary,
Ensure that the electrodes of the HF
instrument have proper tissue contact.
Replace the HF instrument and / or the
connection cable.
replace the cables.
E002
E003
E004
E006
Short circuit
Ensure the instrument
electrodes do not come
into contact with each
other and proceed.
--Error
„Auto-restart”
„Contact OLY”
Non-conductive fluid
Ensure conductive fluid is
used for bipolar
resection.
Electrodes of the HF instrument
may touch each other.
Malfunction of the HF instrument
and / or the connection cable.
DockingConnectorError --Internal software error. Send back to Olympus Service
Use of non-conductive fluid during a
bipolar cutting procedure.
The active and / or neutral electrode
is within an air environment.
The bipolar Olympus HF instrument
has not been properly connected to
the UNIVERSAL socket or damaged
Ensure that the electrodes of the HF
instrument do not touch each other.
Replace the HF instrument and / or the
connection cable.
Ensure that conductive fluid is used
during bipolar resection procedure.
Always immerse the active and / or
neutral electrode within the conductive
fluid.
Check the connection of the bipolar
Olympus HF instrument to the connection
cable and the connection of the
Device was activated by pressing
the footswitch or handswitch while
the instrument recognition data are
read after connecting to the
generator.
Malfunction of the Olympus HF
instrument and / or the connection
cable.
Refer to E058
Refer to E058
Refer to E058
necessary use soft tissue or brush to
protect the coating of the instrument.
/ or the connection cabl e.
Wait for the completion of the data
transfer (about 3 seconds) indicated by
the display of the instrument name on the
screen. Afterwards the device can be
activated.
Replace the Olympus HF instrument and
/ or the connection cabl e.
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 606 01-2-2) .................................. 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
from any metal surface including tabletops and other resistors. This is
especially true if several resistors are connected in series or parallel to obtain
Keep test leads to the minimum length usable; lead inductance and stray
Carefully select suitable ground points to avoid ground loop error in
2 Inspection procedures
The electrosurgical generator and the footswitch must undergo an ins pection / safety check in yearly intervals
in accordance with the national statutory regulations. Inspection is also mandatory after repair, adjustment,
update and upgrade.
Generally the foots witches are inspected together with the electrosurgical unit. If a footswitch alone has to be
checked, only following tests are mandatory. The Numbers used referring to the Inspection Card in chapter 5-3:
For a single footswitch test number 2, 39 and 55 are mandatory.
For a double footswitch test number 2, 38, 39 and 55 are mandatory.
Follow these test instructions. All tests must be done with fully functional and calibrated test equipment and by
technicians trained in the service / maintenance of electrical medical devices. Record the test results in the
“Inspection Card” (refer to chapter 5-3, Inspection Card) for reference in future tests and provide the user of the
electrosurgical unit with a signed report.
During service / maintenance take care of the different hardware and software versions which may be
applicable. Information how to identify the hardware version can be found in chapter 3-2, Board Compatibility.
Information how to identify the software version can be found in chapter 1-3, Software version.
If the electrosurgical unit fails to meet any of the checks, the unit has to be adjusted according to chapter 6
(Adjustment) or refer to chapter 4 (Troubleshooting). If the failure still occurs, contact the manufa cturer.
CAUTION
NOTE
To avoid inadvertent coupling and /
around the resistor elements, keep the resistors at least 10 centimeters away
a specified value. Do not allow the resistor bodies to touch each other.
capacitance can adverse ly affect readings.
measurements.
For tests and c he ck s r e qu ir in g a power cord, use the power cord provided with
the electrosurgical unit.
Inspection is mandatory after repair, adjustment, update and upgrade.
2-1 Visual inspection of the electrosurgical generator and accessories
1) Check that the labels according to chapter 5-1 (Front panel, Rear panel) are present and legible. The
product name should be clearly visible on the front panel. Verify that the type plate shows details about the
type of the device, reference number, line voltage range, supply frequency, output power classification,
output frequency, duty cycle, serial number, manufacturing date and manufacturer according to Fig. 5.2.1,
Fig. 5.2.2, Fig. 5.2.3 or Fig. 5.2.4
Fig. 5.2.1. Sample of type plate of the electrosurgical unit
Fig. 5.2.2. Sample of type plate of the electrosurgical unit ( Standard PK version)
electrosurgical generator. Fill out the table 7.1 after the first startup of the generator. The field “Actual
Procedure” can only be filled, if a procedure is chosen.
5) The table 7.2 is used every time before a mode is changed in order to perform a test. The settings of the
used mode are noted in one line of table 7.2. Restore the values of table 7.2 either after each performed
test or afte r the ins pec ti on. This should be done, to make sure that the physician will be provided with the
last output power setting.
2-2 Verifying the contact quality monitor function
1) Connect the power cord and the footswitch to the electrosurgical generator (refer to chapter 1-5-3 and
1-5-8).
2) All steps for this test are described in the table 7.3 at the next page. Assign the footswitch according to the
column “Mode”. Connect the appropriate resistor R (J004) described in the column “Action” via the
connection cable (J011) with the neutral electrode socket at the front panel (refer to chapter 1-5-2). For
some tests leave the connector open or short circuit the conn ecti on cabl e (J011).
3) Follow the steps described in the column “Action” and verify the reaction of the corresponding contact
quality monitor indicator for non-split neutral electrode or split neutral electrode at the front panel (refer to
chapter 1-5-2) according to table 7.3.
4) Repeat step 2 and 3 until all action items in table 7.3 have been checked.
5) Record the test results in the Inspection Card (refer to chapter 5-3).
Always disconnect the neutral electrode connector (J011) before connecting a
new resistor.
Any
bipolar
mode
Any
monopolar
mode
During standby and
activation
1) The neutral electrode
socket is left open,
nothing is connected.
2) Activate any bipolar
output.
During standby:
1) Short circuit the
neutral electrode
connector.
2) Connect a R = 5 Ω
with the neutral electrode socket
During standby:
1) Connect a R = 140 Ω
with the neutral
electrode connector
The contact quality monitor is
independent from the bipolar mode.
The indicator for
electrode is illuminated red. During
activation the HF-output is working.
Pop-Up Window at the screen will
appear.
Contact quality monitor indicator for
non-
illuminates green.
Contact quality monitor indicator for
split neutral electrode illuminates
green.
During standby and
activation:
1) Connect a R = 170 Ω,
with the neutral
electrode connector
2) Activate any
monopolar output.
Table 7.3: Checking the contact quality monitor
Contact quality monitor indicator for
split neutral electrode illuminates
2-3 Checking the DC resistance (according to IEC 60601-2-2)
1) Activate the safety test function in the service menu (see chapter 6-1, Safety Test) and verify that the
button “Relays on” is marked white.
2) Connect the digital multimeter (J003) with the bipolar connector on the front panel (see chapter 1-5-2).
3) Verify the resistance is ≥ 2 MΩ.
4) Deactivate the safety test function in the service menu.
5) Record the test results in the Inspection Card (see chapter 5-3).
2-4 Checking the earth resistance (according to IEC 60601-1 and IEC 62353)
1) Connect the electrosurgical generator with an electrical safety tester (J001) according to the tester’s
instructions for use.
2) If the power cord and the electrosurgical unit are m easured together, verify the protective earth resistance
≤ 0.3 Ω against metal parts which can be touched.
3) Record the test results in the Inspection Card (see chapter 5-3).
2-5 Checking the earth leakage current (according to IEC 60601-1)
1) Connect the electrosurgical generator with an electrical safety tester (J001) according to the tester’s
instructions for use.
2) Switch on the electrosurgical unit.
3) Verify under normal condition (NC) the earth leakage current is ≤ 0.5 mA.
4) Verify under single fault condition (SFC) the earth leakage current is ≤ 1.0 mA
5) Record the test results in the Inspection Card (see chapter 5-3).
For this test an interconnection of the three receptacles of MONOPOLAR 1
allowed. Before interconnect the three receptacles
2-6 Checking the patient leakage current (according to IEC 60601-1)
NOTE
1) Switch the electrosurgical generator on and activate the safety test function in the service menu (see
chapter 8-2, Safety Test) and verify that the button “Relays on” is marked white.
2) Connect the UNIVERSAL cable (J008) to the UNIVERSAL socket and the connection cable P-cord (J011)
to the neutral socket.
3) Connect two 4mm cables “banana” (J007) to every receptacle of the BIPOLAR socket.
4) Connect three 4mm cables “banana” to the 4mm receptacles of the MONOPOLAR 1 socket. Leave the
8 mm BOVIE connector open.
5) Connect three 4mm cables “banana” to the 4mm receptacles of the MONOPOLAR 2 socket. Leave the
5/9 mm ERBE connector open.
6) Verify again that the Button “Relays on” at the touch screen is marked white and short circuit all
connectors.
and MONOPOLAR 2 is
verify, that the safety test function is activated and the button “Relays on” is
marked white.
7) Switch the electrosurgical generator off, cable it with the elec trical safety tester (J001) according to the
tester’s instructions for use and switch it on again. Start the test with the electrical safety tester according
to the tester’s instructions for use.
8) Verify under normal condition (NC) for AC the patient leakage current is ≤ 0.01 mA.
9) Verify under normal condition (NC) for DC the patient leakage current is ≤ 0.01 mA.
10) Verify under single fault condition (SFC, “open earth”) for AC the patient leakage current is ≤ 0.05 mA.
11) Verify under single fault c ondition (SFC, “open earth”) for DC the patient leakage current is ≤ 0.05 mA.
12) Disconnect all cables from the electrosurgical generator.
13) Deactivate the safety test function in the service menu.
14) Record the test results in the Inspection Card (see chapter 5-3).
2-7 Checking the current and power consumption and output waveform
CAUTION
1) Connect the load resistor RL = 500 Ω (J005) via a 4mm cable “banana” (J007) to the right receptacle of
the MONOPOLAR 1 socket and via the connection cable “P-cord” (J011) to the neutral socket in the front
panel.
2) Cable the electrosurgical generator with the electrical safety tester according to the testers instructions for
use. Activate the function to measure current and power consumption.
3) Switch the electrosurgical generator on and select the PureCut (Effect 3) mode at the MONOPOLAR 1 socket. Set the level to 300. Assign the footswitch to the MONOPOLAR 1 socket. (Perform the setting
according to the instruction for use.)
4) Activate the output power by pressing “CUT” at the footswitch.
5) Verify the current consu mption I
6) Connect high voltage probe to oscilloscope and to generator output socket (signal to right receptacle of
the MONOPOLAR 1 socket and signal ground to neutral socket)
A connection of a 4 mm plug to any
other receptacle except
the right-hand-side receptacle of
the MONOPOLAR 1 socket and
the MONOPOLAR 2 socket may destroy
the socket during activation.
is ≤ 10 A.
L
•Recommended oscilloscope settings:
o Channel 1: high voltage probe 1000:1, DC, 200 V/div (minimum total voltage range
displayed on oscilloscope: -700 V … +700 V)
o Time:
minimum 2 ms/div (minimum total time range displayed on oscilloscope:
20 ms)
maximum 5 ms/div (maximum total time range displayed on oscilloscope:
50 ms)
7) Activate the output power by pressing “CUT” at the footswitch. Record the waveform in the time range
after the high power cut support pulse (ca. 100 ms after HF output start) in steady state.
8) Verify output waveform:
The amplitude level of the output voltage must be stable. No oscillation in the frequency range of
50 … 200 Hz. A maximum amplitude fluctuation from minimum peak voltage to maximum peak voltage of
110 V is allowed for steady state.
NOTE
Table 7.4 is showing good and bad examples how the output waveform should
look like. From the f igures in this table it is also clear to see, which parameter
is to be measured.
9) Disconnect high voltage probe.
10) Connect the load resistor RL = 75 Ω (J005) via the connection cable (J008) with the UNIVERSAL socket in
the front panel.
11) Select the SalineCut (Effect 3) mode at the UNIVERSAL socket. Set the level to 320. Assign the footswitch to the UNIVERSAL socket. (Perform the setting according to the instruction for use.)
12) Activate the output power by pressing “CUT” at the footswitch.
13) Verify the apparent power consumption S
14) Record the test results in the Inspection Card (see chapter 7-3)
15) Switch the electrosurgical generator off and disassemble the test set-up.
is ≤ 1500 VA.
L
Setup Picture of oscilloscope (2 ms / div) Picture of oscilloscope (5 ms / div)
“good”
WB91051W
“bad”
WB91051W
230 VAC
“bad”
WB91051W
wit
115 VAC
Table 7.4: good and bad examples of the output waveform
2-8 Checking the high frequency leakage current (according to IEC 60601-2-2)
The monopolar high frequency leakage current has to be measured according to the procedure 19.3.101 a) 2)
(neutral electrode isolated from earth at high frequency) as described in IEC 60601-2-2.
The bipolar high frequency leakage current has to be measured according to the procedure 19.3.101 a) 3)
(bipola r application) as described in IE C 60601-2-2.
The high frequency current is measured from the appropriate output connector of each pole while the
electrosurgical unit is operated at maximum output power setting in an appropriate mode and the output being
unloaded and loaded at rated load. The high frequency current is measured with the electrosurgical analyzer
through an internal resistance of 200 Ω.
2-8-1 Measurement of the monopolar high frequency leakage current under loaded condition
CAUTION
Fig. 5.2.4 and Fig. 5.2.5 are showing an example how to set up the test to measure the monopolar high
frequency leakage current under loaded condition. The load resistor R
connection cable (J007, banana) with the active pole MONOPOLAR 1 and via the connection cable J011 with
the NEUTRAL connector. The high frequency leakage current is floating from appropriate pole to the
equipotential bonding port. It is measured via the electrosurgical analyzer via a measuring resistance of 200 Ω.
Fig. 5.2.4 shows the measurement from the neutral pole; Fig. 5.2.5 shows the measurement from the active
pole.
A connection of a 4 mm plug to any
other receptacle except
the right-hand-side receptacle of
the MONOPOLAR 1 socket and
the MONOPOLAR 2 socket may destroy
the socket during activation.
= 500 Ω (J005) is connected via the
L
1) Assign the footswitch to the MONOPOLAR 1 socket and select the monopolar PureCut mode with effect 3.
Set the power level to 300. (Perform the setting according to the instruction for use.)
2) Set up the measurement according to Fig. 5.2.4 (Measuring of the high frequency leakage current under
loaded condition at the neut ral pole.)
3) Activate the output power by pressing the corresponding footswitch pedal.
4) Verify the leakage current is ≤ 150 mA.
5) Set up the measurement according to Fig. 5.2.5 (Measuring of the high frequenc y leakage current under
loaded condition at the act iv e pole.)
6) Activate the output power by pressing the corresp onding footswitch pedal.
7) Verify the leakage current is ≤ 150 mA.
8) Repeat step 2 - 7 for the monopolar SprayCoag mode with effect 3 and power level 120.
9) Record the test results in the Inspection Card (see chapter 5-3).
right-handMONOPOLAR 2 socket may destroy the socket during activation.
Page 88
ESG-400
2-8-2 Measurement of the monopolar high frequency leakage current under unloaded condition
CAUTION
Fig. 5.2.6 and Fig. 5.2.7 are showing an example how to set up the test to measure the monopolar high
frequency leakage current under unloaded condition. In this test the output is unloaded, the load resistance
used in the test before is removed. The high frequency leakage current is floating from appropriate pole to the
equipotential bonding port. It is measured via the electrosurgical analyzer via a measuring resistance of 200 Ω.
Fig. 5.2.6 shows the measurement from the neutral pole; Fig. 5.2.7 shows the measurement from the active
pole.
A connection of a 4 mm plug to any
other receptacle except
the right-hand-side receptacle of
the MONOPOLAR 1 socket and
the MONOPOLAR 2 socket may destroy
the socket during activation.
1) Assign the footswitch to the MONOPOLAR 1 socket and select the monopolar PureCut mode with effect 3.
Set the power level to 300. (Perform the setting according to the ins truction for use.)
2) Set up the measurement according to Fig. 5.2.6 (Measuring of the high frequency leakage current under
unloaded condition at the neutral pole.)
3) Activate the output power by pressing the corresponding footswitch pedal.
4) Verify the leakage current is ≤ 150 mA.
5) Set up the measurement according to Fig. 5.2.7 (Measuring of the high frequency leakage current under
unloaded condition at the active pole.)
6) Activate the output power by pressing the corresponding footswitch pedal.
7) Verify the leakage current is ≤ 150 mA.
8) Repeat step 2 - 7 for the monopolar SprayCoag mode with effect 3 and power level 120.
9) Record the test results in the Inspection Card (see chapter 5-3).
right-handMONOPOLAR 2 socket may des troy the socket during activation.
Page 90
ESG-400
2-8-3 Measurement of the bipolar high frequency leakage current under loaded condition
CAUTION
A connection of a 4 mm plug to any
other receptacle except
the right-hand-side receptacle of
the MONOPOLAR 1 socket and
the MONOPOLAR 2 socket may destroy
the socket during activation.
Fig. 5.2.8 and Fig. 5.2.9 are showing an example how to set up the test to m easure the bipolar high frequency
leakage current under loaded condition. The load resistor R
= 500 Ω (J005) is connected via the connection
L
cables (J007, banana) with both BIPOLAR receptacles. The high frequency leakage current is floating from
appropriate pole to the equipotential bonding port. It is measured via the electrosurgical analyzer via a
measuring resistance of 200 Ω. Fig. 5.2.8 shows the measurement from terminal 1; Fig. 5.2.9 shows the
measurement from termin al 2.
1) Assign the footswitch to the BIPOLAR socket and select the BipolarCut mode with effect 3. Set the power
level to 100. (Perform the setting according to the instruction for use.)
2) Set up the measurement according to Fig. 5.2.8 (Measuring of the high frequency leakage current under
loaded condition at terminal 1.)
3) Activate the output power by pressing the corresponding footswitch pedal.
4) Verify the leakage current is ≤ 70 mA.
5) Set up the measurement according to Fig. 5.2.9 (Measuring of the high frequency leakage current under
loaded condition at term inal 2.)
6) Activate the output power by pressing the corresp onding footswitch pedal.
7) Verify the leakage current is ≤ 70 mA.
8) Record the test results in the Inspection Card (see chapter 5-3).
2-8-4 Measurement of the bipolar high frequency leakage current under unloaded condition
Fig. 5.2.10 and Fig. 5.2.11 are showing an example how to set up the test to measure the bipolar high
frequency leakage current under unloaded condition. In this test the output is unloaded, the load resistance
used in the test before is removed. The high frequency leakage current is floating from appropriate pole to the
equipotential bonding port. It is measured via the electrosurgical analyzer via a measuring resistance of 200 Ω.
Fig. 5.2.10 shows the measurement from terminal 1; Fig. 5.2.11 shows the measurement from terminal 2.
9) Assign the footswitch to the BIPOLAR socket and select the BipolarCut mode with effect 3. Set the power
level to 100. (Perform the setting according to the instruction for use.)
10) Set up the measurement according to Fig. 5.2.10 (Measuring of the high frequency leakage current under
unloaded condition at terminal 1.)
11) Activate the output power by pressing the corresponding footswitch pedal.
12) Verify the leakage current is ≤ 70 mA.
13) Set up the measurement according to Fig. 5.2.11 (Measuring of the high frequency leakage current under
unloaded condition at terminal 2.)
14) Activate the output power by pressing the corresponding footswitch pedal.
15) Verify the leakage current is ≤ 70 mA.
16) Record the test results in the Inspection Card (see chapter 5-3 ).
For the measurement of this (high current) value, it is important, that the cable
2-9 Checking the output power
1) All constraints for these tests are listed in the inspection card in chapter 5-3 under number 31 to 47. The
constraints are the output socket, the way of activation (e.g. footswitch, handswitch), the settings and the
load resistance. For measuring and to simulate the appropriate resistance the electrosurgical analyzer
(J002) is used.
2) Connect the appropriate output of the electrosurgical generator to the variable load of the electrosurgical
analyzer (J002) (according to the inspection card in chapter 5-3). Set the electrosurgical generator to
continuous measuring and set t he internal mea suri ng resistance to the appropriate value (according to the
inspection card in chapter 5-3). Start the measuring with the electrosurgical generator. (Settings o f the
electrosurgical analyzer are done according to the analyzer’s instruction for use.)
3) Select the mode and set the power level according to the inspection card i n chapter 5-3.
4) Activate the output power by pressing the corresponding footswitch pedal or handswitch button. During
the activated output the output tone can be heard.
5) Verify the output power is in the range according to the inspection card in chapter 5-3.
6) Repeat step 2 - 5 until test number 30 to 45 in the inspection card in chapter 5-3 have been checked.
7) Record the test results in the Inspection Card (see chapter 5-3).
NOTE
of the instrument is not “forming an inductor”. So do not wrap it up like a coil.
Either use it flat or unfold it completely.
2-10 Checking for certain features and error messages
1) All constraints for these tests are listed in the inspection card in chapter 5-3 under number 48 to 50. The
constraints are the output socket, the way of activation (e.g. footswitch, handswitch), the settings and the
load resistance. Low inductive high load resistors (J005) are used.
2) Connect the appropriate output of the electrosurgical generator to the appropriate load resistor (according
to the inspection card in chapter 5-3).
3) Select the mode and set the power level according to the inspection card in chapter 5-3.
4) Activate the output power by pressing the corresponding footswitch pedal. During the activated output the
output tone can be heard.
5) Verify the r eaction of the electrosurgical generator according to the inspection car d in chapter 5-3.
6) Repeat step 2 - 5 until test number 46 to 48 in the inspection card in chapter 5-3 have been checked.
7) Record the test results in the Inspection Card (see chapter 5-3).
1) Connect the electrosurgical generator via power cord (J016) to mains. Switch the generator on by
pressing the “Power Switch”.
2) The generator should boot without any alarm. If an alarm occurs, refer to Chapter 4 (Troubleshooting).
2-11-2 Display and sound check
1) Check the adjustment of display
brightness and volume via touch
screen. Enter the “Select Menu”
by pressing the push button
“MENU push button”. Change
the Volume via the roc ker switch.
A sound should be carried
according to the setting. Change
the Brightness via the rocker
switch. The brightness should
change according to the setting.
2) Check the adjustment of the
volume via the volume control
knob at the rear of the housing.
There will be an acoustic
feedback for the setting.
3) Record the test results in the Inspection Card (refer to chapter 5-3).
2-11-3 Functionality of push buttons
1)
by pressing.
2) The buttons should perform according to the
description in the instruction for use.
3)
Card (refer to chapter 5-3).
2-11-4 Communication test
1) Connect the sockets “LINK-IN” and “LINK-OUT” at the rear of the housing by the Communication Cable
(J012) with each other. In this way a ring communication is established.
2) The Error Message “E394 Communication error” should appear.
3) Record the test results in the Inspection Card (refer to chapter 5-3).
2-11-5 Restore of output power settings
Restore the settings by using the tables created in chapter 7-2-1. When not done while inspecting, restore all
power settings off the changed modes noted in table 7.2. Finally restore the las t active procedure if applic able
and assign all modes to the sockets.
2-12 Inspection label (For applicable markets)
1) Cover or exchange an inspection label (as shown in Fig. 5.2.14) at the rear panel of the electrosurgical
unit’s housing and mark the due date of the next periodic safety check (month / year). The electrosurgical
unit must undergo a periodic safety check at annual intervals.
2) Record the due date in the safety check report (see chapter 5-3).