Olympus ESG-100 Electrosurgical Unit - Instructions For Use
Olympus ESG-100 Electrosurgical Unit - Instructions For Use
ELECTROSURGICAL UNIT
ESG-100
W7092100_03 (2018-12)
Olympus ESG-100 EN Instructions for Use
Contents
1 Important information
1.1 Intended use
1.2 Applicability of endoscopic treatment
1.3 Instructions for use
1.4 User qualification
1.5 Environment of use
1.6 Electrosurgical unit compatibility
1.7 Repair and modification
1.8 Signal words
1.9 Danger, warnings and cautions
1.10 Reporting serious incidents
2 General description
3 Inspection prior to use
4 Symbols, definitions and functions
4.1 Symbols and descriptions
4.1.1 Front panel
4.1.2 Rear panel
4.1.3 Packaging
4.2 Front panel
4.2.1 Buttons / Switches
4.2.2 Indicators
4.2.3 Displays
4.2.4 Connectors
4.3 Rear panel
5 Accessories
5.1 Footswitch
5.2 P-cord
5.3 A-cord
5.4 Peristaltic pump unit AFU-100 and communication cable
6 Installation and commissioning
6.1 Installation of equipment
6.2 Connection to an AC mains power supply
6.3 Equipotential bonding
6.4 Connection of footswitch
6.5 Connection to the peristaltic pump unit AFU-100
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7 Operation
7.1 Power supply
7.2 Acoustic signals and tone volume adjustments
7.3 Neutral electrode (for monopolar treatment only)
7.3.1 Split type neutral electrode
7.3.2 Non-split neutral electrode
7.3.3 Connection of the neutral electrode
7.4 Connection of instruments
7.5 Mode selection
7.6 Output power setting
7.7 Activation of selected mode
7.8 Performing the electrosurgical intervention
7.9 Procedure after use
8 Cleaning, storage and disposal
8.1 Cleaning
8.2 Storage
8.3 Disposal of the unit
9 Troubleshooting
9.1 Footswitch operation
9.2 Neutral electrode operation
9.3 Error codes and measures
9.4 Periodic safety checks
9.5 Returning the electrosurgical unit for repair
10 Service operation mode
11 System chart
12 Specifications
12.1 Mode characteristics
12.2 Output characteristics
12.3 Technical data
13 Electromagnetic compatibility
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1 Important information
1.1 Intended use
The ESG-100 is an electrosurgical unit for tissue coagulation and cutting in general and
endoscopic surgery in conjunction with designated electrosurgical accessories,
endoscopes applicable for electrosurgery, light sources and ancillary equipment.
Contraindications:
Electrosurgical interventions are contraindicated if, in the judgment of the physician,
tissue coagulation and cutting could have a negative effect on the state of the patient.
Electrosurgical tissue coagulation and cutting may be contraindicated for patients with
cardiac pacemakers, a weakened immune system or blood coagulation disorders.
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Do not service or maintain any part of the product while in use with a patient.
Follow the dangers, warnings and cautions given below when handling this
electrosurgical unit. This information is to be supplemented by the dangers, warnings
and cautions given in each chapter.
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control of the user. It is therefore extremely important to read, understand and follow the
instructions supplied with the electrosurgical unit and the accessories in order to ensure
safety and effectiveness.
Always use the electrosurgical unit as outlined in these instructions for use. Improper
use will not only impede functions and prevent optimum performance, but may cause
equipment damage and / or complications. Before each use, always inspect the
equipment as outlined in these instructions for use.
Environmental conditions
CAUTION Interference of the unit with other equipment
Be sure that this electrosurgical unit is not used adjacent to or stacked with other
equipment (other than the components of this electrosurgical unit or system) to avoid
electromagnetic interference.
Before use, thoroughly confirm the compatibility of all equipment.
To ensure electrical safety, the electrosurgical unit should not be used in conjunction
with:
Electrical equipment whose safety against leakage current is not guaranteed.
Electrosurgical equipment whose safety in combined use is not guaranteed.
The electrosurgical unit complies with the electromagnetic compatibility (EMC) standard.
Nevertheless, when the electrosurgical unit is active it may disturb neighboring
electronic equipment. If an auxiliary computer system is in use together with the
electrosurgical unit and endoscopic imaging techniques, the image on the monitor might
freeze or blackout. Follow the instructions in chapter 13 (Electromagnetic compatibility)
regarding electromagnetic ambient conditions.
Never loop the cords (active cord, bipolar cord, neutral electrode cord) or bundle cords
together with cords belonging to other medical equipment. The high frequency signals
or spark discharge noise generated by the unit may interfere with the operation of other
medical equipment.
Do not use the electrosurgical unit in a location exposed to strong electromagnetic
radiation (microwave or short-wave medical treatment equipment, Magnetic Resonance
Imaging, radio or mobile phone equipment). Electrosurgical unit malfunction can occur.
CAUTION Unsuitable temperature and humidity
The electrosurgical unit should only be used under the conditions as described in
chapter 12.3 (Technical data). Use under other conditions may impede normal
performance and / or result in equipment damage.
Accessories
WARNING Mechanical stress
Do not apply excessive bending, straining, or squeezing force to any cords. It may
cause malfunction.
CAUTION Non-compatible accessories and accessory damage
The electrosurgical unit shall only be used with compatible accessories. When
connecting accessories (cords, electrodes, instruments) avoid output settings where the
maximum output voltage of the electrosurgical unit may exceed the rated accessory
voltage (refer to chapters 12.1, Mode characteristics, 12.2 Output characteristics, and
the instructions for use of the accessory).
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Refer to chapter 12.3 (Technical data) for a list of compatible neutral electrodes.
Before use, the electrosurgical unit and accessories must be examined for damage. All
communication cables and its plugs must be free of scratches and cracks. Cables and
accessories with damaged insulation or connections must not be used.
Electric shock
WARNING Grounding failure
To prevent the risk of electric shock, the housing of the electrosurgical unit must be
grounded. Always connect the power cord plug to a properly grounded wall outlet. Do
not use a 3-pin / 2-pin adapter, as it can impair safe operation of the unit.
WARNING User shock
To prevent user shock, malfunction and damage of the electrosurgical unit, keep liquids
away from all electrical equipment. If liquid gets on or into the electrosurgical unit,
terminate operation immediately and contact Olympus or your distributor.
CAUTION Injury during servicing
When the housing is opened, there is a danger of electric shock. The unit must only be
serviced by authorised technicians.
Burns
WARNING Patient and / or user
The maximum output voltage characteristics of the electrosurgical unit are shown in the
diagrams in chapter 12.2 (Output characteristics). When setting the power level, first set
it to a low level and increase it gradually. If the output is initially set to a high level, the
electrode’s insulation may be damaged and cause user and / or patient burns.
Furthermore, it is recommended that you perform basic testings before using the
electrosurgical unit. If the instructions for use of the endoscopic instrument to be used
stipulate a rated voltage, the output should be set so that it does not exceed that
voltage.
Contact with the tip of the electrodes may cause burns when the electrosurgical unit is
active.
During operation, temporarily unused electrodes should be stored in an electrically
insulated container. Unused electrodes should never be placed on the patient.
Otherwise, it may cause patient and / or user burns.
To prevent patient burns, the electrosurgical unit and ancillary cords should not come in
contact with the patient or metal parts of the operating table. Furthermore, the patient
should also be kept away from metallic parts of the operating table or other devices.
If the electrosurgical unit is used in conjunction with another electrosurgical unit, never
use both electrosurgical units simultaneously. Keep the electrosurgical instrument
connected to the not-used electrosurgical unit away from the target area while the other
electrosurgical unit is in operation. Do not activate output of both units simultaneously.
Patient or user injury may occur due to the concentration of electric current.
To prevent patient burns, the patient’s skin surfaces should not touch each other (e.g.
bare arm and side of chest) or any metal items in the procedure room. Remove any
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metallic items from the patient (wristwatches, jewelry, etc.) before starting the
procedure.
To prevent patient burns during endoscopic treatment, the patient’s clothes must be dry.
During endoscopic treatment be sure that the distal end of the endoscope and / or
instruments do / does not contact bridging fluids surrounding the target tissue. Electric
current may flow to the surrounding tissue via the fluids and cause burns.
The endoscopic treatment performed should not include an operation in which part of
the treated tissue (polyp head, etc.) or part of the endoscope distal end or endotherapy
instrument is in contact with or close to surrounding tissue during high frequency
exposure. Otherwise, current flows to the tissue through the part of the treated tissue,
the metallic parts at the endoscope’s distal end or endotherapy instrument and may
cause burns.
When using an electrocardiograph or other physiological monitoring equipment
simultaneously with the electrosurgical unit on a patient, any monitoring electrodes
should be placed as far away as possible from the electrodes used with the
electrosurgical unit. If placed too close, high frequency signals or spark discharge noise
from the electrosurgical unit may interfere with the operation of an electrocardiograph or
other physiological monitoring equipment. Needle monitoring electrodes should not be
used, as they may cause patient burns. Physiological monitoring equipment
incorporating high frequency current limiting devices is recommended.
To prevent burns, the user and assistant should wear chemical-resistant gloves during
the procedure.
CAUTION High frequency leakage current
Wherever possible, the patient should not be able to come into contact with electrically
conductive components that are grounded. Route all connecting cables so that they are
not in direct contact with the patient or other cables. Capacitive coupling may occur.
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Fire / Explosion
DANGER Ignitable anaesthetics / fire supporting gases
The risk of flammable gases or other materials being ignited exists with any surgical
application of electrical energy. Precautionary measures must be taken to keep
flammable materials and substances away from the site of intervention (do not use
flammable anaesthetics, nitrous oxide or oxygen). Otherwise, explosion or fire may
result and cause serious injuries. This electrosurgical unit is not explosion-proof. Do not
use the unit within an explosion zone.
WARNING Ignitable gas in the gastro-intestinal tract
If the intestines contain a flammable gas, replace this gas with air or a non-flammable
gas before performing the operation, to minimize the risk of fire or explosion.
WARNING Ignitable cleaning- and disinfection agents
Flammable agents used for cleaning and disinfection must be allowed to evaporate
before the electrosurgical unit is used. Also ensure that flammable solutions are neither
on the patient’s skin (e.g. under neutral electrode) nor in the patient’s body cavity when
the electrosurgical unit is used.
Non-flammable agents should be used for cleaning and disinfection wherever possible.
WARNING Ignitable materials
If absorbent cotton or gauze is used during the procedure, it can be ignited by a spark
generated in the normal operation of the equipment.
When performing electrosurgery, arcs occur which could lead to burning or deflagration
of combustible gases.
WARNING Risk of fire
Disconnect the power plug before changing the fuses! Replace fuses as marked. The
fuses must only be replaced by authorised technicians.
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2 General description
The ESG-100 electrosurgical unit enables the user to perform common monopolar and
bipolar applications. Both can be operated in cutting and coagulation modes. The
electrosurgical unit is equipped with a user friendly display that allows the user to select
from a list of optimized modes. All settings are saved automatically and are at the user’s
disposition when switching on the electrosurgical unit the next time or when the user
changes the modes during a procedure.
The electrosurgical unit is equipped with a high voltage power supply which allows fast
control of the output resulting in safely controlled tissue effects and protection against
over- and under-dosage. In addition, the integrated high power cut support (HPCS) is a
precondition for optimized cutting procedures without initial delay.
Another feature of the electrosurgical unit is the fast spark monitor (FSM). This
technology measures the spark intensity in intervals of a few milliseconds when cutting
tissue. The fast spark monitor ensures the application of output powers that are as low
as possible and as much as necessary to achieve well defined tissue effects.
Moreover, the contact quality monitor (CQM) analyses continuously the contact
resistance of the neutral electrode, ensuring a safe application and minimizing the risk
of thermal injuries to the patient. The contact quality monitor status is continuously
displayed by visual indicators.
Finally, the leakage protection sensor (LPS) automatically monitors the high frequency
leakage current through the patient and produces a visual and acoustic signal if the
current is too high.
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Power on / off
Caution
Up
Down
Bipolar cutting
Bipolar coagulation
Monopolar cutting
Monopolar coagulation
Footswitch assignment
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Manufacturer
Date of manufacture
Serial number
Reference number
Loudspeaker
Footswitch connection
Operating instructions
Fuse
Operating instructions
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4.1.3 Packaging
This way up
Quantity
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Monopolar coagulation
Bipolar coagulation select button (2)
select button (4)
Monopolar coagulation
mode indicator (12)
Activation indicator
monopolar coagulation (16)
Footswitch assignment to
monopolar connector indicator (18)
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0 Power switch
This switch turns on and off the electrosurgical unit.
1 Bipolar cut select button
This button is used for the selection of a bipolar cutting mode. The level
display (21) shows the selected power level. The mode display (22) shows the
selected mode.
2 Bipolar coagulation select button
This button is used for the selection of a bipolar coagulation mode. The level
display (21) shows the selected power level. The mode display (22) shows the
selected mode.
3 Monopolar cut select button
This button is used for the selection of a monopolar cutting mode. The level
display (21) shows the selected power level. The mode display (22) shows the
selected mode.
4 Monopolar coagulation select button
This button is used for the selection of a monopolar coagulation mode. The
level display (21) shows the selected power level. The mode display (22)
shows the selected mode.
6/5 Up / down button
These buttons increase / decrease the value displayed at level display (21)
during normal operation.
7 Toggle button
This button switches to the next mode shown in the mode display (22).
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4.2.2 Indicators
8 Error indicator
This indicator illuminates red if any error occurs.
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4.2.3 Displays
21 Level display
This display shows the currently selected power level.
1 … 120 Power level
22 Mode display
This display shows the currently selected mode during normal operation.
Cut Cutting mode
PulseCut Pulsed cutting mode
SoftCoag Soft coagulation mode
ForcedCoag Forced coagulation mode
RFCoag Controlled tissue coagulation with acoustic
resistance feedback (radiofrequency coagulation)
RFCoag + RCAP Deep tissue coagulation with resistance controlled
automatic power (radiofrequency coagulation)
Mid.Ped. -> Toggle Middle pedal of the footswitch is functioning as a
toggle pedal if the peristaltic pump unit is
disconnected
Mid.Ped. -> Pump Middle pedal of the footswitch is activating the
pump flow with connected peristaltic pump unit
Error: No. Error notice and related error number
NOTE The mode display messages may depend on the language setting of
the electrosurgical unit.
4.2.4 Connectors
23 Bipolar connector
This terminal connects the plug of the bipolar applicator.
24 Monopolar connector
This terminal connects the plug of the monopolar applicator.
25 Neutral electrode connector
This terminal connects the plug of the neutral electrode.
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26 Footswitch connector
This terminal connects the footswitch with the electrosurgical unit, so that
cutting and coagulation modes can be activated by the footswitch.
27 Communication port for peristaltic pump unit AFU-100
This terminal is used for the communication between the electrosurgical unit
and the peristaltic pump unit.
28 Equipotential bonding connector
This terminal is used for potential equalization.
29 Mains connector with integrated fuses
This terminal serves as a connection to the mains power supply.
30 Type plate
The type plate contains specific information about the electrosurgical unit
regarding type of device, reference number (REF), line voltage range, output
power classification, serial number and the registered office of the
manufacturer.
31 Volume control
This knob is used for adjusting the output volume.
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5 Accessories
5.1 Footswitch
Cut pedal (32) Middle pedal (34) Coagulation pedal (33) Footswitch plug (35)
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The footswitch middle pedal (34) may have three different functions:
1) If the peristaltic pump unit is connected and switched on, the footswitch middle
pedal (34) activates the pump flow.
2) If there is no communication of the electrosurgical unit with the pump, the user has
the possibility to choose between two functionalities:
2a) The user toggles between the modes as it is done by the toggle button (7) at the
front panel (see fig. 5.1). The change will be indicated by a beep tone. This is the
default setting.
Example: A bipolar coagulation mode is preset (e.g. SoftCoag). By pressing the
footswitch middle pedal (34) the user toggles between the bipolar modes (e.g.
RFCoag -> RFCoag + RCAP -> SoftCoag).
2b) The user changes either between monopolar cut and monopolar coagulation or
between bipolar cut and bipolar coagulation mode without using one of the select
buttons (1, 2, 3, 4) at the front panel (see fig. 5.2). The change will be indicated by
a beep tone.
Example: A monopolar cut mode is preset (e.g. Cut 1). By pressing the footswitch
middle pedal (34) the user changes to a monopolar coagulation mode (e.g.
ForcedCoag 1). The last used coagulation mode will be called.
To use the function 2b), change the footswitch function in the service menu as
described in chapter 10 (Service operation mode).
RFCoag
Fig. 5.1: Example of toggling Fig. 5.2: Example of toggling between cut and
between bipolar modes coagulation modes
5.2 P-cord
The P-cord (Olympus REF: MAJ-814) is a separate accessory.
Clamp (37)
36 Plug on the unit side
This plug connects the P-cord to the electrosurgical unit.
37 Clamp
This clamp connects the neutral electrode to the P-cord.
38 Lever-locking arm
This arm secures the connector of the neutral electrode with the clamp.
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5.3 A-cord
The A-cord (Olympus REF: MH-969) is a separate accessory.
Plug on the Plug on the
unit side (39) accessory side (40)
Fig. 5.3: System of ESG-100 and AFU-100 Fig. 5.4: Communication cable
(REF: WB950167) (REF: WB950241)
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NOTE Place the instructions for use near the electrosurgical unit or in another
easily accessible place.
Before using an optional item, thoroughly review and understand the
instructions for use provided with that item and check the compatibility
with the electrosurgical unit.
Specifications, design and accessories are subject to change without
any notice or any obligation of the manufacturer.
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DANGER Connect the power plug of the power cord directly to a grounded wall
outlet or to a multiple power socket outlet equiped with an insulating
transformer of protection class I, conforming to IEC 60601-1. The
multiple power socket outlet shall conform with the requirements of the
IEC 60601-1-1 standard. In this case, observe the maximum permitted
current or power loading of the multiple power socket outlet and the
insulating transformer.
WARNING Firmly plug in the power cord so it will not accidentally be dislodged
during the operation.
CAUTION Always use the power cord provided with the electrosurgical unit or a
cable of similar quality (see chapter 12.3, Technical data). Never
attempt to modify the power cord.
If the same circuit breaker is used to supply power to other electrical
equipment, carefully consider the power requirements of the additional
equipment and use circuit breakers that have ample capacity.
Otherwise, the electrosurgical unit does not work correctly.
Portable multiple power socket outlets must not be placed on the floor.
Do not use an additional extension cable or other multiple power socket
outlets that are not expressly approved by the manufacturer for joint
use.
NOTE Before connecting to the power supply, check that the supply voltage
agrees with the electrical data on the type plate of the electrosurgical
unit.
If the voltage of the facility is different from the voltage indicated on the
type plate of the electrosurgical unit, contact Olympus or your
distributor.
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Fastener ring
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Fig. 6.3: Connection of the electrosurgical unit and the peristaltic pump unit
NOTE If the communication to the peristaltic pump unit is established and the
peristaltic pump unit is switched on, the middle pedal (34) of the
footswitch activates the pump flow.
7 Operation
Prepare this electrosurgical unit and other equipment to be used with this unit for the
particular operation. Refer to the respective instructions for use for each item. Confirm
that the connections of the power cord, footswitch, neutral electrode and instruments
are secure and correct.
WARNING Before each use, inspect this unit as instructed below. Inspect other
equipment to be used with this unit as instructed in their respective
instructions for use. Should the slightest irregularity be suspected, do
not use the electrosurgical unit and refer to chapter 9 (Troubleshooting).
If the irregularity is still suspected after consulting chapter 9, contact
Olympus or your distributor. Damage or irregularity may compromise
patient or user safety and may result in more severe equipment
damage.
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WARNING If the electrosurgical unit fails to start up (no indicators illuminates and
the level and mode display (21 / 22) are off), confirm that the power
cord is connected securely to a grounded wall outlet and the mains
connector (29) on the electrosurgical unit and confirm that the grounded
wall outlet is powered. If it still fails to start up, remove the power cord
from the grounded wall outlet and contact Olympus or your distributor.
Equipment damage or malfunction may have occurred and fire or
electric shock can result.
WARNING Because the output tones play an important role of noticing the output,
do not lower the volume to the inaudible area. If the output tone is
inaudible, high frequency output may not be detected by the user. This
could cause patient injury.
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The alarm tone is associated with an error message shown on the level display (21)
and has a louder tone with a higher frequency than the warning “beep” tone.
NOTE The volume of the warning and alarm tone are not adjustable.
When a split type neutral electrode (patient grounding pad) is connected to the
electrosurgical unit, it is possible to detect unintended detachment of the neutral
electrode from the patient. Refer to chapter 12.3 (Technical data) for a list of compatible
neutral electrodes.
If the contact between the neutral electrode and the patient’s skin is insufficient, the
contact quality monitor indicator for split neutral electrodes (20) illuminates red.
Reattach the neutral electrode or use a new plate. The contact quality monitor indicator
for split neutral electrode (20) will only light green while the contact between the neutral
electrode and the skin of the patient is within an acceptable resistance range (see
chapter 12.3, Technical data).
WARNING Always use compatible split type neutral electrodes, otherwise the loss
of safe contact between the neutral electrode and the patient will not
result in a warning signal of the contact quality monitor.
CAUTION Always use split type neutral electrodes if possible. By using a non-split
neutral electrode the contact quality monitor does not work. An
unintended detachment of the neutral electrode will not be detected and
this may result in patient burns.
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Improper connection between the neutral electrode and the patient’s skin surface may
cause burns. Always attach and inspect the warning functions of the neutral electrode
as described below. For further details on neutral electrodes, refer to the neutral
electrode’s instructions for use.
1) Before connecting any neutral electrode to the electrosurgical unit, make sure the
contact quality monitor indicator for split neutral electrodes (20) illuminates red and
the contact quality monitor indicator for non-split neutral electrodes (19) is off.
2) Peel off the protective liner from the neutral electrode and attach the plate to the
patient’s body according to the neutral electrode manufacturer’s instructions for
use.
3a) For neutral electrodes with a pre-attached cable consider the following procedure:
Insert the neutral electrode plug into the neutral electrode connector (25) on the
front panel of the electrosurgical unit (see fig. 7.1).
3b) For neutral electrodes without a pre-attached cable consider the following
procedure: Lift the lever-locking arm (38), and then position the neutral electrode
tab evenly between the clamp (37) jaws. Lock the clamp (37) by fully pressing
down the lever-locking arm (38) (see fig. 7.2). Insert the P-cord plug on the unit
side (36) into the neutral electrode connector (25) on the front panel of the
electrosurgical unit (see fig. 7.1).
4) Verify that the contact quality monitor indicator for split neutral electrodes (20)
illuminates green when using a split neutral electrode or the contact quality monitor
indicator for non-split neutral electrodes (19) illuminates green when using a non-
split neutral electrode.
Fig. 7.1: Connection of the neutral Fig. 7.2: Connection of the P-cord to the
electrode neutral electrode
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CAUTION Use the largest neutral electrode that will fit to the patient. Otherwise,
patient burns may result.
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Bipolar instruments
Insert the bipolar cord plug into the bipolar connector (23) on the front panel of the
electrosurgical unit (see fig. 7.4 and 7.5).
WARNING Securely connect the instrument. Otherwise, the high frequency may
not be output during treatment and, in this case, mechanical tissue
cutting by the electrosurgical instrument may occur and cause bleeding
or perforation of the patient.
CAUTION Olympus instruments should be used for endoscopic electrosurgical
procedures. For details, refer to the instructions for use of the
instrument. If you have any questions concerning the applicability of
your instrument, please contact Olympus or your distributor.
For using a monopolar cutting, press the monopolar cut select button (3) on the front
panel. The monopolar cut mode indicator (11) illuminates and the (last used) power
level and monopolar cutting mode appear on level display (21) and mode display (22).
Press the toggle button (7) until the needed monopolar cutting mode appears on the
mode display (22).
For using a monopolar coagulation, press the monopolar coagulation select button (4)
on the front panel. The monopolar coagulation mode indicator (12) illuminates and the
(last used) power level and monopolar coagulation mode appear on level display (21)
and mode display (22).
Press the toggle button (7) until the needed monopolar coagulation mode appears on
the mode display (22).
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For using a bipolar cutting, press the bipolar cut select button (1) on the front panel. The
bipolar cut mode indicator (9) illuminates and the (last used) power level and bipolar cut
mode appear on level display (21) and mode display (22).
Press the toggle button (7) until the needed bipolar cutting mode appears on the mode
display (22).
For using a bipolar coagulation, press the bipolar coagulation select button (2) on the
front panel. The bipolar coagulation mode indicator (10) illuminates and the (last used)
power level and bipolar coagulation mode appear on level display (21) and mode
display (22).
Press the toggle button (7) until the needed bipolar coagulation mode appears on the
mode display (22).
RFCoag
The medical purpose of RFCoag is to achieve a controlled tissue coagulation. By
activating the electrosurgical unit, the amount of energy emitted and the duration of
application are measured and displayed.
The electrosurgical unit provides an acoustic feedback of the coagulation status. The
frequency of the RFCoag tone is proportional to the tissue resistance at any particular
moment. As the measured tissue resistance increases, the frequency of the acoustic
feedback tone also increases. This permits acoustic monitoring of the coagulation
status, since the latter is directly connected with the tissue resistance.
In the deactivated state of the electrosurgical unit, the level display (21) shows the set
power level. During activation, the average applied power level is indicated on the level
display (21). The current mode, the application time and the applied energy are
indicated on the mode display (22), e.g. “RFC. 00:00 0J”.
Energy is applied until the tissue resistance exceeds a limit value (see chapter 12.3,
Technical data). Then the power output is automatically reduced because the
coagulation process is complete due to dehydration of the tissue (see chapter 12.2,
Output characteristics). This is indicated by an intermittent acoustic signal.
RFCoag + RCAP
The medical purpose of RFCoag + RCAP is to achieve a deep tissue coagulation
without significant tissue desiccation. By activating the electrosurgical unit, the amount
of energy emitted and the duration of application are measured and displayed. In the
deactivated state of the electrosurgical unit, the level display (21) shows the set power
level. During activation, the average applied power level is indicated on the level display
(21). The current mode, the application time and the applied energy are indicated on
the mode display (22), e.g. “RCAP 00:00 0J”.
Once the tissue resistance increases significantly, which indicates beginning tissue
desiccation, the power is reduced automatically. This enables the tissue to rehydrate,
resulting in normal electrical resistance of the tissue after a few seconds. Detecting this
decrease of resistance, the unit automatically increases the power again to the preset
value and continues the heating process. This cycle will be repeated until the activation
is stopped or the tissue resistance exceeds a limit value. In the latter case, the power
output is automatically reduced. This is indicated by an intermittent acoustic signal.
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Modes overview
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Instructions for Use EN Olympus ESG-100
CAUTION High current densities can cause nerve and muscle stimulation. High
current densities may occur when modes with high power cut support
(HPCS) are used. Nerve and muscle stimulations may cause discomfort
or pain in patients without sedation, pain medication or general
anesthesia. To reduce the probability of nerve and muscle stimulations
use modes without HPCS.
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Table 7.2: Change of the power level with the resulting tissue effects
WARNING Use the lowest appropriate power level to achieve the desired effect.
Inappropriate output can cause burns to the patient and / or user,
patient bleeding and / or perforation. It is recommended to do
appropriate examination before using on a human body.
NOTE The power level is the maximum power (watts) which can be applied
during the activation of the electrosurgical unit. The real applied power
depends on the tissue characteristics (e.g. resistance).
If the minimum / maximum power level of any mode is reached, a
warning tone can be heard.
If the minimum power level of any mode is reached and the down button
(5) is pressed again, the level display (21) shows “---”. In this case, the
power output is set to zero.
The power level cannot be changed while output is activated.
This electrosurgical unit stores the output setting of each mode
automatically. By switching on the power, the last output settings will be
recalled for each mode individually.
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NOTE If the cut and / or coagulation power level is set to “---” (zero) and the
footswitch is pressed, a warning tone can be heard and the level display
(21) shows “InF”, the mode display (22) shows “Level: 0 Watt”.
40 W7092100_03
Olympus ESG-100 EN Instructions for Use
If output is not required, keep the foot away from the pedal to prevent
accidental pressing. Otherwise, it may cause user and / or patient
burns.
When the footswitch is not operated and the output indicator lights or
the output tone can be heard, stop the procedure immediately, switch
off the electrosurgical unit. Otherwise, it may cause perforation,
bleeding and user and / or patient burns.
If there is a malfunction at the footswitch, continuous output of high
frequency may cause unintended burns, bleeding and / or perforation of
the patient and / or user. If the high frequency output is not active during
the procedure, the instrument may cut the tissue mechanically, cause
bleeding and / or perforation.
If the output does not stop when the user’s foot is released from the
footswitch pedal, immediately switch off the electrosurgical unit to
prevent patient burns, perforation and bleeding.
Do not increase the unit’s output if a function is not working as
expected; doing so could cause patient injury, burns, bleeding and / or
perforation. In this case, inspect the cord connections, the contact of the
neutral electrode and the settings of the electrosurgical unit for any
abnormalities.
Ensure that you will press the correct pedal before starting the
procedure. Otherwise, it may cause perforation, bleeding and patient
burns.
CAUTION Patients may feel a neuromuscular stimulus when a spark discharge
from the instrument occurs during activation. The neuromuscular
stimulus is caused by low frequency components generated during
discharging. To prevent this, minimize the discharge by selecting a
lower power level or by activating the output when the electrode is in
good contact with the tissue to be cauterized.
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Instructions for Use EN Olympus ESG-100
WARNING When performing marking, set the power level to the lowest necessary
limits for this application. Otherwise, perforation and / or bleeding may
result.
Do not output while the tunica muscularis is snared. Otherwise,
perforation and / or bleeding may result.
When cutting a mucous membrane, set the power level to the lowest
value at which safe cutting is possible. Otherwise, perforation may
result. It is recommended that you perform basic experiments before
using the electrosurgical unit.
When performing coagulation, set the power level to the lowest
necessary limits at which safe coagulation is possible. Otherwise,
perforation may result. It is recommended, that you perform basic
experiments before using the electrosurgical unit.
Endoscopic papillotomy
WARNING Set the power level to the lowest value at which safe cutting is possible.
Otherwise, perforation and / or bleeding may result.
Hot biopsy
WARNING Set the power level to the lowest value at which safe cutting is possible.
Otherwise, perforation and / or bleeding may result.
Do not activate the output while any metal portion of the hot biopsy
forceps is in contact with adjacent tissue which is not intended to be
grasp. Otherwise, perforation and / or burns of the adjacent tissue may
result.
Do not apply the cup of the hot biopsy forceps to the tissue but pull the
tissue sufficiently to avoid perforation.
If the biopsy tissue cannot be cut, check the tissue contact condition
and output setting again. Note that setting an excessive power level
may result in perforation and / or bleeding.
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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
during cleaning.
1) Switch off the electrosurgical unit and disconnect the power cord from the
grounded wall outlet.
2) If the equipment 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.
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Instructions for Use EN Olympus ESG-100
WARNING After cleaning the electrosurgical unit, dry it thoroughly before storage
or using it again. If it is used while still wet, there is a risk of electric
shock.
Patient debris and reprocessing chemicals are hazardous. During
cleaning and disinfection, always wear appropriate personal protective
equipment, such as eye wear, face mask, moisture-resistant clothing
and chemical-resistant waterproof gloves that fit properly so that your
skin is not exposed. Always remove contaminated protective clothing
before leaving the reprocessing area.
8.2 Storage
Before storage of the electrosurgical unit, disconnect the power cord and store it
properly according to the environmental conditions described in chapter 12.3 (Technical
data).
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9 Troubleshooting
If the electrosurgical unit has visible damage, do not use the electrosurgical unit and
contact Olympus or your distributor. 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 Olympus or your distributor for repair.
The mode display (22) is asking for the footswitch: “Footswitch ???”
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Instructions for Use EN Olympus ESG-100
Contact quality
Mode Indication
monitor
Bipolar application Standby and activation
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Olympus ESG-100 EN Instructions for Use
105 InF CUT Pedal Self test The cut pedal (32) of the
on footswitch is pressed while
switching on. Release the cut
pedal (32) to continue. If the
message does not disappear
when the cut pedal (32) is
released, please contact the
technical service.
106 InF COAG Pedal Self test The coagulation pedal (33) of
on the footswitch is pressed while
switching on. Release the
coagulation pedal (33) to
continue. If the message does
not disappear when the
coagulation pedal (33) is
released, please contact the
technical service.
107 InF MIDDLE Self test The middle pedal (34) of the
Pedal on footswitch is pressed while
switching on. Release the
middle pedal (34) to continue.
If the message does not
disappear when the middle
pedal (34) is released, please
contact the technical service.
120 InF Level: 0 Watt Activation The power level for the chosen
121 mode is set to zero. Increase
122 the power level to continue.
123
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126 InF Max. time Activation The maximum time limit for the
limit application has been
exceeded. Permanent
exceeding of this time limit can
damage the unit. Release the
footswitch and wait until the
message disappears to
continue.
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200 Err Error: 200 Self test The recall of the last stored
language setting was not
successful. The language
setting has been reset to
default (English language).
Press the monopolar
coagulation button (4) to
continue. If this error occurs
again, please contact the
technical service.
201 Err Error: 201 Mode select parameter The recall of the last stored
202 Error: 202 Bipolar cut mode setting was not
203 Error: 203 Bipolar coagulation successful. The setting has
204 Error: 204 Monopolar cut been reset to default. Press
205 Error: 205 Monopolar coagulation the monopolar coagulation
button (4) to continue and
check the settings. If this error
occurs again, please contact
the technical service.
206 Err Error: 206 Bipolar Cut 1 The recall of the last stored
207 Error: 207 Bipolar Cut 2 power level was not
208 Error: 208 Bipolar Cut 3 successful. The level has been
209 Error: 209 Bipolar RFCoag + RCAP reset to default. Press the
210 Error: 210 Bipolar SoftCoag monopolar coagulation button
211 Error: 211 Bipolar RFCoag (4) to continue and check the
212 Error: 212 Monopolar PulseCut slow level. If this error occurs again,
213 Error: 213 Monopolar PulseCut fast please contact the technical
216 Error: 216 Monopolar ForcedCoag 1 service.
217 Error: 217 Monopolar ForcedCoag 2
219 Error: 219 Monopolar Cut 1
220 Error: 220 Monopolar Cut 2
221 Error: 221 Monopolar Cut 3
222 Error: 222 Monopolar SoftCoag
227 Err Error: 227 Toggle function of the The recall of the last stored
footswitch setting for the toggle function
of the footswitch middle pedal
(34) was not successful. The
setting has been reset to
default. Press the monopolar
coagulation button (4) to
continue and check the
setting. If this error occurs
again, please contact the
technical service.
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Instructions for Use EN Olympus ESG-100
320 Err Error: 320 Output stage The unit has fallen below the
325 Error: 325 Power supply minimum operating
temperature. Switch off the
unit and wait until it has
reached the specified
operating temperature (see
chapter 12.3, Technical data).
If the error appears
continuously, please contact
the technical service.
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Footswitch function
This menu allows changing the function of the footswitch middle pedal (34) as
described in chapter 5.1 (Footswitch) if no peristaltic pump unit is connected.
3a) Press the up / down button (6 / 5) until the mode display (22) shows
“Footswitch Func.”
3b) Press the bipolar cut select button (1) to enter this function.
3c) Use the up / down button (6 / 5) to change between “Toggle MODE” (toggles
between modes) and “Toggle CUT/COAG” (toggles between cut and
coagulation modes) shown in the mode display (22).
3d) Press the bipolar cut select button (1) to confirm and exit the chosen function.
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Instructions for Use EN Olympus ESG-100
Language selection
This menu allows changing the language setting used in the mode display (22).
4a) Press the up / down button (6 / 5) until the mode display (22) shows
“Language select”.
4b) Press the bipolar cut select button (1) to enter this function.
4c) Use the up / down button (6 / 5) to scroll between the languages shown in the
mode display (22).
4d) Press the bipolar cut select button (1) to activate the chosen language and
exit this function.
5) Press the monopolar coagulation select button (4) to exit the service operation
mode and to enter the normal operation mode.
NOTE Use the monopolar coagulation select button (4) to switch back to the
previous menu, e.g. from menu 1 (service operation mode) to menu 0
(normal operation mode).
P.03 ニホンゴ
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11 System chart
Electromagnetic compatibility has been successfully tested with HF equipment that
does not exceed a complete length (instrument incl. cables, adapters) of 4.5 m.
Exceeding this length can cause electromagnetic disturbances.
The recommended combinations of equipment and accessories that can be used with
this electrosurgical unit are shown below. New products released after the introduction
of this electrosurgical unit may also be compatible for use in combination with this
electrosurgical unit. For further details, contact Olympus or your distributor.
WARNING If combinations of equipment other than those shown below are used,
the full responsibility is assumed by the medical treatment facility.
Endoscope
with cord
without cord
P-cord
MAJ-814
Fluid reservoir
Pump tubing
WB920137
Communication cable ESG-100: WB991036 WB920138
WB950241 WB991046
AFU-100: WB950167
Footswitch Footswitch
WB950243 WB950242
Cart WM-60
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Instructions for Use EN Olympus ESG-100
12 Specifications
12.1 Mode characteristics
Mode Mode display Default Min. Max. Rated Max. Timing
power power power load output
level level level [Ohm] voltage
[W]* [W]* [Vp]
*The power level is the maximum power (watts) which can be applied during the activation of the
electrosurgical unit. The real applied power depends on the tissue characteristics (e.g. resistance).
All cutting modes are supported by the high power cut support (HPCS). The high power
cut support optimizes the start of the cutting procedure by applying high power to the
tissue to support immediate spark ignition and reduces the risk of mechanical cutting.
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HPCS
Spark Spark
CUT
C O AG
t1 time
Fig. 12.1: Example of high power cut support during PulseCut fast / slow (t1 is the
pulse delay time)
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80
60
40
Power level 60
20
0
10 100 1000 10000
Load [Ohm]
140
120
Load = 500 Ohm
100
Power output [W]
80
60
40
20
0
0 20 40 60 80 100 120
Pow er level
700
Cut 3
600
Cut 2
High frequency voltage [Vp]
500
Cut 1
400
300
200
100
0
0 20 40 60 80 100 120
Pow er level
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140
During „cut phase“
120
100
Power level 120
Power [W]
80
60
40
Power level 60
20
0
10 100 1000 10000
Load [Ohm]
Monopolar SoftCoag
140
120
Power level 120
100
Power [W]
80
60
40
Power level 60
20
0
10 100 1000 10000
Load [Ohm]
140
120
Load = 100 Ohm
100
Power output [W]
80
60
40
20
0
0 20 40 60 80 100 120
Pow er level
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250
150
100
50
0
0 20 40 60 80 100 120
Pow er level
Monopolar ForcedCoag 1
60
50
Power level 50
40
Power [W]
30
20
10
Power level 25
0
10 100 1000 10000
Load [Ohm]
60
50
Load = 500 Ohm
40
Power output [W]
30
20
10
0
0 10 20 30 40 50
Pow er level
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Monopolar ForcedCoag 2
140
120
Power level 120
Power [W] 100
80
60
40
Power level 60
20
0
10 100 1000 10000
Load [Ohm]
140
120
Load = 500 Ohm
100
Power output [W]
80
60
40
20
0
0 20 40 60 80 100 120
Pow er level
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Instructions for Use EN Olympus ESG-100
140
Cut 2, 3
120
Power level 120
100
Cut 1
Power [W]
80
60
40
Power level 60
20
0
10 100 1000 10000
Load [Ohm]
140
120
Load = 500 Ohm
100
Power output [W]
80
60
40
20
0
0 20 40 60 80 100 120
Pow er level
700
600 Cut 2, 3
High frequency voltage [Vp]
500
Cut 1
400
300
200
100
0
0 20 40 60 80 100 120
Pow er level
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Bipolar SoftCoag
140
120
Power level 120
100
Power [W]
80
60
40
20
Power level 60
0
10 100 1000 10000
Load [Ohm]
140
120
Load = 100 Ohm
100
Power output [W]
80
60
40
20
0
0 20 40 60 80 100 120
Pow er level
250
200
High frequency voltage [Vp]
150
100
50
0
0 20 40 60 80 100 120
Pow er level
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Instructions for Use EN Olympus ESG-100
50
Power level 40
40
30
Power [W]
20
*)
10
Power level 20
0
10 100 1000 10000
Load [Ohm]
50
40
30
RFCoag + RCAP
20
RFCoag
10
0
0 10 20 30 40
Pow er level
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Output
Monopolar terminals
Socket 6 mm A-cord
Bipolar terminal
General data
Frequency 50 / 60 Hz
Power fuse
Operation mode
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Size
Weight 6.5 kg
Weight 1.9 kg
Environmental conditions
Normal operation
Accessories
Compatible HF cords
Connecting cable
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Patient weight 5 to 15 kg
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13 Electromagnetic compatibility
Precautionary measures
Electromedical devices are subject to special precautionary measures concerning
electromagnetic compatibility (EMC). This device is to be used only for the purposes
described in this document and has to be installed, set up, and operated in compliance
with the EMC guidelines.
The electrosurgical unit is intended for use in the electromagnetic environment specified below.
The customer or the user of this electrosurgical unit should assure that it is used in such an
environment.
RF emissions Group 1 This electroosurgical unit uses RF energy only for its
CISPR 11 internal functions. Therefore, its RF emission is very
low and it is unlikely that electronic equipment in
close proximity of the device will experience
interference
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This electrosurgical unit is intended for use in the electromagnetic environment specified
below. The customer or the user of this elecotrosurgical unit should assure that it is used in
such an environment.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 ± 1 kV for ± 1 kV for hospital environment.
input/output lines input/output lines
Voltage dips, short 0% UT* for ½ cycle 0% UT * for ½ cycle Mains power quality should be
interruptions and (100% dip in UT) (100% dip in UT) that of a typical commercial or
voltage variations hospital environment. If the
on power supply 0% UT for 1 cycle 0% UT for 1 cycle user of this power control unit
input lines (100% dip in UT) (100% dip in UT) requires continuous operation
IEC 61000-4-11 during power mains
0% UT for 0% UT for interruptions, it is
250 cycles 250 cycles recommended that the power
(100% dip in UT) (100% dip in UT) control unit be powered from
an uninterruptible power
70% UT for 70% UT for supply or a battery.
25 cycles 25 cycles
(30% dip in UT) (30% dip in UT)
*Note: UT is the a.c. mains voltage before application of the test level.
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This electrosurgical unit is intended for use in the electromagnetic environment specified
below. The customer or the user of this elecotrosurgical unit should assure that it is used in
such an environment.
Conducted RF 3 Vrms and 6 Vrms in 3 Vrms and 6 Vrms in Field strengths from fixed RF
c c
IEC 61000-4-6 ISM bands ISM bands transmitters, as determined by
150 kHz to 80 MHz an electromagnetic site
a
survey should be less than
Radiated RF 3 V/m 3 V/m
the compliance level in each
IEC 61000-4-3 80 MHz to 2.7 GHz b
frequency range . Interference
27 V/m 27 V/m is possible in the proximity of
380 to 390 MHz devices bearing the following
symbol:
28 V/m 28 V/m
430 to 470 MHz
9 V/m 9 V/m
704 to 787 MHz
28 V/m 28 V/m
800 to 960 MHz
28 V/m 28 V/m
1700 to 1990 MHz
28 V/m 28 V/m
2.4 to 2.57 GHz
9 V/m 9 V/m
5.1 to 5.8 GHz
Note 1: The higher frequency range applies for 80 MHz and 800 MHz.
Note 2: These guidelines may not be applicable in all situations. The spread of
electromagnetic fields differs depending on the absorption and reflection of buildings,
objects and people.
a
The field strength of stationary transmitters such as base stations of mobile phones
and land mobile devices, ham radio stations, AM and FM radio and TV broadcasters are
theoretically not 100% predictable. A site study is recommended to determine the
electromagnetic environment regarding the stationary transmitters. If the field strength
measured at the operation site of this device exceeds the compliance levels listed
above, the device should be monitored to ensure that it functions as intended.
Additional measures such as changing the orientation or operation site of the device
may be required if unusual features of performance are observed.
b
The field strength should be less than 3 V/m for the frequency range of 150 kHz to
80 MHz.
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c
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are
6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and
40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are
1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz,
10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to
21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
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