Remed ELPIS-4 User manual

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The user of this device must sufficiently understand its functions and the
precautions that must be observed for its safe use and stable performance.
For the safe use and post management of the device, be sure to thoroughly
understand the details of the User Guide before using the device. This is essential
to guaranteeing the safe use and stable performance of the device.
The User Guide provides a guide to the efficient use of the ELPIS-4, 3, 2. For clinical
definitions, pathological effects etc., of its functions, refer to the related medical
publications.
As the User Guide has been arranged in independent chapters, some of the
descriptions have been duplicated.
If you encounter any problems during operation of the equipment, stop its use
immediately, and contact the customer service center of REMED
(Refer to chapter 11).
Copyright
This User Guide is protected by the Copyright Act.
Transferring or storing all or part of the contents of the User Guide to another media
through translation, copying, scanning, photography, etc. is prohibited without the prior
written approval of REMED.
The User Guide may include editing errors. In addition, technical changes to improve
performance may be made to this device after this manual has been published, without
any prior notice.

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There may be changes. These contents are subject to change without notice.
Contents
1. Information on safety········································································································ 6
1.1 Definitions of symbol·······································································6
1.2 Requirements for safety···································································6
1.2.1 Precautions for electrical safety ·················································6
1.2.2 Classifications········································································7
1.3 Precautions during operation ····························································7
1.4 Do and Don’t ·················································································9
1.5 Abnormal reaction ········································································ 10
1.6 General warning··········································································· 10
2. Electrosurgical Unit (ESU) ···························································································· 11
2.1 Mechanism ··················································································11
2.2 Objectives··················································································· 13
2.3 Reference··················································································· 13
3. Installation ·················································································································14
3.1 Standard configuration & Optional ··················································· 14
3.2 Electrical installation condition························································· 15
3.3 Environmental condition·································································15
3.3.1 Application environment ························································· 15
3.3.2 Storage environment ····························································· 15
3.4 Installation method ······································································· 15
3.4.1 Precautions during installation················································· 15
3.4.2 Connection of power ····························································· 15
4. Product description ·································································································17
4.1 External view··············································································· 17
4.1.1 Front view ··········································································· 17
4.1.2 Rea view············································································· 17
4.2 Control unit ················································································· 18
5. Preparations for operation···························································································· 19
5.1 Moving and fixing equipment ·························································· 19
5.2 Power connection········································································· 19
5.3 Warning before use······································································· 19
5.4 Return Electrode Monitoring (REM) Alarm Check································ 19
5.5 Check for mode use······································································ 20
5.5.1 Bipolar Mode check······························································· 20
5.5.2 Monopolar Mode check·························································· 20

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6. Operation instructions ····························································································21
6.1 How to connect each mode ···························································· 22
6.1.1 Bipolar connection method ····················································· 22
6.1.2 Monopolar connection method················································· 23
6.2 How to use Patient Plate································································ 24
6.3 How to use each mode·································································· 25
6.3.1 Bipolar mode ······································································· 25
6.3.2 Monopolar mode ·································································· 27
7. Messages ···················································································································33
7.1 REM system················································································ 33
8. ELPIS-4, 3, 2 relating journal papers········································································· 34
8.1 Electrosurgery: history, principles, and current and future uses. ··················· 34
8.2 Electrosurgery··············································································· 34
9. Technical specfications ··························································································35
9.1 Size and weight ··········································································· 35
9.2 Power ························································································ 35
9.3 Bipolar Mode outputs ···································································· 35
9.4 Monopolar Mode outputs ······························································· 35
9.5 Environmental condition·································································36
9.5.1 Application environment ························································· 36
9.5.2 Storage environment ····························································· 36
10. EMC emissions and immunity··················································································· 37
11. Maintenance·······························································································································41
11.1 Cleaning procedure····································································· 41
11.2 Routine inspection of equipment ···················································· 41
11.3 Safety inspection ········································································ 41
11.4 Troubleshooting·········································································· 42
11.5 Regular inspection for performeance maintenance ···························· 43
11.6 Warranty··················································································· 43
12. Contact information·······························································································45

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Figure Contents
[Figure 01] Monopolar electrosurgical··························································11
[Figure 02] Bipolar electrosurgical······························································ 12
[Figure 03] Electrosurgical Waveform ························································· 13
[Figure 04] Standard configuration & Optional ·············································· 14
[Figure 05] Power cable connection···························································· 16
[Figure 06] Front view·············································································· 17
[Figure 07] Rear view ·············································································· 17
[Figure 08] Device control section ······························································ 18
[Figure 09] ELPIS-4, 3, 2 Segment displays················································· 21
[Figure 10] ELPIS-4, 3, 2 Power standbys ··················································· 21
[Figure 11] Bipolar Forceps connection - Handswitching·································22
[Figure 12] Bipolar Forceps connection - Footswitching·································· 22
[Figure 13] Monopolar connection - Handswitching········································ 23
[Figure 14] Monopolar connection - Footswitching········································· 24
[Figure 15] Bipolar mode –Hand & Foot······················································ 25
[Figure 16] Monopolar Cut function ···························································· 28
[Figure 17] Monopolar Coag function·························································· 28

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1. Information on safety
1.1 Definitions of symbols
❑When there is specific information in the User Guide that needs to be emphasized
for safety, the following terms and symbols are indicated. All warnings and
precautions shall always be observed.
❑The manufacturer or agent of the product is not responsible for any
personal/material damage caused by erroneous use, operation for purposes
other than its intended objective and negligence of productmaintenance.
Warning
“Warning” symbol is used to indicate a life-threatening risk to
the operator if the warning is disregarded.
Caution
“Caution” symbol is used to indicate that injury or damage
can be caused if the caution is disregarded.
Note
“Note” symbol is used to highlight important items for the
installation, application, and maintenance of the equipment.
1.2 Requirements for safety
1.2.1 Precautions for electrical safety
❑The rated power for this equipment is AC 220 V.
❑Confirm that all the connecting sections (power line or peripheral equipment) are
adequately connected to the equipment.
❑Confirm that the equipment is completely grounded.
❑Repair, expansion, and installation of equipment shall not be performed by anyone
other than the specialized personnel authorized by the manufacturer. Arbitrary
disassembling/assembling of equipment by the user is absolutelyprohibited.
❑Before connecting other equipment that is not specified in the User Guide, be sure
to inform this company or the agency with authority over product marketing.
Note
•To avoid electrical noise during use, the equipment shall be
installed at a significant distance from any generator, X-ray
equipment, broadcasting device, mobile electric wire, and
so forth.
•An independent power circuit is essentially required, and
sharing of power with other electronic devices is not
recommended.

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Caution
•Installed equipment shall be subject to regular safety
inspections from specialized personnel authorized by the
manufacturer.
•For electrical safety, equipment shall always be connected
toa safely grounded power supply for operation.
•Do not use the equipment in parallel with other electronic
medical equipment.
•Do not use the equipment near flammable anesthetic or
solvent.
•Do not place items that can cause danger to the equipment,
such as oils, chemicals etc. near the equipment.
•When equipment is operated, do not use any mobile
phones, radio sets, mobile radio transmitters, wireless toys,
etc. in the proximity of the equipment.
•During the operation of the equipment, the patient shall not
take drinks, water, etc. which can influence the equipment.
•During the operation, if the patient experiences any
abnormal symptoms, the operator must stop the operation
immediately, and contact the doctor in charge.
1.2.2 Classifications
❑Protection type and level for electric shock: Class I, BFtype
❑Electromagnetic compatibility (EMC) test standard: Type 2, class A
1.3 Precautions during operation
❑ Installation and re-installation of equipment shall always be performed by
specialized personnel authorized by the manufacturer.
❑ Installed equipment shall be subject to regular safety inspections from specialized
personnel authorized by the manufacturer.
❑ Repair or installation of equipment shall only be performed by the specialized
personnel authorized by the manufacturer, and as such, all arbitrary
disassembly/assembly of equipment by the user is absolutelyprohibited.
❑ For electrical safety, equipment shall always be connected to a safely grounded
power supply for operation.
❑ The operator and manager of equipment shall thoroughly understand the User Guide,
and it must be kept in the close proximity of theequipment.
❑ To prevent safety accidents and ensure adequate maintenance, place the safety
marks, guide phrases and regular inspection table provided with the equipment at
an easily visible location near the equipment.

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❑ As a fan is installed in the body of the equipment for air circulation, remove
curtains or any other objects which can block the flow of air from near the
equipment.
❑ From the surroundings of the location where equipment is installed, remove
water, alcohol, flammable materials, and so forth.
❑ When equipment is operated, do not use any mobile phones, radio sets, mobile
radio transmitters, wireless toys, etc. in the proximity of theequipment.
❑ During the operation of the equipment, the patient shall not take drinks, water,
etc. which can influence the equipment.
❑ Do not use an electrosurgical unit unless you have learned the proper training.
Electrosurgical units should only be used by trained personnel.
❑ Accessories should be disinfected prior to use, and sterilized disinfectants
should be treated with non-flammable chemicals. Non-flammable drugs should
be able to volatilize before applying high frequency surgery, and some
materials, such as cotton or gauze, may become saturated due to oxygen
sparks due to normal use of the high frequency surgical device.
❑ The patient should not touch a grounded metal part or any metal part related, e.
g. operating table support.
❑ If the output of the electrosurgical unit is low or does not work correctly in a
normal operating environment, the Patient Plate may be installed incorrectly in
the patient, or the part connected to the device may be defective. In such a
case, you should first check that the Patient Plate is properly applied and
connected before selecting a higher output power.
❑ The Patient Plate should be attached to the area to be easily attached and
large with good blood circulation. Avoid bony protrusions, and the femur, lower
legs, buttocks or dorsal side are good.
❑ The Patient Plate should not be affixed to:
•Near ECG electrode and cable
•Near metallic implants
•Skin contact area (armpit)
•Area with scars
•Hairy area or tattoo area
❑ The Patient plate should be fully attached to the patient when fully seated. If
there is space in the adhesive area, burns may occur.

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❑ If the contact and connector connection is poor, the patient may be burned
due to output error. Be sure to check before use.
❑ An electrical spark from an electric scalpel may cause a fire or an explosion if
flammable anesthetic gas, high oxygen concentration or self-contained
flammable gases are present.
❑ If you need to use a cardiopulmonitor, you should seek advice from a
cardiopulmonary specialist and use an electrosurgical unit. The use of an
electrosurgical unit may affect the use of a cardiopulmonary.
❑ When using an electrosurgical unit and a physiological monitoring device in a
patient, keep the monitoring electrode as far away from the surgical electrode
as possible. A monitoring electrode in the form of a needle is not
recommended.
❑ If you are operating on the chest or head, you should avoid using flammable
anesthetics or oxidizing gases unless they are aspirated and removed.
❑ Using electrosurgical units, laparoscopic surgery for pregnant patients is not
recommended.
❑ Electrosurgical units should use power only as needed.
❑ It is recommended that the use time be minimized to avoid injury to other parts
of the body.
❑ It is safe to use lower power than pediatric surgery.
❑ Continuous use of high power currents over long periods of time can cause
problems with unwanted tissues and injure small tissues.
❑ In surgical procedures where high frequency currents pass through a small
cross-sectional area of the body, it is desirable to use a bipolar technique to
avoid unwanted tissue damage.
❑ An electrical scalpel for cuts and coagulation that is not used temporarily
should be stored in an area where it is isolated from the patient.
❑ Do not reuse disposable accessories.
1.4 Do and Don’t
❑Do not use the equipment in parallel with other electronic medical equipment.
❑In general, patients in the following categories cannot be treated with this
equipment. Prior to any treatment with this equipment, permission of the doctor
in charge must be obtained.
- Patient with high fever, pregnant women and the elderly andchildren
- Patient with evidence of external wound at brain and neck
- Patient with cardiac pacemakers, drug injecting pumps or hearing aids
- Patient with cranial implants

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1.5 Abnormal reaction
❑During the operation of the equipment, if the patient experiences any abnormal
symptoms, the operator must stop the treatment immediately, and contact the
doctor in charge.
1.6 General warnings
❑Be sure to use the equipment in accordance with the User Guide.
❑In the User Guide, the method for the correct use of the equipment is described.
Read the User Guide carefully.
❑Theequipmentshallbe operated under the supervisionof a person who has completed
specialized medical education.
❑This company is not responsible for any disadvantages / damages related to the
operation of equipment by a person without a medical education.
❑This equipment shall not be altered, remodeled, or used for any purpose other than
the intended objective.

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2. Electrosurgical Unit
2.1 Mechanism
[Figure 01] Monopolar electrosurgical
An electrosurgical unit is a medical device that is used to reduce bleeding in a portion of the
body tissue and to dissect or stop the bleeding from the bleeding site. The device consists of
three components: main body, electrode, and patient plate. The high frequency current
generated by the main body is transmitted to the human body, which acts as a resistor against
the current through the end of the electrode. This current flow back to the Patient Plate and
returns to the main body. At this time, the current is concentrated on the tip of the electrode
which contacts with the human body, and large heat is generated. At high currents, water in
the cell is rapidly heated, leading to rupture of the cell membrane. At this time, due to the skin
effect, high-frequency current does not flow inside the human body but flows only to the skin.
The rupture of these membranes occurs along the electrode line, and this condition is the
cutting off. When the energy applied to the whole electrode is small, the current density is
relatively low, so cell heating is slow, cell rupture and tissue cleavage do not occur, and cell
membrane dehydration and coagulation occur. The Patient Plate is required to be attached to
the patient because if the contact surface is narrow like a scalpel electrode, the tissue may be
dissected or lacerated similar to the scalp electrode at its power outlet. Electrosurgery can be
done in two ways:
(1) Monopolar Electrosurgery
Monopolar electrosurgery is the most common form of electrosurgery because of its
ability to be used effectively in various areas. In the monopolar electrosurgical unit, the
return electrode is connected to the patient plate and the active electrode is contacted
to the treatment site. The energy generated through the body flows through the active
electrode and flows through the path of least resistance in the patient's body to the
Patient Plate of the regulating electrode, which is then returned to the body to
complete the electrical circuit. Since monopolar electrosurgery flows through the
patient's body, there are a number of safety considerations such as the location and

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method of placement of the patient plate. In general, the Patient Plate should be close
to the treatment site to keep the electrical circuit as short as possible.
(2) Bipolar Electrosurgery
In bipolar electrosurgery, active electrode and return electrode functions are performed
through bipolar forceps. Current flows only through the epidermis that is contacted by
bipolar forceps, not through the body. When used for small tissue or capillary vessels,
it does not damage surrounding tissues and is mainly used for coagulation. An
electrosurgical unit can generate various types of electrical waveforms, and their
function varies depending on the waveform.
[Figure 02] Bipolar electrosurgical
(3) Cut
High-frequency waveform at duty cycle of 100% rapidly generates heat, evaporates
the cell fluid, and cleaves the tissue by dividing the cell tissue by pressure increase
and pressure. The reason for using powerful high frequencies is to concentrate the
heat because the tissue must not only dry but also destroy
(4) Coagulation
If the high-frequency output is lowered so that the incision does not occur, the heat is
generated by the arc discharge and the bleeding stops. However, if the voltage is
continuously reduced, the arc discharge will not occur and the coagulation will not
occur. Therefore, in coagulation, the output voltage should be higher than the incision,
but by reducing the duty cycle, the high frequency is converted to low frequency to
adjust the power.
(5) Blend Cut
This function adjusts the duty cycle and power so that incision and hemostasis occur at
the same time. In the incision, the heat is very large and the cell fluid evaporates.
However, it does not generate heat continuously and reduces the duty cycle to
evaporate the cell fluid and make the cell liquid and protein dry instead of the cell

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tissue, resulting in hemostasis. You can control the degree of blood and incision by
changing the duty cycle.
[Figure 03] Electrosurgical waveform
2.2 Objectives
This device is an electrosurgical unit. It is prohibited to use it for purposes other than the
intended use.
2.3 References
•Please refer to PubMed (https://www.ncbi.nlm.nih.gov/pubmed)
•You can refer to various clinical papers and principles by searching for Pulsed
electromagnetic field.

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3. Installation
3.1 Standard configuration & Optional
Main system
Power cable
User manual
Electrode Tips
Monopolar
Handswitching Pencil
Monopolar
Footswitching Pencil
Bipolar Forceps
Bipolar Cable
Disposable Patient
Plate
Single Foot Switch
Double Foot Switch
Silicon Rubber Patient
Plate & Cable
(Optional)
[Figure 04] Standard configuration & Optional

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3.2 Electrical installation condition
❑Input power : 220 VAC / 60 Hz
❑Power consumption
1. ELPIS-4: max 1,000 VA
2. ELPIS-3: max 950 VA
3. ELPIS-2: max 800 VA
3.3 Environmental condition
3.3.1 Application environment
❑Temperature : 10∼40℃(50∼104℉)
❑Humidity : 30∼75% RH
3.3.2 Storage environment
❑Temperature : -20∼60℃(14∼140℉)
❑Humidity : 10 ~ 95 % RH
3.4 Installation method
3.4.1 Precautions during installation
❑Install the equipment on a flat surface.
❑Confirm that the power is connected.
❑Install the equipment in a location with appropriate ambient temperature and
humidity, and do not install in a location where it will be exposed to dust or
flammable materials.
❑Be careful not to damage the equipment by excessiveshock.
3.4.2 Connection of power
❑Confirm that power socket and power cable are grounded before operating the
machine.
❑Connect the power cable to the back-powerterminal, as shown in [Figure xx] below
and connect the remaining one to ground.
❑Make sure that the power socket and power cables are grounded.
❑Confirm that the power cable is properly connected to the power terminal andpower

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socket. If the connection is incorrect, unexpected problems canoccur.
❑Grap the plug point when you unplug the powercable.
❑Do not connect several devices to one poweroutlet.
❑In particular, do not use a power cable that generates connectionnoise.
[Figure 05] Power cable connection
Warning
To prevent the danger of electrical shock, connection
shall be made to a protected and grounded power supply.
Caution
Please do not connect the power cable without any
power switch off, as this may cause a fault.
❑Before moving the equipment, remove the connected power cable and the
connection cables for peripheral equipment.
❑Do not apply excessive shock or vibration when moving the unit.
❑Install in a place where air circulation is possible, and do not place on corners or
shelves.
❑Do not place any other equipment on top of the unit, and do not place the unit on
top of other equipment.

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4. Product description
4.1 External view
4.1.1 Front view
[Figure 06] Front view
4.1.2 Rear view
[Figure 07] Rear view

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4.2 Control unit
[Figure 08] Device control section
1. Power button –Power On / Off
2. Mono Cut screen –Monopolar cut function, level
3. Mono cut function selection button –Pure, Blend1, Blend2, Blend3
4. Mono cut level selection button –Monopolar cut function, level selection
5. Mono coag screen –Monopolar coag function, level
6. Mono coag function selection button –Soft, Forced, Spray
7. Mono coag level selection button –Monopolar coag function, level selection
8. Bi coag screen –Bipolar coag function, level
9. Bi coag function selection button –hand Soft, Foot Soft, Hand Forced, Foot Forced
10.Bi coag level selection button –Bipolar coag function, level selection
11.Mono Cut function level display –Displayed Mono function level
12.Mono Cut function level display –Displayed Mono function level
13.Mono Coag function operation display - Light on when the selected function operates
14.Mono Coag function level display –Displayed Mono function level
15.Bi Coag function operation display - Light on when the selected function operates
16.Bi Coag function level display –Displayed Mono function level
17.Monopolar footswitching pencil connection - Monopolar footswitching pencil
connection
18.Monopolar handswitching pencil 1 connection - Monopolar handswitching pencil 1
connection
19.Monopolar handswitching pencil 2 connection - Monopolar handswitching pencil 2
connection
20.Bipoar Forceps connection - Bipoar Forceps connection
21.Disposable/Silicon Rubber Patient Plate connection - Disposable/Silicon Rubber
Patient Plate connection
22.Mode indication –Monopolar 1, Monopolar 2, Bipolar, Patinet Plate

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5. Preparations for operation
5.1 Moving and fixing equipment
❑Before moving the equipment, remove the connected power cable and the
connection cables for peripheral equipment.
❑Do not apply excessive shock or vibration when moving the unit.
❑Install in a place where air circulation is possible, and do not place on corners or
shelves.
❑Do not place any other equipment on top of the unit, and do not place the unit on
top of other equipment.
5.2 Power connection
❑Confirm that power socket and power cable are grounded before operating the
machine.
❑Plug the power cable into the power terminal, and connect the other end to a
grounded power socket.
❑Confirm that the power cable is properly connected to the power terminal andpower
socket. If the connection is incorrect, unexpected problems canoccur.
❑Do not connect several devices to one poweroutlet.
❑In particular, do not use a power cable that generates connectionnoise.
5.3 Waring before use
❑An extra electrosurgical unit is needed to prepare for sudden malfunction of the
electrosurgical unit during surgery.
❑Check the speaker volume before using the unit. If there is an abnormality in the
device during the operation, adjust the volume so that it can be heard.
❑Make sure that the parts (electrosurgical electrode, Patient Plate, Footswitch) that
are connected to the electrosurgical unit are properly connected.
❑Disinfectable accessories should be disinfected before use.
5.4 Return Electrode Monitoring (REM) Alarm Check
Before using this unit, make sure that the REM alarm is working properly as follows.
(1) Adjust the output intensity of all modes to the lowest output intensity of 1.
(2) With the Patient Plate disconnected, press the Cut or Coag pedal on the Monopolar
Footswitch. Make sure that you hear a beep indicating that the Patient Plate is not
connected.
(3) Press 'Menu' on the touch screen to get 4 menus. Select 'Volume' to adjust the
volume, then return to the main screen and check the REM alarm again by pressing
the Cut or Coag pedal of the Monopolar Footswitch. Volume control does not affect
REM alarm sound.

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5.5 Check for mode use
Make sure that each mode and function is selected through the touch screen and that the
output strength is adjusted normally.
5.5.1 Bipolar Mode check
(1) On the touch screen, press Mode select button of Bi Coag mode and select Foot Soft or
Foot Forced.
(2) When you press Bipolar Footswitch, the Bipolar connection / use indicator lights up blue in
the Mode indicator, the color of the function image on the Bi Coag display turns green, and
a bipolar beep sounds. In Foot Soft and Foot Forced mode, make sure that this is the
same.
(3) While holding the bipolar footswitch, be sure to use the Bi Coag and adjust the volume
through the volume function.
(4) Bipolar Hand function check is the same as above. In Bi Coag mode, select either Hand
Soft or Hand Forced, and then touch the both ends of the bipolar forceps instead of
pressing the footswitch.
5.5.2 Monopolar Mode check
(1) Connect the Patient Plate to the unit. In the Mode indicator, the Patient Plate connection /
use indicator and the REM indicator on the touch screen change from red blinking to green.
(2) When you press the foot pedal of the Monopolar Footswitch, Monopolar 1 / Use indicator
lights in yellow, the color of the function image on the Mono Cut display changes to green,
and a Mono Cut sound is emitted. For Pure, Blend 1, Blend 2, Blend 3 make sure that this
is the same in all four modes.
(3) While holding the cut pedal of the Monopolar Footswitch, adjust the 'Volume' of the Menu
so that the sound of Mono Cut can be heard at the time of operation.
(4) When you press the Coag pedal of the Monopolar Footswitch, Monopolar 1 / Use indicator
lights in blue, the color of the function image on the Mono Coag display changes to green,
and a Mono Coag sound is emitted. For Soft Coag, Forced Coag, and Spray Coag check if
it is same in these modes.
(5) While holding the Coag pedal of the Monopolar Footswitch, adjust the volume of the Menu
so that the Mono Coag sound can be heard at the time of operation.
(6) Monopolar Handswitching Pencil 1 & 2 Function check is the same as above but connect
to Monopolar Handswitching Pencil connection and press the motion button of Pencil
instead of pressing footswitch.