(Refer to chapter 11). - ETCOMed€¦ · ELPIS-4 / 3 / 2 User Guide 2017.08.21 Ver M-1.0.0 8/45 As...
Transcript of (Refer to chapter 11). - ETCOMed€¦ · ELPIS-4 / 3 / 2 User Guide 2017.08.21 Ver M-1.0.0 8/45 As...
ELPIS-4 / 3 / 2 User Guide
2017.08.21 Ver M-1.0.0 2/45
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 product maintenance.
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 absolutely prohibited.
❑ 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
to a 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, BF type
❑ 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 absolutely prohibited.
❑ 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 the equipment.
❑ 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 the equipment.
❑ 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 and children
- 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.
❑ The equipment shall be operated under the supervision of 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 excessive shock.
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-power terminal, 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 and power
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socket. If the connection is incorrect, unexpected problems can occur.
❑ Grap the plug point when you unplug the power cable.
❑ Do not connect several devices to one power outlet.
❑ In particular, do not use a power cable that generates connection noise.
[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 and power
socket. If the connection is incorrect, unexpected problems can occur.
❑ Do not connect several devices to one power outlet.
❑ In particular, do not use a power cable that generates connection noise.
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.
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6. Operation instructions
Caution
• Before using the unit, be sure to read the safety instructions and
precautions.
• Check the operating instructions and safety checklist for accessories
and consumables related to this unit. Please note that there may be
some items that are not included in the manual of this unit.
Turn on the power switch located on the back of the unit. As shown in the figure below, the
orange power button will blink, the Remed logo will appear and disappear, and the orange
power button will light. This state is the power standby state.
[Figure 09] ELPIS-4 Segment display
[Figure 10] Power standby
This unit can use Monopolar and Bipolar. Monopolar has two functions, Cut and Coag, and
Bipolar has Coag function. Footswitching and Handswitching types of Monopolar and Bipolar
are available.
Note ∙ • Monopolar and Bipolar functions cannot be used at the same time.
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6.1 How to connect each mode
6.1.1 Bipolar connection method
Warning
• Do not connect a wet accessory to an electrosurgical unit.
• Ensure that all accessories are properly connected and never
use them if the connection cable cover is damaged.
• Do not attach the Patient Plate to the patient's body when using
bipolar. When attached, the current may flow to areas other
than the tissue to which the bipolar electrode is in contact,
resulting in unintended consequences.
(1) Handswitching
Connect the Bipolar Forceps to the front connection of the unit as follows
[Figure 11] Bipolar Forceps connection method - Handswitching
(2) Footswitching
Connect the Bipolar Forceps to the connection on the front and the Single Foot Switch to
the connection on the rear.
[Figure 12] Bipolar Forceps connection method – Footswitching
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6.1.2 Monopolar connection method
Warning
• Do not connect a wet accessory to an electrosurgical unit.
• Ensure that all accessories are properly connected and never
use them if the connection cable cover is damaged.
• Do not attach the Patient Plate to the patient's body when using
bipolar. When attached, the current may flow to areas other
than the tissue to which the bipolar electrode is in contact,
resulting in unintended consequences.
(1) Handswitching
Connect the Monopolar Handswitching Pencil and Patient Plate to the connections on the
front of the unit as follows. This unit has two Monopolar Handswitching Pencil connections
and there are disposable and silicon rubber type
[Figure 13] Monopolar connection method – Handswitching
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(2) Footswitching
Connect the Monopolar Footswitching Pencil and Patient Plate to the connections on the
front of the unit and the Double Foot Switch to the back of the unit as follows.
[Figure 14] Monopolar connection method - Footswitching
6.2 How to use Patient Plate
❑ The Patient Plate should be attached to the area to be easily attached and large, well-
ventilated muscular area, remove hair before attachment, clean and dry. Avoid areas
where bones protrude, and the femur, lower legs, buttocks or dorsal side are good parts.
❑ The Patient Plate should not be affixed to:
• Near ECG electrode and cable
• Near metallic implants
• Skin contact area (armpit)
• Areas 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.
❑ Patient Plate If the contact and connector connection is poor, you may be
burned due to output error. Be sure to check before use.
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6.3 How to use each mode
6.3.1 Bipolar mode
When the unit is in standby mode, press and hold the power button for 2 to 3 seconds, the
unit will turn on and the power indicator will change from the orange standby indicator to the
purple indicator. If the Patient Plate is not connected, the REM indicator on the screen and the
Patient Plate mode indicator will blink.
[Figure 15] Bipolar mode – Hand & Foot
Note
• Bipolar mode does not connect the Patient Plate, so the REM
indicator and the Patient Plate mode indicator will flash.
Bipolar has two different types of Coag functions with Handswitching and Footswitching.
Soft Forced
By lowering the voltage, it does not cause sparks, it dehydrates, coagulates through
drying, and it can solve the problem of bleeding in contact.
The basic method of contacting the tissue with the electrodes is to generate sparks due
to high voltage, causing the tissue to burn quickly and dry and solidify.
Hand Foot Hand Foot
The details for use are as follows.
(1) Handswitching
① Use the Bi Coag function selection button Mode on the machine control panel to select the
desired Handswitching function. LED of the selected function is turned on
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② Connect Bipolar Forceps to the Bipolar Forceps connection on the front of the unit
(see Figure 10).
③ Use the Up / Down arrows to select the output strength. Use the output as you need for
surgery. If you do not know the proper output strength, you should increase the output
strength from the lowest output strength '1'. The output range of each function is as follows.
- ELPIS-4: 100 (W)
- ELPIS-3: 80 (W)
- ELPIS-2: 80 (W)
-
Handswitching Bipolar Forceps are automatically solidified when they come into contact with
the patient's body, so special care is required. When the unit starts to operate, the Bipolar
indicator lights up with the operation sound.
Caution
• When changing the output intensity, make sure that the output
value set on the screen has changed.
• Use proper output strength for the surgical site.
• The output intensity should be kept to a minimum to avoid the risk
of burns
Note
• Bipolar Handswitching mode detects tissue resistance between
Bipolar forceps electrodes and automatically starts or stops
energy transfer to that resistance value. The resistance value is
set at the factory and cannot be changed by the user.
(2) Footswitching
① Select the desired footswitching function by using the Mode button of Bi Coag on the
control panel. The selected Bi Coag function, output strength, and function image will
appear on the Bi Coag display.
② Connect Bipolar Forceps to the Bipolar Forceps connection on the front of the unit
(See Figure 11).
③ Connect the Bipolar Footswitch to the Bipolar Footswitch connection on the back of the unit
(See Figure 11).
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④ Use the Up / Down arrows to select the output strength. Use the output as you need for
surgery. If you do not know the proper output strength, you should increase the output
strength from the lowest output strength '1'. The output range of each function is as follows.
- ELPIS-4: 100 (W)
- ELPIS-3: 80 (W)
- ELPIS-2: 80 (W)
Caution
• When changing the output intensity, make sure that the output
value set on the screen has changed.
• Use proper output strength for the surgical site.
• The output intensity should be kept to a minimum to avoid the
risk of burns
⑤ When using Footswitching Bipolar Forceps, it will solidify when touching the tissue only
while pressing the footswitch. When the unit starts to operate, the Bipolar indicator lights
up with the operation sound.
6.3.2 Monopolar mode
When the unit is in standby mode, press and hold the power button for 2 to 3 seconds, the
unit will turn on and the power indicator will change from the orange standby indicator to the
purple indicator. If the Patient Plate is not connected, the REM indicator on the screen and the
Patient Plate mode indicator will blink.
Warning
• Do not cut to reduce the size of the Patient Plate. High
density current can cause burns.
• To prevent burns to the patient, make sure that all
accessories, including the Patient Plate, are connected
correctly and never use it if the connection cable sheath is
damaged.
• The Patient Plate must be fully in contact with the patient's
skin to prevent patient burns.
• Patient plates should always be checked for contact with the patient
regularly, when the patient's position changes, and during long-
term surgery
Monopolar has Cut and Coag modes, and each mode has the following functions in forms of
Handswitching and Footswitching.
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Cut
Pure Cut is used for hemostasis.
Incision and hemostasis are possible at the same time. As Blend 1 → Blend 3, the deepening of the bleeding effect occurs, while the incision is slow.
[Figure 16] Monopolar cut function
Coag
It is suitable for tissues in small areas in such a way that solidification takes place when the electrode is in contact with the tissue site.
It is a non-contact solidification type with low heat penetration
strength, and is suitable for areas where it is difficult to solidify
in a wide area tissue or contact type.
[Figure 17] Monopolar coag function
(1) Handswitching
A. Cut mode
① Select the desired function using the Mode button of Mono Cut on the machine control
panel.
② Connect the Patient Plate to the Patient Plate connection on the front of the unit
(see Figure 13).
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③ Make sure that the Patient Plate connection / use indicator does not blink and is lit. If it is
blinking, make sure that the Patient Plate is connected or that the Patient Plate is correctly
attached to the patient's body.
④ Connect the Monopolar Handswitching Pencil to the Monopolar Handswitching Pencil
Connector Monopolar 1 or Monopolar 2 on the front of the unit (see Figure 13).
⑤ Use the Up / Down arrows to select the output strength. Use the output as you need for
surgery. If you do not know the proper output strength, you should increase the output
strength from the lowest output strength '1'. The output range of each function is as follows.
Pure (W) Blend 1 (W) Blend 2 (W) Blend 3 (W)
ELPIS-4 1 ~ 400 1 ~ 250 1 ~ 200 1 ~ 150
ELPIS-3 1 ~ 300 1 ~ 230 1 ~ 180 1 ~ 120
ELPIS-2 1 ~ 200 1 ~ 150 1 ~ 120 1 ~ 100
⑥ When you start the unit by pressing the operation button of the Monopolar Handswitching
Pencil, the CUT indicator lights up with the operation sound and the operation of the unit
starts.
B. Coag Mode
① Use the Mono Coag Mode button on the control panel to select the desired function.
② Connect the Patient Plate to the Patient Plate connection on the front of the unit
③ Make sure that the Patient Plate connection / use indicator does not blink and is lit. If it is
blinking, make sure that the Patient Plate is connected or that the Patient Plate is correctly
attached to the patient's body.
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④ Connect the Monopolar Handswitching Pencil to the Monopolar 1 or Monopolar 2, which is
the Monopolar Handswitching Pencil connection on the front of the machine
⑤ Use the Up / Down arrows to select the output strength. Use the output as you need for
surgery. If you do not know the proper output strength, you should gradually increase the
output strength from the lowest output strength '1'. The output range of each function is as
follows.
Contact (W) Spray (W)
ELPIS-4 1 ~ 120 1 ~ 100
ELPIS-3 1 ~ 100 1 ~ 80
ELPIS-2 1 ~ 100 1 ~ 80
Caution
• When changing the output intensity, make sure that the output
value set on the screen has changed.
• Use proper output strength for the surgical site.
• The output intensity should be kept to a minimum to avoid the
risk of burns
⑥ When you start the unit by pressing the operation button of the Monopolar Handswitching
Pencil, the Coag indicator lights up with the operation sound and the operation of the unit
starts.
(2) Footswitching
A. Cut mode
① Use the Mono Cut Mode button on the control panel to select the desired function.
② Connect the Patient Plate to the Patient Plate connection on the front of the unit
(see Figure 13).
③ Make sure that the Patient Plate connection / use indicator does not blink and is lit. If it is
blinking, make sure that the Patient Plate is connected or that the Patient Plate is correctly
attached to the patient's body.
④ Connect the Monopolar Footswitch to the Monopolar Footswitch connection on the back of
the unit
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⑤ Connect the Monopolar Footswitching Pencil to the Monopolar Footswitching Pencil
connection on the front of the unit (see Figure 13).
⑥ Use the Up / Down arrows to select the output strength. Use the output as you need for
surgery. If you do not know the proper output strength, you should increase the output
strength from the lowest output strength '1'. The output range of each is as follows.
Pure (W) Blend 1 (W) Blend 2 (W) Blend 3 (W)
ELPIS-4 1 ~ 400 1 ~ 250 1 ~ 200 1 ~ 150
ELPIS-3 1 ~ 300 1 ~ 230 1 ~ 180 1 ~ 120
ELPIS-2 1 ~ 200 1 ~ 150 1 ~ 120 1 ~ 100
⑦ When you start the unit by pressing the Cut Pedal of the Monopolar Footswitch, the CUT
indicator lights up along with the operation tone and the operation of the unit starts.
B. Coag Mode
① Select the desired function using the Mono Coag Mode button on the control panel.
② Connect the Patient Plate to the Patient Plate connection on the front of the unit
(see Figure 14).
③ Make sure that the Patient Plate connection / use indicator does not blink and is lit. If it is
blinking, make sure that the Patient Plate is connected or that the Patient Plate is correctly
attached to the patient's body.
④ Connect the Monopolar Footswitching Pencil to the Monopolar Footswitching Pencil
connection on the front of the unit (see Figure 14).
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⑤ Connect the Monopolar Footswitch to the Monopolar Footswitch connection on the back of
the unit (see Figure 14).
⑥ Use the Up / Down arrows to select the output strength. Use only as much output as you
need for surgery. If you do not know the proper output strength, you should increase the
output strength from the lowest output strength '1'. The output range of each function is as
follows.
Contact Spray
ELPIS-4 1 ~ 120 1 ~ 100
ELPIS-3 1 ~ 100 1 ~ 80
ELPIS-2 1 ~ 100 1 ~ 80
Caution
• When changing the output intensity, make sure that the output
value set on the screen has changed.
• Use proper output strength for the surgical site.
• The output intensity should be kept to a minimum to avoid the
risk of burns
⑦ When you start the unit by pressing the Coag pedal of the Monopolar Footswitch, the Coag
indicator lights along with the operation sound and the operation of the unit starts.
D. Version
① Press the Menu button on the upper right of the main screen.
② Select Program Setting from the menu screen, and the Program Setting screen appears.
③ When you select Version, a screen showing the software and firmware version information
appears.
④ Press Ok to return to the Program Setting screen.
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7. Messages
7.1 REM system
The ELPIS-4, 3, 2 Checks the patient's electrical contact with the Patient Plate to reduce the
risk of burns. Through the REM system, the output is interrupted and the operation is stopped
in the following cases.
- If the patient is not properly connected to the Patient Plate attached to the patient
- If placing the Patient Plate on the Monopolar Handswitching Pencil connection, not the
Patient Plate connection.
- The Patient Plate has not been properly attached to the patient due to the patient's position
being changed or the adhesive strength weakening.
- Increased resistance due to overload caused by damage to the cord connected to the
Patient Plate.
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8.ELPIS-4, 3, 2 relating journal papers
1. Electrosurgery: history, principles, and current and future uses.
J Am Coll Surg. 2006 Mar;202(3):520-30.
Massarweh NN1, Cosgriff N, Slakey DP.
Abstract
Within the surgeon’s armamentarium, electrosurgical devices stand out as some of the most
useful and most used units. Although widely accepted today, the application of
electrosurgery was considered a stain on the long-standing traditions of the medical
profession until relatively recently. Surgeons who pioneered use of this new technology and
developed the units were chastised as charlatans. Nonetheless, electrosurgery, and the
surgeons who use the units, have endured the test of time and are accepted as a welcome
part of modern surgery and its history.
2. Electrosurgery
Curr Surg. 2006 Nov-Dec;63(6):458-63.
Jones CM1, Pierre KB, Nicoud IB, Stain SC, Melvin WV 3rd.
Abstract
Electrosurgical units (ESUs) are the most common piece of electrical equipment in the
operating room. The constant presence of the ESU in the operating room increases the
potential for patient injury. However, positive patient outcomes can be successfully achieved
through good medical and nursing practice. To prevent injuries related to the use of an ESU,
the surgeon and perioperative nurse must understand the fundamentals of electricity, the
types of ESUs available, their potential complications, and have a working knowledge of
safe practices for the use of this technology in the perioperative setting. Informed surgeons,
nurses, and staff are the patient’s best advocate.
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9. Technical specifications
9.1 Size and weight
❑ Size : 325 (L) 411 (W) 137 (H) mm
❑ Weight : Approx. 10 kg
9.2 Power
❑ Input power : 220 VAC / 60 Hz
❑ Power consumption
- ELPIS-4 : max 1,000 VA
- ELPIS-3 : max 950 VA
- ELPIS-2 : max 800 VA
9.2 Bipolar Mode outputs
❑ ELPIS-4
- Hand : 100 W
- Foot : 100 W
❑ ELPIS-3
- Hand : 80 W
- Foot : 80 W
❑ ELPIS-2
- Hand : 80 W
- Foot : 80 W
9.4 Monopolar Mode outputs
❑ ELPIS-4
- Pure Cut : 400 W
- Blend 1 Cut : 250 W
- Blend 2 Cut : 200 W
- Blend 3 Cut : 150 W
- Contact Coag : 120 W
- Spray Coag : 100 W
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❑ ELPIS-3
- Pure Cut : 300 W
- Blend 1 Cut : 230 W
- Blend 2 Cut : 180 W
- Blend 3 Cut : 120 W
- Contact Coag : 100 W
- Spray Coag : 80 W
❑ ELPIS-2
- Pure Cut : 200 W
- Blend 1 Cut : 150 W
- Blend 2 Cut : 120 W
- Blend 3 Cut : 100 W
- Contact Coag : 100 W
- Spray Coag : 80 W
9.5 Environmental condition
9.5.1 Application environment
❑ Temperature : 10∼40℃ (50∼104℉)
❑ Humidity : 30∼75% RH
9.5.2Storage environment
❑ Temperature : -20∼60℃ (-4∼140℉)
❑ Humidity : 10 ~ 95% RH max
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10. EMC emissions and immunity
Guidance and manufacturer’s Declaration – Electromagnetic Emissions
The ELPIS-4, 3, 2 System is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment
Emission Test Compliance Electromagnetic environment – guidance`
RF emissions EN55011
Group 1
The ELPIS-4, 3, 2 System is intentionally generated and / or used conductively coupled radio-frequency energy which is necessary for the internal functioning of the equipment itself.
RF emissions EN55011
Class A
The ELPIS-4, 3, 2 System is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
Harmonic Emissions IEC 61000-3-2
Class A
Voltage Fluctuations / Flicker Emissions IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ELPIS-4, 3, 2 System is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment.
Immunity Test IEC 60601
IEC 60601 Test Level
Compliance Level Electromagnetic
environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2
± 6 Contact ± 8 Air
± 6 Contact ± 8 Air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Electrical fast Transient / burst IEC 61000-4-4
± 2㎸ for power
supply lines
± 2㎸ for power
supply lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
± 1㎸ differential
mode
± 2㎸ common
mode
± 1㎸ differential
mode
± 2㎸ common
mode
Anti-surge protection needs to be incorporated into the main supply to the equipment if surge protection is to be guaranteed.
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Voltage dips, short interruptions and voltage variations on power supply
<5% UT (>95% dip in UT) for 0.5 cycle
<5% UT (>95% dip in UT) for 0.5 cycle
Mains power quality should be that of a typical commercial or hospital environment. If the user of the ELPIS-4, 3, 2 System requires
Input lines IEC 61000-4-11
40% UT (60% dip in UT) For 5 cycles 70% UT (30% dip in UT) For 25 cycles <5% UT (>95% dip in UT)
for 5sec
40% UT (60% dip in UT) For 5 cycles 70% UT (30% dip in UT) For 25 cycles <5% UT (>95% dip in UT)
for 5sec
Continued operation during
power interruptions, it is
recommended that the ELPIS-
4, 3, 2 System be powered
from an interruptible power
supply
Power Frequency (50/60Hz) Magnetic Field IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment
Radiated RF Immunity EN 61000-4-3
80MHz – 2.5GHz 2Hz 80% amplitude modulation
Equipment should only be used in the vicinity of other equipment compliant with EN 60601-1-2
Conducted RF Immunity EN 61000-4-6
0.15MHz – 80MHz 2Hz 80% amplitude modulation
Equipment should only be used in the vicinity of other equipment compliant with EN60601-1-2
NOTE (UT) is the a.c. mains voltage prior to application of the test level
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ELPIS-4, 3, 2 System is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level
Compliance Level
Electromagnetic environment - guidance
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3
3Vrms 150kHz – 80 3V/m 80MHz – 2.5
3Vrms 3V/m
Portable and mobile RF communications equipment should be used no closer to any part of the ELPIS-4, 3, 2 System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency transmitter.
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Recommended
Separation distance
𝑑 = [3.5
𝑉1] √𝑃
𝑑 = [3.5
𝐸1] √𝑃
80MHz – 800MHz
𝑑 = [7
𝐸1] √𝑃
800MHz – 2.5GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by An electromagnetic site survey(a) should be less than the compliance level in each frequency range(b). Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1. At 80MHz and 800MHz, the higher frequency range applies. NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection structures, object and people.
(a). Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ELPIS-4, 3, 2 System is used exceeds the applicable RF compliance level above, the ELPIS-4, 3, 2 System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ELPIS-4, 3, 2 System (b) . Over the frequency range 150kHz to 80MHz, filed strengths should be less than (V1) V/m
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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ELPIS-4, 3, 2 System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ELPIS-4, 3, 2 System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ELPIS-4, 3, 2 System as recommended below, according to the maximum output power of the communications.
Rated maximum Output power of transmitter, W
Separation distance according to frequency of transmitter
150 kHz - 80 MHz
𝑑 = [3.5
𝑉1] √𝑃
Where V1 = 3
80 MHz - 800 MHz
𝑑 = [3.5
𝐸1] √𝑃
Where E1 = 3
800 MHz - 2.5 GHz
𝑑 = [7
𝐸1] √𝑃
Where E1 = 3
0.01 0.117 0.117 0.233
0.1 0.369 0.369 0.738
1 1.167 1.167 2.333
10 3.689 3.689 7.379
100 11.667 11.667 23.333
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1. At 80MHz and 800MHz, the higher frequency range applies. NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection structures, object and people.
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11. Maintenance
11.1 Cleaning procedure
❑ Cleanliness of the ELPIS-4, 3, 2 and accessories can be maintained through various
methods. Avoid damage or contamination of the equipment using the following
recommended methods.
❑ Periodically clean the equipment’s exterior surface and touch screen with a soft
cloth moistened with alcohol. Do not use abrasives, lacquers, thinners, ethylene,
or oxides, as these materials may cause permanent damage to the equipment.
❑ Wash electrosurgical accessories with as little non-flammable chemicals as
possible. Non-flammable chemicals used for cleaning or disinfection should be
able to volatilize before applying high frequency surgery. Some substances, such
as cotton or gauze, are saturated with oxygen, which can be ignited by sparks
that occur during normal use of the electrosurgical unit.
❑ Do not submerge any section of equipment into liquid or detergent. In addition, no
liquid must be allowed to enter the equipment or accessories.
❑ When the operation for one patient is completed, clean the surface of the
transducer with alcohol and smooth cloth.
11.2 Routine inspection of equipment
❑ The covering of power line of equipment shall not be peeled off and internal lines
shall not be exposed, and shall not be damaged by impact from outside.
❑ There shall be no trace of oil leakage from transducer.
❑ Wash the outside of equipment so that there is no foreign material.
❑ The button for equipment operation, etc. must not shake.
❑ The various parts attached to equipment must not shake.
❑ If any of the above occur, contact customer service for help.
11.3 Safety inspection
❑ In order to ensure safe use, internal cleaning should be performed once per year by
a person authorized by this company.
❑ In order to ensure safe use, be sure to check the equipment including internal
components and output voltage from the person who has been given authorization
from the company once per year.
❑ Please clean the transducer before storing it
❑ When storing the product for a long period of time, be sure to check the product before
using it.
❑ Please note the followings regarding storage conditions.
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- Keep out of water
- Keep away from direct sunlight
- Do not store near heaters
- Avoid locations subject to excessive shock or vibration, exposure to chemicals or
explosive gases.
11.4 Troubleshooting
If the equipment does not operate normally during use, please check the items listed
in the table below before requesting service. If none of the following problems apply,
or if the following remedies do not help, turn off the power to the equipment and contact
the REMED Customer Service Center.
Symptom What to do References in the
User Guide
Equipment
does not turn
on.
Check if the power connector of the
equipment is properly connected. 3.4.2
Check if the power switch of
equipment is turned on. 4.1.2
No heat output
from the unit.
Please check that you have connected
Monopolar Pencil, Bipolar Forceps, etc
correctly.
6.1
Try adjusting the sound from the menu 6.4.3
Increasing the
output strength
does not increase
the output.
Be sure to adjust the output of the set
function. 6.3
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In the following cases, stop the operation by cutting off the power to the
equipment, and contact the service center.
→ When the strength of output of set function is increased, no heat is generated in
electric scalpel
→ The LCD screen of operation panel does not illuminate when power is turned off
and then turned on again.
11.5 Regular inspection for performance maintenance
In order to ensure safe use, be sure to do regular inspection from the person who has
been given authorization from the company once per year.
11.6 Warranty
❑ This product is manufactured through an intensive quality control and inspection process.
❑ Compensation for repair and exchange of the product will be in accordance with the
“Consumer Injury Compensation Rule” announced by the Economy Planning Board.
❑ The warranty period for this equipment is 1 year.
❑ If a failure occurs during the warranty period under normal operating conditions, the
equipment will be repaired free of charge by our service center.
❑ If a problem with the equipment occurs during the warranty period, prepare the
following customer service request to report to our company.
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Customer Service Request Form
The purpose of this form is to obtain information that will enable us to expeditiously process
your service request. Please describe the fault or abnormality in as much detail as possible.
1. User information
- Name of hospital:
- Address of hospital:
- User name/telephone number: (Tel: )
2. Information on the equipment in use
- Name of model : ELPIS-4, 3, 2
- Date of purchase :
- Serial number of product :
3. Description of technical problems (Describe as much detail as possible.)
4. User checklist
If it is impossible to answer the question yes or no, please add information in the remarks
column. If you are unsure of the answer, you can leave the item blank.
Number Inspection item Evaluation
result Remarks
1 Is use of the equipment impossible due to the
current failure? Yes/No
2
When the power switch of the equipment is turned
on, does the display function, or any part of the
equipment function?
Yes/No
3 Is output generated by the equipment? Yes/No
4
Is the strength of the output from equipment
conspicuously different from when it was first
installed?
If so, how would you rank the difference in
performance, in terms of a percentage?
Yes/No
5 Can you perceive a change of output if the output
strength of equipment is adjusted? Yes/No
6
Is there any damaged part in the
external appearance? Describe this in the
remarks column. Yes/No
After completely filling in the form, please return it to us.
Telephone : 031-696-4875
FAX : 042-934-5562
E-mail : [email protected]
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12. Contact information
❑ Purchasing of product and technical inquiry
Address : (Sampyeong-dong) A block No. 401, Silocon park, 35, No. 255 street,
Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do
Telephone : 031-696-4891
Fax : 031-696-4877
❑ Customer support
Address : No. 301∼303, Migeon Techno World II, 187, Techno 2-ro, Yuseong-gu,
Daejeon metropolitan city
Telephone : 031-696-4875
Fax : 042-934-5562
❑ Online support
http://www.remed.kr