Remed ELPIS-4 User manual

ELPIS-4 / 3 / 2 Us e r G u i d e
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.

ELPIS-4 / 3 / 2 Us e r G u i d e
2017.08.21 Ver M-1.0.0
3/45
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

ELPIS-4 / 3 / 2 Us e r G u i d e
2017.08.21 Ver M-1.0.0
4/45
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

ELPIS-4 / 3 / 2 Us e r G u i d e
2017.08.21 Ver M-1.0.0
5/45
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

ELPIS-4 / 3 / 2 Us e r G u i d e
2017.08.21 Ver M-1.0.0
6/45
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.

ELPIS-4 / 3 / 2 Us e r G u i d e
2017.08.21 Ver M-1.0.0
7/45
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.

ELPIS-4 / 3 / 2 Us e r G u i d e
2017.08.21 Ver M-1.0.0
8/45
❑ 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.

ELPIS-4 / 3 / 2 Us e r G u i d e
2017.08.21 Ver M-1.0.0
9/45
❑ 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

ELPIS-4 / 3 / 2 Us e r G u i d e
2017.08.21 Ver M-1.0.0
10/45
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.