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MEDITOM®

300/200/150 BASIC
USER MANUAL

DAIWHA Corporation, LTD.


Copyright owned by DAIWHA Corporation, LTD.
All rights reserved. April, 2008
The equipment being dealt here is a medical device.

MANUFACTURER DAIWHA Corporation, LTD.


NAME OF THE
Electro Surgical Unit.
PRODUCT
300 BASIC
MODEL 200 BASIC
150 BASIC
PACKAGE ONE
To cut or to coagulate the BIOLOGICAL TISSUE with the help OF
PURPOSE
high FREQUENCY current.
STORAGE To be kept in dry area at room temperature.
HOW TO USE
Kindly revert to the manual.
& PRECAUTION
Caution
▶ The given manual will be dealing with the USAGE and the TECHNICALITIES of the
Electro Surgical Unit produced by DAIWHA corporation. (Model: 300/200/150 BASIC).

▶ Circuit replacement or the concerned repairing of the equipment MUST be handled by one,
authorized by DAIWHA Corporation, LTD.

▶ A part of the circuit on the equipment can be changed for enhancing the performance
and safety, without any notice.

▶ The given manual is suited for the PRODUCTS ,whose product codes are given below.
(refer to the rear-sided label)
Product Code(P/C) :
300 Basic : C000
200 Basic : B000
150 Basic : A000

▶Program version : v1.xx

▶User manual number: E.BASIC-OPE-A0-0

▶For any queries concerning the device or the manual, kindly revert to the contact numbers
given below.

▶ Sales or A/S contact:-


Address : DAIWHA Bldg. 733-18,Yeoksam-Dong,Kangnam-Ku, Seoul, Korea
Phone : +82-2-558-1711~6
Fax : +82-2-554-0317
Home page : www.daiwha.com

▶Technical Support
Address : DAIWHA Corporation, LTD.
177 Yeongcheon-Li, Dontan-myeon, Hwasung-si, Gyeonggi-do
Phone : +82-31-376-9383~6
Fax : +82-31-376-9387
Contents
1. Precautions
1.1 Precautions ------------------------------------------------------------------------------- 1
1.2 Checklist before Use -------------------------------------------------------------------- 4
1.3 Precautions during Use ----------------------------------------------------------------- 4
1.4 Guidelines after Use -------------------------------------------------------------------- 5

2. Terms, Symbols & Accessories


2.1 Terms ------------------------------------------------------------------------------------- 6
2.2 Symbols ---------------------------------------------------------------------------------- 7
2.3 Accessories ------------------------------------------------------------------------------ 8
2.4 Controls, Indicators and receptacles -------------------------------------------------- 10

3. Technical Descriptions
3.1 Specification ------------------------------------------------------------------------------ 13
3.2 Output ------------------------------------------------------------------------------------- 14
3.3 Major Functions -------------------------------------------------------------------------- 15
3.4 Safety Devices ----------------------------------------------------------------------------- 16
3.5 Alarm and Error -------------------------------------------------------------------------- 16

Tip! What is Automatic Neutral Plate Monitoring (ANPM)? ---------------- 18

4. Efficacy using this unit


4.1 Intended Purpose ------------------------------------------------------------------------ 20
4.2 Mono-polar Cutting Mode ------------------------------------------------------------- 20
4.3 Mono-polar Coagulation Mode ----------------------------------------------------- 20
4.4 Bi-polar Cutting/ Coagulation Mode ------------------------------------------------- 20
Tip! Correct use of Contact coagulation mode ----------------------- 21
Tip! Correct use of Bi-polar coagulation mode ---------------------- 21
Tip! Use of Irrigation Function. ------------------------------------------ 22

5. How to Connect Accessories


5.1 How to Connect TBH and Neutral Plate -------------------------------------------- 24
5.2 How to Connect Uni -polar Handle and Neutral Plate ----------------------------- 24
5.3 How to Connect Bi-polar Forceps ------------------------------------------------- 25
5.4 How to Connect the Foot Switch --------------------------------------------------------- 25
Contents
6. How to Use
6.1 Mono-polar Cutting/Coagulation Mode ---------------------------------------------- 26
6.2 Bi- Cutting Mode ----------------------------------------------------------------------------- 28
6.3 Bi-Coagulation Mode ------------------------------------------------------------------- 29
Tip! Output Switch Operation Sequence to the mode settings ------------ 30
6.4 User Memory Function ---------------------------------------------------------------- 30
6.5 Summary --------------------------------------------------------------------------------- 30

7. Output & Open Circuit V-peak Graph


7.1 Pure Cutting Mode -------------------------------------------------------------------------- 33
7.2 Blende Cutting Mode ------------------------------------------------------------------------ 34
7.3 Contact Coagulation Mode ----------------------------------------------------------- 35
7.4 Spray Coagulation Mode ------------------------------------------------------------- 36
7.5 Bi- Cutting Mode ---------------------------------------------------------------------------- 37
7.6 Bi-Coagulation Mode ------------------------------------------------------------------ 38

8. Sterilization ------------------------------------------------------------------ 39

9. User Maintenance
9.1 General Maintenance Information --------------------------------------------------- 41
9.2 Responsibility of the manufacturer -------------------------------------------------- 41
9.3 Cleansing -------------------------------------------------------------------------------- 41
9.4 Periodical Inspection ------------------------------------------------------------------ 41
9.5 Periodic Performance Testing ------------------------------------------------------- 42
9.6 Product Life Span --------------------------------------------------------------------- 42
9.7 How to Scrap the Unit and Parts ---------------------------------------------------- 42
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Danger Warning Caution


▶ Definition of Terms

DANGERS:- Possible hazards that may lead to serious injury or even


INSTANT DEATH.
WARNING:- Possible hazards that may cause serious injury or even death.
CAUTION:- Possible hazards that may cause mild injury to the user or patient.

▶ Please use the E.S.U with extreme care only after reading the INSTRUCTIONS properly. Any
DISCREPANCY will have to be checked in advance.

1. Precautions-
1.1 Precautions
Danger
(1) The use of ANESTHETICS or OXIDIZING GASES, like Nitrous oxide (N2O) and oxygen SHOULD be
avoided when the surgical procedure is being carried out in the region of the thorax or the head, till the
AGENTS are sucked away. Non-Flammable agent should be used for cleaning and DISINFECTING.
Flammable agents used for cleaning or disinfecting and the solvents of adhesives, should be allowed to
evaporate before the application of HF surgery. There is a risk of flammable solutions being sucked
inside the PATIENT or in body depressions like umbilicus, and in body cavities like the vagina. Any fluid
sucked in these areas should be mopped up before surgery. Attention should be given to subdue the
dangers of ignition of endogenous gases.

Materials, like cotton, wool and gauze, when saturated with oxidized fluid may get ignited by the sparks
produced by the normal use of the HF surgical equipment. Moreover when the contact between the neutral plate
and human body is not SMOOTH, sparks may occur between them, leading to .ignition, if there are flammable materials
around the neutral plate.

Warning
(1)The entire SURFACE AREA of Neutral Plate must be attached with the patient's body properly. The contact

status must be checked frequently during the operation. When the contact is poor, parts of body touching the
Neutral Plate may get burned. Areas near the heart, scars, delicate body part, joints and the parts with
Projected bones, are likely to be insecure, in case of movement by the patient..
(2) If the patient complains about electric shock, the Electro Surgical Unit should be stopped immediately.

(3) EQUIPOTENTIAL GROUNDING:-The Electro Surgical Unit must be grounded to earth. The grounding
resistance must be maximum 10Ω. Unexpected electric shock may happen when the unit is used without being

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grounded.
In order to prevent micro shock (electric shock to heart), the resistance between the grounded equipments in the
operating room must be maximum 0.2Ω. For that to happen EQUIPOTENTIAL GROUNDING gathering the
ground wires will have to be at a single point.
(4) Special precaution should be exerted to the patients while using Pacemaker implants or Internal cardiac defibrillator[-ICD].

Since such devices may cause potential risks like damage or malfunctioning, please consult the manufacturer of
pacemaker or ICD or the cardiac experts at the hospital before using.

Caution
(1) The medical equipment being dealt here can only be used by the trained doctors.

(2) When the patient gets in contact with the grounded electric conductors [ like the metal part of the

grounded operation table] during the output, it may burn or shock the body part in contact.

(3) Since it operates at high frequency and high voltage, electromagnetic waves are generated naturally. This

might affect other equipments. It can distort an ECG monitor screen in a negative way.

a} When HF SURGICAL EQUIPMENT and PHYSIOLOGICAL MONITORING EQUIPMENT (for example ECG

monitor) are used simultaneously on a PATIENT, the grounding of ECG should be placed through neutral plate

if the units use same ground on earth.

b} Monitoring electrodes, if any, should be placed, as far from the surgical electrodes as possible (Minimum

distance 150mm). Needle monitoring electrodes are not recommended.

C} When the lead of Radio-Frequency electrode is shorter, it is better not to make loops between the leads.

For this reason use of device that applies to EMC (Electro-magnetic Compatibility) is strongly recommended.

(4) Initially set the output to the lowest level at which the desired operation level is achieved and then increase

the output volume to the desired level gradually.

(5) Do check the equipments before using.

(6) Power voltage and frequency must be supplied in a stable manner, within the designated range, on rear side

of product. However, the output may vary depending on power. If the wall outlet voltage in the hospital exceeds

the designated range by ± 5%, the equipment should be calibrated by the manufacturer or supplier again.

If the power frequency in the hospital is not in the designated range, the equipment should be calibrated

again. For exact power usage kindly refer to the product label on the back.

(7) Considering its cooling feature, it can be acknowledged that continuous output can lead to abnormal

operation of the product.

Be sure of the duty cycle.

(8) A short circuit which might occur between the electrodes, during an activating output can damage the

product.

(9) The Failure of the HF SURGICAL EQUIPMENT may lead to unintended increase in the output power.

(10) Do not reuse disposable accessories.

(11) All accessories has to be kept disinfected whenever they are used, especially metal parts which comes in

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contact with the patient's body

(1) Please do operate the unit as per instructions.


The following rules must be observed and keen attention should be paid..

(2) Do not open or disassembles the unit.

- The repairing and the circuit change of the equipment must only be handled by those who have been

authorized by DAIWHA corporation, LTD.

(3) The unit is designed to be used at intervals. Duty cycle:- 10 sec On, 30 sec Idle

(4) When installing the unit,

Do not locate the unit at a place, which can easily be affected by shock or impact (even at the time of movement

& transportation). Again, do not locate the unit at a place which can easily be affected by temperature, humidity

and barometric Pressure. Always keep them clean. At least one grounded duplex wall receptacle and a proper

line voltage should be provided.

(5) While using electricity, connect the AC line voltage of the system only when the correct line voltage has been

verified. Always check the grounding. After using the unit, make sure that the main power is off and then de plug

the power cord.

(6) How to prevent skin burn:-

① The entire area of the NEUTRAL ELECTRODE should be properly attached to the PATIENTS body and as

close to the operating field as possible.

② The PATIENT should not come in contact with the metal parts which are earthed or which have an

appreciable capacitance with the earth(for example operating table supports, etc.). The use of antistatic sheet

is recommended for this purpose.

- It is good to apply ECG gel or cream to increase the effectiveness of firm contact on the neutral electrode.

③ Areas where extreme perspiration is possible- like extremities lying against the body, or skin-to-skin

contact(arm/trunk, leg/leg, breast.) must be kept dry by placing sheets between them. It is easy to get burnt

when these parts get in contact with other metal parts. Skin-to-skin contact (for example the arms and body of

the PATIENT) should be avoided by insertion of dry gauze.

The use of wet towel as conductive agents should not be used as they dry out leading to high-frequency skin

burns. Urine has to be discharged through catheter or any other device.

④ Initial self-test

- At first test the unit at very low RF power and then increase the RF power smoothly to prevent any problem

caused due to improper touch or disconnection of neutral electrode at normal RF power.

⑤ Do not use children's patient plate (neutral plate) for adults. You may increase the risk of getting burnt due to

reduced contact size.

(7) Do not use cords as a handle, insulation may get damaged and chances of burning injury may enhance.

(8) Use accessories like active and neutral electrodes provided by DAIWHA Corporation in order to avoid

incompatibility and unsafe operation. If you intend to purchase accessories other than those of DAIWHA

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Corporation, please check that the accessories are certified by CE for Electro-surgical unit. To insure safety,

check that the accessories which come in direct contact with the patient are CE certified.

(9) The cables attached with the surgical electrodes should be positioned in a way that they do not come in contact

with the PATIENT and LEAD material. Temporary and unused ACTIVE ELECTRODES should be stored so that

they remain isolated from the PATIENT.

(10) For surgical procedures, where the H.F current flows through the parts of the body having a relatively small

cross-sectional area, the use of bi-polar techniques may be desirable in order to avoid unwanted coagulation.

(11) Apparent low output or failure of the HF SURGICAL EQUIPMENT to function correctly at the normal settings

intended for operation indicates faulty application of the NEUTRAL ELECTRODE or poor contact in its

connections. In this case the application of the NEUTRAL ELECTRODE and its connections should be checked

before selecting higher power.

(12) The supplier on request can provide the circuit diagrams, component part lists, descriptions, calibration

instructions, or other information which will assist the appropriately qualified technical personnel. They can help

in repairing those parts of EQUIPMENT which have been designed by the manufacturer as repairable.

(13) When the unit is used in an environment that has strong magnetic fields i.e. MRI room, it may cause

malfunctioning.

(14) Do not use the unit other than your intended purpose. It may cause unexpected side effects.

1.2 Checklist before use:-


(1) Check and clear away the flammable gases or solvent.

(2) Check the cable connection on the back- panel of the unit.

(3) Check that all the accessories that are in direct contact with the patients are sterilized.

(4) Check all the accessories in order to prevent damage or malfunction of the unit.

(5) Check the DRM function in order to prevent patients from burning due to wrong measurement of contact size,

which may happen at the time of troubles in the E.S Unit.

(6) Check contact status between patient plate and patient.

(7) Check whether H.F power settings are appropriate, keeping in mind the corresponding operation.

1.3 Precautions during use:-


(1) When you change the present settings, check if the new setting is appropriate and has been set keeping in

mind the operation type and biological tissue. Please refer to ‘Output Setting Guide,’
Guide,’ if necessary.

(2)Make sure that patients do not touch the grounded metals. It may cause partial burn.

(3) Do not give high output to the tissue areas and do not give high output approval beyond the need. Manipulate

output when electrode is in contact with the tissue, to prevent burn.

(4) If the patient complains about electric shock, stop using the unit immediately and get it examined thoroughly.

(5)Check the contact status between patient plate and patient frequently; especially when a single pad or reusable

plate is being used as a return electrode.

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(6)The sound volume should at least be at the medium level to prevent the dangers of failing to recognize the

sound.

1.4 Guidelines after use-


(1) Please sterilize reusable accessories before you keep them in store.

(2) dispose the disposable accessories as per the prescribed regulations (according to the law). Disposable

accessories should be disposed in a way that there is no risk of contamination.

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2. Terms, Symbols & Accessories


2.1 Terms
- The terms used in this User Manual are being explained below.
- The terminology described below is limited to this Manual and it may be differ from those used generally.

(1) Electro Surgical Unit (ESU)


- The ESU is a medical device that generates high-frequency current, which are applied to the body organs to
generate heat needed for cutting and coagulation.
(2) Cutting or Cut
- It is a method of destroying cells by the heat (more than 100℃) which is produced by applying high-
frequency current from the ESU to tissue.
(3) Coagulation (Coag. Or Co.) .
- It is a method of drying off the moisture in the cells by the heat (60~90℃) produced from the high-frequency
current generated by the ESU and applied to an organ of the human body.
(4) Bi-polar cutting output
- It is the output generated from bipolar output jack when bipolar cut mode is used.
(5) Bi-polar coagulation output
- It is the output generated from bipolar output jack when bipolar coagulation mode is used.
(6) Mono-polar cutting output
- It is the output generated from the mono-polar output jack when pure mode or blend mode is used.
(7) Mono-polar coagulation output
- It is the output generated from mono-polar output jack when contact mode or spray mode is used.
(8) Automatic neutral plate monitoring (ANPM)
- When the dual pad is used, it monitors the contact area of the pad that can minimize burning risks which may
happen in the contact surface of the pad. (Only for 300/200 BASIC Devices).
(9) Active electrode
- It is an electrode made up of metal material and is connected to the terminal of the handle.
- It becomes the path by which the high-frequency current from the mono-polar output jack is applied to the
human body.
- Depending on the usage, a variety of shapes such as lancet, loop, needle, etc. are offered.
(10) Return electrode
- It is an electrode by which we can return to the device when the high-frequency current is applied to the
human body through the active electrode.
- In general, it is called as ‘neutral plate’, patient plate, or pad. It designates the electrodes connected to the
neutral plate outlet.
(11) Irrigation function
- In the bipolar coagulation output of the ESU, saline solution is supplied to the tip of forceps through the
pump so that the forceps’ tip is cooled off to prevent adsorption between the tip and organization due to overheating.

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- For details, refer to Tip on Page 21.

2.2 Symbols
Caution - dangerous high voltage. Explosion Risk if used with flammable

Hazardous electrical output. anesthetics.

Non-ionizing radiation Equipotential grounding

Attention : See instructions for use Alternative Current

Power off Power on


(Power : Disconnection form the (Power : connection to the mains)
mains)
Single foil pad / Fuse replacement with type and
Dual foil pad rating shown

Forceps Twin button handle (TBH)

Unipolar handle RF Isolated: connection of


patient is isolated from earth at
high frequency.
Defibrillation Proof Protective grounding
Type CF applied part

Single use. Do not reuse. Serial number


Disposable.
REF Catalogue No. EU Representative

Manufacturer Manufacturing date

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2.3 Accessories
- Accessories used in this User’s Manual are being explained below.
- Accessories and their description are limited to this User’s Manual. There may be differences from those,
accepted generally.

(1) Twin Button Handle (TBH)


- One side has three plugs which are connected to the ‘mono-polar RF power outlet’, and the other side is to
connect the active electrode.
- There are two switches: yellow one for mono-polar cutting and blue one for mono-polar coagulation.
- Generally called hand piece or pencil, it becomes the path to apply the high-frequency (HF) current flowing
out from the mono-polar outlet to the patients.
- It will be called 'TBH' hereafter.
(2) Uni-polar Handle
- One side has one plug which is connected to the ‘Mono-polar RF Power Outlet’, and the other side is to
connect the active electrode.
- There is no switch. Rather it is used with the foot switch.
- It becomes the path to apply the HF current flowing from the mono-polar outlet to patients.
- It’s called Uni-polar Handle hereafter.
(3) Neutral Plate
- It is a wide plate made up of conductive materials and is connected to the ‘Return Electrode Inlet’. The
material used is either stainless steel or conductive silicon rubber.
- Single foil pad and dual foil pad are sort of the neutral plates.
- It is called either patient plate or dispersive plate.
(4) Single Pad/Dual Pad
- Single pad: Disposable neutral plate with single pole
- Dual pad: Disposable neutral plate with two polarities.

* Single/Dual foil pad


: - Like the neutral plate, nontoxic glue is applied on the thin aluminum foil.
The foil which is split in the middle to provide two polarities is called dual pad, and the one which
is entirely connected to provide single polarity is called single pad.
(5) Pad Cable
- A clamp is installed at one side to connect with the single pad or dual pad, and a plug at the other side is to
connect with ‘Return Electrode Inlet’.
- This is reusable.
(6) Forceps
- It is a kind of a clamp.
- The upper part is wrapped with the wider, insulating material for the grip of hands. The lower part has a
narrow tip .

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- When both tips are insulated to form polarity, it is called bipolar forceps and when both are shortened to form
single polarity, it is mono-polar forceps. When only forceps is mentioned, it means bipolar forceps.
(7) Forceps cable
- This cable connects to the ‘Bipolar RF Power Outlet’.
② Foot switch
- There are two pedals: yellow one for mono-polar or bipolar cutting and blue one for mono-polar coagulation
or bipolar coagulation output.
- It needs to be connected to the ‘Foot Switch Inlet’.
- In this User’s Manual, it is used as ‘foot switch’.
(9) Power Cord
- The cable connects the ‘Main Inlet’ of the device to the wall outlet.
- When purchased separately, it must be specific for medical grades with a grounding terminal. The cross
section area of an inductive wire in power cord must be at least 1.0 ㎟ when the main is 99-121VAC, and
0.75 ㎟ for 198~142VAC. The resistance of the grounding cable inside the cord must be within 0.1Ω.
(10) Equipotential Grounding Cable
- The cable connects ‘Equipotential Grounding’ of the device to the ground.
- When the power code offers the grounding, independent grounding is not necessary. However, when it does
not offer, an independent grounding must be used.

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2.4 Controls, Indicators and Receptacles

1. User Memory 2. User Memory Selection Switch


: Shows the memory number of the current : Used when changes occur in user
user. memory.
3. Cutting RF Power digital Display 4. Pure Cutting Mode Indicator
: Shows the selected cutting mode’s output in : Turns on when the pure cutting mode is
watt. selected by the cutting mode selection
switch.
5. Blend Cutting Mode Indicator 6. Bi-cut Mode Indicator
: Turns on when the blend cutting mode is : Turns on when the bi-cut mode is selected
selected by the cutting mode selection by the cutting mode switch.
switch.
7. Cutting Activation Indicator 8. Cutting Mode Selection Switch

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: Turns on when the cutting output starts. : Used when changes occur in cutting
mode.
9. Cutting RF Power Increase Switch 10. Cutting RF Power Decrease Switch
: Increases the output power of the selected : Decreases the output power of the selected
cutting mode. cutting mode.
11. Coagulation RF Power digital Display 12. Contact Coagulation Mode Indicator
: Shows the output power of the selected : Turns on when the contact coagulation
coagulation mode in watt. mode is selected by the coagulation mode
selection switch.
13. Spray Coagulation Mode Indicator 14. Bi-coag. Mode Indicator
: Turns on when the spray coagulation mode : Turns on when the bi-coagulation mode is
is selected by the coagulation mode selected by the coagulation mode selection
selection switch. switch.
15. Coagulation Activation Indicator 16. Coagulation Mode Selection Switch
: Turns on the coagulation output. : Used when changes occur in coagulation
mode.
17. Coagulation RF Power Increase Switch 18. Coagulation RF Power Decrease
: Increases the output power of the selected Switch
coagulation mode. : Decreases the output power of the selected
coagulation mode.
19. Alarm Indicator 20. Single Pad Mode Indicator
: Turns on when alarm or error happens. : Turns on when single pad used.
21. Dual Pad Mode Indicator 22. Pad Mode Selection Switch
: Turns on when dual foil pad used. : Switches the mode (single/dual) as switch is
pushed.
23. Bipolar RF Power Outlet 24. Mono-polar RF Power Outlet
: Connects bipolar forceps & bipolar : Connects unipolar handle or TBH to Mono-
cutting/coagulation output power polar cutting/coagulation output power
25. Return Electrode Inlet 26. Foot Switch Inlet
: Connects the neutral plate. : Connects the foot switch
27. Volume Control 28. Main Inlet
: Controls sound volume during outputing. : Connect power cord
Alarm cannot be controlled.
29. Power Selection Switch 30. Power Switch
: Selects the correct main voltage(110/220V). : Turns on/off main (power on/off).
Only those who qualifed by DAIWHA
Corporation can manipulate this.
Since arbitrary change can cause the

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product’s output power to fluctuate and
malfunction, users are not allowed to
change.
31. Equipotential Grounding 32. RS232
: Connects the grounding cable and the part When goods are produced or repaired:
used for the earth grounding. Used as the path of input program
When outputting: Used for irrigation function.
Tip: Refer to Irrigation Function.
*No. 13 and 20 to 22 are not applicable for Model 150 Basic.

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3. Technical Descriptions
3.1 Specification
Product Name : Electro Surgical Equipment

Model : MEDITOM® 300/200/150 Basic

Purpose : Cutting or coagulation of biological tissue using high-frequency current

Mains and Line : 110 or 220VAC(±10%)/50 or 60Hz

Frequency See the label on rear side for correct information

Fuses : 300 Basic: Two of F5.0A, 250V for 220VAC

Two of F10.0A, 250V for 110 VAC


200/150 Basic: Two of F4.0A, 250V for 220VAC
Two of F8.0A, 250V for 110 VAC

Power Consumption : 300 Basic: 950VA

200/150 Basic: 800VA

Protection Class : Class 1, Type CF

IPX : Main Unit: IPX1, Stepper Switch: IPX8

Carrier Frequency : 400, 482KHz

Repeat Frequency : 33KHz

Low Freq. Leakage : EN60601-1 [1990] Requirement

Current
High Freq. Leakage : Less than 150mA

Current

Operation Conditions : 10℃~40℃, 30%~ 85% noncondensing, 700mbar~1060mbar

Storage Conditions : -10℃~60℃, 30%~ 95% non condensing, 700mbar~1060mbar

Transportation : -10℃~60℃, 30%~ 95% non condensing, 700mbar~1060mbar

Conditions Do not drop the unit from height more than 50cm

Do not use the hook.

Installation Conditions : 5cm clearance is required on each side of the unit for cooling
Cooling : 300/200 Basic: 1 fan mounted
150 Basic: No fan exists. Natural cooling by convection current

Recommended Duty : 10 sec ON, 30 sec, OFF(Output for 10 seconds, pause for 30 seconds )

Cycle

Size (H, W, D) : 137mm, 300mm, 395mm

Weight : 300 Basic : About 17Kg

200/150 Basic : About 13Kg

APG : Not AP/APG device


Equipment is not suited for use in the presence of a flammable anesthetic mixture with oxygen or nitro
oxide

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Operation Sound : Difference in operation sounds between cutting and coagulation.

Operation Display : Visible difference in operations between cutting and coagulation.

Output Setting : Displayed in [W] unit from Seven Segment (LED number displayer)

※ Above specifications can be changed without notice.

3.2 Output
300 Basic Tolerance: ±20%

Output Mode Carrier Frequency, Repeat Frequency Output RF Power Load Resistance

Pure 400kHz 8 ~ 300W 500Ω


Blend 400kHz, 33kHz 8 ~ 200W 300Ω
Contact 400kHz, 33kHz 5 ~ 90W 300Ω
Spray 400kHz, 33kHz 5 ~ 80W 500Ω
Bi-Cut 482kHz 1 ~ 90W 200Ω
Bi-Coag. 482kHz 1 ~ 80W 100Ω
※ Above specification can be changed without notice.

200 Basic Tolerance: ±20%

Output Mode Carrier Frequency, Repeat Frequency Output RF Power Load Resistance

Pure 400kHz 8 ~ 200W 500Ω


Blend 400kHz, 33kHz 8 ~ 150W 300Ω
Contact 400kHz, 33kHz 5 ~ 80W 300Ω
Spray 400kHz, 33kHz 5 ~ 70W 500Ω
Bi-Cut 482kHz 1 ~ 80W 200Ω
Bi-Coag. 482kHz 1 ~ 70W 100Ω
※ Above specification can be changed without notice.

150 Basic Tolerance: ±20%

Output Mode Carrier Frequency, Repeat Frequency Output RF Power Load Resistance

Pure 400kHz 8 ~ 150W 500Ω


Blend 400kHz, 33kHz 8 ~ 120W 300Ω
Contact 400kHz, 33kHz 5 ~ 70W 300Ω
Bi-Cut 482kHz 1 ~ 70W 200Ω
Bi-Coag. 482kHz 1 ~ 60W 100Ω
※ Above specification can be changed without notice.

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3.3 Major Functions
(1) Display (FND, LED): Displays various setting values.
- User FND: it displays out the selected user numbers, from user memory functions.
- Cut FND: Displays the output setting values of the selected cutting mode (out of Pure, Blend, Bi-cutting
modes)
- COAG. - FND: Displays the output setting values of the selected coagulation mode (out of Contact, Spray,
Bi-coagulation modes)
- LED: Displays the selected mode of the cutting and coagulation modes, and alarm LED
(2) Front Panel Key: Configure various setting values.
- User Selection Key (‘user memory selection switch’).
: Converts the currently selected user memory into other user memories. Can select 10 user memories from
0 to 9.
- Cutting output mode and output setting key
- Cutting Mode Selection Key (‘cutting power increase/decrease switch’).
: To Select a cutting mode (Pure, Blend, and Bi-polar cutting modes), and to configure the power of the
selected mode
- Refer to ‘3.2 Output Table’ for the scope of individual output configuration.
- Coagulation. - Output mode and power setting key
- Coagulation Mode Selection Key (‘Coagulate power increase/decrease switch’).
: Selects a coagulation mode (Contact coagulate, Spray coagulate, and Bi-polar coagulate modes) and
configures the power of the selected mode.
- Refer to ‘3.2 Output Table’ for the scope of individual output configuration.
(3) Output On/Off Switch (‘TBH’, ‘Foot Switch’)
: - provides On/Off power according to the selected mode and power setup value.
-TBH Cut Power switch ('TBH' cutting power switch) When a switch is on, output starts according to the
selected cutting mode and Configured output value ,output stops, when it is off,
- TBH Coagulation. Output switch ('TBH' coagulate output switch): When a switch is on, output starts
according to the selected coagulation mode and configured output value. The output stops, when it is off.
-Foot Cut Power switch (Pedal cutting output switch) When a switch is on, output starts according to the
selected cutting mode and Configured output value, and when it is off, output stops.
- Foot Coagulation. Output switch (Pedal coagulate output switch): When a switch is on, output starts
according to the selected coagulation mode and configured output value. The output stops, when it is off.
(4) Sensor
Alarming status is determined after receiving individual sensor values.
When an alarm situation occurs, output is suspended until the alarm situation is called off.
- Neutral plate (‘Neutral plate’) Determines whether it is an alarm situation by monitoring the resistance and
disconnection of neutral plate.
- HF Leakage: Determines whether it is an alarm situation by monitoring the value of high-frequency leakage.
- Multi OSC. : Determines whether it is an alarm situation by monitoring the operation status of MULTI OSC.

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Transformer
- Main transformer. : - Determines whether it is an alarm situation by monitoring the heat generation of power
transformer.
(5) Speaker
When a front panel key is pressed, or an output ON/OFF switch is pressed, or an alarm is cancelled,
individual sounds are generated through the speaker.
(6) Data Backup
The selected output mode, output setting value, and user memory numbers are changed by the front panel
key, update dates are automatically backed up.

3.4 Safety Device


(1) Fuses on the power supply stage protect the high current.
(2) The enclosure is grounded so that the current that may flow to the patients is grounded and safe protection is
guaranteed.
(3) When a neutral plate is separated from the equipment attached to a patient, high frequency current is
automatically blocked. The Return Fault Indicator and Alarm Sound indicates that it is an alarm situation.
(4) It is designed in a way that even for once if a single switch is pressed, other switches won’t work thereby the
multiple outputs are prevented.
(5) High Frequency Leakage Monitor -it monitors the high frequency current leaking from a patient to earth and
reduces the current down to lower than IEC requirement. When a patient gets in contact with any metal parts
(for example, metal parts of surgery bed or conductive rubber tube) having electric charges, it remains
grounded to earth or retains the substantial electrostatic capacity to reduce the risk of burning.
(6) The function of ANPM is to minimize the risk of burning when contact occurs with the neutral plate, by
monitoring the contact area of a patient and the neutral plate.
The function is available only in the 300/200 Basic model.

3.5 Alarm and Error


- Failure symptoms due to the misuse and excessive use of equipment are detected by internal censors and an
alarm or error occurs.
When an alarm situation occurs, output is suspended and remains unavailable until the alarm situation is called off.
- If an error occurs, turn off the equipment and contact DAIHAW Inc. or sales agent.
- When an alarm or an error occurs, the setting value of individual mode and alarm / error number are indicated
turn by turn. The alarm indicator glitters on the cutting output display panel, and coagulation output display
panel.
Numbers displayed in ‘Coagulation Output Display Panel’ are an error or alarm number.)

When an error occurs, When an alarm occurs,

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(1) Error
- If an error occurs, check out the error number displayed on an equipment, and contact Daihaw Inc. or sales
agent.

(2) Alarm
Alarm Alarm
Alarm Situation How to cancel the alarm
No. Display
By using ‘Dual Pad when single pad mode
is being used.
1 “ALr 1" When the ‘Single Pad’ is pulled out from Connect ‘Single Pad’ to ‘Neutral plate’ jack.
the ‘Neutral plate jack” while using the
single pad mode
When Neutral plate cable gets
disconnected while using the single pad Replace the cable.
mode
By connecting ‘Single Pad’, when the
Use the ‘Dual Pad’.
dual pad mode is being used
When the contact area while using the dual
“ALr Apply larger area to the contact area to the patient.
2 pad mode is small.
2”
When the cable while using the dual pad
mode is disconnected or there is a short Connect the cable and Replace the short line.
line.
When the pad area in contact of the patient
Re-attach the peeled-off Dual Pad, or Replace it with
3 “ALr 3" has fallen to over 20% against the original
a new Dual Pad.
contact area..
Turn off the equipment, and place it in the cool area.
Internal power converter is overheated due
4 “ALr 5” It is automatically cooled when the internal equipment
long-time usage.
is cooled off.
- If an alarm continues to occur even after the counter measures have been taken, contact DAIWHA
Corporation, LTD. or sales agent.
- Even if a plate-related alarm (alarm 1-3) occurs, you can use the both of bi-polar cutting or bi-polar
coagulation modes.

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TIP! What is Automatic Neutral Plate Monitoring (ANPM)?

- An advanced Form of neutral plate alarm used earlier, it is a safety device that minimizes burning that may occur
on the contact area of the pad, by monitoring contact status of pad especially when the ‘Dual Pad’ is being
used.
- It corresponds to DRM function of other brands’ REM or DAIWHA (DT-400P/300P).
DRM FUNCTION:--This function is available only in the 300/200 Basic model.
- 150- Basic model utilizes neutral plate alarm, which only detects whether the neutral plate cable is disconnected
or not.

(1) For Single Pad


(1) Function

: - It monitors only the mounting and cable breaking status of Neutral plate.
2) Directions

① - Press (pad option switch) to turn on ‘Single Pad Mode Lamp’.

② Mount Neutral plate over the Neutral plate jack. Only single pad should be used in addition to metal

plate with cable and rubber plate with cable.


③ Patch the pad on the patient’s body.

3) Alarm

: - When Neutral plate is dismounted from the device or its cable is broken, the alarm tone is generated.
- ‘Cutting Output Display Panel’ and ‘Coagulation Output Display Panel’ will alternately show the
setting values of individual modes, and alarm numbers with 'Alarm Lamp’ flickering. The sound
of alarm is also generated.

(2) For Dual Pad


(1) Function

: - It monitors the contact area of pad as well as the mounting and cable breaking status of Neutral plate.
2) Directions

① - Press (pad option switch) to turn on ‘Dual Pad Mode Lamp’.

② Mount Dual Pad over Neutral plate jack.


③ Patch the pad on the patient’s body in a way that it secures more extended area.

④ When a certain level of contact area is secured, the alarm is generated.

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3) Alarm

- If alarm tone sounds according to following conditions, the output is cut off.
※Alarm Condition
① When a cable is broken or the contact area of pad applied to the patient’s body is too short, alarm tone

is generated.
- When alarm is generated, ‘Cutting Output Display Panel’ and ‘Coagulation Output Display
Panel’ will alternately show the setting values of individual modes, and alarm numbers with
'Alarm Lamp’ flickering and the alarm sound is generated.
- When alarm is generated, patch the pad as closely and firmly as possible, to the surgery area and
cover the larger contact area.

② Alarm is generated when the pad contact area decreases down to 20% of the initial patched area.
- When alarm is generated, ‘Cutting Output Display Panel’ and ‘Coagulation Output Display
Panel’ will alternately show the setting values of individual modes, and alarm numbers with
'Alarm Lamp’ flickering. The alarm sound is generated.
- In such alarm situation, re-patch the pad to the patient to secure the initial contact area. The
alarm situation will be called off.

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4. Efficacy using this unit:-


4.1 Intended Purpose
This product is intended to perform the surgical operation, such as cutting or coagulating of biological tissue by
means of high frequency current emanating from this device.

4.2 Mono-polar Cutting Mode


1) Pure
- Uses non modulated 400KHz HF current.

- comprises of Wave form with minimal homeostasis for gentle cutting.

- has been Designed exclusively for the cutting mode.


2) Blend
- Uses 400KHz HF current which is modulated into 33KHz frequency.

- For cutting with homeostasis.

4.3 Mono-polar Coagulation Mode


1) Contact Coagulation
- Uses 400KHz HF current intensively modulated into 33KHz.

- Waveform is exclusively used for coagulation.

- Uses ball type electrodes or mono-polar forceps.

- Used in a way that it pushes out RF output power with the electrodes in contact of the tissues.

2) Spray Coagulation
- Uses 400KHz HF current intensively modulated into 33KHz.

- Generate higher VP-p than other modes, and are used for the coagulation of spark caused by
high VP-p.

-Usable only through 300/200 Basic model.

4.4 Bi-polar Cutting/Bi-polar Coagulation Mode


- It is used for the elaborate coagulation or cutting of tiny area such as blood vessel, delicate tissue and nerves.
- It reduces the risk of electrical shock as the current path is short. Short current path can be attributed to the fact
that current flows between the tips.
- Even if a pad-related alarm (alarm 1-3) occurs, you can use the both of bi-polar cutting or bi-polar coagulation
modes.
1) Bi-Cut

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- Uses non modulated 482KHz HF current.

- Uses bi-polar scissors to treat blood.

- Especially used for cutting blood vessels and minute tissue.


- It can be used for the coagulation of large tissue.
2) Bi-Coagulation
- Uses non modulated 482KHz HF current.

- Uses bi-polar forceps to treat.

- Especially used for the coagulation of blood vessels and minute tissue.
- Supports the irrigation function in order to prevent the tissue absorption phenomena into the
forceps.

TIP! Correct Usage of Contact Coagulation Mode

(1) Quality coagulation, also referred as dehydration, causes no carbonization and adhesion to
the electrodes.

(2) It is very important to minimize the spark between electrode and tissue for the quality
coagulation. The following procedures are needed to ensure the quality coagulation.

(3) Let out the output with the electrodes adhered to the tissue.

(4) Don't supply HF current (output) to the tissue for a long time.

(5) The output should be low enough to make coagulation. High output produces high voltage
to the tissue, leading to increase in spark.

(6) It is desirable to use a ball type of electrode because it generates fewer sparks as
compared to other types of electrodes. An electrode with small diameter is recommended
as you need higher output in proportion to the diameter. Low output can make coagulation
possible. Don't use electrode of lancet or needle type as it can create spark at the edge.

TIP! Correct Usage of Bi-Polar Coagulation Mode

(1) It is needed for operations on sensitive tissues such as nerve or blood vessel. Those who don’t have
much skill should be fully aware of the following checkpoints.
(2) It happens to deal the tissues as they tend to ooze out on the tips of forceps. You can minimize the problem
by using the following procedures. This problem occurs because the current going through the Forceps heats up
the tips and tissues adhering to the tips dehydrate. To solve this problem, it is essential to reduce the heat at the tips.

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3] Follow the procedures below.

A] - Do not supply HF current to the tissue for a longer time than necessary.
B] Maintain the minimum level of output, ample enough to perform coagulation. If you supply higher output than
required, the tips of Forceps will be heated promptly, aggravating the symptom and peeling off the gilt of tips. When you
have to use higher output than the required value, get the tip parts cooled off (cooled off by having the tip
parts immersed into the distilled water.)
- Use the Forceps with the wider tips for coagulation at the higher output.
- Replace the Forceps with one newer in model. Forceps vary in quality and processing method according to
manufacturer, and low-quality forceps may aggravate the symptom.
- Check the gilt status at the tips of forceps. The peeled gilt at the tips or coarse forceps worsens the condition.
- Especially, be careful to wash the forceps without damaging the tips. If some tissues are adhered to the tips,
remove them with a piece of soft cloth after soaking the Forceps into water.
- Do not remove liquid from the tissues because the tissues without enough liquid tend to adhere to the Forceps. Supply water
such as saline solution to dry up the tissue to avoid the concerned problem.

- Use the irrigation function.

TIP! How to Use Irrigation Function


(1) Function Description
- Supply a saline solution to the tips of forceps through the pump during the output process of bi-polar coagulation
of surgical device, to cool down the tips of forceps and prevent absorption between the tip and tissue.
- Available only for the bi-polar coagulation mode
(2) Components
- Electronic surgical device, foot switch, forceps for irrigation function, pump (the products are recommended only
for the irrigation function), and saline solution
(3) Operation Description
- Connect RS232 connector at the rear side of the electronic surgical device to the output starting switch connector
of the pump with cable.
. (Refer to the RS232 connector wiring diagram below.)
- Insert IV set into the saline bag, and then connect it to the forceps.
- Attach the IV set to the pump.
- Set the pump flowing rate.
- Change the mode of the surgical device into the bi-polar coagulation mode, and set the output.
- When pressing the blue foot switch of the surgical device, bi-polar coagulation output is generated and pump is set
in motion at the same time to provide a saline solution to the forceps.
- If you take your foot off the foot switch, the bi-polar coagulation output and saline provision will be
simultaneously discontinued.

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(4) RS232 connector wiring diagram and pin function description

Wiring diagram of RS232 conn.

IRRG.-A 1
IRRG.-COM 6
TX 2
7
RX 3
IRRIG.-B 8
4
RELAY 9
COM 5
120VAC/60VDC
1A MAX. DSUB9, f emale

- Pin No. 2, No. 3 and No. 5: Used for the program input during manufacturing and repairing of products.
(RS232 Communication)
- Pin No. 1, No. 6 and No. 8: Used for the purpose of irrigation.
- Pin No. 1, and No. 6: Closed between contact points while the bi-polar coagulation output is generated, and
open while output is off.
- Pin No. 6, and No. 8: Open between contact points while the bi-polar coagulation output is generated, and
closed while output is off.

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5. How to Connect Accessories

5.1 How to Connect TBH and Neutral Plate

5.2 How to Connect Uni-polar Handle and Neutral Plate

Plug Uni-polar Handel, mono-polar forceps, laparoscopic instrument, endoscopic instrument, TUR
instrument in the orange color marked hole.

Caution

- Be warned of the fact that if plugged in the wrong hole, the output may continue even when
the foot switch is off.

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5.3 How to Connect Bi-polar Forceps

5.4 How to Connect Foot Switch

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6. How to Use
-150 Basic model excludes the following functions:-
* Spray coagulation mode
- Dual pad mode by ‘Pad Mode Selection Switch’ (only single pad mode)
*Does not use ‘Dual Pad’.
- 150 Basic model is not available for the usage of ‘dual pad’ and spray coagulation mode in the below
diagram.

6.1 Mono-polar Cutting/Coagulation Mode


(1) After checking the main power voltage (110/220V), the power cord should be connected to the ‘Main Inlet’
located at the rear panel of the equipment. If there is no ground circuit in the power cord, the Equipotential
grounding cable must be connected to the ‘Equipotential Grounding’. Contact DAIWHA sales department
when the Equipotential Grounding cable is solicited..

Main Inlet

Equipotential
Grounding

(2) Turn on Power Switch.


- If Neutral plate is not connected, ‘Alarm Indicator’ will flicker with the alarm sound.

Alarm lndicator

Power Neutral plate

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(3) Select out of ‘Single Pad’ mode or ‘Dual Pad’ mode.

1) Single Pad Mode 300/200 Basic 150 Basic

① - Press (pad option switch) to set ‘Single Pad Mode Indicator’.


② Connect ‘Single Pad’ to ‘Return Electrode Inlet’. Alarm will stop and it will be ready for the usage.
③ Patch the Neutral plate firmly on the patient’s body. [Read cautions carefully]

2) Dual Pad Mode

① Press (pad option switch) to set ‘Dual Pad Mode’.


② Connect ‘Dual Pad’ to ‘Return Electrode Inlet’.
③ Patch the Neutral plate firmly on the patient’s body. (Be sure to carefully read cautions)

(4) Press ‘Cutting Mode Selection Switch’ to select the desired cutting mode (Pure, Blend), and then set up the
proper output[W] by the use of ‘Cutting RF Power Increase(▲) Switch’ and ‘Cutting RF Power Decrease
(▼) Switch’.

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(5) Press ‘Coagulation Mode Selection Switch’ to select the desired coagulation mode (Contact, Spray), and then
set up the proper output[W] by the using ‘Coagulation RF Power Increase(▲) Switch’ and ‘Coagulation RF
Power Decrease (▼) Switch’.

* Spray mode is not available for 150 Basic Equipment.


300/200 Basic 150 Basic

② For the use of TBH, connect it to ‘Mono-polar RF Power Outlet’.

② When using the foot switch, connect it to the ‘Foot Switch Inlet’ in the rear panel. Output is generated
from ‘Mono-polar RF Power Outlet’.

Foot Switch Inlet

Mono-polar

6.2 Bi-Cut Mode RF Power

② Connect the foot switch to the ‘Foot Switch Inlet’. Outlet

(2) Press ‘Cutting Mode Selection Switch’ to opt for the bi-polar cutting mode.
(3) Press ‘Cutting RF Power Increase (▲) Switch’ and ‘Cutting RF Power Decrease (▼) Switch’ to set the proper
output [W].
(4) Use bipolar scissors to tear.

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Foot Switch Inlet

Bi-polar RF Power
Outlet

6.3 Bi-Coagulation Mode


② Connect the foot switch to the ‘Foot Switch Inlet’.
(2) Press ‘Coagulation Mode Selection Switch’ to opt for the bi-polar coagulation mode.
(3) Press ‘Coagulation RF Power Increase (▲) Switch’ and ‘Coagulation RF Power Decrease (▼) Switch’ to set
the proper output [W].
(4) Use bipolar forceps to treat.

Foot Switch Inlet


Bi-polar RF Power Outlet

300/200 Basic 150 Basic

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TIP! Output Switch Operation Sequence to mode settings


ettings

* To prevent misuse, the way of using the output switch may vary according to different situations as
follows.

(1) If one of the cutting or coagulation is in bi-polar mode, and the other is in Mono-polar mode, the
Mono-polar mode is not available for the foot switch.
(2) If both the cutting and coagulation are in bi-polar mode, you can use only the finally selected bi-polar mode
for output.
- At this time, the only selected mode is displayed but the unselected mode is not.

6.4 User Memory


(1) It is a function with which your can separately assign settings (usage mode and output) to each of the memory
numbers to select and retrieve the necessary number. Available number ranges from 0 to 9 and it is
convenient to assign each memory number by user or by surgical purpose.
(2) After the selection of memory number, and configuration (usage mode and output), applicable numbers are
automatically memorized.. If you select your number, even though the current number is different one, the
previously configured number appears automatically and remains ready for the use.

6.5 Summary
(1) Preparations
1) Check if the electrode for the ESU is sterilized.
2) After checking the main power voltage, connect the power cord to the ‘Main Inlet’ located at the rear panel
of the equipment.
If there is no ground circuit in the power cord, the equipotential grounding cable must be connected to
the ‘Equipotential Grounding’.
3) Patch Neutral plate as closely and firmly to the surgery area as possible and secure the large contact area.

(2) Operation Sequence


1) After checking the main power voltage (110/220V), connect the power cord to the main power inlet located
at the rear panel of the equipment.
2) Turn on Power Switch.
3) Press ‘Pad Mode Selection Switch’ to configure the pad mode you want to use.
(150 Basic models are not available for the pad mode selection switch.)
4) Mount Neutral plate over ‘Return Electrode Inlet’.

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5) Patch Neutral Plate as closely and firmly to the surgery area as possible and secure as large the contact area
as possible.
6) Method and sequence to operate each of functions

① When operating Mono-polar cut function


A] ② Connect TBH or Uni-polar Handle to ‘mono-polar RF Power Outlet’.
B]. Press ‘Cutting Mode Selection Switch’ to select the proper output mode for the surgery. The
indicator of selected output mode gets on, and the value of applicable mode will be displayed on
the ‘Cutting RF Power Digital Display’.
c. - Use the Cutting RF Power Increase/Decrease Switch to configure the cutting output.
d. Press the yellow switch of TBH, or the yellow pedal of Foot Switch to perform the cutting surgery.

① When operating Mono-polar coagulation function


a. Connect TBH or Uni-polar Handle to Mono-polar output jack.
b. Press ‘Coagulation Mode Selection Switch’ to select the proper output mode for the surgery. The
indicator for the selected output mode gets on, and the value of applicable mode will be displayed
in the ‘Coagulation RF Power Digital Display’.
c. Use the ‘Coagulation RF Power Increase/Decrease Switch’ to configure the coagulation output.
d. Press the blue switch of TBH, or the blue pedal of Foot Switch to perform the coagulation surgery.

③ When operating bi-polar cut function


a. Connect bi-polar forceps to ‘Bi-polar RF Power Outlet’.
b. Press ‘Cutting Mode Selection Switch’ to select Bi-Cut mode for the surgery. The indicator for the
selected output mode gets on and the value of applicable mode will be displayed in the ‘Cutting RF
Power Digital Display’.
c. Use the ‘Cutting RF Power Increase/Decrease Switch’ to configure the cutting output.
d. Press the yellow pedal of Foot Switch to perform the cutting surgery.

④ When operating bi-polar coagulation function


a Connect bi-polar forceps to ’Bi-polar RF Power Outlet’.
b. Press ‘Coagulation mode Selection Switch’ to select Bi-Coagulation mode for the surgery. The
indicator in the selected output mode gets on, and the value of applicable mode will be displayed in
the ‘Coagulation RF Power Digital Display ’.
c. Use the ‘Coagulation RF Power Increase/Decrease Switch’ to configure the coagulation output.
d. Press the blue pedal of Foot Switch to perform the coagulation surgery.

(3) Guidelines after use


1) When the operation of ESU has been finished, turn off power and disconnect all of accessories.
2) Accessories should be kept in the clean environment, and components in contact with patient should be
sterilized.
3) Please sterilize reusable accessories before you keep them in store.
4) Scrap disposable accessories as per the prescribed regulations (according to the law). Exert your caution in a
way that there is no risk of contamination due to the consumable accessories.
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4) Precautions during use


1) Precautions during use

① Check if the current output setting is appropriate for the existing surgical environment including the

surgical area.
② Make sure that patients do not touch grounded metals. It may cause partial burn.

③ Do not give long time output to the tissue areas or higher output beyond the need. Manipulate output

when electrode is always contacted with tissue to prevent tissue burn.


④ If the patient complains about the electric shock, stop using the unit immediately and have it

examined thoroughly.
② Frequently check the contact status between neutral plate and a patient.
⑥ The sound volume should at least be at the medium level to prevent dangers of failing to

recognize the sound.


2) Storage condition or storage method

① Storage Condition: -10℃~60℃, 30%~ 95% non condensing, 700mbar~1060mbar

②place the product package box, at a cool place.

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7. Output & Open Circuit V-peak Graph


7.1 Pure Cutting Mode

300 Basic Output Graph 300 Basic Open Circuit Vpeak Graph

LOADREGULATION(PURE) Open Circuit Peak Voltage(PURE)

350 2500
300W
300 150W
2000
250
Output(W)

Vpeak(V)
200 1500

150
1000
100
500
50

0
0
0

200

400

600

800

1000

1200

1400

1600

1800

30

60

90

120

150

180

210

240

270

300
Load(Ω) Output Power Setting(W)

200 Basic Output Graph 200 Basic Open Circuit Vpeak Graph

LOADREGULATION(PURE) Open Circuit Peak Voltage(PURE)

250 1800
200W
100W 1600
200
1400
1200
Output(W)

150
Vpeak(V)

1000

100 800
600
50 400
200
0
0
0

200

400

600

800

1000

1200

1400

1600

1800

40

80

120

160

200
Load(Ω) Output Power Setting(W)

150 Basic Output Graph 150 Basic Open Circuit Vpeak Graph

LOADREGULATION(PURE) Open Circuit Peak Voltage(PURE)

180 1600
150W
160 75W 1400
140
1200
120
Output(W)

1000
Vpeak(V)

100
800
80
60 600

40 400
20 200
0
0
0

200

400

600

800

1000

1200

1400

1600

1800

30

60

90

120

150

Load(Ω) Output Power Setting(W)

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7.2 Blend mode
300 Basic Output Graph 300 Basic Open Circuit Vpeak Graph

LOADREGULATION(BLEND) Open Circuit Peak Voltage(BLEND)

250 2500
200W
100W
200 2000
Output(W)

150

Vpeak(V)
1500

100 1000

50 500

0
0
0

200

400

600

800

1000

1200

1400

1600

1800

40

80

120

160

200
Load(Ω) Output Power Setting(W)

200 Basic Output Graph 200 Basic Open Circuit Vpeak Graph

LOADREGULATION(BLEND) Open Circuit Peak Voltage(BLEND)

160 1800
150W
140 75W 1600

120 1400
1200
100
Output(W)

Vpeak(V)
1000
80
800
60
600
40
400
20
200
0
0
0

200

400

600

800

1000

1200

1400

1600

1800

30

60

90

120

150
Load(Ω) Output Power Setting(W)

150 Basic Output Graph 150 Basic Open Circuit Vpeak Graph

LOADREGULATION(BLEND) Open Circuit Peak Voltage(BLEND)

140 1600
120W
120 60W 1400

100 1200
Output(W)

1000
Vpeak(V)

80
800
60
600
40
400
20
200
0
0
0

200

400

600

800

1000

1200

1400

1600

1800

30

60

90

120

Load(Ω) Output Power Setting(W)

……………………………………………………………………………………………………………………
34
300/200/150 Basic
……………………………………………………………………………………………………………………
7.3 Contact Coagulation Mode

300 Basic Output Graph 300 Basic Open Circuit Vpeak Graph

LOADREGULATION(CONTACT) Open Circuit Peak Voltage(CONTACT)

100 1600
90W
90 45W 1400
80
1200
70
Output(W)

60 1000

Vpeak(V)
50
800
40
600
30
20 400
10
200
0
0
0

200

400

600

800

1000

1200

1400

1600

1800

15

30

45

60

75

90
Load(Ω) Output Power Setting(W)

200 Basic Output Graph 200 Basic Open Circuit Vpeak Graph

LOADREGULATION(CONTACT) Open Circuit Peak Voltage(CONTACT)

90 1600
80W
80 40W 1400
70
1200
60
Output(W)

1000
Vpeak(V)

50
40 800

30 600
20 400
10
200
0
0
0

200

400

600

800

1000

1200

1400

1600

1800

10

20

30

40

50

60

70

80
Load(Ω) Output Power Setting(W)

150 Basic Output Graph 150 Basic Open Circuit Vpeak Graph

LOADREGULATION(CONTACT) Open Circuit Peak Voltage(CONTACT)

80 1600
70W
70 35W 1400
60 1200
50
Output(W)

1000
Vpeak(V)

40
800
30
600
20
400
10
200
0
0
0

200

400

600

800

1000

1200

1400

1600

1800

10

20

30

40

50

60

70

Load(Ω) Output Power Setting(W)

……………………………………………………………………………………………………………………
35
300/200/150 Basic
……………………………………………………………………………………………………………………
7.4 Spray Mode

300 Basic Output Graph 300 Basic Open Circuit Vpeak Graph

LOADREGULATION(SPRAY) Open Circuit Peak Voltage(SPRAY)

120 4000
80W
40W 3500
100
3000
80
Output(W)

2500

Vpeak(V)
60
2000

40 1500

20 1000

500
0
0
0

200

400

600

800

1000

1200

1400

1600

1800

10

20

30

40

50

60

70

80
Load(Ω) Output Power Setting(W)

200 Basic Output Graph 200 Basic Open Circuit Vpeak Graph

LOADREGULATION(SPRAY) Open Circuit Peak Voltage(SPRAY)

100 4000
70W
90 35W 3500
80
3000
70
Output(W)

60 2500
Vpeak(V)

50
2000
40
30 1500

20 1000
10
500
0
0
0

200

400

600

800

1000

1200

1400

1600

1800

10

20

30

40

50

60

70
Load(Ω) Output Power Setting(W)

……………………………………………………………………………………………………………………
36
300/200/150 Basic
……………………………………………………………………………………………………………………
7.5 Bi-Cut mode

300 Basic Output Graph 300 Basic Open Circuit Vpeak Graph

LOADREGULATION(BI-CUT) Open Circuit Peak Voltage(BI-CUT)

100 700
90W
90 45W 600
80
70 500
Output(W)

60

Vpeak(V)
400
50
40 300
30
200
20
10 100
0
0
0

100

200

300

400

500

600

700

800

900

15

30

45

60

75

90
Load(Ω) Output Power Setting(W)

200 Basic Output Graph 200 Basic Open Circuit Vpeak Graph

LOADREGULATION(BI-CUT) Open Circuit Peak Voltage(BI-CUT)

90 600
80W
80 40W
500
70
60 400
Output(W)

Vpeak(V)

50
300
40
30 200
20
10 100

0
0
0

100

200

300

400

500

600

700

800

900

10

20

30

40

50

60

70

80
Load(Ω) Output Power Setting(W)

150 Basic Output Graph 150 Basic Open Circuit Vpeak Graph

LOADREGULATION(BI-CUT) Open Circuit Peak Voltage(BI-CUT)

80 600
70W
70 35W
500
60
400
50
Output(W)

Vpeak(V)

40 300
30
200
20

10 100

0
0
0

100

200

300

400

500

600

700

800

900

10

20

30

40

50

60

70

Load(Ω) Output Power Setting(W)

……………………………………………………………………………………………………………………
37
300/200/150 Basic
……………………………………………………………………………………………………………………
7.6 Bi-Coag. Mode

300 Basic Output Graph 300 Basic Open Circuit Vpeak Graph

LOADREGULATION(BI-COAG.) Open Circuit Peak Voltage(BI-COAG.)

100 500
80W
90 40W 450
80 400
70 350
Output(W)

60 300

Vpeak(V)
50 250
40 200
30 150
20 100
10
50
0
0
0

100

200

300

400

500

600

700

800

900

10

20

30

40

50

60

70

80
Load(Ω) Output Power Setting(W)

200 Basic Output Graph 200 Basic Open Circuit Vpeak Graph

LOADREGULATION(BI-COAG.) Open Circuit Peak Voltage(BI-COAG.)

80 400
70W
70 35W 350

60 300

50
Output(W)

250
Vpeak(V)

40 200
30 150
20 100
10
50
0
0
0

100

200

300

400

500

600

700

800

900

10

20

30

40

50

60

70
Load(Ω) Output Power Setting(W)

150 Basic Output Graph 150 Basic Open Circuit Vpeak Graph

LOADREGULATION(BI-COAG.) Open Circuit Peak Voltage(BI-COAG.)

70 350
60W
60 30W 300

50 250
Output(W)

Vpeak(V)

40 200

30 150

20 100

10
50
0
0
0

100

200

300

400

500

600

700

800

900

10

20

30

40

50

60

Load(Ω) Output Power Setting(W)

……………………………………………………………………………………………………………………
38
300/200/150 Basic
……………………………………………………………………………………………………………………

8. Sterilization
(1) For cleaning and sterilizing, the unit must be dismounted from the main power.
2) Components should be used only after sterilization, especially metal parts which remain in contact with the
patients body .

Caution
To prevent patient contamination, verify the germicidal effect after sterilization process, and only use the sterilized
components.
(3) Be sure to clean and sterilize the parts before keeping them.
4) Before sterilization, thoroughly inspect the parts and their cord for breaks or cracks in the insulation, corrosion,
or other loose conditions. . Do not use the parts if any of these conditions exist.
5) How to Sterilize
- Various ESU electrodes: High pressure steam sterilization or E.O. GAS sterilization
- Electrode handle and connection cable: - High pressure steam sterilization or E.O. GAS sterilization
- Neutral plate E.O. GAS sterilization.
- High pressure steam sterilization condition: - Pressure(medium pressure), temperature (121 C), Time (20
minutes)
- E.O. GAS sterilization condition: -

* Concentration (E.O. GAS 60%, CO2 GAS 40%)


* Exposure time, temperature (for 105 minutes, 54℃)

* Purification time, temperature (for 12 hours, 54℃)


※ When it is difficult to maintain the concentration level by percentage (%), it is all right to set ETO
to 600mg/liter.
6) Recommended sterilization method by component
Sterilization method
Component Steam ETO
(Autoclave) (EO Gas)
1. 'TBH' with Cable
2. Uni-polar handle with cable
3. Forceps Cable
Available
4. Forceps
Available
5. Active Electrodes
6. Pad Cable
7. Reusable Metal Plate with Cable Non-available
8. Reusable Rubber Plate with Cable Non-available

……………………………………………………………………………………………………………………
39
300/200/150 Basic
……………………………………………………………………………………………………………………

Caution
(1) Do not overheat, overpressure or overtime. It can damage the parts.

(2) The disposable parts should be used only once.

(3) Life of accessory will be reduced in the following cases:

- High mineral content in the autoclave supply water.


- Tight bunching or wrapping of the cord during sterilization.
- Contact occurring between the cord and material instruments during autoclave sterilization.
(4) Sterilize the parts made of plastic, PVC or rubber with EO. If they are sterilized with autoclave, they may
get transformed or their life span may be reduced due to high temperature.

(5) The main body of the unit can not be sterilized in the method prescribed in the above table.

……………………………………………………………………………………………………………………
40
300/200/150 Basic
……………………………………………………………………………………………………………………

9. User Maintenance
9.1 General Maintenance Information
- This section presents information for ordinary maintenance of 300/200/150 Basic. It is recommended that
periodic inspection and performance testing be performed by a qualified biomedical technician to ensure safe
and effective operation.
- If any problem occurs, contact the local agencies or company.

9.2 Responsibility of the manufacturer


- DAIWHA is responsible for the safety, reliability and performance of the Unit only under the following
circumstances.
* Installation and set up procedures in this manual are followed.
- Assembly operation, readjustment, modification, or repairs are carried out by persons authorized by
DAIWHA Corporation, LTD.
* The electrical installation of the relevant room complies with local codes and regulatory requirements, such
as IEC and BSI.

9.3 Cleaning
Warning
- Electric shock hazard: - Always turn off and unplug the unit before cleaning.

- When cleaning with damp cloth, exert cautions to prevent moisture from leaking into the product. It may
cause the product to malfunction.

Caution
- Do not clean the unit with abrasive cleaning or disinfectant compounds, solvents thinner, solvent, benzene,
ammonia or acetone or other materials that could scratch the panels or damage the unit

- Turn off the unit and unplug the power cord from the wall outlet.
- Thoroughly wipe all surfaces of the unit and the power cord with mild cleaning solution or disinfectant and
a damp (not dripping) cloth.
- Do not allow impurities to enter the chassis.
(1) Do not sterilize with autoclave or EO gas.

9.4 Periodic Inspection


(1) All parts that connect to the unit should be checked to prevent damage or malfunction of the unit, whenever
you start surgical operation.
(2) It is required to check up following items at least once a month.

……………………………………………………………………………………………………………………
41
300/200/150 Basic
……………………………………………………………………………………………………………………
- Damage to the Equipotential Grounding cable.
- Damage to the power cord.
- Damage to the volume control.
-Checking whether there is damage to the Bi-polar Forceps, TBH, Unipolar Handle, and Neutral Plate including
damages to any accessories and cleaning status.
- External damage to the unit.
(3) This equipment requires the inspection on the following items at least once a year.
- Internal damages in the unit.
- Accumulation of the lint or debris within the unit or heat sink.

9.5 Periodic Performance Testing


This equipment requires the performance test at least once a year.
- Check if the output is accurately generated. When inaccurate output is detected, please contact sales agents or
DAIWHA Corporation for getting the calibration service.
- Check if the ANPM function is operating properly and accurately.
TIP! Please, refer to the Automatic Neutral Plate Monitoring (ANPM) section?

9.6 Product Life Span


Product life span may vary according to usage practice and usage conditions.
- All disposable accessories: One time use only.
- All reusable accessories: About 3 months
- Recommended product life span: 5 years
* If the unit package indicates maximum years of the use, then follow the instructions.
* Check all reusable parts with eyes before use. Scrap immediately or repair them before use. As for the reusable

parts, the unit life span is significantly different according to usage environment and sterilization method,
there is no warranty period allocated.
* If 5 year has been passed since usage, contact DAIWHA Corporation, LTD. for getting the inspection service
and check if operation can be continued.. Also, do not miss the periodic inspection on the safety and
performance.

9.7 How to Scrap the Unit and Accessories


- Discard the ESU when the time limit is passed.
- Scrap infected parts safely not to cause second infection. Follow the rules and regulations as per the
corresponding laws.

……………………………………………………………………………………………………………………
42

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