User Manual: DT-400S/300S

®
MEDITOM
DT-400S/300S
User Manual
DAIWHA
Copyright © 2014, DAIWHA Corporation. All rights reserved.

Manual No: RD-USM-EN-3-07 (Rev1.00)
Contents
1. Precautions ................................................................................................................... 5
1.1 Overview.................................................................................................................................. 5
1.2 Danger ..................................................................................................................................... 6
1.3 Warnings.................................................................................................................................. 6
1.4 Caution .................................................................................................................................... 6
1.5 Checklist before use .............................................................................................................. 11
1.6 Precautions during use .......................................................................................................... 11
1.7 Guidelines after use .............................................................................................................. 11
2. Terms and Symbols .................................................................................................... 12
2.1 Terms ..................................................................................................................................... 12
(1) Electro Surgical Unit (ESU) .............................................................................................. 12
(2) Cutting or Cut ................................................................................................................... 12
(3) Coagulation (Coag. Or Co.) . ........................................................................................... 12
(4) Bi-polar cutting output ...................................................................................................... 12
(5) Bi-polar coagulation output .............................................................................................. 12
(6) Mono-polar cutting output ................................................................................................ 12
(7) Mono-polar coagulation output ......................................................................................... 12
(8) D.R.M (Daiwha Return electrode Monitor) ....................................................................... 12
(9) Active electrode ................................................................................................................ 12
(10) Return electrode ............................................................................................................. 12
2.2 Symbols ................................................................................................................................. 13
2.3 Controls, Indicators and Receptacles ................................................................................... 15
2.4 Accessories ........................................................................................................................... 18
2.5 Labels – Instruction for use ................................................................................................... 18
3. Specifications ............................................................................................................. 19
3.1 Specifications ........................................................................................................................ 19
3.2 Operating Modes and Output Parameters ............................................................................ 20
3.3 Functions ............................................................................................................................... 20
3.4 Safety Devices....................................................................................................................... 21
4. Effect using the unit ................................................................................................... 25
4.1 Intended Purpose .................................................................................................................. 25
4.2 Modes for Monopolar Cutting ................................................................................................ 25
4.3 Modes for Monopolar Coagulation ........................................................................................ 25
4.4 Modes for Bipolar Cutting ...................................................................................................... 26
4.5 Modes for Bipolar Coagulation .............................................................................................. 26
5. Connecting Accessories with the unit ...................................................................... 28
2
5.1 Twin Button Handle & Return Electrode ................................................................................ 28
5.2 Unipolar Handle & Return Electrode ..................................................................................... 28
5.3 Bipolar Forceps ..................................................................................................................... 29
5.4 Foot switches......................................................................................................................... 29
6. Operating and Sequence ........................................................................................... 30
6.1 Monopolar.............................................................................................................................. 30
6.2 Bipolar ................................................................................................................................... 34
6.3 Summary ............................................................................................................................... 34
6.3.1 Preparations ............................................................................................................... 34
6.3.2 Operation Sequence .................................................................................................. 34
6.3.3 Guidelines after use ................................................................................................... 35
6.3.4 Precautions during use .............................................................................................. 36
7. Output Setting Guide.................................................................................................. 37
8. Sterilization ................................................................................................................. 38
9. Load Regulation & Vpeak Graphs ............................................................................. 39
9.1 Pure Cutting Mode ................................................................................................................ 39
9.1.1 Load Regulatio ........................................................................................................... 39
9.1.2 Open Circuit Peak Voltage ......................................................................................... 40
9.2 Blend1 Cutting Mode ............................................................................................................. 41
9.2.1 Load Regulation ......................................................................................................... 41
9.3.1 Load Regulation ......................................................................................................... 43
9.4.1 Load Regulation ......................................................................................................... 45
9.5 Soft Coagulation Mode .......................................................................................................... 47
9.5.1 Load Regulation ......................................................................................................... 47
9.6 Spray Coagulation Mode ....................................................................................................... 49
9.6.1 Load Regulation ......................................................................................................... 49
9.7 Cutting Biploar Mode ............................................................................................................. 50
9.7.1 Load Regulation ......................................................................................................... 50
9.8 Soft Bipolar Coagulation Mode.............................................................................................. 51
9.8.1 Load Regulatio ........................................................................................................... 51
3
10. User Maintenance ....................................................................................................... 53
10.1 General Maintenance Information ..................................................................................... 53
10.2 Responsibility of the manufacturer .................................................................................... 53
10.3 Cleaning and Disinfecting .................................................................................................. 53
10.4 Periodic Inspection ............................................................................................................ 53
10.5 Periodic Performance Testing ............................................................................................ 54
10.6 Product Life Span .............................................................................................................. 54
10.7 How to Scrap the Unit and Accessories ............................................................................ 54
10.8 Warranty ............................................................................................................................ 54
11. Guidance and manufacture’s declaration on electromagnetic emissions ............. 56
12. Document History....................................................................................................... 61
4
1. Precautions
1.1 Overview
◎ This manual describes how to use the electrosurgical unit (Model: DT-400S/300S) manufactured
by DAIWHA Corporation, and its technical specifications.
◎ Repair or circuit alteration of this equipment can only be carried out by personnel authorized by
DAIWHA. The warranty shall not apply to defects or damage caused by repairs or disassembly by
anyone other than personnel authorized by DAIWHA, and safety shall not be assured.
◎ Parts or circuits which are used for this equipment can be replaced to improve the safety and
performance of this equipment.
◎ Read this manual carefully before using the electrosurgical unit, and understand its functions and
how to use it for safe use.
◎ Contact DAIWHA if you have any questions regarding the equipment or the User Manual.
◎ As the medical equipment, this product can be used only trained doctors.
◎ When the patient contacts grounded electric conductors such as the metal part of the grounded
operation table during the output, it may burn or shock the contacted body part.
◎ Since it operates on high frequency and high voltage, electromagnetic waves are generated
naturally. This might affect other equipment such as distorting an ECG monitor screen in a
negative way. When HF SURGICAL EQUIPMENT and physiological monitoring equipment (for
example ECG monitor) are used simultaneously on the same PATIENT. The grounding of ECG
should be placed through neutral plate in case that the units are using the same ground earth.Any
monitoring electrodes should be placed as far as possible from the surgical electrodes (Minimum
distance 150mm). Needle monitoring electrodes are not recommended.
The lead of Radio-Frequency electrode is the shorter is the better not to make loops between other
leads. For this reason Using device that apply to EMC(Electro-magnetic Compatibility) is strongly
recommended.
◎ Set the output to the lowest level which can achieve the desired operation effect, and then
gradually increase the output volume to the desired level.
◎ Prior to use, check the equipment-whether it has a problem.
◎ Power voltage and frequency must be supplied in a stable manner within the designated range on
product rear side. However, the output may vary depending on power. If the wall outlet voltage in
the hospital exceed the designated range by ± 5%, the equipment should be calibrated again by
manufacturer or supplier.
◎ If the power frequency in the hospital different from the designated range, the equipment should be
calibrated again, too. Please refer to product label on the back for exact power usage.
◎ Considering its cooling feature, continuous output can result in abnormal operation of the product.
Be sure duty cycle.
◎ A short circuit that might occur between electrodes during activating output will damage the
product.
◎ The Failure of the HF SURGICAL EQUIPMENT could result in unintended increase of output
power.
◎ Do not reuse disposable accessories.
◎ All accessories has to be always keep disinfected when you use, especially metal parts which is
contacting with the patient's body
◎ This manual is only applicable to pumps with Program Version v1.xx or above.
1. Precautions5
Safety precautions are classified as below in accordance with the expected danger, seriousness of
damage or urgency.
A precaution which can result in critical personnel injury or immediate loss of life if
Danger instructions are not followed.
A precaution which could result in critical personnel injury or loss of life if instructions are
Warning not followed.
A precaution which could result in minor personnel injury or damage to the product if
Caution instructions are not followed.
1.2 Danger
1) The use of anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be
avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these
agents are sucked away.
Non-flammable agents should be used for cleaning and disinfection wherever possible.
Flammable agents use for cleaning or disinfecting, or solvents of adhesives, should be allowed to
evaporate before the application of H.F. surgery. There is a risk of pooling of flammable solutions
under the PATIENT or in body depressions such as the umbilicus, and in body cavities such as the
vagina. Any fluid pooled in these areas should be mopped up before HF SURGICAL EQUIPMENT is
used.
Attention should be called to the danger of ignition of endogenous gases. Some materials, for
example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in
NORMAL USE of the HF SURGICAL EQUIPMENT.
1.3 Warnings
1) The entire surface area of the Neutral Plate(Patient Plate, Return Electrode) must be reliably
attached to the patient's body. Be sure to check the contact status frequently during the operation.
When the contact is poor, parts of body touching the Neutral Plate(Patient Plate, Return Electrode)
will be burned. Avoid areas such as near heart, scars, joints, and parts with bones projected, parts
with a small area, and palaces where contact is likely to be unstabilized when the patient moves.
2) If the patient complains about electric shock, stop using the product immediately and have it
examined throughly.
3) Equipotential Grounding
The Electro Surgical Unit must be grounded to Earth. The Grounding Resistance must be Maximum
10Ω. Unexpectable Electric shock may be happened when you use the unit with Non-grounding.
Expecially, Equipotential Grounding is required between the devices in the same operating room, it
prevent micro shock. The Micro Shock means electric shock to heart. Sometimes it can be caused a
ventricular and so on. The resistance between the Grounding of equipments in same operating room
must be Maximum 0.1Ω.
4) Cardiac pacemaker or Internal Cardiac Defibrillator-(ICD)
HF SURGICAL EQUIPMENT poses a potential risk to patients with implants ( e.g. cardiac
pacemakers) or something. For PATIENT with cardiac or active implants, a possible hazard exists
because interference with the action of the pacemaker may occur, or the pacemaker may be
damaged. In case of doubt, approved qualified advice should be obtained. Before using this product
to patients who are currently using Pacemaker or ICD, consult with the manufacturer or cardiac
experts at the hospital.
1.4 Caution
1) As the medical equipment, this product can be used only trained doctors.
2) When the patient contacts grounded electric conductors such as the metal part of the grounded
operation table during the output, it may burn or shock the contacted body part.
3) Since it operates on high frequency and high voltage, electromagnetic waves are generated
1. Precautions6
naturally. This might affect other equipment such as distorting an ECG monitor screen in a negative
way.
When HF SURGICAL EQUIPMENT and physiological monitoring equipment (for example ECG
monitor) are used simultaneously on the same PATIENT. The grounding of ECG should be placed
through neutral plate in case that the units are using the same ground earth.
Any monitoring electrodes should be placed as far as possible from the surgical electrodes (Minimum
distance 150mm). Needle monitoring electrodes are not recommended.
The lead of Radio-Frequency electrode is the shorter is the better not to make loops between other
leads. For this reason Using device that apply to EMC(Electro-magnetic Compatibility) is strongly
recommended.
4) Set the output to the lowest level which can achieve the desired operation effect, and then
gradually increase the output volume to the desired level.
5) Prior to use, check the equipment-whether it has a problem.
6) Power voltage and frequency must be supplied in a stable manner within the designated range on
product rear side. However, the output may vary depending on power. If the wall outlet voltage in the
hospital exceed the designated range by ± 5%, the equipment should be calibrated again by
manufacturer or supplier.
If the power frequency in the hospital different from the designated range, the equipment should be
calibrated again, too. Please refer to product label on the back for exact power usage.
7) Considering its cooling feature, continuous output can result in abnormal operation of the product.
Be sure duty cycle.
8) A short circuit that might occur between electrodes during activating output will damage the product.
9) The Failure of the HF SURGICAL EQUIPMENT could result in unintended increase of output power.
10) Do not reuse disposable accessories.
11) All accessories has to be always keep disinfected when you use, especially metal parts which is
contacting with the patient's body
1) Please do operate the unit by the instructed order.
The following rules must be observed and always pay keen attention.
2) Do not open or disassemble the unit.
- The repairing and circuit change of this 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 the place where easily affected by shock, impact & etc.(including the times of
movement & transportation). Do not locate the unit the place where easily affected by
temperature, humidity, barometric pressure also. Keep clean always. At least one grounded
duplex wall receptacle and proper line voltage should be provided.
5) In using of electricity,
Connect the system AC line voltage after correct line voltage has been verified. Always check the
grounding. After using the unit, please be sure to main power off and get rid of the power cord.
6) How to prevent skin burn
① The entire area of the NEUTRAL ELECTRODE should be reliably attached to the PATIENTS
body and as close to the operating field as possible.

② The PATIENT should not come into contact with metal parts which are earthed or which have
an appreciable capacitance to earth(for example operating table supports, etc.). The use of
1. Precautions7
antistatic sheeting recommended for this purpose.
- It is good to spread ECG gel or cream to increase the effectiveness of firm contact on the
neutral electrode.
③ Areas subject to extreme perspiration-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
easily to get burnt when these parts are applied with other metal parts. Skin-to-skin contact (for
example the arms and body of the PATIENT) should be avoided, for example by insertion of
dry gauze.
The use of wet towel as conductive agents should not be used since they dry out, resulting in
high-frequency skin burn to the patient. Urine has to be discharged through catheter or
something.
④ Initial self-test
- First off, test the unit at very low RF power and then increase the RF power smoothly to
prevent any problem caused from 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 burn due to reduced contact size.
⑥Recommendation to position patient leads in such a way that contact with the patient or
other leads is avoided
⑦Instructions stating, use of bipolar techniques may be desirable in order to avoid
unwanted tissue damage for surgical procedures where hf current could flow through relatively
small cross-sectional area of body
⑧Instructions indicating the output power should be selected as low as possible for
intended purpose
7) Do not use cords as a handles ; damage to the insulation and increase of burnsor other injury
may result.
8) Use accessories, active and neutral electrodes provided by DAIWHA Corporation, LTD. in order to
avoid incompatibility and unsafe operation. If you intend to purchase accessories other than
those that DAIWHA Corporation, LTD., please check that the accessories are CE certified for Electro-
surgical unit to make sure safety. Use CE certified accessories for patient contacting parts except
supplied by DAIWHA.
9) The cables to the surgical electrodes should be positioned in such a way that do not contact with
1. Precautions8
the PATIENT or other leads is avoided. Temporary unused ACTIVE ELECTRODES should be
stored so that they are isolated from the PATIENT.
10) For surgical procedures where the h.f. current flow through 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 operating settings may indicate 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 will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information which will assist the USER's appropriately qualified
technical personnel to repair those parts of EQUIPMENT which are designed by the
manufacturer as repairable.
13) It may cause a malfunction when the unit is used in an environment that has strong magnetic
fields i.e. MRI room.
14) Do not use the unit other than your intended purpose. It may cause unexpected side effects.
15)Attention is called to the danger of ignition of endogenous gases
Sales & Address: 3, Yeoksam-ro 33-gil, Gangnam-gu, Seoul, Korea

Service Center Tel : +82-2-558-1711∼6
Fax : +82-2-554-0317
Website: www.daiwha.com
Address: mdi Europa GmbHLangenhagener Str. 71

D-30855 Hannover-Langenhagen, Germany
Tel: +49-511-3908 9530
1. Precautions9
This is medical equipment.
DAIWHA Corporation
135, Donghwagongdan-ro, Munmak-eup, Wonju-si,
Gangwon-do, Korea
Product Name Electrosurgical unit
Model DT-400S/ DT-300S
Packaging Unit 1 Set
Purpose Consistent infusion of medicine
Storage Store at room temperature
Usages and Precautions See the User Manual
1. Precautions10
1.5 Checklist before use
1) Check and clear away flammable gas or solvent.
2) Check the cable connection on the back panel of the unit.
3) Check that all accessories that have direct contact with patients are sterilized.
4) Check all 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 that happens at the time of unit troubles.
6) Check contact status between patient plate and patient.
1.6 Precautions during use

1) Check appropriateness when you change the existing settings, considering operation type and
biological tissue. Please refer to ‘7. Output Setting Guide,’ if necessary.
2) Make sure that patients do not touch grounded metals. It may cause partial burn.
3) Do not give long output to tissue areas or do not give approval high output beyond the need.
Manipulate output when electrode is always contacted with tissue to prevent tissue burn.
4) If the patient complains about electric shock, stop using the unit immediately and have it examined
thoroughly.
5) Frequently check contact status between patient plate and patient, especially when using a single
pad or using reusable plate as return electrode.
6) The sound volume should be at least the medium of level to prevent sound-recognition-fail caused
dangers.
1.7 Guidelines after use

1) Please sterilize reusable accessories before you keep in store.
2) Scrap disposable accessories in the prescribed regulations (according to the law). Scrap
disposable accessories in the way that there is no risk of contamination due to the used consumable
accessories.
1. Precautions11
2. Terms and Symbols
2.1 Terms
- The terms used in this User’s Manual is explained below.
- The terminology described below is limited to this User’s Manual and note that it may be
different from those generally used.
(1) Electro Surgical Unit (ESU)

- The ESU is a medical device that generates high-frequency current applied to body organs
to generate heat used for cutting and coagulation.
(2) Cutting or Cut
- It is a phenomenon of destroying cells by the heat (more than 100℃) that is produced as
applying the high-frequency current from the ESU to tissue.
(3) Coagulation (Coag. Or Co.) .
- It is a phenomenon that moisture in the cells dries off by the heat (60～90℃) produced
when the high-frequency current generated by the ESU is applied to an organ of the
human body.
(4) Bi-polar cutting output
- It is the output from the bipolar output jack when bipolar cut mode used.
(5) Bi-polar coagulation output
- It is the output from the bipolar output jack when bipolar coag. mode used.
(6) Mono-polar cutting output
- It is the output from the mono-polar output jack when pure mode or blend mode used.
(7) Mono-polar coagulation output
- It is the output from the mono-polar output jack when contact mode or spray mode used.
(8) D.R.M (Daiwha Return electrode Monitor)
- As a more advanced safety system than the old Return Electrode Alarm, D.R.M can avoid
the potential burn damage which may result from the little contact area of dual pad by grace
of its monitoring function.
(9) Active electrode
- It’s an electrode of the metal material that 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 the electrode to return to the device the high-frequency current that 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.
※ Applied Parts : electode tip, neutral pad
2. Terms and Symbols12

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

Hazardous electrical output. flammable anesthetics.
Non-ionizing
ionizing Radiation Equipotential Grounding
Attention : See instructions for use Alternative Current
Off On
(Power : Disconnection form the (Power : Disconnection to the
mains) mains)
Single Foil - used with electrodes

Monitor Alarm : Return fault
that do not monitor contact quality.
alarm.
Dual Foil - used with electrodes that
Mono-polar
polar output is disabled.
do monitor contact quality.
Replace Fuse only with type and Replace Fuse only with type and
rating as shown. rating as shown.
Pure Mode : Waveform with minimum Blend1 Mode : Cut waveform

thermal damage and hemostasis. with moderate hemostasis.
Blend2 Mode : Cut waveform with Blend3 Mode : Cut waveform

heavy hemostasis. with maximum hemostasis.
Forced Mode : Standard mode Soft Mode : Soft mode mono-

mono-polar
polar coagulation. polar coagulation.
Spray Mode : Spray mode mono

mono- Bi-polar
polar Cut Mode : Cut mode
polar coagulation. bi-polar
polar cutting.

Symbols13
StandardMode: Standard mode bi- Soft Mode : Soft mode bi-polar
polar coagulation. coagulation.
Hand Twin Switched Output :

Bi-polar
polar Output :
Connection for hand Switched
Connection for bi
bi-polar accessories
mono-polar
polar accessories
Unipolar Handle Output : Return Electrode :

Connection for Unipolar hand bi
bi- Connection for mono
mono-polar
polar accessories dispersive electrode
Inlet for bi-polar

polar foot switch. Inlet for mono
mono-polar foot switch.
RF Isolated : Patient connections

Defibrilation Proof
are isolated from earth at high
Type CF applied part
frequency.
Single use.
Do not reuse. Protective earth
Disposable.
Catalogue number
The manufacturer's catalogue number Serial number
shall be adjacent to the symbol.
Authorized representative in
Manufacturer
European Community
Date of Manufacture Speaker Volume

Symbols14
2.3 Controls, Indicators and Receptacles
- The names of the accessories that are used in this manual I explained
- Name and description of the accessories you want, because you only use in
this manual, may be different from the generally-class to name / description
there
1. DRM(Daiwha Return electrode Monitoring) Set 2. DRM Setting Switch

Indicator Push when in the Dual pad mode after a dual
Twinkles when Dual pad is selected but DRM pad electrode has been properly applied to the
Setting Switch is not pressed yet. After DRM patient and connected to the unit. Pressing this
Setting Switch is pressed, light goes on. switch notifies the unit that the present return
circuit resistance represents safe return
electrode placement and causes DRM Set
Indicator goes on.
The unit will then monitor the patient's resistance
and produce an alarm if the resistance rises by
more than 20+5%, or if a short is detected in the
patient circuit.
3. Single Pad or Dual Pad Selection Switch 4. Bi-polar Mode Activation Indicator
Pressing this switch will select the Single Pad This lamp lights on when the unit is activated in
return electrode or the Dual Pad return Bi-polar modes
electrode.
5. Mono-polar Cut Mode Activation Indicator 6. Mono-polar Coagulation Mode Activation
This lamp lights on when the unit is activated in Indicator
Mono-polar cut modes This lamp lights on when the unit is activated in
Mono-polar coagulation modes
7. Bi-polar Power Increase Switch 8. Bi-polar Power Decrease Switch
Increases the output power level of the Bi-polar Decreases the output power level of the Bi-polar
mode when depressed. mode when depressed.

9. Mono-polar Cut Power Increase Switch 10. Mono-polar Cut Power Decrease Switch
Increases the output power level of the selected Decreases the output power level of the
cut mode when depressed selected cut mode when depressed
11. Mono-polar coagulation Power Increase Switch 12. Mono-polar coagulation Power Decrease
Increases the output power level of the Switch
selcteed coagulation mode when depressed Decreases the output power level of the
selected coagulation mode when depressed
13. Bi-polar Power Digital Display 14. Mono-polar Cut Power Digital Display
Indicates the Bi-polar power level set via Bi- Indicates the Mono-polar cut power level set via
polar Power Level Controls. Mono-polar Cut Power Level Controls.
15. Mono-polar coagulation Power Digital Display 16. Bi-polar Cut Mode Indicator
Indicates the Mono-polar coagulation power Illuminates when Bi-polar cut mode has been
level set via Mono-polar coagulation Power selected.
Level Controls.
17. Bi-polar Coagulation Mode Indicator 18. Mono-polar Pure Cut Mode Indicator
Blink when Bi-polar standard coagulation mode Illuminates when Mono-polar pure cut mode
has been selected. has been selected.
Illuminates(Not blink) when Bi-polar soft
coagulation mode has been selected.
19. Blend 1 Cut Mode Indicator 20. Blend 2 Cut Mode Indicator
Illuminates when Mono-polar Blend 1 cut mode Illuminates when Mono-polar Blend 2 cut mode
has been selected. has been selected.
21. Blend 3 Cut Mode Indicator 22. Contact Coagulation Mode Indicator
Illuminates when Mono-polar Blend 3 cut mode Illuminates when Mono-polar contact
has been selected. coagulation mode has been selected.
23. Spray Coagulation Mode Indicator 24. Bi-polar Cut Mode Select Switch
Illuminates when Mono-polar Spray Selects Bi-polar cut mode by pressing the
coagulation mode has been selected. switch.
25. Bi-polar Coagulation Mode Select Switch 26. Mono-polar Pure Mode Select Switch
Selects Bi-polar Coagulation mode by pressing Selects Mono-polar pure mode by pressing the
the switch. switch.
27. Blend 1 Mode Select Switch 28. Blend 2 Mode Select Switch
Selects Mono-polar blend 1 mode by pressing Selects Mono-polar blend 2 mode by pressing
the switch. the switch.
29. Blend 3 Mode Select Switch 30. Contact Coagulation Mode Select Switch
Selects Mono-polar blend 3 mode by pressing Selects contact coagulation mode by pressing
the switch. the switch.
31. Spray Coagulation Mode Select Switch
Selects Spray coagulation mode by pressing the switch.
32. Return Fault Indicator
Twinkles when the unit detects a problem in the return electrode circuit.
In the DUAL pad mode, it will illuminates when a return electrode cable is open or shorted. It will
illuminates either when patient resistance exceed safety range.
In the SINGLE pad mode, it will illuminates when a return electrode cable is open.
The unit will not produce Mono-polar energy when this indicator illuminates.
33. Bi-polar RF power Outlet 34. Mono-polar RF power Outlet 1
Bi-polar output, activated by Bi-polar switch, For hand switchable Mono-polar accessories.
appears between this jacks. No hand switchable Mono-polar accessories or
We call this Bi-polar Outlet. Mono-polar coagulating forceps may be used
by connecting to long distance terminals in one

jack.
We call this Monopolar Outlet 1.
36. Mono-polar RF power Outlet 2 37. Return Electrode Inlet

For hand switchable Mono-polar accessories. This jack accepts a standard return electrode
No hand switchable Mono-polar accessories or plug.
Mono-polar coagulating Forceps may be used
by connecting to long distance terminals in one
jack.
We call this Monopolar Outlet 1.
38. Sound Volume Controller 39. Bi-polar Foot Switch Inlet

Is a 3-pin threaded connector designed to
accept plugs attached to any two treadle mono-
polar foot switch available from DAIWHA.
40. Mono-polar Foot Switch Inlet 41. Main Inlet with Main Fuse case
Is a 3-pin threaded connector designed to Supplies ac main power to the unit. It only
accept plugs attached to any two treadle should be connected to a source of power
mono-polar foot switch available from corresponding to that listed on the Patcher
DAIWHA. attached right by. A detachable power cord with
a standard 3-prong are supplied with unit. The
fuses in main fuse box provide Dual-pole power
line overload protection.
42. Equipotential Grounding 43. Assist Resistance Indicator

Is Chassis ground connection for additional This red LED bar graph is a visual indicator of
protection against low frequency risk current. patient resistance measured between the
contacts of the return electrode. The number of
red bars illuminated increases with decreasing
resistance and may be used as an aid in
detecting high risk patients. The Assist
Resistance Indicator will light 3 to 8 bars when
the patient's return electrode resistance is within
range.
44. Single Pad Mode Indicator 45. Dual Pad Mode Indicator
Illuminates when the Single pad mode is Illuminates when the Dual pad mode is
selected. selected.
46. Main Power Switch 47. Output Path Selector

Turns unit on and off. This Switch change the path of RF Output
activated by Mono-polar Foot Switch to
Monopolar Outlet 1 or 2

2.4 Accessories
No. Name Size Manufactured by
1 Re-usable Bipolar Forceps - TECNO in Pakistan
Myung Electronics Co., Ltd. in

2 Re-usable Bipolar Forceps Cable 4 [m]
Korea
Shining World Health Care CO.,

3 Re-usable TBH Pencil 4 [m]
LTD. in Taiwan
4 Disposable Single Pad - BIOPROTECH in Korea
5 Disposable Dual Pad - BIOPROTECH in Korea
Shining World Health Care CO.,

6 Pad Cable 4 [m]
LTD. in Taiwan
7 Double Foot Switch 4 [m] KEM Co., Ltd. In Korea
Myung Electronics Co., Ltd. in

8 Power Cord 4 [m]
Korea
9 Metal Plate - Daiwha Corp., Ltd.
10 Rubber Plate - Daiwha Corp., Ltd.
2.5 Labels – Instruction for use

- Label of Equipment for product information
Material : Polyesterfilm
Size : 55 x 65 mm (W x D)

3. Specifications
3.1 Specifications
Product Name Electrosurgical Equipment
Model DT-400S/300S
Purpose Cutting or coagulation of biological tissue using high-frequency current

Mains and Line 120(60Hz) or 230VAC(±10%) (50 or 60Hz)/switchable
Frequency See the label on rear side for correct information
Two of F5.0A, 250V for 230VAC

Fuses
Two of F10.0A, 250V for 115 VAC
Power Consumption 900VA
Protection Class Class 1, Type CF
IPX Foot Switch: IPX6
Carrier Frequency 400 KHz ±10%, 482KHz ±10%
Repeat Frequency 33KHz
Low Freq. Leakage
EN60601-1 [2012] Requirement
Current
High Freq. Leakage

Less than 150mA
Current
Operation Conditions 10℃～40℃, 30%～ 85％ noncondensing, 700mbar～1060mbar

Storage Conditions -10℃～60℃, 30%～ 95％ noncondensing, 700mbar～1060mbar
-10℃～60℃, 30%～ 95％ noncondensing, 700mbar～1060mbar

Transportation
Conditions Do not drop the unit from higher than 50cm
Do not use the hook.
Installation
5cm clearance required on each side unit for cooling
Conditions
Cooling 1 fan mounted
Recommended Duty
10 sec ON, 30 sec, OFF(Output for 10 seconds, pause for 30 seconds )
Cycle
Size (H, W, D) 147mmx 330mm x 417mm

Weight About 16Kg
Not AP/APG device

APG Equipment not suitable for use in the presence of a flammable anesthetic
mixture with or with oxygen or nitro oxide
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)
※ It can be changed without notice to improve performance.
3. Specifications19
3.2 Operating Modes and Output Parameters
(DT-400S) Tolerance:±20%
Carrier Frequency Repeat Output RF Power
Mode Load Resistance(Ω)
(㎑) Frequency(㎑) (W)
Pure mode 400 - 400 500
Blend1 mode 400 33 320 300
Blend2 mode 400 33 240 300
Blend3 mode 400 33 160 300
Forced mode 400 33 120 300
Soft mode 400 33 120 300
Spray mode 400 33 100 500
Cut mode 482 - 100 200
Standard mode 482 - 100 100
Soft mode 482 - 80 100
(DT-300S) Tolerance:±20%
Carrier Frequency Repeat Output RF Power
Mode Load Resistance(Ω)
(㎑) Frequency(㎑) (W)
Pure mode 400 - 300 500
Blend1 mode 400 33 300 300
Blend2 mode 400 33 220 300
Blend3 mode 400 33 140 300
Forced mode 400 33 100 300
Soft mode 400 33 100 300
Spray mode 400 33 100 500
Cut mode 482 - 100 200
Standard mode 482 - 100 100
Soft mode 482 - 80 100
3.3 Functions
1) Good linearity and stabilization of output power by microprocessor.
2) EMC design that is in accord with EN60601-1-2 [2001] and EN60601-2-2 [2001].
3) Remote Control using two Hand pieces (Selection between cutting and coagulation)
4) Selection between cutting and coagulation by Foot switch (Can be also used as an
exclusive switch for laparoscope.
3. Specifications20
5) A safety circuit by D.R.M.(Daiwha Return electrode Monitoring)
- To prevent burns, if the contact is lower than 80% of the adhesive area, the output power
is stopped and the alarm will be operated.
6) When the cutting and coagulation and Bi-polar is operated, it can be differentiated by the
sound and the lamp.
7) The output power can be controled by pressing the Up / Down switch on front panel and
be also shown in numbers.
8) Bi-polar is available even if Return Electrode has not been mounted.
3.4 Safety Devices

1) The fuses on power supply stage protects high current.
2) The enclosure is grounded so that the current that may flow to the patient is grounded and
the patient is protected safely.
3) When the Return electrode is separated from the equipment, the high frequency current is
automatically blocked, and you can see the alarm condition by the Return Fault Indicator
and Alarm Sound.
4) Damage or injury to the patient through malfunction or faulty operation is prevented by
use of the input, output priority algorithm.
5) The High Frequency Leakage Monitoring is to monitor high frequency leakage current
from a patient to earth. It reduces the current to lower than IEC Requirement when a
patient grounded to Earth by material part of a bed or any other materials. It reduces the
skin burns at Return Electrode site.
6) The function of the D.R.M.(Daiwha Return electrode Monitoring) is to monitor the contact
area of the patient and the Pad so as to minimize the danger of burns.
7) Isolated Output Circuitry.
This feature minimizes the potential of alternate site burns.
TIP What is D.R.M(Daiwha Return electrode Monitor)?

- As a more advanced safety system than the old Return Electrode Alarm, D.R.M can
avoid the potential burn damage which may result from the little contact area of dual
pad by grace of its monitoring function.
- For single pad
1) Function
: It monitors only the mounting and cable breaking status of Return Electrode.
2) Component
: Single pad or Dual pad Selection Switch, Single pad Mode Lamp, Return Fault
Indicator
3) How to use
① 'Single pad Mode Lamp' lights when applying power to the device as the default is
single pad mode. If you want to use single pad instead of dual pad, replace it and
then press (Single pad or Dual pad Selection Switch) to switch on 'Single
pad Lamp'.
② Mount Return Electrode to Return Electrode jack by using single pad, metal plate
with cable and rubber plate with cable.
➂ Patch the pad on the patient's body.
3. Specifications21
4) Alarm
: If Return Electrode is dismounted from the device or its cable is broken, Return Fault
Indicator flickers and alarm tone sounds, cutting off the output.
- For dual pad

1) Function
: It monitors the contact area of pad as well as mounting and cable breaking status of
Return Electrode.
2) Component
: DRM Setting Lamp, DRM Setting Switch, Single pad or Dual pad Selection Switch,
Dual pad Mode Lamp, Assist Resistance Indicator, Return Fault Indicator
3) How to use
① 'Single pad Mode Lamp' lights when applying power to the device as the default is
single pad mode. Press (Single pad or Dual pad Selection Switch) in order
to switch on ‘Dual pad Mode Lamp’.
② Mount Return Electrode to Return Electrode jack.
③ Patch the pad on the patient's body as closely as possible so that more Assist
Resistance Indicators could light for the safety, if possible. (Refer to the ‘5) Relation
between the light counts of Assist Resistance Indicator and pad resistance’ in the next
page.)
④ See ‘Assist Resistance Indicator’ change. If more than three lights are turned on, it is
possible to use them.
4) Alarm
(1) Error
- In case of error occurrence In case of alarm occurrence

I
f
a
n
error occurs, check out the error number displayed in equipment, and contact DRE Isales
agent or DRE
(2) Alarm
Alarm Alarm
Alarm Situation How to cancel the alarm
No. Display
When connecting ‘Dual Pad’ while using
the single pad mode
Connect ‘Single Pad’ to ‘Neutral
1 “ALr 1"
When the ‘Single Pad’ is generated from plate’ jack.
‘Neutral plate’ jack while using the single
pad mode
3. Specifications22
When Neutral plate cable is single lined Replace the single lined
while using the single pad mode cable.
When connecting ‘Single Pad’ while using

Use the ‘Dual Pad’.
the dual pad mode
When the contact area is small while using Apply ‘Dual Pad’ to secure
the dual pad mode larger contact area.
2 “ALr 2”
When the cable is disconnected or short Replace the disconnected or
while using the dual pad mode short line.
During the use of dual pad mode, more Re-attach the peeled-off Dual
than 20% of the originally attached sheet Pad, or Replace with a new
is fallen off over 20. Dual Pad.
- ‘DRM Setting Lamp’ and ‘Return Fault Indicator’ start to flicker and alarm tone sounds,
cutting off the output.
※ Alarm condition
- Eight or more lights are on and alarm tone sounds.
: Short circuit is generated between cables.
- 3～8 lights are on and alarm tone sounds.
: Pad contact area decreased 80% smaller than the initial area.
: HF current from surgical unit has deteriorated pad adhesives during long time
operation.
: In this case, Patch the pad to the patient and press 'DRM Setting Switch' to
continue to operate.
- One or two lights are on and alarm tone sounds.
: Return Electrode is dismounted from the device.
: Cable of Return Electrode is broken.
: Pad is detached from the patient.
: Pad is taken out from clamp.
5) Relation between the light count of Assist Resistance Indicator and pad resistance
- The following table shows the resistance at the both ends of pad foil when dual pad is
sticked to the patient.
- In general, 6～8 lights are on in case of new dual pad. If four or less lights are on even
though the pad is completely sticked to the patient, it is necessary to replace the pad
with a new one. The more the lights are on, the higher the conductivity degree of pad
becomes. The high conductivity of pad secures safety of operations by reducing
output loss.
- The wider the pad area sticked to the patient becomes, the smaller the resistance
becomes.
3. Specifications23
Tolerance : ±10%
State Resistance(Ω) LED
Single PAD Below 10 8
31-50 8
51-80 7
81-100 6
Dual PAD
101-110 5
111-120 4
121-130 3
131-141 2
Poor condition 141-150 1
Above 150 0
Open PAD ∞ 0
3. Specifications24
4. Effect using the unit
4.1 Intended Purpose
This product including its associated ACCESSORIES intended for the performance of surgical
operation, such as the CUTTING or COAGULATION of biological tissue by means of high
frequency (H.F) current.
4.2 Modes for Monopolar Cutting

1) Pure
- Waveform with minimum thermal damage and hemostasis.

- None modulated 400KHz alternating current.
- For only cutting.
2) Blend 1
- 400KHz alternating current modulated by 33KHz.

- For cutting with minimum hemostasis.
3) Blend 2

- For cutting with more hemostasis than Blend 1.
4) Blend 3

- For cutting with heavy hemostasis than Blend 2.
4.3 Modes for Monopolar Coagulation

1) Forced Coagulation

- For only coagulation.(Standard coagulation)
- Use Ball type electrodes or Mono-polar Forceps.
- Use in state the electrode contacts with tissue.
2) Soft Coagulation
- 400KHz alternating current maximum modulated by 33KHz.

- For only coagulation.
- Minimize tissue adhesion by ‘Time restricted output’.
4. Effect using the unit25

3) Spray Coagulation

- For coagulation in specious area by spark caused by high Vp-p.
TIP How to apply Contact Coagulation mode

- Quality coagulation refers to even dehydration causing no carbonization as well as no
adhesion to electrode.
- It is very important to minimize the spark between electrode and tissue for the quality coagulation.
The following procedures are to ensure the quality coagulation.
- Let the output out with the electrode adhered to the tissue.
- Don't supply HF current (output) to the tissue for a long time.
- The output should be low enough to make coagulation. High output produces high voltage to the
tissue, resulting in spark increase.
- It is desirable to use a ball type of electrode because it generates less spark compared with other
types of electrodes. If possible, an electrode with small diameter is recommended if possible 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 possible as it is subject to make spark at the edge.
4.4 Modes for Bipolar Cutting

- It is useful for elaborate coagulation and cutting in tiny area, blood vessel or nerve.
- If you hold tissue with Forceps, HF current circulated between the both handles makes the
tissues in the midst of handles coagulated by heating them.
- It reduces the risk of electrical shock as the current path is short.
1) BipolarCut
- Using non modulated 482KHz HF current.

- Use bi-polar scissors to treat blood.
- Especially useful for cutting blood vessels and minute tissue.
- It can be used for the coagulation of large tissue.
4.5 Modes for Bipolar Coagulation

1) BipolarStandard Coagulation
Standard Bi-polar Coagulation

- None modulated 482KHz alternating current.
- Especially high R.F power, it is good to large tissue coagulation.

- Can coagulate the tissue wetted by blood or any other liquid.
2) BipolarSoft Coagulation

- Minimize tissue adhesion by ‘Time restricted output’.
- Especially good to small tissue coagulation.
- Select this mode by 'Bi-polar Coagulation Mode Select Switch[16]'
- 'Bi-polar Coagulation Mode Indicator[17]' illuminates(not blink) in this mode.
TIP How to apply bi-polar mode

- This mode is useful for operations on sensitive tissues such as nerve or blood vessel. Those who
have not much skill should be fully aware of the following checkpoints.
- It often happens to deal the tissues again since they are subject to stick to the tips of Forceps. You
can minimize the problem above mentioned by using the following procedures.
- The problem occurs because the current going through the Forceps heats its tips and this makes the
tissues adhering to the tips dehydrated too much. To solve this problem, it is essential to reduce the
heat at the tips. Follow the procedures below.
- Don't supply HF current (output) to the tissues for a long time.
- Use the minimum output just so as to make cutting and coagulation. If you supply higher output than
is necessary, the tips of Forceps will be too much heated, coming out the gilt of tips. If it is not
evitable to use high output, be mindful to cool the tips sufficiently.
- Use the Forceps with the wide tips for coagulation.
- Use the Forceps with the narrow tips for cutting.
- Replace Forceps with new one from other manufacturer as the quality and processing method vary
according to the manufacturers. Low quality Forceps will often cause the case as stated above.
- Check the silt status at the tips of Forceps since the peeled silt from tips or coarse Forceps makes the
condition worse. Especially, be careful to wash the Forceps not to damage the tips. If some tissues
are adhered to the tips, remove them with a piece of soft cloth after soaking the Forceps in the water.
- Don't remove liquid from the tissues on purpose because the tissues without enough liquid are subject
to adhere to Forceps. Supply some water such as saline solution to dry tissue to avoid this problem.
TIP What is ‘Time restricted output’?

- This method means how to supply output by attenuating it based on the time. See the figure
below.
- You can use this method when dealing tiny tissues as it strongly avoids carbonization and
adherence of tissues.
- The large tissue may not be fully coagulated by supplying output once. Accordingly, press the
foot switch to supply the output once again or change the mode to Standard Coagulation one.

5. Connecting Accessories with the unit
5.1 Twin Button Handle & Return Electrode
Return Electrode is made of wide area metal, conductive rubber or aluminum foil in order to minimize the
burn risk. It is sometimes called Dispersive Electrode, Neutral Plate or Patient Plate.
5.2 Unipolar Handle & Return Electrode
Plug Uni-polar Handle, mono-polar forceps, laparoscopic instrument, endoscopic instrument, TUR
instrument in the orange color marked hole.
Caution
- If they are plugged in the wrong hole, be warned of such malfunction that output may continue
even when the foot switch is off.
5. Connecting Accessories with the unit28

5.3 Bipolar Forceps
5.4 Foot switches
5. Connecting Accessories with the unit29

6. Operating and Sequence
6.1 Monopolar
1) After checking the main power voltage and frequency, the power cord should be connected to
the main power inlet located at the rear panel of the equipment. If there is no ground circuit in
the main power outlet, the Equipotential grounding cable must be connected to the quipotential
Grounding. Contact Daiwha sales department when you need the Equipotential Grounding
cable.
2) The Power Switch is turned on - If the Pad is not connected, The Return Fault Indicator will be
twinkle and the alarm will ring to warn the fault of the Return Electrode.
6. Operating and Sequence30

3) Select Single Pad Mode or Dual Pad Mode
▶ Single Pad Mode
① Connect the Single Pad to the Return Electrode Jack. The Alarm will stop and it will be
ready to be used.
② Attach the Pad firmly to the patient. (Please read carefully the precautions)
▶ Dual Pad Mode
① Connect the Dual Pad to the Return Electrode Jack.
② Press (Single Pad or Dual Pad Selection Switch) to set up the Dual Pad Mode.
The Dual Pad Mode Indicator will be turned on and the DRM will be ready.
③ Attach the Pad firmly to the patient. (Please read carefully the precautions)
④ The changes in the Assist Resistance Indicatorwill be seen. You can set DRM by pressing
(DRM Setting Switch) if the LED light on from 3 to 8 steps.
※ The Assist Resistance Indicator has 2 steps or 0 step when the Return Electrode cable
may be cut off or the Pad is not attached properly to the patient. The Indicator has 8 steps
when the Return Electrode cable may be short-circuited.

4) Select the Cutting mode (Pure, Blend1, Blend2, Blend3) and choose the appropriate output
power[W] by Mono-polar Cut Power Increase or Decrease Switch.
5) Select the Coagulation mode (Contact, Spray) and choose the appropriate output power [W]
by Mono-polar coagulation Power Increase or Decrease Switch.

6) When using T.B.H, connect with the Monopolar Outlet1.
7) When using the foot switch, connect with the Mono-polar Foot Switch inlet located at the rear
panel and use the Monopolar Outlet1 or Monopolar Outlet2.
8) After finishing surgery, Turn OFF the Power Switch.
TIP What is Output Path Selector?
1) This slide switch alters the path of RF Output by Mono-polar Foot Switch. RF Output will go out
to Monopolar Outlet1 When the slide switch is selected Mono Outlet 1.
2) This slide switch alter the path of RF Output by Mono-polar Foot Switch. RF Output will go out
to Monopolar Outlet 2 When the slide switch is selected Mono Outlet 2.

6.2 Bipolar
1) Connect the foot switch to the Bi-polar Foot Switch Inlet located at rear panel.
2) Select the appropriate RF Power [W] by Bi-polar Power Increase or Decrease Switch.
3) Connect the Bi-polar Forceps with Cable.
6.3 Summary
6.3.1 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 as the large
contact area as possible.
6.3.2 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 is not available for the pad mode selection switch.)
4) Mount Neutral plate to ‘Return Electrode Inlet’.

5) Patch Neutral Plate as closely and firmly to the surgery area as possible and secure as the large
contact area as possible.
6) Method and sequence to operate each of functions
6.1) When operating Mono-polar cut function

-Connect TBH or Uni-polar Handle to ‘ono-polar RF Power Outlet’.
- Press ‘Cutting Mode Selection Switch’ to select the proper output mode for the surgery. The
indicator is on for the selected output mode, and the value of applicable mode will be
displayed in the ‘Cutting RF Power Digital Display’.
- Use the Cutting RF Power Increase/Decrease Switch to configure the cutting output.
- Press the yellow switch of TBH, or the yellow pedal of Foot Switch to perform the cutting
surgery.
6.2) When operating Mono-polar coagulation function

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

- Connect bi-polar forceps to ‘Bi-polar RF Power Outlet’.
- Press ‘Cutting Mode Selection Switch’ to select Bi-Cut mode for the surgery. The indicator is
on for the selected output mode, and the value of applicable mode will be displayed in the
‘Cutting RF Power Digital Display’.
- Use the ‘Cutting RF Power Increase/Decrease Switch’ to configure the cutting output.
- Press the yellow pedal of Foot Switch to perform the cutting surgery.
6.4) When operating bi-polar coagulation function

- Connect bi-polar forceps to ’Bi-polar RF Power Outlet’.
- Press ‘Coagulation mode Selection Switch’ to select Bi-Coag. mode for the surgery. The
indicator is on for the selected output mode, and the value of applicable mode will be displayed
in the ‘Coagulation RF Power Digital Display ’.
- Use the ‘Coagulation RF Power Increase/Decrease Switch’ to configure the coagulation output.
- Press the blue pedal of Foot Switch to perform the coagulation surgery.
6.3.3 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 patient contacting components should
be sterilized.
3) Please sterilize reusable accessories before you keep in store.

4) Scrap disposable accessories in the prescribed regulations (according to the law). Exert your
caution in a way that there is no risk of contamination due to the used consumable accessories.
6.3.4 Precautions during use

1) Precautions during use
- Check if the current output setting is appropriate to the existing surgical environment including
the surgical area.
- Make sure that patients do not touch grounded metals. It may cause partial burn.
- Do not give long time output to tissue areas or higher output beyond the need. Manipulate
output when electrode is always contacted with tissue to prevent tissue burn.
- If the patient complains about electric shock, stop using the unit immediately and have it
examined thoroughly.
- Frequently check contact status between neutral plate and a patient.
- The sound volume should be at least the medium of level to prevent sound-recognition-fail
caused dangers.
2) Storage condition or storage method
- Storage Condition: -10℃～60℃, 30%～ 95％ noncondensing, 700mbar～1060mbar
- Put in the product package box, and place in the cool area.

7. Output Setting Guide
Part Cut Mode Cut Power Coag. Mode Coag. Power BI-Coag.
Pure 10～120
Skin Incision
or Blend1 8～100
Muscle Pure Above 15
Dissection or Blend1 Above 15
Tumor
Blend3 Above 10
Excision
Stomach,
Blend2 20 and up
Intestine
or Blend3 20 and up
Resection
Hemostasis Contact 10～65 3～22
Massive
Spray 10～30
Coagulation
Loop
BALL
Neuro Surgery Blend2 20 ～ 80 Contact 1～8
10～25
or Blend3 20 ～ 70
Prostatic Pure 65 and up
Spray 15 and up
Resection or Blend1 55 and up
Bladder
Spray 12～30
Fulguration
Blend2 15 ～ 80
Tumor Excision Spray 10～15
Blend3 15 ～ 70
Cervical
Blend2 10 ～ 80 Contact 25～70
Conization
Bartholin
Blend3 15 ～ 30 Spray 12～22
and Skeneis
Tubal Blend2 8 ～ 50 10～20
Proctologic Blend3 8 ～ 40 Spray 10～22
Abscess/Cyst Blend3 10 ～ 80 Spray 10～15

Lancet 8～30
Rectal, Sigmoid Blend3 Contact 12～30
Loop 10～20
Endoscopic
Pure 25-40 Spray 30-50
surgery
7. Output Setting Guide37

8. Sterilization
1) For cleaning and sterilizing, the unit must be disconnected from the mains. Accessories
have to be always keep sterile when you use in operating room, especially metal parts which is
contacting with the patient's body.
2) Be sure to clean and sterile the accessories before keeping them.
3) Before sterilization, inspect the accessories and their cord for breaks or cracks in the insulation,
corrosion, or loose conditions. Do not use the accessories if any of these conditions exist.
4) Sterilization
Sterilization
Accessory Steam EtO
(Autoclave) (EO Gas)
1. Twin Button Handle with Cable ㆍConcentration of EtO

2. Mono-polar Handle with Cable ㆍGravity : 600mg/liter
3. Forceps Cable displacement ㆍTemperature
4. Bi-polar Forceps ㆍ121℃(250℉) for : 54℃(130℉)
5. Electrodes 20minutes ㆍExposure time
6. Reusable Return Plate Cable : 1 hour 45 minutes
7. Reusable Metal Plate with Cable Non-available ㆍAeration time
: 12 hours at 54℃
8. Reusable Rubber Plate with Cable Non-available
(130℉)
Caution
1. Do not overheat or overpressure or overtime, it can damage the accessories.

2. Do not clean or sterilize disposable accessories. The disposable accessories should be used only
one time.
3. Accessory life will be reduced:
- High mineral content in the autoclave supply water.
- Tight bunching or wrapping of the cord during sterilization.
- Contact between the cord and material instruments during autoclave sterilization.
4. Sterilize the accessories made of plastic, PVC or rubber with EO gas as possible. If they are in
sterilize with autoclave, they may be transformed or the life span may be reduced due to high
temperature.
5. The main body of the unit can not be sterilized.
6.Recommendation on the use of non-flammable agents for cleaning and disinfections wherever
possible
8. Sterilization38
9. Load Regulation & Vpeak Graphs
9.1 Pure Cutting Mode
9.1.1 Load Regulation
(DT-400S)
(DT-300S)
9. Load Regulation & Vpeak Graphs39

9.1.2 Open Circuit Peak Voltage

9.2 Blend1 Cutting Mode
(DT-400S)
(DT-300S)


(DT-400S)
(DT-300S)


(DT-400S)
(DT-300S)


9.5 Forced &Soft Coagulation Mode
(DT-400S)
(DT-300S)


9.6 Spray Coagulation Mode
(DT-400S/300S)

9.7 Cutting Biploar Mode
(DT-400S/300S)

9.8 Standard Bipolar Coagulation Mode
9.8.1 Load Regulatio
(DT-400S/300S)

9.9 Soft Bipolar Coagulation Mode
9.9.1 Load Regulatio
(DT-400S/300S)

10. User Maintenance
10.1 General Maintenance Information
- This section presents information for ordinary upkeep and maintenance of DT-400S/300S. It is
recommended that periodic inspection and performance testing be performed by a qualified
biomedical technician to ensure continued safe and effective operation.
- If any problem occurs, contact the local agencies or company.
10.2 Responsibility of the manufacturer

- DAIWHA is responsible for the safety, reliability and performance of the Unit only under the
following circumstance.
* Installation and set up procedure 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.
10.3 Cleaning and Disinfecting
Warning
- Electric shock hazard Always turn off and unplug the unit before cleaning.
- When cleaning with damp cloth, exert cautions to prevent moist 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 witch a mild cleaning solution or
disinfectant and a damp (not dripping) cloth.
- Do not allow impurities to enter the chassis.
- Do not sterilize with autoclave or EO gas.
10.4 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.
- Damage to the Equipotential Grounding cable.
- Damage to the power cord.
- Damage to the volume control.
10. User Maintenance53

- Checking whether there is damage to Bi-polar Forceps, TBH, Unipolar Handle, and Neutral
Plate including the checkup the damage of any accessories and cleaning status.
- Obvious external damage to the unit.
(3) This equipment requires the inspection on the following items at least once a year.
- Obvious internal damage to the unit.
- Accumulation of the lint or debris within the unit or heat sink.
10.5 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 accurately operating.
TIP! Please, refer to the What is ‘Tip: WHAT iS D.R.M (Daiwha Return electrode
Monitor)?’section?
10.6 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 : 50 times use only
- Recommended product life span: 2 years
* If the unit package indicates maximum years of the use, follow that information.
* 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 not warranty period allocated.
* If 5 year has been passed since usage, contact DAIWHA Corporation, LTD. for getting the
inspection service to determine whether to continue operation. Also, do not miss the
periodic inspection on the safety and performance.
10.7 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, following the rules and regulations in
the corresponding laws.
10.8 Warranty
The manufacturer warrants that the ESU is free from defects in material and workmanship
under normal use and service for a period of months after the purchase data.
The manufacturer its authorized representative takes obligation to carry out the warranty
repair of the ESU or to replace the ESU with an operational one in case the Manufacturer
or its authorized representative determines that the cause of the ESU's failure was related
to the manufacturing process.
If the Buyer finds the defect in the ESU during the warranty period, he must report it and
inform the Manufacturer or its authorized representative within 30 days.

An ESU sent for testing, repair or replacement shall be submitted to the Manufacturer or its
authorized representative in its original or equivalent packaging. The ESU is sent for
repair and back at Buyer's expense.
If no defect is found during testing, the Manufacturer or its authorized representative reserves
the right to submit the invoice to the Buyer for the work carried out.
This warranty is not applicable to ESUs with damaged seal or when failure caused by
violations of requirements of the Operational Manual, by mains voltage non-conformity to
the requirements of IEC, by spills of liquids, by mechanical damages cause by shocks or
an ESU being dropped, by ESU damages caused during transportation, or when
packaging is damaged.
Serial No :
Delivery date :
Quality inspector :

11. Guidance and manufacture’s declaration on
electromagnetic emissions
Guidance and manufacturer’s declaration - electromagnetic emissions
The DT-400S/300Sis intended for use in the electromagnetic environment specified below.
The customer or the user of the DT-400S/300Sshould assure that it is used in such an environment.
Immunity Test Compliance Electromagnetic Environment - Guidance

RF Emissions Group 1 The DT-400S/300S uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment
RF Emissions Class A The DT-400S/300S is suitable for use in ail establishments,

CISPR 11 including domestic establishments and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes
Harmonic Complies The DT-400S/300S is suitable for use in ail establishments,

emissions including domestic establishments and those directly
IEC 61000-3-2 connected to the public low-voltage power supply network that
Voltage Complies The DT-400S/300S is suitable for use in ail establishments,
fluctuations/ including domestic establishments and those directly
Flicker emissions connected to the public low-voltage power supply network that
IEC 61000-3-3
11. Guidance and manufacture’s declaration on electromagnetic emissions56

Guidance and manufacturer’s declaration - electromagnetic immunity
The DT-400S/300S is intended for use in the electromagnetic environment specified below.
The customer or the user of the DT-400S/300S should assure that it is used in such an
environment.
The DT-400S/300S is intended for use in the electromagnetic environment specified below.
The customer or the user of the DT-400S/300S should assure that it is used in such an
environment.
Immunity test IEC 60601-1-2 Compliance level Electromagnetic environment -
Test level guidance
Electrostatic ±6kV Contact ±6kV Contact Floors should be wood, concrete
discharge (ESD) ±8kV air ±8kV air or ceramic tile. If floors are
IEC 61000-4-2 covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast ±2kV for power ±2kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 ± 1kV for ± 1kV for hospital environment.
input/output lines input/output lines
Surge ±1kV differential ±1kV differential Mains power quality should be

IEC 61000-4-5 mode mode that of a typical commercial or
±2kV common mode ±2kV common mode hospital environment.
Voltage dips, <5% Uт <5% Uт Mains power quality should be

short (>95% dip in Uт) (>95% dip in Uт) that of a typical commercial or
interruptions and for 0.5cycle for 0.5cycle hospital environment. If the user
voltage 40% Uт 40% Uт of the DT-400S/300S image
variations (60% dip in Uт ) (60% dip in Uт ) intensifier requires continued
on power supply for 5 cycle for 5 cycle operation during power mains
input lines 70% Uт 70% Uт interruptions, it is recommended
IEC 61000-4-11 (30% dip in Uт) (30% dip in Uт) that the DT-400S/300S image
for 25 cycle for 25 cycle intensifier be powered from an
<5% Uт <5% Uт uninterruptible power supply or a
(<95% dip in Uт ) (<95% dip in Uт ) battery.
for 5 s for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic fields

(50/60Hz) should be at levels characteristic
magnetic field of a typical location in a typical
IEC 61000-4-8 commercial or hospital
environment.
NOTE Uт is the a.c. mains voltage prior to application of the test level.

The DT-400S/300S S is intended for use in the electromagnetic environment specified below.
The customer or the user of the DT
DT-400S/300S S should assure that it is used in such an environment.
Immunity IEC Compliance Electromagnetic environment - guidance

test 60601-1-2 level
test level
Portable and mobile RF communications equipment should
be used no closer to any part of the DT--400S/300S,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance :

Conducted 3 Vrms
RF 150 kHz V1=3Vrms
IEC to 80MHz
61000-4-6
3 V/m
80 MHz to E1=3V/m
Radiated 2.5GHz
RF
IEC
61000-4-3
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 deter-mined
mined 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 from structures, objects 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 DT
DT-400S/300SS is used exceeds the applicable RF compliance
level above, the DT-400S/300S S should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re re-orienting
orienting or relocating
the DT-400S/300S.
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1]V/m.
11. Guidance and manufacture’s declaration on electromagnetic emissions

emissions58
Recommended separation distances between portable and mobile RF
communications equipment and the DT-400S/300S
There is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the DT-400S/300S can help Prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the DT-400S/300S as recommended below, according to the maximum
output power of the communications equipment.
Separation distance according to frequency of transmitter [m]

IEC 60601-1-2
Frequency of 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
Transmitter
Equation
Rated maximum V1=3Vrms

output power of E1=3V/m E1=3V/m
transmitter Separation Distance
[W] (meters) Separation Distance Separation Distance
(meters) (meters)
0.01 0.116 0.1166 0.2333
0.1 0.368 0.3687 0.7378
1 1.166 1.1660 2.3333
10 3.687 3.6872 7.3785
100 11.660 11.6600 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 separation distance for the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects 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 DT-400S/300S is used exceeds the applicable RF compliance
level above, the DT-400S/300S should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating
the DT-400S/300S.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.
Immunity and Compliance Level
Immunity test IEC 60601-1-2 Actual Immunity Level Compliance Level

Test Level
Conducted RF 3Vrms 3Vrms 3Vrms
IEC 61000-4-6 150kHz to 80MHz
Radiated RF 3Vrms 3V/m 3V/m

IEC 61000-4-3 80MHz to 2.5GHz
The DT-400S/300S S is intended for use in the electromagnetic environment specified below.
The customer or the user of the DT-400S/300S S should assure that it is used in such an
electromagnetic environment.
Immunity IEC 60601- Compliance Electromagnetic environment - guidance

test 1-2 level
Test level
Conducted 3 Vrms 3 Vrms The DT-400S/300S S must be used only in a shielded
RF IEC 150kHz to 150 kHz to location with a minimum RH shielding effectiveness
61000-4-6 80MHz 80MHz nad, for each cable that enters the shielded location
with a minimum RF shielding effectiveness and, for
each cable that enters the shielded location.
Field strengths outside the shielded location from fixed RF transmitters, as determined
Radiated 3V/m 80MHz 3V/m 80MHz
RF IEC to 2.5GHz to 2.5GHz by an electromagnetic site survey, should be less than 3V/m.a
61000-4-3
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
NOTE 2) It is essential that the actual shielding effectiveness and filter attenuation of the shielded
location be verified to assure that they meet the minimum specification.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telepho
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 consider
considered.
ed. If the measured field strength
outside the shielded location in which the DTDT-400S/300S S is used exceeds 3V/m, the DT DT-400S/300S
should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, suc such as relocating the
DT-400S/300S S or using a shielded location with a higher RF shielding effectiveness and filter
attenuation.
11. Guidance and manufacture’s declaration on electromagnetic emissions

emissions60
12. Document History
Change Code Revised Description
Rev 0.1 2016.07.06 Created a draft
Rev 1.0 2017.02.27 Added Description
12. Document History61

User Manual: DT-400S/300S

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body and as close to the operating field as possible.

getting burn due to reduced contact size.

other leads is avoided

⑦Instructions stating, use of bipolar techniques may be desirable in order to avoid

small cross-sectional area of body

15)Attention is called to the danger of ignition of endogenous gases

Sales & Address: 3, Yeoksam-ro 33-gil, Gangnam-gu, Seoul, Korea

Address: mdi Europa GmbHLangenhagener Str. 71

Model DT-400S/ DT-300S

Packaging Unit 1 Set

Purpose Consistent infusion of medicine

Storage Store at room temperature

Usages and Precautions See the User Manual

1.6 Precautions during use

1.7 Guidelines after use

(1) Electro Surgical Unit (ESU)

2. Terms and Symbols12

Caution - dangerous high voltage. Explosion Risk if used with

Attention : See instructions for use Alternative Current

Single Foil - used with electrodes

Pure Mode : Waveform with minimum Blend1 Mode : Cut waveform

Blend2 Mode : Cut waveform with Blend3 Mode : Cut waveform

Forced Mode : Standard mode Soft Mode : Soft mode mono-

Spray Mode : Spray mode mono

2. Terms and Symbols

Hand Twin Switched Output :

Unipolar Handle Output : Return Electrode :

Inlet for bi-polar

RF Isolated : Patient connections

Date of Manufacture Speaker Volume

2. Terms and Symbols

1. DRM(Daiwha Return electrode Monitoring) Set 2. DRM Setting Switch

2. Terms and Symbols15

2. Terms and Symbols16

36. Mono-polar RF power Outlet 2 37. Return Electrode Inlet

38. Sound Volume Controller 39. Bi-polar Foot Switch Inlet

42. Equipotential Grounding 43. Assist Resistance Indicator

46. Main Power Switch 47. Output Path Selector

2. Terms and Symbols17

No. Name Size Manufactured by

1 Re-usable Bipolar Forceps - TECNO in Pakistan

Myung Electronics Co., Ltd. in

Shining World Health Care CO.,

4 Disposable Single Pad - BIOPROTECH in Korea

5 Disposable Dual Pad - BIOPROTECH in Korea

Shining World Health Care CO.,

7 Double Foot Switch 4 [m] KEM Co., Ltd. In Korea

Myung Electronics Co., Ltd. in

9 Metal Plate - Daiwha Corp., Ltd.

10 Rubber Plate - Daiwha Corp., Ltd.

2.5 Labels – Instruction for use

2. Terms and Symbols18

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

Two of F5.0A, 250V for 230VAC

High Freq. Leakage

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

-10℃～60℃, 30%～ 95％ noncondensing, 700mbar～1060mbar

Size (H, W, D) 147mmx 330mm x 417mm

Not AP/APG device

Operation Sound Difference in operation sounds between cutting and coagulation.

※ It can be changed without notice to improve performance.