Daiwha Meditom DT-400S User Manual
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Daiwha Meditom DT-400S User Manual

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®
MEDITOM
DT-400S/300S

User Manual

DAIWHA
Copyright © 2014, DAIWHA Corporation. All rights reserved.
Manual No: RD-USM-EN-3-07 (Rev1.00)

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Summary of Contents for Daiwha Meditom DT-400S

  • Page 1: User Manual

    ® MEDITOM DT-400S/300S User Manual DAIWHA Copyright © 2014, DAIWHA Corporation. All rights reserved. Manual No: RD-USM-EN-3-07 (Rev1.00)

  • Page 2: Table Of Contents

    (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 ...................
  • Page 3 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 .......................
  • Page 4 9.8.2 Open Circuit Peak Voltage ..................51 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 ......................

  • Page 5: Precautions

    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.

  • Page 6: Danger

    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 instructions are not followed. Danger A precaution which could result in critical personnel injury or loss of life if instructions are not followed.
  • Page 7 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.
  • Page 8 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-...
  • Page 9 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...
  • Page 10 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...

  • Page 11: Checklist Before Use

    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.

  • Page 12: Terms And Symbols

    (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.

  • Page 13: Symbols

    2.2 Symbols Caution - dangerous high voltage. dangerous high voltage. Explosion Risk Explosion Risk if used with Hazardous electrical output. Hazardous electrical output. flammable anesthetics. flammable anesthetics. Non-ionizing Radiation ionizing Radiation Equipotential Grounding Equipotential Grounding Attention : See instructions for use See instructions for use Alternative Current Alternative Current...
  • Page 14 StandardMode: StandardMode: Standard mode bi- Soft Mode : : Soft mode bi-polar polar coagulation. polar coagulation. coagulation. coagulation. Hand Twin Switched Output : Hand Twin Switched Output : Bi-polar Output : polar Output : Connection for hand Switched Connection for hand Switched Connection for bi Connection for bi-polar accessories mono-polar accessories...

  • Page 15: Controls, Indicators And Receptacles

    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...
  • Page 16 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.
  • Page 17 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.

  • Page 18: Accessories

    KEM Co., Ltd. In Korea Myung Electronics Co., Ltd. in Power Cord 4 [m] Korea Metal Plate Daiwha Corp., Ltd. 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) 2.

  • Page 19: Specifications

    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...

  • Page 20: Operating Modes And Output Parameters

    3.2 Operating Modes and Output Parameters (DT-400S) Tolerance:±20% Carrier Frequency Repeat Output RF Power Mode Load Resistance(Ω) (㎑) Frequency(㎑) Pure mode Blend1 mode Blend2 mode Blend3 mode Forced mode Soft mode Spray mode Cut mode Standard mode Soft mode (DT-300S) Tolerance:±20% Carrier Frequency Repeat...

  • Page 21: Safety Devices

    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.
  • Page 22 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.
  • Page 23 Replace the single lined When Neutral plate cable is single lined cable. while using the single pad mode 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’...
  • Page 24 Tolerance : ±10% State Resistance(Ω) Single PAD Below 10 31-50 51-80 81-100 Dual PAD 101-110 111-120 121-130 131-141 Poor condition 141-150 Above 150 Open PAD ∞ 3. Specifications24...

  • Page 25: Effect Using The Unit

    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.

  • Page 26: Modes For Bipolar Cutting

    3) Spray Coagulation - 400KHz alternating current maximum modulated by 33KHz. - 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.
  • Page 27 - Can coagulate the tissue wetted by blood or any other liquid. 2) BipolarSoft Coagulation - 482KHz alternating current maximum modulated by 20KHz. - 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.

  • Page 28: Connecting Accessories With The Unit

    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 &...

  • Page 29: Bipolar Forceps

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

  • Page 30: Operating And Sequence

    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.
  • Page 31 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) ▶...
  • Page 32 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.
  • Page 33 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.

  • Page 34: Bipolar

    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.

  • Page 35: Guidelines After Use

    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’...

  • Page 36: Precautions During Use

    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.

  • Page 37: Output Setting Guide

    7. Output Setting Guide Part Cut Mode Cut Power Coag. Mode Coag. Power BI-Coag. 10～120 Pure 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...

  • Page 38: Sterilization

    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.

  • Page 39: Load Regulation & Vpeak Graphs

    9. Load Regulation & Vpeak Graphs 9.1 Pure Cutting Mode 9.1.1 Load Regulation (DT-400S) (DT-300S) 9. Load Regulation & Vpeak Graphs39...

  • Page 40: Open Circuit Peak Voltage

    9.1.2 Open Circuit Peak Voltage 9. Load Regulation & Vpeak Graphs40...

  • Page 41: Blend1 Cutting Mode

    9.2 Blend1 Cutting Mode 9.2.1 Load Regulation (DT-400S) (DT-300S) 9. Load Regulation & Vpeak Graphs41...

  • Page 42: Open Circuit Peak Voltage

    9.2.2 Open Circuit Peak Voltage 9. Load Regulation & Vpeak Graphs42...

  • Page 43: Blend2 Cutting Mode

    9.3 Blend2 Cutting Mode 9.3.1 Load Regulation (DT-400S) (DT-300S) 9. Load Regulation & Vpeak Graphs43...

  • Page 44: Open Circuit Peak Voltage

    9.3.2 Open Circuit Peak Voltage 9. Load Regulation & Vpeak Graphs44...

  • Page 45: Blend3 Cutting Mode

    9.4 Blend3 Cutting Mode 9.4.1 Load Regulation (DT-400S) (DT-300S) 9. Load Regulation & Vpeak Graphs45...

  • Page 46: Open Circuit Peak Voltage

    9.4.2 Open Circuit Peak Voltage 9. Load Regulation & Vpeak Graphs46...

  • Page 47: Soft Coagulation Mode

    9.5 Forced &Soft Coagulation Mode 9.5.1 Load Regulation (DT-400S) (DT-300S) 9. Load Regulation & Vpeak Graphs47...

  • Page 48: Open Circuit Peak Voltage

    9.5.2 Open Circuit Peak Voltage 9. Load Regulation & Vpeak Graphs48...

  • Page 49: Spray Coagulation Mode

    9.6 Spray Coagulation Mode 9.6.1 Load Regulation (DT-400S/300S) 9.6.2 Open Circuit Peak Voltage 9. Load Regulation & Vpeak Graphs49...

  • Page 50: Cutting Biploar Mode

    9.7 Cutting Biploar Mode 9.7.1 Load Regulation (DT-400S/300S) 9.7.2 Open Circuit Peak Voltage 9. Load Regulation & Vpeak Graphs50...

  • Page 51: Soft Bipolar Coagulation Mode

    9.8 Standard Bipolar Coagulation Mode 9.8.1 Load Regulatio (DT-400S/300S) 9.8.2 Open Circuit Peak Voltage 9. Load Regulation & Vpeak Graphs51...
  • Page 52 9.9 Soft Bipolar Coagulation Mode 9.9.1 Load Regulatio (DT-400S/300S) 9.9.2 Open Circuit Peak Voltage 9. Load Regulation & Vpeak Graphs52...

  • Page 53: User Maintenance

    - 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.

  • Page 54: Periodic Performance Testing

    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.
  • Page 55 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.

  • Page 56: Guidance And Manufacture's Declaration On Electromagnetic Emissions

    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...
  • Page 57 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.
  • Page 58 Guidance and manufacturer’s declaration Guidance and manufacturer’s declaration - electromagnetic immunity The DT-400S/300S is intended for use in the electromagnetic environment specified below. S is intended for use in the electromagnetic environment specified below. S is intended for use in the electromagnetic environment specified below. The customer or the user of the DT The customer or the user of the DT-400S/300S should assure that it is used in such an environment.
  • Page 59 Recommended separation distances between portable mobile 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.
  • Page 60 IEC 61000-4-3 80MHz to 2.5GHz 80MHz to 2.5GHz Guidance and manufacturer’s declaration Guidance and manufacturer’s declaration - electromagnetic immunity electromagnetic immunity The DT-400S/300S is intended for use in the electromagnetic environment specified below. S is intended for use in the electromagnetic environment specified below. S is intended for use in the electromagnetic environment specified below.

  • Page 61: Document History

    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...

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