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. Terms and Symbols12

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

～

℃

) 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

Содержание Meditom DT-400S

Страница 2: ...olar 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 ...

Страница 3: ...gulatio 39 9 1 2 Open Circuit Peak Voltage 40 9 2 Blend1 Cutting Mode 41 9 2 1 Load Regulation 41 9 2 2 Open Circuit Peak Voltage 42 9 3 Blend2 Cutting Mode 43 9 3 1 Load Regulation 43 9 3 2 Open Circuit Peak Voltage 44 9 4 Blend3 Cutting Mode 45 9 4 1 Load Regulation 45 9 4 2 Open Circuit Peak Voltage 46 9 5 Soft Coagulation Mode 47 9 5 1 Load Regulation 47 9 5 2 Open Circuit Peak Voltage 48 9 6 ...

Страница 4: ...bility 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 ...

Страница 5: ...e 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 ...

Страница 6: ...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 examin...

Страница 7: ...normal 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 wit...

Страница 8: ...use children s patient plate neutral plate for adults You may increase the risk of getting burn due to reduced contact size Recommendation to position patient leads in such a way that contact with the patient or other leads is avoided Instructions stating use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where hf current could flow through ...

Страница 9: ...e 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 ...

Страница 10: ...tion 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 ...

Страница 11: ...e 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 sta...

Страница 12: ...ck 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 b...

Страница 13: ...rm the On Power Disconnection to the mains used with electrodes that do not monitor contact quality used with electrodes that do monitor contact quality Monitor Alarm alarm Mono polar output is disabled only with type and rating as shown Replace Fuse rating as shown Waveform with minimum thermal damage and hemostasis Blend1 Mode with moderate hemostasis Cut waveform with heavy hemostasis Blend3 Mo...

Страница 14: ...andle Output for Unipolar hand bi polar accessories Return Electrode Connection for mono dispersive electrode polar foot switch Inlet for mono Defibrilation Proof Type CF applied part RF Isolated are isolated from earth at high frequency Protective earth Catalogue number The manufacturer s catalogue number shall be adjacent to the symbol Serial number Authorized European Community Date of Manufact...

Страница 15: ...turn 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 Pressing this switch will select the Single Pad return electrode or the Dual Pad return electrode 4 Bi polar Mode Activation Indicat...

Страница 16: ...has been selected 22 Contact Coagulation Mode Indicator Illuminates when Mono polar contact coagulation mode has been selected 23 Spray Coagulation Mode Indicator Illuminates when Mono polar Spray coagulation mode has been selected 24 Bi polar Cut Mode Select Switch Selects Bi polar cut mode by pressing the switch 25 Bi polar Coagulation Mode Select Switch Selects Bi polar Coagulation mode by pres...

Страница 17: ...corresponding to that listed on the Patcher 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 Is Chassis ground connection for additional protection against low frequency risk current 43 Assist Resistance Indicator This red LED bar graph is a visual indicato...

Страница 18: ... CO LTD in Taiwan 4 Disposable Single Pad BIOPROTECH in Korea 5 Disposable Dual Pad BIOPROTECH in Korea 6 Pad Cable 4 m Shining World Health Care CO LTD in Taiwan 7 Double Foot Switch 4 m KEM Co Ltd In Korea 8 Power Cord 4 m Myung Electronics Co Ltd in 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 Mater...

Страница 19: ... 1060mbar Storage Conditions 10 60 30 95 noncondensing 700mbar 1060mbar Transportation Conditions 10 60 30 95 noncondensing 700mbar 1060mbar Do not drop the unit from higher than 50cm Do not use the hook Installation Conditions 5cm clearance required on each side unit for cooling Cooling 1 fan mounted Recommended Duty Cycle 10 sec ON 30 sec OFF Output for 10 seconds pause for 30 seconds Size H W D...

Страница 20: ...epeat Frequency Output RF Power W Load Resistance Ω 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 tha...

Страница 21: ...rom 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...

Страница 22: ...p Mount Return Electrode to Return Electrode jack 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 See Assist Resistance Indicator change If more than three lights are turned on it is possible ...

Страница 23: ...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 ...

Страница 24: ...3 Specifications24 Tolerance 10 State Resistance Ω LED Single PAD Below 10 8 Dual PAD 31 50 8 51 80 7 81 100 6 101 110 5 111 120 4 121 130 3 Poor condition 131 141 2 141 150 1 Above 150 0 Open PAD 0 ...

Страница 25: ...rrent modulated by 33KHz For cutting with minimum hemostasis 3 Blend 2 400KHz alternating current modulated by 33KHz For cutting with more hemostasis than Blend 1 4 Blend 3 400KHz alternating current modulated by 33KHz For cutting with heavy hemostasis than Blend 2 4 3 Modes for Monopolar Coagulation 1 Forced Coagulation 400KHz alternating current modulated by 33KHz For only coagulation Standard c...

Страница 26: ... 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 ...

Страница 27: ...s 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 qual...

Страница 28: ...r 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 If they are plugged in the wrong hole be warned of such malfunction that output may continue even when the foot switch is off ...

Страница 29: ...5 Connecting Accessories with the unit29 5 3 Bipolar Forceps 5 4 Foot switches ...

Страница 30: ...l 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 Elect...

Страница 31: ...tion Switch to set up the Dual Pad Mode The Dual Pad Mode Indicator will be turned on and the DRM will be ready Attach the Pad firmly to the patient Please read carefully the precautions 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...

Страница 32: ...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 ...

Страница 33: ... 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 ...

Страница 34: ...he 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 2Operation Sequence 1 After checking the main power voltage 110 220V connect the power cord to the main power inlet located at ...

Страница 35: ...put 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...

Страница 36: ...als 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...

Страница 37: ...tion Spray 10 30 Neuro Surgery Blend2 or Blend3 Loop 20 80 20 70 Contact BALL 10 25 1 8 Prostatic Resection Pure or Blend1 65 and up 55 and up Spray 15 and up Bladder Fulguration Spray 12 30 Tumor Excision Blend2 Blend3 15 80 15 70 Spray 10 15 Cervical Conization Blend2 10 80 Contact 25 70 Bartholin and Skeneis Blend3 15 30 Spray 12 22 Tubal Blend2 8 50 10 20 Proctologic Blend3 8 40 Spray 10 22 Ab...

Страница 38: ...clave 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...

Страница 39: ...9 Load Regulation Vpeak Graphs39 9 Load Regulation Vpeak Graphs 9 1 Pure Cutting Mode 9 1 1Load Regulation DT 400S DT 300S ...

Страница 40: ...9 Load Regulation Vpeak Graphs40 9 1 2Open Circuit Peak Voltage ...

Страница 41: ...9 Load Regulation Vpeak Graphs41 9 2 Blend1 Cutting Mode 9 2 1Load Regulation DT 400S DT 300S ...

Страница 42: ...9 Load Regulation Vpeak Graphs42 9 2 2Open Circuit Peak Voltage ...

Страница 43: ...9 Load Regulation Vpeak Graphs43 9 3 Blend2 Cutting Mode 9 3 1Load Regulation DT 400S DT 300S ...

Страница 44: ...9 Load Regulation Vpeak Graphs44 9 3 2Open Circuit Peak Voltage ...

Страница 45: ...9 Load Regulation Vpeak Graphs45 9 4 Blend3 Cutting Mode 9 4 1Load Regulation DT 400S DT 300S ...

Страница 46: ...9 Load Regulation Vpeak Graphs46 9 4 2Open Circuit Peak Voltage ...

Страница 47: ...9 Load Regulation Vpeak Graphs47 9 5 Forced Soft Coagulation Mode 9 5 1Load Regulation DT 400S DT 300S ...

Страница 48: ...9 Load Regulation Vpeak Graphs48 9 5 2Open Circuit Peak Voltage ...

Страница 49: ...9 Load Regulation Vpeak Graphs49 9 6 Spray Coagulation Mode 9 6 1Load Regulation DT 400S 300S 9 6 2Open Circuit Peak Voltage ...

Страница 50: ...9 Load Regulation Vpeak Graphs50 9 7 Cutting Biploar Mode 9 7 1Load Regulation DT 400S 300S 9 7 2Open Circuit Peak Voltage ...

Страница 51: ...9 Load Regulation Vpeak Graphs51 9 8 Standard Bipolar Coagulation Mode 9 8 1Load Regulatio DT 400S 300S 9 8 2Open Circuit Peak Voltage ...

Страница 52: ...9 Load Regulation Vpeak Graphs52 9 9 Soft Bipolar Coagulation Mode 9 9 1Load Regulatio DT 400S 300S 9 9 2 Open Circuit Peak Voltage ...

Страница 53: ...Cleaning and Disinfecting 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 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 pan...

Страница 54: ...ck 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...

Страница 55: ...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 c...

Страница 56: ...rence in nearby electronic equipment RF Emissions CISPR 11 Class A The DT 400S 300S is suitable for use in ail establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Complies The DT 400S 300S is suitable for use in ail establishments including do...

Страница 57: ... power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1kV differential mode 2kV common mode 1kV differential mode 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Uт 95 dip in Uт for 0 5cycle 40 Uт 60 dip ...

Страница 58: ...s than the compliance level in each frequency range 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 fixed transmitters such as base stations ...

Страница 59: ...ation 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 o...

Страница 60: ...rence 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 that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification Field stren...

Страница 61: ...12 Document History61 12 Document History Change Code Revised Description Rev 0 1 2016 07 06 Created a draft Rev 1 0 2017 02 27 Added Description ...

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