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11

. Guidance and manufacture’s

IEC 61000-4-3   

80MHz to 2.5GHz

Guidance and manufacturer’s declaration 

 

The DT-400S/300S is intended for use in the electromagnetic environment specified below. 
The  customer  or  the  user  of  the 
electromagnetic environment. 

 

Immunity 

test 

IEC 60601-

1-2 

Test level 

Compliance

Conducted 

RF IEC 

61000-4-6 

 
 

 

Radiated 

RF IEC 

61000-4-3 

3 Vrms 

150kHz to 

80MHz 

 
 

 

3V/m 80MHz 

to 2.5GHz 

150 kHz to 

 

3V/m 80MHz 

to 2.5GHz

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.

 

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telepho

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
outside the shielded location  in  which  the DT
should be observed to verify normal operation. 
If abnormal performance is observed, additional measures may be necessary, suc
DT-400S/300S  or  using  a  shielded  location  with  a  higher  RF  shielding  effectiveness  and  filter 
attenuation.   
 
 

Guidance and manufacture’s declaration on electromagnetic emissions

80MHz to 2.5GHz 

Guidance and manufacturer’s declaration - electromagnetic immunity 

S 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 

Compliance 

level 

Electromagnetic environment 

3 Vrms 

150 kHz to 

80MHz 

 
 

3V/m 80MHz 

to 2.5GHz 

The  DT-400S/300S  must  be  used  only  in  a  shielded 
location  with  a  minimum  RH  shielding  effectiveness 
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 

by an electromagnetic site survey, should be less than 3V/m.

 
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.   

that  the  actual  shielding  effectiveness  and  filter  attenuation  of  the  shielded 

location be verified to assure that they meet the minimum specification. 

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telepho

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 
outside the shielded location  in  which  the DT-400S/300S is used exceeds 3V/m, the DT
should be observed to verify normal operation.   
If abnormal performance is observed, additional measures may be necessary, suc

S  or  using  a  shielded  location  with  a  higher  RF  shielding  effectiveness  and  filter 

 

 

declaration on electromagnetic emissions60 

electromagnetic immunity   

S is intended for use in the electromagnetic environment specified below.   

S  should  assure  that  it  is  used  in  such  an 

Electromagnetic environment - guidance 

S  must  be  used  only  in  a  shielded 

location  with  a  minimum  RH  shielding  effectiveness 
nad,  for  each  cable  that  enters  the  shielded  location 

shielding  effectiveness  and,  for 

each cable that enters the shielded location. 

Field strengths outside the shielded location from fixed RF transmitters, as determined 

by an electromagnetic site survey, should be less than 3V/m.a 

the  vicinity  of  equipment 

 

NOTE 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by 

that  the  actual  shielding  effectiveness  and  filter  attenuation  of  the  shielded 

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 

ed.  If  the  measured  field  strength 

S is used exceeds 3V/m, the DT-400S/300S 

If abnormal performance is observed, additional measures may be necessary, such as relocating the 

S  or  using  a  shielded  location  with  a  higher  RF  shielding  effectiveness  and  filter 

Содержание Meditom DT-300S

Страница 1: ...MEDITOM DT 400S 300S User Manual DAIWHA Copyright 2014 DAIWHA Corporation All rights reserved Manual No RD USM EN 3 07 Rev1 00...

Страница 2: ...lar 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 Label...

Страница 3: ...ulatio 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 Circu...

Страница 4: ...ility 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...

Страница 5: ...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...

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 par...

Страница 7: ...ormal 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 coul...

Страница 8: ...se 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...

Страница 9: ...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...

Страница 10: ...ion 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 roo...

Страница 11: ...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 electrod...

Страница 12: ...k 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 m...

Страница 13: ...m 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 disable...

Страница 14: ...ndle 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 i...

Страница 15: ...urn 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 detecte...

Страница 16: ...as 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 coag...

Страница 17: ...orresponding 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 pro...

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...

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 ho...

Страница 20: ...peat Frequency Output RF Power W Load Resistance 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...

Страница 21: ...om 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 Electro...

Страница 22: ...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 th...

Страница 23: ...rea 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 S...

Страница 24: ...3 Specifications24 Tolerance 10 State Resistance 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: ...rent 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 m...

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 e...

Страница 27: ...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...

Страница 28: ...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 instrum...

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

Страница 30: ...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...

Страница 31: ...ion 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...

Страница 32: ...lend1 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...

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 Monopol...

Страница 34: ...e 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 surger...

Страница 35: ...ut 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...

Страница 36: ...ls 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 th...

Страница 37: ...ion 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 Exci...

Страница 38: ...toclave 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 pl...

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: ...leaning 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 ca...

Страница 54: ...k 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 sterili...

Страница 55: ...uthorized 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 o...

Страница 56: ...ence 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 publi...

Страница 57: ...s Mains 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...

Страница 58: ...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 NO...

Страница 59: ...tion 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 se...

Страница 60: ...ence 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 reflectio...

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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