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Hadeco Bidop ES-100V3, Руководство по эксплуатации

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3 

1-2. Clinical applications 

• 

Detections of arterial and venous blood flow velocity for vascular 

disease 

 

Probes to be used: 

BT2M20S8C 

(2 MHz) 

 

 

BT4M05S8C 

(4 MHz) 

 

 

BT5M05S8C 

(5 MHz) 

 

 

BT8M05S8C 

(8 MHz) 

 

 

BT10M5S8C 

(10 MHz) 

 

*  PEAK & MEAN blood velocity determinations 

*  Detection of arterial and venous blood flow velocity for vascular 

disease 

 

 

 

 

 

Содержание Bidop ES-100V3

Страница 1: ......

Страница 2: ......

Страница 3: ...enu operation 15 4 1 2 MENU for Blood Velocity Measurement mode 16 4 1 3 MENU for Blood Velocity Freeze mode 16 4 1 4 MENU for Heart Rate mode Measurement and Freeze 17 4 1 5 MENU for 2MHz BEEP Measurement mode 18 4 1 6 MENU for 2MHz BEEP Freeze mode 18 4 2 Mode setting details 19 a MEMORY STORE 19 b MEMORY READ 19 c MEMORY CLEAR 20 d MODE Baseline mode 20 e DIR Flow direction 20 f TIME Time scale...

Страница 4: ... 25 5 3 1 Sterilizable probes Amplifier required 25 5 3 2 Sterilization 26 5 4 Warranty 29 6 Supplemental information 30 6 1 Basic mode 30 6 2 LCD display 30 6 2 1 Blood Velocity mode 30 6 2 2 Heart Rate mode Only 2 MHz probe 32 6 2 3 2 MHz BEEP mode 34 6 3 Numerical data 35 6 4 External outputs 36 6 5 Symbol list 36 6 6 Contents in package 36 7 Options 37 7 1 Probe selection 37 7 2 Others 38 7 3 ...

Страница 5: ...d or where gas may be generated 6 Do not place it where the unit tends to fall 7 Do not place it on or adjacent other electronic device 5 Before use 1 Make sure that the unit operates safely and correctly by following the maintenance procedures mentioned in 5 1 Performance check by user 2 Make sure that all cables are connected correctly and safely 3 Using it with other equipment together may caus...

Страница 6: ...ent 7 After use 1 Turn the unit off the way specified 2 Do not pull the cable s too much while disconnecting or it may cause damage 3 Clean the unit cables and probes and place them in right place for the next use 8 Storage 1 Follow the caution 2 to 6 of section 4 Device placement in the previous page 2 Clean the unit probes and place them in right place for the next use 3 When using the unit next...

Страница 7: ...attery is extremity low the LCD display will not operate Also there will be no speaker sounds Replace the battery 2 Use a 9 volt alkaline square type battery A non alkaline may cause a shortage of power 3 When not using the unit for a long time remove the battery 13 Repair services 1 When the unit gets out of order contact the dealer for repair from whom you purchased the unit 2 Only authorized pe...

Страница 8: ... blood flows in extremities The Bidop displays velocity waveform and numerical data Please read this manual carefully to acquaint yourself with the Bidop operation This medical device can be used by doctor for the purposes mentioned in 1 2 Clinical Applications for patient in hospital and clinic For the use with computer please refer to the operating manual for Windows linking software optional ...

Страница 9: ... LCD and unique side Shuttle Button 30 waveform memories CONVENIENT PROBE ACTIVATION BUTTON Freezes waveform and numerical data for notation Turns Bidop ON and OFF MULTIPROBE SELECTION of 2 4 5 8 10 and 20 MHz USB COMPUTER INTERFACE Stores waveforms and numerical data in your computer for data analyzing and filing Communication cable and Smart V Link Windows software are optional PHOTOPLETHYSMOGRA...

Страница 10: ...nous blood flow velocity for vascular disease Probes to be used BT2M20S8C 2 MHz BT4M05S8C 4 MHz BT5M05S8C 5 MHz BT8M05S8C 8 MHz BT10M5S8C 10 MHz PEAK MEAN blood velocity determinations Detection of arterial and venous blood flow velocity for vascular disease ...

Страница 11: ...he speaker 3 Serial port To connect computer USB 4 Volume control To adjust sound volume 5 Shuttle Button To turn the unit ON OFF press it inside To select menu turn it up or down To set the mode or execute command press it inside To display next memory data turn it up and down Press inside Turn up Turn down ...

Страница 12: ...splays waveform numerical data Heart Rate and menu for mode settings See 6 2 LCD Display for details 2 2 Back side view and Probe 9 Probe holder For probe placement when not in use 10 Strap holes To connect neck strap Option 11 Battery cover For battery placement 12 Probe button To turn the unit ON To freeze the waveform numerical data when power is ON To turn the unit OFF press it longer than 2 s...

Страница 13: ... OFF Low battery When battery is low low battery indicator appears Replace the battery for further use Automatic shut off When the AUTO OFF is ON if the unit is left on the power is automatically shut off after following time passes a 15 minutes when in measurement 35 min for FHR waveform mode b 2 minutes when no signal c 5 minutes when on freeze mode Note If Automatic shut off functions while on ...

Страница 14: ... with new one as follows 2 When you replace battery turn the unit off and open the battery cover as shown right 3 To prevent any damage to the battery terminal please insert the battery to battery box as shown right 4 Use a 9 volt ALKALINE square type battery A non alkaline may cause a shortage of power Set the battery in the unit ensuring that the positive and negative terminals correspond to the...

Страница 15: ...int where the maximum Doppler sounds are heard An ideal probe angle to the vessel is approximately 45 to 60 3 When the waveform becomes rhythmical and stable wait more than 5 sec without moving probe and press the probe button to freeze the waveform Note Pressing probe button longer than 2 sec will turn the unit OFF 4 To get numerical data press BACK button or go to menu and change the DISP mode t...

Страница 16: ... button on STORE and next memory number available for storage will be displayed as shown in the right Turn Shuttle Button up and down to change the memory number if necessary 3 Press the Shuttle button to store the data To display stored data 1 Press the Shuttle button to go to MEMORY menu 2 Press the Shuttle button on READ and select the memory number with by turning the Shuttle Button up and dow...

Страница 17: ...h Smart V Link to activate this mode Once the names are registered the unit will show each of names at the beginning of each testing to let you know where to test next Preparation for site guidance mode 1 Connect the unit to the computer with the USB cable and start Smart V Link 2 Go to Site Screen and input abbreviated site test name for each waveform memory and then store the names on the unit 3...

Страница 18: ...ess the probe button the 2nd time to freeze the waveform when it becomes stable and the 2nd guidance STORE as shown in the right will appear 4 Press probe button the 3rd time to store the frozen waveform data on the designated memory number 5 The 1st guidance for the next testing will appear as shown in the right Repeat steps 5 to 7 until all testing is completed Press probe button when the messag...

Страница 19: ... 220 BPM at 5 BPM intervals and press the Shuttle button to set them See 4 2 i UPPER and 4 2 j LOWER for details 3 Put ultrasonic gel on the probe top or patient skin surface 4 Put the probe on the measurement area and move it slowly to locate the point where the maximum sounds are heard 5 When the heart rate becomes stable press the probe button or BACK button while using waterproof probe to free...

Страница 20: ... memory Note2 If the asterisk is shown above the frozen heart rate as a calculation error indicator press probe button and do the testing again Manual counting mode is available if heart rate cannot be calculated see 6 2 2 Heart Rate mode 6 Headset can be used to listen to Doppler sounds It will cut off the speaker Lower limit Upper limit WAVE mode DATA mode ...

Страница 21: ...e right 3 Change the LIMIT 1 by turning the Shuttle button Up Down between 0 and 120 cm s at 1 cm s intervals and press the Shuttle button to set it Set LIMIT 2 for MAX or AVE as follows MAX To beep when max velocity exceeds upper limit AVE To beep when average velocity exceeds upper limit 4 Put ultrasonic gel on the probe top or the skin surface 5 Put the probe on the measurement area and move it...

Страница 22: ...w MENU depending on Basic mode Select the mode by turning Shuttle Button up and down and selected mode will be highlighted Press it once or twice to change the mode setting For MEMORY and OTHERS in MENU pressing Shuttle Button shows sub menu for further mode settings Press BACK button to go back to main menu from sub menu or get out of the menu mode Press inside Turn up Turn down BACK button Shutt...

Страница 23: ...EEZE MANUAL AUTO t OTHERS FREEZE UNIT cm s kHz n OTHERS UNIT FILTER ARTERIAL VENOUS o OTHERS FILTER SMOOTH NORMAL LOW PASS p OTHERS SMOOTH DISP WAVE DATA g DISP CAL ON OFF q OTHERS CAL BACKLIGHT ON OFF 10 to 60 10 sec steps r OTHERS BACKLIGHT AUTO OFF ON OFF s OTHERS AUTO OFF PRB20MHz ON OFF u OTHERS PRB20MHz Note PRB20MHz menu is only available when either a 20MHz probe or no probe is connected 4...

Страница 24: ... Menu Selections Reference in 4 2 MEMORY STORE 1 to 30 FREEZE a MEMORY STORE READ 1 to 30 FREEZE b MEMORY READ CLEAR 1 to 30 ALL c MEMORY CLEAR DISP WAVE DATA BEEP g DISP SOUND ON OFF h SOUND UPPER 60 to 220 every 5 BPM i UPPER LOWER 60 to 220 every 5 BPM j LOWER OTHERS LANGUAGE ENGLISH DEUTSCH ITALIANO ESPANOL FRANCAIS TURKCE POLSKI m OTHERS LANGUAGE BACKLIGHT ON OFF 10 to 60 10 sec steps r OTHER...

Страница 25: ...enu Sub Menu Selections Reference in 4 2 MEMORY STORE 1 to 30 FREEZE a MEMORY STORE READ 1 to 30 FREEZE b MEMORY READ CLEAR 1 to 30 ALL c MEMORY CLEAR DISP WAVE DATA BEEP g DISP DISP BEEP WAVE DATA g DISP OTHERS LANGUAGE ENGLISH DEUTSCH ITALIANO ESPANOL FRANCAIS TURKCE POLSKI m OTHERS LANGUAGE BACKLIGHT ON OFF 10 to 60 10 sec steps r OTHERS BACKLIGHT AUTO OFF ON OFF s OTHERS AUTO OFF Button functi...

Страница 26: ...her data have been already stored in memory number storing a confirmation of OVERWRITE will be shown Press Shuttle Button to overwrite or BACK to cancel it for selecting other memory number available b MEMORY READ 1 Select the memory number where you wish to read waveform data by turning Shuttle Button up and down 2 Press Shuttle Button to show the waveform To show next waveform stored press Shutt...

Страница 27: ...clear all the data except FREEZE in the memory at once select and press on ALL and follow the instruction d MODE Baseline mode 1 Press Shuttle Button to change the baseline mode as follows Compound mode Combined forward and reverse components Separate mode Separation of forward from reverse component e DIR Flow direction 1 Press Shuttle Button to change waveform polarity as follows Forward Flow to...

Страница 28: ...heart rate measurement mode with WAVE mode turning Shuttle button up down to restart the monitoring h SOUND Beep sound for HR Set SOUND mode for ON to activate beep sounds when heart rate gets out of upper and lower limits during the test except 1st 30 sec 1 Press Shuttle Button to change beep sound ON OFF i UPPER Upper limit for HR In case heart rate exceeds the upper limit during the test except...

Страница 29: ...imit m OTHERS LANGUAGE 1 Turn Shuttle Button up and down to select the language you wish for menus and messages and press the button to set it n OTHERS UNIT cm s kHz 1 Press Shuttle Button to change the unit of blood flow as follows cm s Blood flow velocity kHz Doppler shifted frequency o OTHERS FILTER Arterial Venous filter The high pass filter cuts off Doppler signals with lower frequencies than...

Страница 30: ...0 sec steps BACKLIGHT can be also turned ON OFF by pressing BACK button longer than 2 sec When BACKLIGHT is set for Auto off backlight goes off in auto off time of no operation and any button operation will turn the light on again s OTHERS AUTO OFF Automatic shut off 1 Set it for ON OFF for auto off on off See 3 1 Turning the unit ON OFF for more details t OTHERS FREEZE 1 Set FREEZE for AUTO to fr...

Страница 31: ...imated vessel diameter by turning Shuttle button Up Down for anywhere between 0 1 and 20 0 mm at 0 1 mm intervals and Bidop will calculate and show blood volume flow of numerical data MAX Maximum and MN Mean on DATA display Note Set DISP mode for DATA to display numerical data and press BACK button to show flow MAX and MN on 2nd page of numerical data as shown below 2nd page of numerical data 1st ...

Страница 32: ... then wipe with a soft dry cloth but take great care that any water may not penetrate into the probe If using disinfectant please consult in advance with the manufacturer MAIN UNIT To clean the main unit use a damp cloth and then wipe with a soft dry cloth but take great care that any water may not penetrate into the unit Check the unit by maintenance procedures mentioned in 5 1 Performance check ...

Страница 33: ...e probes except ACP and FDP probe Up to 50 times ACP probe Up to 5 times by steam autoclave FDP probe Up to 5 times Note Do not exceed sterilization limits or it may cause damage to probes Cautions 1 Except ACP probe do not sterilize probes by steam autoclave nor put them in washer disinfector or it will damage probes 2 ACP probe should be sterilized by steam autoclave as described in section Inst...

Страница 34: ...lose inside sterilization equipment or it may reduce effectiveness of sterilization because these substances absorb hydrogen peroxide Eliminate water on surface of probe because it may reduce effectiveness of sterilization Sterilization should be performed in accordance with instructions of the sterilization equipment ACP probe Steam autoclave 30 minutes at 121 C 4 minutes at 134 C Do not expose p...

Страница 35: ...ovided above have been validated by the medical device manufacturer as being CAPABLE of preparing a medical device for reuse It remains the responsibility of the processor to ensure that the processing as actually performed using equipment materials and personal in the processing facility achieve the desired result This requires validation and routine monitoring of process Likewise any deviation b...

Страница 36: ... sterilization Probe Except European Union Countries TP 01 One 1 year CRP H CRP 20H1N NRP H Six 6 months NRP 10HF NRP 20H1NF Three 3 months Single use probe Either one year from the date of purchase or out of box failure The guarantee period is after the date of purchase when used under normal condition In the event of any trouble during the warranty period please contact the dealer from who you p...

Страница 37: ...her mode settings Changing mode with probe button Measurement Freeze Press the probe button to go to freeze mode and press it again to get back to measurement mode Note If the probe button is pressed longer than 2 sec the unit will turn OFF With 2 MHz probe you can also change mode Measurement Freeze by pressing BACK button of the unit 6 2 LCD display 6 2 1 Blood Velocity mode Waveforms 1 The base...

Страница 38: ...op will stop monitoring and will display frozen waveform with FREEZE Memory number is shown on top right of LCD for waveform read from MEMORY e g 01 Numerical data Following numerical parameters are displayed on DATA mode Amplitude scale Slow mode 25 6 sec screen Unit cm s Unit kHz Amplitude scale Division Compound mode Separate mode Memory number ...

Страница 39: ...ficient data to calculate 1 The heart mark tracks heart beat while in measurement The heart mark also indicates the speed of heart movements in 3 different size sizes as follows 2 When calculated heart rate is not stable the asterisk will show above HR Manual counting mode 1 Turn Shuttle up and hold to start manual counting and M and the time passed will be shown on the top right while on manual c...

Страница 40: ...LCD will start flashing 5 When on freeze mode by pressing probe or BACK button the latest monitoring waveform of up to 33 minutes can be shown over 4 pages on LCD with FREEZE indicator Turn Shuttle Button down to show next page Approx 8 minutes a page 6 Memory is shown on top right of LCD waveform read from MEMORY as shown in the right Page number Freeze indicator Max Min Memory number Measuring t...

Страница 41: ...ding on limit 3 The amplitude scale velocity or frequency per division is displayed on top left of LCD 4 When pressing probe button to freeze the waveform Bidop will stop monitoring and will display frozen waveform with FREEZE Amplitude scale Limit 1 MAX waveform AVE waveform dotted line will be displayed when on AVE mode for LIMIT 2 LIMIT 2 Base line ...

Страница 42: ...olic velocity cm s or diastolic Doppler shift kHz D Minimum velocity cm s or minimum Doppler shift kHz MIN Resistance Parameter RP RP S D S RP 1 if waveform goes blow base line Pulsatility Index PI PI S MIN MN PI 99 99 S D ratio SD SD S D Heart rate BPM HR Max volume flow MAX Mean volume flow MN Vessel diameter DIAM Samples displayed on LCD Unit cm s Unit kHz ...

Страница 43: ...on cable option 2 Press the Power Button to turn the unit on 3 Run Smart V Link option on your computer Note For software operation refer to the software operating manual 6 5 Symbol list Symbols Description Symbols Description Type BF applied part Back button Headset Shuttle button Power ON OFF Manufacturer Serial port Authorized representative in Europe Volume control 6 6 Contents in package Main...

Страница 44: ...es depending on your applications Standard Doppler probe Standard 2MHz BT2M20S8C 4MHz BT4M05S8C 5MHz BT5M05S8C 8MHz BT8M05S8C 10MHz BT10M5S8C Flat 2MHz BF2M20S8A 8MHz BF8M15S8A Sterilizable probe Amplifier required Small pencil 8MHz VRP 08 10MHz VRP 10 20MHz VRP 20 Long 8MHz LRP 08 10MHz LRP 10 Flat 8MHz FDP 08 Autoclavable 8MHz ACP 08 ...

Страница 45: ...xible 10MHz NRP 10HF 20MHz NRP 20H1NF Single use 10MHz NDP 10H 20MHz NDP 20H Amplifier 8MHz BDP8MS8 10MHz BDP10MS8 20MHz BDP20MS8 PPG probe PG 21 Temperature Probe TP 02 Except European Union Countries 7 2 Others Neck strap Except European Union Countries Smart V Link software with communication cable ...

Страница 46: ...lethysmography Probe Assembly Single channel photoplethysmography PPG probe AC Coupling Arterial pulse waveform studies Toe pressure DC Coupling Venous reflux study 7 3 2 PPG Arterial Pulse Waveform Studies Purpose Arterial pulse waveform studies by photoplethysmography are performed to determine the presence or absence of pulsatile flow and to assess the state of perfusion in the tissue area imme...

Страница 47: ... is to be mounted is warm Cold constricts superficial blood vessels and thus jeopardizes the accuracy of PPG measurements Examination Procedure 1 Apply the sensor with the clear side against the skin surface and fix it in place using Velcro straps PPG clip Option or double sided clear tape 2 The gain is automatically adjusted and the PPG waveform is shown on the LCD High pitched sounds following h...

Страница 48: ...and down to change the number Press BACK to get out of the COUNT sub menu 4 Check that the face of the PPG sensor is free of stains Clean it if necessary 5 Make certain that room temperature is comfortable and that the skin surface of the lower limb is warm Cold constricts superficial blood vessels and thus jeopardizes the accuracy of PPG measurements Examination Procedure 1 Have the patient sit o...

Страница 49: ...elax the foot and avoid all movement 6 The test is completed when the waveform returns to the baseline and Bidop will automatically freeze the waveform and calculate recovery times Note 1 2 is the half recovery time for returning to 50 of refilling amplitude where middle vertical dotted line is shown 7 If you wish to store the data on the memory see 4 2 a MEMORY STORE 8 Press the probe button to g...

Страница 50: ...0 to 60 10 sec steps r OTHERS BACKLIGHT AUTO OFF ON OFF s OTHERS AUTO OFF Note1 STORE menu is available when on freeze mode only Note2 MODE is selectable when in Measurement mode Note3 COUNT is used for DC mode when in Measurement mode 7 3 5 PPG Mode settings MODE AC DC Only available in Measurement mode 1 Select MODE with Shuttle Button 2 Press it to change mode as follows AC For arterial testing...

Страница 51: ...oot temperature screen will be shown as shown in the right 2 Select the temperature unit on UNIT menu for either Celsius C or Fahrenheit F 3 Get the probe tip close to the measurement site less than 4 cm as shown in the right 4 Press the probe button to measure and show the temperature on the LCD Note Comprehensive foot temp study can be organized with Smart V Link for Windows optional Temperature...

Страница 52: ...OLSKI m OTHERS LANGUAGE BACKLIGHT ON OFF 10 to 60 10 sec steps r OTHERS BACKLIGHT AUTO OFF ON OFF s OTHERS AUTO OFF Specifications Temperature measuring method non contact Accuracy 0 5 C measurement range 10 to 40 C when operating temperature is 0 to 40 C Display Resolution 0 1 C FOV 4 1 object distance measuring range Emissivity 0 98 Object 1cm Less than 4cm ...

Страница 53: ...ject and is reflected by the moving object blood flow etc The reflected ultrasound is received by the receiving transducer and is converted into electric signals again The converted signals are amplified and then detected After removing unnecessary noise from the signals and improving S N ratio at the filter circuit the Doppler shift signals are amplified and are converted to audible sounds throug...

Страница 54: ...E mode 35 min Frequency range 80 200 Hz to 5 kHz Mode settings Memory Waveform Direction Time scale Others Waveform memory 30 waveforms LCD display 128 x 64 dots STN LCD with backlight Bi directional waveform normal slow mode Numerical data Systolic diastolic mean velocities RP PI SD HR Heart rate 30 to 300 BPM accuracy of 3 Low battery indicator Velocity accuracy 10 or less comparing with interna...

Страница 55: ...rade against electric shock Type BF applied part 2 Guidance and manufacturer s declaration electromagnetic emissions and immunity IEC60601 1 2 2014 4th Edition Guidance and manufacturer s declaration electromagnetic emissions The ES 100V3 is intended for use in the electromagnetic environment specified below The customer or the user of the ES 100V3 should assume that it is used in such an environm...

Страница 56: ...n power supply input lines IEC61000 4 11 Dip to 0 for 1 cycles 0 phase angle Dip to 70 for 25 30 cycles 0 phase angle Dropout to 0 for 0 5cycle 0 45 90 135 180 225 270 315 Interrupts 100 for 250 300 cycles Not applicable Power frequency 50Hz magnetic field IEC61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or ...

Страница 57: ...n the vicinity of the equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz 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 ...

Страница 58: ......

Страница 59: ...For European Union Countries European Authorized Representative ICHIYAMA GmbH Benderstraße 130 40625 Düsseldorf Germany Tel 0211 298538 Fax 0211 299257 ...

Страница 60: ...Manufactured by Hadeco Inc 2 7 11 Arima Miyamae ku Kawasaki Kanagawa 216 0003 Japan May 2018 Printed in Japan 080 00156 3 1 0123 ...

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