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Hadeco Smartdop 45, Operating Manual

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Hadeco Smartdop 45 Operating Manual Download Page 40

 

34 

3-6. External outputs 

3-6-1.Headset 

Connect the headset when necessary. The headset cuts off the speaker. 

See 3-1. Operating Controls. 

 

3-6-2. Communication port (3.5 mm jack) 

To observe the waveform in high resolution on a PC monitor or to store the waveform 

and numerical data into a computer for future reference as well as an entire report for 

standardized testing modules. 

(1) Connect a computer with dedicated communication cable (option). 

(2) Press the Power Button to turn the unit on. 

(3) Run the communication software (option) on your computer. 

 

Note: For software operation, refer to the software operating manual. 

 

3-7. Symbol list 

 

* Caution must be observed to avoid damage to the unit. Refer the operating manual carefully. 

Symbols Description 

Symbol

Description 

 

 

Type BF applied part 

 

USB connector 

 

 

Headset 

 

Volume control 

 

 

Print button 

 

Charging indicator 

 

 

AC adaptor connector 

 

Keyboard connector 

 

 

Caution*¹ 

 

Back button 

 

 

Power button 

 

Manufacturer 

 

 

Authorized 

representative in Europe

 

 

Summary of Contents for Smartdop 45

Page 1: ......

Page 2: ...s 15 3 2 2 Menu 16 a Menu structure 16 b Menu operation 16 c Menu for Blood Velocity Measurement mode 18 d Menu for Blood Velocity Freeze mode 19 e Menu for Fetal Heart Rate mode Measurement and Freeze 20 3 2 3 Mode Setting Details 21 a MEMORY STORE 21 b MEMORY READ 21 c MEMORY CLEAR 22 d MODE Baseline mode 22 e TIME Time scale 23 f DIR Flow direction 23 g DISP OTHERS DISP Waveform Data 23 h UPPER...

Page 3: ... Rate FHR mode Only 2 MHz probe 29 3 4 Printing waveforms and data 31 3 5 Numerical data 33 3 6 External outputs 34 3 7 Symbol list 34 4 Maintenance 35 4 1 Performance check by user 35 4 2 Cleaning 35 4 3 Warranty 35 5 Options 36 5 1 Probe selection 36 5 2 Sterilizable doppler probes 36 5 3 Photoplethysmograph 39 5 4 Pneumoplethysmograph 45 6 Technical information 51 6 1 Principles 51 6 2 Block di...

Page 4: ...by User 2 Make sure that all cables are connected correctly and safely 3 Using it with other equipment together may cause a misdiagnosis or danger to patient due to a malfunction 4 Double check that all the cables do not obstruct any external connection to the patient 5 Do not sterilize the main unit by gas autoclave or so on to prevent any damage 6 Sterilizable probes should be sterilized before ...

Page 5: ...in and delicate Please handle with great care and use the probe cap when not in use 3 Optional sterilizable probe reusable disposable can be sterilized in the manner described in 5 2 Sterilizable Doppler probes However only one time sterilization is possible for disposable probe and do not reuse it Except optional ACP probe do not sterilize probes by steam autoclave 11 Ultrasonic gel 1 Do not appl...

Page 6: ...epair services 15 Do not disassemble the unit 16 Destruction 1 In case of destruction of the unit follow the instructions for disposal of the destruction appointed by each country or local government 2 Do not place battery in a fire or it may cause an explosion and injury 17 Any connected computer is not allowed to be in the patient area according to IEC60601 1 ...

Page 7: ...tware optional 1 1 Features BI DIRECTIONAL HANDHELD DOPPLER WITH LCD DISPLAY and FAST PRINTER Displays real time velocity waveforms numerical data and heart rate Prints frozen waveform numerical data and monitored heart rate as well as patient data HADECO DESIGNED SMART MICROPROCESSOR Various mode settings are available for optimal measurement with the menu displayed on the LCD and unique Scroll B...

Page 8: ...2 Communication cable and Windows software are optional PHOTOPLETHYSMOGRAPH PPG AND PNEUMOPLETHYSMOGRAPH PV PROBES OPTIONAL Expands arterial venous testing ...

Page 9: ...mental studies Venous compressions Penile digit systolic pressures Flow velocities in recovery room 1 3 Probe selection The frequency of diagnostic ultrasound is inversely proportional to depth of penetration The Smartdop has 5 interchangeable probes with different frequencies Use those probes depending on your applications Note One of these probes comes with Smartdop 45 as a standard accessory Ot...

Page 10: ...4 1 4 Contents of package Main unit 1 Probe 1 AC adaptor 1 Ultrasonic gel 1 Paper 1 Carrying case 1 ...

Page 11: ...s shown in the right 12 o clock 2 Press the power button to turn the unit OFF 3 When Smartdop is turned ON first time the message as shown in the picture right will appear press Enter button to proceed 4 When battery is low low battery indicator appears as shown in the right Smartdop can be used for a few more minutes Recharge the battery as soon as possible for further use Low battery Polarity ma...

Page 12: ... the AC adaptor to the unit to charge battery The charging indicator will go solid orange while charging is in progress Note Use the designated adaptor see 6 3 Specifications 2 When the battery is fully charged the charging indicator will go solid green Unplug the AC adaptor 3 Discharging battery Using and charging the battery repeatedly without fully discharging may cause a shorter full charge ba...

Page 13: ...ws upper right of the menu screen 1 Turn the unit on and press Enter button to display the menu 2 Battery level indicator shows the battery level in 4 steps as shown right 3 Charge the battery when in low Low battery indicator When the battery is low the low battery indicator will be shown on bottom right of LCD Recharge the battery See 2 2 Charging Discharging Battery If battery gets extremely lo...

Page 14: ...harge the battery 2 4 Setting printer paper 1 Press Cover Open Button to open the paper cover and remove the roll shaft 2 Insert the roll shaft into the paper roll 3 Set them in the paper compartment as shown in the right Pull the paper edge out a few inches and close the paper cover tightly Cover Open Button Roll shaft ...

Page 15: ...to maximum If you wish to enter the patient data see 3 2 3 j Patient Data Input 4 Put the probe on the measurement area and move it slowly to locate the point where the maximum Doppler sounds are heard An ideal probe angle to the vessel is approximately 45 to 60 degrees 5 When the waveform becomes rhythmical and stable wait more than 5 sec without moving the probe and then press the probe button t...

Page 16: ...he right 12 o clock 2 Put ultrasonic gel on the probe top or the skin surface 3 Press Power button to turn the unit on Turn the volume control to maximum 4 If you wish to monitor heart rate waveform see 3 2 3 g DISP Waveform Data to change the mode 5 Put the probe on the middle of the abdomen at right angle to the skin surface and move it slowly to locate the point where the maximum heart beat Dop...

Page 17: ...omes stable press the probe button or Right button to freeze it Note If the stable signals are not being detected the mark will be shown above HR 7 Headset Option can be used to listen to Doppler sounds It will cut off the speaker ...

Page 18: ...lays waveform numerical data heart rate and menu for mode settings 4 Speaker Outputs Doppler sounds 5 Probe connector To connect probe 6 Power button To turn the unit on off 7 Volume control To adjust sound volume 8 Strap hole To attach hand strap 9 Headset To connect headset It cuts off the speaker 2 3 4 5 6 7 8 8 9 10 1 12 13 19 1 Scroll Button 14 15 16 17 18 Back Button ...

Page 19: ... number in Freeze mode To move cursor up on the on screen keyboard 15 Right To move cursor right on the on screen keyboard To go to submenu 16 Down To select lower menu item To decrease waveform memory number in Freeze mode To move cursor down on the on screen keyboard 17 Left To move cursor left on the on screen keyboard To go back to main menu from submenu or get out from menu 18 Enter To go to ...

Page 20: ...uter USB 3 Probe Multi probe selection of 2 4 5 8 and 10 MHz 4 Probe button To freeze and unfreeze the waveform To activate and deactivate the printer Note The function is defined in the menu PRB KEY See 3 2 3 s OTHERS PRB KEY for the details 5 Probe cap To protect the probe transducer tip when probe is not in use 4 5 3 2 1 ...

Page 21: ...Menu For changing other mode settings Changing Basic Mode with probe connection Blood Velocity Fetal Heart Rate Connecting 4 5 8 or 10 MHz probe sets on Blood Velocity mode automatically Connecting 2 MHz probe sets on Fetal Heart Rate mode automatically Optional operation modes are available by connecting optional PPG and PV probes See 5 Options Changing mode with probe button Measurement Freeze P...

Page 22: ... structure and Menu operation first a Menu structure b Menu operation 1 Press Enter to show MENU depending on Basic Mode 2 Select the mode by pressing Up and Down buttons and selected mode will be highlighted Press Enter once or twice to change the mode setting 2 MHz only PPG DC only Scroll Button Back Button Up Right Down Left Enter ...

Page 23: ...er or Right button shows sub menu for further mode settings 4 For MEMORY sub menus and LANGUAGE press Up or Down button again for the selection of memory number or language 5 Press Left button to go back to main menu from submenu or get out of the menu mode ...

Page 24: ...Patient LANGUAGE ENGLISH DEUTSCH ITALIANO ESPANOL FRANCAIS k Others Language UNIT cm s kHz l Others Unit FILTER 80Hz 200Hz m Others Filter SMOOTHING 5Hz 10Hz n Others Smooth DISP display mode WAVE DATA g Others DISP CALibration ON OFF o Others CAL AUTO OFF ON OFF p Others Auto off KEYBOARD ENGLISH JAPANESE q Others keyboard P ID PRT Patient data print ON OFF r Others P ID PRT PRB KEY Probe button ...

Page 25: ...isplay mode WAVE DATE g DISP PATIENT date ID NAME SEX AGE DATE SITE MEMO j Patient LANGUAGE ENGLISH DEUTSCH ITALIANO ESPANOL FRANCAIS k Others Language AUTO OFF ON OFF p Others Auto off KEYBOARD ENGLISH JAPANESE q Others keyboard P ID PRT Patient data print ON OFF r Others P ID PRT PRB KEY Probe button PRT FRZ PRINT FREEZE s Others PRB KEY DATA MMM DD YYYY HH MM SS t Others Date OTHERS PRINT u Oth...

Page 26: ...e AUTO OFF ON OFF p Others Auto off KEYBOARD ENGLISH JAPANESE q Others keyboard P ID PRT Patient data print ON OFF r Others P ID PRT PRB KEY Probe button PRT FRZ PRINT FREEZE Others PRB KEY DATA MMM DD YYYY HH MM SS t Others Date OTHERS PRINT u Others Print Note PRINT is only available when in WAVE Freeze mode DISP mode is not changeable when on freeze mode Selections in bold face in the table abo...

Page 27: ...e waveform data and patient data by pressing Up and Down Note The memory number with indicates memory area where other data have been already stored 2 Press Enter to store the data into the memory and it will go back to waveform display Note If other data have been already stored in memory number storing a confirmation of OVERWRITE will be shown Press Enter to overwrite or Left to cancel for selec...

Page 28: ...emory area where data have been already stored 2 Press Enter and then the confirmation screen with waveform data will be displayed as shown in the right Press Enter to clear the memory or press Left to cancel 3 To 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 Enter to change the baseline mode as follows Compou...

Page 29: ...ocessed as positive component g DISP OTHERS DISP Waveform Data 1 Press Enter to change the Display mode as follows Blood Velocity mode WAVE Displays waveforms DATA Displays numerical data See 3 3 1 Blood Velocity mode for more details Fetal Heart Rate mode WAVE Monitoring waveform DATA Numerical data See 3 3 2 Fetal Heart Rate mode for more details Note Display mode cannot be changed when on Freez...

Page 30: ...ng contains ID NAME SEX AGE examination DATE anatomical SITE and MEMOrandum Save the patient data on Measurement mode and it will apply to all of future measurement data until it s changed so that you won t have to input the same data for the same patient again If it is done on Freeze mode the patient data will apply only to the stored FREEZE data selected 1 Prior to the patient data input go to O...

Page 31: ... the data and get out of Patient Data screen Copy Paste Clear of the data You can copy and paste the patient data to the other patient data area when on FREEZE mode mainly for your convenience 1 Press Back Button while Patient Data screen is displayed 2 Scroll to the edit command and press Enter 3 COPY will copy all items of the patient data to clipboard 4 PASTE will paste the clipboard data to th...

Page 32: ... than filtering frequency 200 or 80 Hz for optimal audibility 1 Press Enter to change the filter as follows 200 Hz For arteries 80 Hz For veins n OTHERS SMOOTH Smoothing filter 1 Press Enter to change smoothing frequency as follows 10 Hz For normal signals 5 Hz For noisy signals o OTHERS CAL Calibration 1 Press Enter to change CAL mode as follows ON Displays 4 step 3 2 1 0 1 kHz calibration wavefo...

Page 33: ...tton function as follows PRT FRZ Freezes and prints PRINT Prints and goes to Monitoring mode as follows FREEZE Freezes Note When on FHR DATA mode only FREEZE is functional no matter what is selected on the PRB KEY mode t OTHERS DATE Date and time setting 1 Press Enter to go to Date Setting screen 2 Scroll item with Right and Left and adjust it with Up and Down 3 Press Enter to fix it or press Back...

Page 34: ...m 2 The waveform amplitude is automatically adjusted for optimal observation 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 Smartdop will stop monitoring sequence and will display frozen waveform with FREEZE 5 The read out waveform is displayed with memory number e g 01 on top right of LCD Compound mode M...

Page 35: ...robe Displaying heart rate at the moment DATA mode 1 Heart rate is displayed based on a 4 beat average once the Smartdop gets sufficient data to calculate 2 The heart mark tracks heart beat while in measurement The heart mark also indicates the speed of heart movements in 3 different sizes as follows Fast Medium Slow 3 When calculated heart rate is not stable the asterisk will show above HR Unit c...

Page 36: ... will start flashing for warning 5 When on freeze mode by pressing probe or Right 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 The read out waveform from memories is displayed with memory number e g 01 on top right LCD Lower Heart rate 220 200 FHR monitoring wave...

Page 37: ...nglish Deutsch Italiano Español Français e Unit UNIT cm s kHz f Filter FILTER 80Hz 200Hz g Smoothing filter SMOOTH 5 Hz 10 Hz h Waveform Data DISP Wave Data i Patient data print P ID PRT ON OFF 3 4 2 How to print Printing waveform and data is available on Freeze mode and Patient Data Input mode 1 Press Print button or execute PRINT command on the menu mode to print waveforms Also pressing probe bu...

Page 38: ...utton or execute PRINT command the second time to deactivate the printer 3 4 3 Print sample Note See 3 5 Numerical Data for the meaning of abbreviations and the definitions of Numerical data Unit Time scale Direction Waveform mode Probe Frequency Patient data area Numerical data area Waveform ...

Page 39: ...Doppler shift kHz MN Diastolic 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 below base line Pulsatility Index PI PI Peak to peak MN PI 99 99 S D ratio SD SD S D Heart rate BPM HR Samples displayed on LCD Unit cm s Unit kHz ...

Page 40: ...t a computer with dedicated communication cable option 2 Press the Power Button to turn the unit on 3 Run the communication software option on your computer Note For software operation refer to the software operating manual 3 7 Symbol list Caution must be observed to avoid damage to the unit Refer the operating manual carefully Symbols Description Symbol Description Type BF applied part USB connec...

Page 41: ...water may not penetrate into the probe If using disinfectant 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 4 1 Performance check by user before using the unit 4 3 Warranty Guarantee period Frequency...

Page 42: ...scular lapaloscopic neurovascular cardiovascular Amplifier Model BDP MS8 Frequency 8 10 20 MHz PPG probe Model PG 21 PPG PV probe Model PGV 20 switchable single channel Cuffs DVC 1 9 DPC 2 5 VC 10 VC 12 Sphyg Tubing 120 cm 3 way stopcock Smart V Link software with communication cable Smart Fetal Link software with communication cable Headset 5 2 Sterilizable doppler probes VRP Vascular LRP Lapalos...

Page 43: ...ticular requirements Preparation for cleaning No particular requirements Cleaning Automated Do not do automated cleaning of probes other than ACP probe Manual Do not soak probes into medicinal solution Wipe any contamination from probes with damp cloth Disinfection Not applicable Sterilization Sterilizable probes except ACP probe Low temperature plasma sterilization Hydrogen peroxide low temperatu...

Page 44: ...r Doppler sounds properly when you rub probe tip Packaging No particular requirements Storage No particular requirements Manufacturer contact Hadeco Inc 2 7 11 Arima Miyamae ku Kawasaki 216 0003 Japan Tel 81 44 877 4361 Fax 81 44 855 7301 The instructions provided above have been validated by the medical device manufacturer as being CAPABLE of preparing a medical device for reuse It remains the re...

Page 45: ...chnical information and Interpretations of test result refer to the Operating Manual that comes with your PPG probe 5 3 1 PPG Photoplethysmography Probe Assemblies Single channel photoplethysmography PPG probe Model PG 21 Switchable dual modality PPG PV single channel probe Model PGV 20 5 3 2 Clinical Applications AC Coupling Arterial pulse waveform studies Toe pressure DC Coupling Venous reflux s...

Page 46: ...ct the PPG probe to the main unit and turn it on Note With the PGV 20 probe set the PPG PV mode switch to the PPG mode beforehand 2 Press Enter button to display MENU and make sure MODE is on AC mode If it s been set for DC mode press Enter on MODE to change to AC Press Left to get out of the MENU mode 3 Check that the face of the PPG sensor is free of stains Clean it if necessary 4 Make certain t...

Page 47: ...ets stable and rhythmic press Right or probe button to freeze the waveform Press Print Button to print the waveform of last 5 sec if necessary 5 If you wish to save the data on the memory see 3 2 3 a MEMORY STORE 5 3 4 PPG Venous Reflux Study Purpose The venous reflux study is performed to assess valvular competence by measuring the amount of time required for venous refilling after calf veins hav...

Page 48: ...e 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 on an examination table so that the feet are off the floor 2 Apply the sensor with the clear side agai...

Page 49: ...ially when lifting the foot upward 6 After flexing instruct the patient to relax the foot and avoid all movement 7 The test is completed when the waveform returns to the baseline and Smartdop will automatically freeze the waveform Press Print Button to print the waveform if necessary 8 If you wish to save the data on the memory see 3 2 3 a MEMORY STORE 9 Press the Right to get out of the freeze mo...

Page 50: ...RT Patientdataprint ON OFF r Others P ID PRT PRB KEY Probebutton PRT FRZ PRINT FREEZE s Others PRB KEY DATE MMM DD YYYY HH MM SS t Others Date OTHERS PRINT u Others Print Note MODE is selectable when in Measurement mode and PRINT is available when in Freeze mode COUNT is used for DC mode when in Measurement mode 5 3 6 PPG Mode settings MODE AC DC Only available in Measurement mode 1 Press Enter to...

Page 51: ...e channel probe Model PGV 20 5 4 2 Clinical Applications AC Coupling PV Arterial studies DC Coupling Measurement of maximum venous outflow 5 4 3 PV Arterial Studies Purpose Pneumoplethysmography is useful in detecting arterial occlusive conditions in the lower limbs through analysis of waveform patterns The method is sufficiently sensitive for digital studies PV also offers an alternative to Doppl...

Page 52: ...rd Use pillows to support the leg and hip comfortably 2 Wrap cuffs of appropriate width around the thigh at the groin above the knee below the knee and at the ankle on both limbs Avoid wrapping cuffs tightly The fit should be snug but comfortable 3 Connect a 3 way stopcock to the inlet of the PV interface box Interconnect the stopcock tubing cuff and sphygmomanometer as shown in the diagram below ...

Page 53: ...mb 5 4 4 PV Measurement of Maximum Venous Outflow Purpose Because deep venous occlusion cannot be diagnosed reliably on the basis of presenting signs and symptoms pain and swelling being frequently due to other causes objective screening tests are of value in confirming or ruling out suspected venous obstructions in the lower extremities The test consists of first inducing temporary venous pooling...

Page 54: ...the stopcock tubing cuff and sphygmomanometer as shown below 4 Turn the stopcock so that air is routed from the sphygmomanometer to the sensing cuff at mid calf 5 If you wish to input patient data see 3 2 3 ｊ PATIENT 6 Inflate the sensing cuff to 40 mmHg Wait 10 seconds to allow time for settling and deflate the cuff to 15 mmHg 7 Turn the stopcock so that it blocks sphyg and routes cuff pressure t...

Page 55: ...locked by the occluding cuff 11 After 90 seconds disconnect the sphyg from the occluding cuff The pressures on the screen will drop back to the baseline 12 Smartdop will automatically stop the measurement process and then freeze the waveform Press Print Button to print the waveform if necessary 13 If you wish to save the data on the memory see 3 2 3 a MEMORY STORE 14 Press the Right to get out of ...

Page 56: ...Language AUTO OFF ON OFF p Others Auto off KEYBOARD ENGLISH JAPANESE q Others Keyboard P ID PRT Patient data print ON OFF r Others P ID PRT PRB KEY Probe button PRT FRZ PRINT FREEZE s Others PRB KEY DATE MMM DD YYYYHH MM SS t Others Date OTHERS PRINT u Others Print Note MODE is selectable when in measurement mode and PRINT is available when in Freeze mode 5 4 6 PV Mode setting MODE AC DC Only Meas...

Page 57: ...ltrasound moves straight through biophysical object and is reflected by the moving object blood flow fetal heartbeat 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 s...

Page 58: ...52 6 2 Block diagram ...

Page 59: ... more if used with freeze mode Battery life Approx 2 years 300 full charges Automatic shut off No signal 5 min Freeze 10 min Others 15 min only FHR WAVE 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 Bi directional waveform normal slow mode Numerical data Systolic diastolic mean...

Page 60: ...o condensation Dimensions Main unit 92 W x 210 D x 60 H mm Probe holder not included Probe 20 Diam x 105 L mm Weight 560 grams including battery probe Manufacturing date The first 2 digits and following 2 digits of the serial number represent the year and month of manufacturing respectively The serial number is located inside of the printer paper compartment and it consists of 4 to 8 digits and ma...

Page 61: ...ance RF emissions CISPR 11 Group 1 The Smartdop 45 use RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A Harmonic emissions IEC61000 3 2 Class A Voltage fluctuations flicker emissions IEC61000 3 3 Complies The Smartdop 45 is suitable for use in all establishments...

Page 62: ...r should be that of a typical commercial or hospital environment Surge IEC61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycle...

Page 63: ...d 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 the equipment marked with the following symbol ｓｓｓNOTE 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 a...

Page 64: ...Manufactured by Hadeco Inc 2 7 11 Arima Miyamae ku Kawasaki 216 0003 Japan SD45 OM E 24 June 2013 Printed in Japan 080 00095 2 4 ...

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