Smartdop 45 Bi-Directional Doppler User Manual
Contents
1. Note Only PS2 keyboard is available 28 r OTHERS P ID PRT Patient data print 1 Press Enter to change the mode ON Prints with patient data OFF Prints without patient data s OTHERS PRB KEY Probe button function 1 Press Enter to change the probe button function PHI amp FHRZ Freezes and prints PRINT Prints and goes to Monitoring mode 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 DATE sid 22 2804 TIME 12 588 66 2 Scroll item with Right and Left and adjust it with Up and Down 3 Press Enter to fix it or press Back Button to cancel u OTHERS PRINT Printer activation 1 Press Enter to activate the printer Note Pressing Print Button also activates printer Press Print the second time to deactivate printer 29 3 3 LCD DISPLAY 3 3 1 Blood Velocity Mode Waveforms 1 The base line is automatically located at best position Smartdop has 4 base lines the bottom 1 4 from the bottom the center and 3 4 from the bottom 2 The waveform amplitude is automatically adjusted for optimal observation 3 The amplitude scale velocity or frequency per division is displayed at the upper left of the LCD Amplitude scale Compound mode Separate mode 4 When pressing probe button to freeze the wave2. TKLMN P RSTUVMEYZ i H 1 re ctl O n 1 a a k A R M M n WA s 23 9cm g icm WINA WA 2 t1 i K 4 1 W rt hs H Ti Ui FF p AB 5 N u m e rical m y Lj Vy Ll n LF T Y j M AJ 4 1 ir Li i i fi 1 cms Y 7 V sb 4 26 RPE 8 76 N EE SUE EN Et ON EE ON N N EN 0 PI 1 87 HR 98 BPM data area Waveform 4 8M mode Probe Waveform area Frequency Note See 3 5 Numerical Data for the meaning of abbreviations and the definitions of Numerical data 35 3 5 NUMERICAL DATA oystolic velocity cm s or systolic Doppler shift kHz Mean velocity cm s or mean Doppler shift kHz Diastolic velocity cm s or diastolic Doppler shift kHz RP S D S Resistance Parameter RP 1 if waveform goes below base line PI Peak to peak MN Pulsatility Index PI 99 99 SD Heart rate bpm HR Samples displayed on LCD S 273 6 cms kHz MH d r CM kHz D H z cm kHz RP 8 99 50 923 353 ob 9855 FI 5 04 HE 6H BPM HR 6H BPM Unit cm s Unit kHz 36 3 6 EXTERNAL OUTPUTS 7 3 6 1 Headset Connect the headset when necessary The headset cuts off the speaker oee 3 1 Controls and Functions 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 futu
3. Doppler signal processing and occlusion cuff pressure measurements Preparation 1 Connect the PV probe assembly to the main unit and turn it on Note With the PGV 20 probe set the probe switch to the PV mode beforehand Power button 2 Press Enter button to display MENU MEHL MEMORY and make sure MODE is on AC mode MES nc If necessary change to AC mode PATIENT Press Left to get out of the MENU MERS mode 48 Examination Procedure 1 Place the patient in supine position with the leg and hip rotated outward 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 Su Sphyg Extender 2 To Main unit way stopcock PV interface box 4 Turn the stopcock so that air is routed from the sphygmomanometer to the cuff 5 If you wish to input patient data see 3 2 3 g PATIENT 6 Inflate the cuff to 60 mmHg Then turn the stopcock so that it blocks the sphyg and routs cuff pressure to the PV interface box 49 7 The gain is automatically adjusted and the PV waveform is shown on the LCD 8 When the waveform gets stable and rhythmic
4. press the Right to freeze and print the waveform 9 If you wish to save the data on the MENU memory see 3 2 3 a MEMORY MEMORY PATIENT STORE OTHERS 10 Deflate the cuff and repeat steps 3 through 10 of this section for each cuff on each limb 5 3 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 by means of a constricting thigh cuff followed by measurement of the rapidity of emptying when the constricting cuff is suddenly vented Measurement of maximum venous outflow is frequently employed as an adjunct to Doppler venous compression studies 90 Preparation 1 Connect the PV probe assembly to the main unit and turn the it on Note With the PGV 20 probe set the probe switch to the PV mode beforehand Power button 2 Press Enter button to display MENU MEHU MEMORY scroll to MODE and press Enter to EER DC change to DC mode PRTIEHT OTHERS Examination Procedure 1 Place the patient in supine position with the leg and hip rotated outward Use pillows to support the leg and hip It is important that the patient is comfortable and relaxed
5. 03020001 Feb 2003 0401 Jan 2004 Specifications subject to change 98 6 4 SAFETY STANDARDS The unit confirms to the following standards Manufacturing standard IEC60601 1 1 Protection class against electric shock Class ll device Internally powered equipment Protection grade against electric shock Type BF applied part 2 Leak current Based upon IEC60601 1 Housing leak current 10 1 mA or less 10 5 mA or less Patient leak current 10 1 mA or less 10 5 mA or less 59 5 Hadeco
6. D MEMORY 9 READ RS EEN dub 23 c MEMORY CLEAR uu kde ed ica ooi 23 d Baseline MODE Compound Separate 24 e TIME scale Normal Slow 24 f DIR Flow direction 24 PATIENT data ABUT OR ense 25 h DISP OTHERS DISP Waveform Data 26 UPPER IMIEIOF ER D a d 27 J LOWER limit for FHR i deca ee ede cc A Ro s 27 KXOTHERS BANGUA GE zu r ddr ewer REC P das 27 OTHERS UNIT cm s kHz 27 m OTHERS FILTER Arterial Venous filter 28 n OTHERS SMOOTH Smoothing filter 28 o OTHERS CAL Calibration 28 p OTHERS AUTO OFF Automatic shut off 28 q OTHERS KEYBOARD External 28 r OTHERS P ID PRT Patient data print 29 s OTHERS PRB KEY Probe button function 29 COIRERS SAE sch scien iE us o Re ee en R 29 u OTHERS PRINT Printer activation 29 COIS OIA x as oak De DR dele EVA ME dn d yi 30 3 3 1 Blood Velocity Mode 30 3 3 2 Fetal Heart Rate FHR Mode 31 3 3 3 Battery R CALOTS s aa a dear bd a daaa A bio dete aw dos 33 3 4 Printing Waveforms amp Data 34 3 9 INumerieal Dal usua DEL ERK eee ROC BARA SR es 36 osouEXIBIal OUPS asa
7. OFF 1 Connect the probe with round polarity mark up 12 o clock on the probe connector and press the power button to turn the unit ON 2 Press the power button again to turn the unit OFF Power button 3 When Smartdop is turned ON first time the message as shown in picture right will MEMORY CLEQRED appear press Enter button to proceed PUSH ENTER BUTTON 4 When battery is low low battery indicator appears as shown right You can use Enter button omartdop for some time though we strongly recommend recharging battery as soon as possible for further use Low battery indicator 5 AUTOMATIC POWER OFF When the AUTO OFF mode is ON if the unit is left on the power is automatically shut off after following time passes a 35minutes when in measurement Only Fetal Heart Rate WAVE mode b 15minutes when in measurement Except Fetal Heart Rate WAVE mode C 2 minutes when no signal d 5 minutes when on freeze mode 2 2 CHARGING DISCHARGING BATTERY 1 Turn the unit off and plug the AC adaptor to the unit to charge battery Charging indicator The charging indicator will go solid orange while charging is in progress Note Use the designated adaptor FRIWO Model FW 3299 15 0974 for Europe 2 When the battery is fully charged the charging indicator will go solid green AC adaptor connector Unplug the AC adaptor 3 Discharging battery When the batt
8. 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 right Pull the paper edge out a few inches and close the paper cover Cover Open Button 2 5 MEASURING BLOOD VELOCITY This section explains the fundamental use of measuring blood velocity Refer to 3 Appearance and Mode Settings for various uses 1 Connect the probe to the Smartdop with the round polarity mark up on the probe connector 12 o clock 2 Put ultrasonic gel on the probe top or patient skin 3 Press the power button to turn the unit on Turn the volume control to maximum If you wish to enter the patient data see 3 2 3 g Patient Data Input Power button Volume control 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 60 degrees gt Blood flow 5 When the waveform becomes rhythmical and stable wait more than 5 sec without moving the probe and then press the probe button to freeze and print the waveform of last 5 sec Note Probe button function can be selected from Freeze amp Print Freeze and Print on PRB KEY mode setting 6 Headset can be used to listen to Doppler sounds It will cut off the speaker Headset connector 10 2 6 MEASURING FETAL HEART RATE 2 MHz onl
9. 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 through a speaker or a headset oimultaneously the Doppler shift signals are applied to the CPU and converted to blood flow velocity wave form signals which can be displayed and printed 55 6 2 BLOCK DIAGRAM uong MOVE uolng ew n nJ uojnq 4 uonnq eqoJg 027 fid2 cod asn E e Jayeeds HUN UIEN indino l li 1 M07 ssed pueg 7 I Jojdepe Sy JO eJI2SO 1 yH 56 6 3 SPECIFICATIONS Probes Power Consumption Recharge Full charge life Battery life Automatic shut off Freguency range Mode settings Waveform memory LCD display Printer Model Freq Probe povver multi freq BI2M20S8C 2 MHz 80 mW cm or less BI4M05S8C 4 MHz 180 mW cm or less BI5M05S8C 5 MHz 180 mW cm or less BI8M05S8C 8 MHz 180 mW cm or less BT10M5S8C 10 MHz 180 mW cm or less Ni MH rechargeable battery pack or AC adaptor FRIWO model FW 3299 15 0974 Input 230 V AC 50 Hz Output 12 V DC 580 mA Fuse 250 V 80 mA Or 120 V AC 12 V DC 580 mA for US and Canada DC 12 V 300 mA Approx 3 hours by the AC
10. data on the MEHI memory see 3 2 3 a MEMORY STORE OTHERS 15 Press the Right to get out of the freeze mode 5 3 5 Menu for PV MODE Coupling 0 ID NAME SEX AGE DATE SITE MEMO ENGLISH DEUTSCH ITALIANO ESPANOL FRANCAIS AUTO OFF ON OFF KEYBOARD ENGLISH JAPANESE erm P ID PRT Patient PRB KEY Probe button PRT amp FRZ PHINT FREEZE DATE MMM DD YYYY HH MM SS Note MODE is selectable when in Measurement mode and PRINT is available when in Freeze mode 53 5 3 6 PV Mode setting MODE AC DC Only Measurement mode 1 Press Enter to change the mode AC AC coupling mode for arterial pulse waveform studies DC DC coupling mode for venous reflux study 54 6 TECHNICAL INFORMATION 6 1 PRINCIPLES Model Smartdop 45 is designed to obtain various blood flow velocity through the ultrasound which is transmitted from probe to patient body and is reflected by the blood hemocyte etc The unit amplifies the high frequency oscillation output and then supplies it to the transmitter transducer It is converted to ultrasound by the transducer and the ultrasound is transmitted to external objects The ultrasound 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
11. stable and rhythmic press Right or probe button to PP 16 8 HR 89 freeze and print the waveform 5 If you wish to save the data on the MEHU memory see 3 2 3 a MEMORY MEMORY PATIENT STORE OTHERS 42 5 2 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 have been emptied through exercise Preparation 1 Connect the PPG probe assembly to the main unit and turn it on Note With the PGV 20 probe set the probe switch to the PPG mode beforehand 2 Press Enter button to display MENU Scroll to MODE and press Enter to change to DC mode COUNT PHTTEMT OTHERS 3 If desired scroll to COUNT and press Enter and then change the number of times for patient dorsiflexes Press Left to get out of the MENU mode 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 lime is warm Cold constricts superficial blood vessels and thus jeopardizes the accuracy of PPG measurements 43 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 against the skin surface to the medial malleolus over the posterior tibial vein Fix the probe in place with d
12. structure and Selecting mode setting from menu first a Menu structure MODE TIME DIR DISP menu placement depends on basic mode Measurement Freeze Blood velocity 2 1 Fetal heart rate 1 1 17 LOWER COUNT OTHERS PP 2 MHz XR only LANGUAGE m r z m D SMOOTH Smoothing Display mode Calibration AUTO OFF Auto shut off KEYBOARD PID PRT Patient data print PRB KEY Probe button g D 7 z m r V b Menu operation 1 Press Enter to go to Menu mode omartdop will display the menu depending on Basic Mode Scroll Button 2 Select the mode by pressing Up button or Down button and selected FEE DU mode will be highlighted Press Enter 2 button once or twice to change the DIF mode PATIENT 3 For MEMORY PATIENT and OTHERS press Enter button or Right button to display sub menu Press Up button or Down button for the selection of sub menu HHHD 1254567398 MAME TARO HALELO SER MALE HOE 31 DATE Jan 31 28805 SITE RADIAL RIGHT d l EXHMIHHT OT HEF S BEES ENGLISH UM IT cm FILTER z Hz SMOOTH BHz DISP WAVE 18 4 For MEMORY sub menus and LANGUAGE press Up or Down button again for the selection of memory number or language FREEZE 5 Press Left button to go back to main menu from submenu or get out of the menu mode c Menu for Bloo
13. unit and patient are not under abnormal conditions 4 When any abnormality is found on the unit or the patient take proper action such as stopping operating the unit in a manner safe to the patient 5 Do not let the patient touch the unit 6 Use the designated accessories only such as the probe 7 Do not use the accessories with other devices 8 Use the unit under the operating environments specified on the specifications 9 Use the Smartdop as specified in the operation manual 7 After use 1 Return all switches to the conditions before use and turn off the power supply following the prescribed procedures 2 Do not apply excessive force to disconnect the cables such as pulling them too strongly 3 Clean the unit accessories cables and probes and place in right place for the next use 8 Storage 1 Take care of 1 to 5 of section 4 in the previous page 2 Clean the unit accessories cables and probes and place in right place for the next use 3 When using the unit next time follow the maintenance procedures to make sure it works properly and safely 9 Do the periodical inspection by following the procedures mentioned in 4 1 Performance Check Procedures by User 1 Inspection must be done once a year 10 Probes 1 Clean the probe using damp cloth or a recommended probe cleaner before use Using alcohol or thinner may damage the probe 2 The probe transducer tip is very thin and delic
14. 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 the other patient data area t overwrites the existing data All items except DATE will be pasted at once 5 CLEAR will delete the patient data 6 PASTE and CLEAR commands require PATIENT the confirmation as shown right Press Enter to proceed or press Left to cancel CLEAR 7 Press Back Button to go back to Patient PASTE Data screen h DISP OTHERS DISP Waveform Data 1 Press Enter to change the Display mode Blood Velocity mode WAVE Displays waveforms DATA Displays numerical data See 3 3 1 Blood Velocity mode for the details Fetal Heart Rate mode WAVE Monitors heart rate in graph Monitoring mode DATA Displays heart rate every moment See 3 3 2 Fetal Heart Rate mode for the details Note Display mode cannot be changed on Freeze mode 26 When Display mode is WAVE in measurement mode pressing Up or Down resets monitoring data and restarts measurement i UPPER Upper limit for FHR When the heart rate exceeds the upper limit the LCD flushes After more than 30 seconds have passed since the start 1 Press Up and Down to select the upper limit of heart rate and press Enter to fix it
15. when used under normal conditions In the event of a problem during the warranty period please contact your dealer In case the warranty period is over please consult the dealer for a charged service 38 5 OPTIONS 5 1 OPTIONAL ACCESSORIES Doppler probes 2 4 5 8 and 10 MHz with curled or straight cable PPG probe Model PG 21 PV probe Model PV 20 PPG PV probe Model PGV 20 svvitchable single channel Cuffs DVC 1 9 DPC 2 5 VC 10 VC 12 ophyg Tubing 120 cm 3 Way stopcock Smart V Link software with communication cable Smart Fetal Link software with communication cable 5 2 PHOTOPLETHYSMOGRAPH With the PG 21 and PGV 20 PPG mode Smartdop senses the reflection of light from the hemoglobin of the red blood cells in surface vessels by utilizing infrared light Basically How to use photoplethysmograph is described in this manual For other matters such as Cautions Technical information and Interpretations of test result refer to the Operating Manual comes with your PPG probe assembly 39 5 2 1 PPG Photoplethysmography Probe Assemblies Single channel photoplethysmography PPG probe Probe button MERO PPG probe N e Model PG 21 owitchable dual modality PPG PV single channel probe EN the main PPG PV mode switch PPG probe Model PGV 20 5 2 2 Clinical Applications AC Coupling Arterial pulse waveform studies Toe pressure DC Coupling Venous reflux stud
16. 2 Wrap a wide occluding cuff at mid thigh and a sensing cuff at mid calf 3 Connect a 3 way stopcock to the inlet of PV interface box Interconnect the stopcock tubing cuff and om as shown below ophyg Extender maiale To Main unit way stopcock PV interface box 91 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 g PATIENT MEMORY OTHERS 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 to the PV interface box 8 Disconnect the sphyg from the stopcock and attach it to the occluding cuff at the thigh 9 Press Right to begin the measurement process 10 Inflate the occluding cuff at the thigh to at least 60 mmHg Pressures in the cuff are plotted on the screen The graph will indicate a gradual increase in waveform amplitude signifying that venous outflow is blocked by the occluding cuff 11 After 90 seconds disconnect the sphyg from the occluding cuff Th PETI c rom the occluding cuff The pressures s 62 mmHa on the screen will drop back to the J 9 62 mmHa 129 baseline 12 Smartdop will automatically stop the measurement process and then freeze and print the waveform 52 13 If you wish to save the
17. OPERATING MANUAL Smartdop 45 BI DIRECTTONAL BLOOD FLOVVMETER VVith VVaveform Display and Printer 9 Hadeco Excellence in Human Service and Technology Hadeco Inc TABLE OF CONTENTS Cautions 1 Introduction Y Fedlilfes mis HERRIE oud Item 2 1 2 Clinical Applications 3 1 5 Piobe Sele liod uier 000 00 4 144 AGCOSSONGOS EER DORRE BEREA RU E EER OE RA ed 4 2 Quick Start 2 1 Turning the Unit On Off 5 2 2 Charging Discharging Battery 6 2 3 Checking Battery Level 7 2 4 Setting Printer Paper 8 2 5 Measuring Blood Velocity 9 2 5 Measuiing Fetal nea Bate qosa UR ea ede 11 3 Appearance and Mode Settings 3 1 Operating Controls 13 2 2 Mode Sell US a aia obo aa bao aaa AGE Oe A 16 A 2 1 Basic MOOSS s za saa da ca we Rae PEE Ma Res 16 0 Uum 17 a Merit STUCCIU Aaa aca doo dos aO ese Cte a Redi a bes 17 D Menu Operallon ausus d x dX seed eat do OE EES 18 c Menu for Blood Velocity Measurement Mode 19 d Menu for Blood Velocity Freeze Mode 20 e Menu for Fetal Heart Rate Mode Measurement amp Freeze 21 3 2 3 Mode Setting Deftails 22 a MEMORY STORE uu so cad Ee ee ee ee SI da ics 22
18. The heart rate is selectable every 5 bpm Upper limit Lower limit 131 BPhMx 2 j LOWER Lower limit for FHR When the heart rate is blow the lower limit the LCD flushes After more than 30 seconds have passed since the start 1 Press Up and Down to select the lower limit of heart rate and press Enter to fix it The heart rate is selectable every 5 bpm k OTHERS LANGUAGE 1 Press Up and Down to select the language in which menus and messages are written And press Enter to fix it I OTHERS UNIT cm s kHz 1 Press Enter to change the unit of blood flow cm s Blood flow velocity kHz Doppler frequency shift 27 m OTHERS FILTER Arterial Venous filter The high pass filter cuts low frequency components of the Doppler signal to reduce noise Choosing 200 Hz for artery or 80 Hz for vein is recommended 1 Press Enter to change the frequency of filter n OTHERS SMOOTH Smoothing filter 1 Press Enter to change the smoothing frequency o OTHERS CAL Calibration 1 Press Enter to change the mode ON Displays 4 step 3 2 1 0 1 kHz calibration waveform OFF Measurement mode p OTHERS AUTO OFF Automatic shut off 1 Press Enter to change the mode For the explanation of Automatic shut oif refer to 2 1 Turning the unit ON OFF q OTHERS KEYBOARD External 1 Press Enter to change the keyboard ENGLISH 104 English keyboard PS2 JAPANESE 109 Japanese keyboard PS2
19. adaptor 2 5 hours or more if used with freeze mode Approx 2 years 300 full charges No signal 2 min Freeze 5 min Others 15 min only FHR WAVE mode 35 min 80 200 Hz to 5 kHz Memory Waveform Direction Time scale Others 30 waveforms 128 x 64 dots STN LCD Bi directional wave form normal amp slow mode Numerical data Systolic diastolic amp mean velocities RP PI SD HR Heart rate 30 to 300 BPM accuracy of 5 Battery level and low battery indicators Paper 58 mm W x 25 m roll L Thermal 57 Velocity accuracy opeaker output External outputs Electrical safety Resolution 384 dots line Print speed 25 mm s 10 or less comparing with internal phantom testing 250 mW or more Headset USB port Conform to IEC60601 1 Internally powered equipment Type BF applied part Operating environment otorage and transpo Dimensions Weight Manufacturing date 10 to 40 degrees Centigrade 85 humidity or less with no condensation rt environment 0 to 50 degrees Centigrade Main unit 115 W x 210 D x 60 H mm Probe 20 Diam x 105 L mm 560 grams including battery amp probe 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 may start with Serial number or S N Examples
20. ate Please handle with care and use the probe cap when not in use 11 Ultrasonic gel 1 Use ultrasonic gel only for non invasive use Using other materials such as baby oil and cream may cause incorrect Doppler sounds 2 Using other materials may damage the probe 3 The ultrasonic gel enclosed is non sterile and do not use it for surgeries 4 Incidence of allergy Discontinue use of gel if an allergic reaction occurs 12 Battery 1 When battery is extremely low the LCD display will not operate Also there will be no speaker sounds Charge the battery 2 Battery life is 300 full charges When full charging life is obviously short contact your dealer for replacing 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 persons should perform the repair services 14 Do not disassemble the Smartdop 15 Destruction 1 In case of destruction of the unit follow the instructions for disposition of the destruction appointed by each country or local government 16 Any connected computer is not allowed to be in the patient area according to IEC60601 1 1 INTRODUCTION Thank you very much for choosing the Smartdop 45 The Hadeco Smartdop 45 is a uniquely designed bi directional handheld Doppler with LCD display and fast printer It detects arterial and venous blood flows in extremities as well as fetal heart sounds The Smart
21. carefully before you operate the unit 1 Only skilled persons should operate the unit 2 Use the unit for blood flow measurement purposes only 3 Do not apply any modification to the unit 4 Unit installation 1 Take care of storage and operating environments 2 Do not place near water 3 Dot not place where atmospheric pressure temperature humidity ventilation sunlight dust salt sulfur and so forth will not affect the unit adversely 4 Take care of the stability conditions such as inclination vibration and shock during transportation and installation works 5 Do not place where chemicals are stored or where gas may be generated 6 Do not place where the unit tends to fall 5 Before use 1 Make sure that the unit operates safely and correctly by following the maintenance procedures mentioned in 4 1 Performance Check Procedures by User 2 Make sure that all cables are connected correctly and safely 3 Using more then one equipment together may result in erroneous diagnosis from malfunction or cause a danger 4 Recheck external connections to the patient carefully 5 Do not sterilize the main unit by gas autoclave or so on to prevent any damage 6 Operation 1 Do not use the unit simultaneously with an electric cautery cardioverter other ultrasonic device or mobile phone 2 Be careful not to exceed time and volume which is necessary for diagnosis treatment 3 Always watch so the
22. d Velocity Measurement mode MODE X Compound A Separate 5 TE may Sow 5 b ID NAME SEX AGE DATE SITE Note Selections in bold face in the table above are defaults 19 ENGLISH DEUTSCH ITALIANO LANGUAGE ESPANOL FRANCAIS FILTER 80Hz 200Hz OTHERS d Menu for Blood Velocity Freeze mode moe Compud Ay Separate o fom e Reverse b os ID NAME SEX AGE DATE SITE PRINT Note Selections in bold face in the table above are defaults ENGLISH DEUTSCH ITALIANO LANGUAGE ESPANOL FRANCAIS AUTO OFF ON OFF OTHERS 20 e Menu for Fetal Heart Rate mode Measurement and Freeze MEMORY PATIENT data ID NAME SEX AGE DATE SITE MEMO ENGLISH DEUTSCH ITALIANO ula ESPANOL FRANCAIS AUTO OFF ON OFF KEYBOARD ENGLISH JAPANESE P ID PRT Patient Ure data print ON OFF PRB KEY Probe button PRT amp FRZ PRINT FREEZE DATE MMM DD YYYY HH MM SS Note When in Freeze mode PRINT is available and only WAVE is selectable on DISP mode Selections in bold face in the table above are defaults Button functions limited to Fetal Heart Rate mode 1 Right To freeze the waveform amp numerical data 2 Up Down To cancel and restart the measurement on Monitoring mode 3 Left To go to next page on Freeze mode 21 3 2 3 Mode Setting Details To get to following menu items see 3 2 2 b Menu Operatio
23. dop displays velocity waveforms numerical data and fetal heart rate Also it prints them out Please read this manual carefully to acquaint yourself with the Smartdop 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 refer to the operating manual for Windows linking software 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 Button 30 waveform memory for waveform numerical data heart rate and patient data CONVENIENT PROBE ACTIVATION BUTTON Freezes amp prints waveform and numerical data for notation MULTIPROBE SELECTION of 2 4 5 8 and 10 MHz AUTOMATIC POWER OFF USB COMPUTER INTERFACE otores waveforms and numerical data in your computer for data analyzing and filing Communication cable and Windows software are optional Photoplethysmograph PPG and Pneumoplethysmograph PV PROBES OPTIONAL Expands arterial amp venous testing 1 2 CLINICAL APPLICATIONS 1 2 1 Detections of fetal heart rate Probe to be used 2 2058 2 MH
24. ection 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 15 3 2 MODE SETTINGS 3 2 1 Basic Modes omartdop has following five Basic Operation Modes Blood Velocity Measurement For measuring blood velocity Blood Velocity Freeze For observing waveforms and numerical data Fetal Heart Rate Measurement For measuring fetal heart rate Fetal Heart Rate Freeze For observing heart rate and graph e Menu For changing Other Mode Settings Changing Basic Mode with probe connection Blood Velocity Fetal Heart Rate Connect 4 5 8 or 10 MHz probe to the probe connector and turn the unit on for Blood Velocity mode Connect 2 MHz probe to the probe connector and turn the unit on for Fetal Heart Rate mode Optional operation modes are available by connecting optional PPG and PV probes See 5 Options Changing mode with probe button Measurement Freeze Press the probe button to go to freeze mode and press again to get back to measurement mode With 2 MHz probe Fetal Heart Rate mode pressing Right button also changes this mode 16 3 2 2 Menu Using Scroll Button various mode settings are changeable on Menu mode oome menus have sub menus Refer to following Menu
25. er Outputs Doppler sounds 5 Probe connector To connect probe 6 Power button Q To turn the unit on off 7 Volume control To adiust sound volume 8 Strap hole To attach hand strap 13 9 Headset ih 10 AC adaptor connector To connect the designated AC adaptor 11 Keyboard connector connect PS2 keyboard 12 Charging indicator H 13 Scroll Button 14 15 16 17 18 Up Hight Down Left Enter 19 Print Back Button 121 4 To connect headset It cuts off the speaker Indicates battery status Orange Charging Green Fully charged Consists of 5 internal buttons and has following functions To select upper menu item To increase waveform memory number in Freeze mode To move cursor up on the on screen keyboard To move cursor right on the on screen keyboard To go to submenu To select lower menu item To decrease waveform memory number in Freeze mode To move cursor down on the on screen keyboard To move cursor left on the on screen keyboard To go back to main menu from submenu or get out from menu To go to menu mode To perform the selected command on the menu To activate deactivate the printer To go back to previous screen 14 3 1 2 Front right view and Probe 1 Probe holder For probe placement when not in use 2 Communication port gt gt To connect computer USB 3 Probe Multi probe sel
26. ery is not fully discharged charging battery may cause the short charge life of the battery In this case we recommend discharging the battery before charging Turn the unit off and plug the AC adaptor Press Back Button and hold it and press Enter button to display battery level e While holding Back Button press Right button to discharge the battery e The DISCHARGE will be displayed on the LCD e After the discharging completed charge process will start automatically and the DISCHARGE will disappear then charging indicator will go solid orange Back Button Enter button Note Ittakes about 3 hours to fully charge battery Battery life 1s 300 full charges Contact your dealer for replacing battery Right button 2 3 CHECKING BATTERY LEVEL Battery level indicator shows upper right of the menu screen 15 MODE id TIME DIR Te 1 Turn the unit on and press Enter button to PRTIENT display the menu 2 Battery level indicator shows the battery Low level in 4 steps as shown right LI 3 Charge the battery when in low Medium Empty M Y When turning the unit on in case battery is extremely low the message shown right appears and all data such as waveform memories and PUSH ENTER BUTTON mode settings have been cleared MEMORY CLEARED 1 Press Enter button to go to Measurement mode and charge the battery 2 4 SETTING PRINTER PAPER 1 Press Cover
27. f each mode in 3 2 3 Mode Setting Details Mode Abbrev a Baseline mode MODE b Time scale TIME c Flow direction DIR d Language LANGUAGE e Unit UNIT f Smoothing filter SMOOTH g Waveform Data DISP h Patient data print P ID PRT 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 Selection Compound Separate Normal Slow Forward Reverse English Deutsch Italiano Espafol Fran ais cm sec kHz b Hz 10 Hz VVave Data ON OFF Also pressing probe button makes print when Print button PRB KEY is on PRI amp FRZ or PRINT mode stops printing automatically 34 THERS a 2 Smartdop prints following waveforms and then DRTE aM ENGLISH PHITENT FREEZE Tan 1 Ha Blood Velocity mode TIME is Normal Waveform of the 5 sec before freezing TIME is Slow VVaveform of the 25 sec before freezing FHR mode Monitoring mode Waveform of up to the 33 minutes before freezing 3 Press Print button or execute PRINT command the second time to deactivate the printer 3 4 2 Print sample Units L D 1 7 7 7 JT 7 7 7 LLLA Sep 29 2004 12 00 00 ID 1214567890 i Mene MEDE 4 Patient A A h SITE LEFT RADIAL A Time scale 20 8 AE EER MEMO 1234567 836BECDEF GHI data area i n
28. form Smartdop will stop monitoring sequence and will display frozen waveform with FREEZE 30 5 The read out waveform is displayed with Memory number memory number e g 01 at the upper right of the LCD Numerical data Following numerical parameters are displayed on DATA mode 25 5 EMS 4 7 CM 2 comes H 99 Sp BE AA ar44 HE S BPM Unit cm s Unit kHz See 3 5 Numerical Data for the meaning of abbreviations and the definitions of parameter 3 3 2 Fetal Heart Rate FHR mode Only 2 MHz probe Displaying heart rate at the moment DATA mode Heart rate is displayed based on a 4 beat average once the Smartdop gets sufficient data to calculate The heart mark V tracks heart beat while in measurement Asterisk is displayed when calculated When calculated heart rate is not stable heart rate is not stable the asterisk is displayed 31 Note The heart mark also indicates the speed of heart movements in 3 different size of heart marks ia y Fast Medium Slow Monitoring heart rate in graph WAVE mode Monitoring mode 1 The measurement range of heart rate is 60 to 220 bpm 2 The heart rate at the moment is displayed on the bottom left of the screen FHR monitoring waveform Heart rate 220 200 Upper limit 100 Lower limit 60 Measuring time Heart r he momen 23 0 Asterisk is displayed when calculated heart rate is not stable 3 Heart mar
29. k indicates the same as in DATA mode 4 Two dotted lines indicate Upper and Lower limits of heart rate When the heart rate is out of limits LCD will flash After more than 30 seconds have passed since the start 32 5 When pressing probe button or Right button to freeze the waveform omartdop will stop monitoring sequence and will display the monitoring waveform of up to the last 33 minutes within 4 pages with em 15 BPM 2 28 FREEZE indicator Approx 8 minutes a page Max Min Press Left button to go to next page 6 The read out waveform from memories Page number Memory number is displayed with memory number e g 01 at the upper right of the screen 3 3 3 Battery Indicators Battery level indicator Battery level indicator shows upper right of the menu screen See 2 3 Checking Battery Level for the details Low battery indicator When the battery is low the low battery indicator will be shown on bottom right of LCD Recharge the battery oee 2 2 Charging Discharging Battery 33 156 115 EP 2 28 Battery level indicator MEHU MODE TIME DIF PATIENT Low battery indicator 3 4 PRINTING WAVEFORMS and DATA 3 4 1 The mode settings influencing printed chart The following mode settings influence the printed waveform and data omartdop prints depending on the present mode settings Change modes before printing if desired Note Refer to the description o
30. me Soie on EE RE baie our Gerace am aros 37 cM A cr 37 4 Maintenance 4 1 Performance Check Procedures by User 38 65 INGE ab quide edat Ste eaa ED DE so en od Ble ER EE 38 A M ri MEER 30 5 Options 5 1 Optional Accessories x Ree RE DECRE epe dod 39 5 2 Photoplethysmograph 39 5 2 1 PPG Photoplethysmography Probes 40 5 2 2 Clinical Applications 40 5 2 3 PPG Arterial Pulse Waveform Studies 40 5 2 4 PPG Venous Reflux Study 43 De OV Menur PERG aacsuxductu at ae t dos acid e deae due SCR ES 46 5 2 6 PPG ModeSettings 46 5 3 Pneumoplethysmograph 47 5 3 1 PV Pneumoplethysmography Probes 47 5 3 2 Clinical Applications 48 5 3 3 PV Arterial Pulse Waveform Studies 48 5 3 4 PV Measurement of Maximum Venous Outflow 50 Menu Or PV ab dde fei b b CUR Ce C e de cs 53 5 3 6 PV Mode Settings 54 6 Technical Information o C ce sam a a LT TOILET ER EA 55 0 2 BIOCK DIAGlIAN used auno EE ER AE BE ERI s aw es 56 0 DDECHICSHIOLS a ER AAS Aa ERA 57 6 4 Safety Standards t s DECR Rar 59 CAUTIONS Please read the following important points
31. n Do the mode setting once and subsequent Smartdop use will revert to this mode However when battery gets extremely low the settings will get back to default settings a MEMORY STORE 1 The first memory number available will be MEMORY selected automatically and displayed right FREEZE side of STORE on the menu If necessary change the memory number in which you wish to store the waveform including numerical data and patient data by pressing Up and Down Note The memory number with indicates in which data is being stored 2 Press Enter to store the data into the memory and it will go back to display the waveform automatically Note When storing the data into data existing memory the confirmation OVERWRITE will be displayed Press Enter to overwrite or press Left to cancel When on measurement mode the data have been frozen before executing STORE command 22 b MEMORY READ 1 Select the memory number from which HENGERES you wish to read the data waveform numerical data and patient data by CLEAR pressing Up and Down 2 Press Enter button to read the data from the memory 3 Press Up and Down to display next waveform if necessary Note When going into freeze mode the frozen data will be stored automatically into memory of FREEZE If you need to see the frozen data after reading other data from the memory read FREEZE on the LCD c MEMORY CLEAR 1 Select the mem
32. n Measurement mode and it will apply to all of future measurement data until its 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 MEHR 12245678938 OTHERS DATE menu and set the date MAME TARO HRDECO n SER MALE AGE 31 and time for an initial setting DATE Tan 31 28685 SITE RHDIRL RIGHT Scroll to the item where you wish to input MEMO DOPPLER E AMINAT 10 and press Enter to display data input screen With SEX pressing Enter Screen keyboard changes Male to Female or vice versa ABCDEFGHIJKLM DATE data can be changed on PATIENT menu when on FREEZE mode only 2 Scroll to the letter you wish and press Enter to type it Pressing Back Button or entering Backspace deletes the letter you typed previously 3 After entering the data press and hold Print Back for longer than 1 sec to save the data or scroll to m Back and press Enter to do it 4 Press Left to get out of Patient Data screen When using external PS2 keyboard 1 Press any key on the keyboard to open Patient Data screen 2 Use cursor keys to select item and input the data by typing letters 3 Press Esc or End to save the data and get out of Patient Data screen 25 Copy Paste Clear of the data You can copy and paste the patient data to the other patient data area
33. ory number in which data MEMORY STORE H a2 you wish to clear by pressing Up and READ BL s Down Ihe memory number with PLI Ell ou indicates in which data Is being stored Press Enter and then the confirmation screen with waveform stored in the memory will be displayed as shown in the picture right Press Enter to clear the 4 CLEAR memory or press Left to cancel Y If you choose ALL and press Enter all MEMORY data in the memories will be cleared STORE HO ai READ FREEZE except FREEZE frozen data suz an 23 d MODE Baseline mode 1 Press Enter to change the mode Compound mode A Combined forward and reverse components Separate mode AA Separation of forward from reverse component ur 18 8 Compound mode oeparate mode e TIME Time scale 1 Press Enter to change the time scale Normal 2 56 sec screen Intended use Examinations for artery Slow 2 12 8 sec screen Intended use Examinations for vein f DIR Flow direction 1 Press Enter button to change the direction of waveform Forward Flow toward probe is processed as positive component Reverse Flow away from probe is processed as positive component 18 8 cm s Forward mode Heverse mode 24 g PATIENT Patient data input The patient data can be input This setting contains ID NAME SEX AGE examination DATE anatomical SITE and MEMOrandum Save the patient data o
34. ouble sided clear tape 3 If you wish to input patient data see 3 2 3 g PATIENT MEI eu OTHERS 4 Press Right or probe button to begin the measurement process 5 Ask the patient to flex the foot specified number of times on COUNT following the foot animation on LCD The exercise should be forceful especially when lifting the foot upward 6 After flexing instruct the patient to relax the foot and avoid all movement 7 The test is complete when the waveform on the LCD returns to the baseline amplitude omartdop will automatically freeze and print the venous reflux study waveform jo sec 44 8 If you wish to save the data on the memory see 3 2 3 a MEMORY STORE OTHERS 9 Press the Right to get out of the freeze mode 45 5 2 5 Menu for PPG m MODE Goupin s 0 cow H LANGUAGE ENGLISH DEUTSCH ITALIANO ESPANOL FRANCAIS AUTO OFF ON OFF KEYBOARD E ENGLISH JAPANESE P ID PRT Patient data print ON OFF PRB KEY Probe button PRT amp FRZ PRINT FREEZE DATE MMM DD YYYY HH MM SS 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 2 6 PPG Mode settings MODE AC DC Only Measurement mode 1 Press Enter to change the mode AC AC coupling mode for arterial pulse waveform studies DC DC coupling mode for venou
35. re reference as well as a report of 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 EN symbols Descriptions 1 2 oymbols Descriptions O Headset Volume control b i 4 AC adaptor connector Keyboard connector 5 21 Power button Print Button La Charging indicator 37 4 MAINTENANCE 4 1 PERFORMANCE CHECK PROCEDURES BY USER Perform the following performance checks once a year 1 Make sure if there is no damage and or crack on the main unit and probe 2 Shake the main unit and make sure if there are no sounds inside from internal components coming out 3 Turn the unit on and make sure if the LCD displays normally 4 2 CLEANING PROBE Hemove the Doppler gel from the probe head after use Clean the probe using damp cloth and then wipe with a soft dry cloth but take great care that any 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 4 3 WARRANTY This equipment is guaranteed for the period of one year after the date of purchase
36. s reflux study COUNT Only DC Measurement mode oet the number of times for patient dorsiflexes 1 Press Up and Down to select number of times and press Enter to fix it 46 5 3 PNEUMOPLETHYSMOGRAPH With the PV 20 and PGV 20 PV mode Smartdop senses volume changes in a limb or digit by measuring the pressure changes in a recording cuff Basically How to use pneumoplethysmograph is described in this manual For other matters such as Cautions Technical informations and Interpretations of test result refer to the Operating Manual comes with your PV probe assembly 5 3 1 PV Pneumoplethysmography Probe Assemblies oingle channel pneumoplethysmography PV probe a the main unit Model PV 20 To the cuff Switchable dual modality PPG PV single channel probe the main unit E Q8 ua PPG PV mode ES switch To the cuff Model PGV 20 47 5 3 2 Clinical Applications AC Coupling Arterial pulse waveform studies DC Coupling Measurement of maximum venous outflow 5 3 3 PV Arterial Pulse Waveform 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 Doppler techniques for segmental blood pressure studies Pneumoplethysmography is particularly useful for patients in whom vessel calcification prevents accurate
37. y This section explains the fundamental use of measuring fetal heart rate Refer to 3 Appearance and Mode Settings for various uses 1 Connect the 2 MHz probe to the omartdop with the round polarity mark up on the probe connector 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 h DISP Waveform Data to change the mode Power button Volume control 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 Doppler sounds are heard EE Caution Verify the fetal heart rate Maternal heart rates match the maternal pulse rates 11 6 When the heart rate becomes stable press the probe or Right button to freeze it Note If the stable signals are not being detected the mark will be shown above HR FREEZE HE 1 58 BPI 7 Headset can be used to listen to Doppler sounds It will cut off the speaker Headset connector 12 3 APPEARANCE AND MODE SETTINGS 3 1 OPERATING CONTROLS 3 1 1 Front left view Scroll Button 1 Paper cover For printer paper 2 Cover Open Button To open the paper cover 3 LCD display Displays waveform numerical data heart rate and menu for mode settings 4 Speak
38. y 5 2 3 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 immediately beneath the sensor site When used with a suitable cuff and manometer the method permits the measurement of systolic blood pressure in the fingers and toes 40 Preparation 1 Connect the PPG probe assembly to the main unit and turn it on Note With the PGV 20 probe set the probe switch to the PPG mode beforehand 2 Press Enter button to display MENU and make sure MODE is on AC mode If necessary change to AC by pressing PATIENT OTHERS Enter on MODE 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 that room temperature is comfortable and especially that the skin surface where the probe is to be mounted is warm Cold constricts superficial blood vessels and thus jeopardizes the accuracy of PPG measurements 41 Examination Procedure 1 Apply the sensor with the clear side against the skin surface and fix it in place using Velcro strips or double sided clear tape 2 If you wish to input patient data see 3 2 3 g PATIENT MEMORY OTHERS 3 The gain is automatically adjusted and the PPG waveform is shown on the LCD 4 When the waveform gets
39. z Evaluation of fetal heart rate and sounds throughout pregnancy except where fetal heart is not developed sufficiently during the first trimester 1 2 2 Detections of arterial and venous blood flow velocity Probes to be used BT4MO5S8C 4 MHz BT5MOBSSC 5 MHz BT8MOBSSC 8 MHz BT10M5S8C 10 MHz ABI studies PEAK 8 MEAN blood velocity determinations Peripheral vascular procedures Blood pressure segmental studies Venous compressions Penile amp 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 Other probes are available as optional accessories 2 2058 2 MHz Fetal heart rate and sounds BI4MO5SSC 4 MHz Deep peripheral blood velocity and flow BT5MOBSSC 5 MHz Deep peripheral blood velocity and flow BTSMOBSSC 8 MHz Superficial blood velocity and flow BT10M5S8C 10 MHz Superficial blood velocity and flow 1 4 ACCESSORIES Carrying case 1 AC adaptor 1 Ultrasonic gel 1 mo 1 Headset 1 2 QUICK START For the first time of use and in case the unit has been not used for a while fully charge the internal battery 2 1 TURNING THE UNIT ON
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