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EDAN SONOTRAX Basic, User Manual

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III 

 

Product Information 

Product Name: 

Ultrasonic Pocket Doppler 

Model:

  SONOTRAX  Lite,  SONOTRAX  Basic, 

SONOTRAX  Basic  A,  SONOTRAX  Pro, 
SONOTRAX  II,  SONOTRAX  II  Pro, 
SONOTRAX Vascular 

Terms Used in this Manual 

T

his guide is designed to give key concepts on safety 

precautions. 

WARNING 

A 

WARNING

 label advises against certain actions or 

situations  that  could  result  in  personal  injury  or 
death. 

CAUTION 

A 

CAUTION

  label  advises  against  actions  or 

situations  that  could  damage  equipment,  produce 
inaccurate data, or invalidate a procedure. 

NOTE

 

A 

NOTE

  provides  useful  information  regarding  a 

function or a procedure.

理邦保密文件

EDAN CONFIDENTIAL

Summary of Contents for SONOTRAX Basic

Page 1: ...mber 01 54 457373 Version 1 2 Product Model SONOTRAX 2009 Project Code 2006A 1000 Signature Originator wangjing 2016 11 24 17 19 51 Reviewers liuxiaoqian 2016 11 25 18 31 52 Reviewers huangdong 2016 1...

Page 2: ...E D A N C O N F I...

Page 3: ...ying with this manual User s operation failing to comply with this manual may result in malfunction or accident for which Edan Instruments Inc hereinafter called EDAN can not be held liable EDAN owns...

Page 4: ...EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability and performance...

Page 5: ...de is designed to give key concepts on safety precautions WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death CAUTION A CAUTION label ad...

Page 6: ...t 23 2 2 6 Batteries 24 2 3 Probes 26 2 3 1 Waterproof Obstetrical Probes 26 2 3 2 Waterproof Vascular Probes 27 Chapter 3 Basic Operation 28 3 1 Opening the Package and Checking 28 3 2 Installing Rep...

Page 7: ...amining Optional 55 4 5 Completing Examining 59 Chapter 5 Maintenance 60 5 1 Maintenance 60 5 2 Cleaning 60 5 3 Disinfection 62 5 4 Sterilization 62 Chapter 6 Warranty and Service 64 6 1 Warranty 64 6...

Page 8: ...3 1 MI Mechanical Index 90 A4 3 2 TI Thermal Index 91 A4 3 3 Measurement Uncertainties 92 A4 4 Prudent Use Statement 94 A4 5 References for Acoustic Output and Safety94 A4 6 Probe Acoustic Output Para...

Page 9: ...s hereinafter called the Doppler are intended to be used by health care professionals including registered nurses practical nurses midwives ultrasound technicians and physician assistants by prescript...

Page 10: ...onnection between the equipment and personnel complies with permitted leakage currents and dielectric strength of IEC EN 60601 1 WARNING and CAUTION messages must be observed To avoid the possibility...

Page 11: ...as being prescribed by such a trained clinician and trained in device placement 4 The device is not protected against defibrillation 5 Do not use the device with HF surgical equipment 6 Do not touch...

Page 12: ...processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC EN 60601 1 1 Anybody who connects additional...

Page 13: ...hock do not disassemble or modify the battery 16 The battery should be charged used or stored away from the static electricity 17 Remove the batteries and store them in a cool and dry environment if t...

Page 14: ...leak from the battery spills onto your skin or clothes wash well with fresh water immediately 24 The device shall only be used when the battery cover is closed 25 If the liquid leak from the battery g...

Page 15: ...ment or accessories that are not approved by the manufacturer or that are not IEC 60601 1 approved to the device The operation or use of non approved equipment or accessories with the device is not te...

Page 16: ...service according to the EMC Information provided in this user manual 35 Do not service or maintain the device or any accessory which is in use with a patient CAUTION 1 Federal U S law restricts this...

Page 17: ...hat may endanger the patient operator or machine performance If the damage is found replace them with good ones at once 8 The following safety checks should be performed once every two years or as spe...

Page 18: ...and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal Bat...

Page 19: ...bols No Symbol Definition 1 CE marking 2 Disposal method 3 Caution Federal U S law restricts this device to sale by or on the order of a physician 4 Operating instructions 5 Caution 6 Current Direct 7...

Page 20: ...UTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 13 General symbol for recovery recyclable 14 Power adapter connector 15 Headphones 16 Refer to User Manual Background Blue Symbol White 17 Warning Ba...

Page 21: ...SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX II SONOTRAX II Pro and SONOTRAX Vascular SONOTRAX Lite and SONOTRAX Vascular are for simple auscultation intermittent listening SONOTRAX Basic SON...

Page 22: ...features of the Dopplers are listed in the following chart Model Function STA Vascular STA Lite STA Basic STA Basic A STA Pro STA II STA II Pro LCD Display LCD Backlight Mini USB Probe Socket Probe D...

Page 23: ...ltrasonic Pocket Doppler User Manual 15 Socket Volume Adjustable Modes Switching Audio Recording and Playing Powered by Alkaline Batteries Powered by Rechargeab le NI MH Batteries Powered by NI MH Bat...

Page 24: ...NOTRAX 2009 Series Ultrasonic Pocket Doppler User Manual 16 Pack Low Battery Detecting indicating Auto Shutdown Vascular Examining Note configured not available available STA SONOTRAX E D A N C O N F...

Page 25: ...nic Pocket Doppler User Manual 17 2 2 Main Unit NOTE The pictures and interfaces in this manual are for reference only 2 2 1 Appearance Take 2 0 MHz obstetrical probe for example Figure 2 1 Front Pane...

Page 26: ...SONOTRAX 2009 Series Ultrasonic Pocket Doppler User Manual 18 Figure 2 2 Rear Panel Figure 2 3 Top Panel 10 11 Figure 2 4 Left Panel 5 6 7 8 9 E D A N C O N F I...

Page 27: ...ONOTRAX Vascular have a LED in the bottom left corner of its display panel area When powered on the LED turns green If the LED flashes in green it indicates that the probe is disconnected or poorly co...

Page 28: ...cket Doppler User Manual 20 Figure 2 5 LCD Item Screen Element Description 1 FHR Refresh Frequency 2 Working Mode 3 Playing Indicator 4 Recording Indicator 5 Battery Indicator 6 Numeric FHR 7 Probe Ty...

Page 29: ...follows 1 MODE Button Only for SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX II SONOTRAX II Pro Function Select the working mode 2 START STOP Button Only for SONOTRAX Basic SONOTRAX Basic A SO...

Page 30: ...or outputting audio signals the earphone or line in cable connects to the Doppler via this socket 2 Charge socket for charging the NI MH battery pack the dedicated power adapter connects to the Dopple...

Page 31: ...gnal output connector to configure a medical system must ensure that the system complies with the requirements of the valid version of the system standard IEC EN 60601 1 1 If in doubt consult our tech...

Page 32: ...connect any other plug to the probe socket except the plug of the probes mentioned above 2 Do not stretch the probe cable for more than two meters long 2 2 6 Batteries SONOTRAX Lite SONOTRAX Basic SON...

Page 33: ...es 1 Alkaline Battery 2 Rechargeable NI MH Battery 3 NI MH Battery Pack NOTE The alkaline battery and rechargeable NI MH battery can be replaced by those of identical specifications purchased locally...

Page 34: ...The 2 MHz obstetrical probe features in deep penetration and is designed for use during the third trimester pregnancy The 3 MHz obstetrical probe features in high sensitivity and is designed for use a...

Page 35: ...z waterproof vascular probes can be connected to the main unit for artery and vein blood flow examining Figure 2 9 4 5 8 MHz Vascular Probes The main information on the probe is as follows 4 0 MHz 5 0...

Page 36: ...Package and Checking Open the package take out the Doppler and accessories carefully Keep the package for possible future transportation or storage Check the components according to the packing list...

Page 37: ...th one hand press the thumb of the other hand on the cover notch and push it upward and forward The compartment cover is open Figure 3 1 Opening battery compartment 2 Install the battery Put the alkal...

Page 38: ...l 30 Figure 3 2 Putting batteries into the compartment cover 3 Close the compartment Put the battery compartment cover back into the compartment push it forward and downward until it clicks closed Fig...

Page 39: ...ool and dry environment 2 Do not remove the NI MH battery pack frequently after initial installation 3 If the Doppler is not used for an extended period charge the NI MH batteries or the NI MH battery...

Page 40: ...pler User Manual 32 Figure 3 4 Taking out the probe 2 Placing the probe Hold the main unit with one hand Pinch the probe and align it with the probe holder Push the probe inwards using mild force unti...

Page 41: ...the probe before switching on the Doppler and place the probe after switching off the Doppler 3 Replacing the probe Remove the old probe Switch off the Doppler hold the main unit with one hand and pin...

Page 42: ...be into the probe interface of the Doppler NOTE Place the temporarily unused probe carefully and avoid falling off splash or stress etc When the Doppler is not used for a long time it s recommended to...

Page 43: ...e probe properly When the probe is well connected the LCD stops flashing and shows the probe frequency in the bottom right corner 3 5 Selecting Working Mode The Doppler has four working modes They are...

Page 44: ...TRAX Basic A SONOTRAX Pro SONOTRAX II and SONOTRAX II Pro have backlight You can enable or disable it Keep pressing the button until the working mode on LCD displays 4 Press the button The backlight i...

Page 45: ...ery 3 8 1 Battery Energy Indication After switched on the Doppler gives indication of battery energy For SONOTRAX Lite and SONOTRAX Vascular the LED in the bottom left corner of the display panel ligh...

Page 46: ...ppler shuts down automatically You should replace the batteries or charge the rechargeable batteries 3 8 2 Replacing Alkaline Batteries CAUTION Make sure the Doppler is shut down before charging the b...

Page 47: ...E BATTERY 3 8 3 Charging the NI MH Batteries When the rechargeable NI MH batteries are low in energy 1 Take the NI MH batteries out from the main unit by using the procedures described in section 3 2...

Page 48: ...s working 1 5 m away from the patient 3 8 4 Charging NI MH Battery Pack When the NI MH battery pack is low in energy charge the battery pack with the provided power adapter 1 Put the plug of the powe...

Page 49: ...ry pack is fully charged approximately 3 4 hours are needed Remove the power adapter plug and the Doppler is ready for examining again Figure 3 7 Charging NI MH Battery Pack The specifications of the...

Page 50: ...42 WARNING The AC DC power adapter meets the requirements of Standard IEC60950 and it should be placed outside the patient environment when it s working 1 5 m away from the patient The Doppler is not...

Page 51: ...igher sensitivity and is optimized for early pregnancy after 10 weeks gestation NOTE In some cases fetal heart beats at 10 weeks gestation can not be detected due to the maternal physical difference a...

Page 52: ...he real time heart rate it changes continuously If the Doppler works in mode 2 the numeric is the average of every 8 heart beats it changes slowly If the Doppler works in mode 3 press the button once...

Page 53: ...midline below the umbilicus During examining the pregnant woman s prolonged lying in the supine position should be avoided owing to the possibility of supine hypotension Sitting up or lateral positio...

Page 54: ...Pro and SONOTRAX II Pro Recording In mode 1 2 or 3 press and hold the button for three seconds the machine starts recording and the LCD reads The longest record time is 240 seconds When the time is u...

Page 55: ...he real time status NOTE Observe the LCD pay attention not to mistake the recorded fetal heart sound for the real time sound 4 3 FH Sound Recording by PC The signal of fetal heart sound can be transfe...

Page 56: ...er Manual 48 socket with the symbol of the PC refer to figure 4 1 If the PC has no audio input socket insert the plug into the microphone socket the socket with the symbol Figure 4 1 Audio Input Socke...

Page 57: ...sories Entertainment Sound Recorder Refer to figure 4 2 Figure 4 2 Run the sound recorder Perform FHR examination with the method described in section 4 1 When the ideal signal is detected unplug the...

Page 58: ...d Recorder Figure 4 4 Recording Click on the start key to start recording refer to figure 4 3 You can record 60 seconds each time When the time is up click on the start key again to keep on recording...

Page 59: ...on File Open search for the folder and select the file click on Open to load the file and then click on the play key If you have any other program that supports waveform wav files installed on your PC...

Page 60: ...r connection is detected 2 The audio cable has been plugged to the wrong socket of the PC instead of the audio input socket or the microphone socket Insert the plug to the right socket 3 The Line in o...

Page 61: ...ser Manual 53 Figure 4 5 Volume control menu c If the line in or and microphone volume control is are not shown in the Volume Control menu click on Options Properties tick Line In and Microphone as sh...

Page 62: ...SONOTRAX 2009 Series Ultrasonic Pocket Doppler User Manual 54 Figure 4 6 Properties d Make sure Line In and Microphone is not mute click on to exit E D A N C O N F I...

Page 63: ...The Doppler is not intended for ophthalmic use Do not use it for examining ophthalmic vessels or any other procedures which may cause the ultrasound beam to pass through the eye 4 MHz 5 MHz or 8 MHz...

Page 64: ...zed for examining blood vessels the 5 MHz vascular probe is optimized for examining deeper vessels and the 8 MHz vascular probe is optimized for examining surface vessels Apply a liberal amount of gel...

Page 65: ...SONOTRAX 2009 Series Ultrasonic Pocket Doppler User Manual 57 Figure 4 8 Probe sites 1 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 E D A N C O N F I...

Page 66: ...z 7 Great Saphenous Vein 4 5 8 MHz 8 Small Saphenous Vein 8 MHz 9 Dorsalis Pedis Artery 8 MHz 10 Posterior Tibial Vein 8 MHz 11 Carotid Artery 4 5 8 MHz 12 Subclavian Artery 4 5 MHz 13 Subclavian Vein...

Page 67: ...creen always displays the probe frequency NOTE When applied to the patient the ultrasound transducer may warm slightly less than 4 C 7 2 F above ambient temperature When NOT applied the ultrasound tra...

Page 68: ...o conductive fluid If the damage is evident replacement is recommended The probe is frangible and must be handled with care Wipe the remaining gel after use to prolong the probe life The overall check...

Page 69: ...sing a soft cloth dampened with mild near neutral detergent ethanol 75 or isopropanol 70 and then air dry it or wipe it dry with a dry cloth CAUTION 1 Do not use strong solvent such as acetone 2 Never...

Page 70: ...each use clean the probe and then disinfect it by wiping it with a soft cloth dampened with ethanol 75 or isopropanol 70 Then wipe it dry with a dry cloth CAUTION Pay attention not to immerse the pro...

Page 71: ...mage Function Check Check if the Doppler can be switched on or off properly see 3 4 Switching On and 3 7 Switching Off When the Doppler is switched on check if the display panel works as described in...

Page 72: ...amage caused by improper use or maintenance c damage caused by alteration or repair by anyone not authorized by EDAN d damage caused by accidents e replacement or removal of serial number label and ma...

Page 73: ...ing repaired 6 2 Contact Information If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send an email t...

Page 74: ...Pro SONOTRAX II SONOTRAX II Pro SONOTRAX Vascular Safety Complies with IEC 60601 1 2005 EN 60601 1 2006 IEC 60601 1 2 2007 EN 60601 1 2 2007 IEC EN 61266 IEC EN 60601 2 37 Classification Anti electri...

Page 75: ...hours Degree of Safety in Presence of Flammable Gases Equipment not suitable for use in presence of flammable gases Working System Continuous running equipment EMC CISPR 11 Group 1 Class B Physical Sp...

Page 76: ...re 86 kPa 106 kPa Transport Storage Temperature 20 C 55 C 4 F 131 F Humidity 25 RH 93 RH non condensing Atmospheric Pressure 70 kPa 106 kPa Display 45 mm x 25 mm LCD display FHR Performance Essential...

Page 77: ...o Shut down 1 minute after no signal or operation auto shut down Recommended Battery Type Alkaline battery AA LR6 1 5 V Rechargeable NI MH battery AA R6 1 2 V Ultrasonic Gel pH 5 5 8 0 Acoustic Impeda...

Page 78: ...Pro 9 hr 8 hr SONOTRAX II Pro 8 hr Rechargeable NI MH Battery Nominal Capacity 1800 mAh Nominal Voltage 2 4 VDC Continual Working Time 8 hr Necessary Charge Time 4 hr Ultrasound Nominal Frequency 2 0...

Page 79: ...ar Probe 8 0 10 MHz p 1 MPa Iob 10 mW cm2 Ispta 100 mW cm2 Working Mode Continuous wave Doppler Effective Radiating Area of Transducer 2 0 MHz Obstetrical Probe 245 15 mm2 3 0 MHz Obstetrical Probe 24...

Page 80: ...Type TI Value MI Isppa 3 W c m2 CW 2 0 0 0563 TIS 0 0704 0 021 0 015 TIB 0 0113 CW 3 0 1 63 TIS 0 0116 0 0041 0 001 63 TIB 0 0217 CW 4 0 20 24 TIS 0 0142 0 0125 0 020 24 TIB 0 0589 CW 5 0 52 593 TIS...

Page 81: ...ts supplied or recommended by the manufacturer should be used with the Doppler Parts Part Number Probe 2 0 MHz Obstetrical Probe 02 01 210326 3 0 MHz Obstetrical Probe 02 01 210327 4 0 MHz Vascular Pr...

Page 82: ...H Battery Pack 01 21 064182 Power Adapter American Standard 21 21 064158 Power Adapter European Standard 01 21 064161 Power Adapter Brazilian Standard 21 21 064184 Power Cord Australian Standard 01 13...

Page 83: ...ufacture s declaration electromagnetic emission The SONOTRAX Series Ultrasonic Pocket Doppler is intended for use in the electromagnetic environment specified below The customer or the user of the dev...

Page 84: ...its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 Class B The SONOTRAX Series Ultrasonic Po...

Page 85: ...et Doppler User Manual 77 Harmonic emissions IEC EN61000 3 2 Not applicable power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions IEC EN61000 3...

Page 86: ...romagnetic immunity The SONOTRAX Series Ultrasonic Pocket Doppler is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is...

Page 87: ...kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floor are covered with synthetic material the relative humidity should be at least 30 Electrical Fast Transient Burst IE...

Page 88: ...e s to earth Not applicable Not applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC EN61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5...

Page 89: ...ppler User Manual 81 Power frequency 50Hz 60Hz magnetic field IEC61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial...

Page 90: ...ow The customer or the user of the device should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mob...

Page 91: ...000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m P d 2 1 80 MHz to 800 MHz P d 3 2 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufac...

Page 92: ...e may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electr...

Page 93: ...s an electromagnetic site survey should be considered If the measured field strength in the location in which the SONOTRAX Series Ultrasonic Pocket Doppler is used exceeds the applicable RF compliance...

Page 94: ...ic Pocket Doppler is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interfe...

Page 95: ...mum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz P d 2 1 80 MHz to 800 MHz P d 2 1 800 MHz to 2 5 GHz P d 3 2 0 01 0 12 0 12 0 23 0 1 0 3...

Page 96: ...e to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation dis...

Page 97: ...ound intensity arises There is no easy answer to the question of safety surrounding the use of diagnostic ultrasound equipment Application of the ALARA As Low As Reasonably Achievable principle serves...

Page 98: ...e of diagnostic ultrasound however exposure levels should always be limited to As Low As Reasonably Achievable the ALARA principle A4 3 Explanation of MI TI A4 3 1 MI Mechanical Index Cavitations will...

Page 99: ...frequency the greater the potential for mechanical bioeffects The AIUM and NEMA formulate mechanical index MI in order to indicate the potential for mechanical effects The MI is defined as the ratio o...

Page 100: ...B and TIC TIS Soft Tissue Thermal Index It provides an estimate of potential temperature rise in soft or similar tissues TIB Bone Thermal Index It provides an estimate of potential temperature rise wh...

Page 101: ...the 8 bit resolution of the Agilent DSO6012 Digital Oscilloscope and the signal to noise ratio of the measurement 3 Temperature 1 percent Based on the temperature variation of the water bath of 1 C 1...

Page 102: ...coustic output and long exposure time should be avoided while acquiring necessary clinical information A4 5 References for Acoustic Output and Safety 1 Bioeffects and Safety of Diagnostic Ultrasound i...

Page 103: ...ing Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued in 2008 6 Medical electrical equipment Part 2 37 Particular requirements for the basic safety and essential performance...

Page 104: ...ning Mode System SONOTRAX Operating Mode CW mode Transducer CD2 0 Working Frequency 2 0 MHz Acoustic Output MI ISPTA 3 mW cm2 ISPPA 3 W cm2 Global Maximum Value 0 021 0 0563 0 015 Associated Acoustic...

Page 105: ...50 Ele cm 1 25 Operating Control Conditions Fixed Acoustic Output Reporting Table for Track 1 Non scanning Mode System SONOTRAX Operating Mode CW mode Transducer CD3 0 Working Frequency 3 0 MHz Acous...

Page 106: ...8 Associated Acoustic Parameter Pr 3 MPa 0 007 W0 mW 1 2 1 2 fc MHz 3 0 3 0 3 0 Zsp cm 2 35 2 35 2 35 Beam dimensions X 6 cm 1 7 1 7 Y 6 cm 0 532 0 532 PD sec CW CW PRF Hz N A N A EBD Az cm 1 11 Ele c...

Page 107: ...ating Mode CW mode Transducer CD4 0 Working Frequency 4 0 MHz Acoustic Output MI ISPTA 3 mW cm2 ISPPA 3 W cm2 Global Maximum Value 0 0125 20 24 0 02024 Associated Acoustic Parameter Pr 3 MPa 0 0249 W0...

Page 108: ...nditions Fixed Acoustic Output Reporting Table for Track 1 Non scanning Mode System SONOTRAX Operating Mode CW mode Transducer CD5 0 Working Frequency 5 0 MHz Acoustic Output MI ISPTA 3 mW cm2 ISPPA 3...

Page 109: ...ler User Manual 101 Parameter fc MHz 4 99999 4 99999 4 99999 Zsp cm 1 2 1 2 1 2 Beam dimensions X 6 cm 0 2484 0 2484 Y 6 cm 0 4534 0 4534 PD sec CW CW PRF Hz N A N A EBD Az cm 0 4 Ele cm 0 8 Operating...

Page 110: ...perating Mode CW mode Transducer CD8 0 Working Frequency 8 0 MHz Acoustic Output MI ISPTA 3 mW cm2 ISPPA 3 W cm2 Global Maximum Value 0 0141 48 66 0 04866 Associated Acoustic Parameter Pr 3 MPa 0 0399...

Page 111: ...SONOTRAX 2009 Series Ultrasonic Pocket Doppler User Manual 103 PRF Hz N A N A EBD Az cm 0 3 Ele cm 0 6 Operating Control Conditions Fixed E D A N C O N F I...

Page 112: ...s Equal Contrast List parameter specified in TRACK1 of FDA Guidance TRACK1 parameter NOTE pr 3 Derated Peak rare factional Acoustic Pressure W0 Output Power zsp zsp zB 3 Depth for Bone Thermal Index f...

Page 113: ...se Repetition Frequency MI Mechanical Index ISPTA 3 Derated Spatial peak Temporal average Intensity ISPPA 3 Derated Spatial peak Pulse average Intensity Az Aperture X width Y Dimeter Ele EDS Entrance...

Page 114: ...4 32 6 45 109 6 Ba 24 9 24 9 7 7 75 45 7 T 6 6 2 0 55 3 70 35 34 83 6 10 107 1 Ba 24 9 24 9 5 5 100 45 7 T 6 6 1 0 53 5 72 62 35 64 6 30 105 5 Ba 24 9 24 9 3 7 200 45 7 T 6 6 0 49 8 75 47 35 86 6 24 1...

Page 115: ...112 3 52 44 6 61 108 2 Ba 43 6 13 5 75 44 5 T 6 3 0 57 1 108 4 52 28 6 34 107 9 Ba 43 6 13 5 100 44 5 T 6 3 0 57 1 113 8 54 56 6 39 107 9 Ba 43 6 13 5 200 44 5 T 6 3 0 57 1 112 2 54 82 6 22 103 3 Ba 4...

Page 116: ...E D A N C O N F I...

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