EDAN Sonotrax Pro User Manual
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EDAN Sonotrax Pro User Manual

Ultrasonic pocket doppler
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EDAN Agile PLM Electronic Signature Information
--Signatures related to this document and performed in EDAN Agile PLM.
文件名称(Document Name)：SONOTRAX(2009)说明书_英语（A6版）
文件编号(Number)：01.54.457373
版本(Version)：1.2
产品型号(Product Model)：SONOTRAX(2009)
项目编码(Project Code)：2006A-1000
签批信息(Signature):
作者(Originator) : 王 璟 (wangjing)
2016-11-24 17:19:51
审核人(Reviewers) : 刘 小倩 (liuxiaoqian)
2016-11-25 18:31:52
审核人(Reviewers) : 黄 东 (huangdong)
2016-11-24 18:14:11
批准人(Approvers) : 王 力维 (wangliwei)
2016-12-02 10:03:44
批准人(Approvers) : 冀 伟 (jiwei)
2016-12-02 11:03:58
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

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  • Page 1 EDAN Agile PLM Electronic Signature Information --Signatures related to this document and performed in EDAN Agile PLM. 文件名称(Document Name)：SONOTRAX(2009)说明书_英语（A6版） 文件编号(Number)：01.54.457373 版本(Version)：1.2 产品型号(Product Model)：SONOTRAX(2009) 项目编码(Project Code)：2006A-1000 签批信息(Signature): 作者(Originator) : 王 璟 (wangjing) 2016-11-24 17:19:51 审核人(Reviewers) : 刘 小倩 (liuxiaoqian) 2016-11-25 18:31:52 审核人(Reviewers) : 黄...
  • Page 3 Edan Instruments, Inc. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages.
  • Page 4 EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual. Responsibility of the Manufacturer EDAN only considers itself responsible for any...
  • Page 5 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 his guide is designed to give key concepts on safety precautions.

  • Page 6: Table Of Contents

    Contents Chapter 1 Safety Guide .......... 1 1.1 Intended Use/Indications for Use ....1 1.2 Safety Precautions .......... 2 1.3 Symbols ............11 Chapter 2 Doppler and Accessories ....13 2.1 Features ............13 2.2 Main Unit ............. 17 2.2.1 Appearance ..........17 2.2.2 Display Panel ........
  • Page 7 3.8.3 Charging the NI-MH Batteries ....39 3.8.4 Charging NI-MH Battery Pack ..... 40 Chapter 4 Examining ........... 43 4.1 FH Examining ..........43 4.2 FH Sound Recording and Playing ....46 4.3 FH Sound Recording by PC ......47 4.3.1 Recording Sounds .........
  • Page 8 A4.1 Ultrasound in Medicine ......89 A4.2 Ultrasound Safety and the ALARA Principle ................90 A4.3 Explanation of MI/TI ......... 90 A4.3.1 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 Parameters List ..

  • Page 9: Chapter 1 Safety Guide

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Chapter 1 Safety Guide NOTE: This user manual is written to cover the maximum configuration. Therefore, your model may or may not have some of the parameters and functions described, depending on what you have ordered.

  • Page 10: Safety Precautions

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease. 1.2 Safety Precautions This unit is internally powered equipment, and it is an IEC/EN 60601-1 Type B applied part.
  • Page 11 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual WARNING Placement of the ultrasound transducer on the abdomen is critical to obtaining the fetal heart beat as opposed to maternal heart beat or other abdominal noise. The user should be trained in proper placement techniques either through acceptable Ob/Gyn...
  • Page 12 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual WARNING 10 SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet hands. Make certain that your hands are clean and dry before touching a power cord. 11 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g.
  • Page 13 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual WARNING 13 Do not attempt to charge normal alkaline batteries. They may leak, catch fire or even explode. 14 Do not solder the leading wire and the battery terminal directly. 15 Do not destroy the battery: Do not pierce the battery with a sharp object such as a needle;...
  • Page 14 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual WARNING 21 If the rechargeable batteries are stored alone and not used for a long time, we recommend that the batteries should be charged at least once every 6 months to prevent overdischarge. 22 Replacement of the battery or charging the battery shall be done at least 1.5 meters away from patients.
  • Page 15 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual WARNING 28 Batteries have life cycles. The alkaline batteries are intended to be used once. If the time that the Doppler using NI-MH battery becomes much shorter than usual, the battery life is at an end. Replace them with those of identical specifications.
  • Page 16 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual WARNING 33 The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
  • Page 17 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual CAUTION Electromagnetic Interference - Ensure that the environment in which the device is operated is not subject to any source of strong electromagnetic emissions, such radio transmitters, mobile telephones, etc. Prior to examination using the Doppler, check for visible damages of the main unit and probe that...
  • Page 18 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual CAUTION Test the pregnant woman’s leakage current  according to IEC 60601-1: Limit: d.c 10 µA, a.c 100 µA. The leakage current should never exceed the limit. The data should be recorded in an equipment log.

  • Page 19: Symbols

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 1.3 Symbols Symbol Definition CE marking Disposal method Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Operating instructions Caution Current: Direct TYPE B APPLIED PART Part Number SERIAL NUMBER...
  • Page 20 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Date of manufacture MANUFACTURER AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY General symbol recovery/recyclable Power adapter connector Headphones Refer to User Manual (Background: Blue; Symbol: White) Warning (Background: Yellow; Symbol&Outline: Black) NOTE: The user manual is printed in black and white.

  • Page 21: Chapter 2 Doppler And Accessories

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Chapter Doppler Accessories 2.1 Features There seven different models available: SONOTRAX Lite, SONOTRAX Basic, SONOTRAX Basic SONOTRAX Pro, SONOTRAX SONOTRAX SONOTRAX Vascular. SONOTRAX Lite and SONOTRAX Vascular are for simple auscultation (intermittent listening). SONOTRAX Basic, SONOTRAX...
  • Page 22 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual The features of the Dopplers are listed in the following chart: Model STA II Vascular Lite Basic Basic A Function √ √ √ √ √ Display √ √ √ √ Backlight Mini USB √...
  • Page 23 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Socket Volume √ √ √ √ √ √ √ Adjustable Modes √ √ √ √ √ Switching Audio √ √ Recording and Playing Powered by √ √ √ √ √ Alkaline Batteries Powered by Rechargeab NI-MH Batteries...
  • Page 24 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Pack Battery √ √ √ √ √ √ √ Detecting & indicating Auto √ √ √ √ √ Shutdown Vascular √ Examining Note: √ = configured - = not available * = available STA=SONOTRAX...

  • Page 25: Main Unit

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 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 Panel...
  • Page 26 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Figure 2-2 Rear Panel Figure 2-3 Top Panel Figure 2-4 Left Panel...

  • Page 27: Display Panel

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Display POWER Speaker Panel Button Probe Probe Battery Socket Holder Compartment Charge Earphone Charge Indicator/ Socket Socket Power Indicator Volume Buttons Control 2.2.2 Display Panel SONOTRAX Lite and SONOTRAX Vascular have a LED in the bottom left corner of its display panel area.
  • Page 28 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Figure 2-5 LCD Screen Item Description Element FHR Refresh Frequency Working Mode Playing Indicator Recording Indicator Battery Indicator Numeric FHR Probe Type...

  • Page 29: Buttons

    Doppler. Their primary functions are as 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...

  • Page 30: Socket

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual (4) Volume Control Indicator Function: Adjust volume. Rotate the volume gear toward “+” to turn up the volume, or rotate it toward “-” to turn down the volume. 2.2.4 Socket The two sockets are located on the top panel of the Doppler.

  • Page 31: Probe Socket

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Furthermore all configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1. Anybody who connects additional equipment to the signal input connector or signal 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.

  • Page 32: Batteries

    2.2.6 Batteries SONOTRAX Lite, SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro and SONOTRAX Vascular are powered either by two alkaline batteries or two rechargeable NI-MH batteries. SONOTRAX II and SONOTRAX II Pro are powered by a NI-MH battery pack supplied by the...
  • Page 33 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Figure 2-7 Batteries Alkaline Battery Rechargeable NI-MH Battery NI-MH Battery Pack NOTE: The alkaline battery and rechargeable NI-MH battery can be replaced by those of identical specifications purchased locally. Alkaline battery: LR6, AA, 1.5 V. Rechargeable NI-MH battery: AA, R6, 1.2 V.

  • Page 34: Probes

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 2.3 Probes 2.3.1 Waterproof Obstetrical Probes The 2 MHz/3 MHz waterproof obstetrical probes can be connected to the main unit for fetal heart examining. The 2 MHz obstetrical probe features in deep penetration and is designed for use during the third trimester pregnancy.

  • Page 35: Waterproof Vascular Probes

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual IPX8: Water Ingress Protection Code. It indicates that this probe does not get soaked under water within 1 meter deep for five hours. 2.3.2 Waterproof Vascular Probes The 4 MHz/5 MHz/8 MHz waterproof vascular probes can be connected to the main unit for artery and vein blood flow examining.

  • Page 36: Chapter 3 Basic Operation

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Chapter 3 Basic Operation NOTE: To ensure that the Doppler works properly, please read this chapter and Chapter 1 Safety Guide before operation; follow the steps when connecting all the components. 3.1 Opening the Package and Checking Open the package;...
  • Page 37 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual compartment cover. Start from step 3 for battery installation. 1) Open the battery compartment. Turn the Doppler upside down. Hold the main unit with one hand; press the thumb of the other hand on the cover notch and push it upward and forward.
  • Page 38 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 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. Figure 3-3 Closing the battery compartment...

  • Page 39: Probe Operation

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual CAUTION 1 If the Doppler is not used for an extended period, take the alkaline/NI-MH batteries out and store them in a cool and dry environment. 2 Do not remove the NI-MH battery pack frequently after initial installation.
  • Page 40 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 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 until it clicks in position.
  • Page 41 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Figure 3-5 Placing the probe CAUTION Do not take out or place the probe when the Doppler is on. Remember to take out the probe before switching on the Doppler, and place the probe after switching off the Doppler.

  • Page 42: Switching On

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Figure 3-6 Removing the probe Replace it with a new probe: Put the USB socket of new probe 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 connect the probe to the Doppler and keep them safely in the package.

  • Page 43: Selecting Working Mode

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual switch on the Doppler. If the probe is not connected or poorly connected, the LCD displays a flashing “--- MHz” sign. You should reconnect the probe properly. When the probe is well connected, the LCD stops flashing and shows the probe frequency in the bottom right corner.

  • Page 44: Enabling Or Disabling Backlight

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual doppler working mode switches among these modes, and the working mode is shown in the top left corner of LCD. When the doppler is swiched on, it enters mode 1 automatically. 3.6 Enabling or Disabling Backlight SONOTRAX Basic SONOTRAX...

  • Page 45: Replacing/Charging The Battery

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual For SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX Pro, switches automatically if there is no input signal or no operation is performed for 60 seconds. 3.8 Replacing/Charging the Battery 3.8.1 Battery Energy Indication...

  • Page 46: Replacing Alkaline Batteries

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual SONOTRA Basic Other Models The panes disappear gradually with the energy consumption. When the energy is low, empty battery symbol flashes. Approximately five minutes later, the Doppler shuts down automatically. You should replace the batteries or charge the rechargeable batteries.

  • Page 47: Charging The Ni-Mh Batteries

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual according to local regulations. New alkaline batteries with identical specifications are required. Install them to the Doppler as introduced in section 3.2. WARNING DO NOT CHARGE THE ALKALINE 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...

  • Page 48: Charging Ni-Mh Battery Pack

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual After the batteries are fully charged, install them back to the Doppler. WARNING battery charger should meet requirements of Standard IEC60950, and it should placed outside patient environment when it's working (1.5 m away from the patient).
  • Page 49 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 3) When the charging indicator goes off, the battery 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 provided power adapter are as follows:...
  • Page 50 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 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 available for examining during charging.

  • Page 51: Chapter 4 Examining

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Chapter 4 Examining 4.1 FH Examining Before applying the Doppler for fetal heart (FH) examining, a proper probe should be chosen. The 2.0 MHz obstetrical probe is optimized for deep penetration and late pregnancy. The 3.0 MHz obstetrical probe has higher sensitivity and is optimized for early pregnancy (after 10 weeks gestation).
  • Page 52 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual probe faceplate and place the probe against the abdomen at the predetermined location. Move the probe around or tilt it until clear and rhythmic heart sound is heard from the headphone or speaker. At the same time, a numeric FHR is displayed on the LCD (except SONOTRAX Lite).
  • Page 53 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual NOTE: The best quality records will only be obtained if the probe is placed in the optimum position. Positions with strong placental sounds or umbilical blood flow sound should be avoided. If the fetus is in the cephalic position and the mother is supine, the clearest heart sound will normally be found on the midline below umbilicus.

  • Page 54: Fh Sound Recording And Playing

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual NOT applied, the ultrasound transducer may warm slightly (less than 4° C (7.2° F) above ambient temperature). 4.2 FH Sound Recording and Playing This function is only available with SONOTRAX Pro and SONOTRAX II Pro. Recording: In mode 1, 2 or 3, press and hold the button for...

  • Page 55: Fh Sound Recording By Pc

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual When the machine is not recording in mode 1, 2 or 3, press the button once, the machine plays the recorded sound, and the LCD reads When the recorded sound comes to the end or the button is pressed again, the Doppler stops playing and returns to the real-time status.
  • Page 56 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 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 “ ”).
  • Page 57 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Turn on PC and run the sound recorder (Click on Start > Programs > Accessories > Entertainment > Sound Recorder). Refer to figure 4-2. Figure 4-2 Run the sound recorder Perform examination with method described in section 4.1.
  • Page 58 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Figure 4-3 Sound 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: Playing Sound Files

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Click on File > Save, input the file name, select a folder and click on Save to save the signals in a “.wav” file. To start a new recording, click on File > New. 4.3.2 Playing Sound Files The recorded sounds are saved as waveform (.wav) files in your computer.
  • Page 60 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual reason could be: 1. Poor connection of the audio cable between the Doppler and the PC. - Check the plugs of the cable and re-connect it if any poor 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.
  • Page 61 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 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 shown in figure 4-6, click on OK:...
  • Page 62 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Figure 4-6 Properties d) Make sure Line In and Microphone is not mute, click on to exit.

  • Page 63: Vascular Examining (Optional)

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Figure 4-7 Volume Control e) Start a new recording. 4.4 Vascular Examining (Optional) WARNING 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.
  • Page 64 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual with low frequency has a deeper penetration depth, while the probe with high frequency has better resolution and wider detecting range. The 4 MHz vascular probe is optimized 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.
  • Page 65 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Figure 4-8 Probe sites...
  • Page 66 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Item Probe Sites Vertebral Artery (4/5 MHz) Carotid Artery (4/5/8 MHz Jugular Vein (4/5 MHz) Femoral Artery (4/5 MHz) Femoral Vein (4/5 MHz) Popliteal Artery (4/5 MHz) Great Saphenous Vein (4/5/8 MHz) Small Saphenous Vein (8 MHz) Dorsalis Pedis Artery (8 MHz) Posterior Tibial Vein (8 MHz) Carotid Artery (4/5/8 MHz)

  • Page 67: Completing Examining

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual volume as required. High pitched pulsatile sounds are emitted from arteries while veins emit a non-pulsatile sound similar to a rushing wind. Vascular examination only provides audio signals of arteries and veins. The LCD screen always displays the probe frequency.

  • Page 68: Chapter 5 Maintenance

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Chapter 5 Maintenance 5.1 Maintenance You must check that the equipment does not have visible evidence of damage that may affect the patient and the operator’s safety or the Doppler’s capability before each use. Pay special attention to the cracks on the probe and the cable before immersing them into conductive fluid.
  • Page 69 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual of dust and dirt. Clean the exterior surface of the main unit with a dry, soft cloth. If necessary, clean it using a soft cloth dampened with mild near neutral detergent, ethanol (75%) or isopropanol (70%), and then wipe it dry with a dry cloth immediately.

  • Page 70: Disinfection

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 5.3 Disinfection In normal use the main unit does not need disinfection. In case of being soiled, clean the main unit case and then disinfect it by wiping it with a soft cloth dampened with ethanol (75%) or isopropanol (70%).
  • Page 71 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Checking Checking Method Item Visual Check Inspect the Doppler for any damage. Function Check if the Doppler can be switched on or off properly (see 3.4 Switching Check On and 3.7 Switching Off). When the Doppler is switched on, check if the display panel works as described in 2.2.2 Display Panel;...

  • Page 72: Chapter 6 Warranty And Service

    EDAN will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product...

  • Page 73: Contact Information

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual is being 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 to EDAN service department at: support@edan.com.cn.

  • Page 74: Appendix 1 Product Specifications

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Appendix Product Specifications Product Name: Ultrasonic Pocket Doppler Model: SONOTRAX Lite, SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II, SONOTRAX II Pro, SONOTRAX Vascular Safety: Complies with: IEC 60601-1:2005, EN 60601-1:2006, IEC 60601-1-2:2007,...
  • Page 75 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Ingress of Water: liquid proof) Probes: IPX8 Water Ingress Protection Code, indicating this probe does not get soaked under water within 1 meter deep for five hours. Degree of Safety in Equipment not suitable for use Presence of in presence of flammable gases Flammable Gases:...
  • Page 76 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Working: +5° C ~ +40° C Temperature: ( +41º F ~ +104º F) 25% RH~ 80% RH Humidity: (non-condensing) Atmospheric Pressure: 86 kPa ~ 106 kPa Transport Storage -20° C ~ +55° C Temperature: (-4º...
  • Page 77 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Recording and Playing: Audio Sampling Frequency: 4 kHz Recording Length: 240 seconds White Backlight: Two Brightness Adjustable: OFF, ON Auto 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:...
  • Page 78 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Lite SONOTRAX 9 hr 8 hr Basic SONOTRAX 9 hr 8 hr Basic A SONOTRAX 8 hr SONOTRAX 9 hr 8 hr SONOTRAX 8 hr II Pro Rechargeable NI-MH Battery Nominal Capacity: 1800 mAh Nominal Voltage: 2.4 VDC Continual Working Time:...
  • Page 79 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual 8.0 MHz Vascular Probe 8.0 MHz Working Frequency 2.0 MHz Obstetrical Probe (2.0± 10%) MHz 3.0 MHz Obstetrical Probe (3.0± 10%) MHz 4.0 MHz Vascular Probe (4.0± 10%) MHz 5.0 MHz Vascular Probe (5.0±...
  • Page 80 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Doppler Probes sppa.3 spta.3 Model (W/c (mW/cm Type Value (MHz) 0.0704 CW 2.0 0.0563 0.021 0.015 0.0113 0.0116 0.001 CW 3.0 1.63 0.0041 0.0217 0.0142 0.020 CW 4.0 20.24 0.0125 0.0589 0.2055 0.049 CW 5.0 52.593 0.01755...

  • Page 81: Appendix 2 Ordering Information

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Appendix Ordering Information CAUTION Only the parts 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 Probe 12.01.14346 5.0 MHz Vascular Probe...
  • Page 82 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Alkaline Batteries 01.21.064086 Rechargeable NI-MH 21.21.064180 Batteries NI-MH Battery Pack 01.21.064182 Power Adapter 21.21.064158 (American Standard) Power Adapter 01.21.064161 (European Standard) Power Adapter 21.21.064184 (Brazilian Standard) Power Cord 01.13.036606 (Australian Standard) Power Cord 21.13.036425 (Brazilian Standard) Power Cord...

  • Page 83: Appendix 3 Emc Information

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Appendix 3 EMC Information A3.1 Electromagnetic Emissions Guidance and manufacture’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 device should assure that it is used in such an environment.
  • Page 84 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual The SONOTRAX Series Ultrasonic Pocket Doppler uses RF energy only for its internal function. Therefore, its RF emissions Group 1 CISPR 11 RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
  • Page 85 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual power supply network that supplies buildings used for domestic purposes. Harmonic emissions Not applicable IEC/EN61000-3-2 Voltage fluctuations Not applicable /flicker emissions IEC/EN61000-3-3...

  • Page 86: A3.2 Electromagnetic Immunity

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual A3.2 Electromagnetic Immunity Guidance and manufacture’s declaration–electromagnetic 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 used in such an environment. Electromagnetic 60601 test...
  • Page 87 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Floors should be wood, concrete or ceramic tile. Electrostatic floor are covered 6 kV contact 6 kV contact discharge with synthetic 8 kV air 8 kV air (ESD) material, IEC 61000-4-2 relative humidity should be at least 30%.
  • Page 88 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual ± 1 kV line(s) to Surge line(s) IEC/EN61000- Not applicable ± 2 kV line(s) to applicable earth Voltage dips, <5%UT(>95% dip in short UT) for 0.5 cycle interruptions, 40%UT(60% dip in voltage UT) for 5 cycles variations on Not applicable 70%UT(30% dip in...
  • Page 89 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Power frequency magnetic fields Power should be at levels frequency characteristic of a (50Hz/60Hz) 3 A/m 3 A/m typical location in magnetic typical field commercial IEC61000-4- hospital environment.

  • Page 90: A3.3 Electromagnetic Immunity

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual A3.3 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic 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 used in such an environment.
  • Page 91 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Recommended separation distance  Conducted 150 kHz to 80 MHz to 80 MHz 61000-4-6  80 MHz to 800 MHz Radiated 3 V/m 3 V/m  800 MHz to 2.5 GHz 80 MHz to Where P is the maximum output power 2.5 GHz rating of the transmitter in watts (W)
  • Page 92 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual compliance level in each frequency range. Interference 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.
  • Page 93 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.

  • Page 94: A3.4 Recommended Separation Distances

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual A3.4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the SONOTRAX Series Ultrasonic Pocket Doppler The SONOTRAX Series Ultrasonic Pocket Doppler is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 95 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Separation distance according to frequency of transmitter Rated maximum 150 kHz to 80 80 MHz to 800 output power 800 MHz to 2.5 GHz of transmitter    0.01 0.12 0.12 0.23 0.38 0.38 0.73...
  • Page 96 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

  • Page 97: Appendix 4 Ultrasound Intensity And Safety

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Appendix Ultrasound Intensity and Safety A4.1 Ultrasound in Medicine The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its known benefits for non-invasive investigations and medical diagnosis, including investigation of the human fetus, the question of clinical safety with regards to ultrasound intensity arises.

  • Page 98: A4.2 Ultrasound Safety And The Alara Principle

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual A4.2 Ultrasound Safety and the ALARA Principle Ultrasound waves dissipate energy in the form of heat and can therefore cause tissue warming. Although this effect is extremely low with Doppler, it is important to know how to control and limit patient exposure.

  • Page 99: A4.3.2 Ti (Thermal Index)

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual tissue. Although no confirmed adverse mechanical effects on patients or mammals caused by exposure at intensities typical of present diagnostic ultrasound instruments have ever been reported, the threshold for cavitation is still undetermined. Generally speaking, the higher the acoustic pressure, the greater the potential for mechanical bioeffects;...

  • Page 100: A4.3.3 Measurement Uncertainties

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual In order to indicate the potential for temperature rise caused by thermal effects, the AIUM and NEMA formulate thermal index (TI). It is defined as the ratio of the total acoustic power to the acoustic power required to raise the tissue temperature by 1º...
  • Page 101 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual overall systematic uncertainties were determined as follows: 1. Hydrophone Sensitivity: ± 23 percent for intensity, ± 11.5 percent for pressure. Based on the hydrophone calibration report by ONDA. The uncertainty was determined within ± 1 dB in frequency range 1-15 MHz.

  • Page 102: A4.4 Prudent Use Statement

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual A4.4 Prudent Use Statement Although no confirmed bioeffects on patients caused by exposure from present diagnostic ultrasound equipment have ever been reported, the potential exists that such bioeffects may be identified in the future.
  • Page 103 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual "Information Manufacturers Seeking 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 of ultrasonic medical diagnostic and monitoring equipment" issued by IEC in 2007.

  • Page 104: A4.6 Probe Acoustic Output Parameters List

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual A4.6 Probe Acoustic Output Parameters List Acoustic Output Reporting Table for Track 1 Non-scanning Mode System: SONOTRAX Operating Mode: CW mode Transducer: CD2.0 Working Frequency: 2.0 MHz SPTA.3 SPPA.3 Acoustic Output (mW/cm 2 ) (W/cm 2 ) Global Maximum Value 0.021...
  • Page 105 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual (µ sec) (Hz) (cm) 2.50 Ele. (cm) 1.25 Operating Control Fixed Conditions Acoustic Output Reporting Table for Track 1 Non-scanning Mode System: SONOTRAX Operating Mode: CW mode Transducer: CD3.0 Working Frequency: 3.0 MHz SPTA.3 SPPA.3 Acoustic Output...
  • Page 106 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual (MPa) 0.007 (mW) (MHz) 2.35 2.35 2.35 (cm) (cm) Beam Associated dimensions 0.532 0.532 Acoustic (cm) Parameter (µ sec) (Hz) (cm) 1.11 Ele. (cm) 2.22 Operating Control Fixed Conditions...
  • Page 107 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Acoustic Output Reporting Table for Track 1 Non-scanning Mode System: SONOTRAX Operating Mode: CW mode Transducer: CD4.0 Working Frequency: 4.0 MHz SPTA.3 SPPA.3 Acoustic Output (mW/cm 2 ) (W/cm 2 ) 0.0125 20.24 0.02024 Global Maximum Value (MPa)
  • Page 108 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual (Hz) (cm) 0.45 Ele. (cm) Operating Control Fixed Conditions Acoustic Output Reporting Table for Track 1 Non-scanning Mode System: SONOTRAX Operating Mode: CW mode Transducer: CD5.0 Working Frequency: 5.0 MHz SPTA.3 SPPA.3 Acoustic Output (mW/cm 2 ) (W/cm 2 ) 0.01755...
  • Page 109 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Parameter 4.99999 4.99999 4.99999 (MHz) (cm) 0.2484 0.2484 (cm) Beam dimensions 0.4534 0.4534 (cm) (µ sec) (Hz) (cm) Ele. (cm) Operating Control Fixed Conditions...
  • Page 110 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Acoustic Output Reporting Table for Track 1 Non-scanning Mode System: SONOTRAX Operating Mode: CW mode Transducer: CD8.0 Working Frequency: 8.0 MHz SPTA.3 SPPA.3 Acoustic Output (mW/cm 2 ) (W/cm 2 ) 0.0141 48.66 0.04866 Global Maximum Value (MPa)
  • Page 111 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual (Hz) (cm) Ele. (cm) Operating Control Fixed Conditions...

  • Page 112: A4.7 Standard Parameters Equal Contrast List

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual A4.7 Standard Parameters Equal Contrast List parameter specified in TRACK1 of FDA Guidance TRACK1 parameter NOTE Derated Peak-rare-factional Acoustic Pressure Output Power , Depth for Bone Thermal Index Center Frequency, Acoustic -6dB Beamwidth Pulse Duration...
  • Page 113 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Pulse Repetition Frequency Mechanical Index Derated Spatial-peak Temporal-average SPTA.3 Intensity Derated Spatial-peak Pulse-average SPPA.3 Intensity Aperture X width Y Dimeter Ele. Entrance Dimensions Of The Scan Entrance Beam Dimensions...

  • Page 114: Appendix 5 Overall Sensitivity

    SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Appendix 5 Overall Sensitivity Two-way Attenuation Overall     B=∑B Diameter of Target Sensitivity      Distance   Reflector (r.m.s) (r.m.s)   ∑B (T: ultrasonic attenuation A(dB) (mm) (S=A(d)+B+C)
  • Page 115 SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual Two-way Attenuation   B=∑B Overall   Diameter of      Distance (r.m.s) (r.m.s)   Sensitivity Target Reflector   ∑B (T: ultrasonic attenuation A(dB) (S=A(d)+B+C) (mm) (d)(mm) phantom No.

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