EDAN SONOTRAX Lite User Manual
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EDAN SONOTRAX Lite User Manual

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  • Page 2: About This Manual

    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 3 Terms Used in this Manual This 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.

  • Page 4: Table Of Contents

    Table of Contents Chapter 1 Safety Guide......................1 1.1 Intended Use........................1 1.2 Safety Precautions ......................1 1.3 Symbols......................... 4 Chapter 2 Doppler and Accessories..................5 2.1 Features ......................... 5 2.2 Main Unit ........................6 2.2.1 Appearance......................6 2.2.2 Display Panel....................... 7 2.2.3 Buttons ........................
  • Page 5 Chapter 5 Product Specifications ..................29 Chapter 6 Maintenance ......................33 6.1 Maintenance ........................ 33 6.2 Cleaning ........................33 6.3 Disinfection of the Probe..................... 33 Chapter 7 Warranty and Service..................35 7.1 Warranty........................35 7.2 Contact information..................... 35 Appendix 1 Ordering Information ..................36 Appendix 2 EMC Information-Guidance and Manufacture’s Declaration .....

  • Page 6: Chapter 1 Safety Guide

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Safety Guide 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 7 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Safety Guide WARNING Do not attempt to charge normal alkaline batteries. They may leak, catch fire or even explode. Remove the batteries and store it at a cool and dry environment if the monitor is not used for a long time.
  • Page 8 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Safety Guide CAUTION Prior to examination using the Doppler, check for visible damages of the main unit and the probe that may endanger the patient/operator or machine performance. If the damage is found, replace them with good ones at once. The following safety checks should be performed once every two years or as specified in the institution’s test and inspection protocol by a qualified person who has adequate training, knowledge, and practical experience to perform these tests.

  • Page 9: Symbols

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Safety Guide 1.3 Symbols The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices. The symbol indicates that the device should be sent to the special agencies according to local regulation for separate collection after its useful life.

  • Page 10: Chapter 2 Doppler And Accessories

    Doppler and Accessories Chapter 2 Doppler and Accessories 2.1 Features There are seven different models available: SONOTRAX Lite, 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).

  • Page 11: Main Unit

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories √ = configured - = not available * = available 2.2 Main Unit NOTE: The pictures and interfaces in this manual are for reference only. 2.2.1 Appearance Take 2.0MHz obstetrical probe for example. Figure 2-1 Front Panel Figure 2-2 Rear Panel Figure 2-3 Top Panel...

  • Page 12: Display Panel

    Doppler and Accessories 2.2.2 Display Panel SONOTRAX Lite and SONOTRAX 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 connected. If the LED flashes in orange, it indicates that the battery is too low to support working.

  • Page 13: Buttons

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories Numeric FHR Probe Type 2.2.3 Buttons At most there are three push buttons (MODE, START/STOP and REC/PLAY) and a volume control button on the main unit of the Doppler. Their primary functions are as follows: (1) MODE Button (Only for SONOTRAX Basic / SONOTRAX Basic A / SONOTRAX Pro / SONOTRAX II / SONOTRAX II Pro)

  • Page 14: Probe Socket

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories (2) Charge socket : for charging the NI-MH battery pack, the dedicated charger connects to the Doppler via this socket. (For SONOTRAX II and SONOTRAX II Pro only) NOTE: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g.

  • Page 15: Batteries

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories 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 manufacturer.

  • Page 16: Waterproof Vascular Probes

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories Figure 2-8 2.0/3.0MHz obstetrical probe The main information on the probe is as follows: 2.0MHz/3.0MHz:means central frequency is 2.0MHz/3.0MHz. Waterproof: The probe is waterproof. IPX8: Water Ingress Protection Code. It indicates that this probe does not get soaked under water within 1 meter deep for five hours.

  • Page 17: Chapter 3 Basic Operation

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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 18 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 2) Install the battery. Put the alkaline batteries or NI-MH batteries into the battery compartment cover. CAUTION The direction of the batteries should comply with the polar mark on the cover. Reversed connection is forbidden.

  • Page 19: Probe Operation

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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. 3 If the Doppler is not used for an extended period, charge the NI-MH batteries or the NI-MH battery pack at least every three months.
  • Page 20 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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 21: Switching On

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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 22: Switching Off

    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 lights up in green. When it flashes in orange, the battery power is low.

  • Page 23: Charging The Ni-Mh Batteries

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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 main unit by using the procedures described in section 3.2 Installing/Replacing Battery.

  • Page 24: Charging Ni-Mh Battery Pack

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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 charger. 1) Put the plug of the charger into the charge socket of the Doppler (on the top panel). 2) Connect the charger to a power supply socket (100V-240V~, 50Hz/60Hz).

  • Page 25: Chapter 4 Examining

    At the same time, a numeric FHR is displayed on the LCD (except SONOTRAX Lite). If the Doppler works in mode 1, the numeric is the real-time heart rate, it changes continuously.

  • Page 26: Fh Sound Recording And Playing

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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 the umbilicus.

  • Page 27: Fh Sound Recording By Pc

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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 transferred to a personal computer (PC) and recorded by the sound recorder.
  • Page 28 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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 earphone (if it’s connected) and insert the other plug of the audio cable into the earphone socket on the Doppler.

  • Page 29: Playing Sound Files

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 4.3.2 Playing Sound Files The recorded sounds are saved as waveform (.wav) files in your computer. You can play the waveform file with the sound recorder. Run the sound recorder, click 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 30 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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: Figure 4-6 Properties d) Make sure Line In and Microphone is not mute, click on...

  • Page 31: Vascular Examining (Optional)

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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 32 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining Vertebral Artery (4.0MHz) Carotid Artery (4.0/8.0MHz) Carotid Artery (4.0/8.0MHz) Jugular Vein (4.0MHz) Subclavian Artery (4.0MHz) Subclavian Vein (4.0MHz) Brachial Artery (8.0MHz) Ulner Artery (8.0MHz) Radial Artery (8.0MHz) Femoral Artery (4.0MHz) Femoral Vein (4.0MHz) Popliteal Artery (4.0MHz) Great Saphenous Vein (4.0/8.0MHz) Small Saphenous Vein (8.0MHz)

  • Page 33: Completing Examining

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 4.5 Completing Examining After examining, 1) Switch off the Doppler. 2) Wipe the remaining gel off the patient and the probe with a clean soft cloth or tissue. 3) Place the probe back to the holder. - 28 -...

  • Page 34: Chapter 5 Product Specifications

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications Chapter 5 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/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 61266...
  • Page 35 Ultrasonic Gel: Weight: 60g Acoustic Impedance: 1.533 10 Stand-by Time (hour): Rechargeable NI-MH Battery Alkaline Batteries Model NI-MH Batteries Pack SONOTRAX Vascular 9 hr 8 hr SONOTRAX Lite 9 hr 8 hr SONOTRAX Basic 9 hr 8 hr - 30 -...
  • Page 36 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications SONOTRAX Basic A 9 hr 8 hr SONOTRAX II 8 hr 9 hr 8 hr SONOTRAX Pro 8 hr SONOTRAX II Pro Rechargeable NI-MH Battery Nominal Capacity: 1800m Ah Nominal Voltage: 2.4 VDC Continual Working Time: 8 hr...
  • Page 37 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications Low Output Summary Table (for systems with no transducers having global maximum index values exceeding 1.0) System: SONOTRAX series Ultrasonic Pocket Doppler Transducer Model spta.3 sppa.3 TI Type TI Value (MHz) (mW/cm (W/cm 0.20...

  • Page 38: Chapter 6 Maintenance

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Maintenance Chapter 6 Maintenance 6.1 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 39 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Maintenance CAUTION Pay attention not to immerse the probe socket into the disinfector. The main unit is not waterproof, do not disinfection it. Never try to sterilize the probe or the main unit. - 34 -...

  • Page 40: Chapter 7 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 is being repaired.

  • Page 41: Appendix 1 Ordering Information

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Ordering Information Appendix 1 Ordering Information CAUTION Only the parts supplied by the manufacturer should be used with the Doppler. Parts Part Number Probe 2.0MHz Obstetrical Probe 02.01.210326 3.0MHz Obstetrical Probe 02.01.210327 4.0MHz Vascular Probe 12.01.14346 5.0MHz Vascular Probe 02.01.104822...

  • Page 42: Appendix 2 Emc Information-Guidance And Manufacture's Declaration

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual EMC Information Appendix Information-Guidance Manufacture’s Declaration A2.1 Electromagnetic Emissions - for all Equipment and Systems Guidance and manufacture’s declaration–electromagnetic emission The SONOTRAX Series Ultrasonic Pocket Doppler is intended for use in the electromagnetic environment specified below.

  • Page 43: A2.3 Electromagnetic Immunity - For All Equipment And Systems That Are Not Life-Supporting

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual EMC Information Power frequency magnetic Power frequency fields should be at levels (50Hz/60Hz) characteristic of a typical 3 A/m 3 A/m magnetic field location typical IEC61000-4-8 commercial hospital environment. A2.3 Electromagnetic Immunity - for all Equipment and Systems that are not Life-supporting Guidance and manufacture’s declaration –...

  • Page 44: A2.4 Recommended Separation Distances

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual EMC Information 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 45: Appendix 3 Overall Sensitivity

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Overall Sensitivity Appendix 3 Overall Sensitivity Overall Sensitivity (2MHz Probe) Reflection Loss A(d) Two-way Attenuation ⎛ ⎞ Diameter of Target Distance Overall Sensitivity B=∑B ⎜ ⎜ ⎟ ⎟ (r.m.s.) (r.m.s) Reflector (S=A(d)+B+C) ⎝ ⎠...
  • Page 46 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Overall Sensitivity Overall Sensitivity (3.0 MHz Probe) Two-way Attenuation Overall Diameter of ⎛ ⎞ B=∑B Distance Reflection ⎜ ⎜ ⎟ ⎟ (r.m.s.) (r.m.s) Sensitivity Target ⎝ ⎠ Loss A(d) (S=A(d)+B+C) Reflector ∑B (mm) (dB) (mm) (T:mm...

This manual is also suitable for:

Sonotrax basicSonotrax proSonotrax iiSonotrax ii proSonotrax vascularSonotrax basic a

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