EDAN SONOTRAX Basic User Manual

EDAN SONOTRAX Basic User Manual

Sonotrax series ultrasonic pocket doppler
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Summary of Contents for EDAN SONOTRAX Basic

  • 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...........................3 Chapter 2 Doppler and Accessories..................4 2.1 Features ...........................4 2.2 Appearance........................5 2.3 Display Panel........................6 2.4 Buttons ..........................7 2.5 Socket ..........................8 2.6 Probes ..........................9 2.6.1 Waterproof Obstetrical Probes ................9 2.6.2 Waterproof Vascular Probes .................9 2.6.3 Probe Socket......................10 2.7 Batteries.........................11...
  • Page 5 5.2 Cleaning ........................31 5.3 Disinfection of the Probe....................31 Chapter 6 Warranty and After-Sales Service................32 6.1 Warranty........................32 6.2 After-Sales Service......................32 Appendix 1 Ordering Information ..................33 Appendix 2 EMC Information-Guidance and Manufacture’s Declaration .......34 A2.1 Electromagnetic Emissions - for all Equipment and Systems........34 A2.2 Electromagnetic Immunity - for all Equipment and Systems ........34 A2.3 Electromagnetic Immunity - for all Equipment and Systems that are not Life-supporting........................35...
  • 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 Check if the equipment has visible evidence of damage that may affect the personnel’s safety or the device’s capability before use. If the damage is evident, replace the defective part(s) before use. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g.
  • Page 8: 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. Type B applied part. 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 9: Chapter 2 Doppler And Accessories

    Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX II Pro. SONOTRAX Lite is for simple auscultation (intermittent listening). SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX II Pro not only detect fetal heart sound; they also display the fetal heart rate on a LCD screen.
  • Page 10: Appearance

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories 2.2 Appearance NOTE: The pictures and interfaces in this manual are for reference only. Take 2.0MHz obstetrical probe for example. Figure 2-1 Front Panel Figure 2-2 Rear Panel Figure 2-3 Top Panel Figure 2-4 Left Panel - 5 -...
  • Page 11: Display Panel

    Battery Indicator: For SONOTRAX Basic, a battery symbol appears on the LCD after it’s powered on. When the battery is low, this symbol flashes; the Doppler will shut down automatically after 7 seconds. For SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX II Pro, there is a battery symbol on the LCD.
  • Page 12: Buttons

    Doppler. Their primary functions are as follows: (1) Power Button Function: Switch on or off the Doppler. (2) MODE Button (Only for SONOTRAX Basic / SONOTRAX Basic A / SONOTRAX Pro / SONOTRAX II / SONOTRAX II Pro) Function: Select the working mode. (3) START/STOP Button...
  • Page 13: Socket

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories 2.5 Socket The two sockets are located on the top panel of the Doppler. (1) Earphone socket : the earphone or line-in cable connects to the Doppler via this socket. Figure 2-6 Line-in Cable Signal Interface 2 Signal...
  • Page 14: Probes

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories 2.6 Probes 2.6.1 Waterproof Obstetrical Probes 2.0MHz/3.0MHz waterproof obstetrical probes can be connected to the main unit for fetal heart examining. The 2MHz obstetrical probe features in deep penetration and is designed for use during the third trimester pregnancy.
  • Page 15: Probe Socket

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories Figure 2-8 4.0/5.0/8.0MHz Vascular Probes The main information on the probe is as follows: CD4.0/CD5.0/CD8.0: CD means continuous wave Doppler, 4.0/5.0/8.0 means the central frequency is 4.0/5.0/8.0 MHz. MS3-14346: Part number of 4.0MHz waterproof vascular probe. MS3R-104822: Part number of 5.0MHz waterproof vascular probe.
  • Page 16: Batteries

    Do not stretch the probe cable for more than two meters long. 2.7 Batteries SONOTRAX Lite, SONOTRAX Basic, SONOTRAX Basic A and SONOTRAX Pro are powered either by 9V alkaline batteries (IEC Type No. 6LR61/6LF22 or equivalent) or by rechargeable NI-MH batteries (8.4V).
  • Page 17: Chapter 3 Operation

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation Chapter 3 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 Operation For SONOTRAX II and SONOTRAX II Pro, insert the battery connector into the battery socket in the compartment. (Figure 3-2 b) Figure 3-2 Connecting battery connector 3) Close the compartment. Slide the cover back to close the battery compartment. Figure 3-3 Closing battery compartment CAUTION Take out the alkaline/NI-MH battery and keep it in a cool and dry environment if the...
  • Page 19: Probe Operation

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation 3.3 Probe Operation (1) Taking out the probe Hold the main unit with one hand. Pinch the probe head and pull it outwards with mild force, and then take out the whole probe slantwise in the direction of the arrow. Figure 3-4 Taking out the probe (2) Placing the probe Hold the main unit with one hand.
  • Page 20: Switching On The Doppler

    SONOTRAX II Pro have different modes available. Press the MODE button to switch to the next mode. After self testing, SONOTRAX Basic enters the previous mode in which the Doppler worked, and other models automatically enters mode 1. - 15 -...
  • Page 21: Real-Time Fhr Display Mode (Mode 1)

    3.5.4 Backlight Brightness Setting Mode (Mode 4) This mode is only available with SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX II Pro. Keep pressing the MODE button until the working mode on LCD displays 4.
  • Page 22: Fetal Heart (Fh) Examining

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation NOTE: The setting under this mode will be saved automatically after mode switches or normal power off. After changing frequency, the records related to the original frequency will be cleared automatically. 3.6 Fetal Heart (FH) Examining FH examining with 2.0MHz/3.0MHz obstetrical probe 1) Confirm the fetus’s position by hand.
  • Page 23: Fh Sound Recording And Playing By Build-In Recorder

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation 3.7 FH Sound Recording and Playing by Build-in Recorder This function is only available with SONOTRAX Pro and SONOTRAX II Pro. Recording: Press the REC/PLAY button and hold for three seconds in mode 1, 2 or 3, the machine starts recording, and RECORDING appears on the LCD.
  • Page 24 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation Audio Input Socket Figure 3-7 Audio Input Socket on the PC Turn on PC and run the sound recorder (Click on Start > Programs > Accessories > Entertainment > Sound Recorder). Refer to figure 3-8. Figure 3-8 Run the sound recorder Perform FHR examination with the method described in section 3.6.
  • Page 25: Playing Sound Files

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation Figure 3-9 Sound Recorder Figure 3-10 Recording Click on the start key to start recording, refer to figure 3-9. You can record 60 seconds each time. When the time is up, click on the start key again to keep on recording.
  • Page 26 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation socket or the microphone socket. - Insert the plug to the right socket. 3. The Line in or microphone is muted on PC. - Change the setting of the PC in these steps: a) Double-click on the volume symbol in the bottom right corner of your desktop;...
  • Page 27 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation Figure 3-12 Properties d) Make sure Line In and Microphone is not mute, click on to exit. e) Start a new recording. - 22 -...
  • Page 28: Vascular Examining (Optional)

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation 3.9 Vascular Examining (Optional) WARNING The device 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 29 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation 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 30: Switching Off The Doppler

    Press the POWER button on the SONOTRAX Lite again to switch it off. If there is no signal input or no operation is performed to SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX II Pro for 60 seconds, it will automatically shut down.
  • Page 31 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation Figure 3-14 Charging NI-MH battery (3) Charging the lithium-ion polymer battery For the lithium-ion polymer battery, charge it in the machine by putting the plug of the charger into the charge socket of the Doppler (on the top panel), and then connecting the charger to power supply (100V-240V~, 50Hz/60Hz).
  • Page 32: Chapter 4 Product Specifications

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications Chapter 4 Product Specifications Product Name: Ultrasonic Pocket Doppler Model: SONOTRAX Lite, SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II, SONOTRAX II Pro Safety: Complies with: IEC 60601-1:1988+A1+A2, EN 60601-1:1990+A1+A2,...
  • Page 33 9V Alkaline SONOTRAX Lite 8 to 10 hours Battery SONOTRAX Basic 10 to 13 hours SONOTRAX Basic A 6 to 8 hours (with backlight) SONOTRAX Pro 6 to 8 hours (with backlight) 8.4V NI-MH Battery SONOTRAX Lite 2.5 to 5 hours...
  • Page 34 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications Rechargeable NI-MH Battery Charge Temperature: 0°C to +45°C (+32°F to +113°F) Storage Temperature: -20°C to +35°C (-4°F to +95°F) Normal Charge Time: 14 to 16 hours (25mA) ≥ 500 times Circle Life: Lithium-ion Polymer Battery Type: Lithium-ion Polymer Battery...
  • Page 35 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications < 100mW/cm spta Working Mode Continuous wave Doppler 2.0MHz Obstetrical Probe (245±15%) mm Effective Radiating Area of 3.0MHz Obstetrical Probe (245±15%) mm Transducer (32±15%) mm 4.0MHz Vascular Probe (32±15%) mm 5.0MHz Vascular Probe (14±15%) mm 8.0MHz Vascular Probe Low Output Summary Table...
  • Page 36: Chapter 5 Maintenance

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual Maintenance 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. If the damage is evident, replacement is recommended.
  • Page 37: Chapter 6 Warranty And After-Sales Service

    Material and Manufacture EDAN warrant that there’s no defect in material and manufacture. During the warranty period, EDAN will repair or replace the defective part free if the defect has been confirmed as material or manufacture defect. Software or Firmware...
  • Page 38: 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 12.01.14320 3.0MHz Obstetrical Probe 12.01.14321 4.0MHz Vascular Probe 12.01.14346 5.0MHz Vascular Probe 12.01.104822...
  • Page 39: 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 40: A2.3 Electromagnetic Immunity - For All Equipment And Systems That Are Not Life-Supporting

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual EMC Information A2.3 Electromagnetic Immunity - for all Equipment and Systems that are not Life-supporting Guidance and manufacture’s declaration – electromagnetic immunity The SONOTRAX Series Ultrasonic Pocket Doppler is intended for use in the electromagnetic environment specified below.
  • Page 41: A2.4 Recommended Separation Distances

    SONOTRAX Series Ultrasonic Pocket Doppler User Manual EMC Information A2.4 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 42: 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 43 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...

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