About this Manual P/N: 01.54.455405-11 Release Date: July 2012 © Copyright EDAN INSTRUMENTS, INC. 2012. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying 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.
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. NOTE A NOTE provides useful information regarding a function or a procedure.
Table of Contents Chapter 1 Safety Guide............................................................................................................ 1 1.1 Intended Use.................................................................................................................. 1 1.2 Safety Precautions ......................................................................................................... 1 1.3 Symbols......................................................................................
Chapter 5 Product Specifications ......................................................................................... 29 Chapter 6 Maintenance ......................................................................................................... 33 6.1 Maintenance ................................................................................................................ 33 6.2 Cleaning ..............................................................................................................
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. 1.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Safety Guide WARNING 7 Do not attempt to charge normal alkaline batteries. They may leak, catch fire or even explode. 8 Remove the batteries and store it at a cool and dry environment if the monitor is not used for a long time. 9 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.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Safety Guide CAUTION 7 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.
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. Consult Instructions for Use Attention. Direct current Type B applied part.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual 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).
SONOTRAX Series Ultrasonic Pocket Doppler User Manual √ = configured - = not available Doppler and Accessories * = 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.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual 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. Change for a new battery or charge the rechargeable battery in time.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual 6 Numeric FHR 7 Probe Type Doppler and Accessories 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) Function: Select the working mode.
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. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment).
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.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Figure 2-8 Doppler and Accessories 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. 2.3.2 Waterproof Vascular Probes The 4.0MHz/5.0MHz/8.
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; take out the Doppler and accessories carefully. Keep the package for possible future transportation or storage. Check the components according to the packing list.
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. Figure 3-2 Putting batteries into the compartment cover 3) Close the compartment. Put the batter compartment cover back into the compartment, push it forward and downward until it clicks closed.
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. 3.3 Probe Operation (1) Taking out the probe Hold the main unit with one hand.
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. (3) Replacing the Probe Remove the old probe: Switch off the Doppler; hold the main unit with one hand and pinch the jacket of the mini USB socket. Lift the jacket up slightly and pull it out with mild force; take out the probe.
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. 3.4 Switching on Press the POWER button on the front panel to switch on the Doppler.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 3.7 Switching Off Press the POWER button on the front panel to switch off the Doppler. For SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX II Pro, it switches off 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 After switched on, the Doppler gives indication of battery energy.
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. 2) Replace them with new batteries with identical specifications, or charge them with the provided charger.
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). During charging, a battery sign appears on the LCD with continuous changing energy sign, and the charging indicator on the Doppler lights up.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining 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).
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Examining NOTE: 1 The best quality records will only be obtained if the probe is placed in the optimum position. 2 Positions with strong placental sounds or umbilical blood flow sound should be avoided. 3 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.
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. You can play the recorded sound files, burn them into CDs or e-mail them to whomever you want. 4.3.
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. Figure 4-3 Sound Recorder Click on the start key Figure 4-4 Recording to start recording, refer to figure 4-3. You can record 60 seconds each time.
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, double-click on the file to play it. 4.3.
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 - 25 - to exit.
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. 4MHz, 5MHz or 8MHz vascular probes are to be connected to the Doppler to perform vascular examination. Choose the appropriate probe as required.
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) Posterior Tibial Artery (8.0MHz) Dorsalis Pedis Artery (8.
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.
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 Classification: Anti-electric Shock Type: Internally powered equipment Anti-electric Shock Degree: Type B equipment Degree of Protection against Harmful Ingress of Wa
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications Transport and Storage: Temperature: -20°C ~ +55°C (-4ºF ~ +131 ºF) Humidity: 25% ~ 93% (non-condensing) Atmospheric Pressure: 700hPa ~1060hPa Display: 45mm*25mm LCD display FHR Performance: Sensitivity: 10 weeks gestation (3MHz) FHR Measuring Range: 50bpm ~ 210bpm Resolution: 1bpm Accuracy: ±3bpm Audio Output Power: 0.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications SONOTRAX Basic A 9 hr 8 hr / SONOTRAX II / / 8 hr SONOTRAX Pro 9 hr 8 hr / SONOTRAX II Pro / / 8 hr Rechargeable NI-MH Battery Nominal Capacity: 1800m Ah Nominal Voltage: 2.4 VDC Continual Working Time: 8 hr Necessary Charge Time: 4 hr Ultrasound Nominal Frequency Working Frequency 2.0MHz Obstetrical Probe 2.0MHz 3.0MHz Obstetrical Probe 3.0MHz 4.0MHz Vascular Probe 4.0MHz 5.0MHz Vascular Probe 5.
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 (MHz) Ispta.3 (mW/cm2) CW 2.0 47.227 CW 3.0 1.423 CW 4.0 17.297 CW 5.0 44.25 CW 8.0 45.44 TI Type TI Value TIS 0.20 TIB 0.19 TIS 0.014 TIB 0.17 TIS 0.01 TIB 0.13 TIS 0.3031 TIB 0.2876 TIS 0.08 TIB 0.33 - 32 - MI Isppa.
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. If the damage is evident, replacement is recommended. The probe is frangible and must be handled with care.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual CAUTION 1 Pay attention not to immerse the probe socket into the disinfector. 2 The main unit is not waterproof, do not disinfection it. 3 Never try to sterilize the probe or the main unit.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Warranty and After-Sales Service Chapter 7 Warranty and Service 7.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: a) damage caused by mishandling during shipping. b) subsequent damage caused by improper use or maintenance.
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 8.0MHz Vascular Probe 12.01.14347 Accessory Alkaline Batteries 01.21.064086 Rechargeable NI-MH Batteries 21.21.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Appendix 2 EMC Information EMC Information-Guidance Manufacture’s Declaration and 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. The customer or the user of the device should assure that it is used in such an environment.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Power frequency (50Hz/60Hz) magnetic field IEC61000-4-8 3 A/m 3 A/m EMC Information Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. A2.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual a b 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.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Overall Sensitivity Appendix 3 Overall Sensitivity Overall Sensitivity (2MHz Probe) Two-way Attenuation B=∑Ba+Bw Reflection Loss A(d) Diameter of Target Distance Reflector (d) (mm) (mm) ∑Ba (T:mm Ba:dB) 50 1.58 A=45.7dB@ 2MHz 75 4.8 4.0 - Ba 40 9.6 8.0 - T 20 4.8 3.4 - Ba 40 9.6 6.8 - T 20 4.8 3.4 - Ba 40 9.6 6.8 - T 20 4.8 - - Ba 40 9.6 - - T 20 4.8 3.4 2.2 Ba 40 9.6 6.8 4.4 T 20 4.8 3.
SONOTRAX Series Ultrasonic Pocket Doppler User Manual Overall Sensitivity Overall Sensitivity (3.0 MHz Probe) Diameter of Target Reflector (mm) 1.58 A=44.5dB@ 3MHz 50 75 100 200 2.38 A=42.0dB@ 3MHz 50 75 100 200 Doppler Frequency (Hz) Two-way Attenuation B=∑Ba+Bw Reflection Loss A(d) (dB) Distance (d) (mm) ∑Ba (T:mm Ba:dB) T 10 4 - - Ba 43.6 17.9 - - T 10 3 - - Ba 43.6 13.5 - - T 10 3 - - Ba 43.6 13.5 - - T 10 1 - - Ba 43.6 6.
