MS1R-36708-Sonotrax Series Ultrasonic Pocket Doppler User
Contents
1. 1 Chapter 2 Safety Guidance 3 CAM OIG M 3 2 m 5 TOMTOM m 5 Chapter 3 Doppler and Accessorics 7 i u u us ee ee E 7 As s E 9 IBAON uuu Tr 9 S OC o ERO 10 od 00 mt 11 De Del WV AGC LIE OL EO OG 11 24 92 Waterproof VASCULAR ProDES uu ua 11 12 1 AE umm 13 Chapter an ae ee FO 07 000 B 14 4 1 Opening Package and 14 4 Battery E E n E E 14 4 3 Qperation PN r P L E 15 4 4 Switch on the LA ma M enn 16 23s drea 16 4 5 1 Real time FHR Display Mode Mode 1 16 4 5 2 Averaged FHR Display Mode Mode 2 17 Mode MOGE uuu TN 17 4 5 4 Back Li2. EDAN INSTRUMENTS INC 591195 5 Jo ddoq 394204 User Manual nual Ver 1 5 lease Date Nov 2008 Part Number MS1R 36708 V1 5 Copyright Copyright EDAN INSTRUMENTS INC 2008 All rights reserved Statement Edan Instruments Inc hereinafter called EDAN makes no warranty of any kind with regard to this material including but not limited to the implied warranties of merchantability and fitness for a particular purpose EDAN assumes no responsibility for any error that may appear in this document or for incidental or consequential damage in connection with the furnishing performance or use of this material No part of this document may be photocopied reproduced or translated to another language without prior written consent of EDAN information contained in this publication 1s believed to be correct EDAN shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance or use of this material This publication may refer to information and protected by copyrights or patents and does not convey any license under the patent rights of this company nor the rights of others This company does not assume any liability arising out of any infringements of patents or other rights of third parties The information contained in this document 15 subject to change without notice Responsibility of the Manufactu
3. 11115422 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 15 SONOTRAX Series Ultrasonic Pocket Doppler User Manual 3 Removing and Connecting a Probe One probe has been connected to SONOTRAX Series ultrasonic pocket Doppler while packed by the manufacturer If you need to replace it with another probe take out the probe first then pull out the plug of the probe from its socket figure 4 5 Connect the plug of another probe to the socket and then the probe can be used Figure 4 5 Remove the Probe Fa ss W a L i d IM J P d pe i J 4 e L d ot ER Jj Le m mmm i TWH WE 1 111 UU uU S lt NOTE Place 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 4 4 Switch on the Doppler Press the POWER button on front panel to switch on the Doppler 4 5 Modes Setting SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX II and II Pro Dopplers have a number of mode opti
4. 32 A1 1 Electromagnetic Emissions for all Equipment and Systems 32 A1 2 Electromagnetic Immunity for all Equipment and Systems 33 A1 3 Electromagnetic Immunity for all Equipment and Systems that are not L i Ol Mm Utm 34 A1 4 Recommended Separation Distances 35 Appendix l 36 IV SONOTRAX Series Ultrasonic Pocket Doppler User Manual Chapter 1 Introduction 1 1 Intended Use The SONOTRAX Series Ultrasonic Pocket Dopplers are intended to be used by health care professionals including registered nurses practical nurses midwives ultrasound technicians and physicians assistants by prescription from licensed physicians in hospitals clinics and private offices The 2 MHz and or 3 MHz waterproof probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being They can also be used to verify fetal heart viability following patient trauma The 4 MHz and or 8 MHz waterproof vascular probes are indicated for the detection of blood flow veins and arteries for assisting in the detection of peripheral vascular disease 1 2 Features There are six different models available SONOTRAX Lite SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX
5. SONOTRAX II Pro Recording Press the REC PLAY button and hold for 3 seconds under mode 1 2 or 3 the machine starts recording RECORDING will appear on the LCD The longest record time depends on the recording sampling frequency set in mode 5 The machine records 480 seconds with 4KHz frequency and 240 seconds signal with 8KHz frequency The machine will stop recording and return to monitoring status when the limited time 1s over or when you press the REC PLAY button again Playing Press the REC PLAY button under mode 1 2 or 3 when the machine is not recording PLAYING will appear the LCD the machine plays the recorded signals When playing 1 over or pressing the REC PLAY button again it will return to the monitoring status 4 8 Record Fetal Heart Sounds The fetal heart sound signal can be transferred to a personal computer PC and recorded by its Sound Recorder You can play the recorded sound files burn them into CDs or e mail them to whomever you want 4 8 1 Record Sounds Insert one plug of the special audio cable supplied by the manufacturer to the audio input Q socket socket with the symbol lt 7 of the PC refer to figure 4 7 If the PC has no audio gt Input socket Insert plug into microphone socket socket with symbol Figure 4 The Audio Input Socket on the PC Audio Input Socket SONOTRAX Series Ultrasonic Pocket Doppler User Manual Turn on the PC
6. Doppler shuts down automatically PLAYING PLAYING Is highlighted when the Doppler ts playing the recorded audio signals RECORDING SONOTRAX Series Ultrasonic Pocket Doppler User Manual RECORDING 15 highlighted when the Doppler 15 recording Displaying Here displays the fetal heart rate value whose unit 15 bpm beat minute Probe Type The Doppler can detect and identify the probe when the probe 1s not connected or not well connected to the Doppler the symbol and MHZ symbol on the LCD screen flash when the probe is well connected the flashing stops the probe type displays on the LCD screen Communication The Doppler can communicate with PC This function 1s reserved 3 3 Buttons At most there are four push buttons Power MODE START STOP and REC PLAY and volume control button on the SONOTRAX Series Ultrasonic Pocket Doppler Their primary functions are as follows 1 Power Button Function Switch on or off the Doppler 2 MODE Button MODE Only for SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX II Pro Function Select the working mode 3 START STOP Button 10 Only for SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX SONOTRAX II Pro Function Start stop monitoring Mode 3 setting Mode 4 and Mode 5 2 4 REC PLAY Only for SONOTRAX SONOTRAX Pro Function Start stop recording or play
7. 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 Check for any mechanical damage C Check all the cables and accessories If there is any problem contact us or your local distributor immediately 4 2 Installing Battery 1 Open the battery compartment Turn the rear panel up Press the top stripe symbols of the compartment cover hard with one thumb Meanwhile slide the cover out along the direction of arrowhead with the other thumb figure 4 1 Figure 4 1 Remove the compartment cover Battery socket Battery connector 2 Place the battery For SONOTRAX Lite SONOTRAX Basic SONOTRAX Basic and SONOTRAX Pro Doppler there 15 a battery connector that has been inserted to the battery socket In the compartment Take out a new battery and connect the battery to the connector put the assembly back into the compartment with the connector inward 4 SONOTRAX Series Ultrasonic Pocket Doppler User Manual For SONOTRAX II and SONOTRAX II Pro Doppler insert the plug of the lithtum ion polymer battery into the battery socket and put them into the compartment with the wires inward 3 Slide the compartment cover back to close the compartment CAUTION Take out the battery and keep it in cool and dry environment if the Doppler will not be used for a long time ES CAUTION For
8. 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 Inspect the equipment for mechanical and functional damage Inspect the safety relevant labels for legibility Verify that the device functions properly as described in the instructions for use Test the the pregnant woman s leakage current according to IEC EN 60601 1 Limit 100 uA B The leakage current should never exceed the limit The data should be recorded in an equipment log If the device is not functioning properly or fails any of the above tests the device has to be repaired 4 CAUTION If the rechargeable button battery is used please charge it fully before use in order to protect its performance and life Under normal temperature the battery should be charged for 14 hours continuously at standard charge circuit 4 CAUTION The battery must be taken out from the battery compartment if the device will not be used for a long time SONOTRAX Series Ultrasonic Pocket Doppler User Manual CAUTION The device shall only be used if the battery cover is closed t CAUTION The battery must be proper disposed according to local regulation after their use 4 CAUTION The device could be sent back to the manufacturer for recycling or proper dispos
9. mode 15 changed 4 5 4 Back Light Brightness Setting Mode Mode 4 This mode is only for SONOTRAX Basic A SONOTRAX SONOTRAX SONOTRAX II Pro When the Doppler works on this mode the Working Mode on LCD displays 4 Press START STOP button to set the brightness of white back light OFF displayed at the LCD means the white back light is disabled while ON means the white back light 15 enabled NOTE The setting under this mode will be saved automatically after mode switching or normal power off 4 5 5 Record Sampling Frequency Setting Mode Mode 5 SONOTRAX Pro SONOTRAX II Pro Doppler have the build in function of recording and playing audio signals this mode 15 used to set the record sampling frequency When the Doppler works on this mode the Working Mode on LCD displays 5 Press START STOP button the sampling frequency switches between 4 and 8 on the LCD 4 means the frequency is 4KHz the longest record time is 480 seconds while 8 means 8KHz the longest record time 15 240 seconds NOTE 1 The setting under this mode will be saved automatically after mode switches or normal power off 2 After changing frequency the records related to the original frequency will be cleared automatically SONOTRAX Series Ultrasonic Pocket Doppler User Manual 4 6 Fetal Heart FH Monitoring FH monitoring with 2 0MHz waterproof probe 3 0MHz waterproof probe Feel the position of the fetus
10. 00 sec 0 00 sec set a SEL gt 44 gt e e Click Start to start recording refer to figure 4 9 You can record 60 seconds every time when time is up click Start again to keep on recording Click Stop to stop recording refer to figure 4 10 Click File Save input the file name select a folder and click Save To start a new recording click File 20 SONOTRAX Series Ultrasonic Pocket Doppler User Manual 4 8 2 Play Sound Files The recorded sounds are saved as a waveform wav file In your computer You can play the waveform file Sound Recorder Startup the Sound Recorder click File Open search for the folder and select the file click Open to load the file click Play If you have any other program that supports waveform wav files installed on your PC double click the file to play it 4 8 3 Burn CD or Send in Email The waveform files saved in your PC are normal audio data files You can burn them into CDs or e mail to whomever you want 4 8 4 Record Troubleshooting If there 1s audio output from the speaker or earphone but when recording starts no sound 15 input The green line recording area has no waveform The reason could be 1 The plug of audio cable is not well connected to the Doppler or the PC socket Re connect the cable if this condition 1s detected 2 The plug of audio cable has bee
11. Compliance level level environment guidance Floors should be wood concrete or ceramic tile If 6 kV contact 6 kV contact floor are covered with 8 kV air 8 kV air synthetic material the relative humidity should be at least 30 Electrostatic discharge ESD IEC 61000 4 2 nee SONOTRAX Series Ultrasonic Pocket Doppler User Manual A1 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 The customer or the user of the device should assure that it 15 used in such an environment Immunity test IEC 60601 test level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the SONOTRAX Series Ultrasonic Pocket Doppler including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 35 Radiated 3 80 MHz to 800 MHz 61000 4 3 80 MHz to 2 5 GHz 1 WP 800 MHz to 2 5 GHz l Where 15 the maximum output power rating of the transmitter In watts W according to the transmitter manufacturer and d 15 the recommended separation distance metres m Field strengths from fixe
12. 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 are not only used to listen in the fetal heart they also display the fetal heart rate on a LCD screen Different model has different feature refer to the chart below for details SONOTRAX SONOTRAX SONOTRAX Lite Basic Pro II Pro LCD Display LCD Backlight Mini USB Probe Socket SONOTRAX Basic A NE EN EM Probe Detecting Probe Identifying EN Built in Speaker NM Attached Earphone mE Volume Adjustable Modes Switching SONOTRAX Series Ultrasonic Pocket Doppler User Manual Audio Recording and 1 Playing Maines 9 _ Lithium ion Polymer Battery Charge in Machine Low Battery Detecting Low Battery Indicating Auto Shutdown Vascular Monitoring SONOTRAX Series Ultrasonic Pocket Doppler User Manual Chapter 2 Safety Guidance This unit 15 internally powered equipment and the degree of shock protection 15 type Type B protection means that these person connections will comply with permitted leakage currents dielectric strengths of IEC EN 60601 1 2 1 Safety Precautions WARNING and CAUTION messages must be observed To avoid the possibility of injury observe the following precautions during the operation of the device A WARNING This device is
13. Probe 3 0MHz Waterproof Probe 4 0MHz Waterproof Vascular Probe 8 0M Hz Waterproof Vascular Probe IPX8 Water Ingress Protection Code which indicates this probe can work continuously for 5 hours when being immersed into water within 1 meter depth Degree of Safety in Presence of Flammable Gases Equipment not suitable for use in presence of flammable gases Working System Continuous running equipment EMC Group I Class B Physical Characteristic size 32 Depth x 85 Width x 138 Height mm Weight 290 5 including a battery and a probe Environment Working Temperature 5 40 C Humidity lt 80 Atmospheric Pressure 860hPa 1060hPa Transport and Storage Temperature 10 55 Humidity lt 93 Atmospheric Pressure 860hPa 1060hPa Display 45 25mm LCD display FHR Performance sensitivity 10 weeks gestation FHR Measuring Range 50bpm 210bpm 206 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Resolution 1bpm Accuracy 3bpm Audio Output Power 0 5W Recording and Playing Audio Sampling Frequency 4KHz 7 Recording Length 480s 240s Recording can be played White Back Light Two Brightness Adjustable OFF ON Audio Output Power 0 5W Auto Shut down After 1 minute no signal or no operation auto shut down Battery Type Recommended 9 volt DC alkaline battery Type No 6LR61 6LF22 or equivalent Stand by Time hour Battery SONOTRAX Basic gt 8 h wit
14. and SONOTRAX Pro Doppler follow the reverse order of installing a battery described in section 4 2 to replace the battery For SONOTRAX II and SONOTRAX II Pro Doppler charge their lithium ion polymer battery the machine by inserting the DC plug of the special charger supplied by EDAN m to the charge socket on the Doppler and connecting the AC plug of it to the a c 110 240V 50 60 Hz power supply It takes about 4 hours to fully charge the battery When charging the LED of the charger 1s orange when the battery 15 fully charged the LED turns to green CAUTION Make sure the Doppler is shutdown before charging the battery or opening the battery compartment C CAUTION Only charge the lithium ion polymer batter of SONOTRAX II and SONOTRAX Pro in the machine Do not use the Doppler for monitoring until the charger is disconnected with the Doppler 25 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Chapter 5 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 60601 1 1998 1 2 EN 60601 1 1990 1 2 IEC EN 60601 1 2 2001 IEC EN 61266 Classification Anti electric Shock Type Internally powered equipment Anti electric Shock Degree Type B equipment K Degree of Protection against Harmful Ingress of Water Main Unit Non protected 2 0MHz Waterproof
15. mobile RF communications equipment and Series Ultrasonic Pocket Doppler The SONOTRAX Series Ultrasonic Pocket Doppler 15 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 interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SONOTRAX Series Ultrasonic Pocket Doppler as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum m output power of transmitter 80 MHz to 800 MHz 800 MHz to 2 5 GHz 1 0 1167 0 2334 For transmitters rated at maximum output power not listed above the recommended separation distances in metres 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 NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Nm SONOTRAX Series Ultrasonic Pocket Doppler User Manual Appendix 2 Overall Sensitivity Overall Sensitivity 2MHz Probe Reflect
16. startup the sound recorder Click Start Programs Accessories Entertainment Sound Recorder Refer to figure 4 8 Figure 4 8 Startup the Sound Recorder m Accessibility Games v Communications e Realtek Sound Manager dag Entertainment Sound Recorder Startup gt System Tools volume Control Internet Explorer Address Book e Windows Media Player W MSN amp Calculator 3 Outlook Express GY Command Prompt Remote Assistance I Notepad windows Media Player Paint Windows Messenger Program Compatibility Wizard Windows Movie Maker Synchronize Windows Catalog 9 Microsoft Office Tour Windows HTML Help Workshop Windows Explorer Acrobat Distiller 7 0 WordPad Adobe Acrobat 7 0 Professional Adobe Designer 7 0 Set Program Access and Defaults rd Programs E Documents gt Settings P Search 9 Help and Support Windows Professional Shut Down Monitor the FHR with the method described in section 4 6 When the ideal signal is detected unplug the earphone first If it s connected insert the other plug of the audio cable into the earphone socket on the Doppler Figure 4 9 The Sound Recorder Figure 4 10 Recording Sound Sound Recorder 1 Sound Sound Recorder m Edit Effects Help File Edit Effects Help Position Length Position Length 0
17. surface of the device NOTE Wipe the surface of probe with 70 ethanol or isopropranol alcohol self air dry or clean with a clean dry cloth 29 SONOTRAX Series Ultrasonic Pocket Doppler User Manual 6 3 Disinfection Clean the equipment extertor surface probe etc as above For the disinfecting of 2 0MHz waterproof probe 3 0MHz waterproof probe immerse the probe into solutions of Benzalkonium Bromide 0 5 Chlorhexidine 2 Glutaraldehyde 75 ethanol to disinfect Wipe the probe with a clean dry cloth to remove any remaining moisture NOTE Please pay attention to the height when the probe is immersed in order to prevent the sterilant from entering the probe socket CAUTION Never try to sterilize the probe or equipment by low temperature steam or other methods _ 30 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Chapter 7 Warranty and After Sales Service 7 1 Warranty EDAN s obligation under this warranty is limited to repairing at EDAN s option any part which upon EDAN s examination proves defective If the product doesn t function as warranted during the warranty period we will repair or replace it without charge 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 EDAN s
18. Doppler User Manual 3 5 Probes 3 5 1 Waterproof Probes 2 0MHz 3 0MHz waterproof probe can be connected with the main unit of the SONOTRAX Series Figure 3 7 2 0MHz waterproof probe Figure 3 8 3 0MHz waterproof probe CD2 0 3 0 CD means continuous wave Doppler 2 0 3 0 means central frequency 15 2 0 MHZ 3 0MHz MS3 14320 Part number of the 2 0M Hz waterproof probe MS3 14321 Part number of the 3 0M Hz waterproof probe A Version number of the probe SNxxxxx Serial number of the probe Waterproof The probe 15 waterproof IPX8 Water Ingress Protection Code which indicates this probe can work continuously for 5 hours when being immersed into water within 1 meter depth 3 5 2 Waterproof Vascular Probes The 4 0MHz optional and the 8 0MHz waterproof vascular probes are used for monitoring arteries and veins Figure 3 9 4 0MHz Waterproof Vascular Probes Figure 3 10 8 0MHz Waterproof Vascular Probes siis SONOTRAX Series Ultrasonic Pocket Doppler User Manual The main information on the probe 15 as follows CD 4 0 CD8 0 CD means continuous wave Doppler 4 0 8 0 means the central frequency 15 4 0 8 0 MHz MS3 14346 EDAN part number of 4 0MHz waterproof vascular probe MS3 14347 EDAN part number of 8 0MHz waterproof vascular probe A the version number of this vascular probe SNxxxxx Serial number of this vascular probe Waterproof The probe 15 waterproof IPX8 Water Ingress Protection Code which indi
19. Manual Appendix 1 Information Guidance and Manufacture s Declaration A1 1 Electromagnetic Emissions for 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 Emission test Compliance Electromagnetic environment guidance The SONOTRAX Series Ultrasonic Pocket Doppler uses RF RF emissions energy only for its internal function Therefore its RF emissions CISPR 11 are very low and are not likely to cause any interference in nearby electronic equipment The SONOTRAX Series Ultrasonic Pocket Doppler is suitable for use in all establishments including domestic establishments Class B and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF emission CISPR 11 230 SONOTRAX Series Ultrasonic Pocket Doppler User Manual A1 2 Electromagnetic Immunity for all Equipment and Systems 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 IEC 60601 test Electromagnetic Immunity test
20. al after their useful lives 2 2 Symbols P N ml SO Rx only This item is compliant with Medical Device Directive 93 42 EEC of June 14 1993 a directive of the European Economic Community This symbol consisting of two parts see below It indicates that the equipment should be sent to the special agencies according to local regulation for separate collection after its useful life Me indicates that the equipment is put on the market after 13 August 2005 Attention Refer to accompanying documents Part Number Serial Number Date Of Manufacture Manufacturer Authorized Representative In the European Community Recycle Federal U S Law restricts this device to sale by or on the order of a physician 2 3 Ordering Information The accessories for normal use supplied or approved by EDAN can be used with SONOTRAX Series Ultrasonic Pocket Doppler 5 SONOTRAX Series Ultrasonic Pocket Doppler User Manual SONOTRAX Series Ultrasonic Pocket Doppler User Manual Chapter 3 Doppler and Accessories 3 1 Appearance Take example for 2 0MHz waterproof probe Figure 3 1 Front Panel Figure 3 2 Rear Panel Pocket Clip Attachment Battery Volume Control MODE Button START STOP Button REC PLAY Button Charge Warning Earphone Socket Socket SONOTRAX Series Ultrasonic Pocket Doppler User Manual 3 2 Display Panel There 15 a LED at the left bottom corner of the disp
21. by hand firstly to find out the best direction to the fetal heart Apply a liberal amount of gel to the faceplate of probe place the faceplate of probe at the best position for detecting fetal heart Adjust the probe to obtain an optimum audio signal ideally by angling the probe around Adjust the volume according to requirements Refer to figure 4 6 Figure 4 6 FH monitoring The audio fetal heart beat 15 sent out via the built in speaker or attached earphone the FHR value is displayed on the LCD except SONOTRAX Lite NOTES 1 The best quality records will only be obtained if the probe is placed in the optimum position 2 Positions with strong placental sounds swishing or fetal cord pulse indistinct pulse at fetal rate should be avoided 3 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 During monitoring prolonged lying in the supine position should be avoided owing to the possibility of supine hypotension Sitting up or lateral positions are preferable and may be more comfortable to the mother 4 It is not possible to FHR unless an audible fetal heart signal is present The fetal pulse can be distinguished from the maternal pulse by feeling the mother s pulse during the examination 18 SONOTRAX Series Ultrasonic Pocket Doppler User Manual 4 7 Build in Recording and Playing This function is only for SONOTRAX
22. cates this probe can work continuously for 5 hours when being immersed into water within 1 meter depth 3 5 3 Probe Socket Figure 3 11 Probe socket d 07 Probe Coding OO Probe Coding 5 Probe Coding 6 Shab GND TE The probe socket is shown as Figure 3 11 Connect the 2 0MHz waterproof probe 3 0MHz waterproof probe 4 0MHz waterproof vascular probe or 8 0MHz waterproof vascular probe developed by EDAN to the SONOTRAX Series according to real requirements WARNING Do not try to connect any other plug to the probe socket except the plug of the probes mentioned above WARNING N In case of disengaging from the probe interface the connecting cable of the probe can not be dragged for more than 2 meters 340 SONOTRAX Series Ultrasonic Pocket Doppler User Manual 3 6 Battery Power of the SONOTRAX Lite SONOTRAX Basic SONOTRAX Basic and SONOTRAX Pro Doppler comes from a 9V alkaline battery IEC Type No 6LR61 6LF22 or equivalent Power the SONOTRAX II and SONOTRAX II Pro Doppler comes from a lithium ion polymer battery supplied by EDAN SONOTRAX Series Ultrasonic Pocket Doppler User Manual Chapter 4 Operation NOTE To ensure that the Doppler would work properly please read this chapter and Chapter 1 Safety Guidance before operating follow the steps when connecting all the components 4 1 Opening the Package and Checking
23. ce Balance Balance Balance Balance Balance b 9 4 6 OD 415 J qp 9 q p 0 Volume Volume Volume Volume Volume Mute all Mute Mute Mute qur Realtek AC37 Audio e Start a new recording 4 9 Vascular Monitoring Optional If the SONOTRAX Series Ultrasonic Pocket Dopplers are connected with 4MHz or 8MHz probes they can be used to do vascular monitoring which meets most arterial and venous assessment applications including helping to detect arterial and venous disease arterial and venous flow studies and other application where detection of blood flow 15 important Choose appropriate probe as needed The 8MHz probe has better resolution and wider detecting range than the 4MHz probe but the 4MHz has a deeper detecting depth Apply a liberal amount of gel on the site to be examined Place the probe at 45 to the skin surface over the vessel to be examined Adjust the position of the probe to obtain the loudest audio signal Refer to figure 4 13 for the probe sites ue SONOTRAX Series Ultrasonic Pocket Doppler User Manual Figure 4 13 Probe sites Vertebral Artery 4 0MHz Carotid Artery 4 0 8 0MHz Jugular Vein 4 0MHz Carotid Artery 4 0 8 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 Ar
24. ce per month or less If damage 15 evident replacement 15 recommended before use The equipment should undergo periodic safety testing to insure proper personnel isolation from leakage currents This should include leakage current measurement The recommended testing interval Is once every two years or as specified in the institution s test and inspection protocol The accuracy of FHR is controlled by the equipment and can not be adjusted by user If the FHR result 15 distrustful please use other method such as stethoscope to verify immediately or contact local distributor or manufacturer to get help 6 2 Cleaning Before cleaning switch off the power and take out the batteries Keep the exterior surface of the device clean and free of dust and dirt clean exterior surface display screen included of the unit with a dry soft cloth If necessary clean it with a soft cloth soaked in a solution of soap or water and wipe dry with a clean cloth immediately Wipe the probe with soft cloth to remove any remaining coupling gel Clean with soap and water only 4 CAUTION Don t use strong solvent for example acetone 4 CAUTION Never use an abrasive such as steel wool or metal polish AN C CAUTION Do not allow any liquid to enter the product and do not immerse any part of the device into any liquid 1 CAUTION Avoid pouring liquids on the device while cleaning C CAUTION Don t remain any cleaning solution on the
25. d RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 If the measured field strength in the location in which the SONOTRAX Series Ultrasonic Pocket Doppler is used exceeds the applicable RF compliance level above the SONOTRAX Series Ultrasonic Pocket Doppler should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SONOTRAX Series Ultrasonic Pocket Doppler Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 34 SONOTRAX Series Ultrasonic Pocket Doppler User Manual A1 4 Recommended Separation Distances Recommended separation distances between portable and
26. ght Brightness Setting Mode Mode 4 17 4 5 5 Record Sampling Frequency Setting Mode Mode 5 17 40 Heatt uu u uU ll uu Sus 18 4 7 Build in Recording and 19 4 8 Record Fetal Heart 5 19 Zo E SOUS uuu M dU NE UE E 19 252013 SOUDd Li u u 21 25 Send mi Ill un uu 21 45 4 Record Troubles hotini L U etis ea eri ep uu 21 4 9 Vascular Monitoring Optional a 23 4 10 Switch Doppler u uuu l u uu a usa 25 4 11 Replacing or charging the battery 25 Chapters Product 26 Chapter GIVI RA INCE u S Su amas 29 TTE RTT 29 O O DIAM P 29 il MTS NET mm 30 Chapter 7 Warranty and After Sales Service 31 VER 1 E su s 31 ded VCS EE E 31 Appendix 1 Information Guidance and Manufacture s Declaration
27. h backlight gt 13 h without backlight SONOTRAX Pro gt 8 h with backlight gt 13 h without backlight Lithium ion Polymer 900mAh gt 15 h with backlight gt 24 h without backlight Battery Lithium ion Polymer Battery Nominal Capacity 900mAh Charge Mode Constant current Constant voltage Charge Current Standard 300mA Storage Temperature 20 C 40 C 3 months OF SONOTRAX Series Ultrasonic Pocket Doppler User Manual Circle Life 2500 times 80 capacity Ultrasound p lt I lt 10 mW cm lt 100mW cm Effective Radiating Area of Transducer 245 mm 15 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 Ispta 3 Loos 3 MHz 1 Pe T Value EN Wem CW 2 0 47 227 ESES 0 03948 47 227 TIB 0 014 CW 3 0 2 314 0 0049 2 314 0 13 28 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Chapter 6 Maintenance 6 1 Maintenance The probe acoustic surface 15 frangible and must be handled with care Gel must be wiped from the probe after use These precautions will prolong the of the unit You must check that the equipment does not have visible evidence of damage that may affect the pregnant woman s safety or SONOTRAX Series capability before use The recommended inspection interval 15 on
28. hould be observed at all time A WARNING Replacing battery shall only be done outside the personnel environment 1 5m away from the personnel A WARNINGA Please use probes provided by EDAN sx SONOTRAX Series Ultrasonic Pocket Doppler User Manual A WARNINGAS The stretching length of probe cable should be less than 2m in order to avoid the cable breaking away from the probe socket CAUTION Federal U S law restricts this device to sale by or on the order of a physician 4 CAUTION Refer servicing to qualified personnel AN AAN 4 CAUTION The main unit of the Series is designed for continuous operation and is ordinary Do not immerse in any liquid i e not drip or splash proof 4 CAUTION Keep the device clean Avoid vibration CAUTION Do not use high temperature sterilizing process and E beam or gamma radiation sterilization CAUTION Electromagnetic Interference Ensure that the environment in which the device is operated is not subject to any source of strong electromagnetic interference such as radio transmitters mobile telephones etc Keep them far away AH CAUTION You must check that the equipment does not have visible evidence of damage that may affect personnels safety or monitoring capability before use The recommended inspection interval is once month or less damage is evident replacement is recommended before use 4 CAUTION
29. ing 5 Volume Control Indicator SONOTRAX Series Ultrasonic Pocket Doppler User Manual Function Adjust volume Rotate the volume gear clockwise to turn up the volume while rotate it anti clockwise to turn down the volume 3 4 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 3 6 Line in Cable AN Attention Refer to the accompanying documents Signal Interface 1 I GND 2 Signal l4 3 signal 4 Signal 5 s 5 signal CHARGE 2 Charge socket o the special lithium ion polymer battery 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 Furthermore all configurations shall comply with the valid version of the system standard IEC EN 60601 1 1 Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system and is therefore responsible 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 technical service department or your local distributor 0 SONOTRAX Series Ultrasonic Pocket
30. ion Loss A d Two way Attenuation B gt B B r m s Overall Sensitivity B B rm s S A d B C B dB dB dB ele bebo 75 45 7 56 4 175 DIESCINSI A 45 7dB th Ppa ae foe 100 45 7 0 56 4 174 89 5 82 107 9 B 200 45 agl os 0 49 6 173 90 5 68 100 9 40 50 43 2 60 8 178 6 02 110 0 EN B 40 96 68 44 43 24 cas 100 43 2 T 48 34 56 4 165 85 5 76 105 3 B 96 68 200 43 2 0 51 6 160 85 5 49 100 2 36 Overall Sensitivity 3 0 MHz Probe SONOTRAX Series Ultrasonic Pocket Doppler User Manual Diameter of Target Distance Reflection d Loss A d Reflector rni dB mm 1 58 A 44 5dB 50 3MHz 200 2 38 A 42 0dB 50 3MHz 75 100 200 Doppler Frequency Hz 500 Two way Attenuation B gt B4B gt B B dB P es vs NN J ages T 10 3 B 43 6 13 5 T rus EI IRIS eeu gt 43 6 13 5 10 2 96 43 6 T mm zd EN 21 2 522 50 2 oe S r m s C mV da 186 PE 5 93 175 88 5 87 172 87 5 92 165 85 5 76 160 84 5 59 Velocity of Target cm s 12 5 Overall Sensitivity S A d B C dB 111 9 107 63 107 5 100 3 110 2 105 1 100 9 97 8 EDAN EDAN INSTRUMENTS INC
31. lay panel area Lite When powered on the LED turns into green If the green LED flashes 1 indicates that the probe 15 disconnected or bad connected If the LED turns mto orange flashes 1 Indicates that the battery Is too low to support working Change for a new battery or charge the chargeable battery In time For SONOTRAX Basic SONOTRAX Basic SONOTRAX Pro SONOTRAX II SONOTRAX II Pro Ultrasonic Pocket Doppler while self testing the LCD display 15 as follows Communication Reserved RD lt Recording 5 FHR Display Figure 3 5 LCD display status while self testing Playing Working Mode FHR Refresh Frequency Battery Indicator Probe Type Working Mode Here shows which working mode is the Doppler working on FHR Refresh Frequency When monitor starts the heart shape flashes its frequency indicates the FHR refreshing frequency Battery Indicator For SONOTRAX Basic a battery symbol appears on the LCD after powered on when battery 1s 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 are several green panes in the battery symbol on the LCD which indicates the battery electric energy The green panes disappear gradually with the energy consumption When battery 15 low the empty symbol flashes for 3 times while D1 tone is repeated for 3 times Then the
32. n inserted to the wrong socket of the PC instead of the audio input socket or the microphone socket Insert the plug to the right socket 1f this condition 1s detected 3 The Line in or microphone is muted on PC If this condition is detected change the setting of the PC in these steps a Double click the volume symbol on the right bottom corner mL uve x 9 30 b The Volume Control menu pops up DT us SONOTRAX Series Ultrasonic Pocket Doppler User Manual Figure 4 11 Volume Control Volume Control Options Help Volume Control Wave SW Synth CD Flauer Balance Balance Balance Balance 19 1 Ww j Wm dj Volume Volume Volume Volume Mute all Realtek 4097 Audio If the Line In or microphone volume control 15 not shown the Volume Control menu click Options Properties tick the Line In and Microphone as shown in figure 4 12 click OK Figure 4 12 Properties Properties Mixer device Realtek ACI Audio Adjust volume Playback Recording Other Show the following volume controls SPDIF Aus Player 4 Line In Microphone Phone Line PC Speaker si 22 SONOTRAX Series Ultrasonic Pocket Doppler User Manual d Undo the tick of Line In and Microphone Mute click to exit Volume Control Options Help Volume Control Wave ew Synth Player Line In Microphone Balan
33. not explosion proof and can not be used in the presence of flammable anaesthetics NWARNING Do not throw batteries in fire as this may cause them to explode A WARNING Do not attempt to charge normal alkaline batteries they may leak and may cause a fire or even explode A WARNINGA Charge the lithium ion polymer battery with the special charger supplied by EDAN AN WARNING N Dont touch signal input or output connector and the person simultaneously A WARNINGA 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 Furthermore all configurations shall comply with the valid version of the system standard IEC EN 60601 1 1 Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system and is therefore responsible 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 technical service department or your local distributor NWARNING SONOTRAX Series Ultrasonic Pocket Doppler is a tool to aid the healthcare professional and should not be used in place of normal fetal monitoring A WARNINGA We recommend that exposure to ultrasound should be kept as low as reasonably achievable This is considered to be good practice and s
34. oftware and firmware products which are designated by EDAN for use with a hardware product when properly installed on that hardware product are warranted not to fail to execute their programming instructions due to defects in materials and workmanship If EDAN receives notice of such defects during the warranty period that begins on the date of shipment EDAN shall repair or replace software media or firmware which does not execute their programming instructions due to such defects But EDAN doesn t warrant that operating of the hardware software or firmware shall be uninterrupted or free from error Note The charges of freight and others are excluded under warranty This unit has no parts can be repaired by users themselves the service should be performed by authorized and qualified personnel Limit of Warranty The warranty 1s void in the case of Assembly extensions readjustments of any parts Modification and repair by unauthorized persons Subsequent damage caused by improper use or maintenance Replacement remove of Serial number label and manufacturer label 7 2 After Sales Service If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor or EDAN service department Call us at 86 755 26898321 26899221 Fax us at 86 755 26882223 26898330 Or send email to support edan com cn SONOTRAX Series Ultrasonic Pocket Doppler User
35. ons Press the MODE button to switch to the next mode If the SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX II SONOTRAX II Pro Doppler worked on Model Mode 2 Mode 3 last time before shutdown after self testing the Doppler will enter the same mode automatically If its last mode 1s Mode 4 Mode 5 it will enter Mode 1 after self testing 4 5 1 Real time FHR Display Mode Mode 1 When the Doppler works on this mode the Working Mode on LCD displays 1 As soon as a fetal heart signal 1s detected the heart shape on LCD flashes the FHR display area displays the real time FHR value 16 SONOTRAX Series Ultrasonic Pocket Doppler User Manual 4 5 2 Averaged FHR Display Mode Mode 2 When the Doppler works on this mode the Working Mode on LCD displays 2 The heart shape on LCD flashes when fetal heart signal 1s detected the FHR value indicates the average value of 8 beats which changes slowly 4 5 3 Manual Mode Mode 3 When the Doppler works on this mode the Working Mode on LCD displays 3 Press START STOP button once and immediately start counting count 1 on the moment when the button is pressed The LCD displays the flashing heart shape symbol and Press the button again on the 10 count after 9 beat intervals The Doppler automatically calculates the derived FHR averaged over the 10 beat periods and displays the result This rate value will not disappear until another measurement starts or the
36. rer EDAN only considers itself responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modifications or repairs are carried out by persons authorized by EDAN and The electrical installation of the relevant room complies with national standards and The instrument 1s used in accordance with the instructions for use NWARNING This device is not intended for treatment Upon request EDAN may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which EDAN may define as user serviceable Product Information Product Name Ultrasonic Pocket Doppler Model SONOTRAX Lite SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX II SONOTRAX II Pro Using This Label Guide This guide is designed to give key concepts on safety precautions ANWARNING N 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 II Table of Contents Chapter u u asa 1 Im EUIS C 5 umu I AUR SS xu AE AA
37. tery 4 0MHz Great Saphenous Vein 4 0 8 0MHz Small Saphenous Vein 8 0MHz Posterior Tibial Artery 8 0MHz Dorsalis Pedis Artery 8 0MHz Posterior Tibial Vein 8 0MHz For best results keep the probe as still as possible once the optimum position has been found Adjust the audio volume as required High pitched pulsatile sounds are emitted from arteries while veins emit a non pulsatile sound similar to a rushing wind Vascular monitoring provides audio signals of arteries and veins If it is done with SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX II or SONOTRAX II Pro the figure displayed on the LCD screen is null 7 SONOTRAX Series Ultrasonic Pocket Doppler User Manual 4 10 Switch the Doppler When the monttor 15 finished wipe off the remaining off the probe with a clean soft cloth then put the probe back into the probe frame Press the POWER button on the Lite again to switch it off If there is no signal input or no operation done to SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX SONOTRAX II Pro for 60 seconds it will automatically shut down Or you can press and hold the POWER button for 3 seconds to switch it down manually 4 11 Replacing or charging the battery When the Doppler gives out alarm indicating the battery power 15 low you have to shut down the Doppler to replace or charge the battery For SONOTRAX Lite SONOTRAX Basic SONOTRAX Basic A
38. the lithium ion polymer battery charge it in the machine with the special charge when its power is low Do not charge it with other charges or remove it frequently 4 3 Probe Operation 1 Taking out Probe Hold the Doppler main unit with one hand and hold the top of the probe with another hand Figure 4 2 First take out the top of the probe Figure 4 3 Then take out the whole probe from the probe frame Figure 4 4 2 Placing Probe Follow the opposite steps to take out the probe Hold the main unit with one hand and hold the top of the probe with another hand Figure 4 4 Place the probe from the middle of the unit at the right into the probe holder Figure 4 3 then push the top of the probe Figure 4 2 Figure 4 2 Figure 4 3 Figure 4 4 rd ia comm E 7 E a Meg 7 oL 1 k zn X J d L L Al f A E i ERU ES wj a o E as 4 n Ps T UE s EE Sas Was urs b nz a 5 a a prs e 4 E Lr li Sy Qs N Eg Ed B S E bur yr 1 a TY Ur Ll 111 erm ul E LU mu HALLE LLL UL MAN
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