Manual - Cardiac Direct
Contents
1. R 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 The probe is frangible and must be handled with care Wipe the remaining gel after use to prolong the probe life The overall check of the Doppler including safety check and function check should be performed by qualified personnel every 12 months and each time after service 5 2 Cleaning Before cleaning switch off the Doppler Keep the exterior surface of the device clean and free of dust and dirt Clean the exterior surface display screen included of the main unit with a dry soft cloth If necessary clean it with a soft cloth soaked in soap water and then wipe it dry with a dry cloth immediately Wipe the remaining coupling gel off the probe Clean it with a soft cloth dampened in solution soap water 70 ethanol or isopropranol alcohol and then air dry it or wipe the moisture with a soft dry cloth CAUTION Clean the main unit with soap and water only Avoid strong solvent such as acetone Never use an abrasive such as steel wool or metal polish The main unit is not waterproof Do not immerse any part of it into liquid Avoid pouring liquids on the main unit while cleaning o2. User Manual D SONOTRAX Series Ultrasonic Pocket Doppler Release 1 7 with Software Revision 1 4 1 5 C Eo About this Manual P N 01 54 36708 17 Release Date Aug 2010 Copyright EDAN INSTRUMENTS INC 2007 2010 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 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 Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability and performance of the equipment if Assemb
3. EDAN INSTRUMENTS INC 3 F B Nanshan Medical Equipment Park Nanhai Rd 1019 Shekou Nanshan Shenzhen 518067 PR CHINA Email info edan com cn TEL 86 755 2689 8326 FAX 86 755 2689 8330
4. 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 35 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
5. 0MHz 8 0MHz vascular probes supplied by the manufacturer to the Doppler through the probe socket CAUTION 1 Do not try to connect any other plug to the probe socket except the plug of the probes mentioned above 2 Do not stretch the probe cable for more than two meters long 2 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 SONOTRAX II and SONOTRAX II Pro are powered by lithium ion polymer batteries supplied by the manufacturer L 5 4 M S he K a 9 g Y Y T D x D E 4 LO Q D Q3 Alkaline Battery Rechargeable NI MH Battery Lithium ion Polymer Battery Figure 2 12 Batteries e D S 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 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 Check all the cables and accessories If there is any problem contact us or your local distributor immediately 3 2 Installing Replacing Battery To install or r
6. C mm T mm B dB dB dB dB 2 COCOR 50 45 7 0 57 6 186 94 5 93 109 2 B 40 9 6 8 0 CCE 75 45 7 56 4 75 5 78 107 8 DOCCE A 45 7dB 9 BEE 100 45 7 Pa 40 56 4 174 5 82 107 9 fo feel 200 45 7 a a a P O 49 6 173 90 5 68 100 9 C zorog L rams 50 43 2 178 89 6 02 110 0 43 2 1 52 107 1 js 75 3 70 90 5 5 07 A 43 2dB MH 20 48 3 4 eo mg Lele ess lal S on ae 200 43 2 5 49 100 2 Doppler Frequency Hz 333 Velocity of Target cm s es ae ae SONOTRAX Series Ultrasonic Pocket Doppler User Manual Overall Sensitivity Overall Sensitivity 3 0 MHz Probe Two way Attenuation Diameter of l s B YB B Overall Sensitivity S A d B C Distance Reflection d Loss A d mm dB 2 Ba T mm B dB cs IE BESES Target Reflector mm 61 5 179 S72 186 O X Nn O LAA bd a N SS fr fof fe 50 2 171 BE m OO oO CO CO ON LAA 2 38 A 42 0dB 61 5 194 6 73 110 2 ite Pe ese we pops IRZ 172 5 92 105 1 afe e T 10 2 stil 2 ee oe 4A m eae B ass 96 T 10 l 200 50 2 160 84 5 59 97 8 Pe os os Doppler Frequency Hz 500 Velocity of Target cm s 12 5 es P N 01 54 36708 17 EDAN www edan com cn EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany TEL 49 40 2513175 FAX 49 40 255726 E mail antonjin yahoo com cn
7. Serial number of the probe Waterproof The probe is waterproof IPX8 Water Ingress Protection Code It indicates that this probe can work continuously for five hours when being immersed into water within one meter deep 2 6 2 Waterproof Vascular Probes The 4 0MHz S5 0MHz 8 0MHz waterproof vascular probes can be connected to the main unit for artery and vein blood flow examining SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories E 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 1s 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 MS3 14347 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 is waterproof IPX8 Water Ingress Protection Code It indicates that this probe can work continuously for five hours when being immersed into water within one meter deep 2 6 3 Probe Socket The probe socket is as shown in figure 2 9 Power Supply E E Probe Coding 1 E 5 GND eooo i enan Figure 2 9 Probe socket 10 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories Connect the 2 0MHz 3 0MHz obstetrical probes or 4 0MHz 5
8. Ultrasonic Pocket Doppler is 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 Ele E 1 For transmitters rated at a 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 NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 36 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Overall Sensitivity Appendix 3 Overall Sensitivity Overall Sensitivity 2MHz Probe Reflection Loss A d Two way Attenuation B Ba Bw Overall Sensitivity Reflector SB B B Droa O r m s S A d B
9. the battery is fully charged 4 to 6 hours are needed Remove the charger plug and then the Doppler is available for examining again Figure 3 15 Charging lithium ion polymer battery NOTE The Doppler is not available for examining during charging ye 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 IEC EN 60601 1 2 2007 IEC EN 61266 Classification Anti electric Shock Type Internally powered equipment Anti electric Shock Degree Type B equipment L Degree of Protection against Harmful Ingress of Water Main Unit Not protected Probes IPX8 Water Ingress Protection Code indicating this probe can work continuously for five hours when being immersed into water within one meter deep Degree of Safety in Presence Equipment not suitable for use in presence of of Flammable Gases 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 C 40 C 41 F 104 F Humidity 25 80 non condensing Atmospheric Pressure 860hPa 1060hPa Transport an
10. 123 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 Consult Instructions for Use Stand by Polarity of d c power connector Class Il equipment cs Can be used in residential areas AX Attention Attention Refer to accompanying documents to Attention Refer to accompanying documents documents RR S Date Of Manufacture Authorized Representative in the European Community amp General symbol for recovery recyclable Rx only U S Federal U S Law restricts this device to sale by or on the order of a physician SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories Chapter 2 Doppler and Accessories 2 1 Features There are six different models available SONOTRAX Lite SONOTRAX Basic SONOTRAX 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 The features of the Dopplers are listed in the following chart SONOTRAX SONOTRAX SONOTRAX SONOTRAX RRIT SONOTRAX Lite Basic Basic A Pro Il Pro LCD Backlight S Socket E A R e H H H E H 9 N pov ee lt
11. 2 2 ee p A l I Ll 2 Ll 2 L Modes Modes Switching L Bae FEJ gt KE L L Audio Recording J peery te NI MH Battery 8 4V RRR R Lithium ion Polymer q N Battery Battery Charged in i K Machine Low Battery Detecting amp nm Auto Auto Shutdown 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 Pocket Clip Attachment Compartment e E Volume Control MODE Button START STOP Button REC PLAY Button Earphone Socket Charge Eaka Warning Figure 2 3 Top Panel Figure 2 4 Left Panel SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories 2 3 Display Panel SONOTRAX Lite has 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 For SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX II and SONOTRAX II Pro while self testing the LCD is shown as follows 9 Communication PY UN ORI Soo g Recording x FHR Display Playin Working Mode ae FHR Refresh Frequency Battery Indicator Probe Type Figure 2 5 LCD display statu
12. R button on the front panel to switch on the Doppler 3 5 Modes Setting SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX IT and 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 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation 3 5 1 Real time FHR Display Mode Mode 1 When the Doppler works in this mode the working mode on LCD displays 1 As soon as a fetal heart signal is detected the heart shape on LCD flashes and the FHR display area displays the real time FHR value 3 5 2 Averaged FHR Display Mode Mode 2 Keep pressing the MODE button until the working mode on LCD displays 2 The heart shape on LCD flashes when fetal heart signal 1s detected and the FHR value indicates the average value of every eight beats 3 5 3 Manual Mode Mode 3 Keep pressing the MODE button until the working mode on LCD displays 3 Press the START STOP button once and start counting immediately viz count one at 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 nine beat intervals The Doppler automatically calculates and displays the average FHR over the 10 beats This rate value will not disappear until another measurement st
13. 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 Anybody who connects additional equipment to the signal input connector or signal output connector to configure a medical system must ensure that the system complies with the requirements of the valid version of the system standard IEC EN 60601 1 1 If in doubt consult our technical service department or your local distributor 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 The 3MHz obstetrical probe features in high sensitivity and is designed for use during the entire pregnancy The main information on the probe 1s as follows CD2 0 3 0 CD stands for continuous wave Doppler 2 0 3 0 means central frequency is 2 0 MHz 3 0MHz MS3 14320 Part number of the 2 0MHz waterproof probe MS3 14321 Part number of the 3 0MHz waterproof probe A Version number of the probe SNxxxxx
14. X 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 b The volume control menu pops up id Volume Control Options Help Volume Contral Wave SWM Synth LD Player Balance Balance Balance Balance gt 4 DU ado aby 4 volume volume Volume volume r EEIT Mute all 1 Mute Mute Mute Realtek 4097 Audio Figure 3 11 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 gt Properties tick Line In and Microphone as shown in figure 3 12 click on OK 22 E SONOTRAX Series Ultrasonic Pocket Doppler User Manual Properties Mixer device Realtek ACS Audio a Adjust volume for LS Playback Recording Show the following volume controls SPDIF Aus a EN Player S Microohone Phone Line _ PC Speaker Figure 3 12 Properties d Make sure Line In and Microphone is not mute click on Ed to exit ii Volume Control Options Help Volume Control Wave SW Synth CD Player Line In Balance Balance Balance Balance Balance Operation Microphone Balance gt gt J dE OD d o GoD de 4 Volume Volume Volume Vol
15. aa an gens 5 DS Display PF AMG sitet uae Ase aees ica ade a US ies adh atleast 6 2 SEE narea abil eadaens deck aac shay ih ueta E aun bell ah ta toautaueces 7 ZINCK TTT 8 DO EOD CS aa Bs arrest er aia note sea cen T tee eat ee eee 9 20 1 Waterproof Obstetrical Probe a a RENN OT oa Tee art ae 9 20 2 Water proor Vascular Proves satan aed ees 9 DOB PrOD SOC CL T 10 DAT Baos pe eR Se PPR ee ee 11 Chapter 5 ODpEration sisiane e eii ee Eear oara ES aE E E OKE aiaa 12 3 1 Opening the Packase and Checkin T 12 5 2 KEH ETZ REPlaCim Galler T 12 FS i 6 01 8 a 0 8 een eRe ee ene EA ET aL Eee mn er Onn tere nce 14 SA SWIC MI on TSO Ppl CF TTT 15 3 5 Lea 15 3 5 1 Real time FHR Display Mode Mode Tis 16 3 5 2 Averaged FHR Display Mode Mode 21 16 Dad Manuail Mode ModE 3 Verear renien tes aSboectsoxeesdunstoineuavorodeus E AOAN 16 3 5 4 Backlight Brightness Setting Mode Mode T 16 3 5 5 Record Sampling Frequency Setting Mode Mode 51 16 3 0 Fetal Hearn D RD TTT 17 3 7 FH Sound Recording and Playing by Build in Record r sese 18 3 8 FH Sound Recordine Dy PC TTT 18 S O IRECORGING Sound Serrone reia E EE EE TN 18 KR Playn Sound FileSeseresrenae e a cael ieee ocean 20 526 0 Burning R sendin 0E Ma eeri a eee 20 POARC T TOU DICSHOOUING zaii ea ain nee Gate ieee 20 S Vascular 1x amino GC PUONa T 23 SLO S Wire mine 615 Le TOM let TT 25 Sch FRE PIA IGG harene the Is ADL V css2 ike ore that arid arias he G daiwa sala Hea a
16. acture 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 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 RF emission Class B use in all establishments including domestic establishments and CISPR 11 those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes A2 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 Compliance level s s level environment guidance Immunity test Floors should be wood concrete or ceramic tile If 6 kV contac
17. and switch on the Doppler 4 Apply a certain amount of coupling gel to the probe faceplate and place the probe against the abdomen at the predetermined location Move the probe around or tilt it until clear and rhythmic heart sound is heard from the headphone or speaker At the same time a numeric FHR is displayed on the LCD except SONOTRAX Lite 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 During examining the pregnant woman s 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 4 Itis impossible to examine FHR unless a fetal heart sound is present The fetal pulse can be distinguished from the maternal pulse by feeling the mother s pulse during the examination B ie SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation 3 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 The l
18. anufacturer CAUTION Federal U S law restricts this device to sale by or on the order of a physician Refer servicing to qualified personnel The main unit is designed for continuous operation and is ordinary Do not immerse it in any liquid i e not drip or splash proof 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 SONOTRAX Series Ultrasonic Pocket Doppler is a tool to aid the healthcare professional and should not be used in place of normal fetal monitoring Keep the device in a clean environment and avoid vibration during storage The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal Batteries are hazardous waste Do NOT dispose them together with house hold garbage At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries For more detailed information about recycling of this product or battery please contact your local Civic Office or the shop where you purchased the product On SONOTRAX Series Ultrasonic Pocket Doppler User Manual Safety Guide 1 3 Symbols C The symbol indicates that the device complies with the European Council 0
19. arts or the mode is changed 3 5 4 Backlight Brightness Setting Mode Mode 4 This mode is only available with SONOTRAX Basic A SONOTRAX Pro SONOTRAX II and SONOTRAX IT Pro Keep pressing the MODE button until the working mode on LCD displays 4 Press the START STOP button to disable or enable the backlight OFF displayed on the LCD means the backlight is disabled while ON means the backlight is enabled NOTE The setting in this mode will be saved automatically after mode change or normal power off 3 5 5 Record Sampling Frequency Setting Mode Mode 5 This mode is only available with SONOTRAX Pro and SONOTRAX II Pro Keep pressing the MODE button until the working mode on LCD displays 5 Press the START STOP button the sampling frequency switches between 4 and 8 on the LCD 4 means the frequency is 4KHz and the longest record time is 480 seconds while 8 means 8KHz and the longest record time is 240 seconds EG SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation 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 3 6 Fetal Heart FH Examining FH examining with 2 0MHz 3 0MHz obstetrical probe 1 Confirm the fetus s position by hand 2 Determine the probable probe location for ideal FHR examining 3 Take out the probe
20. d Storage Temperature 20 C 55 C 4 F 131 F Humidity 25 93 non condensing Atmospheric Pressure 700hPa 1060hPa ae SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications Display 45mm 25mm LCD display FHR Performance Sensitivity 10 weeks gestation 3MHz FHR Measuring Range 50bpm 210bpm Resolution Ibpm Accuracy 3bpm NOTE In some cases fetal heart beats at 10 weeks gestation can not be detected due to the maternal physical difference and the operator s technique Audio Output Power 0 5W Recording and Playing Audio Sampling Frequency 4KHz 8KHz Recording Length 480s 240s White Backlight Two Brightness Adjustable OFF ON Auto Shut down 1 minute after no signal or operation auto shut down Recommended Alkaline Battery Type 9 volt DC alkaline battery IEC Type No 6LR61 6LF22 or equivalent Stand by Time hour 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 SONOTRAX Basic A 2 to 4 hours with backlight SONOTRAX Pro 2 to 4 hours with backlight 7 4V Lithium ion SONOTRAX II l l 10 to 15 hours with backlight Polymer Battery SONOTRAX II Pro _ 28 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications Rechargeable NI MH Battery Charge Temperatur
21. e 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 Lithium ion Polymer Battery Charge Current Standard Storage Temperature 20 C to 40 C 4 F to 104 F 3 months 20 C to 60 C 4 F to 140 F 1 month gt 300 times after 300 circles only 90 of the capacity can be restored Circle Life Ultrasound 2 0MHz Obstetrical Probe 2 0MHz Nominal Frequency 3 0MHz Obstetrical Probe 3 0MHz 4 0MHz Vascular Probe 4 0MHz 5 OMHz Vascular Probe 5 OMHz 8 OMHz Vascular Probe 8 OMHz 2 0MHz Obstetrical Probe 2 0 10 MHz Working Frequency p lt MPa Top lt 10 mW cm 29 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Product Specifications Ispta lt 100mW cm Working Mode Continuous wave Doppler l E 2 0MHz Obstetrical Probe 245 15 mm Effective Radiating Area of Transducer 3 0MHz Obstetrical Probe 245 15 mm 4 0MHz Vascular Probe 32 15 mm 5 OMHz Vascular Probe 32 15 mm 8 0MHz Vascular Probe 14 415 mm 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 Isppa 3 MHz mWiom Type T Value Mo W cm G aes S saan TIB 0 17 0 001423 0 01 cwao 1729 soa ons 0 017297 TIS 0 3031 CW 5 0 44 25 OTs 0 008475 0 04425 P PD n
22. ecording 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 Click on the stop key to stop recording refer to figure 3 10 Click on File gt Save input the file name select a folder and click on Save to save the signals in a wav file To start a new recording click on File gt New 3 8 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 gt 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 3 8 3 Burning CD or Sending 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 3 8 4 Record Troubleshooting If there is audio output from the speaker or earphone but the PC recorder does not have any input The green line recording area has no waveform The reason could be 1 Poor connection of the audio cable between the Doppler and the PC Check the plugs of the cable and re connect it if any poor connection is detected 2 The audio cable has been plugged to the wrong socket of the PC instead of the audio input 20 SONOTRA
23. eives 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 All the service should be performed by authorized and qualified personnel Limit of Warranty The warranty is 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 or remove of Serial number label and manufacturer label 6 2 After Sales Service If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send an email to EDAN service department at support edan com cn T 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 3 0MHz Obstetrical Probe 12 01 14321 Ro ae SONOTRAX Series Ultrasonic Pocket Doppler User Manual EMC Information Appendix 2 EMC _Information Guidance and Manuf
24. eplace a battery perform the following steps 1 Open the battery compartment Turn the Doppler upside down Press the two stripe marks on the battery compartment cover with your thumbs respectively Slide the cover in the direction of the arrow with mild force to open the compartment Figure 3 1 Opening battery compartment 2 Install Replace the battery Remove the old battery from the connector if necessary NOTE Do not use excessive force when disconnecting the battery and the connector in case the connector falls off Connect the new battery to the battery connector and then put the assembly into the battery compartment Figure 3 2 a 210 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 a 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 1 Take out the alkaline NI MH battery and keep it in a cool and dry environment if the Doppler is not used for an extended period 2 Do not remove the lithium ion polymer battery frequently after the initial installation If the Doppler is not used for an extended period charge the battery at least every three months a13 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Ope
25. hing length of probe cable should be less than two meters in order to avoid the cable breaking away from the probe socket SONOTRAX Series Ultrasonic Pocket Doppler User Manual Safety Guide 10 11 12 13 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 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 Anybody who connects additional equipment to the signal input connector or signal output connector to configure a medical system must ensure that the system complies with the requirements of the valid version of the system standard IEC EN 60601 1 1 If in doubt consult our technical service department or your local distributor The device shall only be used when the battery cover is closed Do not throw batteries in fire as this may cause explosion Do not attempt to charge normal alkaline batteries They may leak catch fire or even explode Replacement of the battery shall be done at least 1 5 meters away from patients Charge the lithium ion polymer battery with the special charger supplied by the m
26. ly 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 is used in accordance with the instructions for use 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 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 II Table of Contents Chapter LE Satety Guid ETT 1 I Sat Cra Care eee E eee ee l I S 0 Ra NUL IN E TAE AEE E A N E A E AE EE E l L e E E E AEEA TEATR 3 Chapter 2 Doppler and ACCeSSsoOriES eecccccsssscccceccosssssccceccccssssccceecossssssecececsssssscceeessssssssceeosso 4 DoW EET 4 2 SIC ALAIN CO eiorinn cates anal encod ease Wes ETEA va gc poses ee csc Ps d
27. n A O N gt Do not remain any solution on the surface after cleaning 5 3 Disinfection of the Probe Clean the probes as above Immerse them into the solutions of Benzalkonium Bromide 0 5 Chlorhexidine 2 Glutaraldehyde or 75 ethanol and then wipe them with a clean dry cloth to remove the remaining moisture 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 sdi SONOTRAX Series Ultrasonic Pocket Doppler User Manual Warranty and After Sales Service Chapter 6 Warranty and After Sales Service 6 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 here s no defect in material and manufacture During the warranty period EDAN will repair or replace the defective part free 1f the defect has been confirmed as material or manufacture defect Software or Firmware EDAN software 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 rec
28. ongest record time depends on the recording sampling frequency set in mode 5 The machine stops recording and returns to the examining status when the time is over or when you press the REC PLAY button again Playing Press the REC PLAY button in mode 1 2 or 3 when the machine is not recording PLAYING appears on the LCD and the machine plays the recorded signals The machine stops playing and returns to the examining status when the signal playing 1s completed or when you press the REC PLAY button again NOTE Only the last set of recorded fetal heart sounds is saved in the Doppler It is cleared when new sounds are recorded 3 8 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 3 8 1 Recording Sounds Insert one plug of the special line in cable supplied by the manufacturer to the audio input socket A the socket with the symbol of the PC refer to figure 3 7 If the PC has no audio input Y h socket insert the plug into the microphone socket the socket with the symbol 18 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation Swuas 71 ZHOS VW AQTERRR 8 Audio Input Socket Figure 3 7 Audio Input Socket on the PC Turn on PC and run the sound recorder Click on Start gt Programs gt Accessorie
29. r can communicate with PC This function is reserved 2 4 Buttons At most there are four push buttons Power 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 Power Button Function Switch on or off the Doppler Q 2 MODE Button MODE Only for SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX II SONOTRAX II Pro Function Select the working mode 3 START STOP Button 810P Only for SONOTRAX Basic SONOTRAX Basic A SONOTRAX Pro SONOTRAX II SONOTRAX II Pro Function Start stop examining Mode 3 setting Mode 4 and Mode 5 4 REC PLAY PEX Only for SONOTRAX Pro SONOTRAX II Pro Function Start stop recording or playing fetal heart sound 5 Volume Control Indicator co Function Adjust volume Rotate the volume gear clockwise to turn up the volume while rotate it anti clockwise to turn down the volume 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 Q 1 Earphone socket the earphone or line in cable connects to the Doppler via this socket Figure 2 6 Line in Cable Signal Interface 1 l GND 2 Signal 4 S 3 Signal 4 Signal 5 BP 5 Signal CHARGE 2 Charge socket g the special lithium ion polymer battery charger connects to the Doppler via this socket For SONOTRAX II and
30. ration 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 Place the probe tail into the bottom right part of the probe holder and then push the probe head in until it clicks into the holder 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 _14 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation 3 Replacing the Probe Remove the old probe Switch off the Doppler hold the main unit with one hand pinch the jacket of the mini USB socket and pull it out with mild force take out the probe CAUTION Do not pull the probe cable directly Figure 3 6 Removing the probe Replace it with a new probe Put the USB socket of new probe into the probe interface of the Doppler NOTE Place the temporarily unused probe carefully and avoid falling off splash or stress etc When the Doppler is not used for a long time it s recommended to connect the probe to the Doppler and keep them safely in the package 3 4 Switching on the Doppler Press the POWE
31. rsardt ats uae tases da oko 29 Chapter 4 R UG RTT Se S TTT 27 Chapter 5 VIAIN CCN ATICE TT 31 e WAT TTT 31 De CICA TTT 31 Dx gt Dismiection ot LNG y PLO HT 31 Chapter 6 Warranty and After Sales Servi e cccccccccsssssssssssscccccsssssssssssccccccccssssscsssccssees 32 OL WY AT A cata shed N cna ee eke eas 32 OZ et Ale S Cl ICC rage tates eee tone eee eee eee ae 32 Appendix 1 Ordering Information ssssssscceeececcccccoccssssssceeeccccococosossssessseccececcososssssssssssssseseeee 33 Appendix 2 EMC Information Guidance and Manufacture s Declaration 0000 34 A2 1 Electromagnetic Emissions for all Equipment and Systems cccccceeeeeeeeees 34 A2 2 Electromagnetic Immunity for all Equipment and Systems sss eee eee eee 34 A2 3 Electromagnetic Immunity for all Equipment and Systems that are not Geers bo 01 6 y TTT 35 A2 4 Recommended Separation Distances esse 36 Appendix 3 Overall SensSitl Vity HTH 37 IV 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 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 technician
32. s 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 5 MHz and or 8 MHz waterproof vascular probes are indicated for the detection of blood flow in veins and arteries for assisting 1n the detection of peripheral vascular disease 1 2 Safety Precautions e This unit is internally powered equipment and it is an IEC EN 60601 1 Type B applied part Type B protection means that the connection between the equipment and personnel complies with permitted leakage currents and dielectric strength of IEC EN 60601 1 WARNING and CAUTION messages must be observed To avoid the possibility of injury observe the following precautions during the operation of the device WARNING 1 This device is not intended for treatment 2 This device is not explosion proof and can not be used in the presence of flammable anaesthetics Do not touch the signal input output connector and the patient simultaneously 4 We recommend that exposure to ultrasound should be kept as low as reasonably achievable This is considered to be good practice and should be observed at all time 5 Only use probes provided by the manufacturer The stretc
33. s gt Entertainment gt Sound Recorder Refer to figure 3 8 gt fan Communications gt fan Realtek Sound Manager da Entertainment J Sound Recorder 7 Startup gt System Tools gt volume Control 2 Internet Explorer Address Book wi msn E Calculator e Outlook Express BJ Command Prompt e Remote Assistance T Notepad windows Media Player W Paint 8 Windows Messenger Program Compatibility Wizard A Windows Movie Maker Synchronize eo Windows Catalog 7 Microsoft Office gt Tour Windows xP ty fan HTML Help workshop K Windows Explorer Windows Update AS Acrobat Distiller 7 0 A WordPad amp Set Program Access and Defaults Adobe Acrobat 7 0 Professional Adobe Designer 7 0 Programs Documents Settings Search Professional Help and Support Run Windows XP Shut Down Figure 3 8 Run the sound recorder Perform FHR examination with the method described in section 3 6 When the ideal signal 1s detected unplug the earphone if it s connected and insert the other plug of the audio cable into the earphone socket on the Doppler 19 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation y Sound Sound Recorder Saks 7 Sound Sound Recorder HoR File Edit Effects Help File Edit Effects Help Position pe Length Position Length 0 00 sec 0 00 sec 35 745 sec 60 00 sec Figure 3 9 Sound Recorder Figure 3 10 Recording Click on the start key e to start r
34. s while self testing Working Mode It indicates the mode in which the Doppler is working FHR Refresh Frequency When the examination starts the heart shape symbol flashes and its frequency indicates the FHR refreshing frequency 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 IT and SONOTRAX II Pro there is a battery symbol on the LCD The green panes in it indicate the battery electric energy The green panes disappear gradually with the energy consumption When the electric energy is low the empty battery symbol flashes Approximately five minutes later the Doppler shuts down automatically PLAYING PLAYING is lit when the Doppler is playing the recorded fetal heart sound RECORDING RECORDING is lit when the Doppler is recording fetal heart sound SONOTRAX Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories FHR Displaying This area displays the fetal heart rate value and its unit is bpm beat per minute Probe Type The Doppler can detect and identify the probe when the probe is not connected or poorly connected the symbol and MHz symbol on the LCD screen flash when the probe is well connected the flashing stops and the probe type is shown on the LCD screen Communication The Dopple
35. t 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 E 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 The customer or the user of the device should assure that it is used in such an environment Immunity test IEC 60601 test level i tee 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 3 5 Radiated RF S Vii d 22 Ve 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz i he 800 MHz to 2 5 GHz 1 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency
36. tery CAUTION Make sure the Doppler is shut down before charging the battery or opening the battery compartment 1 Replacing the alkaline battery For the alkaline battery follow the procedures described in section 3 2 Installing Replacing Battery to remove it from the main unit and then replace it with a new one of the same specifications Dispose of the old battery according to local regulations after use WARNING DO NOT CHARGE THE ALKALINE BATTERY 2 Charging the NI MH battery For the rechargeable NI MH battery follow the procedures described in section 3 2 Installing Replacing Battery to remove it from the main unit and charge it with the provided charger During charging the indicator in the charger slot is lit in red When it goes off the battery is fully charged approximately 12 hours are needed Remove the battery from the charger and install it to the Doppler WARNING Fit the battery to the sockets of the charger properly before plugging the charger into power socket 295 lt SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation i 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 When the orange indicator of the charger turns green
37. ume Volume A as Mute all Mute Mute Mute Realtek 4C97 Audio e Start a new recording aD amp Volume 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 4MHz SMHz or 8MHz vascular probes are to be connected to the Doppler to perform vascular examination Choose the appropriate probe as required The probe with how frequency has a deeper penetration depth while the probe with high frequency has better resolution and wider detecting range The 4MHz vascular probe is optimized for examining blood vessels the SMHz vascular probe is optimized for examining deeper vessels and the 8MHz vascular probe is optimized for examining surface vessels Apply a liberal amount of gel on the site to be examined Place the probe at a 45 angle on the skin over the vessel to be examined Adjust the position of the probe to obtain the loudest blood flow sound Refer to figure 3 13 for the probe sites 93 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation 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 Arter
38. y 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 0MHz Posterior Tibial Vein 8 0MHz Figure 3 13 Probe sites For best results keep the probe as still as possible once the optimum position is found Adjust the volume as required High pitched pulsatile sounds are emitted from arteries while veins emit a non pulsatile sound similar to a rushing wind Vascular examination only provides audio signals of arteries and veins The figure displayed on the LCD screen is null _24 SONOTRAX Series Ultrasonic Pocket Doppler User Manual Operation 3 10 Switching Off the Doppler When the examination is finished switch off the Doppler wipe the remaining gel off the probe with a clean soft cloth and then place the probe back into the holder 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 IT and 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 3 11 Replacing Charging the Battery When the Doppler gives out an alarm indicating the battery power is low you should shut down the Doppler to replace or charge the bat
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