About This Manual
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1. mm phantom No B dB rt E Pr ss 6 se 575 1846 9126 109 3 Bapao I A 45 7dB asat gt MH rT 68 6 rar Ce ges a ee oe eee DE CRE SSA RE HAN oe oe ae 7 E II e a A 43 24B Ba 24 9 249 77 T 6H 2MHz 100 43 2 C 9 249 9 E ERPE 5 181 8 90 20 104 6 De Meli men 9054 i FAA IN e e ge Bo SD5 SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity A3 2 Overall Sensitivity of SD5 3MHz Wired Probe Diameter of Two way Attenuation Target B 2Ba TD Mom OP SAO a Mo Beas H O mm aah No B dB dB dB Searels E aa Ala e 1 a a e e E pes A 44 5dB Ba 43 6 135 wie e eo SEE e Joel om ne n me KOR A T 6 1 ae O EA sw A aaa H BBE BS HT O aa a e mas 96 _ Overall Sensitivity C meen V r m 3MHz 42 0 6 2 160 4 81 96 101 0 MO ee O BBel 6s j Doppler Frequency Hz 500 at 3 SD5 SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity A3 3 Overall Sensitivity of SD6 2MHz Wireless Probe Diameter of Two way Attenuation Target B B By Reflector d mm Loss A d YB T ultrasonic attenuation o S be phantom No B dB o G 3 mm O e NET a eo Js em D DO ps E REE erate Poe ett tot os es oo e l Ba 24 9 249 De en EI e E a oe en Ba 24 9 249 77 og PO EEE aa a ina e aos ro Overall Sensitivity C meen V2. Declaration 33 A2 1 Electromagnetic Emissions For all EQUIPMENT and SYSTEMS 33 A2 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS 34 A2 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFESUPRORENG e e S e ULA 35 A2 4 Recommended separation distances between portable and mobile RF communication equipment and the EQUIPMENT or SYSTEM For EQUIPMENT or SYSTEM that are not HEES PPR TIN Lella 36 Appendix 3 Overall Sensitivity aaa 37 A3 1 Overall Sensitivity of SD5 2MHz Wired Probe M 37 A3 2 Overall Sensitivity of SD5 3MHz Wired Probe M 38 A3 3 Overall Sensitivity of SD6 2MHz Wireless Probe i 39 A3 4 Overall Sensitivity of SD6 3MHz Wireless Probe 40 IV SD5 SD6 Ultrasonic TableTop Doppler User Manual Safety Guide Chapter 1 Safety Guide NOTE Familiarize yourself with this user manual before attempting to operate the Doppler Follow the operation and maintenance instructions to ensure proper use of it 1 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 WARNING 1 This device is not explosion proof and can not be used in the presence of flammable anaesthetics 2 SD5 SD6 Ultrasonic Table T
3. millimeter and then rotate it clockwise back into position 20 SD5 SD6 Ultrasonic Table Top Doppler User Manual Examining Chapter 4 Examining WARNING Always check if the main unit and the probe are in good condition prior to use CAUTION Handle the probe with care Do not drop it on hard surfaces 4 1 FHR Examining The 2MHz and 3MHz obstetrical probes are designed for FHR examining The 2MHz probe is optimized for deep penetration and is widely used in the third trimester pregnancy The 3MHz probe is a general purpose probe It has better resolution and wider detection range than the 2MHz probe therefore is optimized for early fetal heart detection Follow these procedures to perform FHR examining 1 Feel the position of the fetus by hand to find the best position to detect the fetal heart 2 Switch on the Doppler and the probe 3 Apply a small amount of coupling gel to the acoustic face of probe place the probe face at the best position for detecting fetal heart Angle the probe to obtain an optimum audio signal Adjust the volume if required Clear fetal heart sound should be heard from the speakers earphone and numeric FHR value should be displayed on the LCD 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 mo
4. r m 2MHz 43 2 9 9 i 164 2 83 90 104 3 FER O Ba 249 249 37 Doppler Frequency Hz 333 a 39 SD5 SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity A3 4 Overall Sensitivity of SD6 3MHz Wireless Probe Diameter of Two way Attenuation Target B 2Ba TD Mom OP SAO a Mo Beas H O mm aah No B dB dB dB Searels E se Ala e 1 a Paa a e fa e A 44 5dB Ba 43 6 135 Re a Y eo prete Joel om on me Bal 43 6 96 T 6 1 A aaa oe a so e OE mw aw EAE BS HT ing e ie SO ee a A 42 0dB Bal 43 6 96 Overall Sensitivity C me ramos V rm 3MHz 42 0 FRENA 6 Ts 2 150 8 78 02 100 9 at O O Del a se ee BBel 6s j Doppler Frequency Hz 500 er _ AQ P N 01 54 110755 13 EDANUSA 4901 Morena Blvd Suite 505 www edanusa com San Deigo CA 92117 Tel 888 850 4597
5. that the device should be sent to the special agencies pot according to local regulations for separate collection after 1ts useful life The device is protected against splashing water Water splashed against the enclosure from any direction shall have no harmful effects P N Part Number Serial Number Date Of Manufacture val Manufacturer REP Authorized Representative in the European Community ES General symbol for recovery recyclable A Federal U S Law restricts this device to sale by or on the order of a Rx only U S physician SD5 SD6 Ultrasonic TableTop Doppler User Manual Introduction Chapter 2 Introduction 2 1 Intended Use The SD5 Ultrasonic TableTop Doppler hereinafter called SDS5 and SD6 Ultrasonic Table Lop Doppler hereinafter called SD6 are intended to be used by health care professionals including registered nurses practical nurses midwives ultrasound technicians and physician assistants by prescription from licensed physicians in hospitals clinics and private offices The 2 MHz and or 3 MHz obstetrical 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 vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral
6. 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 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 SD5 SD6 is used exceeds the applicable RF compliance level above the SD5 SD6 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SD5 SD6 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 35 SD5 SD6 Ultrasonic Table Top Doppler User Manual EMC Information A2 4 Recommended separation distances between portable and mobile RF communication equipment and the EQUIPMENT or SYSTEM For EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the SD5 SD6 The SD5 SD6 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SD5 SD6 c
7. 3 2 4 Charging Wireless Probe Battery 13 AN AU UC rana 14 gt Comectuno he Power Gables idas 14 FEU DE O eo 14 E IN SOCK A E TA 14 3 4 2 Connecting and Disconnecting a Wired Probe aaa 15 FI SWC SOR ilaele 15 AS Oil 16 37 Usmo A A a A ank 17 SS USAS ECU LOCK aa AA ANA A AAA AAA AN AAA AN lani 17 39 ae Doppler GTS A AN ANA RE AAA AAA An 19 239 TLO ER Backlioht Omand E o oo 19 292 switcoine Key soud On and OT casa 19 E Seti Atos E AA A AAA A AA a 19 Pe MOOS NG T na A a ANA SN DA a ANA SN Da ag 19 K R RIR TLS S TIM AAA AA AN 19 3370 Seta Dato Formati 20 mo AO A ee ee E AAA 20 Chapter B EXAMINE oda cias 21 o eH SE LT 21 III S ASC UM eri iii 22 Chapter 5 Recording and Playing esscsekecseccvecesssesicasiscceusseseslesseascecasobenseiadsocesesdsonlesseiocecencbeaiencaens 24 Chapter 6 Maintenance and Cleaning ccccccccsssssssssccccssssssssssscccccccccsssssssccccccssscssssssssccseses 25 As o A macdeasenaients 25 02 Matic liado 25 e BG RR RR CRI RR 26 A RI eee eo 26 Chapter 7 Warranty and Service ea 27 0 BENE a REI IAA 27 IRA C OMAGE MORNA ON ROSI RR CRE ARPA E O RE 27 Chapters Product Specincations ias 28 Sal Environmental T L ST Le rta oa aio 28 S Physica RIE Se citado isis COREA RENE 28 S Pertormanco Specials tete tiles 29 5 4 Battery SPECIICANONS tia 30 8 5 ow Ouuu Summary able nadan 31 Appendix 1 Ordering Information a 32 Appendix 2 EMC Information Guidance and Manufacture s
8. 60Hz magnetic field IEC61000 4 8 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 6 kV contact 8 kV air 2 kV for supply lines 1 kV line to line 2 kV line to ground lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip In UT for 5 sec power 6 kV contact 8 kV air 2KV for supply lines power 1 kV line to line 2 kV line to ground lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Floors should be wood concrete or ceramic tile If floor are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the SD5 SD6 requires continued operation during power mains interruptions it is recommended that the SD5 SD6 be powered from an uninterruptible power supply or a battery NOTE UT is the a c mai
9. R volume t SD5 SD6 Ultrasonic TableTop Doppler User Manual Introduction 2 2 4 Indicators 1 Main unit indicator The indicator of the main unit indicates the connection status of the main unit and AC power The indicator lights up in green the AC power is connected The indicator flashes in green the main unit is charging the main unit battery The indicator goes off the AC power 1s not connected 2 Probe indicator The indicator of the probe indicates the status of the probe The indicator lights up in green the probe is switched on The indicator flashes in yellow when the volume control key is pressed the volume has been decreased increased to its minimum maximum The indicator lights up continuously in yellow the probe battery 1s low The indicator flashes in green the probe battery is being charged 2 2 5 LCD The Doppler has four modes examining mode recording mode playing mode and setting mode In the former three modes the LCD displays as follows Bb W N Oo CO N O bal A O The battery is installed and the battery energy is full Battery Indicator C The main unit battery is low X The main unit battery is not installed Recording Indicator The Doppler is recording fetal heart sound Only in the recording mode playing mode AC Indicator Az AC power is connected Playing Indicator The Doppler is playing the rec
10. User Manual EDANUSA SD5 SD6 Ultrasonic Table Top Doppler Version 1 3 aS Cor About this Manual P N 01 54 110755 13 Release Date July 2012 Copyright EDAN INSTRUMENTS INC 2009 2012 All rights reserved Statement This manual will help you understand the operation and maintenance of the product better It 1s 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 Assembly operations extensions re a
11. a fast speed To switch on the wireless probe aN 0 0 Press the ON OFF key on the wireless probe The probe indicator lights up in green NOTE 1 The ON OFF keys of the wireless probe and the main unit need to be pressed separately 2 The wired probe is ready to use when the main unit is switched on 3 6 Switching Off When the examination is finished switch off the main unit wipe the remaining gel off the probe with a clean soft cloth and then place the probe back into the holder To switch off the main unit perform any one of these operations 0 1 Press the ON OFF key do on the main unit 2 Put the probe into the probe holder 3 Auto shut off If the main unit does not receive signal for a period of time it will be switched off automatically The auto shut off time 1s preset in the setup menu Refer to section 3 9 3 Setting Auto Shut Off Time To switch off the wireless probe 0 0 Press the ON OFF key do on the wireless probe NOTE lt is recommended to switch off the probe first and then put the probe into the probe holder 16 SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 3 7 Using Earphone In a noisy environment the earphone is recommended to hear ideal fetal heart sound Insert the earphone plug into earphone socket on the back of the main unit figure 2 4 The speakers will be muted when the earphone is connected WARNING Turn down the volume before using earphone to your
12. able OFF ON Audio Output Power 2W Auto Shut off minute 3 minute no signal and no operation 29 SD5 SD6 Ultrasonic TableTop Doppler User Manual Product Specifications Ultrasound 2MHz Wired Wireless Probes 2MHz 3MHz Wired Wireless Probes 3MHz Nominal Frequency 4MHz Wired Wireless Probes 4MHz 5MHz Wired Wireless Probes SMHz SMHz Wired Wireless Probes 8MHz 2MHz Wired Wireless Probes 2 0 10 MHz 3MHz Wired Wireless Probes 3 0 10 MHz Working Frequency 4MHz Wired Wireless Probes 4 0 10 MHz 5MHz Wired Wireless Probes 5 0 10 MHz 8MHz Wired Wireless Probes 8 0 10 MHz 2MHz Wired wireless probe 5 3MHz Wired wireless probe 4MHz Wired probe Lo 15 8688 mW cm 4MHz Wireless probe Io 20 99 mW cm SM Hz Wired probe Iso 23 15 mW cm SMHz Wireless probe Io 24 793 7m W cm 8MHz Wired probe Toh 21 68 mW cm 8MHz Wireless probe Lo 32 41 mW cm p lt 1MPa Ispta lt 100mW cm Working Mode Continuous wave Doppler 2MHz 3MHz Wired Wireless probes 245 15 mm Effective Radiating Area of Probe 4MHz SMHz Wired Wireless probes 32 15 mm 8MHz Wired Wireless probes 14 15 mm 8 4 Battery Specifications renee 30 SD5 SD6 Ultrasonic TableTop Doppler User Manual Product Specifications Nominal Voltage 7 2V 3 7V Charge Voltage Standard 4 2V Expected Battery Life Approx 10h Approx 3h Charge Mode Constant current Constant
13. an help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SD5 SD6 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 D D 1 2 P D 2 3 P d 35 JP 1 995MHz to2 010MHz 2 985MHz to 3 015MHz ose f see H en a Ow w e a For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters 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 Rated maximum output power of transmitter W 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 e SD5 SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity Appendix 3 Overall Sensitivity A3 1 Overall Sensitivity of SD5 2MHz Wired Probe Diameter of Two way Attenuation LE _ V r m s Overall Sensitivity Target B B tBw A ra S A d B C Reflector d mm Loss A d YB T ultrasonic attenuation dB
14. ave visible evidence of damage that may affect personnel s safety or examining capability before use lf damage is detected replacement is recommended 8 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 1 2 Symbols L Arana do Headphones Equipotentiality Alternating Current Fuse ON OFF for a part of equipment Menu Recording and play back Graphical recorder Move the cursor downwards Move the cursor upwards speaker Minus Plus Charge battery Push right SD5 SD6 Ultrasonic TableTop Doppler User Manual Safety Guide AN Caution Refer to accompanying documents BA Consult Instructions for Use e Type B applied part This symbol indicates the unit is internally powered R equipment and the degree of protection against electrical shock is type B C The symbol indicates that the device complies with the European Council 0123 Directive 93 42 EEC concerning medical devices The symbol indicates
15. d for examining deeper vessels and the 8MHz vascular probe is optimized for examining surface vessels Choose the appropriate probe as required 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 4 1 for the probe sites 0 SD5 SD6 Ultrasonic TableTop Doppler User Manual Examining Vertebral Artery 5MHz Carotid Artery 5 8MHz Jugular Vein SMHz Carotid Artery 5 8MHz AY Subclavian Artery SMHz LS 7 e LA NA A Po A Mm y ig T N Subclavian Vein SMHz Brachial Artery 8 MHz Ulner Artery 8 MHz Radial Artery 8MHz Femoral Artery SMHz Femoral Vein SMHz Popliteal Artery SMHz Great Saphenous Vein 5 8MHz Small Saphenous Vein 8MHz Posterior Tibial Artery 8MHz Dorsalis Pedis Artery 8MHz Posterior Tibial Vein BMHz Figure 4 1 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 numeric displayed on the LCD screen is null D SD5 SD6 Ultrasonic TableTop Doppler User Manual Recording and Playing Chapter 5 Rec
16. djustments 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 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 Sale Guides ilari lano 1 SA evi l NOY AAA AAA T AAA E aaceee ete 2 Chapter 2 Introduction sissu aaa eda asa A A IIA 4 A O A A an aaa ol 4 2 AE ME e A ETA O 4 DLO SS A A a a 6 ES A alain I DZ s T a A A O a A 8 AP O O A o OP PERO PPP OO Po A E 8 Chapter B Basic Operations ii Banda aii and 10 3 Openmo Package and CHECKING illa a 10 AS TS AU AA A IA ili 10 32 Pine Mam Unit Bate dada AAA a a 10 3 2 2 Fitting Wireless Probe Battery an nn nn ni A ia dk in norra 12 3 2 3 Charging Main Unit S eee ee eee eee eee E eee 13
17. ears CAUTION 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 3 8 Using Security Lock A security lock is provided You can lock the main unit to a stationary object To lock the main unit 1 Insert the key into the lock slot Apply a certain amount of pressure to the key and then rotate it clockwise The lock hook 1s open 2 Insert the lock hook into security slot on the back of the main unit Rotate the key anticlockwise to close the lock hook da SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation To unlock the main unit Insert the key into the lock slot Apply a certain amount of pressure to the key and then rotate 1t clockwise The lock hook is open and you can remove the lock from the main unit 18 SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 3 9 Changing Dop
18. ent should undergo periodic safety testing to ensure proper patient isolation from live parts This should include leakage current measurement and insulation testing The recommended testing interval is once a year or as specified in the institution s test and inspection protocol 3 Mechanical Inspection Make sure all exposed screws are tight Check the external cables for splits cracks or signs of twisting Replace any cable that shows serious damage Pay particular attention to the supply socket WARNING Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards CAUTION The maintenance must be performed by professional personnel 6 2 Maintenance Avoid scratching and damaging the LCD The gathering of dew on the LCD may occur with abrupt temperature or humidity changes A table environment is recommended for the main unit Keep the exterior surface of the main unit clean free of dust and dirt _25 SD5 SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning Handle the probe with care to avoid damaging the cover piezoelectric crystals and mechanical movement Do not contact the probe with hard or sharp objects Do not excessively flex the probe cable Wipe the remaining gel off the probe after use Keep the probes in a dry environment where the tempera
19. etic Emissions For all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The SD5 SD6 is intended for use in the electromagnetic environment specified below The customer or the user of the SD5 SD6 should assure that it is used in such an environment Emissiontest Compliance Electromagnetic environment guidance The SD5 SD6 uses RF energy only for its internal RF emissions function Therefore its RF emissions are very low and are CISPR 11 not likely to cause any interference in nearby electronic equipment RF emissions The SD5 SD6 is suitable for use in all establishments IEC 61000 3 2 other than domestic and those directly connected to the public low voltage power supply network that supplies Voltage building used for domestic purposes fluctuations flicker emissions 1EC61000 3 3 Complies 33 SD5 SD6 Ultrasonic Table Top Doppler User Manual A2 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The SD5 SD6 is intended for use in the electromagnetic environment specified below The customer or EMC Information the user of SD5 SD6 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level a environment Electrostatic discharge ESD IEC 61000 4 2 fast IEC Electrical transient burst 61000 4 4 Surge 61000 4 5 Power frequency 50
20. ials and workmanship that occur within warranty period The warranty 1s void in cases of a damage caused by mishandling during shipping b subsequent damage caused by improper use or maintenance c damage caused by alteration or repair by anyone not authorized by EDAN d damage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty 1s determined to be defective because of defective materials components or workmanship and the warranty claim 1s made within the warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute product for use when the defective product is being repaired 7 2 Contact information 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 A SD5 SD6 Ultrasonic TableTop Doppler User Manual Product Specifications Chapter 8 Product Specifications 8 1 Environmental Specifications Worki n ES Relative Humidity 25 80 non condensing Atmospheric Pressure 860hPa 1060hPa Relative Humidity 25 93 non condensing Atmospheric Pressure 700hPa 1060hPa 8 2 Physical Specifications Dimensions Main Unit 265mm x 155mm x 180 mm Probes 140mm x 40mm x 32 mm Dimensions and Weigh
21. ns voltage prior to application of the test level dis SD5 SD6 Ultrasonic Table Top Doppler User Manual EMC Information A2 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity The SD5 SD6 is intended for use in the electromagnetic environment specified below The customer or the user of SD5 SD6 should assure that it is used in such an environment Immunity IEC 60601 test i Electromagnetic environment Portable and mobile RF communications equipment should be used no closer to any part of the SD5 SD6 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 JP d 35 JP 1 995MHz to2 010MHz d 35 JP 2 985MHz to 3 015MHz a 3 Vrms 3Vrms d 1 2 JP 80 MHz to 800 MHz eigas L LAA d 2 3 JP 800 MHz to 2 5 GHz La Where P is the maximum output power i rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended Radiated RF 3 V m separation distance in metres m IEC Field strengths from fixed RF 61000 4 3 SO oa 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 S NOTE 1 At 80 MHz and 800 MHz
22. onfirm the choice 5 In the same way choose the Minute from 00 to 59 Choose the Year Month and Day 6 Move the cursor to EXIT and then press the Setup key 19 SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 3 9 6 Setting Date Format Y ou can choose to switch the date on or off When it is on the date format has three options DD MM Y Y YY MM DD YY YY and YY YY MM DD To switch the date on and off or change date format 1 Press the Setup key to open setup menu 2 Press the Up Down key to move the cursor to Date Format press the Setup key 3 Press the Up Down key to toggle between ON and OFF If you choose ON the cursor moves to the date format Select a format 4 Press the Setup key NOTE If no operation is performed in 30 seconds the device will also exit from the setup menu The setting changes will not be effective 3 10 Replacing Fuses WARNING Switch off the main unit and unplug it before replacing the fuses Two fuses are located on the rear panel of the device their specifications are Size DSmm 20mm Model T400mAH250V When any one of the fuses 1s blown perform the following steps to replace it 1 Using a flat head screw driver push the fuse in for about one millimeter and then rotate it anticlockwise 2 Remove the old fuse and replace it with a new fuse that is supplied by the manufacturer or of the same specifications 3 Push the new fuse into the socket for about one
23. op Doppler is a tool to aid healthcare professionals and should not be used in place of normal fetal monitoring 3 This device is not intended for treatment 4 Do not apply this device and other ultrasonic equipment simultaneously on a same patient in case of possible hazard caused by leakage current superposition 5 Do not touch accessible parts of non medical electrical equipment and the patient simultaneously 6 Do not apply this device simultaneously with other PATIENT connected equipment such as a cardiac pacemaker or other electrical stimulators on a same patient 7 The device is not protected against defibrillation Do not use it with HF surgical equipment CAUTION 1 Federal U S law restricts this device to sale by or on the order of a physician 2 Refer servicing to qualified service personnel The main unit is designed for continuous operation and is ordinary It is not waterproof do not immerse it in any liquid i e not drip or splash proof Keep the device clean Avoid vibration Apply the SD5 SD6 in an environment with a temperature between 5 C 41 F and 40 C 104 F 6 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 SD5 SD6 Ultrasonic TableTop Doppler User Manual CAUTION Safety Guide 7 Check that the equipment does not h
24. orded fetal heart sound Only in the SD5 SD6 Ultrasonic TableTop Doppler User Manual Introduction Infrared Indicator as Infrared signal is received Only available with A SD6 VAN Infrared signal is not received indicating that poor quality 5 signal is received Probe Indicator The probe is well connected Only available with __ SD5 E Es The probe is not connected Date and Time Heart Beat Indicator When fetal heart signal is received the heart shape flashes to indicate the FHR refreshing frequency EN FHR numeric measurement value In the setting mode the LCD displays as the right figure Backlight shows Key Sound The rectangular mark that moves up and down is called the cursor Press the Up key or the Down key to move it back or forth Language Auto Shut Off SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation Chapter 3 Basic Operation 3 1 Opening Package and Checking Open the package take out the Doppler and accessories carefully Place them on a flat clean surface 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 Using Batteries CAUTION The fitting of the batteries should be carried out by the manufacturer authorized personnel Do not
25. ording and Playing The built in recorder of the Doppler provides recording and playing fetal heart sound of 240 seconds at most To record fetal heart sound A Press and hold the Record Play control key le for two seconds The character REC on the LCD lights up Recording starts Ae Press the Record Play control key again to stop recording and return to the real time examining mode To play the fetal heart sound A Press the Record Play control key le in the real time examining mode The character PLA on the LCD lights up The Doppler plays the recorded fetal heart sound _24 SD5 SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning Chapter 6 Maintenance and Cleaning 6 1 Inspection 1 Visual Inspection Prior to using the device every time do the following inspections Check the device and accessories to see if there is any visible evidence of damage that may affect patient safety Check the power socket and power cables Check if the device functions properly to make sure it is in good condition If any damage is detected stop using the device on the patient Replace the damage part s or contact the manufacturer for service before reusing it 2 Routine Inspection The overall check of the device including safety check and function check should be performed by qualified personnel every 6 to 12 months and each time after service The equipm
26. pler Settings 3 9 1 Switching Backlight On and Off 1 Press the Setup key to open setup menu 2 Press the Setup key when the cursor stays at Backlight 3 Press the Up Down key to toggle between ON and OFF 4 Press the Setup key 3 9 2 Switching Key Sound On and Off 1 Press the Setup key to open setup menu 2 Press the Up Down key to move the cursor to Key Sound press the Setup key 3 Press the Up Down key to toggle between ON and OFF 4 Press the Setup key 3 9 3 Setting Auto Shut Off Time The Auto Shut Off feature facilitates the economical use of the Doppler The main unit will switch off automatically after no signal is received and no operation is performed for 1 minute 3 minutes or infinite time 1 Press the Setup key to open setup menu 2 Press the Up Down key to move the cursor to Auto Shut Off press the Setup key 3 Press the Up Down key to move the cursor among options 4 Press the Setup key 3 9 4 Choosing Language 1 Press the Setup key to open setup menu 2 Press the Up Down key to move the cursor to Language press the Setup key 3 Press the Up Down key to select the required language 4 Press the Setup key 3 9 5 Setting Date and Time 1 Press the Setup key to open setup menu 2 Press the Up Down key to move the cursor to Real Time Clock press the Setup key 3 Press the Setup key when the cursor stays at Hour 4 Press the Up Down key to choose a number from 00 to 23 and then press the Setup key to c
27. pplied only by inner power 3 4 Using Wired Probe 3 4 1 Probe Socket SD5 adopts wired probes The probe cable is a telephone cable with a standard RJ11 plug on each terminal 14 SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation RJ11 Interface 1 PowerVCC 5V 2 GND 3 Signal Wire 4 Signal Wire 3 4 2 Connecting and Disconnecting a Wired Probe To connect the wired probe to the main unit 1 Take out the probe cable from package Insert one modular plug of the cable into the probe socket of the main unit 2 Insert the other modular plug into the probe socket of the probe Modular Plug To disconnect the probe press the housing of the modular plug and then pull it out Housing 3 5 Switching On WARNING Make sure all the metal parts are linked to the protective earth cord and the power cord is free of defect before switching on the main unit 15 SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation CAUTION To avoid unwanted noise do not take out or place the probe when the main unit is on Remember to take out the probe before switching on the main unit and place the probe after switching off the main unit To switch on the main unit 0 Pick up the probe and then press the ON OFF key do on the main unit All the real time examining menu elements light up in a few seconds A start up sound 1s heard The Doppler performs a self test by displaying the FHR numerics in
28. ption The Doppler supports 2MHz 3MHz 4MHz 5MHz and 8MHz probes supplied by the manufacturer The probe nominal frequency 1s disclosed on the probe type label Probes of SD5 are wired while probes of SD6 are wireless WARNING 1 Do not touch the charge sockets of the Wireless Doppler probe and the patient at the same time 2 Do not immerse the probes or the probe cable in any liquid CAUTION Do not stretch the probe cable for more than three meters 2 2 3 Control Keys Control keys are provided to switch on or off the device perform the functions and change the settings A beep sound will be heard when you press a key of the main unit Or you can switch off the sound Refer to section 3 9 2 Switching the Key Sound On and Off for operation procedures 1 ON OFF key Function Switch on off the main unit or the probe A 2 Up Key Record Play Control Key Me Function Move the cursor upwards to the previous item in the setting mode Recording and playing control in the real time examining mode VA 3 Down Key Print Control Key E Function Move the cursor downwards to the next item in the setting mode Printing control reserved AL 4 Setup Key Confirm Key O Function Enter setup menu in the real time examining mode Confirm selection in the setting mode 5 Volume Control Keys 9 7 Function Decrease the FHR volume O Increase the FH
29. remove them afterwards 3 2 1 Fitting Main Unit Battery The main unit is powered either by alternating current or a Ni MH battery It is recommended to power the main unit solo by a battery during operation Therefore charge the battery fully before use to ensure enough power Connecting to mains power supply will charge the battery no matter if the main unit is on or off WARNING Switch off the Doppler and remove the power cord before fitting the main unit battery To fit the battery for the main unit 1 Follow the arrow direction to open the battery compartment cover The battery connecting cable amp connector and the metal insert show up 10 SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation Battery Connecting Metal Insert Cable 8 Connector 2 Tilt the battery sideways and put 1ts bottom left corner into the battery compartment from the left end of the compartment to the right Make sure connector Q stays out of the compartment Battery Connector Battery Connector 3 Keep pushing the battery into the compartment until the metal insert springs back to lock the battery able SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 4 Connect the two connectors D amp and then put them into the compartment 5 Close the battery compartment cover 3 2 2 Fitting Wireless Probe Battery The wireless probe is powered by a lithium battery To fit the battery for the p
30. robe 1 Remove the screw on the battery compartment cover with a screw driver and then take the cover away with your hand SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 2 Fit the battery Make sure the polarities correspond with the battery compartment diagram 3 Close the battery compartment cover and fix it with the screw 3 2 3 Charging Main Unit Battery Observe the battery indicator on the LCD the panes in it indicate the main unit battery electric energy They go off gradually with the consumption of the battery When the battery indicator turns into O the battery power 1s low You need to switch to outer AC power and charge the battery in time To charge the main unit battery you need to connect the Doppler to 100V 240V power supply Connecting the main unit to power supply for approximately 3 hours will charge the battery fully no matter if it is on or off During this period the main unit indicator flashes in green and the panes in the battery indicator increase gradually When the battery 1s fully charged the indicator has four panes 3 2 4 Charging Wireless Probe Battery When the wireless probe battery 1s low the probe power indicator turns into yellow You need to switch off the probe and charge the battery in time To charge the probe battery you need to place the probe in the probe holder Connecting the main unit to alternating current is recommended It takes 4 to 5 hou
31. rs to fully charge the probe battery During this period both the main unit indicator and the probe indicator will flash in green 13 SD5 SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 3 2 5 Care of Batteries WARNING 1 Replacement of batteries shall be done at least 1 5 meters away from the patient 2 Close the battery compartment before using the main unit or the probe 3 Charge the battery with specified charger only 4 Do not expose the batteries to high temperatures heat them or dispose of them in fire 5 Do not disassemble the batteries 6 Short circuit should be avoided CAUTION 1 Keep the batteries in a cool and dry environment The environment temperature must not exceed the range of 20 C 40 C 4 F 104 F 2 If the Doppler is not used for an extended period charge the batteries at least once a month 3 The batteries must be properly disposed according to local regulations after their useful life 3 3 Connecting the Power Cable Apply the power cable provided with the Doppler Put the connector of the power cord to the power socket on the Doppler figure 2 4 Put the plug of the power cord into a grounded 3 slot power output special for hospital usage NOTE Make sure the AC power supply of the Doppler complies with the following specification 100V 240V 50Hz 60Hz WARNING If the protective grounding protective earth system is doubtful the power of the Doppler must be su
32. t Weight 8 Main Unit 1 7 kg with battery and probe Wireless Probe 120 g with battery Wired Probe 85 g Transport and Storage Main unit Operating Voltage 100V 240V Power Suppl al Operating Frequency 50Hz 60Hz 7 2V 2000mAh Ni MH Battery Probe 3 7V 700mAh Lithium Battery Standards IEC EN 60601 1 IEC EN 60601 1 2 IEC EN 61266 IEC EN Compliance 60601 2 37 Anti electric Shock Type Class I equipment with internal power supply Anti electric Shock Degree Type B applied parts _ 28 SD5 SD6 Ultrasonic TableTop Doppler User Manual Product Specifications Degree of Protection against Main Unit Not protected Harmful Ingress of Water Probe IPX4 Degree of Safety in Presence of Equipment not suitable for use in presence of Flammable Gases flammable gases Disinfection Sterilizing Method Refer to this user manual for details N C Earth Leakage Current Limit S F C SOOuA 1000uA Enclosure Leakage Current Limit Patient Leakage Current Limit Patient Auxiliary Current Limit Display Effective display area 62 0 mm W x 44 0 mm H Number of characters 128 64 Dots Dot size 0 39 mm W x 0 55 mm H Dot pitch 0 44 mm W x 0 60 mm H 8 3 Performance Specifications FHR Measurement Range SObpm 210bpm FHR Performance Resolution 1 bpm Accuracy 3 bpm Audio Sampling Frequency 4KHz Recording and Playing Recording Length 240s White Back Light Two Brightness Adjust
33. ther 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 It is not possible to examine FHR unless an audible fetal heart signal is detected The fetal pulse can be distinguished from the maternal pulse by feeling the mother s pulse during the examination A SD5 SD6 Ultrasonic Table Top Doppler User Manual Examining Special notes for using SD6 1 To ensure good communication make sure there is no barrier between the infrared sender on the probe and the infrared receivers on the main unit Aiming the infrared sender of the probe to the main unit allows the best communication result 2 To avoid signal interference do not switch on two or more SD6 wireless probes in the same area synchronously 3 Applying SD6 in a room of 30 m or smaller allows the best quality It is not recommended to use it in an expansive room gt 50 m 4 2 Vascular Examining The 4MHz 5MHz and 8MHz vascular probes are designed for vascular examining The probe with low frequency has a deeper penetration depth while the probe with high frequency has better resolution and wider detecting range The 4MHz vascular probe 1s optimized for locating blood vessels quickly the 5MHz vascular probe 1s optimize
34. ture had better be lower than 45 C 6 3 Cleaning To clean the main unit Switch off the Doppler and unplug it from AC power supply Wipe the case with a cloth that has been dampened in soap or detergent solution and then dry it with a clean cloth The recommended cycle is one week or when needed Clean the probe after each use to avoid cross infection and prolong its useful life To clean the probe Switch off the probe Wipe it with a cloth that has been dampened in soap or detergent solution and then dry it with a clean cloth CAUTION 1 Do not use strong solvent such as acetone 2 Do not use an abrasive such as steel wool or metal polish 3 Neither the main unit nor the probe is waterproof do not immerse any part of them in liquid Entry of liquid into the Doppler may destroy the equipment 4 Do not allow any liquid remain on the surface 6 4 Disinfection In normal use the main unit does not need disinfection In case of being soiled clean the main unit case and disinfect it with 70 ethanol or isopropranol alcohol After each use clean the probe and disinfect it with 70 ethanol or isopropranol alcohol CAUTION Do not sterilize the main unit of the Doppler or the probe _ 26 SD5 SD6 Ultrasonic Table Top Doppler User Manual Warranty and Service Chapter 7 Warranty and Service 7 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects in mater
35. vascular disease 2 2 Major Parts 2 2 1 Main Unit SD5 i CU 4 5 1 Probe g 2 Probe Cable 3 Main Unit SD6 ALCD 5 Speakers 6 Probe Socket 7 Infrared Receivers Figure 2 1 Overview SD5 SD6 Ultrasonic TableTop Doppler User Manual Figure 2 2 Top View of the Main Unit 12 13 14 15 16 Figure 2 3 Main Unit Control Keys Figure 2 5 Right View of the Main Unit _5 Introduction 8 Probe Holder 9 Handle 10 Probe Sensor Socket 11 Main Unit Control Keys 12 Main Unit Indicator 13 On OFF Key 14 Setup Key Confirm Key 15 Up Key Record Play Control Key 16 Down Key Print Control Key 17 Fuses 18 Power Socket 19 Equipotential Grounding Terminal 20 Main Unit Label 21 Security Slot 22 Earphone Socket 23 Battery Compartment SD5 SD6 Ultrasonic TableTop Doppler User Manual Introduction NOTE The main unit is not waterproof Do not immerse it in any type of liquid 2 2 2 Probes Wireless Probe 1 Acoustic Face 2 Probe Control Keys 3 Infrared Sender 4 Probe Socket Wired Probe 4 5 Probe Cable Figure 2 6 Top View of the Probe 6 Volume Decreasing Key 7 Volume Increasing Key 8 ON Off Key only available on wireless probe Figure 2 7 Probe Control Keys ialog 10 Probe Type Label 11 Probe Battery Compartment 12 Probe Charge Socket Figure 2 8 Bottom View of the Probe SD5 SD6 Ultrasonic TableTop Doppler User Manual Introduction Descri
36. voltage Circle Life gt 300 times after 300 circles only 90 of the capacity can be restored Storage Temperature 20 C 60 C 4 F 140 F 1 month or 20 C 40 C 4 F 104 F 3 months 8 5 Low Output Summary Table Low Output Summary Table for systems with no transducers having global maximum index values exceeding 1 0 System Ultrasonic TableTop Doppler Transducer Model Ispta 3 Isppa 3 MHz ie APS mo W cm 0 03539 CW 2 0 4 742 E RE 0 0077 0 004742 0 1372 CW 3 0 9 601 MIN 0 0084 0 009601 TIS 0 07059 CW 4 0 40 54 OTs 0 01408 0 04054 CW 5 0 56 18 oe 0 01447 0 05618 TIS 0 1412 CW 8 0 6 673 OTs 0 002999 0 006673 zas SD5 SD6 Ultrasonic TableTop Doppler User Manual Ordering Information Appendix 1 Ordering Information CAUTION Only the parts supplied by the manufacturer should be used with the Doppler ame pe Probe 2 MHz Wired Probe 3 MHz Wired Probe 4 MHz Wired Probe 5 MHz Wired Probe 8 MHz Wired Probe Probe Cable 2 MHz Wireless Probe 3 MHz Wireless Probe 4 MHz Wireless Probe 5 MHz Wireless Probe 8 MHz Wireless Probe Accessory Ni MH Battery for Main Unit 01 21 064131 Lithium Battery for Wireless Probe 11 21 064125 Earphone 01 14 104751 mate Consumable Coupling Gel 11 57 78001 2302 SD5 SD6 Ultrasonic Table Top Doppler User Manual EMC Information Appendix 2 EMC Information Guidance and Manufacture s Declaration A2 1 Electromagn
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