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EDAN SD3 Series User Manual

Ultrasonic pocket doppler
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EDAN Agile PLM Electronic Signature Information
--Signatures related to this document and performed in EDAN Agile PLM.
文件名称：SD3说明书_英文
文件编号：01.54.455714
版本：1.9
产品型号：SD3 LITE;SD3 PLUS;SD3 PRO;SD3
项目编码(Project Code)：2209A000
签批信息:
作者 : 周 睿 (zhourui)
审核人 : 刘 小倩 (liuxiaoqian)
审核人 : 余 俊煜 (yujunyu)
批准人 : 吴 明花 (wuminghua)
批准人 : 吴 明花 (wuminghua)
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)
2019-01-17 10:00:18
2019-01-17 13:40:37
2019-01-17 10:33:49
2019-01-18 11:20:19
2019-01-18 11:20:19

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  • Page 1 EDAN Agile PLM Electronic Signature Information --Signatures related to this document and performed in EDAN Agile PLM. 文件名称：SD3说明书_英文 文件编号：01.54.455714 版本：1.9 产品型号：SD3 LITE;SD3 PLUS;SD3 PRO;SD3 项目编码(Project Code)：2209A000 签批信息: 作者 : 周 睿 (zhourui) 2019-01-17 10:00:18 审核人 : 刘 小倩 (liuxiaoqian) 2019-01-17 13:40:37 审核人...
  • Page 3 Edan Instruments, Inc. (hereinafter called EDAN) cannot be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages.
  • Page 4 Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.

  • Page 5: Table Of Contents

    Table of Contents Chapter 1 Safety Guide ......................1 1.1 Intended Use/Indications for Use .................. 1 1.2 Safety Precautions ......................1 1.3 Symbols ......................... 6 Chapter 2 Doppler and Accessories ..................8 2.1 Features ......................... 8 2.2 Main Unit ........................9 2.2.1 Appearance ......................
  • Page 6 5.1 Maintenance ........................ 27 5.2 Cleaning ........................27 5.3 Disinfection ......................... 27 5.4 Sterilization ......................... 28 Chapter 6 Warranty and Service ..................29 6.1 Warranty ........................29 6.2 Contact information ..................... 29 Appendix 1 Product Specifications ..................30 Appendix 2 Ordering Information ..................34 Appendix 3 EMC Information ....................

  • Page 7: Chapter 1 Safety Guide

    1.1 Intended Use/Indications for Use The SD3 Series Ultrasonic Pocket Dopplers 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.
  • Page 8 SD3 Series Ultrasonic Pocket Doppler User Manual Safety Guide patients of the prudent use of diagnostic ultrasound outweigh the risks, if any that may be present. Prudent Use (Approved May 1999) The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes.
  • Page 9 SD3 Series Ultrasonic Pocket Doppler User Manual Safety Guide WARNING Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason, make sure that all external devices operated in the vicinity of this device comply with the relevant EMC requirements. X-ray equipment and magnetic resonance imaging (MRI) devices can emit high levels of electromagnetic radiation.
  • Page 10 SD3 Series Ultrasonic Pocket Doppler User Manual Safety Guide WARNING 23 The rechargeable batteries should be charged by using the dedicated charger supplied by the manufacturer. 24 If the rechargeable batteries are stored alone and not used for a long time, we recommend that the batteries should be charged at least once every 6 months to prevent overdischarge.
  • Page 11 SD3 Series Ultrasonic Pocket Doppler User Manual Safety Guide WARNING 40 The appliance coupler or mains plug is used as isolation means from supply mains. Position the Doppler in a location where the operator can easily access the disconnection device.

  • Page 12: Symbols

    SD3 Series Ultrasonic Pocket Doppler User Manual Safety Guide 1.3 Symbols Definition Symbol CE marking Disposal method Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Operating instructions Caution MR Unsafe – keep away from magnetic resonance imaging...
  • Page 13 SD3 Series Ultrasonic Pocket Doppler User Manual Safety Guide Headphones Output Conforms to UL Std. 60601-1, IEC Std. 60601-2-37 Certified to CSA Std. C22.2 No 601.1, CSA Std. C22.2 No 18 * 60601-2-37, Refer to User Manual (Background: Blue; Symbol: White) Warning (Background: Yellow;...

  • Page 14: Chapter 2 Doppler And Accessories

    SD3 Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories Chapter 2 Doppler and Accessories 2.1 Features There are five different models available: SD3 LITE, SD3, SD3 PLUS, SD3 PRO and SD3 VASCULAR. SD3 LITE and SD3 VASCULAR are for simple auscultation (intermittent listening). SD3, SD3 PLUS and SD3 PRO not only detect fetal heart sound;...

  • Page 15: Main Unit

    √ √ √ √ = configured × = not available For the Essential Performance of SD3 series, refer to Appendix 1 in details. 2.2 Main Unit NOTE: The pictures and interfaces in this manual are for reference only. 2.2.1 Appearance Take 2 MHz obstetrical probe for example.

  • Page 16: Display Panel

    SD3 Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories SD3 PRO/SD3 PLUS SD3/SD3 LITE/ SD3 VASCULAR Figure 2-2 Rear Panel Figure 2-3 Left Panel Figure 2-4 Top Panel Figure 2-5 Right Panel Working State Indicator Display Panel (SD3 Speaker...
  • Page 17 SD3 Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories Real-time Test Record Play Charge Error Real-time Test Figure 2-6 OLED Display When 4/5/8 MHz vascular probe is plugged in, the OLED displays the probe type instead of the FHR.

  • Page 18: Buttons

    SD3 Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories charge error For SD3 LITE without OLED, the LED is shown as follows: Power on Green Power off Low capacity Orange Probe off Flickering green Probe off and low capacity Flickering orange 2.2.3 Buttons...

  • Page 19: Probe Socket

    SD3 Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories (2) Charge socket : (SD3 PRO, SD3 PLUS) for charging the battery, the dedicated power adapter connects to the Doppler via this socket. NOTE: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g.

  • Page 20: Probes

    SD3 Series Ultrasonic Pocket Doppler User Manual Doppler and Accessories 2.3 Probes 2.3.1 Waterproof Obstetrical Probes 2 MHz/3 MHz waterproof obstetrical probes can be connected to the main unit for fetal heart examining. The 2 MHz obstetrical probe features in deep penetration and is designed for use during the third trimester pregnancy.

  • Page 21: Chapter 3 Basic Operation

    SD3 Series Ultrasonic Pocket Doppler User Manual Basic Operation Chapter 3 Basic Operation NOTE: To ensure that the Doppler works properly, please read this chapter and Chapter 1 Safety Guide before operation; follow the steps when connecting all the components.

  • Page 22: Probe Operation

    SD3 Series Ultrasonic Pocket Doppler User Manual Basic Operation  SD3 PLUS, SD3 PRO Battery Installation 1) Remove the screws of the battery compartment using a cross-head screw driver. Remove the battery compartment cover. 2) Put the battery in the compartment.

  • Page 23: Switching On

    SD3 Series Ultrasonic Pocket Doppler User Manual Basic Operation 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.

  • Page 24: Replacing Alkaline Batteries

    SD3 Series Ultrasonic Pocket Doppler User Manual Basic Operation battery symbol flashes. Approximately five minutes later, the Doppler shuts down automatically. You should replace the batteries or charge the rechargeable batteries. 3.6.2 Replacing Alkaline Batteries CAUTION Make sure the Doppler is shut down before charging the battery or opening the battery compartment.

  • Page 25: Charging The Doppler (Sd3 Plus, Sd3 Pro)

    SD3 Series Ultrasonic Pocket Doppler User Manual Basic Operation NOTE: If the charging indicators are flashing in red, it indicates that the batteries are defective or non-rechargeable or that short circuit occurs. WARNING Make sure the batteries are not connected reversely before plugging the charger into the power socket.
  • Page 26 SD3 Series Ultrasonic Pocket Doppler User Manual Basic Operation Figure 3-1 On a Table Figure 3-2 On the Wall NOTE: The Doppler is not available for examining during charging. WARNING The charge stand can be fixed only on a concrete wall.

  • Page 27: Chapter 4 Examining

    SD3 Series Ultrasonic Pocket Doppler User Manual Examining Chapter 4 Examining 4.1 FH Examining Before applying the Doppler for fetal heart (FH) examining, a proper probe should be chosen. The 3 MHz waterproof probe is used for more than 9-week gestation and the 2 MHz is used for more than 12-week gestation.

  • Page 28: Fh Sound Recording And Playing

    SD3 Series Ultrasonic Pocket Doppler User Manual Examining When applied to the patient, the ultrasound transducer may warm slightly (less than 5° C (9° F) above ambient temperature). When NOT applied, the ultrasound transducer may warm slightly (less than 4° C (7.2° F) above ambient temperature).

  • Page 29: Playing Sound Files

    SD3 Series Ultrasonic Pocket Doppler User Manual Examining 2. Turn on PC and run the sound recorder (Click on Start > Programs > Accessories > Entertainment > Sound Recorder). Perform FHR examination with the method described in section 4.1. When the ideal signal is detected, unplug the earphone (if it’s connected) and insert the other plug of the audio cable into the earphone socket on the Doppler.

  • Page 30: Vascular Examining (Optional)

    SD3 Series Ultrasonic Pocket Doppler User Manual Examining 2) If the line in or/and microphone volume control is/are not shown in the Volume Control menu, click on Options > Properties, tick Line In and Microphone and click on OK. 3) Make sure Line In and Microphone is not mute and exit.
  • Page 31 SD3 Series Ultrasonic Pocket Doppler User Manual Examining Vertebral Artery (4/5 MHz) Vertebral Artery (4.0MHz) Carotid Artery (4.0/8.0MHz) Carotid Artery (4/5/8 MHz) Carotid Artery (4.0/8.0MHz) Carotid Artery (4/5/8 MHz) Jugular Vein (4/5 MHz) Jugular Vein (4.0MHz) Subclavian Artery (4/5 MHz) Subclavian Artery (4.0MHz)

  • Page 32: Completing Examining

    SD3 Series Ultrasonic Pocket Doppler User Manual Examining NOTE: When applied to the patient, the ultrasound transducer may warm slightly (less than 6° C (10.8° F) above ambient temperature). When NOT applied, the ultrasound transducer may warm slightly (less than 6° C (10.8° F) above ambient temperature).

  • Page 33: Chapter 5 Maintenance

    SD3 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. Pay special attention to the cracks on the probe and the cable before immersing them into conductive fluid.

  • Page 34: Sterilization

    SD3 Series Ultrasonic Pocket Doppler User Manual Maintenance ethanol (75%) or isopropanol (70%). Then wipe it dry with a dry cloth. CAUTION Pay attention not to immerse the probe socket into the disinfector. 5.4 Sterilization Do not sterilize the Doppler, unless this is necessary according to your hospital regulation.

  • Page 35: Chapter 6 Warranty And Service

    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.

  • Page 36: Appendix 1 Product Specifications

    SD3 Series Ultrasonic Pocket Doppler User Manual Product Specifications Appendix 1 Product Specifications Product Name: Ultrasonic Pocket Doppler Model: SD3 LITE, SD3, SD3 PLUS, SD3 PRO, SD3 VASCULAR Safety: Complies with: IEC 60601-1:2005, EN 60601-1:2006, IEC 60601-1-2:2014, EN 60601-1-2:2015, IEC/EN 61266:1994, EN 60601-2-37: 2008,...
  • Page 37 SD3 Series Ultrasonic Pocket Doppler User Manual Product Specifications Environment: Working: Temperature: +5° C ~ +40° C ( +41º F ~ +104º F) Humidity: 25% RH ~ 80% RH(non-condensing) Atmospheric Pressure: 86 kPa ~ 106 kPa Transport and Storage: Temperature: -20°...
  • Page 38 SD3 Series Ultrasonic Pocket Doppler User Manual Product Specifications Battery Supply Type Battery  Support 3 AA alkaline battery LR6 Internal Normal working time: ≥10 hours (recommended battery) battery (Please use the new battery in 22° C~26° C (71.6º F~78.8º F), when you plug the probe to start simulated monitoring.)
  • Page 39 SD3 Series Ultrasonic Pocket Doppler User Manual Product Specifications 5.0 MHz Vascular Probe (5.0± 10%) MHz 8.0 MHz Vascular Probe (8.0± 10%) MHz 2.0 MHz/3.0 MHz p- < 1 MPa I < 20 mW/cm < 100 mW/cm spta Obstetrical Probe 4.0 MHz/5.0 MHz/8.0...

  • Page 40: Appendix 2 Ordering Information

    SD3 Series Ultrasonic Pocket Doppler User Manual Ordering Information Appendix 2 Ordering Information CAUTION Only the parts supplied by the manufacturer should be used with the Doppler. Parts Part Number Probe 2.0 MHz Obstetrical Probe 12.01.210721 3.0 MHz Obstetrical Probe 12.01.210722...

  • Page 41: Appendix 3 Emc Information

    A3.1 Electromagnetic Emissions Guidance and manufacture’s declaration–electromagnetic emission The SD3 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.

  • Page 42: A3.2 Electromagnetic Immunity

    A3.2 Electromagnetic Immunity idance and manufacture’s declaration–electromagnetic immunity The SD3 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.

  • Page 43: A3.3 Electromagnetic Immunity

    Guidance and manufacture’s declaration – electromagnetic immunity The SD3 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.
  • Page 44 If the measured field strength in the location in which the SD3 Series Ultrasonic Pocket Doppler is used exceeds the applicable RF compliance level above, the SD3 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 SD3 Series Ultrasonic Pocket Doppler.

  • Page 45: A3.4 Recommended Separation Distances

    The SD3 Series 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 SD3 Series Ultrasonic Pocket Doppler can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SD3 Series Ultrasonic Pocket Doppler as recommended below, according to the maximum output power of the communications equipment.
  • Page 46 SD3 Series Ultrasonic Pocket Doppler User Manual EMC Information 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.

  • Page 47: Appendix 4 Ultrasound Intensity And Safety

    SD3 Series Ultrasonic Pocket Doppler User Manual Ultrasound Intensity and Safety Appendix 4 Ultrasound Intensity and Safety A4.1 Ultrasound in Medicine The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its known benefits for non-invasive investigations and medical diagnosis, including investigation of the human fetus, the question of clinical safety with regards to ultrasound intensity arises.

  • Page 48: A4.3.2 Ti (Thermal Index)

    SD3 Series Ultrasonic Pocket Doppler User Manual Ultrasound Intensity and Safety MI = r, α × C = 1 (MPa / MHz ) A4.3.2 TI (Thermal Index) Heating of tissues is caused by absorption of ultrasound when the ultrasound energy is applied.

  • Page 49: A4.4 Prudent Use Statement

    SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting A4.4 Prudent Use Statement Although no confirmed bioeffects on patients caused by exposure from present diagnostic ultrasound equipment have ever been reported, the potential exists that such bioeffects may be identified in the future. Therefore, the ultrasound should be used prudently. High levels of acoustic output and long exposure time should be avoided while acquiring necessary clinical information.

  • Page 50: A4.6 Transducer Acoustic Output Parameters List

    SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting A4.6 Transducer Acoustic Output Parameters List Acoustic output reporting table for IEC60601-2-37 (IEC60601-2-37, Edition 2.1, 2015-06, table 201.103) Transducer Model: SD3 CW2.0 Working Mode: CW mode Working Frequency:2.0MHz Index label Below Below...
  • Page 51 SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting Acoustic output reporting table for IEC60601-2-37 (IEC60601-2-37, Edition 2.1, 2015-06, table 201.103) Transducer Model: SD3 CW 3.0 Working Mode: CW mode Working Frequency:3.0MHz Index label Below Below surface surface surface surface Maximum index value 0.018...
  • Page 52 SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting Acoustic output reporting table for IEC60601-2-37 (IEC60601-2-37, Edition 2.1, 2015-06, table 201.103) Transducer Model: SD3 CW4.0 Working Mode: CW mode Working Frequency:4.0MHz Index label Below Below surface surface surface surface Maximum index value 0.012...
  • Page 53 SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting Acoustic output reporting table for IEC60601-2-37 (IEC60601-2-37, Edition 2.1, 2015-06, table 201.103) Transducer Model: SD3 CW5.0 Working Mode: CW mode Working Frequency:5.0MHz Index label Below Below surface surface surface surface Maximum index value 0.013...
  • Page 54 SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting Acoustic output reporting table for IEC60601-2-37 (IEC60601-2-37, Edition 2.1, 2015-06, table 201.103) Transducer Model: SD3 CW8.0 Working Mode: CW mode Working Frequency:8.0MHz Index label Below Below surface surface surface surface Maximum index value 0.0057...

  • Page 55: A4.7 Track1 Acoustic Output Range Summary

    SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting A4.7 Track1 Acoustic Output Range Summary TRACK1 SUMMARY Mode of Operation Transducer Global Maximum Output Level CW mode Max I (mW/cm2) 35.4722 SPTA.3 Min I (mW/cm2) 17.5000 SPTA.3 Max I (W/cm2) 0.03547 SPPA.3...
  • Page 56 SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting Acoustic Output Reporting Table for Track1 Non-autoscanning Mode System : Operating Mode: CW mode Transducer: CW2.0 Working Frequency: 2.0 MHz spta.3 sppa.3 Acoustic Output (mW/cm (W/cm 0.02649 Global Maximum Value 0.01936 26.4861 0.02738...
  • Page 57 SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting Acoustic Output Reporting Table for Track1 Non-autoscanning Mode System : Operating Mode: CW mode Transducer: CW4.0 Working Frequency: 4.0 MHz spta.3 sppa.3 Acoustic Output (mW/cm (W/cm 0.01685 Global Maximum Value 0.01185 16.845 0.02368...
  • Page 58 SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting Acoustic Output Reporting Table for Track1 Non-autoscanning Mode System : Operating Mode: CW mode Transducer: CW8.0 Working Frequency: 8.0 MHz spta.3 sppa.3 Acoustic Output (mW/cm (W/cm 0.009476 Global Maximum Value 0.005621 9.4761 0.01590...

  • Page 59: Appendix 5 Troubleshooting

    SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting Appendix 5 Troubleshooting Phenomenon Possible Cause Solution The speaker is muted. Turn up the volume. Bad connection between the Make sure that the probe is well probe and main unit. connected to the main unit.
  • Page 60 SD3 Series Ultrasonic Pocket Doppler User Manual Troubleshooting or displays charge error Battery defective. Replace the battery. when the Doppler (SD3 Main board defective. Replace the main board. PLUS or SD3 PRO) is being charged. Charge stand defective. Replace the charge stand.

  • Page 61: Appendix 6 Overall Sensitivity

    SD3 Series Ultrasonic Pocket Doppler User Manual Overall Sensitivity Appendix 6 Overall Sensitivity Two-way Attenuation   Diameter of   Overall Sensitivity B=∑B      Distance (r.m.s) (r.m.s)     Target A(dB) (S=A(d)+B+C) ∑B (T: ultrasonic attenuation...

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