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EDAN Agile PLM Electronic Signature Information

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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 : 余俊煜 (yujunyu) 2019-01-17 10:33:49

批准人 : 吴明花 (wuminghua) 2019-01-18 11:20:19

Содержание SD3 LITE

Страница 1: ...and performed in EDAN Agile PLM SD3 _ 01 54 455714 1 9 SD3 LITE SD3 PLUS SD3 PRO SD3 Project Code 2209A000 zhourui 2019 01 17 10 00 18 liuxiaoqian 2019 01 17 13 40 37 yujunyu 2019 01 17 10 33 49 wumin...

Страница 2: ......

Страница 3: ...ted 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 sh...

Страница 4: ...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 inac...

Страница 5: ...15 3 2 Installing Replacing Battery 15 3 3 Probe Operation 16 3 4 Switching On 17 3 5 Switching Off 17 3 6 Replacing Charging the Battery 17 3 6 1 Battery Energy Indication 17 3 6 2 Replacing Alkalin...

Страница 6: ...c Immunity 37 A3 4 Recommended Separation Distances 39 Appendix 4 Ultrasound Intensity and Safety 41 A4 1 Ultrasound in Medicine 41 A4 2 Ultrasound Safety and the ALARA Principle 41 A4 3 Explanation o...

Страница 7: ...flow in veins and arteries for assisting in the detection of peripheral vascular disease 1 2 Safety Precautions Safety of Ultrasound SD3 was designed with physician and patient safety in mind In early...

Страница 8: ...practice may or may not be relevant to extended exposure times and altered exposure conditions It is therefore considered appropriate to make the following recommendation In those special situations i...

Страница 9: ...y 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...

Страница 10: ...ovided by the manufacturer or purchased locally Replace lithium batteries with only those provided by the manufacturer 32 Stop using the battery if abnormal heat odor discoloration deformation or abno...

Страница 11: ...or machine performance If the damage is found replace them with good ones at once 7 The following safety checks should be performed once every two years or as specified in the institution s test and...

Страница 12: ...o sale by or on the order of a physician 4 Operating instructions 5 Caution 6 MR Unsafe keep away from magnetic resonance imaging MRI equipment 7 Current Direct 8 TYPE B APPLIED PART 9 Part Number 10...

Страница 13: ...to UL Std 60601 1 IEC Std 60601 2 37 Certified to CSA Std C22 2 No 601 1 CSA Std C22 2 No 60601 2 37 19 Refer to User Manual Background Blue Symbol White 20 Warning Background Yellow Symbol Outline B...

Страница 14: ...y the fetal heart rate on an OLED screen The features of the Dopplers are listed in the following chart Model Function SD3 LITE SD3 SD3 PLUS SD3 PRO SD3 VASCULAR Display Panel LED Indicator No Signal...

Страница 15: ...onal Optional Optional Charge Stand Optional Optional Charging the Doppler Rechargeable Lithium Battery Trolley Optional Optional Optional Optional Optional Gel configured not available For the Essent...

Страница 16: ...te Indicator SD3 LITE SD3 VASCULAR 4 Battery Compartment SD3 PLUS SD3 PRO 5 Charge Stand Socket SD3 PLUS SD3 PRO 6 Battery Compartment SD3 LITE SD3 SD3 VASCULAR 7 Volume Control 8 Probe Holder 9 Probe...

Страница 17: ...nstead of the FHR No Symbol Description 1 HR being calculated 2 Full capacity 3 4 capacity 2 4 capacity 1 4 capacity Empty the flickering interface prompts replacement or charging of battery 3 HR 50 2...

Страница 18: ...primary functions are as follows 1 REC PLAY Only for SD3 PRO Function Start stop recording or playing fetal heart sound 2 Volume Control Indicator Function Adjust volume Rotate the volume gear toward...

Страница 19: ...cket The probe socket is as shown in figure 2 7 Figure 2 7 Probe socket Connect the probes supplied by the manufacturer to the Doppler through the probe socket CAUTION 1 Do not try to connect any othe...

Страница 20: ...stetrical probe features in deep penetration and is designed for use during the third trimester pregnancy The 3 MHz obstetrical probe features in high sensitivity and is designed for use as early as 9...

Страница 21: ...purchased locally Replace lithium batteries with only those provided by the manufacturer See Appendix 1 Product Specifications for details about battery specifications 2 If the batteries have been in...

Страница 22: ...r stored the battery must be charged Connecting to power supply will charge the battery no matter if the Doppler is powered on 3 The installation of battery must be carried out by qualified personnel...

Страница 23: ...reconnect the probe properly When the probe is well connected the OLED shows the probe frequency 3 5 Switching Off Press the POWER button on the front panel to switch off the Doppler For SD3 SD3 PRO a...

Страница 24: ...E BATTERY 3 6 3 Charging the NI MH Batteries When the rechargeable NI MH batteries are low in energy 1 Take the NI MH batteries out from the main unit by using the procedures described in section 3 2...

Страница 25: ...r adapter are as follows Input AC 100 240 V 50 60 Hz 0 2 A Output DC 5 V 1 A 3 6 5 Charging the Charge Stand For the Doppler equipped with a charge stand put the plug of the power adapter into the cha...

Страница 26: ...uring charging WARNING 1 The charge stand can be fixed only on a concrete wall 2 When you need to install the charge stand a second time drill new holes and change the screws 3 The charger and the pow...

Страница 27: ...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 OLED excep...

Страница 28: ...ing and returns to the real time status NOTE Only the last set of recorded fetal heart sounds is saved in the Doppler It is cleared when new sounds are recorded Playing Press the button once the machi...

Страница 29: ...e sound recorder click on File Open search for the folder and select the file click on Open to load the file and then click on the play key If you have any other program that supports waveform wav fil...

Страница 30: ...5 MHz or 8 MHz vascular probes are to be connected to the Doppler to perform vascular examination Choose the appropriate probe as required The probe with low frequency has a deeper penetration depth w...

Страница 31: ...4 0 8 0MHz Subclavian Artery 4 0MHz Subclavian Vein 4 0MHz Jugular Vein 4 0MHz Brachial Artery 8 0MHz Ulner Artery 8 0MHz Radial Artery 8 0MHz Femoral Artery 4 0MHz Hz Popliteal Artery 4 0MHz Great S...

Страница 32: ...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 4 5 Completing Examining After examining 1 Switch...

Страница 33: ...of the main unit with a dry soft cloth If necessary clean it using a soft cloth dampened with mild near neutral detergent ethanol 75 or isopropanol 70 and then wipe it dry with a dry cloth immediately...

Страница 34: ...or disinfection check if the Doppler functions well If any problem is detected please contact the manufacturer for service before reusing it Checking Item Checking Method Visual Check Inspect the Dopp...

Страница 35: ...DAN d damage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty is determined to be defective because of defective material...

Страница 36: ...egree Type B equipment Degree of Protection against Harmful Ingress of Water Main Unit Ordinary equipment Sealed equipment without liquid proof Probes IPX8 Water Ingress Protection Code Degree of Safe...

Страница 37: ...double color screen FHR Performance Essential Performance FHR Measuring Range 50 bpm 240 bpm Resolution 1 bpm Accuracy 2 bpm Sensitivity 9 weeks gestation 3 MHz Audio Output Power 2 W Recording and P...

Страница 38: ...er 1 Normal working time 16 hours recommended battery Please use the newly charged battery in 22 C 26 C 71 6 F 78 8 F when you plug the probe to start simulated monitoring 2 Charge mode charge in the...

Страница 39: ...z Obstetrical Probe 245 15 mm2 4 0 MHz Vascular Probe 32 15 mm2 5 0 MHz Vascular Probe 32 15 mm2 8 0 MHz Vascular Probe 14 15 mm2 Low Output Summary Table for systems with no transducers having global...

Страница 40: ...l Probe 12 01 210722 4 0 MHz Vascular Probe 12 01 210875 5 0 MHz Vascular Probe 12 01 210876 8 0 MHz Vascular Probe 12 01 210877 Accessory Alkaline Batteries 01 21 064086 Rechargeable NI MH Batteries...

Страница 41: ...nment guidance RF emissions CISPR 11 Group 1 The SD3 Series Ultrasonic Pocket Doppler uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause...

Страница 42: ...c tile If floor are covered with synthetic material the relative humidity should be at least 30 Electrical Fast Transient Burst IEC EN61000 4 4 2 kV for power supply lines 1 kV for input output lines...

Страница 43: ...ation applicable to the frequency of the transmitter Recommended separation distance P d 2 1 150 kHz to 80 MHz P d 2 1 80 MHz to 800 MHz P d 3 2 800 MHz to 2 7 GHz d 6 E at RF wireless communications...

Страница 44: ...3 V m c The ISM industrial scientific and medical bands between 0 15 MHz and 80 MHz are 6 765 MHz to6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The amateur...

Страница 45: ...A3 4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the SD3 Series Ultrasonic Pocket Doppler The SD3 Series Ultrasonic P...

Страница 46: ...on 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 se...

Страница 47: ...verning bodies in ultrasound have issued statements to the effect that there are no known adverse effects from the use of diagnostic ultrasound however exposure levels should always be limited to As L...

Страница 48: ...ne Thermal Index It provides an estimate of potential temperature rise in the cranial bones or superficial bones A4 3 3 Measurement Uncertainties The uncertainties in the measurements were predominant...

Страница 49: ...ety 1 Bioeffects and Safety of Diagnostic Ultrasound issued by AIUM in 1993 2 Medical Ultrasound Safety issued by AIUM in 1994 3 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipmen...

Страница 50: ...rface Below surface At surface Below surface Maximum index value 0 019 0 16 0 40 N A Index component value N A 0 16 N A 0 40 Acoustic Parameters pr at zMI MPa 0 027 P mW 24 21 24 21 N A P1x1 mW N A N...

Страница 51: ...surface Below surface Maximum index value 0 018 0 29 0 46 N A Index component value N A 0 29 N A 0 46 Acoustic Parameters pr at zMI MPa 0 031 P mW 44 65 44 65 N A P1x1 mW N A N A zs cm 3 70 zb cm 3 70...

Страница 52: ...surface Below surface Maximum index value 0 012 0 13 0 15 N A Index component value 0 13 N A N A 0 15 Acoustic Parameters pr at zMI MPa 0 024 P mW 6 69 6 69 N A P1x1 mW N A N A zs cm N A zb cm 2 75 z...

Страница 53: ...surface Below surface Maximum index value 0 013 0 18 0 24 N A Index component value 0 18 N A N A 0 24 Acoustic Parameters pr at zMI MPa 0 029 P mW 7 65 7 65 N A P1x1 mW N A N A zs cm N A zb cm 1 40 z...

Страница 54: ...rface Below surface Maximum index value 0 0057 0 098 0 056 N A Index component value 0 098 N A N A 0 056 Acoustic Parameters pr at zMI MPa 0 016 P mW 2 58 2 58 N A P1x1 mW N A N A zs cm N A zb cm 2 15...

Страница 55: ...3 mW cm2 30 8334 Min ISPTA 3 mW cm2 19 2886 Max ISPPA 3 W cm2 0 03083 Min ISPPA 3 W cm2 0 01929 Max MI 0 0210 Min MI 0 0146 Max Isata transducer face 19 91 Min Isata transducer face 15 38 CW4 0 Max I...

Страница 56: ...Beam dimensions X 6 cm 0 4674 0 4674 Y 6 cm 0 4292 0 4292 PD usec PRF Hz EBD Az cm 2 5 Ele cm 1 25 Operating Control Conditions Fixed Acoustic Output Reporting Table for Track1 Non autoscanning Mode...

Страница 57: ...Beam dimensions X 6 cm 0 4584 0 4584 Y 6 cm 0 4769 0 4769 PD usec PRF Hz EBD Az cm 0 9 Ele cm 0 45 Operating Control Conditions Fixed Acoustic Output Reporting Table for Track1 Non autoscanning Mode...

Страница 58: ...ucer CW8 0 Working Frequency 8 0 MHz Acoustic Output MI Ispta 3 mW cm2 Isppa 3 W cm2 Global Maximum Value 0 005621 9 4761 0 009476 Associated Acoustic Parameter Pr 3 MPa 0 01590 W0 mW 2 576 2 576 fc M...

Страница 59: ...oes not sound after the main unit is switched on Main board defective Replace the main board The battery is in low energy Replace the battery or charge the rechargeable battery The speaker sounds but...

Страница 60: ...ser Manual Troubleshooting 54 or displays charge error when the Doppler SD3 PLUS or SD3 PRO is being charged Battery defective Replace the battery Main board defective Replace the main board Charge st...

Страница 61: ...5 T 6 6 5 1 0 66 1 204 2 100 4 6 17 104 77 Ba 66 1 75 36 0 T 6 6 5 1 0 66 1 174 8 85 4 6 22 108 32 Ba 66 1 100 38 5 T 6 6 5 1 0 66 1 174 2 87 5 5 98 110 58 Ba 66 1 200 45 5 T 6 6 4 0 59 9 300 2 142 3...

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