User Manual

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Users Manual

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SD1 Ultrasonic Pocket Doppler User Manual WARNING 8. The device is not protected against defibrillation. About this Manual 9 SHOCK HAZARD — Do not attempt to replace batteries with wet it 0154457085 hands. MPN: 0154457985010 10 Do not connect any equipment or accessories that are not approved by 1 Fetal heart icon 3 FHA numeric/Sound yolume numenc Release Date: Apr. 2018 the manufacturer or that are not TEC 60601—1 approved to the device. 2 Fetal heart signal 4 Battery indicator The operation or use of non—approved equipment or accessories with intensity indiéator © Copyright EDAN INSTRUMENTS, INC. 2018. All rights reserved. Statement the device is not tested or supported, and device operation and safety are not guaranteed. This manualwill help you understand the operation and maintenance of the 11 Using accessories other than those specified by the manufacturer may 6 soundyolume fouch ke decrease 5 ME Sound volume tey product better. It is reminded. that the product shall be used strictly result in increased electromagnetic emissions or decreased 7 On/Off touch key complying with this manmal. User‘s operation failing to comply with this electromagnetic immunity of the device. manual may result in malfunction or accident for which Edan Instruments, 12 The device should not be used adjacent to or stacked with other Inc. (hercinafter called EDAN)cannot be held liable. equipment and that if adjacent or stacked use is necessary, the device Item Description EDAN owns the copyrights of this manual. Without prior written consent should be observed to verify normal operation in the configuration in Fetal .I which it will be used 1 heart Indicates fetal heart beat and flickers to the of EDAN, any materials contained inthis manual shall not be photocopied, 13 The medical electrical equipment needs to be installed and put into icon fetal heart beat, reproduced or translated intoother languages. service according to the EMC Information provided in this user manual. This indicator displays on the Materialsprotected by the copyright law, including but not limited to 14 Portable and mobile RF communications equipment can affect medical 1:5"*1 lgfi side of the screen a"dr:'ale confidential information: such as. technical. information: and. patent electrical equipment; refer to section. Recommended. Separation leart three stams: empty, ha informationare contained in this manual, the user shall not disclose such Distances 2 signal empty and full, which — or maintain the device or any accessory which is in use 15 Do not service intensit indcator respectivelyand represents mncllom low, hi‘;h fasl heart information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly with a pationt signal intensity. or implicitly, any right or license to use any of the intellectualproperties of Displays fetal heart rare EDAN. rur within the range from 50 bpm EDAN holds the rights to modify, update, and ultimately explain this cavtion numeric to 240 bpm. When fetal heart manual 1: Refer servicing to qualified personnel. :‘s;;:yf:u'flfthe range,it Responsibility of the Manufacturer 2 Keep the device in a clean environment and avoid vibration during Samd voun mme EDAN only considers itself responsible for any effect on safety, reliability storage. 3 displayed in the center of the Do not sterilize the Doppler: screen, the same area as the and performance of the equipment if a c Electromagnetic Interference — Ensure that the environment in which Sound FHR numeric. When you Assembly operations, extensions, re—adjustments, modifications or repairs adjust sound volume, the are carried out by persons authorized by EDAN, and the device is operated is not subject to any source: of. strong volume hmmeric sound volume. numeric.wl will The electrical installation of the relevant room complies with national electromagnetic emissions, such as radio transmitters, mobile display for 0.5 second before standards, and telephones, ec. switching back to display Prio to examination using the Doppler, check for visible damages of FHR numeric. Sound volume The instrument is used in accordance with the instructions for use. w ranges from level 0 to 7. EDAN will make available on request circuit diagrams, component part the main unit and the probe that may endanger the patient/operator or Battery indicatordisplays lists, descriptions, calibration instructions, or other information that will machine performance. Ifthe damage is found, replace them with good on the right side of the assist service personnel to repair those parts of the equipment that are ones at once. screen. There are 5 The following safety checks should be performed once every two years battery levels, represented designated by EDAN as repairable by service personnel. o Battery by 0 to 4 panes in the Product Information or as spevified in the institution‘s test and inspeotion protocol by a 4 indicator icon. When battery is Product Name:Ultrasonic Pocket Doppler qualified person who has adequate training, knowledge, and practical empty, battery empty icon Model:SD1 experience to perform these tests. Bwibe cisplayed ana Terms Used in this Manual @ Inspect the equipment for mechanical and functional damage. flickering, and the battery @ Tnspect the safety relevant labels for legibility. needs replacing This guide is designed to give key concepts on safety precautions. Sound WARNING @ Inspect the equipment for mechanical and functional damage. volume AWARNING label advises against certain actions or situations that could @ Tnspect the safety relevant labels for legibility. s increase E... .. keyfor a litle while to increase result in personal injury or death. The leakage current should never exceed the limit. The data should be touch sound volume. recorded in an equipment log. Ifthe device is not functioning properly ke CAUTION Sound A CAUTIONlabel advises against actions or situations that could damage or fails any of the above tests, the device has to be repaired. volume Reif equipment, produce inaccurate data, or invalidate a procedure. The device and accessories are to be disposed of according to local s decrease [Touch the key for a little while to decrease s NotE regulations after their useful lives, Alternatively, they can be returned to touch sound volume. the dealer or. the. manufacturer for. recycling or proper disposal. ke ANOTE provides useful information regarding a function or a procedure. owor ‘Whenthe Doppler is of%, touch this key ® Precautions Batteries are hazardous waste. Do NOT dispose them together with ; fouen for a litle while to switch it on; house—hold garbage.. fe When the Doppler is on, touch this key caUrion * for a litle while to switch it off. Federal (U.S.) Law restricts this device to sale by or on the order of a Battery physician. Intended Use/Indications for Use SD1 is powered by two AA alkaline batteries. Battery specification: LR6, The SD1 is a pocket Doppler device used for detecting the fetal heartbeat AA, 15 V; NotE: from the 10th week of gestation. Tt is intended to be used by medical Note: This user manual is written to cover. the maximum: configuration. professionals only. You can use AA alkaline batteries of the same specification purchased Therefore, your model may or may not have some of the parameters and Features locally functions described, depending on what you have ordered. ® FHR monitoring and display # FH signal intensity This unit is internally powered equipment, and it is an TEC/EN indicator ®— Operation 60501—1 Type BF applied part. Type BF pretection means that the # FH sound # FH icon nore: connection between the equipment and personnel complies with ® Switching off when no signal received @ Battery indicator To ensure that the Doppler works properly, please read this chapter and Chapterafety Precautions before operation; follow the steps. when permitted leakage currents and dielectric strength of TEC/EN for 2 Min connecting all the components. soso1—1. ® Sound volume adjustment ® Low battery waming ® Bluctooth connection (Optional) ® Sound volume levels Opening the Package and Checking WARNING and CAUTION messages must be observed. To avoid the Open the package; take out the Doppler and accessories carefully. Keep the possil y of injury, observe the following precautions during the Appearance ( Above pictures are just for reference) package for possible future transportation or storage. Check. the operation of the device. components according to the packing list. Loudspeaker # Check for any mechanical damage. WaRNING ® Check all the cables and accessories. Tt is to b used by health care professionals on the order of a physician. ( TF there is any problem, contact us or your local distributor immediately. 1 + The Doppler is a tool to aid the healthcare professional in hospitals, clinics or at home and should not be used in place of normal fetal ; s LCD Sergen \ Installing the Battery a) Unscrew the screw with a cross screudriver and remove the battery monitoring, It is not intended for treatment or use during labor and \ F Scre 5 delivery. compartment cover. 3. Placement of the ultrasound transducer on the sbdomen is crifical to | Touch Keys ©) Insert the battery into the compartment carefully. Ensure its anode and cathode terminals are aligned with the anode and cathode marks on the obtaining the fetal heart beat as opposed to matemnal heart beat or other “ Battery Col riment Cover abdominal noise. The user should be trained in proper placement | compartment. ¢} Install the compartment cover and secure it with the screw. techniques either through acceptable Ob/Gyn training and individeal state accreditation, or as being prescribed by such a trained clinician Ultrasonic Transducer Head Removing/ Replacing the Battery and trained in device placement. a) Unscrew the screw with a cross screwdriver and remove the battery 4 This device is not explosion—proof and cannot be used in the presence compartment cover. of flammable anesthetics. b) Take out the used battery. You can also replace it with a new one. 5 Magnetic and electrical fields are capable of interfering with the proper Ensure the new battery‘s terminals are placed in the right direction as performance of the device. For this reason, make sure that all external indicated by the anode and cathode marks. devices operated in the vicinity of this device comply with the relevant ¢} Install the compartment cover and secure it with the screw. EMC requirements. X—ray equipment and magnetic resonance imaging (MRI) devices can emit high levels of electromagnetic radiation. 6. 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. 7. Do not use the device with HP surgical equipmentand do not use it in an MRT environment.

These limits are designed to provide reasonable protection against harmful WARNING CAUTION interference in a residential installation. This equipment generates, uses 1 Turn off the Doppler before removing or replacing the battery. 1 The Doppler‘s degree of protection against harmful ingress of water and can radiate radio frequency energy and, if not installed and used in 2 Replace alkaline batteries with those of identical specifications is IP22. Do not immerse it in water. accordance with the instructions, may cause harmful interference to radio provided by the manufacturer or purchased 2 The Doppler is delicate and sensitive. Please handle it with care and communications. However, there is no guarantee that interference will not locally.SeeChapterProduct Specificationsfor details about battery try to avoid dropping on to the ground or any hard surfaces. Any occur in a particular installation. If this equipment does cause harmful specifications. damage caused by dropping is not covered by the warranty. interference to radio or television reception, which can be determined by 3 If the batteries have been inserted incorrectly, the Doppler will not 3 Keep the coupling gel away from children. If swallowed, consult a turning the equipment off and on, the user is encouraged to try to function or it will be damaged. physician at once. correctthe interference by one or more of the following measures: 4 Do not disassemble or short-circuit batteries. -Reorient or relocate the receiving antenna. 5 Do not recharge batteries. Note: -Increase the separation between the equipment and receiver. 6 Do not dispose of batteries in fire or water. 1 The best quality of fetal heart signal is obtained only when the Doppler -Connect the equipment into an outlet on a circuit different from that to 7 Do not allow metal objects to contact the battery terminals. is placed on the best monitoring position. which the receiver is connected. 8 Do not mix with used or other battery type (such as alkaline with 2 Do not place the Doppler near positions where placental sound or -Consult the dealer or an experienced radio/TV technician for help. carbon zinc). umbilical blood flow sound is loud. 2.Any changes or modifications to this unit not expressly approved by the 9 Do not solder the batteries directly. If soldering or welding 3 If the fetus is in the cephalic position and the mother is supine, the party responsible for compliance could void the user's authority to operate connection to the battery is required, consult our engineer for proper clearest heart sound will normally be found on the midline below the the equipment. methods. navel. During monitoring, the pregnant woman‘s prolonged lying in 10 Do not over-discharge batteries. the supine position should be avoided to reduce the possibility of  Maintenance and Cleaning 11 To install or remove batteries, follow the equipment manufacturer‘s supine hypotension. Putting a pillow or cushion under the patient‘s head or feet can be of help. Maintenance instructions. 4 It is not possible to obtain accurate FHR unless a clear fetal heart Before each use, check if the equipment has visible evidence of damage 12 Keep battery away from small children. If swallowed, consult a physician at once. signal is detected. If the calculated FHR is not in accordance with the that may affect the patient and the operator‘s safety or the Doppler‘s 13 Store the battery in cool, dry place before use.Do not keep batteries beat of the fetal heart sound, the fetal heart sound auscultation result functioning. If the damage is evident, contact the manufacturer for service at temperature of 45°C or above, or at humidity of 75% or above. shall prevail. or replace it. 14 Dispose the battery according to the local regulations. Refer to 5 When applied to the patient, the Doppler may warm slightly (less than The overall check of the Doppler, including safety check and function IEC61429 for standard disposal when necessary. 2°C (35.6°F) above ambient temperature). When NOT applied, the check, should be performed by qualified personnel every 12 months, and Doppler may slightly (less than 5°C (41°F) above ambient temperature). each time after service. And safety check must include current leakage test Switching On After Monitoring and insulation test. Besides the above requirements, comply with local Touch the On/Off touch key for about 1second when the Doppler is off, 1) Switch off the Doppler. regulations on maintenance and measurement. and the Doppler will display the switching on interface before 2) Wipe the remaining gel off the patient and the probe with a clean soft The accuracy of FHR is determined by the Doppler and cannot be adjusted switching to display the test interface . cloth or tissue. by user. If you have doubt concerning the accuracy of FHR, verify it with Switching Off other methods such as using a stethoscope, or contact local distributor or Touch the On/Off touch key for about 1second when the Doppler is on,  Mobile Application Software (APP) the manufacturer for help. and the Doppler will be switched off. SD1 can connect to mobile phones with its Bluetooth function (optional). The Doppler is frangible and must be handled with care.Wipe the If the Doppler is not in operation or no signal is received for 2 minutes, the The SD1 APP has both Android and iOS versions. remaining gel off the Dopplerafter each use. These measures can help Doppler will switch off automatically. iOS APP operating environment: Android APP operating prolong the Doppler‘s life.  FHR Monitoring environment: Replace the accessories such as the battery according to use. If any of the A) hardware environment A) hardware environment Before applying the Doppler to inspect FHR, you should always check accessories are damaged, refer to chapter Ordering Information for Processor: dual-core Apple A6 CPU: frequency≥1.0GHz whether the Doppler is in good condition and whether there is evident RAM: ≥1GB RAM: ≥1GB details and order new ones. damage that might affect patient‘s safety and the device‘s function.If B) software environment: iOS B)software environment: Android Please check the label for the date of manufacture, the service life is 5 evident damage is found, stop using it at once and replace it with a good 8.0 and above operating system 4.3 and above operating system years (The service life is limited to the Doppler, not including the C)network environment: support C)network environment: support one. replaceable accessories. The only replaceable accessory of SD1 is battery. Bluetooth Bluetooth Procedures to Monitor FHR: How to use SD1 Medical APP The frequency of usage is 8 hours/day). a) Have the patient lie on her back. 1.Download and install software Cleaning b) Apply appropriate Scan either of the following QR codes to download the SD1Medical APP, Before cleaning, switch off the Doppler. amount of coupling gel and install and run it as prompted. Keep the exterior surface of the device clean and free of dust and dirt. to the ultrasonic Note: Clean the exterior surface of the Doppler with a dry, soft cloth. If necessary, transducer head of the 1 Your mobile phone may prohibit the clean it using a soft cloth dampened with mild near neutral detergent, Doppler and switch on installation of ―applications from ethanol (75%) or isopropanol (70%), and then wipe it dry with a dry cloth the Doppler. unknown sources‖. Enter Settings to immediately. c) Palpate the patient‘s allow the installation first. 2 For normal functioning of the APP, CAUTION abdomen gently to TBC TBC 1 Do not use strong solvent, such as acetone. confirm the fetus‘s The coupling gel please give the APP function-related 2 Never use an abrasive such as steel wool or metal polish. position. permissions. 3 The Doppler‘s degree of protection against harmful ingress of water is should not exceed d) Place the Doppler on 3 For how to use the APP, read the IP22. Do not immerse it in water. this limit. the patient‘s abdomen, instructions in the About 4 Do not remain any solution on the surface after cleaning. and move it around the sub-interface under the Settings This area can Disinfection fetus‘s position or tilt it interface of the APP. In normal use theDoppler does not need disinfection. In case of being until a clear and be immerged in 2.Activate the device soiled, clean the main unit case and then disinfect it by wiping it with a rhythmic heart sound is coupling gel Open the APP and go to Settings>Activation and input SD1 activation soft cloth dampened with ethanol (75%) or isopropanol (70%). Then wipe heard and FHR numeric is stably displayed. code (14 numbers after 01). it dry with a dry cloth. Note: 3.Pair device Open Bluetooth function of the mobile to automatically pair the SD1. CAUTION 1 Do not mistake the maternal heart rate for fetal heart rate.Do not 4.Start detection Do not immerse the Doppler into the disinfector. mistake the maternal heart rate for fetal heart rate. The fetal pulse should be different from the maternal pulse, which can be measured at Put the coupling gel on SD1 and position the probe to the optimal place of Sterilization the wrist or neck. maternity's abdomen. And click the "start" key. After pressing start, Do not sterilize the Doppler. 2 Do not wear gloves to touch the keys. If there's water and coupling gel confirm that the data on the APP and the SD1 probe match. As with any Bluetooth communication, it is important to make sure the NOTE: on the fingers, please clean them first or the touching effect will be influenced. connection is not compromised. After cleaning or disinfection, check if the Doppler functions well. If any How to Find the Best FH Signal: 5.Adjust the fetal heart beat sound volume problem is detected, please contact the manufacturer for service before 1) The easiest way: take the position the doctor last monitored for FHR When using mobile phone to play the fetal heart beat sound, you can adjust reusing it. the volume with the volume keys of the mobile phone. When using SD1 to as a reference and move the Doppler around the position slowly Checking Item Method play the heart beat sound, touch ‗volume+‘ or ‗volume -‘ to adjust the until the best FH signal is found. volume. Visual Check Inspect the Doppler for any damage. 2) The fetal heart position may change as the fetus moves inside the 6.Finish the monitoring Check if the Doppler can be switched on and off uterus. You can confirm the fetal position first according to the When the monitoring is finished, click ‗Stop‘ touch key and the detection normally (see Switching On and Switching position of the uterus fundus in different gestational weeks. data will be saved automatically. Off)When the Doppler is switched on, check if the Functional The clearest and loudest fetal heart sound is generally obtained Note:Please make sure your mobile phone has enough battery power,and display panel works as described in LCD Check Display&Touch Keys; touch the ultrasonic when the Doppler is placed on the fetus‘s back. Fetal movement is avoid killing the process directly or switching to other applications during transducer head gently with your hand and check if usually the movement of fetal limbs. So, if frequent fetal movement the fetal heart monitoring. the Doppler gives out sound normally. occurs at the right side of the abdomen, the fetus‘s back is 7.Real time detection mode and DEMO mode probablyat the left sideand vice versa.You can find the fetus‘s back We provide DEMO mode for users' reference. You can turn on DEMO key  Product Specifications according to fetal movement‘s position. in Setup and enter fetal heart monitoring interface to watch the DEMO. Product Information If the fetus is in cephalic delivery position, the fetal heart is either on The word ‗DEMO‘ is displayed in the interface to distinguish from real Product Name Ultrasonic Pocket Doppler the right side or on the left side below the navel; if the fetus is in time detection. breech delivery position, the fetal heart is either on the right side or Model SD1 on the left side above the navel. WARNING Complied Standards Steps to Find Fetal Heart: SD1 complies with Part 15 of the FCC Rules. Operation is subject to the IEC 60601-1:2005/A1:2012, EN 60601-1:2006/A1:2013, IEC following two conditions: 60601-1-2:2014, IEC 60601-2-37:2015,IEC 61266:1994 Have the patient lie on back and relax >> confirm fetal position by hand >> 1)this device may not cause harmful interference, and Classification apply coupling gel to the Doppler>> place the Doppler on patient‘s 2)this device must accept any interference received, including interference abdomen and start looking for the fetal heart >> the fetal heart is found Anti-electric Shock Type: Internally powered equipment that may cause undesired operation. when the Doppler gives out a continuing thumping sound Anti-electric Shock Degree: Type BF equipment ―boom-boom-boom‖. NOTE: Degree of Protection against IP22. Do not immerse it in water. 1.This equipment (SD1) has been tested and found to comply with the Harmful Ingress of Water: limits for a Class B digital device, pursuant to part 15 of the FCC Rules. Degree of Safety in Presenceof Equipment not suitable for use in

Flammable Gases: presence of flammable gases The American Institute of Ultrasound in Medicine (AIUM) states that output indices on Working System: Continuous running equipment given its track record of over 25 years of use and no confirmed biological diagnostic ultrasound equipment, Revision 2" issued by AIUM/NEMA in effects on patients or instrument operators, the benefits of the prudent use 2004 EMC: CISPR 11 Group 1 Class B of diagnostic ultrasound clearly outweigh any risks. 5. "Information for Manufacturers Seeking Marketing Clearance of Ultrasound Safety and the ALARA Principle Diagnostic Physical Specifications Ultrasound waves dissipate energy in the form of heat and can therefore Ultrasound Systems and Transducers" issued in 2008. Length*Width* Height: (48±2) mm× (39±2) mm× (147±3) Size: cause tissue warming. Although this effect is extremely low with Doppler, 6. ―Medical electrical equipment—Part 2-37: Particular requirements for mm it is important to know how to control and limit patient exposure. Major the basic safety and essential performance of ultrasonic medical diagnostic Weight: < 180g governing bodies in ultrasound have issued statements to the effect that and monitoring equipment" issued by IEC in 2007. Size: (24±2) mm× (13±2) mm there are no known adverse effects from the use of diagnostic Acoustic Output Reporting Table for Track 1 Acoustic output ◆FHR ◆Sound volume ultrasound,however, exposure levels should always be limited to As Low reporting table for IEC60601-2-37(IEC60601-2-37, Edition 2.1, 2015-0, LCD: Display: ◆Battery level level As Reasonably Achievable (the ALARA principle). table 201.103) ◆Signal intensity ◆FH icon Explanation of MI/TI Transducer Model: SD1, Operating Mode: PW mode pH: 5.5~8.0 MI (Mechanical Index) MI TIS TIB Coupling Acoustic Impedance: 1.5x106 Pa.s/m ~1.7x106Pa.s/m Cavitations will be generated when ultrasound wave passes through and At Bel At Bel TI Gel: Index label ow ow (35°C/95ºF) contacts tissues, resulting in instantaneous local overheating. This Surf surf C Surf Surf Environment ace ace phenomenon is determined by acoustic pressure, spectrum, focus, ace ace Temperature:+5°C ~ +40°C ( +41ºF ~ +104ºF) transmission mode, and factors such as states and properties of the tissue Maximum index 0.0 N/ 0.05 0.01 value 1 A Working: Humidity:15% RH ~ 95% RH(non-condensing) and boundary. This mechanical bioeffect is a threshold phenomenon that Index component occurs when a certain level of ultrasound output is exceeded. The threshold N/A 0.05 NA 0.01 Atmospheric Pressure:70kPa ~ 106 kPa value is related to the type of tissue. Although no confirmed adverse mechanical pr.αat Temperature:-25°C ~ +70°C (-13ºF ~ +158ºF) 0.0 Transport and zMI Humidity:15% RH ~ 95% RH (non-condensing) effects on patients or mammals caused by exposure at intensities typical of 2 (MPa) Storage: present diagnostic ultrasound instruments have ever been reported, the Atmospheric Pressure:70 kPa ~106 kPa N/ P (mW) 7.35 7.35 threshold for cavitation is still undetermined. Generally speaking, the A Performance Specifications higher the acoustic pressure, the greater the potential for mechanical P1x1 FHR Measuring Range: 50 bpm ~ 240 bpm Acoust N/A N/A (mW) Accuracy: ±2 bpm bioeffects; the lower the acoustic frequency, the greater the potential for ic FHR (Essential zs(cm) 3.50 Note: FHR measurement result may not be mechanical bioeffects. Param Performance): zb(cm) 3.70 accurate if the equipment is measuring beyond its eters measuring range. The AIUM and NEMA formulate mechanical index (MI) in order to 3.7 zMI(cm) FHR Resolution: 1bpm indicate the potential for mechanical effects. The MI is defined as the ratio 0 Output Power: 2w zPII.α 3.7 Audio Output: of the peak-rarefactional acoustic pressure (should be calculated by tissue Background noise: <45dBA (cm).α 0 acoustic attenuation coefficient 0.3 dB/cm/MHz) to the acoustic frequency. fawf 3.0 N/ Power off when the Doppler receives no signal or 3.00 3.00 Auto Power-off: MI = Pr, α (MHz) 0 A operation for 2 minutes. TransmissionRange (Without Obstacles) :>5m fawf ×CMI prr 50 Bluetooth: (Indoor range depends on the building‘s structure (Hz) 00 CMI = 1 (MPa / MHz ) and material.) N/ TI (Thermal Index) srr(Hz) Nominal Frequency: 3MHz A Working Frequency: 3MHz Heating of tissues is caused by absorption of ultrasound when the npps 1 p_<1 MPa ultrasound energy is applied. The temperature rise is determined by the Ipa.α at 0.0 Iob<10 mW/cm2 zPII.α acoustic intensity, exposed area and thermo physical properties of the 2 Ispta<100 mW/cm2 (W/cm2) Ultrasound: tissue. Ispta.α at Isata<10 mW/cm2 Other Isppa.3<190 W/cm2 In order to indicate the potential for temperature rise caused by thermal inform zPII.α or 5.6 ation zSII.α(m 9 Ispta.3<94 mW/cm2 effects, the AIUM and NEMA formulate thermal index (TI). It is defined W/cm2) Effective Radiating Area: 490mm2 ±15% as the ratio of the total acoustic power to the acoustic power required to Ispta at Working Mode: pulse wave zPII or raise the tissue temperature by 1ºC (1.8°F). 12. Battery Specifications zSII According to different thermo physical properties of the tissue, TI is 26 (mW/cm2 Specification: Two AA 1.5V alkaline batteries (AA, LR6, 1.5V) divided into three kinds: TIS, TIB and TIC. ) Working Duration: ◆≥6h TIS (Soft Tissue Thermal Index): It provides an estimate of potential pr. at 0.0 temperature rise in soft or similar tissues. zPII Bluetooth Specifications 4 (MPa) TIB (Bone Thermal Index): It provides an estimate of potential FCC ID SMQSD1MEDAN temperature rise when the ultrasound beam passes through soft tissue and a Operating control Modulation: GFSK π /4-DQPSK 8DPSK focal region is in the immediate vicinity of bone. conditions Fixed Frequency: 2400-2483.5MHz TIC (Cranial Bone Thermal Index): It provides an estimate of potential Tolerance Frequency: ≤ 20ppm temperature rise in the cranial bones or superficial bones. RF output power: ≤ 20dBm (EIRP) Measurement Uncertainties Acoustic Output Reporting Table for Track1(Non-autoscanning Occupied Channel Bandwidth: ≤ 2MHz The uncertainties in the measurements were predominantly systematic in Mode) Transmitter Unwanted Emissions: ≤﹣30dBm origin; the random uncertainties were negligible in comparison. The Transducer Model: SD1 ,Operating Model: PW Low OutputSummary Table overall systematic uncertainties were determined as follows: ISPTA.3 ISPPA.3 Acoustic Output MI (mW/cm^ (W/cm^2 (For systems whose global maximum valuedoes not exceed 1.0) 1. Hydrophone Sensitivity: ± 12percent for intensity, ± 6 percent for 2) ) System: SD1 Ultrasonic Pocket Doppler pressure. Based on the hydrophone calibration report by ONDA. The Global Maximum Value 0.01 5.69 0.02 Model Ispta.3 TI TI Isppa.3 uncertainty was determined within ±1 dB in frequency range 1-15 MHz. Pr.3 MI (MHz) (mW/cm2) Type Value (W/cm2) 2. Digitizer: ±0.3 percent for intensity. ± 0.15 percent for pressure. (MPa) 0.02 SD1 TIS 0.05 W0 5.69 0.01 0.02 Based on the stated accuracy of the 8-bit resolution of the Agilent (mW) 7.35 8.97 CD3.0 TIB 0.01 DSO6012 Digital Oscilloscope and the signal-to-noise ratio of the fc  Ordering Information measurement. (MHz) 3.00 3.00 3.00 Zsp (cm) 3.70 3.70 3.70 3. Temperature:±2.4 percent for intensity uncertainty, ±1.2 percent for CAUTION X-6 pressure uncertainty. (cm Only the parts supplied by the manufacturershould be used with the Beam ) 2.50 2.50 Based on the temperature variation of the water bath of ±1ºC (1.8°F). Associate dimension Doppler. 4. Spatial Averaging: ± 3.5 percent for intensity, ± 1.75percent for d Y-6 s Acoustic (cm pressure. Paramete ) 2.50 2.50 5. Non-linear Distortion: N/A. r PD 72.2 Parts Part Number No effects of nonlinear propagation were observed. (usec) 5 72.25 Main Unit PRF SD1 Since all the above error sources are independent, they may be added (Hz) 5000 5000 Doppler(Non-Bluetooth 02.06.262535 on an RMS basis, giving a total uncertainty of ± 12.73 percent for all Az. version) intensity values reported, ± 6.37 percent for all the pressure values,,± 12.6 (cm SD1 Doppler(Bluetooth ) 2.50 02.06.262639 percent for the Mechanical Index, uncertainty of ±12.73% percent for EBD version) Ele. power,±0.15 percent for center frequency, ±6.87%for the MI. (cm Accessories Prudent Use Statement ) 2.50 AA Alkaline Battery 01.21.064086 Operating Although no confirmed bioeffects on patients caused by exposure from Normal Carry Case 01.56.465616 Control present diagnostic ultrasound equipment have ever been reported, the Fixed Coupling Gel 01.57.078170 Condition potential exists that such bioeffects may be identified in the future. s  Ultrasound Intensity and Safety Therefore, the ultrasound should be used prudently. High levels of acoustic Standard Parameter Equal Contrast List output and long exposure time should be avoided while acquiring IEC60601-2-37 Standard Parameters Ultrasound in Medicine necessary clinical information. Paramete Note Paramete Note The use of diagnostic ultrasound has proved to be a valuable tool in r Reference for Acoustic Output and Safety r medical practice. Given its known benefits for non-invasive investigations 1. ―Bioeffects and Safety of Diagnostic Ultrasound‖ issued by AIUM in Center and medical diagnosis, including investigation of the human fetus, the Attenuated Frequency, 1993 Peak-rare-factiona question of clinical safety with regards to ultrasound intensity arises. pr.α fawf Acoustic l Acoustic There is no easy answer to the question of safety surrounding the use of 2. ―Medical Ultrasound Safety‖ issued by AIUM in 1994 Working Pressure 3. "Acoustic Output Measurement Standard for Diagnostic Ultrasound Frequency diagnostic ultrasound equipment. Application of the ALARA (As Low As Peak-rare-factiona -12dB Output Reasonably Achievable) principle serves as a rule-of-thumb that will help Equipment, l Acoustic X Beam pr you to get reasonable results with the lowest possible ultrasonic output. Revision 3" issued by AIUM/NEMA in 2004 Pressure Dimensions 4. "Standard for real-time display of thermal and mechanical acoustic

P Output Power Y IEC Electromagnetic Table-Test specifications for ENCLOSURE PORT IMMUNITY to RF Immunity Complianc wireless communications equipment Depth for Soft 60601 environment-guidanc Pulse test e level IMM zs Tissue Thermal td test level e Test Duration UNIT Index Portable and mobile Freq Bran Maxi a) Modu Dist Y Pulse RF communications uenc d Service mum a) lation ance TEST Repetition y (MH b) Powe equipment should be (m) LEVE Attenuated Output Frequency (MH z) r(W) Pα(Zs) prr used no closer to any L Power (Pulse Conducted 3 Vrms 3 Vrms z) part of the SD1 (V/m) Repetition Rate) RF 150 kHz 150 kHz to Pulse Ultrasonic Pocket IEC61000-4- ~ 80 MHz 80 MHz 380- TETRA modul Attenuated Equivalent Doppler, including 385 1.8 0.3 27 390 400 ationb) Ita.α(Zs) Temporal-average deq Beam 6 6Vrmsc)i 6Vrmsc)in cables, than the 18Hz Intensity Diameter n ISM ISM bands recommended FM C) Attenuated bands between separation distance ±5 Pulse-averag calculated from the GMRS kHz Ipi.α at max e Intensity at between 0,15 MHz 430- zbp Break-point Depth equation applicable to 450 460, deviati 2 0.3 28 MI the point of 0,15 MHz and 80 MHz 470 FRS 460 on Maximum the frequency of the and80 1kHz MI transmitter. MHz sine Depth for Bone -12dB Output Recommended zb Aaprt 710 Pulse Thermal Index Beam Area separation distance: 745 LTE modul Attenuated 704- Brand ationb) 0.2 0.3 9 Ipi.α Pulse-intensity MI Mechanical Radiated RF d  1.2 P 150 kHz 787 13, 17 217 Index 10V/m 780 Integral IEC61000-4- to 80 MHz Hz Soft Tissue 80 MHz ~ Pulse-intensity TIS Thermal 3 d  1.2 P 80 810 GSM Ipi Integral 2.7 GHz 870 800/900, Index MHz to 800 MHz TETRA Bone d  2.3 P 800 800,iDE Pulse TIB Thermal MHz to 2.7 GHz 800- modul Equivalent Beam N 820, 2 0.3 28 Index 10 V/m 960 ationb) deq(Zb) Diameter at the d=6 /E at RF 930 CDMA Cranial-bone 18 Hz point of Zsp 80 MHz to 850, TIC Thermal wireless LTE Index 2.7 GHz communications Band 5 equipment bands 1720 GSM  EMC Information 1845 1800; (Portable RF Electromagnetic Emissions CDMA communications 1900; Guidance and manufacturer’s declaration – electromagnetic GSM Pulse emission equipment (including 1700 modul 1900; The SD1 Ultrasonic Pocket Doppler is intended for use in the peripherals such as -199 ationb) 2 0.3 28 DECT; electromagnetic environment specified below. The customer or the antenna cables and 1970 0 217 LTE user of the device should assure that it is used in such an environment. Hz external antennas) Band 1, Electromagnetic 3, Emission test Compliance should be used no environment - guidance 4,25;U The SD1Ultrasonic Pocket closer than 30 cm (12 MTS Doppler uses RF energy only inches) to any part of Bluetoot for its internal function. h, RF emissions Therefore, its RF emissions the SD1 Ultrasonic Group 1 WLAN, Pulse CISPR 11 are very low and are not Pocket Doppler, 2400 802.11 modul likely to cause any including cables 2450 -257 b/g/n, ationb) 2 0.3 28 interference in nearby 0 RFID 217 electronic equipment. specified by the 2450, Hz RF emission manufacturer). LTE Class B The SD1 Ultrasonic Pocket CISPR 11 Where P is the Brand 7 Doppler is suitable for use in Harmonic all establishments, including maximum output 5240 Pulse Not emissions domestic establishments and power rating of the 5500 5100 WLAN modul applicable -580 802.11 ationb) 0.2 0.3 9 IEC/EN61000-3-2 those directly connected to transmitter in watts the public low-voltage power 5785 0 a/n 217 Voltage (W) according to the supply network that supplies Hz fluctuations Not transmitter Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance /flicker emissions applicable buildings used for domestic manufacturer and d is purposes. between the transmitting antenna and the ME EQUIPMENT or ME IEC/EN61000-3-3 the recommended SYSTEM maybe reduce to 1m. The 1 m test distance is permitted by IEC Electromagnetic Immunity separation distance in 61000-4-3. Guidance and manufacture’s declaration–electromagnetic immunity metres (m). a) For some services, only the uplink frequencies are included. The SD1 Ultrasonic Pocket Doppler is intended for use in the Field strengths from b) The carrier shall be modulated using a 50% duty cycle square wave electromagnetic environment specified below. The customer or the user of fixed RF transmitters, signal. the device should assure that it is used in such an environment. c) As an alternative FM modulation, 50% pulse modulation at 18 Hz may as determined by an be used because while it does not represent actual modulation, it would be Electromagnetic electromagnetic site IEC 60601 test Complia worst case Immunity test environment-gui survey, a should be less level nce level Recommended Separation Distances dance than the compliance Floors should be Recommended separation distances between portable wood, concrete or level in each frequency range.b and mobile RF communications equipment and the SD1 ceramic tile. If Electrostatic 8kV Ultrasonic Pocket Doppler floor are covered Interference may occur discharge 8kV contact contact with synthetic The SD1 Ultrasonic Pocket Doppleris intended for use in an (ESD) 15kV air 15kV in the vicinity of material, the electromagnetic environment in which radiated RF disturbances are IEC 61000-4-2 air equipment marked relative humidity controlled. The customer or the user of theSD1 Ultrasonic Pocket should be at least with the following 30%. Doppler can help prevent electromagnetic interference by maintaining symbol: a minimum distance between portable and mobile RF ±2kV Electrical Fast NOTE1:At 80 MHz and 800 MHz, the higher frequency range applies. communications equipment (transmitters) and the SD1 Ultrasonic forpowersupply Transient/Burs Not lines NOTE2: These guidelines may not apply in all situations. Electromagnetic Pocket Doppleras recommended below, according to the maximum t applicabl Not applicable ±1kV output power of the communications equipment. IEC/EN61000- e propagation is affected by absorption and reflection from structures, forinput/outputl 4-4 objects and people. Rated Separation distance according to frequency of ines ±1 kV line(s) a Field strengths from fixed transmitters, such as base stations for radio maximum transmitter (m) Surge Not toline(s) (cellular/cordless) telephones and land mobile radios, amateur radio, output IEC/EN61000- applicabl Not applicable 150 kHz to 80 MHz to 800 MHz to ±2 kV line(s) AM and FM radio broadcast and TV broadcast cannot be predicted 4-5 e power of to earth 80 MHz 800 MHz 2.7GHz theoretically with accuracy. To assess the electromagnetic environment transmitter <5%UT(>95% Voltage dips, dip inUT) due to fixed RF transmitters, an electromagnetic site survey should be (W) d  1.2 P d  1.2 P d  2.3 P short considered. If the measured field strength in the location in which the for 0.5cycle interruptions, SD1 Ultrasonic Pocket Doppler is used exceeds the applicable RF 0.01 0.12 0.12 0.23 40%UT(60%di and 0.1 0.38 0.38 0.73 p in UT) compliance level above, the SD1Ultrasonic Pocket Doppler should be voltage Not for5 cycles observed to verify normal operation. If abnormal performance is 1 1.2 1.2 2.3 variations applicabl Not applicable 70%UT(30%di observed, additional measures may be necessary, such as reorienting or on power e 10 3.8 3.8 7.3 p in UT) supply relocating the SD1 Ultrasonic Pocket Doppler. for25 cycles 100 12 12 23 input lines b Over the frequency range 150 kHz to 80 MHz, field strengths should be <5%UT(>95% For transmitters rated at a maximum output power not listed above, IEC/EN61000- less than 3 V/m. dip inUT) 4-11 c the recommended separation distance d in meters (m) can be for 5s The ISM (industrial, scientific and medical) bands between 0,15 MHz Power frequency estimated using the equation applicable to the frequency of the and 80 MHz are 6,765 MHz to6,795 MHz; 13,553 MHz to 13,567 MHz; magnetic fields transmitter, where P is the maximum output power rating of the 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The Power should be at levels transmitter in watts (W) according to the transmitter manufacturer. amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 frequency characteristic of a NOTE 1: At 80 MHz and 800 MHz, the separation distance for the (50Hz/60Hz) 30 A/m 30 A/m typical location in MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, higher frequency range applies. magnetic field a typical 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 NOTE 2: These guidelines may not apply in all situations. IEC61000-4-8 commercial or MHz,21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to hospital Electromagnetic propagation is affected by absorption and reflection 29,7 MHz and 50,0 MHz to 54,0 MHz. environment. from structures, objects and people. Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity The SD1 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.

repaired. E Contact Information B If you have any question about maintenance, technical specifications or D d A Y Y C S malfunctions of devices, contact your local distributor. 3Ba B B s m Alternatively, you can send an email to EDAN service department at: 5 4 T 5 7 I 7 5. 12 support@edan.com.cn. o 0 [ [ToGo|®| z4s 4| + EDAN INSTRUMENTS, INC. 7 4 T 5 o 6 8 4 6. L1 Address: #15. Tinhui Road, Jinsha Community, Kengzi Sub—District, L.s8 5 4. B 6 8. 0 0 0 8. PingshanDistric, 518122 Shenzhen, PR. China Email: info@edan.com.cn 3MHz I 4 T 5 6 I 9 6. 12 o 6 [so[ao|f®|a s o o 2 Tel: +86—755—2689 8326 Fax: +86—755—2689 8330 2 5 T 5 6 8 4 5. 12 wwwedan.com.cn o z2 [Bofoo|f®|& s ral e 7 ® Definition of Symbol 5 3 T 5 7 1 6 5. 12 o 2 B JT5] 8 x s s s + N Symbo Definitio N Symbol u. Definition 7 4 T 5 7 1 5 6. 12 o. 1 n o. ass 5| 2 B |TGo| 8 zl _ s 4| s Authorized Representativ CE — 3MHz I 4 T 5 6 1 6 6. L1 I c eom marking 10 e in the 0o s [so[Toc]f 8| s J3 s o * European Community 2 5 T 5 7 7 4 5. 13 General o n B [f5o|®| z[ss _ + Disposal Rex symbol for 2 method 11 \C ;‘9 recovery/recy Doppler Frequency (Hz) 505 Velocity of 10 clable D: Diameter . wes Refer to User fTarset A: Attenuation S: Overall Sensitivity ofTarget Operatin Manual & A(dB)) (S—A+B+C)0B 3 |j1| 12 (Background: Reflector(mm) instructio Blue; N . Vs: — Signal 5 C:Signal to : Noise ns Symbol: ot e d: Distance (d)(mm} R;\/IS (mv)gn Ratio (dB) White) MR B:Two—wayAttenuat v Noi C= 2010&0[M c vise Unsafe—Keep jon(dB) " V,(rms. away from RMS (mV) B—}Ba+Bw 4 & Caution 13 ® magnetic resonance ® Troubleshooting imaging Problem Possible Cause Solution (MRLD) equipment Battery level is very low. Replace the battery. Type BF Non—ionizing 5 applied 14 (((i’)) electromagnet Fail to power ]])3:2;;:_)1/ 1.s not installed Re—install the battery. part ic radiation on, or shut Touch the OnOf Dustproof down shortly Fail to switch on the touch key for a while and afig . Doppler as instructed. to power on the switching on Doppler. 6 P/N Part 1s IP22 waterproof The Doppler has Contact service Number degree is malfunctions. personnel. TP22(rainproo Sound volume has been Adjust sound volume turned down to the lowest sn u \i u] D level. to appropriate level. Serial Federal Loudspeaker If the Doppler is Set to play fetal heart Number does not configured with Bluetooth, sound by mobile phone (Start (U.S) law work. fetal heart sound can be or the Doppler on the with H RX Onlu restricts this played by mobile phone. APP. 7 SN on 16 device to sale The Doppler has Contact service battery by or on the malfunctions. personnel. compart ment order of a There is strong Use the Doppler awa cover) physician. interference source such as from stron: PP Y high frequency machines inters 8 Federal and mobile phones nearby. imterfsrence sources. Communicati Date of FCC ID: ons FHR cannot The fetal heart position Ee:]?;?:sllh;e310]?;11: 8 &I Manufact 17 SMQSDIME Commission: be displayed has changed because of rate monitorin: ure DAN ECC ID: stably. fetal movement. m & SMQSDIME position. DAN ]g];;;f:rg;ldw;sgelr]:fis Find the best fetal heart Manufact abdomen causes false rate monitoring 9 urer displayi position. isplaying. There is strong interference source such as gse the Doppler away . . om strong high frequency machines interference sources and mobile phones nearby. ‘ Sensitivity is Tl_]e Doppl_er is not applied Apply coupling gel to Tow and noise with coupling gel. the Doppler. . . Relocatethe Doppler is too much. The Doppler is not placed wl to the best fetal heart at the best monitoring flls osition. rate monitoring P position. The Doppler has Contact service malfunctions. personnel. The Bluetooth of mobile is Open the Bluetooth of not open. mobile. The Doppler used is not . Doppler configured with Bluetooth glse the 2?’1)18].' with cannot be function. uetooth function. conn_ecled to Use the FHR and mobile phone. The Bluetooth function of sgund detected and Doppler h Ifuncti displayed on the SD1 opp er has mafunctions, itself, and contact service personnel. ® and Warranty EDAN warrants that EDAN‘s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is 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 numberlabel and manufacture label. If a product covered by this warranty is determinedto be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period, EDAN will, at its discretion, repair or teplace the defective parl(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being


Document Created: 2018-06-08 08:16:11
Document Modified: 2018-06-08 08:16:11
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