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    2020-07-21 09-06-32 Winscan To PDF

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    abdou gue

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    = ALO KA a | ProSoundg danny MNI-1173 Rev.7 ALOKA ULTRASOUND DIAGNOSTIC EQUIPMENT SSD-4000 Manual Number : MN1-1173 Rev.7 C€... ALOKA CO., LTD. MN1-1173 Rov.7 Safety alert symbols Safety alert symbols "The four indications [Danger], [Warning], [Caution] and [Note] used on this equipment and in this instruction man- = ual have the following meaning, &\ Danger = Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. ‘A waming message is inserted here. A Warning : Tndicates a potentially bazardous situation which, if not avoided, could result in death or serious injury. A warning message is inserted here. = A Caution Indicates a potentially hazardous situation which, ifnot avoided, may result in minor or moderate injury. ‘A caution message is inserted here. A\ Note = Indicates a strong request conceming an item that must be observed in order to prevent damage or deterion- tion ofthe equipment and also to ensure that itis usd efficiently. ‘An explanatory text is inserted hers, ‘uoyE90"] uoHTeyESU] Jo suoNIpUEL jeHUDLIGONAUE, re poyjsyy uoHe|e}su| eee ss a senna ‘sjoqe'TJo worysog sun | Jo Butea, “SuOHvoIpur pur sfoqUIAS INQ "ZIT sqoqunds woe Ayes L-I-Z suomeo4puy pur sjoquuss et" tz iad et we re € ‘sua pue sUOHedIpY| ‘sjoquAS jo BuIUeEW! “Z “ suopmesaid 131 S991A0(] HOSGON Buy9auNOD 10} SHORONASUT AIApRE JeOETOeTAL “~-so0KNoCL BOMION SuoouUAL JOY SuONONIASU KJOS “youn oa fononbag WB mn oEAHOD) Lt “(gg wossjua pure -pY woHONpLIOD) ‘iepesmer etisaonse Brammer espa ee souepny “9-1 “~ Ayyunury opuRewId.nD9|9 BusuRAKED BANOO HORBIE|DVC PUR aouEPIND —“¢-H-[ “en 96m JO} SUOMPINSON “FHL cworssjuo apouemo.3oo79 Rayua9U09 eAROUP UOHAR|SOp pue OaUEPM|) EH] Aymnquedwos onousieuranooy yo ourapms ayy, 7-9-1 suops0sIp one sHouRemIONs9,9 FO wORUEAANT YL, —“T-9-L aah Aayquedizos onouteuton} 291 swuouasqnbayl samo wwomuonans of01§ -Z-4-1 “yuouuaaN FUPHOM. “LIL suonipueg jemsumuon au Aare ~ Ayquedcaoo syonitewonsoys, “~-woresado Jo apons amy 01 Buyps0o3y * apixo snonfu 40 UOB.AxO tplas Jo a MEA SMPTE ouomseay gear 2 o soso og) w doneydde jo Aes 30 ssfep 2 0 aps029y Joye Jo ssaifuy yume ysupese wonoayoxd jo aa1fop a1p oy Buypioooy Sypoys atsj29}— ysurEe woHsoqOx Jo oauop ayy 01 Burp0oy “Jo0ys op 29[9 wuree uooa}and Jo oA omp 0 RuIpios9y coo jOnPOTTSSEI Teonmaoeunnegd yesouad & mE as—) “~vequoSie ButouRUD punosAAN Ue HALA asf) semod opsnooe Suyasszu00 stoynesatd vm 0511 Jo os0dma ot wl e1 TH TL @S/) JO} Suo|NeDeld SLNALNOO + EORLELT-IN. 3.2, 33. 34, 3-6. MN1-1173 Rev 3-1-1. Working environment. 3-1-2. Installation location .. 3-1-3. Power source, ESD prevention procedures... 3-2-1, Hlesto-statc discharge (ESD) guidelines Installing the Equipment... 3-3-1. Installation procedure. Connecting a Probe to the Equipment... : 3-1, Method of connecting an elettonic type probe. 3-4-2. Method of connecting a mechanical scanner. Connecting Options to the Equipment... 4-5-1. Connecting the equipment tothe physiological signal terminal. Connecting to other devices .. 4. Specifications and Name of Each Part 4a. 42. 5. COMPOSITION Sl. 52, Specifications. Name and Function of Each Par. 4-21. Exterior drawing and name of each part 422, Front pane... 423, Right side panel 424, 4-2-5. Rear panel... 426. 421, Standard composition... Options 5-2-1. Peripheral equipment. 5.2.2, Table of optional probes (EU nations) 52:3, Table of optional probes (Outside BU)... 6. Principle of Operation o1. Principle of Operation soe 7. Cleaning and Sterilizing Tl. 72. Method of Cleaning and Sterilizing the Equipment... 7-1-1. Cleaning that is carried out et the end of each dey. 7 7-1-3. Cleaning that is carried out as necestary afer Use... Cleaning and Sterilizing Condition. rennn Cleaning that must be carried out once 2 week. MNI-1173 Rey.7 8. Preparations for Use i BL 82, 9. Screen Display 9-1, Character Displaynonane 9-4-1, — Automatic display area... 9-1-2, Character display in the textarea 9-2, Graphic Display 93 10. After Using the Equipment 101. 10-2. Cleaning the Equipment. 10-2-4. Cleaning that is carried out a the end of each day . 10-2-2, Cleaning that must be carried out once a week. 10-2-3. Cleaning that is carried out as necessary afler us 10-3, State of the Equipment and Accessories... 11. Storing the Equipment 11-1, Preparations for Storing the Equipment. 1-1-1. Storage preparation procedure. 11-2, Storage Location and Environmental Conditions. 112-1. Storage environment wn 12. Moving the Equipment 12-1, Precaution for moving, 12.2, State of the Equipment and Accessories Before Moving the Equipment. 12-2-1. Moving preparation procedure... 12.3, Inspection Before Re-use... 13. Safety Inspection 13-1, Maintenance and Inspectio 131-1. Woekly inspecti 131-2, Monthly inspection. 13-4.3. Issues that require caution about electrostat 13-2. Safety Inspection, MNI-II73 Rev.7 B38 13-6 133. (Checking the Measurement Accuracy... Inspection method, 13-6 Evaluation of results 13-7 13-3-3, Inspection Procedure nnn 138 13-1 Bld 13-4, Measurement Accuracy Inspection Data Sheet ULTRASOUND DIAGNOSTIC EQUIPMENT Safety Inspection Data Sheet... 141. 142, 14d 142. 143 148 14.2.2. Assistant Messages ..n.ns 15. DISPOSAL the Equipment 15-1. Precaution of disposal snore ASeL 16, Probe use and care 16-1. Application use. 16-1-1, Contra indication , 161-2, Warnings... 16-2. Connecting a Probe to the Equipment er 162-1, Method of connecting an electronic type probe 163. About activating of probe.. 16-4, Usable probe nsw 164-1. Use of probe. 16-42. Specifications 16-43. Clinical Measurement Accuracy. 16-44, Clinical Measurement Range.. 16-5, Handling and maintenance of probe. 16-5-1, Caution about handling. 16-5-2. Cleaning of probe 16.5.3. Disinfection of probe. 16-5-4, Sterilization of probe .. 16.5.5. Maintenance and Inspection. 16.5-6. Storage Location and Environmental Conditions. 16-6, Transesophageal Echocardiogram probe... 17. Acoustic Output Safety Information 17-1, About acoustic output index. 171-1, Mechanical index (MD) 17-4 MNI-1173 Rev.7 172. 173. 17-4, 74, 175, 17-6. 1-1-2, Thermal index (11). Ultrasound wave, interaction between vital tissues. Possible Biological Effects. 17-31, Mechanical effects. 17-3-2, Thermal, Derivation and Meaning of MUTI Introduction... 17-41, Introduction. 17-42, Mechanical index (MD). 17-4-3, Thermal index (MD.. ‘Setting condition influencing device output... ‘Recommendation on ALARA (As Low As Reasonably Achievable). Default Setting. Reference Acoustic Output Tables... 17-9-1, Acoustic Output Measurements... ‘The condensation codes which are used in Acoustic Output Tables, ‘MNI-1173 Rev.7 1-4.Purpose of Use 1. 1-1. PRECAUTIONS FOR USE Purpose of Use This equipment is intended to be used by doctors and other qualified persons for performing slice diagnoses and blood circulation diagnoses in the following parts of the human body. Do not use it for any other applications, + Thorax + Abdomen. + Porineum and pelvis + Lower fimbs + Back + Upper limbs + Head + Cranial nerves + Neck, 4 Warning ‘The acoustic power from this equipment exceeds the upper ophthalmological limit indicated in the U.S. FDA standards, DO NOT use this equipment for performing ultrasound diagnosis of the eyes. Ay Caution The intended use of probe differs depending upon the type of probe. Solect a probe thet moets your purpose of use. Do not use it for any application that is not covered in the instruction manual of the probe. The probe can hart the human body. This section consists of 16 pages. MM MNI-1173 Rev.7 1-1.Purpose of Use 4-1-1. Precautions concerning acoustic power ‘The tissues ofthe human body consist of soft tissues, wate, bone, and other tissues, Ultrasound energy is prosres- sively absorbed and attenuated by the body as it penetrates it, hence tissues located behind water, which causes only ‘a stmall degree of attenuation, receive a relatively large amount of ultrasound energy. ‘Also, itis necessary to be careful of bioeffects due to heat in the vicinity of tissues, such 2s bone, that readily convert ‘ultrasound energy into heat. ‘8S/) 40} SuopNeDe.d'| Particularly, a fetus atthe bone formation stage is exposed to a high risk of damage due to heating because almost all of the ultrasound energy passes through the amniotic fluid without being attonuated. Even in the case of @ fetus prior to bone development, the cells are active, hence there is a possibilty of growth being affected, even when the temperature rise is low. Pro-sound SSD-4000 shows the dynamics of blood flow using the Ultrasound Doppler Method, “Mechanical bioeffecs such as heating and cavitation occur when the body is exposed to ultrasound energy for along poriod. You can reduce the risk of damage to the tissues by interrupting the ultrasound energy before it reaches the level at which tissue damage occurs. To this end, i is necessary to obtain a grasp of the functions ofthe equipment, acquire familiarity with the method of operating it, and understand the parameters that affect the acoustic power. Also, get into the habit of always freezing the image as soon as you have obtained the necessary diagnosti informa- tion, A Caution (1) Use as low an output as possible within reason. (2). Scan the body for only as long as is necessary to make a diagnosis. Prolonged use can harm the human body. 1-1-2. Use with an ultrasound enhancing agent Ifyou wish to use an ultrasound enhancing agent, be sure to use only a substance that has been approved for use as, ‘an ultrasound enhancing agent. Before using an enhancing agent, carefully read the instructions for using the enbancing agent and also any eaution- ary notes, 1-1-3, Use with a general pharmaceutical Ifyou perform an ultrasound examination after having the patient ingest a goncral pharmaceutical, the ultrasound ‘ay affect the pharmacological effect ofthe pharmaccutical. Before using a general pharmaceutical, careflly read the instructions for using the pharmaceutical and also any cau~ tionary notes 12 ‘MNI-1173 Rev.7 1-2.Classification 1-2. Classification 1-2-4. According to the type of protection against electric shock: * Class I equipment 1-2-2. According to the degree of protection against electric shock: + ‘Type BF equipment Classification Probe Physiological signal ‘Type BF equipment All probes and scanners | ECG lead, PULSE transducer, PCG microphone ‘Table Classification according to degree of protection [Remark] ‘Type BF equipment refers to a component of the ultrasound diagnostic equipment, which is consisting of the ultra- sound probe and ECG lead only and not used directly for a heart but applied indirectly from outside, 1-2-3. According to the degree of protection against harmful ingress of water * Ordinary equipment A Warning “The equipment is not protected in any woy against water ingress, so do not use it in a place where there is 8 possibility of water getting into it. = ‘Take care not to spill liquid onto or into the equipment. This is because of the danger of electric shock. If you do happen to spill liquid on the equipment, contact one of Aloka's sales offices or agents listed on the back cover of this instruction manual. 1-2-4. According to the degree of safety of application in the presence of a flammable P= anaesthetic mixture with air or with oxygen or nitrous oxide + Equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. i Q\ Danger ‘Do not use this equipment in a flammable atmosphere. = Ttmay cause an explosion if wed in such an atmosphere. 4-2-5. According to the mode of operation = + Continuous operation ‘MNI-1173 Rev.7 4-2,Classification 1-2-6. Electromagnetic compatibility «+ The elecromagaetic compatibility (EMC) of this device isin conformity with the TEC 60601-1-2 which isthe {ntemational standard for EMC with medical equipment, ‘97 40} suoyneoeidl"} | MNL-I173 Rev.7 1-3.Safety 1-3. Safety Lee A\ Warning ‘Do not remodel or modify equipment. = Unexpected accident can eke place. = 2\ Warning + Clea ai dsinoca probe eveiy ie Wi wae — + Using contaminated probes may result in infection, Z\ Warning — ‘Wear medical gloves during inspection, and wash your hands after inspection; otherwise you may become infected from patient. A\ Caution Hold a probe tightly not to slip, especially when using ultrasound gel or others; otherwise, the probe may slip = cout of your hands and hit a patient, Avoid rapid temperature change which may cause condensation, Avoid using where condensation exist, A\ Caution ‘Alvrays use this in dried state, Condensation may appear when using from cold to warm places. Use without proper care, then, can cause short-circuiting, = AX Caution ‘Uso of an ultrasonic beam into the air without coating the probe with an ultrasound medium, may cause sur- p= fice temperature (o rise. a ‘Before using, coat probe adequately with ultrasound gel.(*) = ‘Wha probe is not in use even during an examination, freeze image. In the event that the surfice temperature feels abnormal, immediately stop using the probe, and contact our — office, (C9) When performing a puncture or a surpical operation, use ultrasound medium as described in the instruc- tion manual forthe probe. a i 5 a z ¢ 8 MNI-1I73 Rev.7 1-4.Environmental Conditions 1-4. Environmental Conditions 1-4-1. Working environment ‘This equipment is intended to be used under the following environmental conditions. Be sure to install it in an envi- ronment that satisfies these conditions, 4-4-4-1. Working environment ‘Ambient temperature: 10—40C Relative humidity: 30—75% Atmospheric pressure: 700 — 1060 hPa { A Caution ‘The presence of electromagnetic waves may result in a mis-diagnosis or a breakdown of the equipment. Ifthe ‘equipment is to be used near a motor (elevator, pump room, ete), power transmission line or wireless equip- ‘ment, it is necessary to electrostatically shield it. [Remark] Mechanical scanner : Ambient temperature : 20 — 40°C Please take more than 3minutes to start to use the scanner after turning the power switch on when Mechanical ‘scanners were connected to the system. 1-4-2. Storage environment Store the equipment in an environment that satisfies the following conditions. 1-4-2-4. Storage environment Ambient temperature: -10-—~50°C Relative humidity: 10-90% ‘Atmospheric pressure: 700 — 1060 hPa ‘Avoid rapid temperature change which may cause condensation, Avoid using where condensation exist. A\ Caution ‘Always use this in dried state, Condensation may appear when moving from cold to warm places. ‘Use without proper care, then, ean eause shor-cireuting. [Remark] Mechanical scanner : Ambient temperature : 0— 50°C ‘Please take more than 3minutes to start to use the scanner after turning the power switch on when Mechanical scanners were connected to the system. 16 MNI-1173 Rev.7 = 1-5.Power Requirements 1-5. Power Requirements ‘The power requirements for this equipment are as follows. Power requirements Unit = Rated supply voltages or voltage ranges o (100 V specifications) 100v — (IS V specifications) usv (200 — 240 V specifications) 200 —240V. = Rated frequency or rated frequency range s0V60H2 é Power input 1000VA nee ‘Auxiliary mains socket outlets SO0VA ‘Table Power requirements 17 ‘MNI-1173 Rev.7 4-6.Electromagnetic compatibility 1-6. Electromagnetic compatibility 1-6-1. The prevention of electromagnetic wave disorders ‘This device meets IEC 60601-1-2 which is the intemational standard for EMC with modieal equipment. “Medical devices are apt to emit electromagnetic waves or receive interference from electromagnetic waves, 987) 0} suogneDed"| ‘The EMC standard prescribes the testing of electromagnetic wave interference in transmitting and receiving. An electromagnetic wave transmit testing relates to electromagnetic wave interferences being transmitted from dovices that are tested, i ‘The electromagnetic wave level that occurs from a device is called as “electromagnetic emission” and the tolerance | of a device for the electromagnetic wave interference from other device is called as "electromagnetic immunity. QS Caution (1) Install this equipment where the electromagnetic radiation does not affect. ‘Note that the clectromagnetic radiation may cause the following phenomena on this equipment. * Distortion in viewing monitor + Noise on physiological signals + Noise from loudspeaker * Noise on image (2) Position this equipment and its exbies (o.g. probe cables, ECG cables, VO cables, et.) as far away as ‘possible from other medical cloctrical equipment, @) Note that electromagnetic radiation from this equipment may cause the abnormal operation on the other ‘medical electrical equipment nearby In this case, stop using such equipment immediately. (4) This equipment intended to use in hospitals and/or institutions in order to prevent the electromagnetic interference. Use this equipment in facilites equivalent to the hospital or instittion. Note that electromagnetic radiation from this equipment may cause the disturbance tothe radio receiver, TV set, ete. Position this equipment as far away as possible from the radio receiver, TV set, and its cables and antenna. () Do not use the portable radio commanication devices (eg. cellular phone, cordless phone, radio trans- civ, et.) near this equipment. (© Hthe AC ine voltage to this equipment fluctuates, the equipment may lock-up. ‘Shut off the equipment. Keep power switch off for S minutes, Then the equipment sutomatically shat itself off After that, reboot the power. 18 MNI-1173 Rev. 4-6.Electromagnetic compatibility 1-6-2. The guideline of electromagnetic compatibility Our ultrasound diagnostic devices have been confirmed that no electromagnetic waves against the electromagnetic = ‘wave interference standard are emitted by testing. As an ultrasound diagnostic device receives radio frequency sig- nals ( supersonic wave signals on 4 Radio Frequency), there is a possibility to receive the electromagnetic wave in- terference that occurs from electromagnetic wave sources, As for the electromagnetic sources having possibility to generate electromagnetic wave disorders, there are medical ‘equipment, communication devices, and radio or television broadcasting antennas. ‘When cellular'mobile communication machinery such as cellular phones, transceivers, and amateur radio equipment ‘are used, thete can be effects affecting the operations of this device. The device should be placed apart from other electrical apparatuses (including medical use) as much as possible, ‘When other electric apparatuses aro installed in the neighborhood of this device, confirm the following. + Are there any adverse effcis of the electromagnetic waves occurring from other equipment affecting to this device ? + Are there any adverse effects of the electromagnetic waves occurring from this device affecting to other ‘equipment ?| 19 MNI-IN73 Rev.7 1-6 Electromagnetic compatibility 4-6-3. Guidance and declaration directive conceming electromagnetic emission a 3 'SS1-4000 is intended to use in the electromagnetic environment which is specified in the following. 2 Itis desirable for customers or uscrs of SSD- 4000-to confirm that the SSD- 4000 is used in such & 2 ‘environment, = : < Conformity Electromagnetic enviroament - ‘ Guidance CISPRIL Group! “The SSD-4000 uses RF energy only RE emission {or its internal functions. ‘Therefore, the RF emission is very low and there is few possibility of allowing interferences to other clectronic equipment in the neighborhood. Chass B ‘The SSD-4000 is suitable for using in all buildings including general residential housing and connecting aE esata! to the commercial under-voltage Higher harmonic emission power supply system direetly which is supplied to housing as homo-use. TEC 61000-3-3 Conformity Powser-supply variations/flickers emission Table Guidance and declaration directive conceming electromagnetic emission 1-6-4. Restrictions for use Tis necessary fora doctor to examine whether any arifuets affect images or diagnoses with effect atributable to the lectromagnetic wave interference. 1410 i MNI-1173 Rev.7 5 1-6.Electromagnetic compatibility a = 4-6-5. Guidance and Declaration directive concerning electromagnetic immunity = ‘SSD.- 4000 is intended to use inthe electromagnetic cavironment which is specified in the following, | Itis desirable for customer ot users of SSD- 4000 to confitm thatthe SSD- 4000 is used in such environments = . = Immunity TEC 60601Testing, Conformity level Blectromagnetie environment = examination level ~ Guidance a TRC 6100-4 ORV contact + ORV contact {tis desirable that the loot = Electrostatic + SRV atomospheric = 8kV atomospherio ‘material is made of wood, discharge (ESD) | concrete or ceramic tle. e aa Ifthe Moor covered with — | synthetic materials, it is desirable = | thatthe relative humidity of these = | is 30% atleast. = TEC 61000-4-4 ForPower supply ine | For Power supply line | tis desirable that the quality of Electrical fast £2kV £2kV cloctie power source is the same = transvient / burst Forlnput line: 1kV | Forinputline+ 1kV | as the standard business or hospital environments. 5 weesiwors | 2ikv mew iis desnble hat ea of = Surge Differential mode Differential mode clectric power source isthe same EV EV asthe standard business or = Common mode Common mode [ Hospices LL. TEC 61000-4-11 <5% Up <5% Uy | Itis desirable that the quatity of = Voltage dip, (© 95% Fall in Up) (95% Fallin Uz) electric power source is the same : Short-time power | 9.5 eycle interval 05 cycle interval | as tho standard business or = cat, and vollage ‘hospital environments. f fluctuation onthe — | <40% Ur <40% U; ‘When the user of SSD-4000 power supply inne | (6% Fallin Uy) (60% Fall in Us) demands continuous operations | ine 3 cycle kuseral ‘sisyaketdeavall even during the time of power cut, = ee Pea | itis recommendable thatthe < 10% Ur < 10% Up | SSD-4000 is supplied of power = (30% Fall in Up) (©30% Fall in Uy ae ne - Sie ea ier uninterruptive power supply | 25 cycle interval 25 cycle interval eae oe j | <5% Up <5% Up L | 95% Fall in Up) (95% Fall in Up, 5 seconds 5 soconds | = | TBC 61000-4-8 | 3s 3 Atm Itis desirable that the power Power frequency | frequency magnetic field has | fms (50/60H%2) magnetic the same level of characteristic as — ficld the general place such as the x standard business or hospital = | environments ‘Remarks Uy is AC power supply voltage before applying a testing evel ee =] ‘Table Guidance and Declaration directive concerning electromagnetic immunity ‘9897 0 suognedsig'L MNI-II73 Rev.7 1-6.Electromagnetic compatibility 4-6-6, Guidance and Declaration directive concerning electromagnetic immunity (conduction RF and emission RF). ‘SSD-4000 is intended to use in the electromagnetic environment which is specified in the following. Itis desirable for customers or users of SSD-4000 to confirm that the SSD-4000 is used in such an environment. Immunity TEC 6060T Testing | Conformity | Electromagnetic environment examination level level Guidance Cellular and Mobile RF communication ‘equipment including cables shall not be used ‘lose to the any parts of this SSD-4000 within the recommended separation distances calculated by the equations corresponding to the frequencies of those transmitters TEC 61000-4-6 3.Vimns vie3v ‘Recommended separation distances Conduction RF 150 kHz —80MBz. 3.5 (PS) Cre TRC 61000-4-3, 3.V/m E,=3 Vim Emission RF 80MHz—2.5GHz “( « Here, P stands for the maximum output power rating that expresses in watt (W) ofthe transmitter by the transmitter manufacturing ‘company, and dis the recommended separation distance expressed in meter (mm). ‘The electric field strength from a non-transitory RF transmitter shall be set at lower than the conformity level in each frequency bandwidth b as having been decided by the spot electromagnet investigation a. {As for the next symbol, itis displayed on the device which generates clectromagoctic waves intentionally. In the neighborhood of the device displaying. this symbol, interference may occur, i) EDP omt~ss Ther sonta2a ‘Table Guidance and Declaration directive concerning electromagnetic immunity 112 MNI-1173 Rev.7 1-6 Electromagnetic compatibility eee Ml Wii es = & hu ‘Remark Apply high frequency ranges in 80MEz and 800MEz. Remark2 These guidances are not applicable in all circumstances. [As for the electromagnetic diffusion, itis influenced by reflection or absorption of buildings, substance, and ‘bumans. a For example, it is not possible theoretically to estimate precisely field intensities from fixed transmitters of| \ireless-telephone-base stations, such as Mobil radio, amateur radio, AM/FM radio and TV broadcast base stations Consider a spot electromagnetic investigation to assess electromagnetic environment caused by & non-transitory RF transmitter aceurately. ‘When the field intensity measured at the place where SSD-4000 is used is higher than the applied RF conformity level mentioned above, it shall be monitored whether the SSD-4000 operates normally. ‘When abnormal movement was confirmed, an investigation forthe placement or installment of the SSD-4000 ‘may be nevessaty. b For the outside of 1S0kH1z.—SOMHz frequency bandwidth, itis desirable that the field intensity is less than. 3V/m, ‘Table Guidance and Declaration directive conceming electromagnetic immunity Recommended separation distance between cellular and mobile RF communication equipment and SSD-4000. ‘SSD-4000 is intended to use in the electromagnetic environment that RP interference is controlled. Customers or users of SSD-4000 can promote the prevention of EMI (Electromagnetic interference) by managing, the shortest distance between mobile RF communication equipment (a transmitter) and SSD-4000 in the following recommendation based on the maximum output of transmitter devices “The separation distances (mi) based on the frequencies of transmitters 36hiiz— 30M eOMi—800MHiz | S00Niz—2.5GHla : 5 7 Cre Ge “tre “Cae oor «| SSSCNG o.l6 0.233 01 030 0309 ] 0738 1 1167 1167 2333 10 3.689 3.689 71378 | 100, 11.67 11.67 | 23.33 For a rated transmitter with its maximum output electricity not listed above, the recommended distance of d expressed in meter (m) can be decided by the equation corresponding to the frequency of the transmitter. The P in the equation is the rating of the maximum output electricity of a transmitter expressed in watt (W) by the transmitter manufacturing supplier. Remark1 Apply a high frequency band in separation distance for 80MEZz and 800MHz, Remark2 These guidelines are not applicable for all situations. As for the electromagnetic diffusion, itis influenced by reflection or absorption of buildings, substance, and humans. ‘Table Recommended separation distance between cellular and mobile RF communication equipment and SSD-4000. MNI-1173 Rov.7 4-6.Electromagnetic compatiblity e 4-6-7. Combined use with High frequency surgical equipment z ‘When the device is used concomitantly with « high frequency surgical equipment,the device and the parts there of 3 hhave not been equipped with any means to protect the patient from burn injury 5 “The high frequency surgical equipment may apply an electromagnetic field and electric current of high frequency to a the patient intentionally. g ‘With these radiated high frequencies, the device may be affected with interference when it is drawing monochrome 5 ‘of color images. Qs Caution (1) When a probe, examining operators hands, and a puncture attachment are located on the path of high fre- ‘quency electrical current, there may be incidents of the damage to the probe and the burn injuries of the patient or the examining operator, (2) As damage to an insulating membrane and burn injuries to the patient and examining operator may be caused by rough handling of the electrode needle, do not put an excessive foree to the needle in puncture ‘with using a puncture attachment guiding it properly. (3) Operate the device with caution paying attention to the positions of the counter electrode plates and the connecting cord against the probe. 1a MNI-1173 Rev.7 41-7.Safety Instructions for Connecting Network Devices 1-7. Safety Instructions for Connecting Network Devices a 1-7-1, Electrical safety Instructions for Connecting Network Devices The electromagnetic compatibility (EMC) of this device is in conformity with the IEC 60601-1-2 which is the {international standard for EMC with medical equipment-The following instructions are applicable, when connecting ‘network devices to the Ultrasound system, ‘The instructions are provided in order forthe entire system with network devices to meet = TEC60601-1-1 Electrical Safety Standard [Remark] = Connecting to network equipment requires the optional DICOM library (SOP-4000-10B) = 4-7-1-1. Network Devices = All non-medical network devices connected to the Ultrasound system, including Hubs, Work Stations and Personal Computers, must comply with TEC60950 standard and must be Class I device. 1-7-1-2. Installation and Network Connections (1) Non-medical devices must be kept at least 1.5 meters away from a patient. @) When connecting the Ultrasound system with Computer Devices located out side of the Ultrasound exami- nation room, a separation device (Network Hub) must be used in-between, = 1-7-2. Other precautions = Once you switch ON the ultrasound diagnostic equipment, do not switch it OFF again for? -3 minutes. Ifyou switch OFF the equipment while it is starting up, the hard disk may break down, A primary battery is used to maintain the unit in an operable condition. Ifthe battery runs down, the clock on the system is shown a wrong time. (In tis case, the operation of the ultrasound diagnostic equipment is unaffected.) JE the above phenomenon occurs, the battery must be replaced, so contact your nearest Alok branch to do this, 3 ‘The equipment contains a primary battery lithium battery), so when disposing of i conform to the “Laws Relating to the Disposal and Cleaning of Waste”. ‘Connecting Giuuas ‘Maximum cable connectors length TAN cable TAN cable: Straight (in case of hub-use), cross 20m = connector (when connecting to PC directly) a & Caution = ‘When a cable other than the specified or longer than the maximum length is used, the EMC characteristic of this device may be influenced, ‘MNI-1173 Rev.7 4-7 Safety Instructions for Connecting Network Devices 987) 40} suogMeDale!"| 116 ‘MNI-1173 Rev.7 2-4.Symbols and indications 2. MEANING OF SYMBOLS, INDICATIONS | AND TERMS 2-1. Symbols and Indications 24-1. Safety alert symbols The four indications [Danger], [Warning], [Caution] and [Note] used on this equipment and in this instruction man- ual have the following meaning. | Q Danger Indicates an imminently hazardous situation which, if not avoided, will result in death or scrious injury. A warning message is inserted here. | A Warning | ndicates a potentially hazardous situation which, if not avoided, could result in death or scrious injury. ‘A warning message is inserted here L\ Caution | Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. A caution message is inserted here. A Note Indicaies a strong request concerning an item that must be observed in order to prove tion of the equipment and also to ensure that it is used efficiently. ‘An explanatory text is inserted here. This section consists of 8 pages. ed z g 3 a zg a a ‘MNI-1173 Rev.7 2-4.Symbols and Indications 2-1-2. Other symbols and indications “The following marks are used in this equipment and this instruction manual. ANSI standard 2535.3, BS 5378 PARTI, Appendix A ‘Various places ‘Symbol Position Meaning | Danger Carefly read te pertinent items in his manual, and ; trade the equipment with great care. j Veroueriness | ant standard 25353 TEC6060I-1, Attached table D BS 5378 PARTI, Appendix A Biohazard Onthesideof | ANSI standard 2835.3 probe connector | 1507000 No.0659 BS 5378 PARTS, Appendix A A Lef side panel | Be careful of explosion, Be careful oF electric shock Left side panel Be careful of fire BS 5378 PARTI, Appendix A Left side panel ‘Be careful of acoustic power 22 EERE MN1-1173 Rev.7 2:4.Symbols and indications ‘Symbol Position Meaning oe PEU-4000 ‘Type BF applied part; IEC60601-1, Attached table D Indicates the ON position ofthe switch Power switch F | 1Bc00417-5007 E Indicates the OFF position ofthe switeh. Power switel = 1560417-5008 a snc = Pwd Rear panel = 160417-5032 I ‘Equi-potential terminals i Rear panel = 1EC60417-5021 E Various places Electrostatic discharge (ESD) symbol: i ab A symbol warning of no touching to the pins cropping out. 5 nin eps cpg toa = them, there can be of malfunction or breaking down of [ | the device by electosatic discharge, & = 2 ‘suJO] pue suogea!pUl ‘s}oqUIAS Jo BuueSWZ MN1-1173 Rev.7 2-1.Symbols and Indications ‘Symbol Position ‘Meaning , "This mark indicates this product complies with Directive C 4 Left side panet | 93/42/RBC relating to Medical Device. 0123 IPX 8 Fonteriek Protected against the effects of continuos immersion in water MP-23458 MP-2614B one MNI-1173 Rev.7 — 2-2.Meaning of Terms 2-2. Meaning of Terms ‘The following terms used in this instruction manual have the meaning deseribed below. i [Remark] : An item that must be known in order to use the equipment. — Assembly : Installing and connecting the standard component parts and options in the main equipment using tools, E AX Caution = ‘This equipment must be assembled by a person recognized by Aloka when itis delivered to the customer's premises, It must not be assembled by the customer. Installation : Placing the assembled equipment in an environment witere it can be used by the customer, then install- {ng and connecting the peripheral equipment. Moving : Moving the equipment in its assembled form manually. = A Caution ‘Transport not conforming to instructed state can cause failure, For transport of Device, be sure to contact us, MNI-1I73 Rev.7 2-3.Position of Labels 2-3. Position of Labels Ce: Altay Ev sepreenate ot Bate Meerbush, Germany J ‘suuaL pue SUOREDIPU] ‘sjoqUiAS yo BUIUEOW' al “Tis protucts protected by one or mors othe ples ed below Usa aprsar? “aostess aezaar? 5952298 5518048 S515 aK9 H6E812 9700010 511091 6138.59, EuPat. : 0082.41 tomo 0,144,088 9770,069 Oasz7T1 O7e4857 0.808.119 ALOKA CO.,LTD. paseo 26 MN1-1173 Rev.7 2-3.Position of Labels Labels ‘Warning Caution message ea ‘To ensure proper grounding and reduce the risk of electric shock, connect only to a hospital grade outlet. > & NN Caution to reduce the risk of electric shock, do not remove cover. Refer servicing to qualified personnel, Risk of explosion if used in the ptesence of flammable anesthetics, Use acoustic exposure levels As Low As Reasonable Achievable (the ALARA principle) to obtain diagnostic information. Minimize exposure time. DL Boe 28 ‘MNI-1173 Rev.7 2-3,Position of Labels 2.Meaning of Symbols, Indications and Terms. MNI-1I73 Rev.7 3+1.Environmental Conditions of Installation Location 3. INSTALLATION METHOD 3-1. Environmental Conditions of Installation Location [Remark] Jn this instruction manual, installation refers to the placing of assembled equipment in an environment where it can. ‘be used by the eustomer, and installing and connecting the peripheral equipment. Ay Caution ‘This equipment mast be assembled by a person recognized by Aloke when itis delivered to the user's premises. Te must not be assembled by the user. Insta this equipment in a stable place where there is no possiblity of causing the equipment to fall or topple 3-1-1. Working environment ‘This equipment is intended to be used under the following environmental conditions. Working environment Ambient temperature: 10—40°C Relative humidity: 30—75% Atmospheric pressure: 700 — 1060 hPa Avoid rapid temperature change which may cause dew condensation, Avoid using where dew condensation or water drops exist. A Caution ‘Always use tis in dried state. Condensation may appear when moving from cold to warm places, | Use without proper care, then, can cause short-circuiting, This section consists of 10 pages. MN1-1173 Rev.7 3+1.Environmental Conditions of Installation Location 3. INSTALLATION METHOD 3-1. Environmental Conditions of Installation Location [Remark] In this instruction manual, installation refers to the placing of assembled equipment in an environment where it can be used by the customer, and installing and connecting the peripheral equipment. A Caution ‘This equipment must be assembled by a person recognized by Aloka when it is delivered to the user's promises. Ttmust not be assembled by the user, Install this equipment in a stable place where there is no possibilty of causing the equipment fo fall or topple over 3-1-1. Working environment ‘This equipment i ntnded tobe sed under the following environmental conditions. ‘Working cavironment ‘Ambien temperature: 10— 40°C Relative humidity: 30— 715% Atmospheric pressure: 700 —1060 hPa Avoid rapid temperature change which may cause dew condensation, Avoid using where dew condensation or water drops exist. A\ Caution ‘Always use this in dried state. Condensation may appear when moving from cold to warm places. Use without proper care, then, can cause short-circuiting, This section consists of 10 pages. MNI-1173 Rev.7 3-1.Environmenta! Conditions of Installation Location | 3-1-2. Installation location Install the equipment in a location where sufficient clearance can be obtained on both sides of it, g E 3 & Front 20 mm min 30mm min Fig, Instalistion location A Caution ‘Be sure to leave sufticiont space on both sides of the equipment otherwise the temperature inside the equipment wil rise, resulting in a possible breakdown. 3-4-3. Power source Install the equipment no more than 3.0 meters away from 2 power outlet in the wall. Ensure that the power outlet satisfies the following conditions. Power outlet Plug Protective 1o0y — 120v af specifications De 200v-240V f \ Protedtive specifications , J earth terminal o ‘Table Plugs and power outlets 32 3-2-1. Electro-static discharge (ESD) guidelines (1) Donot install the device on the floor covered with a carpet or synthetic materials, ‘The floor materials on which the device is installed shall be wood, concrete or ceramic tile. When installing the device on the floor covered with carpet or synthetic materials without any other choice, itis requested the floor materials to be grounded 2) Keep the humidity atthe installing place at higher than 30%, (3) When connecting probes, foot SW, and cables to the respective connectors of the device, do not bring your hand closer to the connecting pins as much as possible. Also, whenever carrying out any work, do it ater turning off electric power source while the power cord to the device is connected with the power source. [ A\note For those staff using this device, explain the meaning of ESD warning symbol. | or those statTusing ths device ive thet 1g on the protective procedure of ESD mentioned above, MNI-LI73 Rev.7 3-2.ESD prevention procedures 3-2. ESD prevention procedures ‘This device can be installed in accordance with “The electromagnetism adaptability guideline” mentioned in this book, and it is necessary for a doctor or a qualified person to examine the device by means of laminography and blood circulation dynamic diagnosis for humans, For the details, refer to Section 1-6-2. “The guideline of electro- magnetic compatibility”, When conducting a diagnosis, be careful not to cause any deterioration and trouble on the parts being sensitive to static electricity in accordance with the following electrostatic discharge (ESD) guidelines. M fs = 33 powjeyy uone|EysUI'E ‘MNI-I173 Rev.7 3-3.Installing the Equipment 3:3. Installing the Equipment 3-3-1. Installation procedure (1) Move the equipment to the place were itis to be installed, Caution Ifthe temperature and humidity of the place where the equipment was stored are different from the tempera ture and humidity ofthe room to which the equipment is newly moved, condensation may occur. Leave the equipment to stand fora while in the newly installed location to allow it to become acclimated to the environ- ‘ment before switching it ON, If you switch ON the equipment while there is condensation inside it, a break down may occur. @) Setthe lock levers of the front casters in the ON position, SS Fig. Lock levers of front casters [Remark] Set the two or more casters when fixing. (2) Install and connect the peripheral oquipment. [Remark] For details of this procedure, refer to sub-section 3-4. (4) Ifyou moved and re-installed equipment that was used in a different location, ensure that there are no loose parts, daznage, or signs of weat on the equipment. Check to soo if'any of the cables of the peripheral equip- ‘ment are protruding from the equipment. (5) Insert the power plug into the power outlet, QS Warning (1) Insert the power plug directly into a power outlet in the wall, @ Do not connect the equipment to an extension cable, or to a branched circuit. This may cause you to receive an electri shock. ©) Connect probe to the equipment, {Remark} For details ofthis procedure refer to Section 3-4. “CONNECTING A PROBE TO THE EQUIPMENT”. 34 MNI-L173 Rev.7 3-4.Connecting @ Probe to the Equipment 3-4. Connecting a Probe to the Equipment (On the front pane! of the equipment are probe connectors, Connect probes to these connectors. A\ Note Ensure that the pins on the probe connector are not bent. If you attempt to insert a connector with bent pins, you are liable to damage the probe connector on the equipment. 3-4-1. Method of connecting an electronic type probe ‘The lock lever of the connector moves over the range shown below. [Remark] ‘When connecting a probe to the connector on the equipment, ensure that the lock lever (marked with ¢ circle) is in the RELEASE position. Lock lever ‘aSvaTsy Movable 3 range fe Mark / Fig. Lock lever (1)__Insert the connector of the electronic type probe firmly into the connector on the front panel ofthe equipment. @) Once you have inserted the connector completely, turn the lock lever 1/4 of a tum clockwise to the LOCK, position. = range Fig. Connector ‘MNI-1173 Rev.7 3-4.Connecting a Probe to the Equipment A Note Tethe lock lever is difficult to tum, check to see if the connector is inserted completely. ‘If you attempt to tum the lock lever without firmly inserting the probe connector, you are liable to damage both the probe connector and the connector on the equipment, (3) Finally, confirm that the probe connector is fixed securely to the connector on the equipment. Powe uopeyeysuye Fig. Connector 3-4-2. Method of connecting a mechanical scanner ‘The lock lever of the connector moves over the range shown right [Remark] ‘When connecting a scanner to the connector on the equipment, ensure that the lock lever is in the RELEASE. position, vee AS Fig, Lock lever (Q)__ Insert the connector of the mechanical scanner firmly into the connector on the right side panel of the equipment, Fig, Connector MNI-1173 Rev.7 3-4,Connecting a Probe to the Equipment 2) Once you have inserted the connector completely, tum the lock lover 1/4 of a turn clockwise to the LOCK, position, @) Finally, confirm thatthe scanner connector is fixed securely to the connector on the equipment. QA Note Ifthe lock lever is difficult to turn, check to see if the connector is inserted completely. -f you attempt to turn the lock lever without firmly inserting the probe connector, you are liable to damage both the probe connector and the connector on tho equipment. MNI-I173 Rev.7 3-5.Connecting Options to the Equipment 3-5. Connecting Options to the Equipment A Caution This option must be assembled by a person recognized by Aloka when it is delivered to the user's premises, Ie must not be assembled by the user, Connect only options specified by Aloka to this equipment. For connectable options, refer to Section 5-2. “Options”. 3-5-1. Connecting the equipment to the physiological signal terminal poueW OReHEISUTE ‘On the front panel are connector sackets for connecting an ECG lead eord. A Caution “The minimum amplitude of the ECG input necessary for conditioning the ECG signal is S0,1V. ‘The signal which is lower than this level may cause inaccurate results. 35-11. Connecting the ECG lead cord Right side of the physiological unit ECG lead cord PCG microphone Fig, Connecting the ECG fead cord (1) Insert the connector of the ECG lead cord firmly into the connector on the panel with the groove on the con- nector faces upward. 2) Sethe HUM FILTER switch to 50 Hz or 60 Hz, depending on the mains supply frequency. (B) Before connecting the ECG lead cord to the patient, insert the three jacks of the ECG lead cord into the eor- responding ECG electrodes. [Remark] ‘The ECG lead method is second limb lead. 38 MNI-1173 Rev.7 3-5.Connecting Options to the Equipment 3-5-1-2._ Connecting the PCG microphone (1) Insert the plug of the PCG microphone firmly into the connector of the PCG. id Note ‘The PCG microphone does not readily withstand impacts, so do not drop it or strike it against other objects. 3-6-1-3. Connecting the ECG transducer (1) Insert the connector of the CG transducer firmly into the connector of the PULSE on the panel. A\ Note If cables are connected from both the PULSE and ECG to DC IN, the output signal from the ECG me displayed preferentially. ‘fan output signal is unnecessary, do not connect a cable to the DC IN connector. 3-6-1-4. Connecting another ECG monitor ‘The PULSE and ECG signals obtained by another ECG monitor can be displayed on the images instead of the physiological signals obtained by this equipment, Right side of the physiological unit ps the PULSE ‘output connector of, the ECG monitor From the ECG oitput connector of the ECS monitor Fig, Connecting to another ECG monitor (1) Connect the cable from the ECG output connector of the ECG monitor to the DC IN connector of the ECG of the physiological signal unit, @ Connect the cable from the PULSE output connector of the ECG monitor to the DC IN connector of the PULSE of the physiological signal unit. 39 MNI-I173 Rev.7 3-6.Connecting to other devices Ax Caution ‘() Carefully read the instruction manual of the ECGPULSE monitor to be used with this equipment to censure that you use the monitor correctly. @) Do not use the monitor if the instruction manual states that it must not be used together with ultrasound 2 image diagnostic equipment or similar medical electronic equipment. & (3) Perform a safety check on the ECGPULSE monitor to be used with this equipment. If the monitor is 5 abnormal, do not use it with this equipment because you may receive an electric shock. = - g A\ Caution g ‘The use of an ECGPULSE monitor with this equipment may cause electromagnetic interference to the equip- sient, Ian ECGPULSE monitor impairs the diagnosis, do not use it together with this equipment. 3-6. Connecting to other devices On the rear panel of this device, an equipotential terminal is equipped. ‘When equipotential grounding is required to comply with IEC 60601-1-1, use this terminal, ‘As for the equipotential terminal, refer to Section 4-2-6, “REAR PANEL” 3-10 ‘MNI-1173 Rev.7 4-1 Speatfications 4. SPECIFICATIONS AND NAME OF EACH PART 4-1. Specifications ‘Scanning method: Blectronic sector scan Electronic convex scanning Blectronic linear scanning Mechanical radial scan (Option) Modes: B BB BM M B/D (PW and CW(Option) modes) D (PW and CW(Option) modes) Flow Power flow Tissue Doppler Imaging (Option) VOL (Option) Direction of slice image display: Longitudinal inversion Lateral inversion 90 degrees rotation Image depth: 13 steps between 2 to 24cm [Remark] Image depth varies with the probes. This section consists of 10 pages. Med yor Jo EWEN pue suoJesypeds > MNI-1173 Rev.7 4-1.Specifications. Image depth: Character display ‘Measurement func ‘Accuracy of display: Preset function: Physiological signals: Gain: STC: Contrast: AGC Acoustic Power: Image processing: ID (umber of patient being examined): ‘NAME (name of patient being examined): Date, time: Probe frequency: Heart rate value: BGC syne delay time value: Display in comment area: Display of hospital name: Basic measurements Obstetric measurements Gynecological measurements Cardiac measurements (Option) Peripheral vascular measurements Urological measurements ‘Other measurements £5% 15 settings can be made, BCG PULSE 42 30 to 90 4B. 8 slide controls 16 steps 16 steps 100% to 0% GAMMA ‘RELIEF POST PROCESS Frc FRAME CORRELATION 14 characters30 to 90 4B 24 characters Automatic display Automatic display Automatic display ‘Automatic display ‘Max 60 characters x 33 lines 20 characters x 2 lines ‘MNI-1173 Rev.7 4-4.Spectfications M mode display: Display method: Sweep speed: Modulation method: Signal analysis: Display pattern: Speed range: Low frequency rejection filter: Signal analysis: Display pattern: Speed range: Low frequency rejection filter: Flow: Processing method: Speed range: Low frequeney rejection filter: Cine memory function: Search Scroll Store, review Loop playback Dimensions: Width: Depth: Height: Weight: 150kg {Remark} ‘Scrolling / Moving Bar Can be set to one of 7 values Pulse modulation High speed Fourier conversion (FFT) method Power spectrum display Approx. + 6.22cm/s to + 318.8em/s Switchable through 12 steps (for Auto operation) High speed Fourier conversion (FFT) method Power spectrum display “Approx. # 6.22cm/s to + 796,2em/s Switchable through 12 steps (for ‘Auto operation) Self-correlating method Approx. + 6.22em/s to + 199.2cm/s MITT filter Switchable through 6 steps 490m, 860mm, 1310 — 1560mm ‘The actual dimensions and weight of the equipment are within + 10% of the above values. 43 MNI-1173 Rev.7 4-2.Name and Function of Each Part 4-2. Name and Function of Each Part 4-2-1. Exterior drawing and name of each part (4)Viewing monitor (2)Cable hanger (8) Left side panel (3) Handle ‘Ped YOR Jo SWeN Pure Suogedyoeds'> (4) Probe holder (®) Front panel Fig, Exterior drawing 44 ‘MNI-1173 Rev.7 4-2.Name and Funetion of Each Part Displays diagnostic images. Can also display external video signals. ‘Used to hang the probe cables. ‘Used to carry the equipment about. Place the probes and ultrasound gel on the probe holder. “This pane! has a floppy drive and connector for connecting to the physiological signal cabies, On the rear panel are power cable and circuit breaker. Has various switches for setting the operation of the equipment, — For details, refer to Section 1 of the How to Use Instruction, ‘Do not lift the equipment by the panel or apply an unreasonable force to it because this may cause the equip- © Viewing monitor @ Cable hanger 3) Handle (8) Probe holder () Right side pane! = (© Rearpanel — (7) Operation panel = A Caution = ment to break down, = (8) Loftside pane! (9) Front panel = (0) Caster ‘This pane! has & power switch, etc. ‘This pancl has connectors for connecting probes, a foot switch connector. Used to move the equipment. > For details, rofor to Section 12. “MOVING THE EQUIPMENT”. 4s MNI-1173 Rev.7 4-2.Name and Function of Each Part 4-2-2. Front panel lol (1) Foot switch connector = g : (2) Electronic probe connectors g ~~_(4) VOL contro! cable connector g (3) Mechanical _scanner/ z Independent probe connector 2 o g Fig. Fr A 2 ig Front pane 2 (1) Foot switch connector Used for connecting to the optional foot switch. @) Electronic probe connector These connectors are for connecting the electronic conver, lincar und sector ‘probes. When two probes are connected, press the PROBE switch on the ‘operation panel, [Remark] ‘Do nat connect probes other than electronic probes to these connectors, 3) Mechanical scanner / Independent probe connector ‘Used for comnecting to the optional mechanical radial scanner ot Independent probe. [Remark] ‘This connector is not attached ifthe optional mechanical scan unit (SCU-4000B) or Independent probe connection unit(U-9094) is not to be connected. @) VOL control Cable connector This connector is for a connecting VOL control cable when connecting an optional electronic convex scanner. [Remark] ‘This connector is not attached if the optional VOL, mode unit (EU-9084B) is not to be connected. MNI-L173 Rev.7 = 4-2.Name and Funetion of Each Part 4-2-3. Right side panel (8) ECG connector (4) PCG connector (3) PULSE comeotor (©) Floppy drive Fig, Left side panel r (1) DEIN coneetor Usod to connect a preamplifed sigoal obtained from another piece of = cquipment such asa polygraph. = Q) HUMFILTER ‘This switch is for eliminating hum noise, Set the filter value to either 50 Hz. or 60 Hz depending upon the frequency of the mains supply used. re @) PULSE comector ‘Used for connecting the cable of a PULSE transducer (4) PCG connector Used for connecting a PCG microphone cable, (3) ECG connector ‘Used for connecting the ECG signal cable. (6) Floppy drive ‘The floppy drive enables you to transfer data inside the system to a 3.5 floppy disk, orto transfer data from another piece of equipment to the sys- tem-via floppy disk. 47 MNI-1173 Rev.7 4-2.Name and Function of Each Part 4-2-4. Left side panel (1) Power switch » | 5 (2) PULSE POSI/SENS control z (8) PCG POSISENS control 2 (4) ECG POSI/SENS control g 3 Fig. Left side panel iad () Power switeh ‘This switch supplies power to the equipment. Setting the switeh to the Iside turns ON the equipment and causes the lamp at top left of the operation panel to light green, indicating that power is being supplied to the equipment. ‘When the switch is set to the © side, power to the equipment is cut off. (2) PULSE POSUSENS control ‘The interual control changes the display position of PULSE waveform, and ‘the outer control adjusts the sensitivity @) PCG POSVSENS control The intemal control changes the display position of PCG waveform, and the ‘outer control adjusts the sensitivity. — ECGPOSV/SENS control The internal control changes the display position of ECG waveform, and the ‘outer control adjusts the sensitivity. 48 MNI-I173 Rev.7 4-2.Name and Function of Each Part 4-2-5. Rear panel a @ (1) Pote: lal 5 equalizoing [> terminal Qo a of GP Ala. ‘AG INPUT Potential equalizing terminal Protective earth terminal 4-2-6. Caster wo @ Front caster lock lever Rear easter lock lever Rear left Rear right (2) Protective earth terminal Fig. Left side panel ‘This terminal is intended to equalize the potential between this equipment and other equipment, This terminal is for connecting the equipment to a protective earth via the power cable, Fig, Front and rear casters Set fo ON to fix each front caster. Lower this lever when you wish to prevent the rear casters from swiveling, ‘Comering / Lock Release Fixing / Lock only 49 a Wed YOR JO eWEN pur suoReoYneds'y ‘MNI-1173 Rev.7 4-2.Name and Function of Each Part 4-2-7. Viewing monitor a ® @ ©) CONTRAST knob BRIGHTNESS knob ‘Volume knob Speaker VIDEO IN ACIN (2) BRIGHTNESS knob (4) Speaker \(1) CONTRAST knob (6)ACIN (5) VIDEO IN Fig. Viewing monitor ‘Used to adjust the contrast ofthe observation viewing monitor screen. ‘Used to adjust the brightness of the observation viewing monitor sercen, Adjusts the volume ofthe Doppler sound, Enables you to listen to the Doppler sound, Usod for connecting a video signal tothe monitor, Used for connecting the cable that supplies power to the monitor. 4-10 MN1-1173 Rev.7 5-1. Standard composition Wa u 5. COMPOSITION 5-1. Standard composition ‘Type number Diagnostic equipment proper USI- 150 1 Viewing monitor TPC-1530(U) 1 i Cable hanger MP-HA6500-1 1 Fe Power cord (100V—120V) CP-116, 1 = Power cord (200V-—240V) cp-il7 1 = ‘Video printer control cable AUW1-150, L C Color printer control cable L-CABLE-342 1 = ‘Overlay Sheet ‘MP-SE4000-1 1 = ‘Video printer installation metal fittings MP-FX4000-1 1 = ‘VCR/Color printer installation metal fitings MP-FX4000-2C 1 — Function Switch Label P32-SSD4000-3, 1 Instruction manual MNi-1173 1 = MNI-1174 1 MNI-1175 1 This section consists of 8 pages. sa NOILISOdWOO'S MNI-I173 Rev.7 5-2.0ptions 5-2. Options 5-2-1. Peripheral equipment EU nations [Outside EU! Recording Color Printer UPZIMDIUC) (00V — 120v) ° emenent Color Printer ‘up-2iMD(CED) @o0v—240v)| ° Color Printer cP900UM (100V — 1209) ° Color Printer cP9008 (@00V—240¥) ° ° [BAW Printer UP-895MD (100V-— 120V) - ° BAW Printer UP-89SCE 200V —240V) ° ° BAW Printer UP-89SMDISYN Oo ° BIW Printer Poiw (looy —120v) ° BIW Printer P91 @00v —240V) ° ° ver SVO-9500MD4 (NTSC) ° ver SVO-9500MDP4(PAL) ° ° ver AG-1350(NTSC) - ° ver AG-TBSOE(PAL) ° ° Functional Physiologial signal wait PIEU-4000 Oo O° ooo Steerable CW Doppler unit ‘UCW-40008 ° ° Mechanical sean unit ScU-40008, fe) ° ata management system (VCM) | EU-9083 fe) ° VOL mode unit BU.9084C ° ° Serial VO Isolation unit siu-4000 ° ° Feapende pe conan | 94 ° ° eVOL mode unit FU-9107 ° ° 52 ‘MNI-LI73 Rev.7 5-2.0ptions z EU nations | Outside EU SOFTWARE | CARDIO APPLICATION 30P-4000-38 Oo oO SOFTWARE, ‘TDI FUNCTION SOFTWARE _| SOP-4000-98 Oo ° DICOM LIBRARY ‘SOP-4000-10B ° ° SOFTWARE THE FUNCTION SOFTWARE | SoP-4000-128 ° ° FREE ANGULAR MMODE _| sop-4000-11B ° ° FUNCTION SOFTWARE FLOW PROFILE SOP-4000-138 ° ° MEASUREMENT SOFTWARE ‘TELINDEX MEASUREMENT | SOP-4000-14B ° ° SOFTWARE, Other equipment | Foot switch MP2345B Oo Oo ‘Triple foot switeh MP.2614B ° ° VER/Color printer instalation | MP-FX4000-4 O° ° ‘metal fitings Cable hanger for ASU-1000C- | MP-HTASS00-2 ° ° 35 ‘Probe holder for ASU-1000C-3.5. | MP-P14000-1 ° ° 53 NOILISOdOO'S MNI-1173 Rov.7 6-2.0ptions 5-2-2. Table of optional probes (EU nations) [Remark] For deals of using a probe or scanner, refer tothe instruction manual fr the probe or scanner A Caution ‘Use probes only for tei intended purpose, Do not use them incoreely. Main ‘Applicable part Name Type. | a ccentone | Appian | MPP? Remarks Transesophageal | USTS293.5 | SMHZ90" Cardiac Intrscorporeal | Rotary plane electronic sector probe “Trans esophageal lecironic sector «(| USTS298 | 90" Cardiac, General | Surface ofbody | Newrosurgery be fe usts299 90° Cardiac Surface of body Puncture clectonie | UST-5268°-5 | SMiz,90° Tnireoperative | Intopertive sector probe Puncture clectronie | UST-S2109 | Sz, 90° Intreoperative | Intraoperative sector probe lostwonie conver | USE990.3 | SMHz,60R,60° | Abdominal, | Surface of body probe General ust9i23 | 60R,60° Abdominal, Surface ofbody General usr91023.s |3.sa20R,90° | Abdominal, | Surfce of body General Electronic conver [UST9I28 | 14R,120° ‘Abdominal, | Surface of body probe Genera “Transvaginal uso [9R,i80° OIGYN Intracorporeal | Tene vaginal electonie convex probe Transrectal electronic | UST-676P | 9R.180° ‘tiny organ | Intrecorporeal | Trane rectal convex probe Intraoperative USF9S77.5 | 7.5MIIZ20R,65° | Intaoperative | Intraoperative clectonie convex . ans UST995-15 | 7.5MHI220R,65° | Intraoperative | Intraoperative usr9104s | stin20R.65° | tntroperative | tntroperative 54 MNI-1173 Rev.7 5-2.Options canna Mai ‘on | APblicablo part Remarks | Name TyPENO. specications | APpleation ery femarks | Blcctronic linear probe | UST.5524-7.5 | 75MBz42mm | Peripheral vessels | Surfuce of body | ‘Beam steering usts7i0-75 | 7.5Miiz,60mm — | Thyroid Surface of body UsEss4s 38mm Peripheral vessels | Surface of body | Beam steering | USTSs48 2mm Thyroid Surface of body | Beara steering | | | | ust-ss42 29mm Pv ‘Surface of body | Beam steering Tatraoperative UST55367.5 |7.5MH233mm | Intraoperative | Intraoperative clectronc Tinear probe POO | USTS7IT-7.5 |7.5MHz60mm | Intrsoperative | Intraoperative USTS33 10mm Intraoperative | Intraoperative Beam steering usrss34F7.5 |75MHz,42mm | Intraoperative | Intraoperative Beam steering | “Trenarecal composite | UST-672-5/7.5 | SMUiz9R,120° | Urinary organ | Intracorporcal | Tronsrectal probe 7.5SMHz,60mm. | Electronic convex | ASU-1009 408,60" OB/GYN Surface ofbody | EU-9107 or scotor scanner | Transvaginal “ASU-1003, 9R, 163° electronic convex | EU-9107 or sector scanner U-9084C is necessary ‘Transrectal “ASU-67 7S/OMH,360° | Urinary organ | Intracorporeal|"Transrectal mechanical radial SCU-40008 is scanner necessary Tndependent probe | UST.2265-2 | 2MHz Cardiac Surface of body | UCW-40008, EU-9094 are necessary USE-2266-5 | SME Peripheral vessels | Surface of body | UCW-4000B, EU.9094 are necessary 55 NOLLISOdWOO'S MNI-1173 Rev.7 5-2.Options 5-2-3. Table of optional probes (Outside EU) [Remark] For details of using a probe or scanner, efor to the instruction manual for the probe or scanner. Ay Caution Use probes only for their intended purpose, Do not use them incorrectly. Main ‘on | APblicablepart Name TYPONO. | soeciteations | APPlcation aia Remarks “Transesophageal | UST-5293-5 | SMIz,90° Candie Tintracorporeal | Rotary plane electron sector probe “Trans esophageal Electronie sector | UST-5298 90° Cardiac, General | Surface of body | Neurosurgery be a ust:5299 90° Cardiae Surface of body Puncture electronie | USTS268P-5 | SMFiz,90° Tnraoperative | Intraoperative sector probe Puncturs-loctronic | USTS2109 | SMFiz,90° Intraoperative | Intraoperative sector probe Blecironie convex | UST990-5 | SMHz,608,60° | Abdominal, | Surface of body probe General usr9123 oR, 60° ‘Abdominal, | Surface of body General UST-9102-3.5 |3.5MHz20R,90° | Abdominal, | Surface of body General lecttonic convex | UST-9128, R12 Abdominal, | Surface of body probe General “Transvaginal UST9124 9R,180° oBiGYN Tntracorporeal | Trans vaginal electronic convex probe Transrectal electronic. | USTS676P 9R,180" Urinary organ | ntracorporeal | Trans rectal conver probe Intraoperative UST987-7.5 | 7.5Mi,20R,65° [Intraoperative | Intraoperative electronic convex hig UST995-75 | 7.5Mr1z.20R,65° | Intmoperative | Intraoperative UST91045 | SMHTz.20R,65° | Tatruoperative | Intraoperative 56 MN1-1173 Rev.7 &-2.Options Main " Applicable part | licati Remarks Della jena ne specications | pplication of body Electronic lincar probe | UST-5524-7.5 | 7.5MHz,42mm | Peripheral vessels | Surface of body ‘Beam steering | | USE5710-75 |75Mbz60mm — | Thyroid USTSS46 38mm Peripheral vessels Beam stoering | USTs548 2mm Thyroid | Surface of body | ‘Beam steering | UST-5542 29mm Pv | Surface of body | Beam steering Intraoperative UST-S536-7.5 | 75MHz33mm | Intraoperative | Intraoperative electric linear ae USTSI9E7.5 |7.5MHz,60mm | Intraoperative | Intraoperative usrs33 10mm Intraoperative | Intragperative Beam steering | | USPSS340-7.5 | 7.5MHz, 42mm | Intraoperative | Intraoperative Beam stecring ‘ransrectal composite |UST.672-5/7.5 |SMEz9R,120° | Urinary organ | Intracorporeal | Transrectal probe 7SME,60mm Electronic conver | ASU-1009 | 40R,60° ‘OBIGYN Surface of body | BU-9107 or seetor seaner | U-9084C is necessary ‘Transvaginal ‘ASU-1003 9R, 163° ‘OB/IGYN Intracorporeal | Transvaginal lectronie convex EU-9107 or sector scanner | | EU-9084C is | necessary ASU-67 7SIOMHz360° | Usinary organ | Tntracorporeal | Transtectal SCU-40008 is | | necessary Independent probe | UST-2265-2 | 2MFiz | Cardiac Surface ofbody | UCW-4000B, | FU-9094 are recessary ust2266.5 | saz Peripheral vessels | Surface ofbody | UCW-4000B, BU-9094 are | necessary $7 MNI-1173 Rev.7 6-1.Principle of Operation — 6. PRINCIPLE OF OPERATION 6-1. Principle of Operation This ultrasound diagnostic equipment uses electric sector probes, electric convex probes, and electric linear probes. ‘The probe that has an array ofthe rectangular oscillators receives the clectrical pulses from the transmission circuit, and oscillates ultrasound waves. Then, the probe receives the reflective echo from the body of subject, and outputs the signals for sliced images. ‘The method of transmitting and receiving varies depending on the sector, convex and linear probes, The electric see- ‘or scan uses the phase control system to obtain several ultrasound waves that form the slice image of a fan, This = system is explained below. ‘To swing the ultrasound wave leftward on the slice image, the oscillators’ transmitting timing of the ultrasound. waves should be made delayed gradually from the right oscillator to the left. Since the left oscillators receive the sm ‘echo earlier than the right oscillators, the left oscillators should transmit the ultrasound waves late by prolonging the delay timing with the delay line, This makes the reception timing of each oscillator be synchronized, which forms ‘one ultrasound wave. To swing the wave rightward on the slice image, the transmitting and receiving timing of the right most oscillator should be made delayed the most. The operations above are repeated to form the scanning plane = of the fan, For electric convex scan and electric linear scan, multiple oscillators constitute a block which transmits and receives ultrasound waves. So, the ultrasound transmitted from each oscillator forms one ultrasound wave, showing the same effect as that of the ultrasound wave oscillated from the center of the multiple oscillators. After the first oscillator transmits and receives the ultrasound, other oscillators of the first block transmit and re- - cceives successively to form the second ultrasound wave, The center ofthe second ultrasound is shifted from the cen- ter of the first ultrasound by one oscillator. The operations shown above are repeated to form several ultrasound = ‘waves, which constitutes « scanning plane. ‘The obtained ultrasound as shown above are converted to video signals with the digital scanning converter, and are displayed on the display monitor. = ‘This equipment also transmits and receives the ultrasound in the same direction several times, and detects the dif- ference of the ultrasound waves of each time, which makes it possible to detect the data of the liquid, such as blood flow (the dircetion, the speed and the variation). Its also possible to color the data and superimpose them on the B mode image, ‘This section consists of 2 pages. ot 2 2 a 3 ° 2 2 MNI-173 Rev.7 6-1.Principle of Operation In addition to that, using the Pulse Doppler method, this equipment detects and displays the data of blood flow of any sample point. Attaching optional UCW-4000B makes it possible to detect and display the data of blood flow vor all the ultrasound waves using the CW Doppler method. ‘With optional mechanical scan nit SCU-4000B, this equipment can obtain slice images scared mechanically. The scanning section ofthe mechanical seanner rotates the oscillators mechanically to emit the ultrasound pulses to the body. Then, the equipment receives the reflective waves of ultrasound from the body, and amplifies them large enough to display images using the amplifier. Afler the waves are detected, they are converted to video signals with the digital scanning converter, and are displayed on the display monitor. ‘The use of optional data control unit FU-9083 can file the slice images of digital data without converting, Optional VOL mode supporting unit EU-9084C ean make pseudo three-

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