Instruction for use ARIETTA 60 hitacho aloka, Study Guides, Projects, Research of Biology

Download Instruction for use ARIETTA 60 hitacho aloka and more Study Guides, Projects, Research Biology in PDF only on Docsity! HITACHI Inspire the Next Instruction for use This document is the instruction manual for the ARIETTA 60 Diagnostic Ultrasound System. Before using the instrument, please read this manual. ALOKA illuminate the the change CE... Hitachi Aloka Medical, Ltd : 1 MN1-5908 rev.2 Instruction for use Thank you for purchasing the Hitachi Aloka ARIETTA 60 Diagnostic Ultrasound System; we truly appreciate your business. Itis very important to thoroughly understand the functions, action and maintenance of this instrument and to use it accordingly. This will enable you to use it safely and correctly, and to maintain its normal operation through a long service life. Before using the instrument, please read this manual. Be sure to keep this manual for future reference. Note that the diagnostic ultrasound system windows referred to in this instruction manual might differ from the windows actually displayed. This manual is applicable to ARIETTA 60, ARIETTA S60 and ARIETTA V60. The word, ARIETTA 60 in the manual is deemed to be ARIETTA 60, ARIETTA S60 and ARIETTA V60, if the case may be. Trademarks and Registered Trademarks Microsoft, Windows, Microsoft Excel, and Windows Media are either registered trademarks or trademarks of Microsoft Corporation in the United States and other countries. Adobe, Acrobat, and Reader are trademarks or registered trademarks of Adobe Systems Incorporated in the United States and other countries, The company name, product names, and logo of McAfee, in both English and Japanese, are trademarks or registered trademarks of McAfee, Inc. or its affiliated companies. Linux is a trademark or registered trademark of Mr. Linus Torvalds in Japan, and other countries Real-time Tissue Elastography, HI REZ, and HaTHI are registered trademarks in Japan of Hitachi Medical Corporation VS-FlexGrid Pro copyright© 1999-2000 Videosoft Corporation This software is based in part on the work of the Independent JPEG Group, Other company names, product names and system names mentioned in the instruction manual of this instrument may be the trademarks or registered trademarks of their respective organizations. This document omits symbols such as ™ and *. Copyright© Hitachi Aloka Medical, Ltd. Alll rights reserved, Precautions concerning the software incorporated into this instrument Regarding the software installed in this instrument, the following actions are prohibited. (1) Reselling, assigning, or transferring the software itself (2) Reverse engineering, reverse compiling, or reverse assembling (3) Modification, alteration or translation (4) Creating copies or duplicates (5) Leasing to third parties 2 . Hitachi Aloka Medical, Ltd, Instruction for use MN1-5908 rev.2 45 46 46-1 4-6-2 463 46-4 46-5 47 47-1 47-2 473 48-1 4-8-2 483 4-8-4 49 4-10 410-1 4-10-2 4-103 4-10-4 4-105 4-106 4-10-7 4-108 411 411-1 4-11-2 4-113 411-4 411-5 4-11-6 4-11-7 Adjusting Audio Volume .......... 00... ce cece cece cece eee ee nee seen ee eens 76 Mode Display ....... 2.66.6 cccce cence cece eee cee ee eee ee ee ene ee eens seen ene 77 Displaying B Mode Images ............ cece cece eect eect eee eee eee eal 78 Displaying M Mode Images ............ cece eee eee e cece eect eeeeeeeeeeeaadd 80 Displaying Color Flow Mode Images........... 0c ecccce ee eeeee eect eee eee ena e ed 82 Displaying the PW waveform. . . 83 Displaying the CW Waveform .......... 0c cc cce cece cece cece eee ee eee ee ee ena e ed 85 Playing Back Cine Memory ImagéS. ........ 2.0000 c eee eee eee eee eee e eens 87 Searching or Scrolling in Single Screen .......... eee c eee e eee ee cece ee ee eee ed 88 Searching or scrolling in dual screen. ........... cece cece e eee ee ee eee eee cena ee 89 Continuous playback of tomographic images............ cece cece eee eee ee 90 Entering COMMeENtS........... 6. cece cece cece e eee e eee ee eee ence eee 91 Selecting and Entering a Word 0.0.2... 00... cece cece cece eee eee eee e eee eee eae 92 Moving and Deleting Words ........... 00 cccce cece ece eect ee eeeeee ee eens 93 Registering a Word in the User Dictionary. ........... 0. cc cece cece cece cena ee! 94 Deleting a Word from the User Dictionary ..............c ccc eee cece eee eee eee 95 Displaying Body Marks ............. 20. cece eee ee eee ee neces cece een eee eee 96 Taking Measurements............ 00 cece cece cece eee ee eee eee teen eee enee 98 Distance measurement : Dist ..... 26.2.0... cece cece eee eee teeter eee eed! 99 Area and circumference measurement: Area-T............cse eee eeee ee eeee 100 Area and circumference measurement: Area-E... ++ 101 Velocity Measurement: M. VEL... «102 Time Measurement: Time..... 22... 00ce ec ee cece eee e eee eee eee teen teen eee 103 Blood flow velocity measurement: D.Velocity 1.0.0.0... cece eee cece eee eee 104 Blood flow velocity measurement: D.Velocity 2.0.0.0... cece eee e cece eee eee 105 Pulsatility Index Measurement: Pl... .. 06. cece c cece cece ee eee eee eee ee 106 Outputting IMages..... 2... cece cece cece cence eee en eee e eee 108 Printing Images... . 2.2... cece ccc eee eee cece eee eee eee e eee 108 Saving a Still Mage... 2... cece eee eee eee ee teen ee en ee: 109 Storing Moving Images ........ 0.6. c cece eee eee cece cee cee eee e nena 110 Saving a Moving Image at a Specified Time: Post ECG/Post Time ............ 111 Saving a Moving Image at a Retrospectively Specified Time: Pre ECG/Pre Time 2111 Storing a Moving Image for the Desired Amount of Time: Manual .. . 2.112 Saving a Moving Image at a Specified Range after Freezing ...............08 113 Hitachi Aloka Medical, Ltd MN1-5908 rev.2 [5 412 Viewing Instruction Manuals ........... 0.0 ccc ee ecee cece cece eee ee eens 114 4-12-1 Viewing the Instruction Manuals on the Monitor..............ce cee eee e eee 115 4-12-2 Opening the Instruction Manual Stored on the CD-ROM .. 2117 413 Procedures After Using the Instrument ............. cc ceee eee eeee eens 118 414 Inspection after using the instrument. ............ cece eee ee eee ene 120 Maintenance ... +6121 5-1 Cleaning....... 2... cece cece cece cece cece eee eee e eee ee eee eeaeennes 122 5-1-1 Cleaning Frequency. 0.0.0.0... cece cece cece ee ee eee eee eeeeeene nena: 122 5-1-2 Clean the instrument ...... 0.00.00. cee ce cece ee een e eee ee eee eneee ene e ene 123 5-1-3 Cleaning the Filters 0.0.0.0... cece cece ec c eee ee eee eee teen eee en ee: 124 5-1-4 Cleaning the Trackball ......... ccc cece cece cece eee ee eee eee eee ee eee eee 125 5-1-5 Clean the endovaginal/endorectal probe holder.......... 00... ee eee ee eee 126 5-2 Maintenance Inspection........ 0.00. ccc ce cee ce cece eee cece een ee eee aeee 128 5-2-1 Daily inspection: For a long service life. . . +. 129 5-2-2 Measurement accuracy inspection 0.0.2.0... 0.0. c cece cece cece eee 130 5-2-3 Measurement accuracy inspection record table. ........ 0. eee cee cece eee 134 5-2-4 Safety Inspection ©... . cece cee cece eee eee eee ee eee eee ee ee eee: 137 5-2-5 Diagnostic ultrasound system safety inspection data sheet...............008 139 5-3 Troubleshooting If you think the instrument may be broken............ 140 5-4 Repair, readjustment, and disposal of this product ... . 142 Product Configuration ............cccececececcvececeeees 143 6-1 Standard Configuration ...........c cece cc cece eee cece ee ee ee senna anes 144 6-2 OPTIONS. 0.0... cece eee eee e eee eee ee ee eee e nena ennes 145 6-3 Led 0) 0) 148 6-3-1 Probe Functions: Basic FUNCtIONS.......... 2... ce eee e cence ence eee e eee eee 151 6-3-2 Probe Standard Functions: Optional Functions. .......... 0... cece eeeee ee eee 153 6-3-3 Measurement SCOPES ...... 6.66 cece cece ee eee cee e eee eee 156 Safety Guidelines . +157 7-1 Guidelines for Electromagnetic Compatibility. .............. cece eee 158 7-1-1 Guidance and directive concerning electromagnetic emissions.............. 158 6| @Hitachi Aloka Medical, Ltd, MN1-5908 rev2 7-1-2 7-1-3 7-1-4 7-2 7-3 7-3-1 7-3-2 7-3-3 7-3-4 7-3-5 7-3-6 7-3-7 7-3-8 73-9 Basic Performance ......... 2c. cee cece cee e eee ee nent cece eee eee ne nese ences 159 Guidance and Declaration Directive Concerning Electromagnetic Immunity . 160 Table Guidance and Declaration Directive Concerning Electromagnetic Immunity (conducted RG and emitted RF) ..... 06... cece ccc ccc cece eee eee eeeeeeeee 161 Recommended Separation Distance between Cellular and Mobile RF Communi- cation Instruments and the ARIETTA 60..........0c0cce eee eee eee eeee eee enene 162 Electrostatic discharge (ESD) guidelines. ..................e cee ee cence 163 Ultrasound Output Safety Information............6...0seeeeeeeeee ences 164 Acoustic Power Index ...... 2.00.0 cee eee ee eee ee een e eee eeee eee eneee ene enens 164 Ultrasound Wave, Interaction between Vital Tissues..............0e0eeeeeeee 166 Derivation and Meaning of MI/Tl . . -. 169 Setting Conditions Influencing Device Output .......... 00. ccc eee eee eee 171 ALARA: As Low As Reasonably Achievable recommended................005 172 Default Settings 0.0... 0... ccc eee eee ee cee ee eee eee ee eter ee ene 173 Acoustic Power Upper Limit........... 0.00. e eee e eee 173 Protocol for Calculating the Measurement Uncertainties .................008 174 Lo) ee errr. 183 8 Messages ........cccccccccccccccccccceccccccecssecscvees 18D 8-1 8-2 8-3 8-4 8-5 Messages About Image Display... - 186 Messages about patient data entry ................ cece eee ee scene eee 188 Messages about saving display images ................ cece eee eee eee ee 192 Messages about searching for, playing and transferring saved images .. 194 Recorder Messages ........ 22... cece cece cence ee eee e ee eee ence eee enees 202 Messages about the presets ...............ccce cece cece cece eee ee ee neee 203 Other Messages. . . . 206 9 License Information ............ccccecececececceeceeeeee e209 9-1 9-2 9-2-1 9-2-2 Warning regarding the software used for this instrument............... 210 Microsoft Software License Terms ...........0:eeccecseee ees eeeeeee eens 211 Notes on Microsoft Software License Terms........... 60. cecceee eee eee e eens 211 Windows XP Embedded and Windows Embedded Standard Runtime ....... 212 Hitachi Aloka Medical, Ltd MN1-5908 rev.2 |7 Safety Precautions 1-1 Safety Precautions The terms below are used as follows in this manual, to prevent hazards and injuries to operators and patients. The severity of a hazard and injury that can occur when failing to observe the displayed safety information is indicated in four levels: Danger, Warning, Caution, and Note. A DANGER Indicates an imminently hazardous situation which, if not avoided, may result in death or serious injury. WARNING. [%3&2tesa potentially hazardous situation which, if not avoided, may result in death or serious A injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or A moderate injury. A NOTE Indicates a strong request concerning an item that must be observed in order to prevent damage or deterioration of the equipment, and also to ensure that it is used efficiently. The safety symbols have the meanings shown below. AN This kind of symbol means attention is required, ) This symbol means the noted action is prohibited @e This symbol means the noted action is required 1 0 . ‘©Hitachi Aloka Medical, Lt. Precautions MN1-5908 rev2 Safety Precautions 1-1-1 Warnings and safety information Z\DANGER DO NOT use this instrument in a flammable atmosphere. Use of this instrument in a flammable atmosphere may cause an explosion. Z\WARNING DO NOT attempt to repair the instrument. Do not disassemble. Do not modify (replacement of the power cable is also impossible). |"? Electric shocks and other accidents could result. For details regarding instrument repair, please contact our office. Use probes that are cleaned, disinfected, and sterilized with each examination. Wear medical gloves during examination, and wash your hands as standard practice once the examination is complete. Otherwise, there is a risk of infection to the examiner and patient. Dispose of probes used for patients with Creutzfeldt-Jakob disease. Otherwise, there is a risk of infection to the examiner and patient . At present, there is no method for cleaning, disinfecting and sterilizing probes which have been used on Creutzfeldt-Jakob disease. “1. Disassembly means the use of tools to remove the casing or other parts. “2. Modification means attachment of parts or devices to this instrument other than those specified by the manufacturer, Replacement of a power cable counts as modification ZX CAUTION Do not connect equipment or probes to this instrument unless it is specified in this manual. Use with unapproved devices can result in an electric shock, burn, or other injury to the patient or examiner, and damage to this instrument. QO Do not install this instrument or optional equipment without our approval. Nor should you transport it. |"? Electric shocks and other accidents could result. Contact our office in the event you wish to transport or install this instrument and any optional equipment. Install the instrument in the following locations: + Aflat area with adequate strength and little vibration. + An area where there is no water or other fluid, no large amounts of salt or sulfur, and no direct sunlight. Injuries or bums etc, to the patient or the examiner could result Do not block the ventilation holes. The temperature inside the instrument will rise, leading to fire or breakdown. Do nottouch the pins that are exposed in the probe connector or DC IN sockets at the same time as you touch the patient. Do not touch the patient with anything other than an applied part or equivalent applied part. There is a risk of shorting, and of electric shock to the patient. Do not touch or get close to the pins that are exposed in the probe connector or DC IN sockets. That could cause malfunction due to electrostatic discharge. *1, Installation means the use of tools for mounting and connection. *2. Transportation means the movement of this product on a vehicle, ship, etc. ‘Hitachi Aloka Medical, Ltd. . 1 1 MN1-5908 rev.2 Precautions Safety Precautions ZX CAUTION All non-medical devices connected to the instrument must comply with the relevant IEC or ISO standards (e.g.: IEC 60950-1 for data processing equipment). Furthermore, the entire configured system must comply with the ME systems standard (IEC 60601-1). All configurations must also individually comply fully with the requirements of for medical electrical systems (refer to clause 16 of IEC60601-1-1 or IEC 60601- if there are any applicable ordinances, they should be prioritized. For more details, please contact our office e Regularly perform maintenance inspection and safety inspection of the instrument and probes. With prolonged use, some parts of this instrument may deteriorate, causing it to fall below full performance or causing smoke emission and fire. If anything unusual occurs, immediately stop using it and contact our office. If anything unusual occurs in the instrument or the patient when this instrument is used, take the probe away e from the patient immediately and stop using the instrument. If the test subject's condition is abnormal, take appropriate medical action. When using this instrument, watch to make sure that it is functioning normally, and that the patient is not abnormally affected. If you observe anything abnormal in the instrument, probes, peripherals or options, turn the power off 0 immediately, and stop using the instrument. Such situations can result in injury to the patient or operator, or other unexpected accident. Check for messages, temperature, damage and other aspects of instrument status, then contact our office. e Scan only for the minimum length of time necessary for the diagnosis, and at the lowest possible output. When the subject is a fetus, scan only for the minimum length of time necessary for the diagnosis, and at the lowest possible output. High output and prolonged exposure to ultrasonic waves can adversely affect the internal tissues of the patient. Hold the probe securely during an examination. Store the probe in the probe holder when not in use. Injuries to the patient or the examiner could result, Do not apply unreasonable force when moving a probe inserted into a body cavity. That could injure the patient. Before using, coat the probe adequately with ultrasound medium. Freeze the image as standard practice when the probe is not in use, even during an examination. Use of an ultrasonic beam in air without coating the probe with an ultrasound medium may cause probe surface temperature to rise, potentially causing burns. If anything unusual occurs, such as temperatures rising, immediately stop using it and contact our office. Do not damage, modify or break the probe cables. Do not place heavy objects on the probe cables, twist them, bundle them, or bend them excessively. A damaged probe cable can cause electric shock and short-circuiting, Do not spill water or other liquids on the body of the instrument. The scanner is not protected against the entry of liquids. Using the instrument with water on it can cause electric shock and short-circuiting. Should liquid spill on the instrument, please contact our office. The instrument must be dry when used. Avoid rapid temperature changes which can cause condensation. Using the instrument with condensation or water drops on it can cause electric shock and short-circuiting, 1 2 . ‘Hitachi Aloka Medical, Ltd Precautions MN1-5908 rev2 Safety Precautions This shows the status of the lock lever. 0 Above: Lock released 1 Below: Locked Independent probe connector. a5 The numbers are connector numbers. — — — Foot switch connector. This is the method for adjusting the height of the operation panel. ray Grab the handle on the operation panel and push down on the up-and-down g pedal to move the operation panel up and down. Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Precautions | 15 Safety Precautions Follow the instruction manual to secure the monitor and move the instrument. Move the instrument by grasping the handle at the back of the instrument. Do not lift the instrument by grasping the handle of the operation panel. Otherwise, the instrument could malfunction. Take great care when moving the instrument up or down stairs. Follow the instruction manual to fix the operation panel and move the instrument. Move the instrument by grasping the handle at the back of the instrument. Do not lift the instrument by grasping the handle of the operation panel. There is a risk of the instrument breaking down. Take great care when moving the instrument on steps /¢ RATIENT, CONNECTION keel ated al’ ‘| ) N ECG ~__ Connection terminals for physiological signals (for connecting ) physiological cables) k i >) This shows a type BF applied part. DC-IN :External input terminal LAN cable connection socket. 16 | Precautions ‘Hitachi Aloka Medical, Ltd MN1-5908 rev2 Safety Precautions a Power Ye He va sine cual Connecting USB connectors. Equipotential terminal \ This shows the manufacturer name, model name, and other information. manufacture). Manufacturer. J Year of manufacture mark (the number under the mark indicates the year of This shows safety precautions, etc. CE... 2a This instrument complies with Directive 93/42/EEC relating to Medical Device and Derective 2011/65/EU relating to RoHS. This product cannot be disposed of as regular garbage. Dispose of it in accordance with laws and regulations. Safety and Warning Symbols. This indicates safety information. > & Beware of explosion > Beware of electric ZADANGER DO NOT use this instrument in a flammable atmosphere. Use of this instrument in a flammable atmosphere could cause an explosion. ZA CAUTION Plug the power cable provided directly into a hospital-grade power outlet. There is a risk of short-circuit and electric shock. $ 3 8 & Beware of acoustic output Z\ CAUTION Scan only for the minimum length of time necessary for the diagnosis, and at the lowest possible output. High output and prolonged exposure to ultrasonic waves can adversely affect the tissues of the patient, > Beware of trapping hands oO Follow the supplied documentation Z\ CAUTION Take care to avoid trapping your fingers in unexpected locations. You may pinch your fingers and cause injury. ZA CAUTION Operate this instrument as described in the instruction manual. Not doing so could resutt in injury to the patient or operator and damage to the instrument or its peripheral devices. Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Precautions | 17 Precautions Concerning the Probe 1-3. Precautions Concerning the Probe The handling, cleaning, disinfection, sterilization, and storage of probes varies with the type of probe. For details, refer to the documentation for the probe. The following are common cautions for probes. 1-3-1 Handling precautions These probes are precision instruments. Take care not to damage probes. ©® Caution in handling = Store the probe in the probe holder when not in use. — Hold the probe tightly so that it doesn't slip, especially when using Echo jelly or other lubricants. - Donot pull on the probe cables. Do not fold or kink cables. Do not allow it to get caught beneath the casters. - Connect the probe in accordance with this manual and the documentation for the probe. Note: When a probe is placed in the probe holder on the left, adjust the probe cable so that it does not catch on the USB flash memory on the left side of the instrument front. © Handling the Transesophageal Probes Transesophageal probes are used for ultrasound examination of the heart and thoracic aorta by touching the tip of the probe on the esophagus paries, after the probe is inserted through the esophagus by a doctor. © = Inorder to prevent burns or injury - Before using, coat probe adequately with Echo jelly. = Donot apply unreasonable force when moving a probe inserted into a body cavity. = When the probe is not in use even during an examination, freeze the image as standard practice. © = Inorder to prevent infection — Keep the probes clean and dry. Do not allow Echo jelly, water or any other foreign matter to dry on the probes. = Clean, disinfect, and sterilize any probes that were use. — Dispose of probes used for patients with Creutzfeldt-Jakob disease. Currently, there are no methods for washing, disinfecting, and sterilizing intraoperative probes which have been used on patients afflicted by Creutzfeldt-Jacob disease. @Hitachi Aloka Medical, Ltd, 20 | Precautions MN1-5908 rev2 Precautions Concerning the Probe Cautions concerning transesophageal probes with built-in temperature sensors Some transesophageal probes have built-in temperature sensors (UST-52126) in their tips. These sensors monitor the surface temperature of the probe tip to prevent damage to the esophageal tissue. The sensor is influenced by the temperature of patient's deep body regions. The instrument monitors the surface temperature of the probe tip, assuming that the body temperature of patient is normal. When the probe tip surface temperature exceeds 41°C, the message “TEE T >41.0°C” is displayed at the top of the monitor. Also, the following messages are displayed depending on the probe tip surface temperature. Table 1: Probe tip surface temperature and messages Surface Temperature Display Messages Status “TEE T>41,0°C” “Probe temperature is higher than |The probe tip surface temperature exceeds 41.0°C. 41.0°C." “TEE T>42.0°C” “if the temperature rises any The probe tip surface temperature exceeds 42.0°C. further, transmission will be A beep will sound. terminated." The message is temporarily cleared if [OK] is selected on the dialogue. “TEE T>42.5°C” “TEE thermal limit. Auto cooling _ |The probe tip surface temperature exceeds 42.5°C. mode in progress.” A beep will sound The ultrasonic image freezes and the panel switch lights go out."! The following operations are not possible at that time: + Probe transducer rotation + Panel switches + Touch panel menu (No display) “TEE fetal error (4)" The temperature sensor may be broken. “Discontinue examination and If the scanner is damaged, stop using it immediately turn the system off." and contact our office. “1. The message is cleared when the surface temperature of the probe tip returns to below 410°C, and examination can start. Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Precautions | 21 Precautions Concerning the Probe 1-3-2 Cautions in Performing a Puncture Operation Note: For details, refer to the documentation for the probe and the puncture adapter. Inspection prior to use The probe must be sterile. Ensure that the puncturing needle is not bent. Be sure to check the needle echo using a water tank. Itis necessary to perform inspections according to the documentation provided with the probe and puncture adapter. Do not use any probe or puncture adapter that is abnormal. © Caution when installing the puncture adapter Be sure that the puncture adapter and the puncturing needle have been sterilized before using them. Installing the puncture adapter to the probe in accordance with the documentation for the probe and the puncture adapter. © Cautions in Performing a Puncture Operation A puncture operation must only be performed by a skilled doctor. While performing a puncture operation, ensure that the instrument is functioning normally, and that the patient is not abnormally affected. Ifanything unusual occurs when a puncture operation is performed, take the probe away from the patient immediately, and stop using the instrument. If the patient's condition appears abnormal, provide appropriate medical treatment immediately. © To avoid puncturing an area that is not intended to be punctured Puncture guidelines should be used as a guide for the directionality of puncturing needle insertions. Check if the model names of the currently used puncture adapter and that on the screen are the same. When using probes and puncture adapters that have multiple guidelines, check that the insertion angle of the puncture adapter and the angle set on the screen are the same. Be sure to check the needle echo before using the probe. When the speed of sound in tissue differs from 1,540m/s, the angles of the puncture guideline and needle echo may not match. Check the safety part of the puncture path that is not visible on the monitor. There may be a blood vessel or other organ in the puncture path that is not visible on the screen. Verify the location of the puncturing needle with the needle echo that is displayed on the monitor. When puncturing with a CC41R or C41L47RP connected, check the puncture guideline in the L (longitudinal) image. The biplane lineis displayed in the T (transverse) image as a guideline to the intersection position between the two sections, Mistaking the lines may result in injury to the patient. For details, refer to the documentation for the probe. 22 | Precautions @Hitachi Aloka Medical, Ltd, MN1-5908 rev2 Precautions for use in conjunction with medical devices 1-5 Precautions for use in conjunction with medical devices Thoroughly read the documentation for the other medical devices to be used with this instrument, and use those devices correctly. © Connection to the equipotential terminal Use the equipotential terminal on the back of the instrument to eliminate potential differences relative to other medical devices, the bed, etc. @ Use in conjunction with devices which use high frequencies High frequency surgical instruments may be used to deliberately apply an electromagnetic field or electric current of high frequency to the patient. This instrument has not been equipped with any means to protect the patient from burn injury from any of its parts when it is used in conjunction with a high-frequency surgical instrument. © Simultaneous use with a defibrillator This instrument may not be used in combination with a defibrillator. When using a defibrillator, keep probes and the electrodes for physiological signals far enough away from the patient. @ Use in Conjunction with a ECG Monitor Use only an ECG monitor that conforms to IEC 60601-1 together with this instrument. Do not use the ECG monitor if its documentation prohibits its use together with diagnostic ultrasound system or similar medical electronic instruments. ZX CAUTION Perform safety checks on the other medical devices to be used with this instrument, and do not use them if they are faulty. Electric shock or instrument breakdown could otherwise result. If the instrument does not operate normally, immediately stop using it. When using this instrument together with other medical electrical equipment, position it and its cables (e.g. probe cables, ECG cables, I/O cables, etc.) as far away as possible from other appliances and their cables. Note that electromagnetic radiation from this instrument may cause other medical electrical equipment nearby to function abnormally. In this case, stop combined use with such an instrument immediately. Do not place probes, operator's hands, and puncture adapters etc. in the path of high-frequency current. The probe could be damaged, and the patient, examiner or operator could receive burns. High frequencies may impair the ability of this instrument to produce images. Operate this instrument with caution, paying attention to the positions of the counter electrode plates and the connecting cord relative to the probe Do not apply great force when inserting electrode needles. The insulation coating of the electrode needle could be darnaged, and the patient, examiner or operator could receive burns. Use an attachment capable of suitable puncture guidance, and operate it carefully. Do not use this instrument in conjunction with a defibrillator. Instrument failure could result. Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Precautions | 25 Precautions for maintaining electromagnetic compatibility 1-6 Precautions for maintaining electromagnetic compatibility Electromagnetic compatibility (EMC) means that the instrument can maintain basic performance and safety within the specified electromagnetic environment, without causing electromagnetic interference that cannot be tolerated by other devices in that environment. Medical devices, communications devices, radio and TV broadcasting antennas and similar devices can both emit electromagnetic energy and receive electromagnetic interference. As an diagnostic ultrasound system receives radio frequency signals (ultrasonic wave signals on radio frequencies), itcan receive electromagnetic interference emitted by electromagnetic energy sources. If it receives such interference, effects can include noise in images, disruption of physiological signals, and abnormal sounds from speakers. To prevent this kind of electromagnetic interference and maintain electromagnetic compatibility, it is necessary to pay attention to (1) the electromagnetic environment, (2) use of portable or mobile RF communications equipment, and (3) use in conjunction with other medical electrical equipment. IMPORTANT: The doctor must consider whether artifacts caused by electromagnetic interference could adversely affect images or diagnoses. 1) Electromagnetic Environment This instrument is medical electrical equipment intended for use in hospitals and other health-care facilities. Install the instrument according to the installation conditions and “Guidance and Instrument Conformity’. © Position this instrument as far away as possible from radio receivers, TV sets, and their cables and antennas. Note that electromagnetic radiation from this instrument may cause electromagnetic interference to radio receivers, TV sets, etc. © Ifthe instrumentis to be used near a motor (elevator, pump room, etc.), power transmission line or wireless, instrument that generates electromagnetic waves, it is necessary to electromagnetically shield it. Il) Using Portable or Mobile RF Communications Equipment Do not use the portable radio communication devices (e.g. cellular phone, PHS, radio transceiver, etc.) near this instrument. This instrument may be affected by portable or mobile RF communications equipment. Ill) Use in Conjunction with Other Medical Electrical Equipment If this instrument receives electromagnetic interference, effects can include noise in images, disruption of physiological signals, and abnormal sounds from speakers. Position this instrument and its cables (e.g. probe cables, ECG cables, I/O cables, etc.) as far away as possible from other equipment used with the instrument, and its cables. @Hitachi Aloka Medical, Ltd, 26 | Precautions MN1-5908 rev2 Precautions for maintaining electromagnetic compatibility Check that no effects on the instrument can be observed from electromagnetic waves generated by devices used with it, and that those devices are not affected by electromagnetic waves generated by the instrument. If the instrument is used in conjunction with high-frequency devices, images on this instrument may be impaired by electromagnetic interference. If electromagnetic waves from this instrument cause other medical electrical equipment used with it to function abnormally, immediately stop using the equipment and instrument together. Stop using the other type of device together with this instrument. Reference Guidelines for Electromagnetic Compatibility — p.158 Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Precautions | 27 Purposes of Use 2-1 Purposes of Use This instrument is intended to be used by doctors and other qualified persons for performing tomographic and hemodynamics diagnoses in the following parts of the human body: @ Thorax @ Abdomen © Perineal and pelvic internal organs © Lower limbs @ Back © Upper limbs @ Head @ Neck Do not use it for any applications other than those stated above. Refer to the documentation accompanying probes, as well as this document, for information on probe usage applications. Z\WARNING DO NOT use this instrument for performing ultrasound examination of the eyes. The acoustic power from this instrument exceeds the upper ophthalmologic limit indicated in the U.S. FDA standards. ZA CAUTION Connect the probe in accordance with this manual and the documentation for the probe. Failure to do so could result in injuries or burns to the patient or operator, and other accidents. Do not use the instrument for purposes other than those specified in this manual. ‘Hitachi Aloka Medical, Ltd 30 | Product Summary MN1-5908 rev2 Operating Principles 2-2. Operating Principles Multiple transducers, within all transducers, constitute a block which simultaneously transmits and receives ultrasound waves. So, the ultrasound transmitted from each transducer forms one ultrasound wave, showing the same effect as that of an ultrasound beam oscillated from the center of the multiple transducers. After the first oscillator transmits and receives the ultrasound, other oscillators of the first block transmit and receives successively to form the second ultrasound wave. The center of the second ultrasound is shifted from the center of the first ultrasound by one oscillator. Similarly, repeated transmission and reception while moving the transducers provides several ultrasound beams, which line up to form a scanning plane. Also, the beams can be focused together by adding a time difference to the transmission and reception that creates the beams, to join them in an acoustic focus. Continuously setting the focal time difference according to the ultrasonic wave arrival time can obtain a beam that is joined in overall focus. This instrument can also revise the time difference between ultrasonic waves that arrive at different times due to different speeds within the patient or diagnostic region. The ultrasound beams obtained as explained above are converted to video signals with the digital scanning converter, and are displayed on the measurement monitor. This instrument can be used for individual or combined display in the image display modes listed below. © Bmodeis a display mode in which the tomographic image is formed with plural ultrasound beams by the methods mentioned above. During the process of creating the tomographicimage, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image. @ Mmode is a display mode of ultrasound beams received sequentially and repeatedly on the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body’s on time-series scale. @ There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by the pulse Doppler method. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method. © Color Doppler mode receives ultrasound from the same direction and detects its differences over time to detect three types of information about a fluid analogous to the blood flow: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need. The 4 methods of electronic scanning are as follows. @ Linear Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject. Hitachi Aloka Medical, Ltd MN1-5908 rev.2 Product Summary | 31 Operating Principles @ Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject. @ Sector Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in fan shapes (sectors) and draws a tomographic image of the test subject. © = Trapezoidal Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the test subject. @Hitachi Aloka Medical, Ltd, 32 | Product Summary MN1-5908 rev2 Specifications Pulse Doppler function Sweep speed 7 levels (40.0 mm/s to 300.0 mm/s) Dual-gate Doppler Functions Available Continuous wave Doppler (CW) functions Analysis Method FFT Method Velocity range £601.56 to +24.81 cm/s Wall Filter 12 levels Sweep Speed 7 levels (40.0 mm/s to 300.0 mm/s) Doppler-y 8 levels Tissue Doppler (TDI) Functions TDI (Flow) Color Display Method Display direction and time with red and blue coloring Reference frequency TD (PW) Analysis method 1 frequency FFT Method Velocity range Sample Volume Value +401.04 to +1.25 cm/s 0.5 mm to 20.0 mm Sweep speed Dual-gate Doppler Functions 7 levels (40.0 mm/s to 300.0 mm/s) Available Color flow function Color display method Velocity / velocity dispersion display Velocity display Power display Specified-direction power Doppler High-resolution power Doppler Color Map 30 types Velocity range £401.04 to +0.63 cm/s Wall Filter 3 levels Preset Application Functions Preset Group Loading Functions Region Data Setting Functions Up to 10 types per probe (up to 100 types can be registered by the user ) Up to 4 types per application, preset:QSS Up to 7 types per diagnostic field (up to 9 types can be registered by the user ) Cine Memory Functions Playback Mode Continuous play (B) Frame-by-frame forward and rewind play (B, M/D) Automatic heartbeat detection play(B) (a physiological signal unit is required) Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Product Summary | 35 Specifications Measurement Functions Basic Measurement Functions Applied measurement functions Abdominal Measurement Urological Measurement Cardiology Measurement Vascular Measurement Obstetrics Measurement Gynecological Measurement Superficial Organ Measurement Measurement Accuracy Measurement Features Distance in B-mode General Tolerance Round-off Tolerance +3% +0.01 cm <10 cm distance +0.1 cm >10 cm distance Area by trace in B-mode +6% +£0.01 cm? <100 cm? area +0.1 cm? >100 cm? area Circumference by trace in B-mode +6% +0.01 cm <10 cm distance +0.1 cm >10 cm distance Area by ellipses in B-mode 45% +£0.01 cm? <100 cm? area +0.1 cm? >100 cm? area Volume in B-mode Excursion in M-mode 47% +0.01 cm? <100 cm? area +3% +0.01 cm <10 cm distance +0.1 cm >10 cm distance Time in M-mode Heart rate +3% +0.01 ms <1000 ms time +0.1 s >10 ms time +1 BPM or 5% +1 beat per minute 2-3-1 Power supply conditions Power supply voltage 100 VAC to 120VAC, 200VAC to 240VAC Electrical frequency 50/60Hz Power consumption 900 VA Service power outlet Outlet x 4 36 | Product Summary ‘Hitachi Aloka Medical, Ltd MN1-5908 rev2 Specifications 2-3-2. Environmental Conditions Ambient Temperature +10°C to +40°C -10°C to +50°C Atmospheric Pressure 700 to 1,060 hPa 700 to 1,060 hPa @Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Product Summary | 37 Part Names Il) Operation Panel ijQ ‘\\eeees YC) = 6 O OO ||, Q {yy eo & cy 16 YO es K 4M FOCUS VELOCITY Operation panel diagram 1 [Power] Key 7 [Review] Key 11 [GC Knob 2 [Acoustic Powerl Key 8 [User 2] Key 12 Multi Rotary Encoder 3 [New Patient] Key 9 [User 1] Key 13 [User 3] Key 4 [End Exam] Key 10 Trackball 14 [User 4] Key 5 [Probe/Preset] Key 15 [PAN ZOOM/DEPTH] Key 6 [Menul Key 16 [FOCUS/VELOCITY] Paddle Switch ‘Hitachi Aloka Medical, Ltd 40 | Product Summary MN1-5908 rev2 Part Names Operation panel (trackball area) [Measurement] Key [UNDO] Key (Caliper Key [Cine Search] Key [BF] Key (HI Zoom] Key [Pointer] Key [Body Mark] Key [Enter] Key SAGE BOHWE BOOP HOBL [Single] Key [Duall Key [Update] Key [Auto-optimizer] Key [REC] Key [Print] Key [Store] Key [Freeze/B Gain] Key Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Product Summary | 41 Part Names ‘Hitachi Aloka Medical, Ltd 42 | Product Summary MN1-5908 rev2 Installation and moving 3-1-2. Moving the instrument ZX CAUTION Do not bump the instrument against other equipment in the passageway, walls, columns, or doors. Take great care when moving the instrument a long distance, or ona slope or steps. It may damage the instrument and peripheral equipment or tip it over, resulting in injury. The instrument is heavy and may not stop once it starts moving. Do not apply excessive force to the instrument. There is a risk of injury or damage from the instrument tipping over. Keep the instrument away from moisture when moving it. It could cause short circuiting or electric shock. 1 Shut down the instrument and prepare it for movement. Power cabl Unplug the power plug from the hospital-grade power outlet, coil the power cable lightly, and hang it on the power cable hook. Unsecured objects Detach peripherals etc. from the instrument and put them away in their own cases. Alternatively, wrap them in soft cloth or similar protective materials. Secured peripherals and probes Hang probe cables from the cable hook, then place the probes in the storage pockets without getting it caught between the casters. Ifendovaginal/ endorectal probe holders (for horizontal storage) are used, place probes horizontally. Do not store vertically. Remove USB flash memory. If the optional alphanumeric keyboard is used, hold down the alphanumeric keyboard until a clicking noise is heard. 2 Face the operation panel to the front. Holding the operation panel lever, turn the operation panel towards the front. xe yp ” TT kN Lever position Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Setup Before Use | 45 Installation and moving 3 > Move the operation panel to the lowest position. Holding the operation panel handle, press the operation panel down while depressing the operation panel height adjustment lever with a foot. Push the operation panel height adjustment lever in with a foot NOTE: If the probe cables are hanging down, readjust them without getting them caught between the casters. 4 Fix the monitor in place. TIP: This prevents the monitor from moving while the instrument is moved. Zi . a_ Face the monitor to the front. b Lower the lever at the back of the monitor. c¢ Hold down the lever while gently pushing down on the monitor until it cannot be pushed any further. d_ Release the lever. 21 inch monitor a Raise the lock shaft. 2) b Turn the monitor arm 1 to a position 90° to. ZEA the right, when seen from the front. > When it clicks, the monitor arm 1 is locked. Ze c Once the monitor arm 1 is level, move the monitor arm 2. 1) Monitor Arm 1 2) Monitor Arm 2 d__ Lower the monitor arm 2 to the top of the lock shaft. > When it clicks, the monitor arm 2s locked. e Slide the lever on the back of the monitor to the left (when looking from the front). f Tilt the monitor forward. g_ Slide the lever on the back of the monitor to the right (when looking from the front). ‘Hitachi Aloka Medical, Ltd 46 | Setup Before Use MN1-5908 rev2 Installation and moving Fix the monitor in place Unlock the casters. Step on the caster locks for the front wheels to push them down. Depress the lock release pedals for the rear wheels. Left: Front Wheel (locked) Right: Rear Wheel (locked) oC Step in the direction of the arrow to release the casters. Move the instrument by securely grasping the handle at the back of the instrument with both hands. NOTE: Grasp the handle on the back of the instrument, not the operation panel or its handle. The shaded pedal is the swing lock pedal NOTE: Do not put anything on top of the monitor. When transporting it over long distances or up and down slopes Depress the swing lock pedals for the rear wheels. Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Setup Before Use | 47 Probe connector 3-2. Probe connector ZACAUTION Place the endovaginal/endorectal probe on the special probe holder (horizontal storage) mounted with the special adapter, the transvaginal/transrectal probe holder adapter. Ifa probe other than an endovaginal/endorectal probe is placed on the special probe holder, the probe may fall out and be damaged. Do not place a probe with balloon attached horizontally in an endovaginal/endorectal probe holder. There is a risk of infection. Detach balloons from probes before placing them in probe holders Z\NOTE Plug the probe into the probe connector until it is fully locked into position. Improper connection may not only result in the display of inaccurate images, but may cause damage to the probe as well as the device itself. Preliminary check Check the following points about the probe. @ The probes must be suitable for connection to the instrument. @ The probe connector pins must not be bent. 1 The instrument must be shutdown or frozen. 2 Place the probes in their probe holders. NOTE: Place independent probes in probe holders with dedicated adapters attached. Store in endovaginal/ endorectal probe holders Detach balloons from endovaginal/ endorectal probes before storing them. When storing the probe horizontally, press it firmly all the way into the probe adapter. Example of horizontal placement in endovaginal/endorectal probe holder Example of vertical placement in Gray part in the diagram: Endovaginal/ endorectal probe endovaginal/endorectal probe holder holder adapter 3 Plug the probes into their probe connectors. ‘Hitachi Aloka Medical, Ltd 50 | Setup Before Use MN1-5908 rev2 Probe connector Examples of electronic probe connectors 5 Adjust the probe cable to a convenient length. Adjust the position and length of the probe cable with cable hooks so that it does not become tangled with the USB flash memory strap or chafe against the floor. Note: When a probe is placed in the probe holder on the left, adjust the probe cable so that it does not catch on the USB flash memory on the left side of the instrument front. 3-2-1 Connecting an independent probe Option EU-9166 is required for connecting an independent probe. © connect to the dedicated independent probe connector. Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Setup Before Use | 51 Probe connector 3-2-2 Connecting a probe with a lock Lever Connecting a probe with a lock lever to this instrument requires a junction box. Refer to the probe specification for the probe concerned. 1 The junction box connects to the lowest probe connector. a Plug the junction box into the probe connector. b Screw in the two knurled screws to fasten it. c Lower the lock lever on the left side of the connector socket. 2 Turn the lock lever clockwise, and align it with the RELEASE position. 3 Plug the probe into the connected junction box. RELEASE Lock al PD RELEASE lock lever lf there is ré ni ‘he rotation of the lock lever Re-insert the probe. 5 Adjust the probe cable to a convenient length. Adjust the position and length of the probe cable with cable hooks so that it does not become tangled with the USB flash memory strap or chafe against the floor. Note: When stepping on the operation panel height adjustment lever, be careful not to bump into the junction box or the probe. @Hitachi Aloka Medical, Ltd, 52 | Setup Before Use MN1-5908 rev2 Connecting to other connectors 3-4 Connecting to other connectors 3-4-1 Connecting to a USB Connector Connect USB flash memory etc to a USB connector. There are USB connectors at the following locations: 55 mm max. connector ¥. USB Flash Memory y t 5.5 mm max. Left: (1) Front, (2) back of the instrument panel (2 connectors). Right: USB flash memory size @ Use aUSB flash memory stick that is shorter than 55 mm excluding the connector, with a height from the bottom to the connector less than 5.5 mm. Some devices may not be usable depending on their physical dimensions. Check whether your USB flash memory can be connected before trying to use it. © = If there is a strap on your USB flash memory, it could become a hindrance when using the instrument if it gets tangled in the probe cables, so either adjust or move the strap to alength where it won't get tangled. © For more information on connectable DVD drives, please contact us. 3-4-2. Connecting to the equipotential terminal If interconnection with other devices is required, use this terminal. Connect to the equipotential terminal on the back of the instrument. 3-4-3 Connecting the foot switch Connect the optional foot switch to the foot switch connection socket. 1 Plug in the foot switch connector. 2. The function to assign to the foot switch can be set as a preset. Hitachi Aloka Medical, Ltd MN1-5908 rev.2 Setup Before Use | 55 Connecting to other connectors 3-4-4 Safety Instructions for Connecting Network Devices The electromagnetic compatibility (EMC) of this device is in conformity with the IEC 60601-1-2: Ed.2 Am.1, which is the international standard for EMC of medical instruments. The following instructions are applicable, when connecting the diagnostic ultrasound system to non medical network devices. The instructions are provided in order for the entire system with network devices to meet IEC 60601-1-1 Electrical Safety Standard. All configuration must individually comply fully with the requirements of clause 16 of the ME system regulation (IEC 60601-1-1) or medical electrical systems (IEC 60601-1: Ed.3). If there are any other ordinances, those should be prioritized. For more details, please contact our office. 1) Network devices All non-medical network devices connected to the diagnostic ultrasound system (non-medical devices such as hubs, work stations and personal computers), must comply with the IEC 60950-1 standard, and must be Class | equipment. Network cables which can be connected Connecting connectors LAN cable connector LAN cable Straight (when a hub is used) Cross (when connecting to a PC directly) Max. cable length 20m Il) Installation and network connection Non-medical devices (hubs, work stations, personal computers, etc.) must not be installed in the patient environment (a radius of 1.5m around the patient). When connecting the Diagnostic Ultrasound System with non-medical devices located outside the ultrasound examination room, always connect through a separation device (network hub). ZACAUTION Do not use any cable other than the specified, or longer than the maximum length. It could pick up electromagnetic interference. Z\NOTE Contact your network administrator for the hospital network if a problem occurs after changing the IT network. If the IT network has been changed, it may be open to new and unacceptable risks, so additional risk management is required The IT network may be changed in the following ways + [T network configuration changes + Connection of additional devices to the IT network + Removal of devices from the IT network + Updates or upgrades to devices connected to the IT network ‘Hitachi Aloka Medical, Ltd 56 | Setup Before Use MN1-5908 rev2 Inspection prior to use 3-5 Inspection prior to use 5 Perform a visual check of the instrument and probes before using starting the instrument. After starting the instrument, check from the screen display that it is operating normally. Perform a visual check of the instrument and probes. Visual Check Items Check that there are no scratches, cracks, dents or discoloration in the following locations: (J External surfaces and panels 1 Power cable and power plug ECG cable Checking consumables (J Replace or replenish the Echo jelly. (1 Replace the printer paper with reference to the printer manual. External inspection points on the probes Refer to the documentation for each probe in order to inspect probes that will be used connected to the instrument. Main inspection content [1 The probes must have been cleaned, disinfected and sterilized, as required for the purpose of use [1 The puncture adapter and needle must be sterilized The connectors must be free of holes, dents, cracks and deformation o The cables and connectors must be free of scratches, cracks and deformation IMPORTANT: If there is anything wrong with the instrument, probes or other parts, stop using them immediately and contact our office. Adjust the monitor to a position that is easily visible. Connect the probe to use. Press the [Power] key. f se ie Free space on the hard disk has run low. Check the message content and press the [Enter] key. After startup, delete unnecessary data. > Display the B mode image after setup. If the B mode image is not displayed after three minutes, please contact our office. If necessary, turn on any options and peripherals. Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Setup Before Use | 57 Inspection prior to use Information displayed on the ultrasound image (1) Manufacturer logo (2) Above: Hospital Name, Below: Operator Name (3) Patient Information (4) Current date and time (5) Ml value, TI value, ultrasound output, frame rate (©) Frequency (8, M), display depth, B gain value, dynamic range (BM), reference PRF/transmission/reception frequency (CF), CF gain value (7) Orientation marks, steering marks (8) Counter A, freeze counter A, counter B, freeze counter B (9) Focus marks (10) Preset name (11) Probe name (12) Display frame number/total number of frarnes (when in freeze display) (13) Above: Sample volume value Below: Angle correction value, sample gate depth @Hitachi Aloka Medical, Ltd, 60 | Setup Before Use MN1-5908 rev2 Default 3-6 Default The section explains the hospital name, network, and date and time adjustment. 3-6-1 Setting the hospital name Set the hospital name to be displayed in the Analysis screen. 1 Press the [Probe/Preset] Key. 2 Select [Preset Setup] on the touch panel. 3° Select “SystemPreset”. 4 Select “General”. 5. Select the Hospital Info. tab. 6 Enter the “Hospital Name” in up to 40 characters. 7 Select [Save]. Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Setup Before Use | 61 Default 3-6-2 Configuring the DICOM communication settings w u Ff 7 Reference information Press the [Probe/Preset] key. Select [Preset Setup] on the touch panel. Select “SystemPreset”. Select [DICOM]. Enter the network settings for the instrument under “Ultrasound Equipment” in the Common tab. Enter the settings for network servers on the various tabs. ® Server/Worklist tab Make server and worklist settings. © =MPPS/Commitment tag Make settings for the MPPS server or Storage z Commitment server. ®@ SRtab Make settings for the SR Storage server. ® Printer tab Set the DICOM printer. Server/Worklist tab Select [Save]. If the IT network has been changed, it may be open to new and unacceptable risks, so additional risk management is required. Safety Instructions for Connecting Network Devices — p.56 62 | Setup Before Use @Hitachi Aloka Medical, Ltd, MN1-5908 rev2 Operation panel and monitor adjustment 3-7-1 Adjusting the height of the operation panel Adjust the height of the operation panel using the up-and-down pedal of the operation panel at the front of the instrument. Preliminary check Remove any objects placed on any installed options, or on and behind the the operation panel. NoTE: Do not put objects in spaces such as on top of installed options, or on and behind the the operation panel. 1 Lock the front casters by stepping on their rock/release pedals. 2 Adjust the height of the operation panel by holding the handle with both hands while stepping on the up-and-down pedal of the panel. NOTE: Grasp the operation panel handle, not the operation panel itself nor the probe holders. 3 Release the up-and-down pedal of the operation panel to fix the operation panel in place. 3-7-2. Rotating the operation panel The operation panel can be rotated to 12.5 or 25 degrees to left and right. 1 Push in the alphanumeric keyboard until it makes a clicking noise. NOTE: Take care to avoid trapping your fingers between the alphanumeric keyboard and the operation panel handle. 2 Grasp the operation panel handle lever while rotating the operation panel. NOTE: Grasp the operation panel handle, not the operation panel itself nor the probe holders. Note: There is a USB connector on the left side of the operation panel front handle. When USB flash memory etc. is connected there, hold the operation panel handle so as to avoid breaking the memory. Hitachi Aloka Medical, Ltd MN1-5908 rev.2 Setup Before Use | 65 Operation panel and monitor adjustment 3-7-3 Adjusting the monitor height or orientation ZX CAUTION Adjust the position and orientation of the monitor and operation panel, keeping a sufficient distance between the instrument and the peripheral equipment, walls and people. Do not knock the monitor against the touch panel, USB memory, cable hook, probe, probe holder, operation panel, or other parts. Prevent the probe cables from catching on the monitor, monitor arm, and handle on the back of the instrument. Contact with the monitor may result in injury, or in damage to peripheral equipment, probes, main unit, monitor, or touch panel. Warm the doctor, patient, and others in the areas before adjusting the position and orientation of the monitor, If the LCD monitor is broken, and its internal fluid comes into contact with the skin, wipe it away and wash the skin in running water for at least 15 minutes. Consult a doctor, to ensure safety. If it gets in someone's eyes, rinse them in running water for at least 15 minutes, and consult a doctor immediately. If the LCD monitor is damaged, stop using it immediately and contact our office. Be careful not to pinch your fingers or hands in the monitor arm when adjusting the location or orientation of the operation panel. You may pinch your fingers or hands, causing injury. e Grasp the frame of the monitor in both hands to adjust its height or orientation. Grasp the frame of the monitor in both hands and move it in a large swinging movement. Even when the monitor arm axis is vertical, it is easier to move the monitor if you swing it. Monitor movable range 17 inch monitor Aa) 150° to the left, 180° to the right Tilt 10° forward, 30° backward ‘Hitachi Aloka Medical, Ltd 66 | Setup Before Use MN1-5908 rev2 Operation panel and monitor adjustment A E E 3 180° left-right Tilt 24 10° forward, 30° backward 150 mmm vertically Left: Max Rotation, Right: Rotated Horizontally Setup Before Use | 67 Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Alphanumeric keyboard 3-8-1 Pull the alphanumeric keyboard out 1 Press lightly with your finger. > The alphanumeric keyboard comes out. 2. Pull it out until it clicks. 3-8-2 Put the alphanumeric keyboard away 1) Push it lightly in with your finger. 2 Use both thumbs to push it in until it clicks. ZX CAUTION Take care to avoid trapping your fingers between the alphanumeric keyboard and the operation panel, or between the alphanumeric keyboard and the handle of the operation panel. An injury could result @Hitachi Aloka Medical, Ltd, 70 | Setup Before Use MN1-5908 rev2 4 Operating Procedures The following sections provide basic instrument operating procedures. For detailed instructions, refer to the related attachment. Hitachi Aloka Medical, Ltd MN1-5908 rev.2 Operating Procedures | 71 Ultrasound Examination Process Flow 4-1 Ultrasound Examination Process Flow This section presents a rough outline of processes from pre-examination setup to end of examination. 1 Set up the instrument according the instructions provided in the chapter "Setup Before Use." a Make a visual inspection of the instrument and the probes. Make sure that the exterior of the instrument or the power cable is not scarred, cracked, dented or discolored. b Plug the power cable into a hospital-grade outlet. c Connect a probe. d_ Press the [Power] key. e Confirm the window that is displayed. 2 Press the [New Patient] key to enter patient information. 3 Apply Echo jelly to the body area of the patient that will be examined or the contact surfaces of the probe. 4 Apply the contact surfaces of the probes to the body areas of the patient that will be examined to display an image. 5 Press the [Freeze/B Gain] key when you have captured the required image to produce a still image. 6 Press the [New Patient] key or [End Exam.] key to end the examination. ® Press the [New Patient] key. Select this method to switch patients. @ Press the [End Exam,] key. Select this method when several examinations have been specified for one patient. 7 Whenall examinations have been completed, press the [Power] key. 8 Clean the instrument and the area around it. Clean, disinfect and sterilize the probes according to the instructions in the supplied documentation. @Hitachi Aloka Medical, Ltd, 72 | Operating Procedures MN1-5908 rev.2 Adjusting Ultrasound Output 4-4 Adjusting Ultrasound Output Use the steps below to adjust ultrasound output to suit operating mode. ALARA draws diagnosis information with the lowest supersonic wave sound power level possible that can achieve its objective. This is the same principle as used with ionizing radiation. Diagnostic ultrasound system are said to be harmless and non-invasive. However, since it exposes the human body to ultrasonic waves, it is not completely safe. Therefore make examinations using the lowest possible ultrasound output. @ tum the [Acoustic Power] key to adjust ultrasound output. 9 = —o0 > You can adjust output in 5% increments. In CW mode, you can adjust output in three stages: L,M and H. 4-4-1 Ultrasound Output Limit for Fetal Observation Use the steps below to temporarily cancel the ultrasound output limit for fetal observation. This instrument limits ultrasound output in accordance with IEC 60601-2-37 Ed.2 (2007) when it is used for fetal observation. The MI upper limit and the TI upper limit are both below 1.0. This ultrasound output limit is suited for General, Obstetrics, Obstetrics TV, Fetal, Heart, Obstetrics 3D, and STIC applications. This limit can be temporarily suspended using the follow steps. Canceling ultrasound wave output restrictions Select [Power Limit Override] from the touch panel System tab. > The message “Keep the acoustic output level as low as possible. Refer to ALARA recommendations in the Instruction Manual.” will be displayed. Select [OK]. > The AP value is highlighted. The limit is suspended until the [New Patient] key is pressed. To limit ultrasound output, again select [Power Limit Override] on the touch panel. Hitachi Aloka Medical, Ltd MN1-5908 rev.2 Operating Procedures | 75 Adjusting Audio Volume 4-5 Adjusting Audio Volume This function adjusts the volume of the Doppler sound, R-wave beep, and external input audio. ©@ Adjust with [Audio Volume]. Sound is muted when volume is set to 0. @Hitachi Aloka Medical, Ltd, 76 | Operating Procedures MN1-5908 rev.2 Mode Display 4-6 Mode Display This section describes how to display the following basic modes. B Mode M Mode Color Flow Mode PW Mode CW Mode Hitachi Aloka Medical, Ltd MN1-5908 rev.2 Operating Procedures | 77 Mode Display 4-6-2. Displaying M Mode Images 1 Press the [M] key. > The B/M mode image is displayed. The M cursor is displayed on the B mode image, and then the M mode image is displayed again. 2 Move the M cursor. a Use the trackball to move the position of the cursor. > The M mode image at the M cursor position is displayed. Switching the Active Screen IR Q TO © Active Active @ Press the [Update] key. > The active screens are switched. 80 | Operating Procedures ‘Hitachi Aloka Medical, Ltd MN1-5908 rev2 Mode Display Switching the Screen e To change between B/M mode and the M mode image (single screen), select [Full M/D] from direct switch. @ Press the [Dual] key to go back from single screen to dual screen. When the Screen is Frozen f OO) |O) ( ru ) (OB; )O ge Ho o Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Operating Procedures | 81 Mode Display 4-6-3 Displaying Color Flow Mode Images Preliminary Check Assign [PD] to direct switch, custom switch, or the function menu. If required, assign [Directional] to a direct switch, custom switch or the function menu. To learn how to assign menu items, consult the separate Basic Operation Section. 1 Display the B mode image. 2. Switch to Color Flow mode. ® Press the [CF] key. CF mode is engaged. ® Select [PD]. PD mode is engaged. ® Press the [eFlow] key. eFlow mode is engaged. When PD mode and eFlow mode display the blood flow direction Turn [Directional] to On using direct switch or the function menu. 3. Set the flow area. a Use the trackball to move the flow area. b Press the [Enter] key. c Adjust the size of the flow area using the trackball. d_ Press the [Enter] key. e Repeat steps a to d to set the flow area. 82 | Operating Procedures ‘Hitachi Aloka Medical, Ltd MN1-5908 rev2 Mode Display 4-6-5 Displaying the CW Waveform Use the steps below to display continuous Doppler waveforms. Preliminary check See the "Probe" section in this guide for each probe. The starting position of the cursor can be changed using the CW waveform applicable linear probe. Assign [Cursor Posi. (LN/CV CW)] to the function menu. To learn how to assign menu items, consult the separate Basic Operation Section. 1 Press the [CW] key. > B/CW will be engaged, and the D cursor will be displayed on top of the B mode image. 2 Change the cursor starting position using [Cursor Posi. (LN/CV CW)] when using a linear probe. one 3 Configure the reference mark O. a Roll the trackball to match the reference mark © to the detection position. Qo. e 4 Press the [Update] key. > The B mode image freezes, and a CW waveform appears. To switch to active, press the [Update] key again. Active Active Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Operating Procedures | 85 Mode Display Using angle correction If required, assign the following. © Assign [Angle Correction] to the function menu. © Assign [Auto Angle Correction] to a direct switch, custom switch, or the function menu. For more information on assigning tasks to the menu, angle-correction menus, and presets, refer to the separate Basic Operation Section. Use the [Angle Correction] multi rotary encoder to correct the angle. O The angle is automatically adjusted using [Auto Angle Correction] on the touch panel or custom switch. NOTE: This adjustment can only be performed in color flow mode. Switching the Screen To change B/CW mode to single screen after freezing, press the [Single] key or the [Dual] key. {oo} al 7 \ HOV Ho» H{o0 Active Active To switch between B/CW mode and the CW waveform (single screen) in real time, select [Full M/D). ‘Hitachi Aloka Medical, Ltd 86 | Operating Procedures MN1-5908 rev.2 Playing Back Cine Memory Images 4-7 Playing Back Cine Memory Images Use the steps below to play back images after they have been frozen. Moving tomographic image frames back and forward in cine memory image play is called “searching.” In a sweep image such as an M mode or D mode image, playing the sequence direction in reverse is called “scrolling”. Hitachi Aloka Medical, Ltd MN1-5908 rev.2 Operating Procedures | 87 Playing Back Cine Memory Images 4-7-3 Continuous playback of tomographic images Use the steps below to continuously play back tomographic images stored in cine memory. 1 The [Freeze/B Gain] key allows the image to be frozen. 2 Press the [Cine Search] key to turn it On. 3 Roll the trackball upward to playback the images continuously. To change the playback speed The loop playback speed increases by rotating the trackball further upward. The loop playback speed decreases by rotating the trackball further downward. Pausing pl k Roll the trackball left or right. Continuously playing within a chosen interval 1 The [Freeze/B Gain] key allows the image to be frozen. 2 Press the [Cine Search] key to turn it On. 3 Set the playback range. a Display the ending frame for continuous playback using the trackball. b Press the [Enter] key. c Display the starting frame for continuous playback using the trackball. d_ Press the [Enter] key. 4 Roll the trackball upward to playback the images continuously. To change the playback speed The loop playback speed increases by rotating the trackball further upward. The loop playback speed decreases by rotating the trackball further downward. Pausing playback Roll the trackball left or right. ‘Hitachi Aloka Medical, Ltd 90 | Operating Procedures MN1-5908 rev.2 Entering comments 4-8 Entering comments Preliminary check Key Input 1 Use the steps below to enter text on the screen. Specify preset [Preset Setup > Region > Annotation] to use user dictionaries and other resources. For more details, refer to the separate "Basic Operation Section". Use the virtual keyboard (touch panel) to enter text. Or use the optional alphanumeric keyboard. Press the [Pointer] key. Use the trackball to move the pointer to the insertion point. Changing the direction of the poi Turn the [Pointer] key. Use key input. The virtual keyboard is displayed when the [KB] tab or the [Anno.+KB] tab is selected. [KB] tab [Anno.+K8] tab Changing the text size Select [A © A]. “Small” displays normal size text, “Middle” displays text that is 2.25 times as large and “Large” displays text that is four times as large. The selected text size becomes effective from the cursor location where a text size was selected. Press the [Enter] key. Or select [Enter] on the virtual keyboard. Deleting all entered comments after freezing Configure the presets ([Preset Setup > Region > Annotation]) to “Erase” under Comment Auto Delete. Displaying all entered comments even after freezing Configure the presets ([Preset Setup > Region > Annotation]) to “Remain” under Comment Auto Delete. Hitachi Aloka Medical, Ltd MN1-5908 rev.2 Operating Procedures | 91 Entering comments 4-8-1 Selecting and Entering a Word Choose and enter a word from the user or system dictionary. 1 Press the [Pointer] key. 2 Use the trackball to indicate where to enter the word. 3. Select the Anno.+KB tab or the Anno tab. Using the first or the first two characters in a word to search for a word Use Anno.+KB tab on the virtual keyboard or the optional alphanumeric keyboard (EP-9165) to enter the first or the first two characters in the word you want to display. Displayin words in order from the most recen Set the Preset Learning Function ([Preset Setup > Dictionary]) to [On]. For more details, refer to the separate Basic Operation Section > The words registered in the dictionary appears on the touch panel. Anno.+KB tab Anno. tab 4 Select a word. > The selected word is displayed on the image. @Hitachi Aloka Medical, Ltd, 92 | Operating Procedures MN1-5908 rev.2 Entering comments 4-8-4 Deleting a Word from the User Dictionary 1 Press the [Pointer] key. 2 Select [Registration] on the touch panel. > Adialog box will be displayed on the screen. Dictionary: Dalses OK ri The virtual keyboard will be displayed on the touch panel. 3 Use the touch panel to select the word you want to delete. 4 Select [Delete] from the dialogue. 5 Select [OK] from the dialogue. Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Operating Procedures | 95 Displaying Body Marks 4-9 Displaying Body Marks Use the steps below to display schema of scanning cross-sections in the examination window. To learn how to assign body marks, consult the separate Basic Operation Section. e Display/Clear Body Marks. a Press the [Body Mark] key. b Select [Body Mark] on the touch panel. > ifthe [Body Mark] key is On, then body marks will be displayed. If it is Off, then body marks will not be displayed. e Changing body marks. a Press the [Body Mark] key. b Select Body Mark from the function menu. > The selected body mark is displayed. e Moving and rotating probe marks. a Press the [Body Mark] key. b Use the trackball to move the position of the probe. c_ Rotate the [Pointer] key to rotate the direction of the probe mark. e Adding left/right marks to body marks. a Press the [Body Mark] key. b Select [L/R] on the touch panel. > If [L/R] is On, then body marks will display L/R marks. If [L/R] is Off, then body marks will not display L/R marks. e Rotating the fetus mark. NOTE: Itis possible to rotate only single horizontal fetus marks. a Press the [Body Mark] key. b Select Fetus Body Mark from the function menu. c_ Press the [Enter] key. @Hitachi Aloka Medical, Ltd, 96 | Operating Procedures MN1-5908 rev.2 Displaying Body Marks d_ Rotate the [Pointer] key to rotate the direction of the fetus mark. Switching probe mark and fetal mark rotation Press the [Enter] key to change. e Moving the displayed body mark position a Press the [Body Mark] key. b Select [Location] on the touch panel and tum On. > A frame is displayed over the body mark. c Use the trackball to move the frame and press the [Enter] key. To return it to the location before it was moved Press the [UNDO] key. d_ Select [Location] again on the touch panel and turn Off. > The frame is cleared and the body mark's location is confirmed. Hitachi Aloka Medical, Ltd, MN1-5908 rev.2 Operating Procedures | 97