MN1-5908 rev.2 Instruction for use | 1
©Hitachi Aloka Medical, Ltd.
Instruction for use
This document is the instruction manual for the ARIETTA 60
Diagnostic Ultrasound System.
Before using the instrument, please read this manual.
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MN1-5908 rev.2 Instruction for use | 1
©Hitachi Aloka Medical, Ltd.
Instruction for use
This document is the instruction manual for the ARIETTA 60
Diagnostic Ultrasound System.
Before using the instrument, please read this manual.
2 | Instruction for use MN1-5908 rev.
©Hitachi Aloka Medical, Ltd.
Thank you for purchasing the Hitachi Aloka ARIETTA 60 Diagnostic Ultrasound System; we truly
appreciate your business.
It is 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 HdTHI 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. All 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
4-11-5 Saving a Moving Image at a Retrospectively Specified Time: Pre ECG/Pre Time
- MN1-5908 rev.2 |
- 1 Precautions ©Hitachi Aloka Medical, Ltd.
- 1-1 Safety Precautions.
- 1-1-1 Warnings and safety information.
- 1-1-2 Label.
- 1-2 Precautions Concerning Acoustic Output.
- 1-3 Precautions Concerning the Probe.
- 1-3-1 Handling precautions.
- 1-3-2 Cautions in Performing a Puncture Operation..
- 1-4 Precautions for use in conjunction with drugs..
- 1-5 Precautions for use in conjunction with medical devices.
- 1-6 Precautions for maintaining electromagnetic compatibility.
- 1-7 Precautions concerning power plugs and power cables.
- 1-1 Safety Precautions.
- 2 Product Summary
- 2-1 Purposes of Use..
- 2-2 Operating Principles.
- 2-3 Specifications.
- 2-3-1 Power supply conditions.
- 2-3-2 Environmental Conditions.
- 2-3-3 Device classifications.
- 2-4 Part Names.
- 3 Setup Before Use
- 3-1 Installation and moving.
- 3-1-1 Shutting down, and disconnecting the power supply.
- 3-1-2 Moving the instrument.
- 3-1-3 Installing the instrument.
- 3-1-4 Installation Conditions.
- 3-1 Installation and moving.
- 1 Precautions ©Hitachi Aloka Medical, Ltd.
- 4 | MN1-5908 rev. - 3-2 Probe connector. ©Hitachi Aloka Medical, Ltd. - 3-2-1 Connecting an independent probe. - 3-2-2 Connecting a probe with a lock Lever. - 3-2-3 Disconnecting a Probe. - 3-3 Physiological signal cable connection. - 3-4 Connecting to other connectors. - 3-4-1 Connecting to a USB Connector. - 3-4-2 Connecting to the equipotential terminal.. - 3-4-3 Connecting the foot switch. - 3-4-4 Safety Instructions for Connecting Network Devices. - 3-5 Inspection prior to use. - 3-5-1 Screen display. - 3-6 Default. - 3-6-1 Setting the hospital name.. - 3-6-2 Configuring the DICOM communication settings. - 3-6-3 Date and time adjustment. - 3-7 Operation panel and monitor adjustment.. - 3-7-1 Adjusting the height of the operation panel. - 3-7-2 Rotating the operation panel.. - 3-7-3 Adjusting the monitor height or orientation. -. 3-7-4 Adjusting the brightness levels of the monitor, operation panel, and touch panel - 3-8 Alphanumeric keyboard.. - 3-8-1 Pull the alphanumeric keyboard out. - 3-8-2 Put the alphanumeric keyboard away.
- 4 Operating Procedures
- 4-1 Ultrasound Examination Process Flow.
- 4-2 Entering Patient Data.
- 4-3 Switching Probes and Applications.
- 4-4 Adjusting Ultrasound Output..
- 4-4-1 Ultrasound Output Limit for Fetal Observation..
- 4 Operating Procedures
- MN1-5908 rev.2 |
- 4-5 Adjusting Audio Volume. ©Hitachi Aloka Medical, Ltd.
- 4-6 Mode Display.
- 4-6-1 Displaying B Mode Images.
- 4-6-2 Displaying M Mode Images.
- 4-6-3 Displaying Color Flow Mode Images.
- 4-6-4 Displaying the PW waveform..
- 4-6-5 Displaying the CW Waveform.
- 4-7 Playing Back Cine Memory Images..
- 4-7-1 Searching or Scrolling in Single Screen.
- 4-7-2 Searching or scrolling in dual screen..
- 4-7-3 Continuous playback of tomographic images.
- 4-8 Entering comments.
- 4-8-1 Selecting and Entering a Word.
- 4-8-2 Moving and Deleting Words.
- 4-8-3 Registering a Word in the User Dictionary..
- 4-8-4 Deleting a Word from the User Dictionary.
- 4-9 Displaying Body Marks.
- 4-10 Taking Measurements..
- 4-10-1 Distance measurement : Dist.
- 4-10-2 Area and circumference measurement: Area-T
- 4-10-3 Area and circumference measurement: Area-E
- 4-10-4 Velocity Measurement: M. VEL.
- 4-10-5 Time Measurement: Time.
- 4-10-6 Blood flow velocity measurement: D.Velocity
- 4-10-7 Blood flow velocity measurement: D.Velocity
- 4-10-8 Pulsatility Index Measurement: PI.
- 4-11 Outputting Images.
- 4-11-1 Printing Images
- 4-11-2 Saving a Still Image
- 4-11-3 Storing Moving Images
- 4-11-4 Saving a Moving Image at a Specified Time: Post ECG/Post Time
- 4-11-6 Storing a Moving Image for the Desired Amount of Time: Manual
- 4-11-7 Saving a Moving Image at a Specified Range after Freezing
- 6 | MN1-5908 rev. - 4-12 Viewing Instruction Manuals ©Hitachi Aloka Medical, Ltd. - 4-12-1 Viewing the Instruction Manuals on the Monitor - 4-12-2 Opening the Instruction Manual Stored on the CD-ROM - 4-13 Procedures After Using the Instrument - 4-14 Inspection after using the instrument.
- 5 Maintenance
- 5-1 Cleaning.
- 5-1-1 Cleaning Frequency.
- 5-1-2 Clean the instrument
- 5-1-3 Cleaning the Filters
- 5-1-4 Cleaning the Trackball
- 5-1-5 Clean the endovaginal/endorectal probe holder
- 5-2 Maintenance Inspection.
- 5-2-1 Daily inspection: For a long service life.
- 5-2-2 Measurement accuracy inspection
- 5-2-3 Measurement accuracy inspection record table
- 5-2-4 Safety inspection
- 5-2-5 Diagnostic ultrasound system safety inspection data sheet.
- 5-3 Troubleshooting If you think the instrument may be broken.
- 5-4 Repair, readjustment, and disposal of this product
- 5-1 Cleaning.
- 6 Product Configuration
- 6-1 Standard Configuration
- 6-2 Options.
- 6-3 Probes.
- 6-3-1 Probe Functions: Basic Functions
- 6-3-2 Probe Standard Functions: Optional Functions.
- 6-3-3 Measurement Scopes
- 7 Safety Guidelines
- 7-1 Guidelines for Electromagnetic Compatibility
- 7-1-1 Guidance and directive concerning electromagnetic emissions.
- 7-1 Guidelines for Electromagnetic Compatibility
- 5 Maintenance
- MN1-5908 rev.2 | - 7-1-2 Basic Performance ©Hitachi Aloka Medical, Ltd. - 7-1-3 Guidance and Declaration Directive Concerning Electromagnetic Immunity - (conducted RG and emitted RF) 7-1-4 Table Guidance and Declaration Directive Concerning Electromagnetic Immunity - cation Instruments and the ARIETTA 7-1-5 Recommended Separation Distance between Cellular and Mobile RF Communi- - 7-2 Electrostatic discharge (ESD) guidelines. - 7-3 Ultrasound Output Safety Information - 7-3-1 Acoustic Power Index - 7-3-2 Ultrasound Wave, Interaction between Vital Tissues. - 7-3-3 Derivation and Meaning of MI/TI - 7-3-4 Setting Conditions Influencing Device Output - 7-3-5 ALARA: As Low As Reasonably Achievable recommended - 7-3-6 Default Settings - 7-3-7 Acoustic Power Upper Limit - 7-3-8 Protocol for Calculating the Measurement Uncertainties - 7-3-9 Note.
- 8 Messages
- 8-1 Messages About Image Display.
- 8-2 Messages about patient data entry
- 8-3 Messages about saving display images
- 8-4 Messages about searching for, playing and transferring saved images
- 8-5 Recorder messages
- 8-6 Messages about the presets
- 8-7 Other Messages.
- 9 License Information
- 9-1 Warning regarding the software used for this instrument.
- 9-2 Microsoft Software License Terms
- 9-2-1 Notes on Microsoft Software License Terms.
- 9-2-2 Windows XP Embedded and Windows Embedded Standard Runtime
- 8 Messages
- 8 | MN1-5908 rev.
- 9-3 McAfee Embedded Control. ©Hitachi Aloka Medical, Ltd.
- 9-3-1 Software License Agreement
- 9-4 Free Software License Information.
- 9-5 Free Software Module User License Agreement
- 9-5-1 GNU GENERAL PUBLIC LICENSE Version
- 9-5-2 GNU GENERAL PUBLIC LICENSE Version 2 with Exception
- 9-5-3 GNU LESSER GENERAL PUBLIC LICRNSE Version 2.1
- 9-3 McAfee Embedded Control. ©Hitachi Aloka Medical, Ltd.
Safety Precautions
10 | Precautions MN1-5908 rev.
©Hitachi Aloka Medical, Ltd.
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.
The safety symbols have the meanings shown below.
Indicates an imminently hazardous situation which, if not avoided, may result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.
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.
This kind of symbol means attention is required.
This symbol means the noted action is prohibited.
This symbol means the noted action is required.
Safety Precautions
MN1-5908 rev.2 Precautions | 11
©Hitachi Aloka Medical, Ltd.
1-1-1 Warnings and safety information
DO NOT use this instrument in a flammable atmosphere. Use of this instrument in a flammable atmosphere may cause an explosion.
DO NOT attempt to repair the instrument. Do not disassemble. Do not modify (replacement of the power cable is also impossible).*1, * 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.
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.
Do not install this instrument or optional equipment without our approval. Nor should you transport it.*1, * 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:
- A flat 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 burns 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 not touch 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.
Safety Precautions
MN1-5908 rev.2 Precautions | 13
©Hitachi Aloka Medical, Ltd.
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. Do not catch probe cables on the monitor. Contact with the monitor may result in injury, or in damage to peripheral equipment, main unit, monitor, or touch panel. Warn 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 scanner is damaged, stop using it immediately and contact our office.
Do not touch the inner tube or interior of the Jelly warmer while it is powered, or soon after it is switched off. The interior of the Jelly warmer could be hot, which could result in the operator getting burned.
When using the Jelly warmer, always check that the Echo jelly does not get too hot. Burns to the patient could result. Be sure to use Echo jelly and Echo jelly bottles that we market.
Safety Precautions
14 | Precautions MN1-5908 rev.
©Hitachi Aloka Medical, Ltd.
1-1-2 Label
A label stating the content of this clause is affixed to the instrument.
NOTE: Refer to the documentation for the probe concerning labels affixed to the probes.
The following are standard precautions about connection terminals.
The next label indicates that there is the risk of pinching your hands in gaps etc.
Keep your hands away from the connection terminals. Electrostatic discharge could occur, which can cause parts that are sensitive to static electricity to deteriorate or fail. For details, refer to the ESD Guidelines.
Take care to avoid trapping your fingers. There is a risk of electric injury.
Connecting probe connectors. The numbers (1~3) are connector numbers.
Dummy connector. Even if a probe is connected to this socket, no ultrasonic images will be displayed.
Safety Precautions
16 | Precautions MN1-5908 rev.
©Hitachi Aloka Medical, Ltd.
17 inch monitor 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.
17 inch monitor 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.
Connection terminals for physiological signals (for connecting physiological cables)
This shows a type BF applied part.
: External input terminal.
LAN cable connection socket.
Safety Precautions
MN1-5908 rev.2 Precautions | 17
©Hitachi Aloka Medical, Ltd.
Connecting USB connectors.
Equipotential terminal.
This shows the manufacturer name, model name, and other information.
Year of manufacture mark (the number under the mark indicates the year of manufacture).
Manufacturer.
This shows safety precautions, etc.
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
DO NOT use this instrument in a flammable atmosphere. Use of this instrument in a flammable atmosphere could cause an explosion.
Beware of electric shock
Plug the power cable provided directly into a hospital-grade power outlet. There is a risk of short-circuit and electric shock.
Beware of acoustic output
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
Take care to avoid trapping your fingers in unexpected locations. You may pinch your fingers and cause injury.
Follow the supplied documentation
Operate this instrument as described in the instruction manual. Not doing so could result in injury to the patient or operator and damage to the instrument or its peripheral devices.
Precautions Concerning Acoustic Output
MN1-5908 rev.2 Precautions | 19
©Hitachi Aloka Medical, Ltd.
1-2 Precautions Concerning Acoustic Output
The body consist of soft tissues, water, bone, and other tissues. Ultrasound energy is absorbed, reflected,
dispersed, and attenuated as it reaches deep into the body. Tissues behind fluids which cause less
attenuation will receive relatively large amounts of ultrasound energy.
It is necessary to be careful of bioeffects due to heat in the vicinity of tissues, such as bone, that readily
convert ultrasound energy into heat. In particular, in a fetus at the bone formation stage almost all of
the ultrasound energy passes through the amniotic fluid without being attenuated. That raises the
danger from heating.
Even in a fetus prior to bone development, the cells are active, hence there is a possibility of growth
being affected, even when the temperature rise is low.
Mechanical bioeffects such as vibration and cavitation occur when the body is exposed to ultrasound
energy for a long period. Therefore, you can reduce the risk of damage to the tissues by interrupting the
emission of ultrasound energy before it reaches the level at which tissue damage occurs.
To this end, it is necessary to obtain a grasp of the functions of the instrument, 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 diagnostic
information.
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.
The display can be switched to show an acoustic power index suitable for the target region. There is the possibility of effects on the internal tissues of the patient. Ultrasound energy is converted into heat in the body while being attenuated. Particularly, there is a greater possibility of heat being generated in bone and the cranium compared to soft tissue.
Do not use Doppler modes for routine fetal examinations. Doppler modes in fetal examinations are only to be used where clinically indicated, such as in known or suspected high risk pregnancies.
Precautions Concerning the Probe
20 | Precautions MN1-5908 rev.
©Hitachi Aloka Medical, Ltd.
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.
- Do not 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.
In order to prevent burns or injury
- Before using, coat probe adequately with Echo jelly.
- Do not 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.
In order 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.