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Instruction for use ARIETTA 60 hitacho aloka
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©Hitachi Aloka Medical, Ltd.
2 | Instruction for use MN1-5908 rev.
©Hitachi Aloka Medical, Ltd.
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
10 | Precautions MN1-5908 rev.
©Hitachi Aloka Medical, Ltd.
1-1 Safety Precautions
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.
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:
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.
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.
14 | Precautions MN1-5908 rev.
©Hitachi Aloka Medical, Ltd.
1-1-2 Label
NOTE: Refer to the documentation for the probe concerning labels affixed to the probes.
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.
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.
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.
MN1-5908 rev.2 Precautions | 19
©Hitachi Aloka Medical, Ltd.
1-2 Precautions Concerning Acoustic Output
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.
20 | Precautions MN1-5908 rev.
©Hitachi Aloka Medical, Ltd.
1-3 Precautions Concerning the Probe
1-3-1 Handling precautions
These probes are precision instruments. Take care not to damage probes.
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.
Do not allow Echo jelly, water or any other foreign matter to dry on the probes.
Currently, there are no methods for washing, disinfecting, and sterilizing intraoperative probes which have been used on patients afflicted by Creutzfeldt-Jacob disease.