Hitachi ASU-1014 User manual

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Notes for operators and responsible maintenance personnel
★
Please read through this Instruction Manual carefully prior to use.
★
Keep this Instruction Manual together with the ultrasound diagnostic instru-
ment for any future reference.
© Hitachi, Ltd. 2013, 2017. All rights reserved.
Electronic Convex Sector Scanner
ASU-1014
Instruction Manual
M N1-5933 Rev.5

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MN1-5933 Rev.5

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MN1-5933 Rev.5
This is an instruction for model ASU-1014, an ultrasound scanner.
Read the manual carefully before using the instrument. Take special note of the items in section 1, "Safety
Precautions".
Keep this manual securely for future reference.
The CE mark on the scanner indicates that this scanner is valid when it is connected to equipment
bearing the CE mark that is specied as available in section 2 of this document. Therefore, if a
scanner bearing the CE mark is connected to equipment that is specied as available but does not
have a CE mark, part of this instruction manual may not apply.
Symbols used in this document
The terms below are used in the safety information provided to prevent hazards and injuries to the operator
or patients. The severity of the hazard and injury that can occur when failing to observe the displayed safety
information are indicated in four levels: "Danger","Warning","Caution" and "Note".
Danger
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury to
the operator or patient.
Warning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury to
the operator or patient.
Caution
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to
the operator or patient, or property damage only.
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 efciently.
The type of safety information is indicated by the symbols below.
This symbol means attention is required.
This symbol means that the described action is prohibited.
This symbol means the described action is mandatory.
Introduction

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MN1-5933 Rev.5
CONTENTS
1. Safety Precautions......................................................................................................................................1
1-1. Intended use...................................................................................................................................................................1
1-2. Usage precautions..........................................................................................................................................................1
1-2-1. Warnings and safety information ...................................................................................................................2
1-2-2. Cleaning, disinfection and sterilization precautions ......................................................................................3
1-2-3. Labels ..............................................................................................................................................................4
2. Specications and Parts name....................................................................................................................9
2-1. Principles of operation ..................................................................................................................................................9
2-2. Specications ..............................................................................................................................................................10
2-3. Performance ................................................................................................................................................................11
2-4. Name of each parts .....................................................................................................................................................11
2-5. Environmental conditions ...........................................................................................................................................12
2-5-1. Operating environmental conditions............................................................................................................12
2-5-2. Storage environmental conditions................................................................................................................12
2-6. Classication of ME equipment .................................................................................................................................12
3. Preparations for Use .................................................................................................................................13
3-1. Start up check ..............................................................................................................................................................13
3-1-1. Visual check ..................................................................................................................................................13
3-1-2. Verication of cleaning, disinfection and sterilization ................................................................................13
3-1-3. Verication of operation ...............................................................................................................................13
4. Usage........................................................................................................................................................15
4-1. Operation.....................................................................................................................................................................15
4-2. Connecting to the ultrasound diagnostic instrument .................................................................................................16
4-3. Removing from the ultrasound diagnostic instrument...............................................................................................17
4-4. Actions to be taken when an abnormal state is detected............................................................................................18
4-4-1. Ensuring safety of patients...........................................................................................................................18
4-4-2. Handling the instrument ..............................................................................................................................18
5. Cleaning, disinfection and sterilization ...................................................................................................19
5-1. Precautions for cleaning, disinfection and sterilization..............................................................................................20
5-2. Reprocessing instruction according to ISO 17664 .....................................................................................................21
5-3. Point of use (Pre-cleaning)..........................................................................................................................................23
5-4. Containment and transportation.................................................................................................................................23
5-5. Manual cleaning and disinfection ..............................................................................................................................24

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MN1-5933 Rev.5
This Instruction Manual contains the main body of 40pages and 5pages until the CONTENTS.
5-5-1. Manual cleaning ...........................................................................................................................................24
5-5-2. Manual disinfection .....................................................................................................................................25
5-5-3. Cable and connector .....................................................................................................................................25
5-6. Automated cleaning and disinfecting ........................................................................................................................26
5-7. Applicable cleaners and disinfectants / Suppliers List ...............................................................................................27
5-8. Drying.........................................................................................................................................................................29
5-9. Maintenance, inspection and testing...........................................................................................................................29
5-10. Packaging ..................................................................................................................................................................29
5-11. Sterilization................................................................................................................................................................30
5-11-1. Liquid sterilization (USA only)...................................................................................................................30
5-12. Storage .......................................................................................................................................................................30
6. Storage ..................................................................................................................................................... 31
6-1. Actions before storing the scanner..............................................................................................................................31
6-2. Environmental conditions for storage.........................................................................................................................31
7. Moving and Transporting.........................................................................................................................33
7-1. Moving and transporting.............................................................................................................................................33
7-2. Preparing the scanner and accessories for moving.....................................................................................................33
7-3. Packing for transportation...........................................................................................................................................33
7-4. Environmental conditions during transportation .......................................................................................................33
8. Periodic Inspection...................................................................................................................................35
8-1. Safety tests...................................................................................................................................................................35
8-2. Testing of measurement tolerances.............................................................................................................................36
8-2-1. Conducting tests ...........................................................................................................................................36
8-2-2. Result judgement ..........................................................................................................................................36
9. Conguration ...........................................................................................................................................37
9-1. Standard conguration................................................................................................................................................37
10. Disposal of the Device............................................................................................................................39

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MN1-5933 Rev.5

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MN1-5933 Rev.5
1. Safety Precautions
1-1. Intended use
This scanner is intended for use by a doctor or other qualied operator when placed into direct contact with
the skin making ultrasonic observations of surrounding organs.
Caution
Do not use this equipment for other than its intended purpose.
Use for other purposes can cause burns or other injuries to the patient or operator.
1-2. Usage precautions
The terms below are used in the safety information provided to prevent hazards and injuries to the operator
or patients. The severity of the hazard and injury that can occur when failing to observe the displayed safety
information are indicated in four levels: "Danger","Warning","Caution" and "Note".
Danger
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury to
the operator or patient.
Warning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury to
the operator or patient.
Caution
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to
the operator or patient, or property damage only.
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 efciently.
The type of safety information is indicated by the symbols below.
This symbol means attention is required.
This symbol means that the described action is prohibited.
This symbol means the described action is mandatory.

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MN1-5933 Rev.5
1-2-1. Warnings and safety information
Warning
Follow the information in this manual and the documentation supplied with any equipment used
together with this scanner.
Use that is not in accordance with the supplied documentation can result in a serious or moderate
injury, equipment breakdown, or physical damage that impairs operation.
Be sure to preparations for use.
Use of the scanner while failing to notice an abnormal condition can result in injury to the operator
or patient. If any abnormalities are noted on the scanner in the start up inspection, immediately stop
using it and contact one of our ofces and/or distributor's ofces listed on the back cover. See section
3-1 “Start up check” for the start up inspection content and procedure.
Do not use on the eyes.
This scanner is not intended for use on the eyes. The acoustic output can have an adverse effect on
the eyes.
Do not attempt to disassemble, modify, or repair the scanner.
Electric shock or other unforeseen accidents could result. Contact one of our ofces and/or distributor's
ofces listed on the back cover to request repair.
Clean, disinfect and sterilize before using the scanner.
Perform proper cleaning, disinfection and sterilization after use.
Otherwise, there is a risk of infection. Note that the scanner is not sterilized at the factory.
Before using the scanner rst, be sure to clean, disinfect and sterilize it.
Wear medical gloves during examination.
Conducting examinations with the bare hands can expose the operator to a risk of infection.
Dispose the scanner used for patients with Creutzfeldt-Jakob disease.
Otherwise, there is a risk of infection to the operator or patient. Our scanner is not compatible with
any disinfection/sterilization method for Creutzfeldt-Jakob disease.
When using ultrasound contrast agent, follow the supplied documentation.
Unexpected accidents could result. Check the state of the patient and take appropriate precautions to
avoid side effects.
Do not use the scanner fallen on to oor.
Ohterwise, there is a risk of infection. Stop the operation and perform the procedure in section 8
"Periodic Inspection" section 5 "Cleaning, disinfection and sterilization" and section 3-1 "Start up
check".
Caution
Constantly check for anything abnormal about the patient’s condition and scanner.
Continued use without noticing that an abnormal condition has occurred can result in an electric
shock and injury to the operator or patient. If an abnormal condition occurs, immediately move the
scanner away from the patient and stop use of the scanner.
The scanner is vulnerable to damage by impact. Therefore, handle it with care.
There is a risk of damage to the scanner when the scanner is fallen or hit somewhere.
Do not use this scanner with other equipment except for those specically approved in the manual.
Use with unapproved equipment can result in an electric shock, burn, or other injury to the patient or
operator and damage to the scanner and the other equipment.

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MN1-5933 Rev.5
Scan for the minimum length of time necessary for the diagnosis and at the lowest suitable output.
Overuse can adversely affect the internal tissues of the patient.
For details about the acoustic output, please refer to the documentation supplied with the ultrasound
diagnostic instrument.
Regularly perform maintenance inspection and safety tests of the ultrasound diagnostic instrument
and scanner.
If you use equipment for a long period of time, it can reduce the performance, or cause smoke or
re. If anything unusual occurs, immediately stop using it and contact one of our ofces and/or
distributor's ofces listed on the back cover.
Use, move and transport the scanner under the environmental conditions specied in this manual.
Otherwise, it may be damaged.
See section 2-5 "Environmental conditions" and section 7-4 "Environmental conditions during
transportation".
1-2-2. Cleaning, disinfection and sterilization precautions
Warning
Wear protective gloves and other protective gear during cleaning, disinfection and sterilization.
Handling of the scanner with your bare hands before disinfection can result in an infection.
After soaking in cleaning agents, thoroughly wash the scanner with running water.
Residual cleaning agents can cause an adverse reaction on the bodies of the operator or patient.
After soaking in a disinfectant, throughly wash the scanner with deionized water. Leavings of the
disinfectant can cause an adverse reaction on the bodies of the operator or patient.
Perform aeration completely after gas disinfection.
Residual gas can cause an adverse reaction on the bodies of the operator or patient.
Do not clean, disinfect or sterilize using procedures other than those specied in this manual.
Infection could result due to incomplete cleaning, disinfection and sterilization. It can also result in
damage to the scanner or reduced performance. The scanner cannot withstand autoclave sterilization
or boiling and other types of sterilization at temperatures exceeding 50°C (122°F).
For details on the usage conditions of chemicals procedures, refer to the documentation supplied with
the respective chemical equipment.
Infection could result due to incomplete disinfection. This could also cause deterioration of the
scanner.
Caution
Do not immerse the probe in any liquids beyond the range of IPX7 shown in section 2-2 "Specications".
Use when liquid has gotten inside the connector can result in a risk of electric shock to the operator
or patient. If liquid gets inside the connector, immediately stop use and contact one of our ofces and/
or distributor's ofces listed on the back cover.

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MN1-5933 Rev.5
㻞㻙㻝㻢㻙㻝㻘㻌㻴㼕㼓㼍㼟㼔㼕㻙㼁㼑㼚㼛㻘㻌㼀㼍㼕㼠㼛㻙㼗㼡㻘㻌㼀㼛㼗㼥㼛㻘㻌 㻝㻝㻜㻙㻜㻜㻝㻡㻘㻌㻶㼍㼜㼍㼚㻌㻌㻌㼀㻱㻸㻌㻗㻤㻝㻙㻟㻙㻢㻞㻤㻠㻙㻟㻢㻢㻤
Label 3
Label 2
Label 1
Label 1
1-2-3. Labels
(1) Scanner unit
Electronic convex mark
Frequency