Hitachi UST-5412 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 Linear Probe
UST-5412
Instruction Manual
M N1-5163 Rev.18

MN1-5163 Rev.18
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MN1-5163 Rev.18
This is an instruction for model UST-5412, an ultrasound probe.
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 probe indicates that this probe 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
probe 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

MN1-5163 Rev.18
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CONTENTS
1. Safety Precautions
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
2-1. Principles of operation......................................................................................................9
2-2. Specications..................................................................................................................10
2-3. Performance....................................................................................................................11
2-4. Names 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
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
4-1. Operation ........................................................................................................................15
4-2. Connecting to the ultrasound diagnostic instrument ......................................................16
4-3. Removing from the ultrasound diagnostic instrument ...................................................17
4-4. Precautions when performing puncture operations ........................................................18
4-5. Actions to be taken when an abnormal state is detected.................................................19
4-5-1. Ensuring safety of patients..........................................................................................19
4-5-2. Handling the instrument ............................................................................................19
5. Cleaning, disinfection and sterilization
5-1. Precautions for cleaning, disinfection and sterilization..................................................22
5-2. Reprocessing instruction according to ISO 17664 .........................................................23
5-3. Point of use (Pre-cleaning) .............................................................................................25
5-4. Containment and transportation......................................................................................25

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MN1-5163 Rev.18
5-5. Manual cleaning and disinfection...................................................................................26
5-5-1. Manual cleaning ........................................................................................................26
5-5-2. Manual disinfection ...................................................................................................27
5-5-3. Cable and connector...................................................................................................27
5-6. Automated cleaning and disinfecting .............................................................................28
5-7. Applicable cleaners and disinfectants / Suppliers List ...................................................29
5-8. Drying.............................................................................................................................31
5-9. Maintenance, inspection and testing...............................................................................31
5-10. Packaging......................................................................................................................31
5-11. Sterilization...................................................................................................................32
5-11-1. Ethylene oxide (EtO) gas sterilization..........................................................................32
5-11-2. STERRAD®sterilization...........................................................................................33
5-11-3. Liquid sterilization (USA only)...................................................................................34
5-12. Storage..........................................................................................................................34
6. Storage
6-1. Actions before storing the probe.................................................................................35
6-2. Environmental conditions for storage............................................................................35
7. Moving and Transporting
7-1. Moving and transporting ..............................................................................................37
7-2. Preparing the probe and accessories for moving ............................................................37
7-3. Packing for transportation ............................................................................................37
7-4. Environmental conditions during transportation .........................................................37
8. Periodic Inspection
8-1. Safety tests.....................................................................................................................39
8-2. Testing of measurement tolerances.................................................................................40
8-2-1. Conducting tests ...........................................................................................................40
8-2-2. Result judgement .........................................................................................................40
9. Conguration
9-1. Standard conguration...................................................................................................41
9-2. Options............................................................................................................................41
10. Disposal of the Device .......................................................................................................43
This Instruction Manual contains the main body of 44pages and 5pages until the CONTENTS.