Hitachi UST-5550 User manual

i
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.
Intraoperative Electronic Linear Probe
UST-5550 (Compatible with waterproof cover)
Instruction Manual
M N1-5575 Rev.11

MN1-5575 Rev.11
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MN1-5575 Rev.11
This is an instruction for model UST-5550, 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.
War ning
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

MN1-5575 Rev.11
iv
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............................................................4
1-2-3. Labels........................................................................................................................6
2. Specications and Parts name
2-1. Principles of operation....................................................................................................11
2-2. Specications..................................................................................................................12
2-2-1. Specications of the probe..........................................................................................12
2-2-2. Specications of the protect tube ..................................................................................13
2-3. Performance....................................................................................................................14
2-4. Names of each parts........................................................................................................14
2-5. Environmental conditions..............................................................................................15
2-5-1. Operating environmental conditions ............................................................................15
2-5-2. Storage environmental conditions ...............................................................................15
2-6. Classication of ME equipment .....................................................................................15
3. Preparations for Use
3-1. Start up check .................................................................................................................17
3-1-1. Visual check .............................................................................................................17
3-1-2. Deection portion operation check ...............................................................................17
3-1-3. Trocar connection check .............................................................................................17
3-1-4. Probe insertion check .................................................................................................18
3-1-5. Verication of operation ............................................................................................18
3-1-6. Verication of cleaning, disinfection and sterilization .....................................................18
4. Usage
4-1. Operation ........................................................................................................................19
4-1-1. Operation of each part ................................................................................................19
4-1-2. Preparations of the protect tube ....................................................................................20
4-1-3. Insertion of the probe .................................................................................................20
4-1-4. Pulling out the probe ..................................................................................................22
4-2. Connecting to the ultrasound diagnostic instrument ......................................................24

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MN1-5575 Rev.11
4-3. Removing from the ultrasound diagnostic instrument ...................................................25
4-4. Actions to be taken when an abnormal state is detected.................................................26
4-4-1. Ensuring safety of patients..........................................................................................26
4-4-2. Handling the instrument ............................................................................................26
5. Cleaning, disinfection and sterilization
5-1. Precautions for cleaning, disinfection and sterilization..................................................28
5-2. Reprocessing instruction according to ISO 17664 .........................................................30
5-3. Point of use (Pre-cleaning) .............................................................................................32
5-4. Waterproof cover ............................................................................................................32
5-5. Containment and transportation......................................................................................32
5-6. Manual cleaning and disinfection...................................................................................33
5-6-1. Manual cleaning ........................................................................................................34
5-6-2. Manual disinfection ...................................................................................................35
5-6-3. Cable and connector .................................................................................................................... 36
5-7. Automated cleaning and disinfecting .............................................................................36
5-8. Applicable cleaners and disinfectants / Suppliers List ...................................................38
5-9. Drying.............................................................................................................................40
5-10. Maintenance, inspection and testing.............................................................................40
5-11. Packaging......................................................................................................................40
5-12. Sterilization...................................................................................................................41
5-12-1. Ethylene oxide (EtO) gas sterilization..........................................................................41
5-12-2. STERRAD®sterilization...........................................................................................42
5-12-3. Liquid sterilization (USA only)................................................................................................. 43
5-12-4. STERIS®sterilization................................................................................................................ 43
5-13. Storage..........................................................................................................................43
6. Storage
6-1. Actions before storing the probe..................................................................................45
6-2. Environmental conditions for storage............................................................................45
7. Moving and Transporting
7-1. Moving and transporting ..............................................................................................47
7-2. Preparing the probe and accessories for moving ............................................................47
7-3. Packing for transportation ............................................................................................47
7-4. Environmental conditions during transportation .........................................................47

MN1-5575 Rev.11
vi
8. Periodic Inspection
8-1. Safety tests.....................................................................................................................49
8-2. Testing of measurement tolerances.................................................................................50
8-2-1. Conducting tests ...........................................................................................................50
8-2-2. Result judgement .........................................................................................................50
9. Conguration
9-1. Standard conguration...................................................................................................51
9-2. Options............................................................................................................................51
10. Disposal of the Device .......................................................................................................53
This Instruction Manual contains the main body of 54pages and 6pages until the CONTENTS.

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MN1-5575 Rev. 11
1. Safety Precautions
1-1. Intended use
This probe is intended for use by a doctor when placed into direct contact with human internal organs during
surgery making ultrasonic observations.
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.
War ning
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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MN1-5575 Rev. 11
1-2-1. Warnings and safety information
War ning
Follow the information in this manual and the documentation supplied with any equipment used
together with this probe.
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 equipment while failing to notice an abnormal condition can result in injury to the operator
or patient. If any abnormalities are noted on the probe 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.
This equipment must not be used in direct contact with the heart.
This may cause patient to receive an electric shock.
Do not use on the eyes.
This probe 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 probe.
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 probe.
Perform proper cleaning, disinfection and sterilization after use.
Otherwise, there is a risk of infection. Note that the probe is not sterilized at the factory.
Before using the probe rst, be sure to clean, disinfect and sterilize it.
Be sure to sterilize the equipment which blood adhered.
Otherwise, there is a risk of infection. Also be sure to remove the cap from the protect tube before
washing.
Always use a protective tube.
If the probe is damaged during operation, the patient can be injured.
Use a trocar outer sheath with a diameter of 12 mm ( length 170mm or less ) for the protect tube.
When the trocar outer sheath is not the right size, the tube can be loose or difcult to insert and could
result in a hazardous situation.
Attach the protective tube correctly to the trocar outer sheath.
The patient can be injured if the protective tube moves unexpectedly or comes off during the
operation. Also, if the cap is not attached correctly, the lled gas inside the patient's body will be
released, making it difcult to perform the procedure.
Do not try to forcibly perform operations.
Excessive force cause injury to the patient. If an abnormal resistance force is felt, stop use of the
equipment.
To pull out the probe, unlock the angle knob, straighten the deection portion and pull out slowly
and gently.
Pulling out with excessive force can result in an injury to the patient. If you feel resistance on the
probe, such as it catching on something, do not apply excessive force and perform an internal visual
check for any problems.

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MN1-5575 Rev. 11
War ning
During surgery, be sure to wear sterilized medical gloves.
Conducting examinations with the bare hands can expose the operator to a risk of infection.
For the acoustic medium, use sterilized physiological saline.
Using an unsterilized ultrasound medium can cause an infection on the patient.
Dispose the probe used for patients with Creutzfeldt-Jakob disease.
Otherwise, there is a risk of infection to the operator or patient. Our ultrasound probe 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 equipment 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 equipment.
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
equipment away from the patient and stop use of the equipment.
The equipment is vulnerable to damage by impact. Therefore, handle it with care.
There is a risk of damage to the equipment when the equipment is fallen or hit somewhere.
Do not use this probe 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 probe and the other equipment.
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.
Do not use it in continuous contact with the human body more than 60 minutes.
Overuse can adversely affect the internal tissues of the patient.
Regularly perform maintenance inspection and safety tests of the equipment.
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 equipment 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".

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MN1-5575 Rev. 11
1-2-2. Cleaning, disinfection and sterilization precautions
War ning
Wear protective gloves and other protective gear during cleaning, disinfection and sterilization.
Handling of the equipment with your bare hands before sterilization can result in an infection.
After soaking in cleaning agents, thoroughly wash the probe 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 equipment 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 sterilization.
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 equipment or reduced performance. The equipment cannot withstand autoclave steril-
ization or boiling and other types of sterilization at temperatures exceeding 60°C (140°F).
For details on the usage conditions of chemicals and sterilization procedures, refer to the documentation
supplied with the respective chemical or sterilization equipment.
Infection could result due to incomplete sterilization. This could also cause deterioration of the
equipment.