Hitachi UST-9120 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 Convex Probe
UST-9120 (Compatible with waterproof cover)
Instruction Manual
M N1-5531 Rev.10

MN1-5531 Rev.10
ii

iii
MN1-5531 Rev.10
This is an instruction for model UST-9120, 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

MN1-5531 Rev.10
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. Precautions when using the probe in neurosurgery applications ...................................................4
1-2-3. Cleaning, disinfection and sterilization precautions............................................................5
1-2-4. Labels........................................................................................................................7
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. Transducer cover when using the probe in neurosurgery application......................................... 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. Verication of cleaning, disinfection and sterilization.......................................................17
3-1-3. Verication of operation..............................................................................................17
4. Usage
4-1. Operation ........................................................................................................................19
4-2. Connecting to the ultrasound diagnostic instrument ......................................................20
4-3. Removing from the ultrasound diagnostic instrument ...................................................21
4-4. Precautions when performing puncture operations ........................................................22
4-5. When using the probe for neurosurgery applications ....................................................24
4-5-1. How to attach the transducer cover ...............................................................................24
4-5-2. How to remove the transducer cover .............................................................................24
4-5-3. How to puncture using MP-2458 ..................................................................................25
4-5-4. How to remove the puncture adapter (MP-2458) .............................................................25
4-5-5. How to puncture using CIVCO bracket .........................................................................26

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MN1-5531 Rev.10
4-5-6. How to remove CIVCO biopsy needle guide and CIVCO bracket ......................................26
4-6. Precautions when using the probe in neurosurgery applications....................................27
4-7. Actions to be taken when an abnormal state is detected.................................................28
4-7-1. Ensuring safety of patients..........................................................................................28
4-7-2. Handling the instrument ............................................................................................28
5. Cleaning, disinfection and sterilization
5-1. Precautions for cleaning, disinfection and sterilization..................................................30
5-2. Reprocessing instruction according to ISO 17664 .........................................................32
5-3. Point of use (Pre-cleaning) .............................................................................................34
5-4. Waterproof cover ............................................................................................................34
5-5. Containment and transportation......................................................................................34
5-6. Manual cleaning and disinfection...................................................................................35
5-6-1. Manual cleaning ........................................................................................................35
5-6-2. Manual disinfection ...................................................................................................36
5-6-3. Cable and connector .................................................................................................................... 36
5-7. Automated cleaning and disinfecting .............................................................................37
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

MN1-5531 Rev.10
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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MN1-5531 Rev. 10
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.
With the exception of Japan, you can use the probe in neurosurgery applications if you attach our recommended
transducer cover to the probe. When using the probe in neurosurgery applications, refer to Section 1-2-2 under
“Precautions when using the probe in neurosurgery applications”.
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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MN1-5531 Rev. 10
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 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 probe 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 probe 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.
With the exception of Japan neurosurgery applications are possible if our recommended transducer
cover is attached to our probe.
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 distribu-
tor'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 probe which blood adhered.
Otherwise, there is a risk of infection.
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 probe 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".

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MN1-5531 Rev. 10
Caution
Constantly check for anything abnormal about the patient’s condition and probe.
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
probe away from the patient and stop use of the probe.
The probe is vulnerable to damage by impact. Therefore, handle it with care.
There is a risk of damage to the probe when the probe 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 ultrasound diagnostic instrument
and probe.
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 probe 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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MN1-5531 Rev. 10
1-2-2. Precautions when using the probe in neurosurgery applications
Warning
When using this probe in neurosurgery applications, attach our recommended transducer cover to
the probe. Failure to properly use the transducer cover may cause harm to the patient.
Use our recommended transducer cover.
If you use a transducer cover which is not recommended by our company, it may cause harm to the
patient due to tearing or pyrogen.
Do not use the transducer cover attached to CIVCO biopsy needle guide as a standard in neurosur-
gery application.
Verify that the transducer cover packaging has not been opened or damaged.
If you use a contaminated transducer cover, it may cause patient infection although our recom-
mended transducer cover is sterilized.
Verify that there is nothing wrong with the transducer cover.
Store the transducer cover according to its instruction. Do not use the transducer cover if the expira-
tion date has passed, if it is discolored, or if there is visible damage, such as a tear.
Take precaution in handling the transducer cover so as not to break it as this may then result in
direct contact with the edge of bone during a craniotomy.
If the transducer cover breaks, it may cause harm to the patient.
Verify that there is nothing wrong with the transducer cover and that the puncture adapter is
properly attached on the transducer when puncturing.
If you attach the puncture adapter incorrectly, it may come off during the procedure, or it may be
punctured into a non intended area. Refer to the details on Section 4-5-3 “How to puncture using
MP-2458” and Section 4-5-5 “How to puncture using CIVCO bracket”.
Properly use the transducer cover and puncture needle according to this instruction.
If used incorrectly, it may cause patient or user injury.
Verify that the probe is sterilized. Use the sterilized echo jelly attached to our recommended
transducer cover as the acoustic medium.
If you use contaminated ones, it may cause patient infection.
Concerning CIVCO products, follow the guidelines sterilization of CIVCO.
Verify that there are no bubbles of the acoustic medium inside of the transducer cover.
If there are bubbles inside the transducer cover, they may cause clinical images changed and
erroneous display on the monitor leading to misdiagnosis.
When removing the transducer cover, do not pull it forcibly.
If you use excessive force, it may cause probe damage or scattering of contaminated material.
Do not reuse the transducer cover.
If you reuse the transducer cover, it may cause patient infection.
Caution
When disposing the transducer cover, take appropriate measures for prevention of infection.
If you dispose it improperly, it may cause environmental damage.

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MN1-5531 Rev. 10
1-2-3. Cleaning, disinfection and sterilization precautions
Warning
Wear protective gloves and other protective gear during cleaning, disinfection and sterilization.
Handling of the probe 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 probe or reduced performance. The probe cannot withstand autoclave sterilization 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 or sterilization. This could also cause deterioration of the
probe.

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MN1-5531 Rev. 10
Caution
Attach the waterproof cover if the connector will be soaked in liquid.
If the connector is soaked in liquid without the waterproof cover, liquid can get inside and result in
malfunction.
Attach the waterproof cover to the probe and use it by following the instructions in the waterproof
cover manual. Using the wrong combination of the probe and the waterproof cover, incorrectly
mounting the waterproof cover, or using the probe without properly mounting the cover can cause
the probe to malfunction.
Do not use a waterproof cover where a problem has been found.
Using a waterproof cover in an abnormal state can cause injury to the user. Contact one of our ofces
and/or distributor's ofces listed on the back cover.
Do not use the waterproof cover in sterilization that applies changes in pressure.
Using ethylene oxide gas sterilization, low-temperature plasma
sterilization, or other sterilization methods that apply changes in pressure can
damage the probe and the waterproof cover. In these cases, do not use the waterproof cover.
After soaking in chemical solution, check that no liquid has entered into the connector.
If liquid appears to have entered the connector, immediately stop use and contact one of our ofces
listed on the back cover.
Do not use the waterproof cover if the packing has been removed before.
The waterproof cover will not function correctly even if packing that was removed is returned to its
original location. Replace it by a new waterproof cover.
When cleaning the waterproof cover, do not deform the packing by applying unnecessary force.
Use of the waterproof cover while the packing is deformed can cause liquid to enter the probe
resulting in malfunction.
Do not rub the packing of the waterproof cover with a brush.
This could damage the packing. Use of the waterproof cover while the packing is damaged can cause
liquid to enter the probe resulting in malfunction.
Be sure to store the waterproof cover by removing it from the connector.
If the waterproof cover is stored while connected to the probe, the packing can become deformed.
Replace the waterproof cover around two years after it is commercing for use.
The packing for preventing liquid deteriorates with time.
For safe use, replace the waterproof cover by a new one typically two years.

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MN1-5531 Rev. 10
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
1-2-4. Labels
(1) Probe unit
Electronic convex probe mark
Frequency

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MN1-5531 Rev. 10
Label 3
Label 2
STERRAD sterilization compatibility mark
See section 5.
IPX7 mark
See section 2-2, “Specications”.
Type BF applied part
Do not waste the instrument as general waste. Comply
with a local regulation.
See section 10.
Safety warning sign
Biohazard
See section 5.
Follow the instruction manual to operate this instrument.
If not avoided, may result in injury, property damage, or
the equipment trouble.
IPX7
This instrument complies with Directive 93/42/EEC
relating to Medical Device and Directive 2011/65/EU
relating to RoHS.
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
Model
Serial No.
Manufacturer
Address
Rx Only:
By prescription only. U.S. Federal Law
restricts this device to sale on order of a
physician only.

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MN1-5531 Rev. 10
Label A
(2) Storage case
Label B

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MN1-5531 Rev. 10
Label A
Label B
Model
Serial No.
2016-09
DATE OF MANUFACTURE
(in case of 2016-09)
MANUFACTURER
AUTHORISED REPRESENTATIVE IN EUROPEAN
COMMUNITY
This instrument complies with Directive 93/42/EEC
relating to Medical Device and Directive 2011/65/EU
relating to RoHS.
2016-09
Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205
Wiesbaden, Germany
P-3258F

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MN1-5531 Rev. 10
2. Specications and Parts name
2-1. Principles of operation
This probe and the ultrasound diagnostic instrument enable image diagnosis using ultrasonic waves. These
instruments operate under the principles described below.
(1) When an electric pulse signal is applied from the transmitter to the transducer of the probe, the transducer
operates by converting electrical vibrations to mechanical vibration energy for emitting pulse-shaped
ultrasonic waves into the body part contacting the transducer or into liquid or other medium.
(2) The emitted ultrasonic waves are reected by boundaries with different acoustic characteristics (acoustic
impedance) within the body.
(3) The transducer is also used to receive reected ultrasonic waves. The transducer vibrates mechanically due
to the received ultrasonic vibrations and uses an electro-mechanical conversion operation to convert the
received mechanical vibrations to electric energy. The received echo is also converted to electric signals
and a brightness modulation operation is used to convert the electric pulses to shades of brightness for
forming an image.

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MN1-5531 Rev. 10
2-2. Specications
2-2-1. Specications of the probe
Application regions: Intraoperative diagnosis
With the exception of Japan neurosurgery applications are possible if
our recommended transducer cover is attached to our probe.
Form of application to patient: Intraoperative
With the exception of Japan neurosurgery applications are possible if
our recommended transducer cover is attached to our probe.
Connectable instruments: SSD-α5,SSD-α10,Prosound α7,Prosound F75
Field of view: 65°
Frequency: 4～10MHz
Cable length: 3.0 m
Weight: 800 g
Service life: Three years
Range of applied part As shown in the gure below.
Parts treated as applied parts Probe tip itself and 20 cm of the cable near the probe tip.
IPX7 range As shown in the gure below.(waterproof cover MP-2790 unattached)
Whole parts of the probe. (waterproof cover attached)
External dimensions: As shown in the gure below.
Remarks
The dimensions and weight are within ±10% of the indicated values.
Unit: mm
Cable length
Range of applied part
IPX7 range
1000

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MN1-5531 Rev. 10
2-2-2.Transducer cover when using the probe in neurosurgery application
CIVCO Transducer cover 610-1107 , 610-1107-EU
This transducer cover can be used in neurosurgery applications and it is Pyrogen free.
If you are unable to obtain the transducer cover locally, please contact your local Hitachi Medical Systems
representative.

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MN1-5531 Rev. 10
2-3. Performance
For measurement tolerances, operating tolerances and other data, refer to the instruction manual for the
ultrasound diagnostic instrument.
2-4. Name of each parts
Connector
This is the part that connects the ultrasound
diagnostic instrument and probe. Follow the
instructions in section 4-2.
Ultrasonic irradiation area
This incorporates an electronic convex
transducer.
Probe tip
This area is held during operation.
Cable
This cable propagates the ultrasonic signals
that are sent and received.
Front Mark
The round protrusion corresponds
to the front mark (direction
mark) on the image display.
Caution
Do not pull, bend, twist, or apply excessive force to the cable.
The conductors may break and the cable may become unusable.
Do not subject the ultrasonic radiation part to hard impact.
The impact may cause damage to the transducer, and that results in noise or no echo in the image.
In most cases, the ultrasonic radiation part itself is not damaged because the part is made of elastic
material.