Hitachi UST-9135P 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.
Puncture Electronic Convex Probe
UST-9135P
Instruction Manual
M N1-5315 Rev.14

MN1-5315 Rev.14
ii

iii
MN1-5315 Rev.14
This is an instruction for model UST-9135P, 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

MN1-5315 Rev.14
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. Puncture precautions ......................................................................................................................4
1-2-3. Cleaning, disinfection and sterilization precautions ......................................................................7
1-2-4. Labels .............................................................................................................................................8
2. Specications and Parts name
2-1. Principles of operation....................................................................................................13
2-2. Specications..................................................................................................................14
2-2-1. Specications of the probe ........................................................................................................... 14
2-2-2. Specications of the needle guide................................................................................................ 15
2-3. Performance....................................................................................................................16
2-4. Names of each parts......................................................................................................16
2-5. Environmental conditions..............................................................................................17
2-5-1. Operating environmental conditions ............................................................................17
2-5-2. Storage environmental conditions ...............................................................................17
2-6. Classication of ME equipment .....................................................................................17
3. Preparations for Use
3-1. Startup check of the probe .............................................................................................19
3-1-1. Visual check ............................................................................................................19
3-1-2. Verication of cleaning, disinfection and sterilization .....................................................19
3-1-3. Verication of operation ............................................................................................19
3-2. Startup check of the needle guide.................................................................................20
3-2-1. Visual check ............................................................................................................20
3-2-2. Mechanical inspection of the needle guide .....................................................................20
3-2-3. Verication of operation..............................................................................................20
3-3. Checking the needle echo ...............................................................................................21
3-3-1. Check preparation ......................................................................................................21
3-3-2. Checking the needle echo............................................................................................22
3-4. Performing cleaning, disinfection and sterilization........................................................22

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MN1-5315 Rev.14
4. Usage
4-1. Operation ........................................................................................................................23
4-2. Attaching of the needle guide, the guard plate and the lock plate ..................................24
4-3. Leaving the needle ............................................................................................................25
4-4. Removal of the needle guide, the guard plate and the lock plate ...................................25
4-5. Connecting to the ultrasound diagnostic instrument .....................................................26
4-6. Removing from the ultrasound diagnostic instrument ...................................................27
4-7. Puncturing precautions ...................................................................................................28
4-8. Actions to be taken when an abnormal state is detected.................................................30
4-8-1. Ensuring safety of patients..........................................................................................30
4-8-2. Handling the instrument ............................................................................................30
5. Cleaning, disinfection and sterilization
5-1. Precautions for cleaning, disinfection and sterilization..................................................32
5-2. Reprocessing instruction according to ISO 17664 .........................................................33
5-3. Point of use (Pre-cleaning) .............................................................................................35
5-4. Containment and transportation......................................................................................35
5-5. Manual cleaning and disinfection...................................................................................36
5-5-1. Manual cleaning ........................................................................................................37
5-5-2. Manual disinfection ...................................................................................................38
5-5-3. Cable and connector...................................................................................................39
5-6. Automated cleaning and disinfecting .............................................................................39
5-7. Applicable cleaners and disinfectants / Suppliers List ...................................................40
5-8. Drying.............................................................................................................................42
5-9. Maintenance, inspection and testing...............................................................................42
5-10. Packaging......................................................................................................................42
5-11. Sterilization...................................................................................................................43
5-11-1. Ethylene oxide (EtO) gas sterilization..........................................................................43
5-11-2. STERRAD®sterilization...........................................................................................44
5-11-3. Liquid sterilization (USA only)...................................................................................45
5-12. Storage..........................................................................................................................45

MN1-5315 Rev.14
vi
6. Storage
6-1. Actions before storing...................................................................................................47
6-2. Environmental conditions for storage............................................................................47
7. Moving and Transporting
7-1. Moving and transporting ..............................................................................................49
7-2. Preparing the probe and accessories for moving ............................................................49
7-3. Packing for transportation ............................................................................................49
7-4. Environmental conditions during transportation .........................................................49
8. Periodic Inspection
8-1. Safety tests of the probe.................................................................................................51
8-2. Testing of measurement tolerances.................................................................................52
8-2-1. Conducting tests ...........................................................................................................52
8-2-2. Result judgement .........................................................................................................52
8-3. Safety tests of the puncture adapter...............................................................................53
9. Conguration
9-1. Standard conguration...................................................................................................55
9-2. Option .............................................................................................................................55
10. Disposal of the Device .......................................................................................................57
This Instruction Manual contains the main body of 58pages and 6pages until the CONTENTS.

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MN1-5315 Rev. 14
1. Safety Precautions
1-1. Intended use
This probe is intended for use by a doctor when placed into direct contact with the skin making ultrasonic
observations of surrounding organs.
It also enables the doctor to guide the puncture needle under the ultrasound guide into the patient's body.
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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MN1-5315 Rev. 14
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 equipment without noticing an abnormal condition can result in injury to the operator or
patient. If any abnormalities are noted on the equipment 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 “Preparation for use” for the start up inspection content and procedure.
Do not use on the eyes.
This equipment 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 equipment.
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 equipment.
Perform proper cleaning, disinfection and sterilization after use.
Otherwise, there is a risk of infection. Note that the equipment is not sterilized at the factory.
Before using the equipment 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 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 of the probe".

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MN1-5315 Rev. 14
Caution
Constantly check for anything abnormal about the patient’s condition, the 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 equipment 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 this equipment 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.
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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MN1-5315 Rev. 14
1-2-2. Puncturing precautions
Warning
Puncturing must be performed by a skilled doctor.
Improper puncturing can injure the patient. Puncturing operations must be performed by a doctor
who fully understands the characteristics of ultrasound diagnostics and who is skilled and has a
thorough knowledge of puncture operations under an ultrasound guide.
The equipment must be cleaned, disinfected and sterilized before use.
Be sure to always properly clean, disinfect and sterilize after use.
Otherwise, an infection can occur. Note that the equipment is not sterilized when shipped from the
factory. Before using the equipment, be sure to clean, disinfect and sterilize it as required.
When puncturing, be sure to wear sterilized medical gloves.
Puncturing with the bare hands can expose the operator or patient to a risk of infection.
This needle guide, the guard plate and the lock plate are used by attaching them to the probe and
following the instructions in this manual.
Attaching them improperly to the probe or performing puncture operations without attaching them
to the probe can result in the needle guide, the guard plate and the lock plate coming off during sur-
gery or in puncturing of an unintended body part. For details on the attachment procedure, see sec-
tion 4-2 "Attaching of the needle guide, the guard plate and the lock plate".
For the acoustic medium, use sterilized physiological saline solution.
Using an unsterilized acoustic medium can cause an infection on the patient.
Check that the gauge size of the puncture needle that is used matches the gauge size of the needle
guide.
Using when the gauge sizes of the puncture needle and the needle guide do not match can result in
puncturing of an unintended body part. Also, even if the gauge size is the same, the diameters may
vary between different puncture needle manufacturers and products.
For puncture needles diameters can be used for the needle guide, see section 2-2-2 "Specications
of the needle guide".
Use sterilized puncture needles.
Otherwise, an infection can occur.
Do not use needles were bent.
Puncturing of an unintended body part causing an injury to the patient.
Be careful when handling the puncture needle.
Accidentally puncturing your hand or other body part can result in infection of the operator or
patient.
During the puncture operation, display a suitable puncture guide line on the screen of the ultrasound
diagnostic instrument.
Puncturing of an unintended body part can cause an injury to the patient. Display the puncture guide
line on the screen referring to the instruction manual supplied with the ultrasound diagnostic
instrument, use it as an aid in determining the puncturing direction.
Check beforehand any areas not displayed on the ultrasound image that are along the puncturing
path. If other tissues are in the area not displayed on the ultrasound image, there is a risk of
puncturing an unintended body part and causing an injury to the patient.

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MN1-5315 Rev. 14
Warning
Do not puncture the heart region.
Puncturing the heart region may cause a micro electric shock.
Check that no other organs lie in the puncture path.
If another organ lies in the puncture path, an unintended body part can be punctured and cause an
injury to the patient. Before puncturing, carefully check the body parts and constantly conrm the
needle echo during the operation.
Constantly check the safety in the needle insertion direction using the needle echo rendered by the
ultrasonic wave.
A bent puncture needle can result in puncturing of an unintended body part and cause an injury to
the patient.
Do not try to forcibly perform operations.
If excessive force is applied in a direction other than the insertion direction of the puncture needle,
the puncture needle can deviate from the puncture guide line, resulting in puncturing of an
unintended body part and causing an injury to the patient.
For details about the reuse and disposal of puncture needles, follow the instructions in the
documentation supplied with the puncture needles.
Reuse of puncturing needles that are not reusable or improper disposal could result in an infection.
Do not use the needle guide, the guard plate and the lock plate fallen on to oor.
Otherwise, there is a risk of infection. Stop the operation and perform the procedure in section 5
"Cleaning, disinfection and sterilization" section 3-2 "Start up check of the needle guide" and
section 3-3 "Checking the needle echo".
When inserting an RFA(Radio Frequency Ablation) needle, do not insert while bending the needle.
Inserting while bending the needle can break the insulation membrane covering the RFA needle and
could cause burns to the patient.
Before using a needle cannula with the needle guide as a guide, rst check that the cannula moves
smoothly through the tube without causing any damage on the surface of the cannula and then
operate with caution.
If the cannula does not move smoothly or is forced to bend when inserted in or pulled out of the
needle guide, it may damage the insulation membrane covering the cannula and may cause burns to
the tissue exposed to the damaged area of the cannula.

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MN1-5315 Rev. 14
Caution
Handle the needle carefully to ensure that the probe, the needle guide, the guard plate and the lock
plate are not damaged.
Using the probe, the needle guide, the guard plate and the lock plate that have been damaged by a
needle can result in an injury to the operator or patient.
Check beforehand if the patient has any allergic reactions to metals.
If the patient has a metal allergy of stainless steel, the puncture needle may be hazardous for patient as an
allergic risk.
Note
Before carrying out a puncture operation on the patient, check the relative safety not only of the equipment
directly related to the puncture operation, but also of peripheral equipment and measuring instruments.

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MN1-5315 Rev. 14
1-2-3. Cleaning, disinfection and sterilization precautions
Warning
Wear protective gloves and other protective gear during cleaning, disinfection and sterilization.
Handling of the equipment with your bare hands before disinfection or sterilization can result in an
infection.
After soaking in cleaning agents, thoroughly wash the equipment 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 disinfection and 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 or sterilization. It can also result in
damage to the equipment 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 disinfection or sterilization. This could also cause
deterioration of the equipment.
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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MN1-5315 Rev. 14
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
Electronic convex probe mark
Frequency
1-2-5. Labels
(1) Probe unit

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MN1-5315 Rev. 14
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.
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.

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MN1-5315 Rev. 14
Label A
(2) Storage case
Label C
Label B
Label D

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MN1-5315 Rev. 14
Label A Model
Label B
2016-09
Label C
Label D DATE OF MANUFACTURE
(in case of 2016-09)
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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MN1-5315 Rev. 14

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MN1-5315 Rev. 14
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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MN1-5315 Rev. 14
2-2. Specications
2-2-1. Specications of the probe
Application regions: Surface puncturing, abdomen, general areas
Form of application to patient: Surface
Connectable instruments: Prosound α7, SSD-α10, Prosound F75, F37
Field of view: 60°
Frequency: 3.5 MHz
Cable length: 2.0 m
Weight: 1100 g
Service life: Three years
Range of applied part Ultrasonic irradiation area, see the section 2-4.
Parts treated as applied parts Probe tip itself and 1 m of the cable near the probe tip.
IPX7 range As shown in the gure below.
External dimensions: As shown in the gure below.
Unit: mm
Remarks:
The dimensions and weight are within ±10% of the indicated values.
Cable length
IPX7 range
50
28
80
88