Hitachi UST-547 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, 2016. All rights reserved.
Intraoperative Electronic Linear Probe
UST-547
Instruction Manual
MN1-5053 Rev.15

MN1-5053 Rev.15
ii

iii
MN1-5053 Rev.15
This is an instruction for model UST-547, 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 severities 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

MN1-5053 Rev.15
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........................................................................................................................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. 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. When using the probe for neurosurgery applications....................................................22
4-4-1. How to attach the transducer cover ...............................................................................22
4-4-2. How to remove the transducer cover .............................................................................22
4-5. Precautions when using the probe in neurosurgery applications....................................23
4-6. Actions to be taken when an abnormal state is detected.................................................24
4-6-1. Ensuring safety of patients ..........................................................................................24
4-6-2. Handling the instrument..............................................................................................24

v
MN1-5053 Rev.15
5. Cleaning, disinfection and sterilization
5-1. Precautions for cleaning, disinfection and sterilization..................................................26
5-2. Reprocessing instruction according to ISO 17664 .........................................................27
5-3. Point of use (Pre-cleaning) .............................................................................................29
5-4. Containment and transportation......................................................................................29
5-5. Manual cleaning and disinfection...................................................................................30
5-5-1. Manual cleaning ........................................................................................................30
5-5-2. Manual disinfection ...................................................................................................31
5-5-3. Cable and connector .................................................................................................................... 31
5-6. Automated cleaning and disinfecting .............................................................................32
5-7. Applicable cleaners and disinfectants / Suppliers List ...................................................33
5-8. Drying.............................................................................................................................35
5-9. Maintenance, inspection and testing...............................................................................35
5-10. Packaging......................................................................................................................35
5-11. Sterilization...................................................................................................................36
5-11-1. Ethylene oxide (EtO) gas sterilization..........................................................................36
5-11-2. STERRAD®sterilization...........................................................................................37
5-11-3. Liquid sterilization (USA only)................................................................................................. 38
5-12. Storage..........................................................................................................................38
6. Storage
6-1. Actions before storing the probe.....................................................................................39
6-2. Environmental conditions for storage.............................................................................39
7. Moving and Transporting
7-1. Moving and transporting ................................................................................................41
7-2. Preparing the probe and accessories for moving ............................................................41
7-3. Packing for transportation ..............................................................................................41
7-4. Environmental conditions during transportation ............................................................41
8. Periodic Inspection
8-1. Safety tests......................................................................................................................43
8-2. Testing of measurement tolerances.................................................................................44
8-2-1. Conducting tests ...........................................................................................................44
8-2-2. Result judgment............................................................................................................44
9. Conguration
9-1. Standard conguration....................................................................................................45
10. Disposal of the Device .......................................................................................................47
This Instruction Manual contains the main body of 48pages and 5pages until the CONTENTS.

MN1-5053 Rev.15

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MN1-5053 Rev. 15
1. Safety Precautions
1-1. Intended use
This probe is intended for use by a doctor when placed to 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 severities 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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MN1-5053 Rev. 15
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 check, 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 check 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
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 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.
Otherwise, 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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MN1-5053 Rev. 15
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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MN1-5053 Rev. 15
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.
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 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.
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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MN1-5053 Rev. 15
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 sterilization. This could also cause deterioration of the
probe.
Caution
Do not place the probe tip in any liquids beyond the range
shown in the gure right.
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. Water or chemical solution

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MN1-5053 Rev. 15
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M
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R
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L
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A
S
E
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K
Label 3
Label 2
Label 1
Label 1
1-2-4 Labels
(1) Probe unit
Electronic linear probe mark
Frequency

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MN1-5053 Rev. 15
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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MN1-5053 Rev. 15
Label A
(2) Storage case
Label B

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MN1-5053 Rev. 15
Label A
Label B
2016
DATE OF MANUFACTURE
(in case of 2016)
MANUFACTURER
This instrument complies with Directive 93/42/EEC
relating to Medical Device and Directive 2011/65/EU
relating to RoHS.
Model
Serial No.
2016

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MN1-5053 Rev. 15

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MN1-5053 Rev. 15
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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MN1-5053 Rev. 15
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
Field of view: 28.8mm
Frequency: 7.0 to 13.0MHz
Cable length: 2.0 m
Weight: 990 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.
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
Range of applied part
1000
39 15
94

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MN1-5053 Rev. 15
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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MN1-5053 Rev. 15
2-3. Performance
For measurement tolerances, operating tolerances and other data, refer to the instruction manual for the
ultrasound diagnostic instrument.
2-4. Names 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 linear
transducer.
Probe tip
This area is held during operation.
Cable
This cable propagates the ultrasonic signals
that are sent and received.
Front Mark
The 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 irradiation area 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 irradiation area itself is not damaged because the part is made of elastic
material.