Hitachi UST-678 User manual

i
MN1-5255 Rev.15
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.
Transrectum Composite Probe
UST-678
Instruction Manual
MN1-5255 Rev.15

MN1-5255 Rev.15
ii

iii
MN1-5255 Rev.15
This is an instruction for model UST-678, 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.
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

MN1-5255 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. Option usage precautions ...............................................................................................................4
1-2-3. Washing, 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
2-3. Performance....................................................................................................................13
2-4. Names of each parts........................................................................................................13
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 washing, disinfection and sterilization.......................................................17
3-1-3. Verication of operation..............................................................................................17
4. Usage
4-1. Operation ........................................................................................................................19
4-2. Mounting of balloon .......................................................................................................20
4-3. Insertion of the probe......................................................................................................22
4-4. Removal of balloon ........................................................................................................23
4-5. Connecting to the ultrasound diagnostic instrument ......................................................24
4-6. Removing from the ultrasound diagnostic instrument ...................................................25
4-7. Precautions when performing puncture operations ........................................................26
4-8. Actions to be taken when an abnormal state is detected.................................................27
4-8-1. Ensuring safety of patients ..........................................................................................27
4-8-2. Handling the instrument..............................................................................................27

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MN1-5255 Rev.15
5. Washing, Disinfection and Sterilization
5-1. Washing ..........................................................................................................................30
5-1-1. Insertion portion and handle........................................................................................30
5-1-2. Cable and connector...................................................................................................30
5-2. Disinfection ....................................................................................................................31
5-2-1. Chemical disinfection.................................................................................................31
5-2-2. Gas disinfection ........................................................................................................32
5-3. Sterilization.....................................................................................................................33
5-3-1. Ethylene oxide gas (EOG) sterilization ..........................................................................33
5-3-2. STERRAD®sterilization.............................................................................................34
5-3-3. Liquid sterilization ...................................................................................................................... 35
6. Storage
6-1. Actions before storing the probe.....................................................................................37
6-2. Environmental conditions for storage.............................................................................37
7. Moving and Transporting
7-1. Moving and transporting ................................................................................................39
7-2. Preparing the probe and accessories for moving ............................................................39
7-3. Packing for transportation ..............................................................................................39
7-4. Environmental conditions during transportation ............................................................39
8. Periodic Inspection
8-1. Safety tests......................................................................................................................41
8-2. Testing of measurement tolerances.................................................................................42
8-2-1. Conducting tests ...........................................................................................................42
8-2-2. Result judgment............................................................................................................42
9. Conguration
9-1. Standard conguration....................................................................................................43
9-2. Options............................................................................................................................43
10. Disposal of the Device .......................................................................................................45
This Instruction Manual contains the main body of 46pages and 5pages until the CONTENTS.

MN1-5255 Rev.15
vi

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MN1-5255 Rev. 15
1. Safety Precautions
1-1. Intended use
This probe is intended for use by a doctor or other qualied operator for inserting to a human rectum and
making ultrasonic observations of the prostate and surrounding organs.
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", "War ning", "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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MN1-5255 Rev. 15
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 equipment 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.
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 as necessary.
Perform properly wash, disinfect and sterilize after use.
Otherwise, there is a risk of infection. Note that the probe is not sterilized at the factory. Before
using the equipment rst, be sure to wash, disinfect and sterilize it as required.
Wear medical gloves during examination.
Conducting examinations with the bare hands can expose the operator to a risk of infection.
Dispose of 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.
Otherwise, there is a risk of infection. Stop the operation and perform the procedure in section 8
"Periodic Inspection", section 5 "Washing, Disinfection and Sterilization" and section 3-1 "Start up
check".
Caution
Constantly check for anything abnormal about the patient’s condition and 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.

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MN1-5255 Rev. 15
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".
Take care to avoid splashing water on ultrasound diagnostic instrument or other equipment nearby.
Splashed water could cause other equipment to malfunction, or cause accidents.

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MN1-5255 Rev. 15
1-2-2. Option usage precautions
War ning
Use by covering the balloon over the insertion portion.
If the balloon is not used, residual pathogens on the probe could infect the patient.
Use Hitachi-approved balloons only.
Use of an item lacking biocompatibility can cause an adverse reaction by the body of the patient.
Check that the balloon is sterilized.
Use of an infected item could spread infection to the patient.
Do not reuse the balloon and rubber ring.
Use of an infected item could spread infection to the patient.
Do not apply unsterilized acoustic medium to the outer surface of the balloon.
Use of an acoustic medium that is contaminated by a pathogen can cause an infection on the
patient.
Do not use on patients who may have an allergic reaction to latex products.
Use of the balloon for these types of patients could result in anaphylactic shock. Ask the patient
about allergy history beforehand.
Caution
Check the balloon for abnormalities before use.
Store the balloons in a cool, dry location not exposed to direct sunlight and do not use balloons that
have exceeded their expiration date (for items where the expiration date is not displayed; 2 years
from the displayed sterilization date) or severe discoloration, cracks, or other visible defects nds.
Check that the acoustic medium has no air bubbles inside the balloon that is covering the probe.
Air bubbles inside the balloon can result in misdiagnosis caused by overlooking or misinterpreting
lesions due to poor image quality or improper rendering.

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MN1-5255 Rev. 15
Caution
Do not place the insertion portion and handle 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.
War ning
Wear protective gloves and other protective gear during washing, disinfection and sterilization.
Handling of the probe with your bare hands before disinfection or 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 chemical disinfection and sterilization, thoroughly wash the probe with sterilized water.
Residual chemicals 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 wash, disinfect or sterilize using procedures other than those specied in this manual.
Infection could result due to incomplete washing disinfection or 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 disinfection or sterilization. This could also cause
deterioration of the probe.
Thoroughly wash, disinfect or sterilize from inlet/drain port to inlet/drain nipple.
Infection could result due to incomplete disinfection or sterilization. This could also cause
deterioration of the probe.
Water or chemical solution
1-2-3. Washing, disinfection and sterilization precautions

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MN1-5255 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
Label 1
1-2-4. Labels
(1) Probe unit
Electronic convex probe mark
Frequency
Electronic linear probe mark
Frequency
Label 2
Label 4
Label 3
Label 2
Label 1

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MN1-5255 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 4
Label 3
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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MN1-5255 Rev. 15
(2) Storage case
Label A
Label C
Label B
Label D

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MN1-5255 Rev. 15
Label A Model
Serial No.
Label B
2016-09
Label C
Label D DATE OF MANUFACTURE
(in case of 2016-09)
2016-09
DATE OF MANUFACTURE
(in case of 2016-09)
AUTHORISED REPRESENTATIVE IN EUROPEAN
COMMUNITY
MANUFACTURER
This instrument complies with Directive 93/42/EEC
relating to Medical Device and Directive 2011/65/EU
relating to RoHS.
Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205
Wiesbaden, Germany
P-3258F
2016-09

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MN1-5255 Rev. 15
Use by
Do not reuse
Keep away from sunlight
(3) balloon
Label for 1 pieces
Contains or presence natural rubber latex
BALLOON
BL-664-NS
MADE IN JAPAN
Rx Only
Non sterile
Lot number
Label for 10 pieces
10 pieces
BALLOON
BL-664-NS
LOT
MADE IN JAPAN
Rx Only
Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205
Wiesbaden, Germany

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MN1-5255 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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MN1-5255 Rev. 15
2-2. Specications
Application regions: Urological applications
Form of application to patient: Transrectum
Connectable instruments: SSD-α10, Prosound α7, Prosound F75
Field of view: Vertical to Axis (Convex) : 120°
Parallel to Axis (Linear) : 60mm
Frequency: Vertical to Axis (Convex) : 3.0 to 9.0MHz
Parallel to Axis (Linear) : 4.0 to 10.0MHz
Cable length: 2.5 m
Weight: 1,900 g
Service life: Three years
Range of applied part: As shown in the gure below.
Parts treated as applied parts: As shown in the gure below
IPX7 range: As shown in the gure below.
External dimensions: As shown in the gure below.
Remarks
The dimensions and weight are within ±10% of the indicated values.
Cable length
Unit: mm
IPX7 range
Range of applied part Parts treated as applied parts 1000
235
352
φ21

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MN1-5255 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. Name of each parts
Handle
This section is held
when performing
insertion.
Connector
This is the part that connects the ultrasound diagnostic instrument and the probe.
Each connector corresponds to the transducer on the linear side and the convex
side. Connect both connectors to the ultrasound diagnostic instrument.
Follow the instructions in section 4-5.
Insertion portion
The component that
is inserted into the
patient.
Inlet/drain port
Follow the directions
specied in section 4-2.
Scale marks
The scale marks indicate insertion
depth that referenced to the convex
scanning plane.
Inlet/drain nipple
Follow the directions specied
in section 4-2.
Cable
This cable propagates the transmitting
and receiving of ultrasonic signals.
Front side
This point corresponds to the
front mark (direction mark)
side on the convex image
display.
Front side
This point
corresponds to the
front mark
(direction mark)
side on the linear
image display.
Ultrasonic irradiation area
This incorporates an electronic
linear transducer and an electronic
convex transducer.
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.

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MN1-5255 Rev. 15
・Balloon
Cover the insertion portion with this balloon to prevent infection.
Follow the instructions in section 4-2.
・Rubber band
This is used to keep water in the balloon.
・Syringe
・Three-way cock
・Extension tube
These are used to inject water to the balloon from the inlet/drain
nipple. Follow the instructions in section 4-2.
・Purse locks
This is used to tie two cables together.
・Surgical tape
If the ares of the balloon disturb to use, fasten the are by this
tape.
Purse locks
Tube
Inlet/drain port nipple
Syringe
Rubber band