Hitachi UST-9124 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.
Transvaginal Electronic Convex Probe
UST-9124
Instruction Manual
M N1-1162 Rev.21

MN1-1162 Rev.21
ii

iii
MN1-1162 Rev.21
This is an instruction for model UST-9124, 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

MN1-1162 Rev.21
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. 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
2-3. Performance....................................................................................................................13
2-4. Names of each parts......................................................................................................13
2-5. Environmental conditions..............................................................................................14
2-5-1. Operating environmental conditions ............................................................................14
2-5-2. Storage environmental conditions ...............................................................................14
2-6. Classication of ME equipment .....................................................................................14
3. Preparations for Use
3-1. Startup check .................................................................................................................15
3-1-1. Visual check ............................................................................................................15
3-1-2. Verication of cleaning, disinfection and sterilization .....................................................15
3-1-3. Verication of operation ............................................................................................15
4. Usage
4-1. Operation ........................................................................................................................17
4-2. Mounting of rubber boot.................................................................................................18
4-3. Removal of rubber boot..................................................................................................19
4-4. Connecting to ultrasound diagnostic instrument ..........................................................20
4-5. Removing from the ultrasound diagnostic instrument ...................................................21
4-6. Precautions when performing puncture operations ........................................................22
4-7. Actions to be taken when an abnormal state is detected.................................................23
4-7-1. Ensuring safety of patients..........................................................................................23
4-7-2. Handling the instrument ............................................................................................23
5. Cleaning, disinfection and sterilization
5-1. Precautions for cleaning, disinfection and sterilization..................................................26
5-2. Reprocessing instruction according to ISO 17664 .........................................................27

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MN1-1162 Rev.21
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 ........................................................................................................31
5-5-2. Manual disinfection ...................................................................................................32
5-5-3. Cable and connector...................................................................................................33
5-6. Automated cleaning and disinfecting .............................................................................33
5-7. Applicable cleaners and disinfectants / Suppliers List ...................................................34
5-8. Drying.............................................................................................................................36
5-9. Maintenance, inspection and testing...............................................................................36
5-10. Packaging......................................................................................................................36
5-11. Sterilization...................................................................................................................37
5-11-1. Ethylene oxide (EtO) gas sterilization..........................................................................37
5-11-2. STERRAD®sterilization...........................................................................................38
5-11-3. Liquid sterilization (USA only)...................................................................................39
5-11-4. Autoclave sterilization ..............................................................................................39
5-12. Storage..........................................................................................................................39
6. Storage
6-1. Actions before storing the probe.................................................................................41
6-2. Environmental conditions for storage............................................................................41
7. Moving and Transporting
7-1. Moving and transporting ..............................................................................................43
7-2. Preparing the probe and accessories for moving ............................................................43
7-3. Packing for transportation ............................................................................................43
7-4. Environmental conditions during transportation .........................................................43
8. Periodic Inspection
8-1. Safety tests.....................................................................................................................45
8-2. Testing of measurement tolerances.................................................................................46
8-2-1. Conducting tests ...........................................................................................................46
8-2-2. Result judgement .........................................................................................................46
9. Conguration
9-1. Standard conguration...................................................................................................47
9-2. Options............................................................................................................................47
10. Disposal of the Device .......................................................................................................49
This Instruction Manual contains the main body of 50pages and 5pages until the CONTENTS.

MN1-1162 Rev.21
vi

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MN1-1162 Rev. 21
1. Safety Precautions
1-1. Intended use
This probe is intended for use by a doctor or other qualied operator for inserting into a human vagina and
making ultrasonic observations of the uterus 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 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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MN1-1162 Rev. 21
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 startup 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
“Startup inspection” for the startup inspection content and procedure.
Do not use on the eyes.
This probe is not intended for use on the eyes. The acoustic output can have an adverse effect on the
eyes.
Do not attempt to disassemble, modify, or repair the probe.
Electric shock or other unforeseen accidents could result. Contact one of our ofces and/or 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.
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 probe fallen on to oor.
Ohterwise, there is a risk of infection. Stop the operation, and perform the procedure in section 8-1
"Safety tests," section 5 "Cleaning, disinfection and sterilization" and section 3-1 "Startup inspection."
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.

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MN1-1162 Rev. 21
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 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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MN1-1162 Rev. 21
1-2-2. Option usage precautions
Warning
Use by covering the rubber boot over the insertion portion.
If the rubber boot is not used, residual pathogens on the probe could infect the patient. Also, the
puncture guide tube could become loose during puncturing, resulting in puncturing of an unintended
body part.
Use Hitachi-approved rubber boots only.
Use of an item lacking biocompatibility can cause an adverse reaction of the human body.
Check that the rubber boot is sterilized.
Use of an infective item could spread infection to the patient.
Do not reuse the rubber boot.
Use of an infective item could spread infection to the patient.
Do not apply unsterilized acoustic medium to the outer surface of the rubber boot.
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 rubber boot for these types of patients could result in anaphylactic shock. Ask the patient
about allergy history beforehand.
Caution
Check the rubber boot for abnormalities before use.
Store the rubber boots in a cool, dry location not exposed to direct sunlight, and do not use rubber
boots that have exceeded their expiration date (for items where the expiration date is not displayed,
2 years from the displayed sterilization date). Also do not use the rubber boot when there are severe
discolorations, cracks or other visible effects.
Check that the acoustic medium has no air bubbles inside the rubber boot that is covering the probe.
Air bubbles inside the rubber boot can result in misdiagnosis caused by overlooking or
misinterpreting lesions due to poor image quality or improper rendering.

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MN1-1162 Rev. 21
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 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 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 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 disinfection or sterilization. This could also cause
deterioration of the probe.
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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MN1-1162 Rev. 21
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 2
Label 1
Label 1
Electronic convex probe mark
Frequency
1-2-4. Labels
(1) Probe unit
Label 4
Label 3

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MN1-1162 Rev. 21
Label 2
STERRAD sterilization compatibility mark
See section 5.
This instrument complies with Directive 93/42/EEC
relating to Medical Device and Directive 2011/65/EU
relating to RoHS.
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
Label 4(Examples)
Label 3(Examples)
Manufacturer
Model, Serial No.
This label may not be afxed depending on
the destination.
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
Country of manufacture:
JAPAN , CHINA or INDIA
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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MN1-1162 Rev. 21
Label A
(2) Storage case
Label B

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MN1-1162 Rev. 21
Label A(Examples)
Label B(Examples)
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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MN1-1162 Rev. 21
Use by
Do not reuse
Keep away from sunlight
(3) Rubber boot
Label for 1 piece
Contains or presence natural rubber latex
RUBBER BOOT
RB-945BP-NS
MADE IN JAPAN
Rx Only
Non sterile
10 pieces
RUBBER BOOT
RB-945BP-NS
LOT
MADE IN JAPAN
Rx Only
Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205
Wiesbaden, Germany
Lot number
Label for 10 pieces
Rx Only By prescription only. U.S. Federal Law restricts this device
to sale on order of a physician only.

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MN1-1162 Rev. 21
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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MN1-1162 Rev. 21
2-2. Specications
Application regions: Obstetric and gynecological areas
Form of application to patient: Transvaginal
Connectable instruments: SSD-4000, SSD-3500, SSD-1000, ProSound 6, ProSound α 6, F37, F31
Field of view: 180 °
Frequency: 3.0 to 8.5 MHz
Cable length: 2.5 m
Weight: 1,095 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.
Unit: mm
Remarks
The dimensions and weight are within ±10% of the indicated values.
Cable length
1000
IPX7 range
Range of attachments Parts treated as applied parts
140

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MN1-1162 Rev. 21
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
Rubber boot
This covers the insertion portion
for preventing infection. Follow
the instructions in section 4-2.
Insertion portion
The component that is inserted
into the patient.
Handle
This section is held when performing insertion,
puncturing, and other operations.
Connector
This is the part that connects the ultrasound
diagnostic instrument and probe. Follow the
instructions in section 4-4.
Cable
This cable propagates the
ultrasonic signals that are
sent and received.
The dimple corresponds to the
front mark (direction mark) on
the image display.
Ultrasonic irradiation area
This incorporates 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 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.

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MN1-1162 Rev. 21
2-5. Environmental conditions
Use and store the probe under the following conditions.
2-5-1. Operating environmental conditions
Ambient temperature: 10°C to 40°C
50°F to 104°F
Relative humidity: 30% to 75%
Atmospheric pressure: 700 hPa to 1060 hPa
Altitude: 3,000 m or less
2-5-2. Storage environmental conditions
Ambient temperature: –10°C to 50°C
14°F to 122°F
Relative humidity: 10% to 90%
Atmospheric pressure: 700 hPa to 1060 hPa
Caution
Avoid operating or storing the probe in the following locations.
• Locations exposed to water or other liquids
• Locations subject to adverse conditions such as air pressure, temperature, humidity, ventilation,
direct sunlight, dust, or air containing salt, sulfur, or other corrosive substances
• Locations where chemical substances are stored or where gases are generated
Storage in these locations can result in a breakdown or reduced performance.
Avoid rapid temperature change which may cause condensation. Avoid using in locations where
condensation or water droplets can form.
Condensation can occur when moving the probe from a cool location to a warm one. Use when
condensation has occurred can result in a breakdown or reduced performance.
2-6. Classication of ME equipment
• Classication based on degree of protection against electric shock . Type BF applied Part
• Classication for protection against ingress of liquids ..................... IPX7 (Watertight equipment)
• Operation mode................................................................................. Continuous operation
• Method of sterilization ...................................................................... See section 5 “Cleaning, disinfection
and sterilization”
For the range of applied parts, parts treated as applied parts and the range of IPX7, see section 2-2.