Hitachi UST-5417 User manual

-i-
MN1-5752 Rev.8
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.
Electronic Linear Probe
UST-5417
Instruction Manual
MN1-5752 Rev.8

-ii-
MN1-5752 Rev.8

-iii-
MN1-5752 Rev.8
This is an instruction for model UST-5417, an ultrasound probe.
Read the manual carefully before using the equipment. 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 ultrasound diagnostic
instrument 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 ultrasound diagnostic instrument 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

-iv-
MN1-5752 Rev.8
CONTENTS
1. Safety Precautions .............................................................................................................................1
1-1. Intended use ..................................................................................................................................1
1-2. Usage precautions .........................................................................................................................1
1-2-1. Warnings and safety information......................................................................................2
1-2-2. Cleaning, disinfection and sterilization precautions.........................................................4
1-2-3. Labels ...............................................................................................................................5
1-2-4. Option (Elasto coupler) Labels..................................................................................................... 9
2. Specications and Parts name.....................................................................................................11
2-1. Principles of operation ................................................................................................................11
2-2. Specications ..............................................................................................................................12
2-2-1. Specications of the probe .............................................................................................12
2-2-2. Specications of the Elasto coupler* .............................................................................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 .......................................................................................................................17
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....................................................................................................................................................19
4-1. Operation.....................................................................................................................................19
4-2. Attaching of the Elasto coupler ...................................................................................................20
4-3. Removal of the Elasto coupler ....................................................................................................21
4-4. Connecting to the ultrasound diagnostic instrument...................................................................22
4-5. Removing from the ultrasound diagnostic instrument................................................................23
4-6. Puncturing precautions................................................................................................................24
4-7. Actions to be taken when an abnormal state is detected .............................................................25
4-7-1. Ensuring safety of patients .............................................................................................25
4-7-2. Handling the utltrasound diagnostic instrument.............................................................25
5. Cleaning, disinfection and sterilization ..................................................................................27
5-1. Precautions for cleaning, disinfection and sterilization ..............................................................28

-v-
MN1-5752 Rev.8
This Instruction Manual contains the main body of 52pages and 6pages until the CONTENTS.
5-2. Reprocessing instruction according to ISO 17664......................................................................29
5-3. Point of use (Pre-cleaning)..........................................................................................................31
5-4. Containment and transportation ..................................................................................................31
5-5. Manual cleaning and disinfection ..............................................................................................32
5-5-1. Manual cleaning ............................................................................................................33
5-5-2. Manual disinfection .......................................................................................................34
5-5-3. Cable and connector .......................................................................................................35
5-6. Automated cleaning and disinfecting .........................................................................................35
5-7. Applicable cleaners and disinfectants / Suppliers List ...............................................................36
5-8. Drying .........................................................................................................................................38
5-9. Maintenance, inspection and testing ...........................................................................................38
5-10. Packaging ..................................................................................................................................38
5-11. Sterilization ...............................................................................................................................39
5-11-1. Ethylene oxide (EtO) gas sterilization..........................................................................39
5-11-2. STERRAD®sterilization ..............................................................................................40
5-11-3. Liquid sterilization (USA only) ....................................................................................41
5-12. Storage.......................................................................................................................................41
6. Storage .................................................................................................................................................43
6-1. Actions before storing the probe .................................................................................................43
6-2. Environmental conditions for storage .........................................................................................43
7. Moving and Transporting .............................................................................................................45
7-1. Moving and transporting.............................................................................................................45
7-2. Preparing the probe for moving ..................................................................................................45
7-3. Packing for transportation...........................................................................................................45
7-4. Environmental conditions during transportation.........................................................................45
8. Periodic Inspection..........................................................................................................................47
8-1. Safety tests of the probe ..............................................................................................................47
8-2. Testing of measurement tolerances .............................................................................................48
8-2-1. Conducting tests .............................................................................................................48
8-2-2. Result judgment..............................................................................................................48
8-3. Safety tests of the Elasto coupler ................................................................................................48
9. Conguration.....................................................................................................................................49
9-1. Standard conguration ................................................................................................................49
9-2. Options ........................................................................................................................................49
10. Disposal of the Device ................................................................................................................51

MN1-5752 Rev.8

-1-
MN1-5752 Rev.8
1. Safety Precautions
1-1. Intended use
This probe is intended for use by a doctor or other qualied operator when placed into direct contact with
the skin making ultrasonic observations of 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", "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.

-2-
MN1-5752 Rev.8
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 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 check, immediately stop use
the equipment and contact one of our ofces and/or distributor's ofces listed on the back cover.
See section 3. “Preparations for Use”.
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 equipment used for patients with Creutzfeldt-Jakob disease.
Otherwise, there is a risk of infection to the operator or patient. Our equipment is not compatible with
any disinfection/sterilization method for Creutzfeldt-Jakob disease.
When using ultrasonic 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 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.
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 "Cleaning, disinfection and sterilization" and section 3-1 "Start up
check".

-3-
MN1-5752 Rev.8
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.
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 of the equipment specied in this manual.
Long-term use of the equipment, could reduce the performance, or cause smoke or re.
If nds any abnormal condition, immediately stop use the equipment 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".
The Elasto coupler is used by attaching it to the probe and following the instructions in this manual.
If you use the wrong combination of probe and echo coupler or attach the echo coupler to the probe
incorrectly, the probe will deliver incorrect results.
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.

-4-
MN1-5752 Rev.8
1-2-2. Cleaning, disinfection and sterilization precautions
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.
War ning
Wear protective gloves and other protective gear during cleaning, disinfection and sterilization.
Handling of the probe with 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 sterilization.
Residual gas can cause an adverse reaction on the bodies of the operator or patient.
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.
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 probe or reduced performance. The probe cannot withstand autoclave sterilization or
boiling and other types of sterilization at temperatures exceeding 60°C (140°F).

-5-
MN1-5752 Rev.8
1-2-3. Labels
(1) Probe unit
Label 1
Label 2
Label 1
Label 3
Electronic linear probe mark
Frequency
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

-6-
MN1-5752 Rev.8
Label 3
(Examples)
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 equipment 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 equipment.
If not avoided, may result in injury, property damage, or the
equipment trouble.
IPX7
This instrument complies with Directive 93/42/EEC
relating to Medical Device and Directive 2011/65/EU
relating to RoHS.
㻞㻙㻝㻢㻙㻝㻘㻌㻴㼕㼓㼍㼟㼔㼕㻙㼁㼑㼚㼛㻘㻌㼀㼍㼕㼠㼛㻙㼗㼡㻘㻌㼀㼛㼗㼥㼛㻘㻌
㻝㻝㻜㻙㻜㻜㻝㻡㻘㻌㻶㼍㼜㼍㼚㻌㻌㻌㼀㻱㻸㻌㻗㻤㻝㻙㻟㻙㻢㻞㻤㻠㻙㻟㻢㻢㻤
Country of manufacture:
JAPAN or CHINA
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.

-7-
MN1-5752 Rev.8
(2) Storage case
Label A
Label B

-8-
MN1-5752 Rev.8
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

-9-
MN1-5752 Rev.8
1-2-4. Option (Elasto coupler) Labels
Label A
Label B
Label C

-10 -
MN1-5752 Rev.8
〔形名：P‑42123�Rev.00〕〔図番：MM〕
Label A
Label B
Label C
(Examples)
Biohazard
See section 5.
Safety warning sign
Follow the instruction manual to operate this instrument.
If not avoided, may result in injury, property damage, or the
equipment trouble
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.
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

-11-
MN1-5752 Rev.8
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
equipments 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.

-12-
MN1-5752 Rev.8
25 59
105
2-2. Specications
2-2-1. Specications of the probe
Application regions: Mammary gland, Supercial organs
Form of application to patient: Surface
Connectable instruments: ProSound α7, ProSound F75, F37
Field of view: 38mm
Frequency: 4 to 14MHz
Cable length: 2.1 m
Weight: 940 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.
Remarks
The dimensions and weight are within ±10% of the indicated values.
Cable length
Unit : mm
50
IPX7 range

-13-
MN1-5752 Rev.8
23
52
61
2-2-2. Specications of the Elasto coupler*
* This equipment is the option of this probe.
Model Name: MP-2809
Material: Polyphenylene oxide
Service life: Three years
Weight: 15g
External dimensions As shown in the gure below.
Remarks
The dimensions are within ±10% of the indicated values.
Unit: mm

-14 -
MN1-5752 Rev.8
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
Probe tip
This area is held during operation.
Cable
This cable propagates the ultrasonic signals
that are sent and received.
Front mark
The round protrusion indicates the
direction of the front mark (direction
mark) on the image display.
Ultrasonic irradiation area
This incorporates an electronic linear
transducer.
Connector
This is the part that connects the ultrasound
diagnostic instrument and probe. Follow the
instructions in section 4-4.
Elasto coupler (Opiton)
This coupler is attached to the probe to evenly
distribute body surface pressure when the probe
displays images using real-time tissue elastography.
Follow the instructions in section 4-2.
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.