Hitachi Aloka Medical UST-9113P-3.5 User manual

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MN1-1014 Rev.14MN1-1014 Rev.15
Puncture Electronic Convex Probe
UST-9113P-3.5
Instruction Manual
MN1-1014 Rev.15

MN1-1014 Rev.14
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MN1-1014 Rev.14
This is an instruction for model UST-9113P-3.5, 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

MN1-1014 Rev.14
iv
CONTENTS
1. Safety Precautions
1-1. Intended use.....................................................................................................................1
1-2. Usage precautions.............................................................................................................1
1-2-1. Warnings and safety information.................................................................................................... 2
1-2-2. Puncture precautions ...................................................................................................................... 4
1-2-3. Washing, disinfection and sterilization precautions ....................................................................... 7
1-2-4. Labels ............................................................................................................................................. 8
2. Specications and Parts name
2-1. Principles of operation....................................................................................................13
2-2. Specications..................................................................................................................14
2-2-1. Specications of the probe ........................................................................................................... 14
2-2-2. Specications of the puncture adapter ........................................................................................ 15
2-3. Performance....................................................................................................................16
2-4. Names of each parts......................................................................................................16
2-5. Environmental conditions..............................................................................................17
2-5-1. Operating environmental conditions ............................................................................17
2-5-2. Storage environmental conditions ...............................................................................17
2-6. Classication of ME equipment .....................................................................................17
3. Preparations for Use
3-1. Start up check of the probe.............................................................................................19
3-1-1. Visual check ............................................................................................................19
3-1-2. Verication of washing, disinfection and sterilization...................................................19
3-1-3. Verication of operation ............................................................................................19
3-2. Start up check of the puncture adapter ...........................................................................20
3-2-1. Visual check ............................................................................................................20
3-2-2. Mechanical inspection................................................................................................20
3-2-3. Verication of operation..............................................................................................20
3-3. Checking the needle echo ...............................................................................................21
3-3-1. Check preparation ......................................................................................................21
3-3-2. Checking the needle echo............................................................................................22
3-4. Performing washing and sterilization.............................................................................22

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MN1-1014 Rev.14
4. Usage
4-1. Operation ........................................................................................................................23
4-2. Attaching of the puncture adapter...................................................................................24
4-3. Usage of the needle stopper and the depth gauge.................................................................24
4-4. Leaving the needle..........................................................................................................27
4-5. Removal of the puncture adapter....................................................................................27
4-6. Connecting to the ultrasound diagnostic instrument .....................................................28
4-7. Removing from the ultrasound diagnostic instrument ...................................................29
4-8. Precautions when performing puncture operations ........................................................30
4-9. Actions to be taken when an abnormal state is detected.................................................32
4-9-1. Ensuring safety of patients..........................................................................................32
4-9-2. Handling the instrument ............................................................................................32
5. Washing, Disinfection and Sterilization
5-1. Washing ..........................................................................................................................34
5-1-1. Probe tip and accessories ............................................................................................34
5-1-2. Cable and connector...................................................................................................34
5-2. Disinfection ....................................................................................................................35
5-2-1. Chemical disinfection.................................................................................................35
5-2-2. Gas disinfection ........................................................................................................36
5-3. Sterilization.....................................................................................................................37
5-3-1. Ethylene oxide gas (EOG) sterilization ..........................................................................37
5-3-2. Liquid sterilization ...................................................................................................................... 38
6. Storage
6-1. Actions before storing...................................................................................................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

MN1-1014 Rev.14
vi
8. Periodic Inspection
8-1. Safety tests of the probe.................................................................................................43
8-2. Testing of measurement tolerances.................................................................................44
8-2-1. Conducting tests ...........................................................................................................44
8-2-2. Result judgment...........................................................................................................44
8-3. Safety tests of the puncture adapter...............................................................................45
9. Conguration
9-1. Standard conguration...................................................................................................47
9-2. Option .............................................................................................................................47
10. Disposal of the Device .......................................................................................................49
This Instruction Manual contains the main body of 50pages and 6pages until the CONTENTS.

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MN1-1014 Rev. 14
1. Safety Precautions
1-1. Intended use
This probe is intended for use by a doctor when placed to direct contact with the skin making ultrasonic
observations of surrounding organs.
It also enables the doctor to guide the puncture needle under the ultrasound guide into the patient's body.
Caution
Do not use this equipment for other than its intended purpose.
Use for other purposes can cause burns or other injuries to the operator or patient.
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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MN1-1014 Rev. 14
1-2-1. Warnings and safety information
Warning
Follow the information in this manual and the documentation supplied with any equipment used
together with this probe.
Use that is not in accordance with the supplied documentation can result in a serious or moderate
injury, equipment breakdown or physical damage that impairs operation.
Be sure to preparations for use.
Use the equipment without noticing an abnormal condition can result in injury to the operator or
patient. If any abnormalities are noted on the equipment in the start up inspection, immediately
stop using it and contact one of our ofces and/or distributor's ofces listed on the back cover.
See section 3 "Preparations for use".
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 equipment 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 equipments used for patients with Creutzfeldt-Jakob disease.
Otherwise, there is a risk of infection to the operator or patient. Currently, there are no methods
for washing, disinfecting and sterilizing equipments which have been used on patients aficted by
Creutzfeldt-Jacob 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 of the probe".

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MN1-1014 Rev. 14
Caution
Constantly check for anything abnormal about the patient’s condition, equipment.
Continued use without noticing that an abnormal condition has occurred can result in an electric
shock and injury to the operator or patient. If an abnormal condition occurs, immediately move the
equipment away from the patient and stop use of the equipment.
The equipment is vulnerable to damage by impact. Therefore, handle it with care.
There is a risk of damage to the equipment when the equipment is fallen or hit somewhere.
Do not use this equipment with other equipment except for those specically approved in the
manual.
Use with unapproved equipment can result in an electric shock, burn or other injury to the patient
or operator and damage to this equipment and the other equipment.
Scan for the minimum length of time necessary for the diagnosis and at the lowest suitable output.
Overuse can adversely affect the internal tissues of the patient.
For details about the acoustic output, please refer to the documentation supplied with the ultrasound
diagnostic instrument.
Regularly perform maintenance inspection and safety tests of the equipment.
If you use equipment for a long period of time, it can reduce the performance or cause smoke or
re. If anything unusual occurs, immediately stop using it and contact one of our ofces and/or
distributor's ofces listed on the back cover.
Use, move and transport the equipment under the environmental conditions specied in this
manual.
Otherwise, it may be damaged.
See section 2-5 "Environmental conditions" and section 7-4 "Environmental conditions during
transportation".

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MN1-1014 Rev. 14
1-2-2. Puncturing precautions
Warning
Puncturing must be performed by a skilled doctor.
Improper puncturing can injure the patient. Puncturing operations must be performed by a doctor
who fully understands the characteristics of ultrasound diagnostics and who is skilled and has a
thorough knowledge of puncture operations under an ultrasound guide.
The equipment must be washed and sterilized before use.
Be sure to always properly wash and sterilize after use.
Otherwise, an infection can occur. Note that the equipment is not sterilized when shipped from the
factory. Before using the equipment, be sure to wash and sterilize it as required.
When puncturing, be sure to wear sterilized medical gloves.
Puncturing with the bare hands can expose the operator or patient to a risk of infection.
The puncture adapter is used by attaching to the probe and following the instructions in this manual.
Attaching improperly to the probe or performing puncture operations without attaching to the probe
can result in the puncture adapter coming off during surgery or puncturing an unintended body part.
For details on the attachment procedure, see section 4-2 "Attaching of the puncture adapter".
For the acoustic medium, use sterilized physiological saline solution.
Using an unsterilized acoustic medium can cause an infection on the patient.
Check that the gauge size of the puncture needle that is used matches the gauge size of the puncture
adapter.
Using when the gauge sizes of the puncture needle and puncture adapter do not match can result in
puncturing of an unintended body part. Also, even if the gauge size is the same, the diameters may
vary between different puncture needle manufacturers and products.
For puncture needles diameters can be used for the puncture adapter, see section 2-2-2
"Specications of the puncture adapter".
Use sterilized puncture needles.
Otherwise, an infection can occur.
Do not use needles were bent.
Puncturing of an unintended body part causing an injury to the patient.
Be careful when handling the puncture needle.
Accidentally puncturing your hand or other body part can result in infection of the operator or
patient.
During the puncture operation, display a suitable puncture guide line on the screen of the ultrasound
diagnostic instrument.
Puncturing of an unintended body part can cause an injury to the patient. Display the puncture guide
line on the screen referring to the instruction manual supplied with the ultrasound diagnostic
instrument, use it as an aid in determining the puncturing direction.
Check beforehand any areas not displayed on the ultrasound image that are along the puncturing
path.
If other tissues are in the area not displayed on the ultrasound image, there is a risk of puncturing an
unintended body part and causing an injury to the patient.

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MN1-1014 Rev. 14
Warning
Do not puncture the heart region.
Puncturing the heart region may cause a micro electric shock.
Check that no other organs lie in the puncture path.
If another organ lies in the puncture path, an unintended body part can be punctured and cause an
injury to the patient. Before puncturing, carefully check the body parts and constantly conrm the
needle echo during the operation.
Constantly check the safety in the needle insertion direction using the needle echo rendered by the
ultrasonic wave.
A bent puncture needle can result in puncturing of an unintended body part and cause an injury to
the patient.
Do not try to forcibly perform operations.
If excessive force is applied in a direction other than the insertion direction of the puncture needle,
the puncture needle can deviate from the puncture guide line, resulting in puncturing of an
unintended body part and causing an injury to the patient.
For details about the reuse and disposal of puncture needles, follow the instructions in the
documentation supplied with the puncture needles.
Reuse of puncturing needles that are not reusable or improper disposal could result in an infection.
Do not use the equipment fallen on to oor.
Otherwise, there is a risk of infection. Stop the operation and perform the procedure in section 5
"Washing, Disinfection and Sterilization" section 3-1 "Start up check" and section 3-2 "Checking
the needle echo".
When inserting an RFA(Radio Frequency Ablation) needle, do not insert while bending the needle.
Inserting while bending the needle can break the insulation membrane covering the RFA needle and
could cause burns to the patient.
Before using a needle cannula with the puncture adapter as a guide, rst check that the cannula
moves smoothly through the tube without causing any damage on the surface of the cannula and
then operate with caution.
If the cannula does not move smoothly or is forced to bend when inserted in or pulled out of the
puncture adapter, it may damage the insulation membrane covering the cannula and may cause
burns to the tissue exposed to the damaged area of the cannula.

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MN1-1014 Rev. 14
Caution
Handle the needle carefully to ensure that the probe, the puncture adapter, the needle stopper and
the depth gauge are not damaged.
Using the probe, the puncture adapter, the needle stopper and the depth gauge that has been
damaged by a needle can result in an injury to the operator or patient.
Check beforehand if the patient has any allergic reactions to metals.
When using the puncture needle made of the stainless steel, if the patient has a metal allergy of
stainless steel, the puncture needle may be hazardous for patient as an allergic risk.
Note
Before carrying out a puncture operation on the patient, check the relative safety not only of the equipment
directly related to the puncture operation, but also of peripheral equipment and measuring instruments.

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MN1-1014 Rev. 14
1-2-3. Washing, disinfection and sterilization precautions
Warning
Wear protective gloves and other protective gear during washing, disinfection and sterilization.
Handling of the equipment with your bare hands before disinfection or sterilization can result in an
infection.
After soaking in cleaning agents, thoroughly wash the equipment with running water.
Residual cleaning agents can cause an adverse reaction on the bodies of the operator or patient.
After chemical disinfection and sterilization, thoroughly wash the equipment 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 equipment or reduced performance. The equipment cannot withstand autoclave
sterilization or boiling and other types of sterilization at temperatures exceeding 60°C (140°F).
For details on the usage conditions of chemicals and sterilization procedures, refer to the
documentation supplied with the respective chemical or sterilization equipment.
Infection could result due to incomplete disinfection or sterilization.
This could also cause deterioration of the equipment.
Caution
Do not place the probe tip in any liquids beyond the range
shown in the gure right.
The connector which liquid has intruded can cause the
malfunction of the probe and the ultrasound diagnostic
instrument. In this case immediately stop use and contact one
of our ofces and/or distributor's ofces listed on the back
cover.
Water or solution
60 mm or less

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MN1-1014 Rev. 14
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Label 3
Label 2
Label 1
Label 1
Electronic convex probe mark
Frequency
1-2-5. Labels
(1) Probe unit

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MN1-1014 Rev. 14
Label 3
Label 2
This equipment complies with Directive 93/42/EEC relating to
Medical Device.
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.
Manufacturer
Model, Serial No.
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

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MN1-1014 Rev. 14
(2) Storage case
Label A
Label B

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MN1-1014 Rev. 14MN1-1014 Rev. 15
Label A
Model
Serial No.
Label B
2012
This equipment complies with Directive 93/42/EEC
relating to Medical Device.
DATE OF MANUFACTURE
(in case of 2012)
MANUFACTURER
2012

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MN1-1014 Rev. 14

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MN1-1014 Rev. 14
2. Specications and Parts name
2-1. Principles of operation
This probe and the ultrasound diagnostic instrument enable image diagnosis using ultrasonic waves. These
instruments operate under the principles described below.
(1) When an electric pulse signal is applied from the transmitter to the transducer of the probe, the
transducer operates by converting electrical vibrations to mechanical vibration energy for emitting
pulse-shaped ultrasonic waves into the body part contacting the transducer or into liquid or other
medium.
(2) The emitted ultrasonic waves are reected by boundaries with different acoustic characteristics (acoustic
impedance) within the body.
(3) The transducer is also used to receive reected ultrasonic waves. The transducer vibrates mechanically
due to the received ultrasonic vibrations and uses an electro-mechanical conversion operation to
convert the received mechanical vibrations to electric energy. The received echo is also converted to
electric signals and a brightness modulation operation is used to convert the electric pulses to shades of
brightness for forming an image.

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MN1-1014 Rev. 14
2-2. Specications
2-2-1. Specications of the probe
Application regions: Surface puncturing, abdomen, general areas
Form of application to patient: Surface
Connectable instruments: SSD-900, SSD-1000, SSD-3500, SSD-4000, SSD-α5, Prosound 6
Field of view: 60°
Frequency: 3.5 MHz
Cable length: 2.0 m
Weight: 1060 g
Service life: Three years
Range of applied part Ultrasonic irradiation area, see the section 2-4.
Parts treated as applied parts Probe tip itself and 1 m of the cable near the probe tip.
IPX7 range As shown in the gure below.
External dimensions: As shown in the gure below.
Unit: mm
Remarks:
The dimensions and weight are within ±10% of the indicated values.
IPX7 range
50
28 107
123
Cable length
G18