Hitachi C25P User manual

i
MN1-5821 Rev. 4
C25P Probe
Instruction Manual
Specication
MN1-5821 Rev. 4
Notes for operators and responsible maintenance personnel
★
Please read through this Instruction Manual as well as the separate Instruction
Manual “Safety (MN1-5982)” and “Cleaning, Disinfection and Sterilization
(MN1-5998)“ carefully prior to use.
★
Keep this Instruction Manual together with the ultrasound diagnostic instrument
for any future reference.
© Hitachi, Ltd. 2014, 2017. All rights reserved.
Q1E-EP1473-4

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MN1-5821 Rev. 4

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MN1-5821 Rev. 4
Introduction
This is the instruction manual for C25P probe. The probe is available by connecting to Hitachi’s ultrasound diagnostic
instrument and can be mainly used for puncture of abdominal organs.
Prior to use, read this manual as well as the separate instruction manual “Safety” in which information for safe use is
provided.
The probe bears the CE mark but the mark is valid only when the probe is connected to the ultrasound diagnostic
instrument bearing the CE mark.
Symbols used in this document
Safety information is classied into Danger, Warning, Caution, and Note according to the level of hazard. Those terms
are used in safety information provided to prevent hazards and injuries to the operator or patient.
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 that attention is required.
This symbol means that the described action is prohibited.
This symbol means that the described action is mandatory.

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MN1-5821 Rev. 4
This instruction manual contains 4 pages of front matter and 16 pages of the main content.
CONTENTS
1. General Information...................................................................................................................................1
1-1. Intended use...................................................................................................................................................................1
1-2. Classication of ME equipment....................................................................................................................................1
1-3. Standard components ....................................................................................................................................................1
1-4. Options ..........................................................................................................................................................................2
2. Specications and Parts name....................................................................................................................3
2-1. Specications.................................................................................................................................................................3
2-2. Name of each parts........................................................................................................................................................4
3. Preparations before use .............................................................................................................................7
3-1. Preparation for probe.....................................................................................................................................................7
3-1-1. Visual check ....................................................................................................................................................7
3-1-2. Conrmation of cleaning, disinfection, and sterilization ..............................................................................7
3-1-3. Operation check ..............................................................................................................................................7
3-1-4. Applicable probe cover...................................................................................................................................7
3-2. Preparation for the biopsy attachment..........................................................................................................................8
3-2-1. Inspection for the biopsy Attachment ............................................................................................................8
3-2-1. Confrimation of the needle echo ....................................................................................................................8
4-1. How to attach a probe cover and the biopsy attachment ..............................................................................................9
4-2. Operation.....................................................................................................................................................................13
4-3. How to attach/release the magnetic position sensor and the magnetic position sensor attachment..........................15

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MN1-5821 Rev. 4
1. General Information
General information for the probe is provided below.
1-1. Intended use
This probe is intended to be used by doctors or other qualified operators. The probe is placed on the body for
observation of surrounding organs and puncture.
Please refer to the ultrasound diagnostic instrument instruction manual used with this probe for the probe intended use
information.
Regarding with the connectable instrument, please refer to section 2-1. Specications of this manual.
Warning
Do not use this equipment for other than its intended use.
Otherwise it could cause burns or other injuries to the patient or operator.
1-2. Classication of ME equipment
This probe is classied as follows according to IEC60601-1.
Please refer to the section 2-1 for the applied part, the part treated as the applied part, and the range of IPX7.
• Classication based on the 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.................................................................................... Refer to the separate instruction manual
“Cleaning, Disinfection and Sterilization”
1-3. Standard components
The standard components of C25P probe are as follows.
C25P Probe ··························································· 1 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-5821)········································ 1 copy
• Safety (MN1-5982)················································ 1 copy
• Cleaning, Disinfection and Sterilization (MN1-5998) ······ 1 copy

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MN1-5821 Rev. 4
1-4. Options
The following options are available for C25P probe.
• Biopsy Attachment
Table 1 provides biopsy attachments needed for performing a puncture. The attachments listed are manufactured by
Hitachi Medical Corporation and sold as the options of biopsy probe EUP-B715, but they are fully compatible with
C25P probe.
EZU-PA7B1-C is the attachment for Cool-tipTM(17G) or LeVeenTMSuperSlim.
Since each biopsy attachment is disposable, dispose it after one use.
Table 1 Biopsy Attachment for puncture
Product Name Gauge Size Quantity
EZU-PA7B1-1 12 - 13 G 10 pcs/pack
EZU-PA7B1-2 14 - 16 G 10 pcs/pack
EZU-PA7B1-3 17 - 19 G 10 pcs/pack
EZU-PA7B1-4 20 - 23 G 10 pcs/pack
EZU-PA7B1-C 17 G 10 pcs/pack
• Real Time Virtual Sonography (RVS)
Please use the option listed in Table 2 for performing RVS. Regarding how to attach/release the attachment, please
refer to the section 4.3.
Table 2 Option for RVS
Product Name Product No.
Magnetic Position Sensor Attachment RV-005
Warning
Use a needle which is applicable to the biopsy attachment.
Use of the needle which is not applicable to the biopsy attachment can result in puncture at unintended
parts and injury to the patient.
Use EZU-PA7B1-C if Radio Frequency Ablation (RFA) is performed with either Cool-tipTM(17G) or
LeVeenTMSuperSlim.
Sterilize the biopsy attachment prior to use.
The attachments listed in Table 1 are not sterilized, so they must be sterilized prior to use.
Do not reuse the biopsy attachment.
The attachments listed in Table 1 are disposable. Dispose after one use.

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MN1-5821 Rev. 4
2. Specications and Parts name
The specications and the name of each part are provided below.
2-1. Specications
Application: Abdomen
Type of patient contact: Surface
Connectable instruments: ARIETTA 70, ARIETTA 60, ARIETTA Precision, ARIETTA Prologue,
ALOKA ARIETTA 850
NOTE:
At the time of publication of this manual, the connectable diagnostic ultrasound
instrument or instrument software version available with this probe is different
for each country, please refer to the instrument instruction manual or contact
your local Hitachi representative.
Field of view: 70°
Frequency: 3.0 MHz
Cable length: 2.2 m
Service life: 3 years
Applied part: Probe tip including ultrasonic radiation part, see the section 2-2
Part treated as Applied part: Cable up to 1 m length from the probe tip
IPX7 range: See Figure 1
Measurement accuracy: Refer to the instruction manual of the ultrasound diagnostic instrument
External dimensions: See Figure 1
Remark: The tolerance for the dimensions is ±10%.
Figure 1 External View
76
84
35
Cable length
50
IPX7 range
Unit: mm

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MN1-5821 Rev. 4
2-2. Name of each parts
The name of each part is shown in Figure 2 and the explanation for each part is listed in Table 3.
Connector Ultrasonic radiation part
Orientation mark side
Cable
Probe tip
・Biopsy Attachment (Option)
Needle
Guide
Needle
Insert
Biopsy Attachment
Mounting Plate
・Probe
Probe
Needle Guide
Needle Insert
Biopsy Attachment Mounting Arm
Needle Insertion Groove
Figure 2 Name of each parts

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MN1-5821 Rev. 4
Table 3 Name of each part and its explanation
Name Explanation
Ultrasonic radiation part Ultrasound is radiated from this part. The electronic
convex transducer is integrated underneath this part.
Orientation mark side The side of the orientation mark corresponds to the side
of the orientation mark on the image.
Probe tip This part is gripped during operation.
Cable Cable transfers electric input/output signals.
Connector The connector is the part which is connected to the
ultrasound diagnostic instrument.
Needle Guide
Needle Insert
The biopsy attachment is needed to be attached to the
probe for performing a puncture. The attachment consists
of the needle guide and the needle insert. The applicable
needle size is marked on each parts. Refer to 4-1 for how
to attach the biopsy attachment to the probe.
Needle Insertion Groove
A puncture needle is inserted into this part. The insertion
angles are 0°, 15°, and 30°. The angles are marked on the
needle guide.
Biopsy Attachment Mounting
Arm
This part is used to x the probe cover to the probe.
Please refer to 4-1 for how to x.
Biopsy Attachment Mounting
Plate
This part is used to x the biopsy attachment to the probe
rmly.
Caution
Do not pull, bend, twist, or apply excessive force to the cable.
The probe may malfunction due to cable disconnection.
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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MN1-5821 Rev. 4

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MN1-5821 Rev. 4
3. Preparations before use
This chapter describes preparations needed to use the probe safely. Please prepare the probe prior to each use by
following the instructions below.
3-1. Preparation for probe
3-1-1. Visual check
Visually check the probe tip, ultrasonic radiation part, cable, and connector.
If any holes, indentations, abrasion, cracks, deformation, looseness, discoloration, or other abnormalities are
found, do not use the probe. Check also the options as necessary.
3-1-2. Conrmation of cleaning, disinfection, and sterilization
Conrm that the probe is certainly cleaned, disinfected, and sterilized. The degree of reprocessing depends on
the intended use. Please refer to the separate instruction manual “Cleaning, Disinfection and Sterilization“ for
cleaning, disinfection, and sterilization procedure. Conrm also that options are properly cleaned, disinfected,
and sterilized.
3-1-3. Operation check
Connect the probe to the ultrasound diagnostic instrument and check that the displayed scan type and frequency
correspond to those of the probe. Check also that there is no abnormality in the image.
Remark: Please refer to the documentation supplied with the ultrasound diagnostic instrument for how to connect the
probe and information displayed on the monitor.
If the probe is operated in still air, brightness on the top of the image may be non uniform, but this does not
affect the performance of the probe.
3-1-4. Applicable probe cover
Prepare the following applicable probe cover.
Product name: Latex-Free CIV-Flex Covers
Manufacturer: Civco Medical Solutions
Product Number: 610-542
Warning
Make preparations prior to each use.
The operator and the patient may be injured if the equipment has any abnormality.
If any abnormality is found in the equipment, stop using it and contact our ofce written on the back
cover.
Caution
Do not use the probe if the displayed scan type and frequency do not correspond to those of the probe.
Incorrect acoustic output can result in burns or other injuries to the patient. Contact our ofce written
on the back cover.

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MN1-5821 Rev. 4
3-2. Preparation for the biopsy attachment
3-2-1. Inspection for the biopsy Attachment
Visually inspect the biopsy attachment for any break, deformation, crack or denaturalization. If you nd any
damage, do not use them and contact our ofce written on the back cover.
3-2-2. Conrmation of the needle echo
Conduct the following procedure to conrm the needle echo before puncture. This conrmation should be done
before the sterilization of the probe and biopsy attachment.
(1) Fill a tank with water at 40 degrees Celsius, and prepare a test needle for needle echo conrmation.
(2) Connect the probe to the ultrasound diagnostic instrument. Display the puncture guideline on the image.
Refer to the documentation supplied with the ultrasound diagnostic instrument for how to display the
puncture guideline.
(3) Attach the biopsy attachment to the probe according to 4-1. Insert the test needle into the needle insertion
groove. Conrm that the needle can be smoothly inserted.
(4) Put the probe in sterile water so that needle echo is displayed.
(5) Conrm that the needle echo at each angle overlaps with the correspondent puncture guideline. Refer to the
Figure 14 for the relationship between the puncture angle and the displayed puncture guideline.
Test needle
Needle echo
(Solid line)
Puncture guide line
(Dotted line)
Sterile water
Orientation mark
Figure 3 Conrmation of the needle echo
Caution
When a needle cannula for RFA is used, conrm that the needle cannula can be smoothly inserted to
the biopsy attachment without any damage, and operate it carefully.

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MN1-5821 Rev. 4
4. Operation
This chapter describes how to attach a probe cover and the biopsy attachment to the probe, the operation of the probe,
and how to attach/release the magnetic position sensor and magnetic position sensor attachment.
4-1. How to attach a probe cover and the biopsy attachment
(1) Apply sterile ultrasound gel to the ultrasonic radiation part (Figure 4).
(2) Mount a probe cover on the probe tip, pull the cover to smooth a wrinkle, and remove air bubbles from the
ultrasonic radiation part (Figure 5). Be careful not to break the probe cover during this procedure.
(3) Place a sterile rubber band into the groove of the probe to x the probe cover to the probe (Figure 6).
Ultrasonic radiation part
Sterile ultrasound gel
Probe cover
Figure 4 Sterile ultrasound gel applied to the ultrasonic radiation part
Band
Figure 5 Smoothing of a wrinkle Figure 6 Fixing of the probe cover

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MN1-5821 Rev. 4
(4) Assemble the needle Insert to the needle guide (Figure 7). Be sure that the gauze size engraved on each parts is
same. Open the biopsy attachment mounting arm outward to attach the biopsy attachment to the probe (Figure 8).
(5) Place the projected parts of the attachment on the grooves of the probe in order to attach the biopsy attachment to
the probe. Note that the biopsy attachment is attached over the probe cover (Figure 9).
Needle Guide
Needle Insert
Applicable needle size
Figure 7 Biopsy Attachment assembly
Figure 8 Opening of Biopsy Attachment Mounting Arm
Figure 9 Attachment of Biopsy Attachment
Open outward
Biopsy Attachment Mounting Arm
Projected parts of the attachment
Grooves of the probe

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MN1-5821 Rev. 4
(6) Fix the biopsy attachment to the biopsy attachment mounting plate by pushing it towards the direction shown in
Figure 10.
(7) Fix the biopsy attachment mounting arm to the probe while pulling the probe cover as shown in Figure 11. Note that
the wrinkle at the part indicated in Figure 11 should be smoothed as possible.
Biopsy Attachment
Slide
Figure 10 Fixing Biopsy Attachment
Stretch wrinkles of the probe cover.
Biopsy Attachment Mounting Arm
Fix
Figure 11 Fixing Biopsy Attachment Mounting Arm

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MN1-5821 Rev. 4
(8) Conrm that the probe cover does not interfere with the needle path by inserting a needle in each needle insertion
groove (Figure 12).
(9) Conrm that the biopsy attachment is properly attached to the probe (Figure 13). Visually inspect that there is no
hole or tear in the probe cover. Set a new probe cover if a hole or tear is found.
Needle
Needle
Confirm that the probe cover does not
interfere with the needle path.
Figure 12 Conrmation of the needle path
Attached correctly
Confirm the fit of the biopsy attachment.
Attached incorrectly Attached incorrectly
Figure 13 Conrmation of the attachment

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MN1-5821 Rev. 4
4-2. Operation
Mount a probe cover according to 4-1, apply sterile ultrasound gel to either the ultrasonic radiation part or the body of
the patient, and place the ultrasonic radiation part of the probe onto the skin surface. An image of the region of interest
is displayed on the monitor of the ultrasound diagnostic instrument. For details on displaying and adjusting the image,
refer to the documentation supplied with the ultrasound diagnostic instrument.
Fix the probe rmly and perform a puncture by inserting a needle to the needle insertion groove. Conrm that the
puncture guideline which corresponds to the insertion angle is displayed. Figure 14 indicates the relationship between
the insertion angle and the guideline. If the probe is needed to be released from the biopsy attachment during puncture,
release the needle insert as indicated in Figure 15 and then release the probe.
Figure 14 Relationship between the insertion angle and the puncture guideline
Puncture guideline

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MN1-5821 Rev. 4
Figure 15 Release of the probe from the biopsy attachment during puncture
Warning
Use only sterile ultrasound gel.
The use of non-sterile ultrasound gel could result in infection to the patient.
Use only the biopsy attachment specied in this manual.
A puncture with the other attachment can result in puncture at unintended parts.
Sterilize the probe after use, if the probe cover was broken during use.
Sterilize the probe according to the separate instruction manual “Cleaning, Disinfection and
Sterilization“, otherwise there is a risk of infection to the patient.
Do not reuse the probe cover that was used.
Reuse of the probe cover can result in infection to the patient.
Caution
Do not operate the probe with excessive force.
Use with excessive force could result in injury to the patient.
Scan for minimum time necessary at the lowest possible acoustic output.
Acoustic output may affect the patient’s internal tissues.
For details about the acoustic output, please refer to the documentation supplied with the ultrasound
diagnostic instrument.
Do not touch the connector terminal pin of the probe.
Electrostatic discharge may result in malfunction of the probe.
Do not touch the probe connector of the ultrasound diagnostic instrument and the patient at the same
time. It can cause electric shock to the patient.
①Push the lever of
the Needle Insert.
①
①
②
③
②
③
Needle Insert
Needle
Slide the Needle Insert
upward.
Remove the Needle Insert.

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MN1-5821 Rev. 4
4-3. How to attach/release the magnetic position sensor and the magnetic position sensor attachment
This section provides the procedure to attach the magnetic position sensor and the magnetic position sensor attachment
to the probe. Note that a probe cover is mounted after attaching these devices to the probe.
After use, reverse the procedure to remove these devices from the probe.
(1) Place the magnetic position sensor into the magnetic position sensor attachment. The direction mark of the sensor
is upward as shown in Figure 16.
Magnetic Position
Sensor Attachment
Direction mark
(upward)
Magnetic Position Sensor
Figure 16 How to attach Magnetic Position Sensor
(2) Attach the magnetic position sensor attachment to the probe as shown in Figure 17.
Figure 17 How to attach Magnetic Position Sensor Attachment
Caution
Attach the magnetic position sensor to the magnetic position sensor attachment correctly.
A false diagnosis may be caused if the sensor is attached in the wrong direction.
Groove of the probe
Magnetic Position
Sensor Attachment
Projected part
(inside the attachment)

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MN1-5821 Rev. 4
US Importer: Hitachi Healthcare Americas Corporation
Address: 1959 Summit Commerce Park, Twinsburg, Ohio 44087
Distributor
MN1-5821 Rev. 4 ’17.08.31
■Manufacturer
Hitachi, Ltd.
2-16-1, Higashi-Ueno, Taito-ku, Tokyo, 110-0015, Japan
■Contact
[phone]
http://www.hitachi.com/businesses/healthcare/index.html
Overseas Offices:
Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205 Wiesbaden, Germany
EU Importer: Hitachi Medical Systems Europe Holding AG
Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland