Hitachi C41RP User manual

i
MN1-5827 Rev. 6
C41RP Probe
Instruction Manual
Specication
MN1-5827 Rev. 6
Notes for operators and responsible maintenance personnel
★
Please read through this Instruction Manual as well as the separate Instruction
Manual “Safety (MN1-5990)” and “Cleaning, Disinfection and Sterilization
(MN1-6161)“ 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.

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MN1-5827 Rev. 6

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MN1-5827 Rev. 6
Introduction
This is the instruction manual for C41RP probe. The probe is available by connecting to Hitachi's ultrasound
diagnostic instrument and can be mainly used as a transrectal probe for observation of prostate and surrounding organs
respectively. It can also be used for puncture under the condition that the optional puncture adapter is attached to it.
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 patients.
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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MN1-5827 Rev. 6
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
2-1-1. Specication of the probe................................................................................................................................3
2-1-2. Specication of the puncture guide tube........................................................................................................4
2-2. Name of each parts........................................................................................................................................................5
3. Preparations before use .............................................................................................................................7
3-1. Start up check of the 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
3-2. Start up check of the puncture guide tube ....................................................................................................................8
3-2-1. Visual check....................................................................................................................................................8
3-2-2. Mechanical inspection....................................................................................................................................8
3-2-3. Mounting of rubber boot.................................................................................................................................8
3-2-4. Verication of operation ................................................................................................................................8
3-3. Checking the needle echo .............................................................................................................................................9
3-3-1. Check preparation...........................................................................................................................................9
3-3-2. Checking the needle echo.............................................................................................................................10
3-4. Performing washing and sterilization ........................................................................................................................10
4. Operation.................................................................................................................................................. 11
4-1. Operation.....................................................................................................................................................................11
4-2. How to mount the rubber boot....................................................................................................................................12
4-3. How to remove the rubber boot...................................................................................................................................13
4-4. Attaching of the puncture guide tube.........................................................................................................................13
4-4-1. Selecting the guide tube ...............................................................................................................................13
4-4-2. Attaching of the puncture guide tube..........................................................................................................13
4-5. Removal of the puncture guide tube...........................................................................................................................15
This instruction manual contains 4 pages of front matter and 16 pages of the main content.

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MN1-5827 Rev. 6
1. General Information
General information for the probe is provided below.
1-1. Intended use
This probe is intended to be used by a doctor or other qualied operator for ultrasonic observations of the prostate and
surrounding organs. It can also be used for ultrasound-guided 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 range of applied part, the part treated as 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 C41RP probe are as follows.
C41RP Probe ························································· 1 set
Puncture guide tube MP-2452-G18(for 18G needles) ·········· 2
Washing brush(M) L-ki-266 ······································· 2
Storage tray MP-2724················································ 1 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-5827) ······································· 1 copy
• Safety (MN1-5990) ··············································· 1 copy
• Cleaning, Disinfection and Sterilization (MN1-6161) ······ 1 copy

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MN1-5827 Rev. 6
1-4. Options
The following options are available for C41RP probe.
• Puncture
Please use one of the options listed in Table 1 for performing a puncture. Please refer to the section 4-4 for how to
attach Puncture guide tube.
Table 1 Options for puncture
Product Name Product No. Remark
Puncture guide tube MP-2452-G21 Applicable needle size: 21G
Puncture guide tube M P-2452-G16 Applicable needle size: 16G
Puncture guide tube M P-2452-G14 Applicable needle size: 14G
• Wash brush
Please use the options listed in Table 2 for performing wash for MP-2452-G14.
Table 2 Options for wash brush
Product Name Product No.
Wash brush (L) L-ki-265
• Probe cover
Please use the option listed in Table 3 for probe cover. Please refer to the section 4-2 and 4-3 for hoe to attach/release
probe cover.
Table 3 Option for probe cover
Product Name Product No.
Rubber boot RB-665P-NS
• Reprocessing by liquid detergent, disinfectant or sterilant
Whole the probe is able to immerge into the liquids by putting the connector of the ultrasound probe to the waterproof box
WP-001 as below table 4.
Precautions about the waterproof box, please refer to the instruction manual.
Table 4 Accessory for reprocessing by liquid detergent, disinfectant or sterilant
Product Name Product No.
Waterproof box WP-001

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MN1-5827 Rev. 6
2. Specications and Parts name
The specications and the name of each part are provided below.
2-1. Specications
2-1-1. Specication of the probe
Application: Urological applications
Type of patient contact: Transrectum
Connectable instruments: ARIETTA 70, ARIETTA 60
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: 180°
Frequency: 6.0 MHz
Cable length: 2.5 m
Service life: 3 years
Applied part: See Figure 1
Part treated as applied part: See Figure 1
IPX7 range: See Figure 1 (In case that not putting the waterproof box to the ultrasound probe
connector)
In case that putting the waterproof box to the ultrasound probe connector, whole the
probe from the tip of the ultrasound probe to the connector with Waterproof Box WP-
001 is IPX7. range
Measurement accuracy: Refer to the instruction manual of the ultrasound diagnostic instrument
External dimensions: See Figure 1
80
1000
Cable length
IPX7 range
Applied part, Part treated as applied part
Remark: The tolerance for the dimensions is ±10%.
Figure 1 External View
Unit: mm

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MN1-5827 Rev. 6
2-1-2. Specication of the puncture guide tube
Material: Stainless steel
Usable puncture needle size and diameter: 18G (1.26±0.02mm)
Service life: 3 years
External dimensions: See Figure 2
119
2015.5
Remark: The tolerance for the dimensions is ±10%.
Figure 2 External View of puncture guide tube

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MN1-5827 Rev. 6
2-2. Name of each parts
The name of each part is shown in Figure 3 and the explanation for each part is listed in Table 4.
Puncture guide tube
Rubber boot
Grip cover
Front mark
Ultrasonic radiation part
Connector
Cable
Probe tip
Handle
Insertion portion
Front guide
Rear guide
Guide tube
Holding clip
Figure 3 Name of each parts
Table 4 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.
Front mark The dimple corresponds to the side of the orientation mark on the image.
Probe tip The probe tip is the part includes both the insertion portion and the handle.
Handle This part is held during operation.
Insertion portion This part is inserted into the patient.
Grip cover Please do slide on the cable side and detach it when you do puncturing.
Cable Cable transfers electric input/output signals.
Connector The connector is the part which is connected to the ultrasound diagnostic
instrument.
Puncture guide tube This tube is attached to the probe to help insert the probe needle. Attach ir
as per the instructions in section 4-4.
Rubber boot Cover the insertion portion with this rubber boot to prevent infection.
Follow the instructions in section 4-2.

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MN1-5827 Rev. 6
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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MN1-5827 Rev. 6
3. Preparations before use
This chapter describes preparations needed to use the probe safely. Please prepare the probe and the puncture guide
tube prior to each use by following the instructions below.
3-1. Start up check of the probe
3-1-1. Visual check
Visually check the ultrasonic radiation part, insertion portion, handle, cable, and the 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.
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.
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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MN1-5827 Rev. 6
3-2. Start up check of the puncture guide tube
3-2-1. Visual check
Make sure the puncture guide tube is not in the abnormal condition listed below.
• Abnormalities seen in visual such as deformation, cracking, abnormal gaps, damage, foreign matter
adhering, clogged induction tube, sever discoloration.
•The holding clip can not close until the end.
• Loose screws which x the holding clip.
• A spring of the holding clip is damaged.
3-2-2. Mechanical inspection
Check that the puncture guide tube mechanism while attached to the probe.
• The screws have no looseness, backlash, immobility, or other abnormalities.
• The puncture guide tube is rmly attached to the probe.
• There are no tears in the rubber boot.
3-2-3. Mounting of rubber boot
Cover the probe insertion portion with the rubber boot to prevent infection and then attach the puncture guide
tube over this.
3-2-4. Verication of operation
When puncturing under the ultrasonic guide, for safety reason, it is also recommended that you have a full
understanding of ultrasound diagnostic characteristics and conduct practice beforehand using a tub or similar
object.

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MN1-5827 Rev. 6
3-3. Checking the needle echo
3-3-1. Check preparation
(1) Required items
Tub (Depth of 20 cm or more)
Warm water 40°C (104°F)
Thermometer
Puncture guide tube MP-2452-G18 (standard conguration)
or others (user’s selection of the options)
Puncture needle Size: 18G (standard conguration) or others (depend on a user’s selection)
Length: up to 250 mm
(2) Setup procedure
1. Put warm water at 40°C (104°F) into the tub.
Use a thermometer to check the water temperature.
2. Refer to section 4-1 “Operation”, and attach the puncture guide tube to the probe,
and insert the puncture needle into the puncture guide tube.
Check that the puncture needle has no bending or other defects.
3. Connect the probe to the ultrasound diagnostic instrument.
Turn on the ultrasound diagnostic instrument to display the puncture guideline on the monitor screen.
Remarks:For details of the puncture guideline, refer to the instruction manual of the ultrasound diagnostic
instrument.
Caution
Use warm water at 40°C (104°F) in the check of the needle echo.
In the actual puncture operation, the needle echo and guideline may not match and this could result in
puncturing of an unintended body part. It is well-known that the acoustic characteristics of water at
40°C (104°F) are the most similar to those of the human body.

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MN1-5827 Rev. 6
3-3-2. Checking the needle echo
(1) Dip the probe tip into the warm water so that the needle echo is displayed.
Probe
Puncture guide tube
Tub
Water of 40℃
Figure 4 Checking the needle echo 1
(2) Check the following points.
• The needle echo matches with the puncture guideline.
• The echo of the entire needle is displayed fully and clearly.
針エコー
穿刺
ガイドライン
Needle echo
Puncture guideline
Images on the monitor
Figure 5 Checking the needle echo 2
3-4. Performing washing and sterilization
(1) Before use, wash and sterilize the puncture guide tube.
Please refer to the instruction manual of the puncture guide tube.
(2) Wash and disinfect or sterilize the probe to be used in accordance with its usage purpose.
Warning
The equipment must be washed and sterilized before use.
Be sure to always properly wash and sterilize after use.
Failure to do so could result in an infection. Note that the equipment is not sterilized when shipped
from the factory. Before using the equipment for the rst time, be sure to wash and sterilize it as
required.

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MN1-5827 Rev. 6
4. Operation
This chapter describes the operation of the probe and how to attach the puncture guide tube.
4-1. Operation
Mount a probe cover on the probe and insert the probe into the rectal. 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.
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.

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MN1-5827 Rev. 6
4-2. How to mount the rubber boot
Apply a suitable amount of ultrasound gel on the ultrasonic radiation part and then cover it with the rubber boot.
Remove air bubbles or wrinkles on the ultrasonic radiation part.
Apply a suitable amount of
acoustic medium. Rubber boot
Figure 6 How to mount the rubber boot
Warning
Use by covering the rubber boot over the insertion portion.
If the rubber boot is not used, residual pathogens on the scanner 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 by the body of the patient.
Check that the rubber boot is sterilized.
Use of an infected item could spread infection to the patient.
Do not reuse the rubber boot.
Use of an infected 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) or severe discoloration, cracks, or other visible defects
nds.
Check that the acoustic medium has no air bubbles inside the rubber boot that is covering the scanner.
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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MN1-5827 Rev. 6
4-3. How to remove the rubber boot
(1) Wrap the rubber boots in tissue paper and remove the rubber boots from the probe.
(2) Dispose tissue paper and the rubber boots according to the infection prevention procedures of your facility.
Caution
Before disposing of the equipment, disinfect or take other infection-prevention measures.
Disposal of the equipment without taking the proper preventative measures can lead to infection.
4-4. Attaching of the puncture guide tube
4-4-1. Selecting the guide tube
Select a puncture guide tube that matches the size of the puncture needle that is used.
Needle size is
indicated G**
Figure 7 Selecting the guide tube
4-4-2. Attaching of the puncture guide tube
After covering the probe insertion portion with the rubber boot, use the procedure below to attach the puncture
guide tube onto the probe.
(1) When grips on the top of the puncture guide tube holding clip are squeezed from both sides, the holding clip opens.
Squeeze grips
from both sides.
Holding clip
opens.
Figure 8 Attaching of the puncture guide tube 1
(2) Open the holding clip, and insert the hooks of the front guide into the grooves on both sides of the probe tip as
shown in gure below.
Insert the hooks
of the front guide
into the grooves
on both sides.
Fixing position
Keep holding clip
open, and put it on
the xing position.
Figure 9 Attaching of the puncture guide tube 2

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MN1-5827 Rev. 6
(3) Put the holding clip on the xing position.
(4) When part marked “G**” is pushed, holding clip closes and xes on the probe.
Push
Figure 10 Attaching of the puncture guide tube 3
Caution
Carefully attach the puncture guide tube.
There is a risk of infection if the rubber boot is damaged. If the position of the puncture guide tube is
misaligned, check the position of the puncture guide tube again without forcibly trying to attach it.
Note
Remove any air bubbles or wrinkles. Any air bubbles on the ultrasonic irradiation area of the probe or wrinkles
in the rubber boot can result in reduced quality of the ultrasound image.
5) Move the rear guide and check that puncture guide tube is attached rmly on probe. Before inserting into the
patient, check for air bubbles on the acoustic irradiation area again.
Move and check
the xing condition.
Conrm that there are
no air bubbles on the
acoustic irradiation area
Figure 11 Attaching of the puncture guide tube 4

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MN1-5827 Rev. 6
4-5. Removal of the puncture guide tube
(1) When grips on the top of the puncture guide tube holding clip are squeezed from both sides, the holding clip opens.
Squeeze grips
from both sides.
Holding clip
opens.
Figure 12 Removal of the puncture guide tube 1
(2) Open holding clip and pull up the puncture guide tube as shown in gure below.
Figure 13 Removal of the puncture guide tube 2
(3) Immediately wash and sterilize the puncture guide tube after it is removed from the probe.
Note
After use of the probe and puncture guide tube, immediately care of them.
If the probe and puncture guide tube are left uncleaned for a long period of time after use, the adhered muci-
lage and blood coagulate make difcult to care for them.

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MN1-5827 Rev. 6
US Importer: Hitachi Healthcare Americas Corporation
Address: 1959 Summit Commerce Park, Twinsburg, Ohio 44087
Distributor
MN1-5827 Rev.6 ’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