Hitachi C41L47RP User manual

C41L47RP Probe
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1451-6
© Hitachi, Ltd. 2013,2017. All rights reserved .
Notes for operators and responsible maintenance personnel
★ Please read through this Instruction Manual carefully prior to use.
★ Keep this Instruction Manual together with the system with care to
make it available anytime.
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Manufacturer: Hitachi, Ltd.
2-16-1, Higashi-Ueno, Taito-ku, Tokyo,110-0015,
Japan
[phone]
http://www.hitachi.com/businesses/healthcare/
index.html
European
Representative: 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
Local Distributor:

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About this manual
This instruction manual contains safety precautions, the inspection,
the operation procedure and the reprocessing procedure of C41L47RP
Probe.
Please read this manual thoroughly to ensure the safety operation.
If you have any questions concerning the operation of the probe, please
contact a service support.
The following conventions are used throughout the manual to denote
information of special emphasis.
WARNING: “Warning” indicates the presence of a hazard which may
result in severe personal injury, substantial property
damage, or death if the warning is ignored.
CAUTION: “Caution” indicates the presence of a hazard which will or
can cause minor personal injury or property damage if the
caution is ignored.
NOTICE: “Notice” indicates information of installation, operation,
or maintenance, which is important, but not hazard related.

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Graphical Symbols for Use in Labeling of Hitachi Ultrasound Probes
Some graphical symbols that are used in labeling of Hitachi Ultrasound Probes are
compliant with EN980:2008 standard. Refer to the following table about the meanings
of them.
Explanation of Symbol Symbol Descriptive Content
Manufacturer Company
Name and Address
Hitachi, Ltd.
2-16-1, Higashi-Ueno, Taito-ku,
Tokyo, 110-0015, Japan
[phone]
http://www.hitachi.com/businesses/
healthcare/index.html
Authorized
Representative
in The European
Community
Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205
Wiesbaden, Germany
Keep away
from Sunlight
Store the probe in a cool place and keep
away from high temperature, high
humidity, or direct sunlight.
Contains or presence of
natural rubber latex
Contains or presence of natural rubber
latex
Do not re-sterilize
Do not re-sterilize
Do not reuse
Do not reuse

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Definition of symbol
The following symbol is also used for HITACHI Ultrasound Probes.
Location Symbol Definition
Probe connector
This instrument complies with
Directive 93/42/EEC relating to
Medical Device and Directive
2011/65/EU relating to RoHS
Probe connector IPX7 IPX7 mark
See section 1.6.
Probe connector Type BF APPLIED PART
Probe connector General warning sign
Probe connector Warning; dangerous voltage
Probe connector Caution; Biohazard
Probe connector
Follow the instruction manual to
operate this instrument. If not
avoided, may result in injury, property
damage, or the equipment trouble.
Probe connector
STERRAD sterilization compatibility
mark
Probe connector Do not waste the instrument as general
waste. Comply with a local regulation.
Probe connector Rx Only
By prescription only. U.S. Federal Law
restricts this device to sale on order
of a physician only.

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CONTENTS
Page
1. Introduction ................................................. 1
1.1 Features ......................................................... 1
1.2 Principles of operation .......................................... 1
1.3 Intended Use ..................................................... 2
1.4 Components ....................................................... 2
1.5 Accessories (Option) ............................................. 3
1.6 Construction ..................................................... 4
2. Inspection before Use ........................................ 5
2.1 Inspection for Appropriate Connection ............................ 5
2.2 Inspection for Material Surface .................................. 5
3. Operation Procedure .......................................... 6
3.1 Connection and Settings .......................................... 6
3.2 Use of Puncture Guide Fixture (EZU-PA3U) ........................ 10
3.3 How to adjust Puncture Guide Fixture (EZU-PA3U) ................. 11
4. Option of C41L47RP Probe .................................... 13
4.1 Magnetic sensor ................................................. 13
5. Cleaning, Disinfection and Sterilization .................... 15
5.1 Point of use (Pre-cleaning) ..................................... 18
5.2 Containment and transportation .................................. 18
5.3 Manual Cleaning and disinfection ................................ 19
5.4 Drying .......................................................... 22
5.5 Inspection ...................................................... 23
5.6 Packaging ....................................................... 23
5.7 Sterilization ................................................... 24
5.8 Storage ......................................................... 26
6. Cleaning, Disinfection and Sterilization of EZU-PA3U ........ 27
6.1 Point of use (Pre-cleaning) ..................................... 28
6.2 Containment and transportation .................................. 28
6.3 Manual Cleaning and disinfection ................................ 28
6.4 Automated cleaning and disinfection ............................. 30
6.5 Drying .......................................................... 31
6.6 Inspection ...................................................... 31
6.7 Packaging ....................................................... 31
6.8 Sterilization ................................................... 32
6.9 Storage ......................................................... 32
7. Maintenance and Safety Inspection ........................... 33

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7.1 Daily Inspection ................................................ 33
7.2 Store ........................................................... 33
8. Safety Precautions .......................................... 34
9. Specifications .............................................. 36
9.1 Probe ........................................................... 36
9.2 Puncture Guide Fixture EZU-PA3U ................................. 37
9.3 Suppliers List .................................................. 37
9.4 Suppliers List for EZU-PA3U ..................................... 38
10. Disposal of the probe ...................................... 38

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1. Introduction
1.1 Features
C41L47RP Probe is a transrectal Probe.
The acoustic output of this probe when connected to ultrasound
diagnostic scanner was measured according to the IEC60601-2-37
standard. The table of measured acoustic output data is contained
in the operational manual of each ultrasound diagnostic scanner.
This probe is categorized in class Ⅱa according to Directive
93/42/EEC.
According to IEC60601-1 the probe is classified as type BF.
1.2 Principles of operation
This probe and the ultrasound diagnostic scanner enable image
diagnosis using ultrasonic waves. This system operates under the
principles described below.
1) When an electric pulse signal is applied from the transmitter
to the transducer of the probe, the transducer converts electric
signals into mechanical vibration energy for emitting
pulse-shaped ultrasonic waves into the body part, liquid or
other medium contacting the transducer.
2) The emitted ultrasonic waves are reflected by boundaries with
different acoustic characteristics (acoustic impedance) within
the body.
3) The transducer is also used to receive reflected ultrasonic
waves. The transducer vibrates mechanically due to the received
ultrasonic waves and converts mechanical vibrations into
electric energy. Electric signals are converted to shades of
brightness by brightness modulation to obtain an image.

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1.3 Intended Use
C41L47RP Probe is designed for observation and diagnosis of the
following regions mainly by connecting with the HITACHI ultrasound
diagnostic scanner.
Transrectal
Biopsy (with a Puncture Guide Fixture)
Never use the probe for following regions.
1) The heart (Do not contact directly.)
2) The eyeball
1.4 Components
Components of C41L47RP Probe are as follows:
1) Probe ............................... 1 piece
2) Instruction Manual .................. 1 copy
・ Sterilization has not been made to the probe shipped from the
factory. Prior to use of the probe, be sure to clean, disinfect
and sterilize it.
WARNING
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1.5 Accessories (Option)
1.5.1 Puncture Guide Fixture EZU-PA3U
(Gauge size available:14G and 18G)
If you need a Puncture Guide Fixture EZU-PA3U, please contact
a service support.
A well-trained physician only should perform a biopsy.
1.5.2 Probe cover for Single Use (Disposable)
To protect the probe against contamination, using probe cover
is recommended. If using probe cover, lubrication free probe
cover which is dry type is recommended.
Lubrication may cause a deterioration of the probe surface.
And latex rubber may create allergic reactions, use of
non-allergic probe cover is strongly recommended.
Take care for the handling of used probe cover.
1.5.3 Magnetic sensor attachment
Magnetic sensor attachment is needed for Real-time Virtual
Sonography(RVS). It is use to fix the magnetic sensor to the
probe.
The Magnetic sensor attachment is not sterilized when delivered
from the factory. Prior to use, be sure to clean and sterilize it.
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1.6 Construction
The external view of C41L47RP Probe is shown in Fig.1.
Un-immersible part
Immersible part (IPX7)
Head
Applied part
Band groove
Immersible
part:
This part can be immersed in
disinfectant solution and also
can be cleaned by water.
Un-immersible
part:
This part should not be immersed
in disinfectant solution and also
cannot be cleaned by water.
C
able
Fig.1 External view
Connector
Un-immersible
p
art
Magnetic sensor attachment (Option)

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2. Inspection before Use
Prior to use, the probe and the Puncture Guide Fixture must be
carefully inspected that they are appropriate for use. If you find
any damage, do not use them and contact a service support immediately.
2.1 Inspection for Appropriate Connection
2.1.1 Confirm that the system is correctly operating. Refer to
the instruction manual for the ultrasound diagnostic
scanner.
2.1.2 Do not attach or connect unauthorized devices or
instruments to the probe, such as unauthorized biopsy
attachments.
2.1.3 Confirm that the Puncture Guide Fixture and software
version and then settings of the scanner are appropriate
for the probe. Attach the Puncture Guide Fixture on the
probe. Set the ultrasound diagnostic scanner to display
the “Needle guide line”. (Refer to the operation manual
for the ultrasound diagnostic scanner.) Keep the probe head
in the water and insert a puncture needle in the Puncture
Guide Fixture. Then, confirm that the needle is inserted
smoothly and the echo of the needle is displayed on the
dot line “Needle guide line” on the monitor.
2.2 Inspection for Material Surface
2.2.1 Visually inspect the surface of the probe head, housing
and cable for any crack, scratch or denaturalization.
2.2.2 Visually inspect that there is no dirt(dust or any liquid)
on the connector pins.
2.2.3 Visually inspect the Puncture Guide Fixture for damages
such as deformation or denaturalization. If you find any
damage, do not use the Puncture Guide Fixture.
2.2.4 Visually inspect the Magnetic sensor attachment for damages
such as deformation or denaturalization. If you find any
damage, do not use the Magnetic sensor attachment.

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3. Operation Procedure
3.1 Connection and Settings
1) Confirm that the probe and the Magnetic sensor attachment are
disinfected and if necessary sterilized. The Magnetic sensor
attachment is need for Real-time Virtual Sonography(RVS).
Regarding the option for RVS, please refer to “4.Option of
C41L47RP Probe”.
2) It is recommended to use a disposable probe cover for preventing
a patient from infection and the probe cover should be allergy
free material to avoid allergic reaction.
3) Connect the probe to the ultrasound diagnostic scanner and
operate the scanner and adjust the image according to the
instructions given in the operation manual for the ultrasound
diagnostic scanner.
4) The relationship between the direction of the probe and the
right-left orientation mark on the image is shown in Fig.2 and
Fig.3.
Right-left
orientation mark
Fig.2 The relationship between the direction of the probe and
the Right-left Orientation Mark in Convex US image

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Be careful with a probe cover made from the latex. The latex
may cause such allergic reactions as itching, rubor,
urticaria, swelling, fever, anhelation, wheezing, and
depression of blood pressure, shock and so on.
If you observe any of above-mentioned symptoms in your
patient during the operation, stop the use of protective
sleeve immediately and take an appropriate treatment to the
patient.
5) Insert the probe gentry and adjust the probe’s position for
a clear view of the desired image.
6) After using the probe, clean and disinfect or sterilize the
probe immediately. If RVS is carried out, clean and disinfect
or sterilize the Magnetic sensor attachment.
7) Store the probe and the Magnetic sensor attachment in the
environment indicated in “7 Maintenance and Safety Inspection”.
Right-left
orientation mark
Fig.3 The relationship between the direction of the probe and
the Right-left Orientation Mark in Linear US image
WARNING

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・ Do not use the probe if the image and the frequency do not
match the probe. An incorrect acoustic output can result
in burns or other injuries to the patient.
・ Scan for the minimum length of time necessary for the
diagnosis and at the lowest possible output. There is the
possibility that the patient’s tissues could be affected.
For details about the acoustic output, please refer to the
operation manual of the ultrasound diagnostic instrument.
・ Do not hold the needle cannula of the electrosurgical unit
with metal tweezers, forceps, and the like.
[Doing so may damage the insulation section of the needle
cannula, and may cause a burn to a non–treated area.]
The needle guideline can be displayed on US image for perineal
prostate biopsy. This probe can be used for biopsy with the
Puncture Guide Fixture EZU-PA3U.
When the needle guideline is displayed, numeric value is
displayed on the upper right of the US image. This numeric value
means the distance between the surface of acoustic lens and the
needle guideline (see the figure in the next page). Regarding
the needle guideline, refer to the instruction manual of the
ultrasound scanner that the ultrasound probe is connected to.
The numeric value on the image corresponds to the numeric value
engraved on the Puncture Guide Fixture EZU-PA3U. For example,
when the Movable Part for guiding the needle is fixed at 10mm
position, then the numeric value in the upper right on US image
is needed to be adjusted to 10mm. The Movable Part for guiding
the needle and the needle guideline can be fixed at from 10 to
50mm in 5mm steps.
Note that the position of the numeric value on the US image is
different in each ultrasound scanner.
Make sure that there is no damage to the Puncture Guide Fixture
prior to each use, otherwise the needle or needle cannula might
be damaged.
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The needle echo image corresponds with the needle guideline, but
the actual distance from the surface of acoustic lens to the
needle guideline is approximate 3mm shorter than the numeric
value in the upper right on US image, so the numeric value is
rough indication for biopsy.
Before performing a biopsy, display the needle echo in sterile
water, and confirm that the needle echo at each distance overlaps
with the correspondent needle guideline. Water temperature
depends on the type of the ultrasound diagnostic scanner
connected to the probe. If the type of the scanner is EUB series,
HI VISION series, or Noblus, set water temperature at room
temperature. For the other type of the scanner, set it at 40
degrees Celsius.
I
t is fixed to 10mm
position
Biopsy Needle
Numeric Value of
Bio
p
s
y
Guideline
Needle Echo Image
Approx. 7mm
Surface of
Acoustic Lens
Approx.
7mm
Needle guideline
Surface of
A
coustic Lens
Movable Part for
Guiding the Needle
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3.2 Use of Puncture Guide Fixture (EZU-PA3U)
The steps to attach the Puncture Guide Fixture(EZU-PA3U) to the
probe is as follows.
1) Attaching a sterile probe cover to the probe is recommended.
2) Fit the groove of the Puncture Guide Fixture to the projection
on the probe. (See Fig.4.)
3) Screw the Puncture Guide Fixture to attach to the probe firmly.
Visually inspect that there is no hole in the probe cover.
Puncture Guide Fixture(EZU-PA3U）
Probe cover
Projection
Fig4. How to attach the EZU-PA3U
G
roove
screw

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3.3 How to adjust Puncture Guide Fixture (EZU-PA3U)
1) Loose thumbscrew on the back side of the puncture guide.
2) Slide guide groove in the depth on demand.
3) Tighten thumbscrew for fixing guide groove.
The Following figure is an example that guide groove of 14G is
combined with the depth of 30mm
ThumbscrewGuide
groove
Fig5. How to adjust Puncture Guide Fixture (EZU-PA3U)

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1) Warning in case of using probe covers which latex is contained
to. The latex may cause such allergic reactions as itching,
rubor, urticaria, swelling, fever, anhelation, wheezing,
depression of blood pressure, shock and so on.
For the patients suspected of latex allergy, do not use the
latex-containing medical devices. If you observe any of above
mentioned symptoms in your patient during the operation, stop
the use of the latex-containing medical devices immediately
and take an appropriate treatment to the patient.
2) The recommended probe covers are disposable and must not be
reused.
3) Confirm that the needle guide angle corresponds to the angle
indicated on the monitor. The needle guide angle is engraved
on bracket. Otherwise, the biopsy guide line becomes
inconsistent with the inserting position of the biopsy needle.
4) When using the needle cannula of the electrosurgical unit
while using the Puncture Guide Fixture as a guide, be careful
not to damage the insulation coating of the needle cannula.
[When inserting or removing the needle cannula into or from
the needle guide, you may damage the insulation coating of
the needle cannula, which may cause a burn to tissue contacting
the exposed section of the insulation coating.
5) Use a needle whose size is compatible with the Puncture Guide
Fixture. Use of a puncture needle that is not a compatible
size can result in the Puncture Guide Fixture coming off during
puncturing or puncturing of an unintended body part, causing
injury to the patient.
6) During the puncture operation, display a suitable puncture
guideline on the screen of the ultrasound diagnostic
instrument. Puncturing of an unintended body part can cause
injury to the patient. Display the puncture guideline on the
screen referring to the documentation supplied with the
ultrasound diagnostic instrument, to use it as an aid in
determining the puncturing direction.
WARNING

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4. Option of C41L47RP Probe
4.1 Magnetic sensor
4.1.1 How to attach the Magnetic sensor
The procedure of attaching the magnetic sensor is as follow.
1) Confirm that the Magnetic sensor attachment is sterilized or
disinfected.
2) Insert the Magnetic sensor into the Magnetic sensor attachment
in the correct direction as shown in Fig.6.
Never attach the Magnetic sensor attachment to the probe at the
incorrect direction, otherwise it may result in false diagnosis.
3) Attach the Magnetic sensor attachment to the probe as shown
in Fig.7
Do not put your fingers between the Magnetic sensor attachment and the
probe when attaching the Magnetic sensor attachment to the Probe.
Fig.6 How to attach the Magnetic sensor
Direction mark
Magnetic sensor attachment
Magnetic
sensor
Fig.7 How to attach the Magnetic sensor attachment
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