Hitachi EUP-CC531S User manual

Biplane Transrectal / Vaginal Probe
EUP-CC531S
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1357-6
© 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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12
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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 EUP-CC531S.
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.
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
S
tore 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 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
1Introduction .........................................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 ............................................. 5
2Inspection before Use ................................6
2.1 Inspection for Appropriate Connection .................... 6
2.2 Inspection for Material Surface .......................... 6
3Operation Procedure ..................................7
3.1 Connection and Settings .................................. 7
3.2 General Instruction ...................................... 9
3.3 Use of Sterile Puncture Adapter (EZU-PA5V) .............. 11
3.4 Use of Puncture Guide Fixture (EZU-PA3U) ................ 12
3.5 Display of Needle Guide Line ............................ 13
4Magnetic Sensor for EUP-CC531S ......................15
4.1 Magnetic Sensor (EZU-RV2S) .............................. 15
4.2 Magnetic Sensor (EZU-RV3S) .............................. 19
5Cleaning, Disinfection and Sterilization ............22
5.1 Point of use (Pre-cleaning) ............................. 25
5.2 Containment and transportation .......................... 26
5.3 Manual Cleaning and disinfection ........................ 26
5.4 Drying .................................................. 30
5.5 Inspection .............................................. 31
5.6 Packaging ............................................... 31
5.7 Sterilization ........................................... 32
5.8 Storage ................................................. 34
6Cleaning, Disinfection and Sterilization of EZU-PA3U 35
6.1 Point of use (Pre-cleaning) ............................. 37
6.2 Containment and transportation .......................... 37
6.3 Manual Cleaning and disinfection ........................ 37
6.4 Automated cleaning and disinfection ..................... 39
6.5 Drying .................................................. 40
6.6 Inspection .............................................. 40
6.7 Packaging ............................................... 40

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6.8 Sterilization ........................................... 41
6.9 Storage ................................................. 41
7Maintenance and Safety Inspection ...................42
7.1 Daily Inspection ........................................ 42
7.2 Storage ................................................. 42
8Safety Precautions ..................................43
9Specifications ......................................45
9.1 Probe ................................................... 45
9.2 Needle Guides (Option) .................................. 46
9.3 Suppliers List .......................................... 48
9.4 Suppliers List for EZU-PA3U ............................. 48
10 Disposal of the probe ...............................49

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1 Introduction
1.1 Features
The Biplane transrectal/vaginal probe EUP-CC531S has convex
array electronic scanning.
The acoustic output of this probe when connected to Hitachi
ultrasound 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 Hitachi 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
The Biplane transrectal/vaginal probe EUP-CC531S is designed
for observation and diagnosis of the following regions mainly
by connecting with the HITACHI ultrasound diagnostic scanner.
Transrectal/Vaginal
Biopsy
Never use the probe for following regions.
1) The heart (Do not contact directly.)
2) The eyeball
1.4 Components
Components of EUP-CC531S are as follows:
1) Biplane Transrectal/
Vaginal Probe EUP-CC531S ........ 1 piece
2) Syringe kit ..................... 1 set
a) Extension Tube ............... 1 piece
b) Three-way cock ............... 1 piece
c) Syringe ...................... 1 piece
3) 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
CAUTION

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1.5 Accessories (Option)
1.5.1 Sterile Puncture Adapter EZU-PA5V (Disposable)
Attachment for ultrasound guided transrectal biopsy and
aspiration of organs, cyst and tumor. The size of available
needle is 16 to 19G. Application requires special care. Sterile
Puncture Adapter EZU-PA5V is as follows:
Component Model Note
Sterile Puncture Adapter EZU-PA5V 24 pcs
NOTE: If you need Sterile Puncture Adapters, please contact a service
support.
A well-trained physician only should perform a biopsy.
1.5.2 Puncture Guide Fixture EZU-PA3U
Attachment for ultrasound guided transperineal biopsy and
aspiration of organs, cyst and tumor. The size of available
needle is 14G and 18G. Application requires special care.
Puncture Guide Fixture EZU-PA3U is as follows:
Component Model Note
Puncture Guide Fixture EZU-PA3U
(14G,18G are compatible) 1 pc
NOTE: If you need Puncture Guide Fixture, please contact a service
support.
1.5.3 Mechanical Compression Unit for Elastography EZU-TEMC1 and
Balloon Set for Elastography EZU-TEBL1
This mechanical compression unit is used for tissue elasticity
imaging, by using the balloon attached to the probe that is
connected to a Hitachi's digital ultrasound scanner system and
electronic scanning ultrasound tomography system.
Please refer to the instruction manual of option about the
method of handling, cleaning and disinfection of EZU-TEMC1 and
EZU-TEBL1.
CAUTION

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CAUTION
WARNING
1.5.4 Balloon Kit
This is probe cover which is applicable with this probe.
The composition of the “balloon kit” is as follows.
a) Balloon ·············· 12 pieces
b) Rubber Band ·········· 24 pieces
1) This balloon kit is not sterilized. If necessary, using sterilized
probe cover is recommend.
2) This is disposable one. Do not reuse it.
The balloon kit is made by latex. 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.
1.5.5 Probe cover (Disposable)
To protect the probe against contamination, using only
lubrication free probe cover is recommended, which is dry type.
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.
1.5.6 The Magnetic sensor attachment
The Magnetic sensor attachment is used for Real-time Virtual
Sonography (RVS). By using the attachment, the Magnetic sensor
is attached to the probe that is connected to a Hitachi digital
ultrasound scanner system.

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1.5.7 The Spacer for EZU-RV2S
The Spacer for EZU-RV2S is used for Real-time Virtual
Sonography (RVS) with EZU-RV2S. By using the Spacer, the
Magnetic sensor for EZU-RV2S is attached to the Magnetic sensor
attachment.
Sterilization has not been made to the Magnetic sensor attachment
and the Spacer for EZU-RV2S shipped from the factory. Prior to
use of them, be sure to clean, disinfect and sterilize it.
1.6 Construction
lumen
Immersible part (IPX7)
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.
Fig.1 External view
Un-immersible part
Axial scan head
Sagittal scan head
Water running port
Applied part Luer inlet
Cable
Connector
Magnetic sensor attachment (Option)
Spacer for EZU-RV2S (Option)
CAUTION

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2 Inspection before Use
Prior to use, the probe and accessories 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 on the probe, such as unauthorized biopsy
attachments.
2.1.3 Confirm that the Sterile Puncture Adapter, Puncture Guide
Fixture and software version and then settings of the
scanner are appropriate for the probe. Attach the Sterile
Puncture Adapter or Puncture Guide Fixture on the probe.
Set the main unit to display the “Needle guide line”. (Refer
to the operation manual for the main unit.) Keep the probe
head in the water and insert a puncture needle in the Sterile
Puncture Adapter or 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 the envelope of the Sterile Puncture
Adapter or Puncture Guide Fixture for any break,
deformation, crack or denaturalization.
2.2.3 Visually inspect the Magnetic sensor attachment and the
Spacer for EZU-RV2S for any crack, deformation or
denaturalization.
2.2.4 Confirm whether there is the Spacer for EZU-RV2S nearby
when use RVS with EZU-RV2S.
The Spacer for EZU-RV2S is small, please do not lose the Spacer.
CAUTION

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3 Operation Procedure
3.1 Connection and Settings
1) Confirm that the probe is disinfected. In case of using
Real-time Virtual Sonography (RVS), confirm that the
Magnetic sensor attachment is disinfected and if necessary
sterilized. In case of using RVS with EZU-RV2S, confirm that
the Spacer for EZU-RV2S is also disinfected and if necessary
sterilized.
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 ultrasound
diagnostic scanner.

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4) Confirm the direction of the probe. The relationship
between the direction of the probe and the image is shown
in Fig.2. The right-left orientation mark indicates the
direction of the index mark of the probe.
Orientation
mark side
Orientation
mark side
Right-left
orientation mark
Right-left
orientation mark
Sagittal
image
Location of
axial plane*
Axial
image
Location of
sagittal plane*
Sagittal scan
A
xial scan
(*This line is shown by the two-
d
ot chain line in the Figure,
but not displayed on the screen.)
Fig.2 The relationship between the direction of the probe
and the right-left orientation mark

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3.2 General Instruction
1) In prior to starting the examination, prepare
below-mentioned materials.
・ Protective probe cover which is recommended
・ Rubber band
・ Extension tube
・ Three-way cock
・ Syringe
・ Physiological saline
2) Make below-mentioned preparations for the examination.
(1) Covering the probe with the protective probe cover from
the top of probe is recommended.
Be careful with a protective probe cover made from the latex.
The latex may cause such allergic reactions as itching, rubor,
urticaria, swelling, fever, anhelation, wheezing,
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
probe cover immediately and take an appropriate treatment
to the patient.
(2) Tighten the protective probe cover by the rubber band.
(3) Connect the extension tube, three-way cock, syringe
filled with physiological saline to the water injection
port of probe and fill the protection sleeve with
physiological saline. In case of remaining the air in
the protective probe cover, deflate the air bubble with
the syringe.
(4) Return physiological saline to the syringe.
WARNING

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3) Perform the examination under following procedures.
(1) Insert the probe into patient’s body.
(2) Pour an adequate volume of physiological saline into the
protective probe cover.
(3) Perform the examination. Regarding adjustments of image
and so on, refer to the operating manual of the scanner
to which the probe is connected.
(4) When the examination is finished, return physiological
saline in the protective probe cover to the syringe
before removing the probe from the body.
(5) Remove the probe from the body.
4) After using the probe, clean and disinfect and if necessary
sterilize the probe immediately and using RVS, also clean
and disinfect and if necessary sterilize the Magnetic sensor
attachment. In case of using RVS with an EZU-RV2S, also clean
and disinfect/sterilize the Spacer for EZU-RV2S.
5) Store the probe and accessory in the environment indicated
in “7.Maintenance and Safety Inspection”.

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3.3 Use of Sterile Puncture Adapter (EZU-PA5V)
The process of attaching the Sterile Puncture Adapter (EZU-PA5V)
to the probe is as follows. If the Sterile Puncture Adapter shall
be used, take care not to destroy the probe cover.
1) Attach a protective probe cover to the probe. (See “3.2
General Instruction”)
2) Put the picks of the Sterile Puncture Adapter to the grooves
on the tip of the probe. (See Fig.3)
3) Push the other end of the Sterile Puncture Adapter until fix
the dents of the Sterile Puncture Adapter to the projection
on the probe. (See Fig.4)
EZU-PA5V
Fig. 3
E
UP
-
C
C531S
Sheath
Fig. 4

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3.4 Use of Puncture Guide Fixture (EZU-PA3U)
The process of attaching the Puncture Guide Fixture (EZU-PA3U)
to EUP-CC531S is as follows;
1) Attaching the protective probe cover to the probe is
recommended. (See “3.2 General Instruction”)
2) Set the Puncture Guide Fixture on the probe as shown in Fig.5,
and fix it by tightening the screw 1.
3) By loosing the screw 2, the needle holder in which the guide
recess is formed can be moved vertically. The scale on the
Puncture Guide Fixture is of 0.5cm/division.
Fig. 5
Screw 1
Screw 2
EZU-PA3U
G
uide recess
Sheath

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3.5 Display of Needle Guide Line
When puncture is to be conducted, the needle guideline can be
displayed by dot marks. Operation procedure for displaying the
needle guideline on the main unit must be referred to the part
of “Needle Guide Line” in the manual of the connected ultrasound
scanner.
NOTE: The needle guideline will be displayed to provide a visual guide
to the direction of the puncture needle pathway. Be sure to check
the actual location of the needle on the ultrasound image when
performing the puncture operation.
1) When using the sterile puncture adapter EZU-PA5V, make it
sure that the mark “FIX” shows up on the upper right corner
of the screen in place of the above two digits.(See Fig.6)
2) When using the puncture guide fixture EZU-PA3U, the
positional information on the puncture fitting will be shown
in two digits on the upper right corner of the screen showing
the sagittal image.(See Fig.6)
FIX
Sagittal
scan image
Corresponds to puncture needle
position using puncture guide
fixture EZU-PA3U.
Be sure that “FIX” is displayed here when using
Sterile Puncture Ada
p
ter EZU
-
P
A5V.
Fig. 6 Position of Puncture Needle Guide Line
Corresponds to puncture
needle position using
sterile puncture adapter
EZU-PA5V.