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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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