Hitachi EUP-B512 User manual

Biopsy Probe
EUP-B512
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP0780-8
©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.
0123

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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 the EUP-B512.
Please read this manual thoroughly to ensure safe operation. If you
have any questions concerning the operation of the probe, please contact
a service support.
The symbols
The following conventions are used throughout the manual to denote
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.

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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
Upper Limit of Temperature;
The probes that are applicable to
Ethylene Oxide Gas Sterilization
use symbol of “Upper Limit of
Temperature: 55 degrees”.
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 General ........................................................... 1
1.2 Principles of operation ........................................... 1
1.3 Intended Use ...................................................... 2
1.4 Components ........................................................ 2
1.5 Optional Accessories .............................................. 2
1.6 External View ..................................................... 3
2Inspection before Use ......................................... 4
2.1 Inspection for Appropriate Connection ............................. 4
2.2 Inspection for Material Surface ................................... 4
3Operation Procedure ........................................... 5
4Optional Accessories for EUP-B512 ............................. 7
4.1 Magnetic Sensor (EZU-RV2S) ........................................ 7
4.2 Magnetic Sensor (EZU-RV3S) ....................................... 10
5Cleaning, Disinfection and Sterilization ..................... 12
5.1 Point of use (Pre-cleaning) ...................................... 15
5.2 Containment and transportation ................................... 15
5.3 Manual Cleaning and disinfection ................................. 16
5.4 Automated cleaning and disinfection .............................. 19
5.5 Drying ........................................................... 20
5.6 Inspection ....................................................... 21
5.7 Packaging ........................................................ 21
5.8 Sterilization .................................................... 22
5.9 Storage .......................................................... 24
6Maintenance and Safety Inspection ............................ 25
7Safety Precautions ........................................... 26
8Specifications ............................................... 27
8.1 Probe ............................................................ 27
8.2 Suppliers List ................................................... 28
8.3 Disposal of the probe ............................................ 29

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1 Introduction
1.1 General
The EUP-B512 is a convex array probe.
The acoustic output of the EUP-B512 was measured according to
the IEC60601-2-37 standard and the measurement was conducted
by operating with the Hitachi ultrasound diagnostic scanner.
The measured acoustic output is listed in the instruction
manual of the Hitachi ultrasound diagnostic scanner.
The EUP-B512 is categorized in class IIa according to
Directive 93/42/EEC and classified as type BF according to IEC
60601-1.
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 EUP-B512 is designed for observation and diagnosis mainly
of the following regions by connecting with the Hitachi
ultrasound diagnostic scanner.
Biopsy (with Needle Guide Bracket)
General abdominal organs
Never use the probe for following applications.
1) Direct contact to the heart.
2) Biopsy to the heart.
1.4 Components
The components of the EUP-B512 are given below:
1) Probe EUP-B512 .................. 1 piece
2) Magnetic sensor attachment ...... 1 piece
3) Spacer for EZU-RV2S ............. 3 pieces
4) Instruction Manual .............. 1 copy
Sterilization has not been made to the probe and the Magnetic
sensor attachment shipped from the factory.
Prior to use of them, be sure to clean, disinfect and sterilize
them.
1.5 Optional Accessories
1.5.1 Needle Guide Bracket EZU-PA5C4
1) Needle guide bracket ··············· 1 piece
2) Brush ······························ 1 piece
3) Spring(Spare) ······················ 2 pieces
4) Instruction manual ················· 1 copy
5) Case ······························· 1 piece
Please refer to the instruction manual of option about the
method of handling, cleaning and disinfecting the EZU-PA5C4.
WARNING
CAUTION

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1.5.2 Waterproof box EZU-WB1 (Option)
1) Waterproof box EZU-WB1 ·············1 piece
2) Airtight tester ···················· 1 piece
3) Instruction Manual ················· 1 copy
This accessory is necessary for protecting the probe connector
against liquid when the probe is disinfected by
washer-disinfector. About how to connect this accessory to the
probe connector, refer to the instruction manual of Waterproof
box EZU-WB1
1.6 External View
The external view of the EUP-B512 is shown in Fig.1.
Immersible part (IP
X
7
)
Head
Connector
Cable
Un-immersible
part
Magnetic sensor attachment
S
pacer for
E
ZU
-
R
V2S
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 can not be cleaned by water.
Fig.1 External view of the EUP-B512
Applied part

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2 Inspection before Use
Prior to use, the probe must be carefully inspected that it is
appropriate for use.
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 nor
instruments on the probe, such as unauthorized biopsy
attachments.
2.2 Inspection for Material Surface
2.2.1 Visually inspect that the surface of the probe and head,
housing, the cable and the connector for any crack, scratch
or denaturalization. If you find any damage, do not use
the probe, and immediately contact a service support.
2.2.2 Visually inspect that the surface of the Magnetic sensor
attachment and the Spacer for EZU-RV2S for any crack,
deformation or denaturalization. If you find any damage,
do not use them, and immediately contact a service support.