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

( 1 ) Q1E-EP0780
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:

( 2 ) Q1E-EP0780
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.

( 3 ) Q1E-EP0780
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.

( 4 ) Q1E-EP0780
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.

( 5 ) Q1E-EP0780
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

- 1 - Q1E-EP0780
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.

- 2 - Q1E-EP0780
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

- 3 - Q1E-EP0780
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

- 4 - Q1E-EP0780
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.

- 5 - Q1E-EP0780
3 Operation Procedure
1) Confirm that the probe and the Magnetic sensor attachment are
disinfected or sterilized.
2) Connect the probe to the ultrasound diagnostic scanner, operate
the scanner, and adjust the image, all according to the
instructions given in the operation manual for the ultrasound
diagnostic scanner with which the probe is used as connected.
3) 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 on the image indicates the direction
of the needle guide bracket mount part of the probe.
Right-left
orientation mark
Needle guide bracket
mount part
Fig.2 The Relationship b
e
tween the direction of the
probe and the Right-left orientation mark

- 6 - Q1E-EP0780
4) Use a sterile probe cover to protect the probe. The probe cover
should be allergy free material to avoid allergic reaction.
Between the probe and the probe cover, acoustic coupling gel
is required as a couplant.
5) Place the probe on the examination site and adjust the probe’s
position for a clear view of the desired image.
6) After using the probe, perform the reprocessing procedure in
accordance with the procedure stated in “5. Cleaning,
Disinfection and Sterilization” every time immediately after
completing the ultrasound examination.
7) Store the probe in the environment indicated in “6. Maintenance
and Safety Inspection”.
8) After using the Magnetic sensor attachment and the Spacer for
EZU-RV2S, perform the reprocessing procedure in accordance with
the procedure stated in “5. Cleaning, Disinfection and
Sterilization” every time immediately after completing the
ultrasound examination.
9) Store the Magnetic sensor attachment and the Spacer for EZU-RV2S
in the environment indicated in “6. Maintenance and Safety
Inspection”.

- 7 - Q1E-EP0780
4 Optional Accessories for EUP-B512
The usage of the EUP-B512 can be extended by applying the optional
accessory.
The accessory is the Magnetic sensor with which the EUP-B512 enables
RVS (Real-time Virtual Sonography).
There are two types of Magnetic sensors, EZU-RV2S and EZU-RV3S.
The Magnetic sensor (EZU-RV2S) and the Magnetic sensor (EZU-RV3S)
are shown in Fig.3 and Fig.7.
4.1 Magnetic Sensor (EZU-RV2S)
The Magnetic sensor (EZU-RV2S) as shown in Fig.3 is a Magnetic
sensor for the EUP-B512.
Sensor（black）
Projected part
Fig.3 Magnetic sensor (EZU-RV2S)

- 8 - Q1E-EP0780
4.1.1 How to attach the Magnetic Sensor
The procedure of attaching the Magnetic sensor is as follows.
1) Attach the Spacer for EZU-RV2S to the Magnetic sensor.
2) Attach the Magnetic sensor into the probe with the correct
direction as shown in Fig.4.
3) Insert the slot of the attachment into the projected part
of the probe.
1) Never attach the Magnetic sensor attachment to the probe in
the incorrect direction, otherwise it may result in false
diagnosis.
2) Never forget to attach the Spacer for EZU-RV2S to the Magnetic
sensor, otherwise it may result in false diagnosis.
2)
1)
Magnetic sensor
(EZU-RV2S: Black)
Spacer for EZU-RV2S
Projected part of
the EZU-RV2S (Place
the projected part
upward as shown
here)
Spacer for EZU
-
R
V2S
Magnetic sensor
(EZU-RV2S: Black)
Magnetic sensor
attachment
Slot of the
attachment
3)
Fig.4 How to attach the Magnetic sensor attachment
Projected part of the probe
CAUTION

- 9 - Q1E-EP0780
4.1.2 How to release the Magnetic Sensor
The procedure of releasing the Magnetic sensor from the probe
is as follows.
a) Press the area of the Magnetic sensor attachment shown with
the arrow toward the direction A, and then slide out the
attachment toward the direction B as shown in Fig.5 and
release it from the probe.
b) Release the Magnetic sensor from the groove of the probe
as shown in Fig.6 and release the Spacer for EZU-RV2S from
the Magnetic sensor.
Fig.6 How to release the Magnetic sensor
f
rom the groove
of the probe
Slide the attachment in this
direction.
B
A
Press this area
Fig.5 How to release the attachment from the probe

- 10 - Q1E-EP0780
4.2 Magnetic Sensor (EZU-RV3S)
The Magnetic sensor (EZU-RV3S) as shown in Fig.7 is also a
Magnetic sensor for the EUP-B512.
4.2.1 How to attach the Magnetic Sensor
The procedure of attaching the Magnetic sensor is as follows.
a) Attach the Magnetic sensor into the probe with the correct
direction as shown in Fig 8.
b) Insert the slot of the attachment into the projected part of
the probe.
Magnetic sensor attachment
Magnetic sensor
(
E
ZU
-
R
V3S
:
w
hite
)
Probe
Direction mark of the EZU-RV3S
(Place the direction mark upward as
shown here.)
Groove of the probe
Projected part of the probe
Slot of the attachment
Fig.8 How to attach the Magnetic sensor attachment
Slot of the
attachment
Projected part of the probe
Sensor（white）
Direction mark
Fig.7 Magnetic sensor (EZU-RV3S)

- 11 - Q1E-EP0780
Never attach the Magnetic sensor attachment to the probe in the
incorrect direction, otherwise it may result in false diagnosis.
4.2.2 How to release the Magnetic Sensor
The procedure of releasing the Magnetic sensor from the probe
is as follows.
a) Press the area of the Magnetic sensor attachment shown with
the arrow toward the direction A, and then slide out the
attachment toward the direction B as shown is Fig.9 and
release it from the probe.
b) Release the Magnetic sensor from the groove of the probe
as shown in Fig.10.
Clean and sterilize the Magnetic sensor before the first use as
it is not sterilized in the factory.
Slide the attachment in this
direction.
B
A
Press this area
Fig.9 How to release the attachment from the probe
Fig.10 How to release the Magnetic sensor
f
rom the groove
of the probe
CAUTION
CAUTION

- 12 - Q1E-EP0780
5 Cleaning, Disinfection and Sterilization
The probe and accessory must be reprocessed after each use. Refer
to the reprocessing instruction in this chapter.
WARNINGS
‐The probe is delivered unsterile. Prior to the
first use, reprocess the probe.
‐Temperature should not exceed 60°C during
reprocessing
‐Probe connector is not water resistant. When a
washer-disinfector is used, the waterproof box
MUST be used to cover the probe connector.
Limitations on
reprocessing
The probe is not completely submersible. The
immersible part is shown in Fig.1. The un-immersible
part should be disinfected by wipe disinfection.
Transportation
before using
T
he probe should be packed in a sterile pouch or
container to tr
a
nsport from Central Sterile Supply
D
epartment (CSSD) to an operating room. Be careful
n
ot to damage the sterile pouch or container during
transportation.

- 13 - Q1E-EP0780
Levels of reprocessing requirements:
Depending on the application of the product and with regard to risk
evaluation, the user has to classify the medical device according to
the current Medical Device Directive for processing of medical devices
as uncritical, semi-critical or critical. Supporting information
concerning this topic is listed in the table below. The user is
responsible for correct classification of the medical device.
Classification Definition Processing
uncritical
Application part only
contacts intact and
uninjured skin
Cleaning
Disinfection
semicritical
Application part contacts
mucosa (intracavitary
application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect)
critical
Application part contacts
intracorporeal tissue
directly
(operative application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect -
minimum)
Sterilization
According to the intended use, EUP-B512 is classified as semicritical.

- 14 - Q1E-EP0780
The flowchart of the reprocessing process of this probe is as follows.
Point of use
(Pre-cleaning)
Manual Cleaning
Rinsing after manual
cleaning
Manual Disinfection
Drying
Automated Cleaning
Manual cleaning and
disinfection
Washer Disinfector (WD)
Automated Disinfection
Rinsing after manual
disinfection
Packing
S
terilization
Containment and
transportation