Hitachi EUP-O53T User manual

Intraoperative Probe
EUP-O53T
INSTRUCTION MANUAL
Tokyo , Japan
Q1E‐EP0403‐9

©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 shall provide instructions for using, cleaning,
disinfecting and/or sterilizing the Hitachi ultrasound probe.
It also describes safety considerations, maintenance.
For instructions for operating the main unit, refer to the operation
manual for it.
Before using the probe, thoroughly read this manual and keep this book
for future reference. If you have any questions concerning the manual,
please contact a service support.
The following conventions are used throughout the manual to denote
information of special emphasis.
WARNING: “Warning” is used to indicate the presence of a hazard
which can cause severe personal injury, death, or
substantial property damage if the warning is ignored.
CAUTION: “Caution” is used to indicate the presence of a hazard
which will or can cause minor personal injury or property
damage if the caution is ignored.
NOTICE: “Notice” is used to notify people of installation,
operation, or maintenance information 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-
0
015,
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
1. Introduction ················································· 1
1.1 Features ················································· 1
1.2 Principles of operation ·································· 1
1.3 Intended Use ············································· 2
1.4 Composition ·············································· 2
1.5 Accessories (Option) ····································· 2
1.6 Construction ············································· 3
2. Inspection before Use ········································ 4
2.1 Inspection for Appropriate Connection ···················· 4
2.2 Inspection for Material Surface ·························· 4
3. Operation Procedure ·········································· 5
4. Cleaning, Disinfection and Sterilization ····················· 6
4.1 Point of use (Pre-cleaning) ······························ 7
4.2 Containment and transportation ··························· 7
4.3 Manual Cleaning and disinfection ························· 8
4.4 Drying ··················································· 9
4.5 Inspection ·············································· 10
4.6 Packaging ··············································· 10
4.7 Sterilization ··········································· 11
4.8 Storage ················································· 13
5. Maintenance and Safety Inspection ··························· 13
6. Safety Precautions ·········································· 14
7. Specifications ·············································· 15
7.1 Probe ··················································· 15
7.2 Suppliers List ·········································· 16
8. Disposal of the probe ······································· 16

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1. Introduction
1.1 Features
The probe of Model EUP-O53T has Linear Array electronic
scanning type.
The acoustic output of this probe when connected to ultrasound
scanner was measured according to the IEC60601-2-37 standard.
The table of measured acoustic output data is contained in
the operation manual of each ultrasound 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 Linear Array Probe EUP-O53T is designed for observation
and diagnosis mainly of the following regions by connecting
with the HITACHI ultrasound scanner.
Intraoperative
Biopsy (with biopsy attachment)
1.4 Composition
The probe components of the EUP-O53T are as follows:
1) Probe EUP-O53T ...................... 1 piece
2) Instruction manual .................. 1 copy
The probe is not sterilized when shipped, and it must be cleaned,
disinfected, and sterilized prior to its first use.
1.5 Accessories (Option)
1.5.1 Biopsy Attachment EZU-PA5O (Option)
The biopsy attachment EZU-PA5O is a dedicated tool for use
as mounted on a EUP-O53T.
The optional biopsy attachment EZU-PA5O components are as
follows:
1) Biopsy attachment ................... 1 piece
Each of 14G, 18G and 21G exist.
During ordering our biopsy attachment, please specify the
kind of puncture needle gauge used in your hospital.
2) Brush ............................... 1 piece
3) Instruction manual .................. 1 copy
4) Biopsy case ......................... 1 case
Please refer to the instruction manual of the option about
the method of handling, cleaning and sterilizing the biopsy
attachment EZU-PA5O.
CAUTION

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1.6 Construction
Immersible part (IP
X
7
)
Index mark
Connector
Cable
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
Un-immersible part
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. If not, do not use the probe and immediately
contact a service support.
2.1 Inspection for Appropriate Connection
2.1.1 Do not attach or connect unauthorized devices nor
instruments on the probe, such as unauthorized biopsy
attachments.
If a biopsy operation is required, refer to its
instruction manual for inspection, preparation,
operation and cleaning through sterilization.
2.1.2 Check that the system is correctly operating. Refer to
the instruction manual for the main unit.
2.2 Inspection for Material Surface
2.2.1 Visually check the surface of the probe head, housing and
cable for any crack, scratch or denaturalization.