Hitachi EUP-S70 User manual

Sector Scanning Probe
EUP-S70
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1152-6
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123
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 shall provide instructions for using, cleaning,
disinfecting and/or sterilizing the HITACHI ultrasound probes. 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,110-0015,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, dustproof,
dark and dry place and keep away from
high temperature, high humidity and
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 1.5.
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 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 .................................................... 1
1.4Composition ..................................................... 2
1.5Construction .................................................... 2
2.Inspection before Use .......................................3
2.1Inspection for Appropriate Connection ........................... 3
2.2Inspection for Material Surface ................................. 3
3.Operation Procedure .........................................4
4.Cleaning, Disinfection and Sterilization ....................5
4.1Point of use (Pre-cleaning) ..................................... 8
4.2Containment and transportation .................................. 8
4.3Manual Cleaning and disinfection ................................ 8
4.4Drying ......................................................... 11
4.5Inspection ..................................................... 11
4.6Packaging ...................................................... 11
4.7Sterilization .................................................. 12
4.8Storage ........................................................ 14
5.Maintenance and Safety Inspection ..........................14
6.Safety Precautions .........................................15
7.Specifications .............................................16
7.1Probe .......................................................... 16
7.2Suppliers List ................................................. 17
8.Disposal of the probe ......................................18

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1. Introduction
1.1 Features
The probe of model EUP-S70 is a phased array sector scanning type.
The acoustic output of this probe when connected to ultrasound
scanner was measured according to the IEC 61157 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 IEC 60601-1 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.
1.3 Intended Use
The Sector Scanning Probe EUP-S70 is designed for observation and
diagnosis mainly of the following regions by connecting with the
HITACHI ultrasound scanner.
・Cardiac
・General abdominal organs
・Transcranial

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1.4 Composition
The probe components of the EUP-S70 are as follows:
1) Probe EUP-S70···················· 1 piece
2) Instruction Manual··············· 1 copy
1.5 Construction
Connector
Head
C
able
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.
Immersible part (IP
X
7
)
Un-immersible
Fig. 1 External View
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 Check that the system is correctly operating. Refer to the
instruction manual for the main unit.
2.1.2 Do not attach or connect unauthorized devices nor instruments
on the probe, such as unauthorized biopsy attachments.
2.2 Inspection of material surface
2.2.1 Visually check the surface of the probe head, housing and
cable for any crack, scratch or denaturalization.

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3. Operation Procedure
1) Confirm that the probe is cleaned, disinfected and/or sterilized.
2) Connect the probe, operate the main unit, and adjust the image
according to the instructions given in the operation manual for
the main unit.
3) Relationship between 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 index mark on the probe.
4) Use under sterile condition, protecting the probe by using covers
is recommended. Some Latex material may create allergic reaction.
Please use allergy free material covers.
5) After the use of the probe, it should be cleaned and disinfected
and/or sterilized immediately, and then store it in an adequate
place.
Fig. 2 Relationship between Index Mark
and Right-left Orientation Mark
Index mark
Right-left
orientation mark