Hitachi EUP-S50A User manual

Sector Scanning Probe
EUP-S50A
INSTRUCTION MANUAL
Tokyo, Japan
Q1E-EP0659-6
© 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 an
y
time.
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 probes.
It also describes safety considerations, maintenance probe.
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 warnings 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 and
dark, dry environment to avoid high
temperature and 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
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 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) ......................................................................................... 6
4.2 Containment and transportation .................................................................................. 6
4.3 Manual Cleaning and disinfection .............................................................................. 7
4.4 Drying ...................................................................................................................................... 9
4.5 Inspection ............................................................................................................................. 9
4.6 Packaging ............................................................................................................................. 10
4.7 Sterilization ..................................................................................................................... 11
4.8 Storage.................................................................................................................................. 13
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-S50A has phased array Sector 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 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.

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1.3 Intended Use
The Sector Scanning Probe EUP-S50A is designed for observation
and diagnosis mainly of the following regions by connecting with
the HITACHI ultrasound scanner.
・Cardiac
1.4 Composition
The probe components of the EUP-S50A are as follows:
1) Probe EUP-S50A ....................... 1 piece
2) 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, disinfection,
and sterilize the probe.
1.5 Construction
C
onnector
C
able
U
n
-
i
mmersible
p
art
(IP40)
Fig.1 External View
Immersible part (IP47)
Head
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.
Applied Part
CAUTION

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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 or instruments
on the probe, such as unauthorized biopsy attachments.
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.

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3. Operation Procedure
1) Confirm that the probe is disinfected and 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, protect the probe by using an
appropriate cover 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 sterilized, then store it in an adequate place.
Right-left orientation mark
Index mark
Fig.2 Relationship between Index Mark and Right-
l
eft Orientation Mark