Hitachi EUP-L54MA User manual

Linear Array Probe
EUP-L54MA
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP0995-6
© 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 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 probes. It also
describes safety considerations, maintenance.
For instructions about 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 and dry
environment to avoid high temperature,
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 ........................................................1
1.4Composition .........................................................2
1.5External View .......................................................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.Reprocessing Procedure ......................................... 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 ......................................................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 model EUP-L54MA is a linear array type probe.
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.
1.3 Intended Use
The Linear Array Probe EUP-L54MA is designed for observation and
diagnosis mainly of the following regions by connecting with the
HITACHI ultrasound scanner.
Mammary gland
Thyroid
Superficial organs

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Never use the probe for following applications.
Direct contact to the heart.
1.4 Composition
The probe components of the EUP-L54MA are as follows:
1) Probe EUP-L54MA ...................... 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, disinfect
and sterilize the probe.
1.5 External View
The external view of EUP-L54MA is shown in Fig. 1.
Immersible part (IPX7)
Head
U
n
-
i
mmersible part
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 EUP-L54MA
Applied part
C
able
Connector
CAUTION
WARNING

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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 of 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 or instruments
on the probe, such as unauthorized biopsy attachments.
2.2 Inspection of material surface
2.2.1 Visually inspect 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 contact a service support immediately.

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3. Operation Procedure
1) Confirm that the probe is cleaned, disinfected 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) Under sterile condition, protect the probe by using covers. 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
or sterilized, then store it in an adequate place.
Fig. 2 Relationship between Index Mark and the Right-left
orientation mark
Right-left orientation mark
Index mark