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

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4. Reprocessing Procedure
The probe 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.
Limitations on
reprocessing
T
he probe is not completely submersible. The immersible
part is shown in Fig.1. The un-
i
mmersible part should
be disinfected by wipe disinfection.
Transportation
before using
The probe should be packed in a sterile pouch or
container to transport from Central Sterile Supply
D
epartment (CSSD) to an operating room. Be careful not
to damage the sterile pouch or container during
transportation.

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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-L54MA probe is classified as
uncritical.

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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
Manual cleaning and
disinfection
Rinsing after m
a
nual
disinfection
Packing
Sterilization
Containment and
transportation

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4.1 Point of use (Pre-cleaning)
Pre-cleaning should be done immediately after each use.
The procedure is as follows:
1) Remove the probe cover.
2) Clean the probe of all patient’s blood or fluid with running tap water
until the surface of the probe looks visually clean.
3) Wipe the whole surface of the probe with gauze pad and remove
superficial visible impurities.
4.2 Containment and transportation
Putting the contaminated equipment into exclusive
shock and damage proof container for transportation
is recommended. It is recommended that instruments are reprocessed as
soon as possible and not later than 4 hours after usage.
4.3 Manual Cleaning and disinfection
Prepare following items before manual cleaning
and disinfection:
a) Detergent: Cidezyme® (Johnson & Johnson,
#2258) or another cleaning agent with
approved material compatibility for this
medical device.
b) Disinfectant: Cidex® OPA (Johnson &
Johnson, # 20391) or another disinfectant
with approved material compatibility for
this medical device.
c) Two tanks, one for cleaning and one for
disinfection - optional:
1 additional tank for rinsing with deionized/tap water (sufficient
size for immersion of the submergible part of the probe at full length)
d) Soft, fluff free cloth or single use towel
e) Personal protective equipment (gloves, water repellent protective
skirt, face protection mask or protective glasses, see also
instructions of the manufacturer for the detergent and the
disinfectant)
Containment and
transportation
Manual Cleaning
R
insing after manual
cleaning
Manual Disinfection
R
insing after manual
disinfection
M
anual cleaning and
disinfection
Point of use
(Pre-cleaning)

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Manual Cleaning:
Prepare the detergent solution in a tank with cold water (please follow
the instructions of the detergent manufacturer regarding application,
dilution and contact time).
1) The temperature of the detergent solution should be between 15-30 °C,
concentration is 1.6%. Please note the minimum contact time of the
detergent in the manufacturer’s instruction. If a differing detergent
is used, please also note the approved material compatibility for the
medical device.
2) Immerse the immersible part of the probe without connector into the
diluted detergent solution (see Fig. 3). Wipe the immersible part of
the probe under the surface of the detergent solution with a soft cloth
to remove all visible soil. Be sure that all grooves of the probe are
implemented during the cleaning process.
3) The immersible part of the probe should be left in the detergent
solution according to the specified contact time of the detergent
manufacturer.
4) Wipe the un-immergible parts of the probe with a soft cloth dipped
with the detergent solution.
5) Rinse the probe with running tap water for 1 minute. (alternatively:
immerse the immersible part of the probe in a tray filled with deionized
water/tap water (see Fig. 3) for 5 min.)
6) Visually check the outer surface of the probe for cleanness. If
necessary, use magnifying glass for visually check. If there is still
soil visible, repeat all above steps.

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Manual disinfection:
1) Prepare the disinfectant solution in a tank with cold water (please
follow the instructions of the disinfectant manufacturer regarding
application, concentration, microbiological efficiency, service
life and contact time).
2) Confirm the concentration of the disinfectant before immersing the
probe. Although Cidex® OPA does not need to be diluted, it is
recommended to use test strips to verify the concentration. The test
strips can indicate whether or not the concentration is above the
Minimum Effective Concentration (MEC). Please also note the
expiration date of the test stripes. Temperature of disinfectant
solution should be minimum 20 °C. The minimum contact time is 5 minutes.
If a different disinfectant is used, follow the manufacturer’s
instructions. Please also consider the material compatibility for the
medical device.
3) Immerse the immersible part of the probe into the disinfectant (see
Fig. 3). Set a clock to insure the recommended contact time which is
5 minutes.
4) Rinse the immersible part of the probe with deionized water for 1 minute.
(alternatively: immerse the immersible part of the probe in a tray
filled with deionized water (see Fig. 3) for 5 min.)
5) Visually check the outer surface of the probe for leavings of the
disinfectant. If necessary, repeat the rinsing.
Fig. 3 Immersion of the probe
Water
Detergent
Disinfectant

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4.4 Drying
1) Wipe the probe with a single-use, fluff-free wipe or towel to remove
moisture from the surface of the probe.
2) Dry the probe naturally in an ambient temperature between 15-30°C
for a minimum of 4 hours. Alternatively the probe can be dried using
a drying heater at a temperature of less than 60°C.
4.5 Inspection
Inspect the equipment for any damage such as crack, scratch or
deformation. Do not use it if any damage is found.
4.6 Packaging
Pack the probe in a sterile barrier such as
Polypropylene fleece or transparent package made from Polyethylene
film and Tyvek®, and then place it into a tray. The tray should be
also covered with a sterile barrier.
Additionally the probe can be placed on plastic mesh wires supplied
for plasma sterilization and then packed as mentioned above.
The probe can be packed in a simple or double packing.
Please note that the size of a sterile barrier should be large enough
to be able to pack the equipment leaving sufficient space to seal it
completely.
A sterile barrier should be sealed by an appropriate sealing machine
and it is important to confirm that the package is sealed completely.
If the sealing is not complete, pack and reseal again.
4.7 Sterilization
The probe can be sterilized using either ethylen oxide gas (EtO)
sterilization or plasma sterilization (see table in the next page).
Follow the manufacturer's instructions of the sterilizer regarding
usage, temperature and sterilization-time.
Drying
Packaging
Sterilization

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WARNING
The sterilization method and operating conditions are as follows.
Sterilization Method Condition
Plasma Sterilization:
STERRAD® 50, 100S or 200 (*) Short Cycle
Plasma Sterilization:
Sterrad® NX or 100NX (*) Standard cycle
ETO Sterilization
Gas Type: 10% EO/ 90% HCFC
Temperature: 50-55°C
Exposure Time: More than 120 minutes
Pressurization: 162-200kPa
Depressurization: 13-8kPa
Relative humidity: 40-90%
Aeration is minimum 12 hours
*STERRAD® systems are manufactured by "Johnson & Johnson"
1) Before performing sterilization, check that the operation data of
sterilizer are in conjunction with min. and max. data applicable for
the probe.
2) Do not sterilize the probe by Steam Autoclaving. If you autoclave them,
they suffer serious damage and will be not functional.
The packaging procedure is as follows.
1) Put the probe into TYVEK pouch.
TYVEK Pouch
Fig. 4 Packaging
in the pouch

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2) Seal the TYVEK Pouch using a heat
sealer. Ensure that the seal is
complete.
3) Put the sealed pouch into a tray or
plastic mesh wire for sterilization.
4.8 Storage
Store the equipment in a cool, dustproof and dark space to avoid
high temperature, humidity and direct sunlight. Limitations for
the time for sterilized equipment belong to package.
Tray for sterilization
Fig. 6 Packaging in a tray
Probe in the Pouch
Sealed
Fig. 5 Sealing
TYVEK
Pouch

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5. Maintenance and Safety Inspection
1) After using the probe, it should be cleaned and disinfected
or sterilized according to “4. Reprocessing Procedure”, store the
probe in a cool and dark space to avoid high temperature,
humidity and direct sunlight.
2) Visually inspect the surface of the probe head, the 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.