Hitachi EUP-L53 User manual

Linear Array Probes
EUP-L53
EUP-L53S
EUP-L53L
EUP-L52
INSTRUCTION MANUAL
Tokyo, Japan
Q1E-EP0348-14
© 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 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 are 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 1.6.
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 ..................................................... 6
2.Introduction ................................................ 7
2.1Inspection for Appropriate Connection ............................ 7
2.2Inspection for Material Surface .................................. 7
3.Operation Procedure ......................................... 8
4.Reprocessing Procedure ..................................... 10
4.1Point of use (Pre-cleaning) ..................................... 13
4.2Containment and transportation .................................. 13
4.3Manual Cleaning and disinfection ................................ 13
4.4Drying .......................................................... 16
4.5Inspection ...................................................... 16
4.6Packaging ....................................................... 16
4.7Sterilization ................................................... 16
4.8Storage ......................................................... 18
5.Maintenance and Safety Inspection .......................... 18
5.1Daily check ..................................................... 18
6.Safety Precautions ......................................... 19
7.Specifications ............................................. 20
7.1Probe ........................................................... 20
7.2Suppliers List .................................................. 21
8.Disposal of the probe ...................................... 22

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1. Introduction
1.1 Features
The probes of models EUP-L53, L53L, L53S and L52 are Linear Array
Electronic Scanning type.
The acoustic output of these probes 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
operational manual of each ultrasound scanner.
These probes are categorized in class IIa according to
Directive 93/42/EEC.
According to IEC 60601-1 EUP-L53, L53L, L53S and L52 are 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 Probes EUP-L53S, L53, L52 and L53L are designed
for observation and diagnosis mainly of the following regions by
connecting with the HITACHI ultrasound scanner.
Item EUP-L53S
EUP-L52
EUP-L53 EUP-L53L
Small organ ×××
Peripheral Vessel ×××
Pediatric ×××
Abdominal ×××
Biopsy (with coupler attachment
or biopsy attachment)
××
Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
Direct contact to the eye
1.4 Composition
Probe ...................... 1 piece
Instruction Manual ......... 1 copy
1.5 Accessories (OPTION)
1.5.1 Coupler attachment EZU-PA3C1 (Option)
(Applicable model: EUP-L53S and L52)
By attaching the coupler attachment EZU-PA3C1, the blood flow
in the shallow blood vessel can be detected, by keeping a
suitable angle.
The optional coupler attachment EZU-PA3C1 components are as
follows:
Component Model Note
1 Coupler attachment EZU-PA3C1 2 pieces
2 Instruction manual - 1 copy
WARNING

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1.5.2 Coupler attachment EZU-PA3C1H (Option)
(Applicable model: EUP-L53S and L52)
By attaching the coupler attachment EZU-PA3C1H, a biopsy
through the needle guide besides the function of the EZU-PA3C1
can be made.
The optional coupler attachment EZU-PA3C1H components are as
follows:
Component Model Note
1 Coupler attachment EZU-PA3C1H 2 pieces
2 Needle guide * - 2 pieces
3 Instruction manual - 1 copy
* A 20-22 gauge biopsy needle is available inside the needle guide.
1.5.3 Coupler attachment EZU-PA3C2 (Option)
(Applicable model: EUP-L53S and L52)
By attaching the coupler attachment EZU-PA3C2, a better image
for shallow parts by shifting of a focal zone to the parts is
achieved.
The optional coupler attachment EZU-PA3C2 components are as
follows:
Component Model Note
1 Coupler attachment EZU-PA3C2 2 pieces
2 Immobilizing band - 2 pieces
3 Instruction manual - 1 copy
Please refer to the instruction manual of each option about
the method of handling, cleaning, disinfection and sterilizing
it.

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1.5.4 Water bag EZU-WL2 (Option) (Applicable model: EUP-L53)
By attaching a water bag EZU-WL2 to the probe, better contact
with curved region such as mammary gland or thyroid gland can
be attained. The optional water bag EZU-WL2 components are as
follows:
Component Note
1 Outer case 1 piece
2 Balloon * 3 pieces
3 Syringe 1 piece
4 Instruction manual 1 piece
* The optional water bag EZU-WL2 is made of latex.
The latex may cause such allergic reactions as itching, rubor,
urticaria, swelling, fever, anhelation, wheezing, and
depression of blood pressure, shock and so on. For the patients
suspected of latex allergy, do not use the latex-containing
medical devices.
Please refer to the instruction manual of EZU-WL2 about the
method of handling, cleaning and disinfecting it.
1.5.5 Water bag EZU-WL3 (Option) (Applicable model: EUP-L53L)
By attaching a water bag EZU-WL3 to the probe, better contact
with curved region such as mammary gland can be attained.
The optional water bag EZU-WL3 components are as follows:
Component Note
1 Outer case 1 piece
2 Balloon * 10 pieces
3 Syringe 1 piece
4 Instruction manual 1 piece
WARNING

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* The optional water bag EZU-WL3 is made of latex.
The latex may cause such allergic reactions as itching, rubor,
urticaria, swelling, fever, anhelation, wheezing, and
depression of blood pressure, shock and so on. For the patients
suspected of latex allergy, do not use the latex-containing
medical devices.
Please refer to the instruction manual of EZU-WL3 about the
method of handling, cleaning and disinfecting it.
1.5.6 Biopsy Attachment EZU-PA3L (Option) (Applicable
model:EUP-L53)
The biopsy attachment EZU-PA3L is a dedicated tool for use as
mounted on a EUP-L53.
The optional biopsy attachment EZU-PA3L components are as
follows:
Component Note
1 Biopsy guide assembly 1 piece
2 Needle guide (14G,18G,21G) 1 each
3 Brush 1 piece
4 Instruction manual 1 copy
5 Biopsy case 1 piece
Please refer to the instruction manual of EZU-PA3L about the
method of handling, cleaning and sterilizing the biopsy
attachment EZU-PA3L.
WARNING

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1.6 Construction
U
n
-
i
mmersible part
Immersible part:
This part can be immersed in
disinfectant/sterilant solution and
can be cleaned by water.
Un-immersible part:
This part should not be immersed in
disinfectant/sterilant solution and
also can not be cleaned by water.
Cable
Connector
Immersible part (IPX7)
Applied part
Head
Fig. 2 External view (EUP-L53, L53L)
U
n
-
i
mmersible part
Immersible part:
This part can be immersed in
disinfectant/sterilant solution and
can be cleaned by water.
Un-immersible part:
This part should not be immersed in
disinfectant/sterilant solution and
also can not be cleaned by water.
Cable
Connector
Immersible part (IPX7)
Applied part
Head
Fig. 1 External view (EU53S, L52)

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2. Introduction
Prior to use, the probe must be carefully inspected that it is
appropriate for use. If not, do not use the probe and the immediately
contact a service support.
2.1 Inspection of 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) Connect the probe, operate the main unit, and adjust the image
according to the instructions given in the operation manual for
the main unit.
2) Relationship between direction of the probe and the image is
shown in Fig. 3. The right-left orientation mark on the image
indicates the direction of the index mark on the probe.
3) When using under sterile condition, protect the probe by using
covers. Some Latex material creates allergic reaction. Please
use allergy free material covers.
4) Caution in case of wiping off the ultrasound jelly or cleaning
the surface of the acoustic lens.
Fig. 3 Relationship between Index Mark and Right-left Orientation Mark
(EUP-L53S,L52) (EUP-L53, L53L)
Index mark
Index mark
Right-left
orientation mark
Right-left
orientation mark

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The acoustic lens of the probe is manufactured very thin and
delicate to get the high resolution. Therefore, in case of wiping
off the ultrasound jelly or cleaning the surface of the acoustic
lens, please use a soft cloth or tissue paper and handle with care.
(See Fig. 4)
Soft cloth or tissue paper
Acoustic lens
Fig. 4 Wiping off the ultrasound jelly or cleaning the
surface of the acoustic lens
CAUTION

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4. Reprocessing Procedure
The probes must be reprocessed after each use. Refer to the
reprocessing instruction in this chapter. For reprocessing of the
available options for the probes, please refer to the specific
instruction manuals of them.
WARNINGS
‐The probes are
d
elivered unsterile. Prior to the
first use, reprocess the probes.
‐Temperature should not exceed 60°C during
reprocessing.
‐Probe connector is not water resistant.
Limitations on
reprocessing
The probe is not completely submersible. The
immersible part is shown in Fig.1. The un-immersible
part should be
d
isinfected by wipe disinfection.
Transportation
before using
The probe should be packed in a sterile pouch or
container to transport from Central Sterile Supply
Department (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-L53, L53S, L53L, and L52 probes
are 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 manual
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 and any accessories from the probe.
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. 5). 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. 5) 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.