Hitachi EUP-O53T User manual

Intraoperative Probe
EUP-O53T
INSTRUCTION MANUAL
Tokyo , Japan
Q1E‐EP0403‐9

©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 probe.
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-
0
015,
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 place and keep away
from high temperature, high humidity, or 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 ············································· 3
2. Inspection before Use ········································ 4
2.1 Inspection for Appropriate Connection ···················· 4
2.2 Inspection for Material Surface ·························· 4
3. Operation Procedure ·········································· 5
4. Cleaning, Disinfection and Sterilization ····················· 6
4.1 Point of use (Pre-cleaning) ······························ 7
4.2 Containment and transportation ··························· 7
4.3 Manual Cleaning and disinfection ························· 8
4.4 Drying ··················································· 9
4.5 Inspection ·············································· 10
4.6 Packaging ··············································· 10
4.7 Sterilization ··········································· 11
4.8 Storage ················································· 13
5. Maintenance and Safety Inspection ··························· 13
6. Safety Precautions ·········································· 14
7. Specifications ·············································· 15
7.1 Probe ··················································· 15
7.2 Suppliers List ·········································· 16
8. Disposal of the probe ······································· 16

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1. Introduction
1.1 Features
The probe of Model EUP-O53T has Linear Array electronic
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 IEC60601-1 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 Linear Array Probe EUP-O53T is designed for observation
and diagnosis mainly of the following regions by connecting
with the HITACHI ultrasound scanner.
Intraoperative
Biopsy (with biopsy attachment)
1.4 Composition
The probe components of the EUP-O53T are as follows:
1) Probe EUP-O53T ...................... 1 piece
2) Instruction manual .................. 1 copy
The probe is not sterilized when shipped, and it must be cleaned,
disinfected, and sterilized prior to its first use.
1.5 Accessories (Option)
1.5.1 Biopsy Attachment EZU-PA5O (Option)
The biopsy attachment EZU-PA5O is a dedicated tool for use
as mounted on a EUP-O53T.
The optional biopsy attachment EZU-PA5O components are as
follows:
1) Biopsy attachment ................... 1 piece
Each of 14G, 18G and 21G exist.
During ordering our biopsy attachment, please specify the
kind of puncture needle gauge used in your hospital.
2) Brush ............................... 1 piece
3) Instruction manual .................. 1 copy
4) Biopsy case ......................... 1 case
Please refer to the instruction manual of the option about
the method of handling, cleaning and sterilizing the biopsy
attachment EZU-PA5O.
CAUTION

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1.6 Construction
Immersible part (IP
X
7
)
Index mark
Connector
Cable
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
Un-immersible part
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 Do not attach or connect unauthorized devices nor
instruments on the probe, such as unauthorized biopsy
attachments.
If a biopsy operation is required, refer to its
instruction manual for inspection, preparation,
operation and cleaning through sterilization.
2.1.2 Check that the system is correctly operating. Refer to
the instruction manual for the main unit.
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) If a biopsy method is required, refer to its instruction
manual.
5) After the use of the probe, it should be cleaned and disinfected
and sterilized, then store it in an adequate place.
1) Since the acoustic jelly accessory to the ultrasound
scanner is not a sterilized one, never use it.
2) We recommend you to use a sterilized probe cover in order
to minimize sticking of body fluid to the probe. Apply
sterilized jelly to the probe, then put the probe cover
on the probe head. Tightly contact the probe head with the
probe cover.
Fig.2 Relationship between Index Mark
and Right
-
l
eft Orientation Mark
Index mark
Right-left orientation mark
CAUTION

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4. Cleaning, Disinfection and Sterilization
The probe and accessory 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
The probe is not completely submersible. The
immersible part is shown in Fig.1. The un-immersible
p
art should be disinfected by wipe disinfection.
Transportation
before using
The probe should be packed in a sterile pouch or
c
ontainer to transport from Central Sterile Supply
D
epartment (CSSD) to an operating room. Be careful
n
ot to damage the sterile pouch or container during
t
ransportation.
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
P
rocessing
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-O53T probe is classified as
critical.

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The flowchart of the reprocessing process of this probe is as follows.
4.1 Point of use (Pre-cleaning)
Pre-cleaning should be done immediately after each
use. The procedure is as follows:
1) Remove the protective 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.
Point of use
(Pre-cleaning) Manual Cleaning
Rinsing after manual
c
leaning
Manual Disinfection
Drying
Manual cleaning and
disinfection
Rinsing after manual
d
isinfection
Packing
Sterilization
Containment and
transportation
Point of use
(Pre-cleaning)
Containment and
transportation

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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 immersible 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)
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 Figure 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-immersible parts of the probe with a soft cloth dipped
with the detergent solution.
M
anual Clean
i
ng
R
insing after manual
cleaning
M
anual Disinfection
R
insing after manual
disinfection
Manual cleaning
a
nd disinfection

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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.
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 figure
3) for 5 min.)
5) Visually check the outer surface of the probe for leavings of the
disinfectant. If necessary, repeat the rinsing.
4.4 Drying
1) Wipe the equipment with a single-use, fluff-free wipe or towel to
remove moisture from the surface of the equipment.
2) Dry the equipment naturally in an ambient temperature between
15-30°C for a minimum of 4 hours. Alternatively the equipment can
be dried using a drying heater at a temperature of less than 55°C.
Drying
Fig.3 Immersion of
the Probe
Water
Detergent
Disinfectant

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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 equipment 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 equipment can be placed on plastic mesh wires supplied
for plasma sterilization and then packed as mentioned above.
The equipment 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.
Packaging

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4.7 Sterilization
The probe and accessory can be sterilized using either ethylene oxide
gas (EtO) sterilization or plasma sterilization (see table below).
Follow the manufacturer's instructions of the sterilizer regarding
usage, temperature and sterilization-time.
The sterilization method and operating conditions are as follows.
Sterilization Method
C
ondition
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%

A
eration 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 and the Magnetic sensor attachment.
2) Do not sterilize the probe and the Magnetic sensor attachment by
Steam Autoclaving. If you autoclave them, they suffers serious
damage and will be not functional.
Sterilization
WARNING

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The packaging before sterilization is as follows.
1) Put the probe into TYVEK
pouch.
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.
TYVEK Pouch
Fig. 4 Packaging in the pouch
P
robe
TYVEK Pouch
Sealed
Probe
Fig. 5 Sealing
Fig. 6 Packaging in a tray
Tray for
s
terilization
Probe in
t
he Pouch

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4.8 Storage
Store the equipment in a cool, dustproof, dry, and dark
s
pace
to avoid high temperature, humidity and direct sunlight.
Limitations for the time for sterilized equipment belong to
package.
5. Maintenance and Safety Inspection
1) After using the probe, it should be cleaned and disinfected
or sterilized according to “4.Cleaning, Disinfection and
Sterilization”, 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.

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6. Safety Precautions
Never use the probe if the probe head, housing or cable
are cracked or damaged.
Warning in case of using probe covers which latex is
contained to. The latex may cause such allergic reactions
as itching, rubor, urticaria, swelling, fever, anhelation,
wheezing, depression of blood pressure, shock and so on.
For the patients suspected of latex allergy, do not use
the latex-containing medical devices. If you observe any
of above mentioned symptoms in your patient during the
operation, stop the use of the latex-containing medical
devices immediately and take an appropriate treatment to
the patient.
By examination of an early pregnancy the exposure time
shall be as short as possible. Start examination with
acoustic output power set to L (Low).
The probe connector is not water proof. Do not allow liquid
to contact the connector.
Do not drop, hit or bent the probe.
Use only water, detergents and disinfectants in the
suppliers list. Between use store the probe holder of
scanner.
The probe is not delivered disinfected or sterilized.
WARNING
CAUTION