Sector Scanning Probe

EUP-S70

INSTRUCTION MANUAL

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.

Tokyo , Japan
Q1E-EP1152-6

© Hitachi, Ltd. 2013,2017. All rights reserved.

0123
Manufacturer: Hitachi,Ltd
2-16-1, Higashi-Ueno,Taito-ku,
Tokyo,110-0015,Japan
+81-3-6284-3668
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 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

Hitachi,Ltd
2-16-1,Higashi-Ueno,Taito-ku,
Manufacturer Company
Name and Address Tokyo,110-0015,Japan
+81-3-6284-3668
http://www.hitachi.com/businesses
/healthcare/index.html

Authorized Hitachi Medical Systems GmbH

Representative Otto-von-Guericke-Ring 3 D-65205
in The European
Wiesbaden, Germany
Community

Store the probe in a cool, dustproof,

Keep away dark and dry place and keep away from
from Sunlight high temperature, high humidity and
direct sunlight.

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Definition of symbol
The following symbol is also used for HITACHI Ultrasound Probes.

Location Symbol Definition

This instrument complies with Directive
Probe connector 93/42/EEC relating to Medical Device and
Directive 2011/65/EU relating to RoHS
IPX7 mark
Probe connector IPX7 See section 1.5.

Probe connector Type BF APPLIED PART

Probe connector General warning sign

Probe connector Warning; dangerous voltage

Probe connector Caution; Biohazard

Follow the instruction manual to operate

this instrument. If not avoided, may result
Probe connector in injury, property damage, or the equipment
trouble.

Probe connector STERRAD sterilization compatibility mark

Do not waste the instrument as general

Probe connector waste. Comply with a local regulation.

By prescription only. U.S. Federal Law

Probe connector Rx Only 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  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) ..................................... 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 .................................................. 12 
4.8  Storage ........................................................ 14 
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-S70 is a phased array sector scanning type.
The acoustic output of this probe when connected to ultrasound
scanner was measured according to the IEC 61157 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 Sector Scanning Probe EUP-S70 is designed for observation and
diagnosis mainly of the following regions by connecting with the
HITACHI ultrasound scanner.
・ Cardiac
・ General abdominal organs
・ Transcranial

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 1.4 Composition
The probe components of the EUP-S70 are as follows:
1) Probe EUP-S70 ···················· 1 piece
2) Instruction Manual ··············· 1 copy

1.5 Construction
Immersible part (IPX7)

Head Cable

Applied part
Connector

Un-immersible
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

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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 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) Confirm that the probe is cleaned, disinfected and/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.

Index mark

Right-left
orientation mark

Fig. 2 Relationship between Index Mark

and Right-left Orientation Mark

4) Use under sterile condition, protecting the probe by using covers

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/or sterilized immediately, and then store it in an adequate
place.

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4. Cleaning, Disinfection and Sterilization
The probe must be reprocessed after each use. Refer to the reprocessing
instruction in this chapter.

‐ The probe is delivered unsterile. Prior to the first

use, reprocess the probe.
WARNINGS ‐ Temperature should not exceed 60°C during
reprocessing
‐ Probe connector is not water resistant.

Limitations on The probe is not completely submersible. The immersible

part is shown in Fig.1. The un-immersible part should
reprocessing
be disinfected by wipe disinfection.

The probe should be packed in a sterile pouch or container

Transportation to transport from Central Sterile Supply Department
before using (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

Application part only Cleaning
uncritical contacts intact and
Disinfection
uninjured skin
Cleaning
Application part contacts
Disinfection
semicritical mucosa (intracavitary
(Disinfectant with
application)
virucidal effect)

Cleaning
Application part contacts Disinfection
intracorporeal tissue
critical (Disinfectant with
directly virucidal effect - minimum)
(operative application)
Sterilization

According to the intended use, EUP-S70 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)

Containment and
transportation

Manual cleaning and

disinfection
Manual Cleaning

Rinsing after manual

cleaning

Manual Disinfection

Rinsing after manual

disinfection

Drying

Packing

Sterilization

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4.1 Point of use (Pre-cleaning)

Pre-cleaning should be done immediately after Point of use

each use. The procedure is as follows: (Pre-cleaning)

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

Containment and
Putting the contaminated equipment into
transportation
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 Manual cleaning and
cleaning and disinfection: disinfection
a) Detergent: Cidezyme® (Johnson &
Manual Cleaning
Johnson, #2258) or another cleaning
agent with approved material
compatibility for this medical device Rinsing after manual
cleaning
b) Disinfectant: Cidex® OPA (Johnson &
Johnson, # 20391) or another
disinfectant with approved material Manual Disinfection
compatibility for this medical device
c) Two tanks, one for cleaning and one Rinsing after manual
for disinfection - optional: disinfection
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)

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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. 4). 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.
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. 4) 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. 4). 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. 4) for 5 min.)
5) Visually check the outer surface of the probe for leavings of the
disinfectant. If necessary, repeat the rinsing.

Water
Detergent
Disinfectant

Fig. 3 Immersion of the Probe

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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 equipment 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 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.

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 4.7 Sterilization
The probe can be sterilized using either ethylen 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 Condition

Plasma Sterilization:
Short Cycle
STERRAD® 50, 100S or 200 (*)
Plasma Sterilization:
Standard cycle
Sterrad® NX or 100NX (*)

 Gas Type: 10% EO/ 90% HCFC

 Temperature: 50-55°C
 Exposure Time: More than 120 minutes
ETO Sterilization
 Pressurization: 162-200kPa
Depressurization: 13-8kPa
 Relative humidity: 40-90%
 Aeration is minimum 12 hours

* STERRAD® systems are manufactured by "Johnson & Johnson"

WARNING
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

it, it suffers serious damage and will be not functional.

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The packaging before sterilization is as follows.
1) Put the probe into TYVEK
pouch.

Probe

TYVEK Pouch
Fig. 4 Packaging in the pouch
2) Seal the TYVEK Pouch using
a heat sealer. Ensure that Sealed
the seal is complete.

Probe

TYVEK Pouch
Fig. 5 Sealing
3) Put the sealed pouch into a
tray or plastic mesh wire for
sterilization.

Tray for
sterilization
Probe in
the Pouch

Fig. 6 Packaging in a tray

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 4.8 Storage

Store the equipment in a cool, dustproof, dry, and dark space

to avoid high temperature, humidity and direct sunlight.
Limitations for the time for sterilized equipment belong to
package.

5. Maintenance and Safety Inspection

1) Daily visually check the surface of the probe head, housing,
cable and connector for any crack, scratch or denaturalization.
If you find damage, do not use the probe and immediately contact
a service support.
2) After the use of the probe, it should be cleaned and disinfected
and sterilized following “4. Cleaning and disinfection and
Sterilization”, then store it in a cool and dark place avoid
high temperature and humidity, direct sunlight.

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6. Safety Precautions

WARNING
・ Never use the probe if the probe head, housing or cable are
cracked or damaged.
・ Warning is 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.

CAUTION
・ 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.
・ Under sterile condition use appropriate protection for probe
and cable. Some Latex material may create allergic reactions.
・ The probe is not delivered disinfected or sterilized. Before
using the probe, disinfect or sterilize it.
・ 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 the soft cloth or tissue paper
and handle with care.

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7. Specifications
7.1 Probe
Type : EUP-S70 Sector Scanning probe
Acoustic working
frequency : 3.0MHz
Technology : Phased Array Probe
Dimensions : See Fig. 7.
Weight : Approx. 0.7kg
(incl. cable and connector)
Scanning angle : 90°
Probe materials : Bio-compatible allergy free components
Acoustic output : According to IEC 61157
(See Main Unit manual.)
Applicable system : Depending on production and upgrade
status
For detailed information contact a
service support.
Classification : MDD classification IIa.
Cleaning : Applicable detergents are listed in
the suppliers list
Disinfection : Applicable disinfectants are listed
in the suppliers list
Sterilization : Plasma sterilization

Operating conditions :
Ambient temperature ; 25 – 35°C
Contact surface temperature ; max. 42°C
(temperature of examinee)
Relative humidity ; 30 – 85%
(Subject to no condensation)

Storage conditions :
Temperature ; –10 – +55°C
Relative humidity ; 10 – 95%
(subject to no condensation)

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 7.2 Suppliers List
The products listed below are seriously tested and approved for
use with the Sector Scanning Probe EUP-S70.

Product name Manufacturer Purpose

Enzymatic
Cidezyme Johnson & Johnson
detergent
Meliseptol HBV-Tücher Braun Disinfectant
Incidin Liquid Henkel Hygiene GmbH Disinfectant
Incidur Spray Henkel Hygiene GmbH Disinfectant
STERANIOS 2% ANIOS Disinfectant
ANIOXYDE1000 ANIOS Disinfectant
Virkon S ANTEC Disinfectant
CIDEX Johnson & Johnson Disinfectant
CIDEX plus Johnson & Johnson Disinfectant
CIDEX OPA Johnson & Johnson Disinfectant
ALKACIDE ALKAPHARM Disinfectant
ALKAZYME ALKAPHARM Cleaner
Please contact your local distributor for a current version of the
"Disinfectant/Sterilization Method Compatibility for Ultrasound Probe
and Accessory List

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8. Disposal of the probe
Recycle or dispose the equipment properly in compliance with your
organizational rules and your local Law.

CAUTION
Before disposing the equipment, disinfect or take other
infection-prevention measures.
Disposal of the equipment without taking the proper preventative measures
can lead to infection.

Waste Electrical and Electronic Equipment (WEEE) Directive

The illustration on the right is required by the EU WEEE
Directive to appear on all electrical and electronic
equipment.
For proper disposal of this product in an EU nation, contact
an EU office or agency and observe appropriate local and
national regulations and laws.

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 Unit: mm

Fig. 7 Dimensions
E
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