Hitachi EUP-S70 User manual

Sector Scanning Probe
EUP-S70
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1152-6
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123
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.

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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 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,
dark and dry place and keep away from
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
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 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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
Connector
Head
C
able
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.
Immersible part (IP
X
7
)
Un-immersible
Fig. 1 External View
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 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.
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.
Fig. 2 Relationship between Index Mark
and Right-left Orientation Mark
Index mark
Right-left
orientation mark

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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.
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
T
he probe should be packed in a sterile pouch or container
t
o 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-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)
Manual Cleaning
Rinsing after manual
cleaning
Manual Disinfection
D
rying
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 .
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 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)
Point of use
(Pre-cleaning)
Containment and
transportation
M
anual Cleaning
R
insing after manual
cleaning
Manual Disinfection
R
insing after manual
disinfection
M
anual cleaning and
disinfection

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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.
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 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
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.
Packaging

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WARNING
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:
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
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.
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
Probe
TYVEK Pouch
Sealed
Fig. 5 Sealing
P
robe
Fig. 6 Packaging in a tray
Probe in
the Pouch
Tray for
sterilization

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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.