Hitachi EUP-S50A User manual

Sector Scanning Probe
EUP-S50A
INSTRUCTION MANUAL
Tokyo, Japan
Q1E-EP0659-6
© 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 an
y
time.
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 probe.
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 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
dark, dry environment to avoid high
temperature and 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 ......................................................................................................................... 2
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) ......................................................................................... 6
4.2 Containment and transportation .................................................................................. 6
4.3 Manual Cleaning and disinfection .............................................................................. 7
4.4 Drying ...................................................................................................................................... 9
4.5 Inspection ............................................................................................................................. 9
4.6 Packaging ............................................................................................................................. 10
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 of Model EUP-S50A has phased array Sector 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 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.

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1.3 Intended Use
The Sector Scanning Probe EUP-S50A is designed for observation
and diagnosis mainly of the following regions by connecting with
the HITACHI ultrasound scanner.
・Cardiac
1.4 Composition
The probe components of the EUP-S50A are as follows:
1) Probe EUP-S50A ....................... 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, disinfection,
and sterilize the probe.
1.5 Construction
C
onnector
C
able
U
n
-
i
mmersible
p
art
(IP40)
Fig.1 External View
Immersible part (IP47)
Head
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.
Applied Part
CAUTION

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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 or instruments
on the probe, such as unauthorized biopsy attachments.
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) Use under sterile condition, protect the probe by using an
appropriate cover 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 sterilized, then store it in an adequate place.
Right-left orientation mark
Index mark
Fig.2 Relationship between Index Mark and Right-
l
eft Orientation Mark

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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
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.
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
D
isinfection (Disinfectant
with virucidal effect)
critical
Application part contacts
intracorporeal tissue
directly
(operative application)
Cleaning
D
isinfection (Disinfectant
with virucidal effect -
minimum)
Sterilization
According to the intended use, EUP-S50A probe is classified as
uncritical.

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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:
Wipe the whole surface of the probe with gauze pad and remove
superficial visible impurities and leavings of ultrasound jelly.
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
S
terilization
Containment and
transportation
Point of use
(Pre-clean
i
ng)
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 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.
M
anual Cleaning
R
insing after manual
cleaning
M
anual Disinfection
R
insing after manual
d
isinfection
M
anual cleaning
a
nd disinfection

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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.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 Fig. 3)
for 5 min.)
5) Visually check the outer surface of the probe for leavings
of the disinfectant. If necessary, repeat the rinsing.

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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.
Water
Detergent
Disinfectant
Fig.3 Immersion of the probe
Drying

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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.
ETO Gas Sterilizer, closed system
Parameter Specification
Preconditioning None
Conditioning in
Chamber (Dwell)
Temperature: 122.0 - 131.0 °F
(equivalent of 50 – 55 °C)
Humidity: 40 - 90 % RH
Prevacuum: 8 - 26 kPa
Time: 30 - 45 minutes
Exposure Temperature: 122.0 - 131.0 °F
(equivalent of 50 – 55 °C)
Sterilant gas: 10 % EO / 90 % HCFC
Excess pressure: 162 - 200 kPa
Exposure time: 120 - 125 min (full cycle)
Post-vacuum 8 - 26 kPa, 2 times
Aeration Temperature: 50 – 55 °C
Time: min. 11 hours
Plasma sterilization
Sterilization Method Condition
Plasma Sterilization:
STERRAD® 50, 100S or 200 (*) Short Cycle
Plasma Sterilization:
Sterrad® NX or 100NX (*) Standard cycle
* 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.
Sterilization

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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. 1 Packaging in the pouch
Probe
TYVEK Pouch
Sealed
Fig. 2 Sealing
Probe
Fig. 3 Packaging in a tray
Probe in
t
he Pouch
Tray for
s
teril
i
zation

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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.

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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. 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.