Hitachi EUP-C524 User manual

Convex Array Probe
EUP-C524
INSTRUCTION MANUAL
Tokyo,Japan
Q1E-EP0385-6
© Hitachi, Ltd. 2013,2016. 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 Ultrasound Logistics,
Zweigniederlassung der Hitachi Medical Systems Europe
Holding AG
Carl-Zeiss-Strasse 5, D-72555 Metzingen, 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 Ultrasound Logistics,
Zweigniederlassung der Hitachi Medical Systems
Europe Holding AG
Carl-Zeiss-Strasse 5,
D-72555 Metzingen, Germany
Keep away from
Sunlight
Store the probe in a cool, dustproof and dark, dry
place 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
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. General ························································ 1
1.1 General ·····························································1
1.2 Principles of operation ·············································1
1.3 Intended Use ························································2
1.4 Composition ·························································2
1.5 Option ······························································2
1.6 External View ·······················································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 Cleaning and disinfection ···········································8
4.4 Drying ·····························································10
4.5 Inspection ·························································10
4.6 Packaging ··························································11
4.7 Sterilization ······················································12
4.8 Storage ····························································14
5. Maintenance and Safety Inspection ····························· 15
6. Safety Precautions ············································ 16
7. Specifications ················································ 17
7.1 Probe ······························································17
7.2 Suppliers List ·····················································18
8. Disposal of the probe ········································· 18

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1. General
1.1 General
The probe of Model EUP-C524 is Convex 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 Convex Array Probe EUP-C524 is designed for observation and
diagnostic mainly of the following regions by connecting with
the HITACHI ultrasound scanner.
Abdominal
Pediatrics
Fetal
Small organ
1.4 Composition
The probe components of the EUP-C524 are as follows:
1) Probe EUP-C524...........1 piece
2) Instruction Manual.......1 copy
1.5 Option
Needle Guide Bracket EZU-PA5C2
1) Needle guide bracket.....1 piece
2) Brush....................1 piece
3) Spring (Spare)...........2 pieces
4) Instruction Manual.......1 copy
5) Biopsy case..............1 piece
Please refer to the instruction manual of option about the method
of handling, cleaning and sterilizing the needle guide bracket
EZU-PA5C2.

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1.6 External View
The external view of the EUP-C532 is shown in Fig.1.
Immersible part (IP47)
Head
Connector
Cable
Un-immersible part
(IP40)
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 of the EUP-C524
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.
2.1 Inspection for Appropriate Connection
2.1.1 Confirm that the system is correctly operating. Refer to the
instruction manual for the ultrasound diagnostic scanner.
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 inspect the surface of the probe and head, 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.

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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
or sterilized, then store it in an adequate place.
Right-left orientation mark
Index mark
Fig.2 Relationship between Index Mark and Right-left
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
The probe is not completely submersible. The immersible
part is shown in Fig.1. The un-immersible 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
Department (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
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-C524 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
cleaning
Manual Disinfection
Drying
Manual cleaning and
disinfection
Rinsing after manual
disinfection
Packing
Sterilization
Containment and
transportation
Point of use
(Pre-cleaning)
Containment and
transportation

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4.3 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.
Manual Cleaning
Rinsing after manual
cleaning
Manual Disinfection
Rinsing after manual
disinfection
Manual cleaning
and 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.
Water
Detergent
Disinfectant
Fig.3 Immersion of the probe

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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. 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.
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.
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.

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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
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.