Hitachi EUP-C514 User manual

ConvexArrayProbe
EUP‐C514
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‐EP0428‐10

©Hitachi,Ltd.2013,2017.Allrightsreserved.
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,110-0015, 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
S
tore 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 1.7.
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. General ................................................... 1
1.1. General ..........................................................1
1.2. Principles of operation ..........................................1
1.3. Intended Use .....................................................2
1.4. Composition ......................................................2
1.5. Option ...........................................................3
1.6. Option of Hitachi ultrasound diagnostic scanner ..................3
1.7. External View ....................................................4
2. Inspection before Use ..................................... 5
2.1. Inspection for Appropriate Connection ............................5
2.2. Inspection for Material Surface ..................................5
3. Operation Procedure ....................................... 6
4. Option of Hitachi ultrasound diagnostic sensor ............ 7
4.1. Magnetic Sensor (EZU-RV2S) .......................................7
4.2. Magnetic Sensor (EZU-RV3S) ......................................10
5. Reprocessing Procedure ................................... 13
5.1. Point of use (Pre-cleaning) .....................................15
5.2. Containment and transportation ..................................15
5.3. Manual Cleaning and disinfection ................................15
5.4. Drying ..........................................................18
5.5. Inspection ......................................................18
5.6. Packaging .......................................................18
5.7. Sterilization ...................................................18
5.8. Storage .........................................................20
6. Maintenance and Safety Inspection ........................ 21
7. Safety Precautions ....................................... 22
8. Specification ............................................ 23
8.1. Probe ...........................................................23
8.2. Suppliers List ..................................................24
9. Disposal of the probe .................................... 24

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1. General
1.1. General
The EUP-C514 is a convex array probe.
The acoustic output of the EUP-C514 was measured according to the
IEC60601-2-37 standard and the measurement was conducted by operating
with the Hitachi ultrasound diagnostic scanner.
The measured acoustic output is listed in the instruction manual of
the Hitachi ultrasound diagnostic scanner.
The EUP-C514 is categorized in class IIa according to Directive
93/42/EEC and classified as type BF according to IEC60601-1.
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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WARNING
CAUTION
1.3. Intended Use
The EUP-C514 is designed for observation and diagnosis mainly of the
following regions by connecting with the Hitachi ultrasound diagnostic
scanner.
General abdominal organs
General OB/GYN organs
Biopsy (with Biopsy Attachment)
Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
1.4. Composition
The components of the EUP-C514 are given follows:
1) Probe EUP-C514 ··············· 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 and sterilize the probe.

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CAUTION
1.5. Option
1.5.1. Biopsy Attachment EZU-PA34T
The biopsy attachment EZU-PA34T is a dedicated tool for use as mounted
on a EUP-C514. The optional biopsy attachment EZU-PA34T components are
as follows:
1) Biopsy guide assembly ········ 1 piece
2) Needle guide
(14G, 18G and 21G) ··········· 1 each
3) Brush ························ 1 piece
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 biopsy attachment EZU-PA34T.
1.5.2. Needle Guide Bracket EZU-PA5C1
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-PA5C1.
1.6. Option of Hitachi ultrasound diagnostic scanner
1.6.1. Magnetic Sensor Attachment
1) Magnetic sensor attachment
2) Spacer for EZU-RV2S
Please refer to this instruction manual about the method of handling,
cleaning and sterilizing the Magnetic sensor attachment.
The probe has not been sterilized when it was shipped from a factory.
So before using the probe, clean, disinfect and if necessary sterilize
the probe certainly.

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1.7. External View
Immersible part (IP47)
Un-Immersible part (IP40)
Applied part
Head
C
able
Connector
Spacer for EZU-RV2S
(Option of Hitachi
ultrasound diagnostic
scanner)
Magnetic sensor attachment
(
Option of Hitachi ultrasound
diagnostic scanner)
Fig. 1 External View
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 cannot be
cleaned by water.

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2. Inspection before Use
Prior to use, the probe must be carefully inspected that it is
appropriate for use. If you find any damage, do not use the probe and
immediately contact a service support.
2.1. Inspection for Appropriate Connection
1) Confirm that the system is correctly operating. Refer to the
instruction manual for the ultrasound diagnostic scanner.
2) Do not attach or connect unauthorized devices or 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.
2.2. Inspection for Material Surface
1) Visually inspect the surface of the probe and head, housing, the
cable and the connector for any crack, scratch or denaturalization.
2) Visually inspect the Magnetic sensor attachment and the Spacer for
EZU-RV2S for any crack, deformation, or denaturalization.

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3. Operation Procedure
1) Confirm that the probe is cleaned,
disinfected and if necessary
sterilized.
2) Confirm that the Magnetic sensor
attachment and the Spacer for
EZU-RV2S is disinfected or
sterilized, when use RVS
(Real-time Virtual Sonography).
3) Connect the probe to the
ultrasound diagnostic scanner,
operate the scanner, and adjust
the image, all according to the
instructions given in the
operation manual for the
ultrasound diagnostic scanner
with which the probe is used as
connected.
4) Confirm the direction of the
probe. The relationship between
the direction of the probe and
image is shown in Fig. 2. The
Right-left orientation mark on
the image indicates the
direction of the index mark of the
probe.
5) If a biopsy method is required, refer to its instruction manual.
6) Under sterile condition, protecting the probe by using covers is
recommended. Some Latex material may create allergic reaction.
Please use allergy free material covers.
7) After using the probe, perform the reprocessing procedure in
accordance with the procedure stated in “5. Reprocessing procedure
of the probe”every time immediately after completing the ultrasound
examination.
8) After using the Magnetic sensor attachment and the Spacer for
EZU-RV2S, perform the reprocessing procedure in accordance with the
procedure stated in “6. Reprocessing procedure of the Magnetic Sensor
Attachment and the Spacer for EZU-RV2S”every time immediately after
completing the ultrasound examination.
9) Store the Magnetic sensor attachment and the Spacer for EZU-RV2S
in the environment indicated in “7.Maintenance and Safety
inspection”.
Index mark
Right-left
orientation mark
Fig. 2
R
elationship between the
directions
o
f the probe and the
Right-left orientation mark

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4. Option of Hitachi ultrasound diagnostic sensor
In case of using RVS (Real-time Virtual Sonography), confirm that type
of the Magnetic sensor. There are two types of magnetic sensors for
the EUP-C514, the EZU-RV2S and the EZU-RV3S.
The Magnetic sensor (EZU-RV2S) and the Magnetic sensor (EZU-RV3S) are
shown in Fig. 3 and Fig.8.
The use of the EUP-C514 with either of the magnetic sensors enables
the user to perform RVS (Real-time Virtual Sonography).
4.1. Magnetic Sensor (EZU-RV2S)
The Magnetic sensor (EZU-RV2S) as shown in Fig.3 is a magnetic sensor
for the EUP-C514.
4.1.1. How to attach the Magnetic Sensor
The Procedure of attaching the Magnetic sensor is as follows.
1) Confirm that the probe, the Magnetic sensor attachment and the Spacer
for EZU-RV2S are disinfected or sterilized.
2) Connect the probe, operate the ultrasound diagnostic scanner, and
adjust the image according to the instructions given in the operation
manual for the ultrasound diagnostic scanner.
3) To use Real-time Virtual Sonography (RVS), attach the Magnetic sensor
as shown below.
Fig. 3 Magnetic sensor (EZU-RV2S)
Magnetic sensor
(black)
Projected part

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CAUTION
a) Attach the Spacer for EZU-RV2S to the Magnetic sensor.
b) Insert the Magnetic sensor (EZU-RV2S) into the Magnetic sensor
attachment with the correct direction as shown in Fig. 4.
c) Place the Magnetic sensor attachment in the index mark of the probe.
Never attach the Magnetic sensor attachment to the probe in the
incorrect direction, otherwise it may result false diagnosis.
Never forget to attach the Spacer for EZU-RV2S to the Magnetic sensor,
otherwise it may result in false diagnosis.
Fig. 4 How to attach the Magnetic sensor
Hole of the Magnetic
sensor attachment
Spacer for EZU-RV2S
P
rojected part
of the
M
agnetic
sensor
Fit the insertion
direction
Magnetic sensor
(EZU-RV2S: Black)
Index mark
Fit the
insertion
direction
Fig. 5 How to attach the Magnetic sensor attachment
Hole of the
Magnetic sensor
attachment

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CAUTION
4.1.2. How to release the Magnetic Sensor
The procedure of releasing the Magnetic sensor from the probe is as
follow.
1) Turn around the Magnetic sensor attachment and release it from the
probe as shown in Fig. 6.
2) Release the Magnetic sensor from the Magnetic sensor attachment as
shown in Fig. 7 and release the Spacer for EZU-RV2S from the Magnetic
sensor.
The Spacer for EZU-RV2S is small, so please do not lose the spacer.
Fig. 6 How to release the Magnetic sensor
a
ttachment
Fig. 7
H
ow to release the
Magnetic sensor

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4.2. Magnetic Sensor (EZU-RV3S)
The Magnetic sensor (EZU-RV3) as shown in Fig. 8 is also the Magnetic
sensor for the EUP-C514.
4.2.1. How to attach the Magnetic Sensor
The procedure of attaching the Magnetic sensor is as follows.
1) Confirm that the probe, the Magnetic sensor attachments are
disinfected or sterilized.
2) Connect the probe, operate the ultrasound diagnostic scanner, and
adjust the image according to the instructions given in the operation
manual for the ultrasound diagnostic scanner.
3) To use Real-time Virtual Sonography (RVS), attach the magnetic sensor
as shown below.
a) Attach the Magnetic sensor into the probe with the correct direction
as shown in Fig. 9.
Fig. 8
M
agnetic sensor (EZU
-
R
V3S)
Magnetic s
e
nsor
(white)
Direction
mark
Fig. 9 How to attach the Magnetic sensor
Hole of the Magnetic
sensor attachment
Direction
mark of the
E
ZU
-
R
V3S
Magnetic sensor
(EZU-RV3S: White)
Fit the
insertion
direction

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CAUTION
b) Place the Magnetic sensor attachment on the probe as shown in Fig.
10. Fit the projected part of the Magnetic sensor attachment in the
index mark of the probe.
Never attach the Magnetic sensor attachment to the probe in the incorrect
direction, otherwise it may result in false diagnosis.
Index mark
Fit the
insertion
direction
Fig. 10 How to attach the Magnetic sensor attachment
Hole of the
Magnetic sensor
attachment

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4.2.2. How to release the Magnetic Sensor
The procedure of releasing the Magnetic sensor from the probe is as
follow.
1) Turn around the Magnetic sensor attachment and release it from probe
as shown in Fig. 11.
2) Release the Magnetic sensor from the Magnetic sensor attachment as
shown in Fig. 12.
Fig. 11 How to release the Magnetic sensor attachment
Fig. 12
H
ow to release the
Magnetic sensor

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5. Reprocessing Procedure
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 C
e
ntral Sterile Supply
D
epartment (CSSD) to an operating room. Be careful
n
ot 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

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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
m
anual
cleaning
Manual Disinfection
Drying
Manual cleaning and
disinfection
Rinsing after manual
disinfection
Packing
S
terilization
Containment and
transportation