Hitachi EUP-C516 User manual

Convex Array Probe
EUP-C516
INSTRUCTION MANUAL
Tokyo,Japan
Q1E-EP0386-9
© 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 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 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 and dry
environment 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
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 ........................................................ 1
1.4Components .......................................................... 2
1.5Option .............................................................. 2
1.6Option of Hitachi ultrasound diagnostic scanner ..................... 3
1.7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.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) ........................................ 16
5.2Containment and transportation ..................................... 16
5.3Manual Cleaning and disinfection ................................... 16
5.4Drying ............................................................. 19
5.5Inspection ......................................................... 19
5.6Packaging .......................................................... 19
5.7Sterilization ...................................................... 19
5.8Storage ............................................................ 21
6.Maintenance and Safety Inspection ............................. 22
7.Safety Precautions ............................................ 23
8.Specifications ................................................ 24
8.1Probe .............................................................. 24
8.2Suppliers List ..................................................... 25
9.Disposal of the probe ......................................... 26

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1. General
1.1 General
The EUP-C516 is a convex array probe.
The acoustic output of the EUP-C516 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-C516 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.
1.3 Intended Use
The EUP-C516 is designed for observation and diagnosis mainly of
the following regions by connecting with the Hitachi ultrasound
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.
WARNING

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1.4 Components
The components of the EUP-C516 are given below:
1) Probe EUP-C516 ........... 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, disinfect
and sterilize the probe.
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-C516. The optional biopsy attachment
EZU-PA34T components are as follows:
1) Biopsy guide assembly ............. 1 piece
2) Needle guide (14G,18G,21G) ........ 1 each
3) Brush ............................. 1 piece
4) Instruction manual ................ 1 copy
5) Biopsy case ....................... 1 piece
Please refer to the instruction manual of the biopsy attachment
about the method of handling, cleaning, disinfecting 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 the needle guide
bracket about the method of handling, cleaning, disinfecting
and sterilizing the needle guide bracket EZU-PA5C1.
CAUTION

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1.6 Option of Hitachi ultrasound diagnostic scanner
1.6.1 Magnetic Sensor Attachment
1) Magnetic sensor attachment
2) Spacer for EZU-RV2S
The Magnetic sensor attachment which is applicable for
EUP-C516is also compatible with EUP-C514 and is marked as “☆
EUP-C514”.
Please refer to the instruction manual of EUP-C514 about the
method of handling, cleaning, disinfecting and sterilizing the
Magnetic sensor attachment.
1.7 External View
The external view of the EUP-C516 is shown in Fig.1.
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.
Connector
Cable
Un-immersible part
Immersible part (IP
X
7
)
Head
Spacer for EZU-RV2S
(Option of Hitachi ultrasound
diagnostic scanner)
Magnetic sensor attachment
(Option of Hitachi ultrasound
diagnostic scanner)
Fig.
1
E
xternal 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.
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 immediately.
2.2.2 Visually inspect the magnetic sensor attachment and the
Spacer for EZU-RV2S for any crack, deformation or
denaturalization. If you find any damage, do not use them
and contact a service support immediately.

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3. Operation Procedure
1) Confirm that the probe is cleaned, disinfected or sterilized.
2) Confirm that the magnetic sensor attachment and the spacer for
EZU-RV2S are cleaned, disinfected or sterilized, when using 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.
Fig. 2 Relationship between the directions of the prob
e
and the Right-left orientation mark
I
ndex mark
Right-left
orientation mark

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5) If a biopsy method is required, refer to its instruction manual.
6) Under sterile condition, protect the probe by using covers (ref.
To Suppliers List). 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”
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 “5. Reprocessing procedure” 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 “6. Maintenance and Safety inspection”.

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4. Option of Hitachi ultrasound diagnostic sensor
In case of using RVS (Real-time Virtual Sonography), confirm type
of the magnetic sensor. There are two types of magnetic sensors for
the EUP-C516, 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-C516 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-C516.
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 cleaned, 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 RVS (Real-time Virtual Sonography), attach the
magnetic sensor as shown below.
F
ig. 3 Magnetic sensor(
E
ZU
-
R
V2S
)
Sensor (black)
Projected part

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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.
Index mark
Fit the insertion
direction
Fig. 5 How to attach the Magnetic sensor attachment
Hole of the
Magnetic sensor
attachment
Fig. 4 How to attach the Magnetic sensor
Hole of the Magnetic
s
ensor
attachment
Spacer for EZU-RV2S
Projected part of
the Magnetic sensor
Fit the insertion
direction
Magnetic sensor
(EZU-RV2S:Black)
CAUTION

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4.1.2 How to release the Magnetic Sensor
The procedure of releasing the magnetic sensor from the probe
is as follow.
a) Turn around the magnetic sensor attachment and release it from the
probe as shown in Fig. 6.
b) 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, please do not lose the spacer.
Fig. 6 How to release the Magnetic sensor attachment
Fig. 7 How to release the Magnetic sensor
CAUTION

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4.2 Magnetic Sensor (EZU-RV3S)
The magnetic sensor (EZU-RV3S) as shown in Fig. 8 is also the
magnetic sensor for the EUP-C516.
4.2.1 How to attach the EZU-RV3S
The procedure of attaching the magnetic sensor is as follows.
1) Confirm that the probe, the magnetic sensor attachments are
cleaned, 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 RVS (Real-time Virtual Sonography), attach the
magnetic sensor as shown below.
a) Attach the magnetic sensor into the probe with the correct direction
as shown in Fig. 9.
S
ensor (white)
Direction mark
Fig. 8 Magnetic sensor (EZU-RV3S)
Fig. 9 How to attach the Magnetic sensor
Hole of the Magnetic
s
ensor
attachment
Direction mark
of the EZU-RV3S
Magnetic sensor (EZU-RV3S:White)
Fit the insertion
direction

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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
CAUTION

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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 How to release the Magnetic sensor

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5. Reprocessing Procedure
The probe and the magnetic sensor attachment and spacer must be
reprocessed after each use. Refer to the reprocessing instruction
in this chapter.
For reprocessing the biopsy attachment EZU-PA34T and the needle
guide bracket EZU-PA5C1 refer to the instruction manuals of
EZU-PA34T and EZU-PA5C1.
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.

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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