Hitachi EUP-L65 User manual

Linear Array Probe
EUP-L65
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP0739-7
© 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 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 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 scanner............. 7
4.1 Magnetic sensor EZU-RV2S ........................................ 7
4.2 Magnetic sensor EZU-RV3S ....................................... 10
4.3 Elasto Coupler ................................................. 13
5. Reprocessing Procedure..................................... 14
5.1 Point of use (Pre-cleaning) .................................... 17
5.2 Containment and transportation ................................. 17
5.3 Manual Cleaning and disinfection ............................... 17
5.4 Drying ......................................................... 21
5.5 Inspection ..................................................... 21
5.6 Packaging ...................................................... 21
5.7 Sterilization .................................................. 21
5.8 Storage ........................................................ 23
6. Maintenance and Safety Inspection.......................... 24
7. Safety Precautions......................................... 25
8. Specifications............................................. 26
8.1 Probe .......................................................... 26
8.2 Suppliers List ................................................. 27
9. Disposal of the Probe...................................... 27

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1. General
1.1 General
The EUP-L65 is a linear array probe.
The acoustic output of the EUP-L65 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-L65 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-L65 is designed for observation and diagnosis mainly
of the following regions by connecting with the Hitachi
ultrasound diagnostic scanner.
Mammary gland
Thyroid
Superficial organs
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-L65 are given below:
1) Probe EUP-L65 .................. 1 piece
2) Instruction Manual ............. 1 copy
Disinfection has not been made to the probe, shipped from the
factory. Prior to use of the probe, be sure to clean and disinfect
the probe.
1.5 Option
1.5.1 Acoustic coupler for EUP-L65（EZU-TECPL1）
EZU-TECPL1 is used when the operator keeps a constant distance
between the probe and the living body, and/or it is used when
the operator compares the tissue elasticity of the living body
with the acoustic coupler’s one. To attach the acoustic coupler
EZU-TECPL1 to the probe, the acoustic coupler
attachmentEZU-TEATC1 is used.
1.5.2 Acoustic coupler attachment for EUP-L65（EZU-TEATC1）
EZU-TEATC1 fixes the EZU-TECPL1 to the probe.
Please refer to the instruction manual of the EZU-TEATC1 about
the method of handling, cleaning and disinfecting the
EZU-TECPL1 and EZU-TEATC1.
1.5.3 Needle Guide Bracket EZU-PA6L1
1) Needle guide bracket......... 1 piece
2) Brush........................ 1 piece
3) Spring (Spare)............... 2 pieces
4) Instruction manual........... 1 copy
5) Case......................... 1 piece
Please refer to the instruction manual of EZU-PA6L1 about the
method of handling, cleaning and disinfecting the needle guide
bracket EZU-PA6L1.
CAUTION

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1.6 Option of Hitachi ultrasound diagnostic scanner
1) Magnetic Sensor Attachment (Part No. 7349818A)
2) Spacer for EZU-RV2S
3) Elasto coupler (Part No. 7331474A)
Sterilization has not been made to the magnetic sensor attachment
and the Elasto coupler, shipped from the factory. Prior to use of
it, be sure to clean, disinfect and sterilize it.
1.7 External View
C
able
C
onnector
Head
Spacer for EZU-RV2S
(Option of the Hitachi
ultrasound diagnostic
scanner)
Fig. 1 External View
Magnetic sensor attachment
(Option of the Hitachi ultrasound
diagnostic scanner)
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.
Immersible
part（IPX7）
Elasto coupler
(Option of the Hitachi
ultrasound diagnostic
scanner)
Applied part
Un-Immersible 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 you find any damage, do not use the probe
and immediately contact a service support.
2.1 Inspection of 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 nor 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 of material Surface
2.2.1 Visually inspect that the surface of the probe and head,
housing, the cable and the connector for any crack, scratch
or denaturalization.
2.2.2 Visually inspect the magnetic sensor attachment and the
spacer for EZU-RV2S for any crack, deformation or
denaturalization.
2.2.3 Visually inspect the elasto coupler for any crack,
deformation or denaturalization. If you find any damage, do
not use the elasto coupler.

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3. Operation Procedure
1) Confirm that the probe is cleaned and disinfected.
2) 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.
3) 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.
4) 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 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.
6) Confirm that the magnetic sensor attachment, the spacer for
EZU-RV2S and the elasto coupler are cleaned, disinfected and
sterilized.
Fig. 2 Relationship between the directions
o
f the probe
and the Right-left orientation mark
Right-left
orientation mark
Index mark

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7) After using the magnetic sensor attachment, the spacer for
EZU-RV2S and the elasto coupler, perform the reprocessing
procedure in accordance with the procedure stated in
“5.Reprocessing procedure” every time immediately after completing
the ultrasound examination.
8) Store the probe, the magnetic sensor attachment, the spacer for
EZU-RV2S and the elasto coupler in the environment indicated in
“6.Maintenance and Safety inspection”.

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4. Option of Hitachi ultrasound diagnostic scanner
In case of using RVS (Real-time Virtual Sonography), confirm the type
of the magnetic sensor. There are two types of magnetic sensors for
the EUP-L65, the EZU-RV2S and the EZU-RV3S.
The magnetic sensors EZU-RV2S and EZU-RV3S are shown in Fig. 3 and
Fig. 8.
The use of the EUP-L65 with either one 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 is shown in Fig. 3.
4.1.1 How to attach the Magnetic sensor
The procedure of attaching the magnetic sensor is as follows.
1) Confirm the magnetic sensor attachment and the spacer for
EZU-RV2S are cleaned, disinfected and/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 spacer to the EZU-RV2S.
b) Insert the EZU-RV2S into them sensor attachment with the
correct direction as shown in Fig. 4.
Fig. 3 Magnetic sensor EZU-RV2S
Magnetic sensor (black)
Projected part
Projected part
Fit the insertion
direction
Projected part of
the Magnetic sensor
attac
hm
e
n
t
Fig. 4 How to attach the Magnetic sensor
Spacer for
EZU-RV2S

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c) Place the magnetic sensor attachment on the probe as shown in Fig.
5. 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 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
Projected part of
the Magnetic sensor
attac
hm
e
n
t
Fig. 5 How to attach the Magnetic sensor attachment
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 follows.
1) Push 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 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 from the probe
Push here
Fig. 7 How to release the Magnetic sensor from the Magnetic
CAUTION

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4.2 Magnetic sensor EZU-RV3S
The magnetic sensor EZU-RV3S is shown in Fig. 8.
4.2.1 How to attach the Magnetic sensor
The procedure of attaching the magnetic sensor is as follows:
1) Confirm that the probe and the magnetic sensor attachment
are cleaned, disinfected and/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.
Direction mark of the
Magnetic sensor
Fit the insertion
direction
Projected part of
the Magnetic sensor
attac
hm
e
n
t
Fig. 9 How to attach the Magnetic sensor
Direction mark
Fig. 8 Magnetic sensor EZU-RV3S
Magnetic Sensor
(white)

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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
Projected part of
the Magnetic sensor
attac
hm
e
n
t
Fig. 10 How to attach 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 is as follows.
1) Push the magnetic sensor attachment and release it from the
probe as shown in Fig. 11.
2) Release the magnetic sensor from the magnetic sensor
attachment as shown in Fig. 12.
Fig. 12 How to release the Magnetic sensor
f
rom the Magnetic
sensor attachment
Fig. 11 How to release the Magnetic sensor attachment from
the
p
robe
Push here

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4.3 Elasto Coupler
4.3.1 How to attach the Elasto Coupler
To use elastography, attach the elasto coupler as shown below.
Attach the elasto coupler on the probe as straight as possible
as shown in Fig. 13.
4.3.2 How to release the Elasto Coupler
Release the elasto coupler from the probe as shown in Fig. 14.
Fig. 13 How to attach the Elasto coupler
Fig. 14 How to release the Elasto coupler

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5. Reprocessing Procedure
The probe, magnetic sensor attachment and spacer for EZU-RV2S must
be reprocessed after each use. Refer to the reprocessing instruction
in this chapter.
For reprocessing of the needle guide bracket EZU-PA6L1, the acoustic
coupler EZU-TECPL1 and the acoustic coupler attachment EZU-TEATC1
please refer to the corresponding instruction manuals.
WARNINGS
‐The probe is delivered unsterile. Prior to the
first use, reprocess the probe.
‐Temperature should not exceed 40°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
c
ontainer to transport from Central Sterile Supply
D
epartment (CSSD) to an operating room. Be careful
n
ot to damage the sterile pouch or container during
transportation.