Hitachi EUP-L74M User manual

Linear Array Probe
EUP-L74M
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1041-7
© 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, dark and dry
place and keep away from high
temperature, high 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
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 ........................................................1
1.4 Components ..........................................................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. Magnetic Sensor for EUP-L74M ................................... 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 ......................................... 28

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1. General
1.1 General
The EUP-L74M is a Linear Array Probe.
The acoustic output of the EUP-L74M 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-L74M 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-L74M is designed for observation and diagnosis mainly
of the following regions by connecting with the Hitachi
ultrasound diagnostic scanner.
Mammary gland
Thyroid
Superficial organs

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Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
1.4 Components
The components of the EUP-L74M are given below:
1) Probe EUP-L74M ........................ 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) Magnetic Sensor Attachment (part number: 7349294A)
2) Spacer for EZU-RV2S
3) Elasto Coupler (part number: 7226530A)
4) Needle Guide Bracket EZU-PA7L2
Please refer to the instruction manual of EZU-PA7L2 about the
method of handling, cleaning and sterilizing the EZU-PA7L2.
Sterilization has not been made to the magnetic sensor attachment,
the spacer for EZU-RV2S, the elasto coupler and the EZU-PA7L2
shipped from the factory.
Prior to use of them, be sure to clean, disinfect and
sterilize them.
WARNING
CAUTION
CAUTION

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1.6 External View
The external view of the EUP-L74M is shown in Fig. 1.
Immersible part (IP
X
7
)
Head
Connector
Cable
Un-immersible part
Elasto coupler
(Option)
Magnetic sensor
attachment
（Option）
Spacer for
EZU-RV2S
(Option)
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-L74M
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 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 or instruments
on the probe, such as unauthorized biopsy attachments.
2.2 Inspection of material surface
2.2.1 Visually inspect the surface of the probe head, housing, the
cable and the connector for any crack, scratch or
denaturalization. If you find any damage, do not use the probe,
and immediately contact a service support.
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.
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 and contact a service support
immediately.

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3. Operation Procedure
1) Confirm that the probe, the magnetic sensor attachment, the spacer
for EZU-RV2S and the elasto coupler are cleaned, disinfected or
sterilized.
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.
R
ight
-
l
eft orientation mark
Index mark
Fig. 2 Relationship between the directions of the probe
and the Right-left orientation mark

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4) Use a sterile probe cover to protect the probe.
The probe cover should be allergy free material to avoid allergic
reaction. Between the probe and the probe cover, acoustic coupling
gel is required as a couplant.
5) Place the probe on the examination site and adjust the probe’s
position for a clear view of the desire image.
6) 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.
7) Store the probe in the environment indicated in “6.Maintenance and
Safety inspection”.

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4. Magnetic Sensor for EUP-L74M
There are two types of magnetic sensors for the EUP-L74M, the EZU-RV2S
and the EZU-RV3S.
The magnetic sensors EZU-RV2S and EZU-RV3S are shown in Fig. 3and Fig.
7.
The use of the EUP-L74M 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.
Fig. 3 Magnetic sensor EZU-RV2S
Sensor (black)
Projected part

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4.1.1 How to attach the Magnetic sensor
The procedure of attaching the magnetic sensor is as follows.
1) Attach the spacer for EZU-RV2S to the magnetic sensor.
2) Insert the magnetic sensor into the magnetic sensor attachment
with the correct direction as shown in Fig. 4.
3) Place the magnetic sensor attachment in the index mark of the
probe.
2)
1)
Magnetic sensor
(EZU-RV2S: Black)
Spacer for EZU-RV2S
Fit the insertion
direction
Projected part of the
EZU-RV2S
Projected part of
the Magnetic sensor attachment
Spacer for EZU-RV2S
Magnetic sensor (EZU-RV2S: Black)
Fig. 4 How to attach the Magnetic sensor attachment
Projected part of the
Magnetic sensor attachment
I
ndex mark
Fit the insertion direction
3)

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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.
4.1.2 How to release the Magnetic sensor
The procedure of releasing the magnetic sensor from the probe
is as follows.
1) Turn around the magnetic sensor attachment and release it
from the probe as shown in Fig. 5.
2) Release the magnetic sensor from the magnetic sensor
attachment as shown in Fig. 6 and release the spacer from
the magnetic sensor.
Fig. 6 How to release the Magnetic sensor
f
rom the Magnetic
sensor attachment
Fig. 5 How to release Magnetic sensor attachment from the probe
CAUTION

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The spacer for EZU-RV2S is small, please do not lose the spacer.
4.2 Magnetic sensor EZU-RV3S
The EZU-RV3S is shown in Fig. 7.
4.2.1 How to attach the Magnetic sensor
The procedure of attaching the magnetic sensor is as follows.
1) Attach the magnetic sensor into the probe with the correct
direction as shown in Fig. 8.
2) Place the magnetic sensor attachment on the probe as shown
in Fig. 9. Fit the projected part of the magnetic sensor
attachment in the index mark of the probe.
Magnetic sensor (EZU-RV3S: White)
Direction mark of the EZU-RV3S
(Place the direction mark upward as
shown here.)
Projected part of
the Magnetic sensor attachment
Fit the insertion direction
Fig. 8 How to attach the Magnetic sensor attachment
1)
Fig. 7 Magnetic sensor EZU-RV3S
Sensor (white)
Direction mark
CAUTION

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Never attach the magnetic sensor attachment to the probe in the
incorrect direction, otherwise it may result in false diagnosis.
Fig. 9 How to attach the Magnetic sensor attachment
Projected part of the
Magnetic sensor attachment
I
ndex mark
Fit the insertion
d
irection
2)
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 follows.
1) Turn around the magnetic sensor attachment and release it from
the probe as shown in Fig. 10.
2) Release the magnetic sensor from the magnetic sensor
attachment as shown in Fig. 11.
Fig. 11 How to release the Magnetic sensor from
the Magnetic sensor attachment
Fig. 10 How to release the Magnetic sensor attachment fro
m
the probe

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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. 12.
4.3.2 How to release the Elasto Coupler
Release the elasto coupler from the probe as shown in Fig. 13.
Elasto coupler
Fig. 12 How to attach the Elasto coupler
Fig. 13 How to release the Elasto coupler
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.
Please refer to the instruction manual of option EZU-PA7L2 about the
method of handling, cleaning and sterilizing the EZU-PA7L2
WARNINGS
‐The probe is de
l
ivered 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
Department (CSSD) to an operating room. Be careful not
to damage the sterile pouch or container during
transportation.