Hitachi EUP-L75 User manual

Linear Array Probe
EUP-L75
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1199-9
© 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,
and 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, dry and dark
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.............................................................. 2
1.4 Composition............................................................... 2
1.5 Accessories............................................................... 3
1.6 External View............................................................. 4
2. Inspection before Use............................................. 5
2.1 Inspection of appropriate connection...................................... 5
2.2 Inspection of material surface............................................ 5
3. Operation Procedure............................................... 6
4. Option of EUP-L75................................................ 10
4.1 Magnetic sensor (EZU-RV2S)............................................... 10
4.2 Magnetic sensor (EZU-RV3S)............................................... 13
4.3 elasto coupler........................................................... 16
5. Reprocessing Procedure........................................... 17
5.1 Point of use (Pre-cleaning).............................................. 20
5.2 Containment and transportation........................................... 20
5.3 Manual Cleaning and disinfection......................................... 20
5.4 Drying................................................................... 24
5.5 Inspection............................................................... 24
5.6 Packaging................................................................ 24
5.7 Sterilization............................................................ 24
5.8 Storage.................................................................. 26
6. Maintenance and Safety Inspection................................ 27
7. Safety Precautions............................................... 28
8. Specifications................................................... 29
8.1 Probe.................................................................... 29
8.2 Suppliers List........................................................... 30
9. Disposal of the probe............................................ 31

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1. General
1.1 General
The probe of model EUP-L75 is a Linear Array 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 IEC 60601-1 the probe is classified as type BF.
Never use the probe for following applications.
1) Direct contact to the heart.
2) Biopsy to the heart.
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.
WARNING

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1.3 Intended Use
The Linear Array Probe EUP-L75 is designed for observation and
diagnosis mainly of the following regions by connecting with the
HITACHI ultrasound scanner.
Mammary gland
Thyroid
Superficial organs
1.4 Composition
The probe components of the EUP-L75 are as follows:
1) Probe EUP-L75 .......................... 1 piece
2) Instruction Manual ..................... 1 copy
Sterilization has not been made to the probe, the magnetic sensor
attachment, the spacer for RV2S and the elasto coupler shipped from
the factory.
Prior to use, be sure to clean, disinfect and sterilize them.
CAUTION

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1.5 Accessories
1.5.1 Magnetic Sensor Attachment (part number:7347816A)(Option)
1.5.2 Spacer for RV2S (Option)
1.5.3 elasto Coupler for EUP-L75 (part number:7230413A)(Option)
1.5.4 Needle Guide Bracket EZU-PA7L3 (Option)
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-PA7L3 about the
method of handling, cleaning and disinfecting the needle guide
bracket EZU-PA7L3.
1.5.5 Acoustic coupler attachment EZU-TEATC2 (Option)
1) Cover................................ 1 piece
2) Base................................. 1 piece
3) Instruction manual................... 1 copy
Acoustic coupler attachment EZU-TEATC2 fixes the acoustic coupler
(EZU-TECPL1 or SF-001) to the probe.
The SF-001 and EZU-TECPL1 are intended to be used for having a
clear superficial image by keeping a certain distance between the
probe and the skin.EZU-TECPL1 is used when the operator compares
the tissue elasticity of the living body with the Acoustic
coupler’s one.
Please refer to the instruction manual of EZU-TEATC2 about the
method of handling and cleaning EZU-TEATC2, EZU-TECPL1 and
SF-001.
A biopsy should be performed only by a well-trained physician.
CAUTION

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1.6 External View
Un-immersible part
Immersible part (IPX7)
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 can not
b
e
c
leaned by water.
Head
Connector
C
able
elasto coupler for EUP-L75 (Option)
Spacer for EZU-RV2S (Option)
Magnetic sensor attachment
for EUP-L75 (Option)
Applied part
Acoustic coupler
attachment EZU-TEATC2
(Option)
Acoustic coupler
EZU-TECPL1 (Option)
or
Acoustic coupler
SF-001 (Option)

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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 nor instruments
on the probe, such as unauthorized biopsy attachments.
2.2 Inspection of material surface
2.2.1 Visually check the surface of the probe head, housing and cable
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 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 RV2S and the elasto coupler are cleaned, disinfected and/or
sterilized.
2) It is recommended to use a disposable probe cover for preventing
a patient from infection.
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) Relationship between direction of the probe and the image is shown
in Fig. 2. The right-left orientation mark on the image indicates
the index mark on the probe.
Fig. 2 Relationship between direction of the probe and
Right-left orientation Mark
Index Mark
Right-Left orientation mark

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5) Marking Assist as shown in Fig. 3 is the function to help marking
the surface of the body.
6) Use 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 the use of the probe, the magnetic sensor attachment, the
spacer for RV2S and the elasto coupler, it should be cleaned and
disinfected or sterilized, then store it in an adequate place.
8) Store the probe, the magnetic sensor attachment, the spacer for
RV2S and the elasto coupler in the environment indicated in
“6.Maintenance and Safety inspection”.
Marking Assist
Fig. 3 Marking Assist

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The Marking Assist is intended to be used to mark. The scale of Marking
Assist does not correspond to the display scale and the width of
the probe does not correspond to the image width displayed in the
image (see the Figure below).
Display scale
The scale of
the Marking Assist
Not corres
p
ond
The width of the
probe does not
correspond to the
image width.
CAUTION

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Caution in case of wiping off the ultrasound jelly or cleaning the
surface of the acoustic lens.
The acoustic lens of the probe is manufactured very thin and
delicate to get the high resolution. Therefore, in case of wiping
off the ultrasound jelly or cleaning the surface of the acoustic
lens, please use a soft cloth or tissue paper and handle with care.
(See Fig. 4)
Soft cloth or tissue
Acoustic lens
Fig. 4 Wiping off the u
l
trasound jelly or cleaning the
surface of the acoustic lens
CAUTION

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4. Option of EUP-L75
In case of using RVS (Real-time Virtual Sonography), confirm the type
of the magnetic sensor. There are two types of the magnetic sensors
for EUP-L75, EZU-RV2S and EZU-RV3S.
EZU-RV2S and EZU-RV3S are shown in Fig. 5 and Fig. 10.
The use of the EUP-L75 with either one of the magnetic sensors enables
the user to perform RVS (Real-time Virtual Sonography).
4.1 Magnetic sensor (EZU-RV2S)
Magnetic sensor (EZU-RV2S) for EUP-L75 is shown in Fig. 5.
4.1.1 How to attach the magnetic sensor (EZU-RV2S)
The procedure of attaching the magnetic sensor (EZU-RV2S) 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 RVS (Real-time Virtual Sonography), attach the
magnetic sensor as shown below.
Fig. 5 Magnetic sensor (EZU-RV2S)
Magnetic sensor
(
E
ZU
-
R
V2S: black)
Projected part

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a) Attach the spacer for RV2S to the magnetic sensor.
b) Insert the magnetic sensor into the magnetic sensor attachment at
the correct direction as shown in Fig. 6.
c) Place the magnetic sensor attachment on the probe as shown in Fig. 7.
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 at the
incorrect direction, otherwise it may result false diagnosis.
Never forget to attach the spacer for RV2S to the magnetic sensor,
otherwise it may result in false diagnosis.
Projected part of the
magnetic sensor attachment
Spacer for
E
ZU
-
R
V2S
Projected part of
the magnetic sensor
Magnetic sensor
(EZU-RV2S)
Fig. 6 How to attach the Magnetic sensor
Fit the insertion
direction
Magnetic sensor
(EZU-RV2S)
I
ndex mark
Projected part of the
magnetic sensor attachment
Fig. 7 How to attach the Magnetic sensor attachment
Fit the insertion
direction
CAUTION

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4.1.2 How to release the Magnetic sensor
The procedure of releasing the magnetic sensor is as follows.
1) Turn around the magnetic sensor attachment and remove it
from the probe as shown in Fig. 8.
2) Release the magnetic sensor from the magnetic sensor
attachment as shown in Fig. 9 and release the spacer for
RV2S from the magnetic sensor.
The spacer for RV2S is small, please do not lose it.
Fig. 8
H
ow to release the Magnetic sensor attachment
from the probe
Fig. 9 How to release the EZU-RV2S from the Magnetic
sensor attachment
CAUTION

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4.2 Magnetic sensor (EZU-RV3S)
Magnetic sensor for EUP-L75 is shown in Fig. 10.
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 RVS (Real-time Virtual Sonography), attach the
magnetic sensor as shown below.
Direction mark
Fig. 10 Magnetic sensor (EZU-
R
V3S)
Magnetic Sensor
(
E
ZU
-
R
V3S: white)

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a) Attach the Magnetic sensor into the probe at the correct direction
as shown in Fig. 11.
b) Place the magnetic sensor attachment on the probe as shown in Fig. 12. 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 at the
incorrect direction, otherwise it may result in false diagnosis.
I
ndex mark
Projected part of the
Magnetic sensor attachment
Fig. 12 How to attach the Magnetic sensor attachment
Fit the insertion
direction
Fig. 11 How to attach the Magnetic sensor
Projected part of the
Magnetic sensor attachment.
D
irection mark of the
Magnetic sensor
Fit the insertion
direction
CAUTION