Hitachi EUP-LV74 User manual

Linear Array Probe
EUP-LV74
INSTRUCTION MANUAL
Notes for operators and responsible maintenance personnel
Please read through the Instruction Manual carefully prior
to use.
Keep this Instruction Manual for future reference whenever
necessary.
Tokyo , Japan
Q1E-EP1191-6
©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 the procedure for inspection,
operation and reprocessing of the EUP-LV74. The manual also
contains the general information and the specification of the
probe. The probe is usable with the HITACHI ultrasound diagnostic
scanner. About the operation of the HITACHI ultrasound diagnostic
scanner please refer to its instruction manual.
To ensure safe operation, it is essential that you fully understand
the function, operating and maintenance instructions by
thoroughly reading and understanding this manual. Please contact
a service support, if you have any questions concerning the
operation of the probe.
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,
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 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. Introduction ······························································································ 1
1.1 General··························································· 1
1.2 Principles of operation··········································· 1
1.3 Intended Use······················································ 1
1.4 Components List··················································· 1
1.5 Accessories······················································· 2
1.6 External View····················································· 3
2. Inspection procedure ·················································································· 4
3. Operation Procedure ·················································································· 5
4. Reprocessing Procedure ············································································· 6
4.1 Point of use (Pre-cleaning)······································· 9
4.2 Containment and transportation···································· 9
4.3 Manual Cleaning and disinfection·································· 9
4.4 Drying···························································· 12
4.5 Inspection························································ 12
4.6 Storage··························································· 12
5. Daily Inspection (Maintenance) ···································································· 13
6. Safety Precautions ···················································································· 13
7. Specifications··························································································· 14
7.1 Probe····························································· 14
7.2 Suppliers List···················································· 15
8. Disposal of the probe················································································· 16

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1. Introduction
1.1 General
The model EUP-LV74 is a linear array electronic scanning type
probe. The probe is capable of acquiring Real-time 3D image by
mechanical drive of the acoustic elements.
The acoustic output was measured with operating the Hitachi
Ultrasound diagnostic scanner according to the IEC 60601-2-37
standard. The measured acoustic output is listed in the
instruction manual of the Hitachi ultrasound scanner.
The probe is categorized in class IIa according to Directive
93/42/EEC and classified as type BF according to IEC 60601-1.
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-LV74 is designed for observation and diagnosis, mainly
of the following regions.
The EUP-LV74 is operational with only the HITACHI ultrasound
scanner.
Mammary gland
Thyroid
Superficial organs
1.4 Components List
The components of the EUP-LV74 are given below.
1) EUP-LV74..................... 1 piece
2) Instruction Manual........... 1 copy
3) Correct Backlash CD-ROM...... 1 piece

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The CD-ROM contains the probe’s specific parameters to be loaded
to the Hitachi ultrasound diagnostic scanner. Hitachi service
engineer installs the CD-ROM to the scanner. Store the CD-ROM
in a safe place.
1.5 Accessories
1.5.1 Needle Guide Bracket EZU-PA7LV1 (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-PA7LV1 about the
method of handling, cleaning and disinfecting the needle guide
bracket EZU-PA7LV1.
CAUTION

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1.6 External View
The external view of the EUP-LV74 is given in Fig. 1.
Immersible part (IP
X
7
)
Un-
i
mmersible
part
Scan head
H
andle housing
Cable
Connector
Immersible part: This part can be immersed in disinfectant
solutio
n
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.
Fi
g
. 1
E
xternal View
Applied part

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2. Inspection procedure
Prior to each use, the probe must be carefully inspected that
it is appropriate for use.
(1) Visually inspect the surface of the probe head, the housing,
the cable and the connector for any crack, scratch or
denaturalization.
(2) Confirm that neither unauthorized devices nor instruments
such as unauthorized biopsy attachments are attached to the
probe.
(3) Inspect that the ultrasound diagnostic scanner with which the
probe is connected is correctly operating.
If you find any abnormality, do not use the probe, and immediately
contact a service support.

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3. Operation Procedure
(1) Confirm that the probe is cleaned and disinfected.
(2) Cover the probe with a disposal probe cover to protect the
probe. The probe cover should be allergy free material to avoid
allergic reaction. Apply acoustic coupling gel inside and
outside of the probe cover. Acoustic coupling gel is required
as a couplant.
(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 the B-mode image is shown in Fig.
2. The right-left orientation mark on the image indicates the
direction of the index mark on the probe.
(5) Perform the reprocessing
procedure in accordance
with the procedure stated
in “4. Reprocessing
procedure” every time
immediately after
completing the ultrasound
examination.
(6) Store the probe in
accordance with the storage
condition indicated in
“7.Specification”.
Right-left
orientation
mark:
Index
mark
Fig. 2 Relationship between
Index Mark and Right-left
Orientation Mark

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4. Reprocessing Procedure
The probe 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 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-immer
s
ible
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
not to damage the s
t
erile 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
According to the intended use, EUP-LV74 probe is classified as
uncritical.

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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 manual
cleaning
Manual Disinfection
Drying
Manual cleaning and
disinfection
Rinsing after manua
l
disinfection
Containment and
transportation

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4.1 Point of use (Pre-cleaning)
Pre-cleaning should be done immediately after each use.
The procedure is as follows:
1) Remove the probe cover.
2) Clean the probe of all patient’s blood or fluid with running tap
water until the surface of the probe looks visually clean.
3) Wipe the whole surface of the probe with gauze pad and remove
superficial visible impurities.
4.2 Containment and transportation
Putting the contaminated equipment into exclusive
shock and damage proof container for transportation
is recommended. It is recommended that instruments are reprocessed as
soon as possible and not later than 4 hours after usage.
4.3 Manual Cleaning and disinfection
Prepare following items before manual cleaning
and disinfection:
a) Detergent: Cidezyme® (Johnson & Johnson,
#2258) or another cleaning agent with
approved material compatibility for this
medical device.
b) Disinfectant: Cidex® OPA (Johnson &
Johnson, # 20391) or another disinfectant
with approved material compatibility for
this medical device.
c) Two tanks, one for cleaning and one for
disinfection - optional:
1 additional tank for rinsing with
deionized/tap water (sufficient size for
immersion of the submergible part of the
probe at full length)
d) Soft, fluff free cloth or single use towel
e) Personal protective equipment (gloves, water repellent protective
skirt, face protection mask or protective glasses, see also
instructions of the manufacturer for the detergent and the
disinfectant)
Containment and
transportation
Manual Cleaning
R
insing after manual
cleaning
Manual Disinfection
R
insing after manual
disinfection
M
anual cleaning and
disinfection
Point of use
(Pre-cleaning)

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Manual Cleaning:
Prepare the detergent solution in a tank with cold water (please follow
the instructions of the detergent manufacturer regarding application,
dilution and contact time).
1) The temperature of the detergent solution should be between 15-30 °C,
concentration is 1.6%. Please note the minimum contact time of the
detergent in the manufacturer’s instruction. If a differing
detergent is used, please also note the approved material
compatibility for the medical device.
2) Immerse the immersible part of the probe without connector into
the diluted detergent solution (see Fig. 3). Wipe the immersible
part of the probe under the surface of the detergent solution with
a soft cloth to remove all visible soil. Be sure that all grooves
of the probe are implemented during the cleaning process.
3) The immersible part of the probe should be left in the detergent
solution according to the specified contact time of the detergent
manufacturer.
4) Wipe the un-immergible parts of the probe with a soft cloth dipped
with the detergent solution.
5) Rinse the probe with running tap water for 1 minute. (alternatively:
immerse the immersible part of the probe in a tray filled with
deionized water/tap water (see Fig. 3) for 5 min.)
6) Visually check the outer surface of the probe for cleanness. If
necessary, use magnifying glass for visually check. If there is
still soil visible, repeat all above steps.

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Manual disinfection:
1) Prepare the disinfectant solution in a tank with cold water (please
follow the instructions of the disinfectant manufacturer regarding
application, concentration, microbiological efficiency, service
life and contact time).
2) Confirm the concentration of the disinfectant before immersing the
probe. Although Cidex® OPA does not need to be diluted, it is
recommended to use test strips to verify the concentration. The
test strips can indicate whether or not the concentration is above
the Minimum Effective Concentration (MEC). Please also note the
expiration date of the test stripes. Temperature of disinfectant
solution should be minimum 20 °C. The minimum contact time is 5
minutes. If a different disinfectant is used, follow the
manufacturer’s instructions. Please also consider the material
compatibility for the medical device.
3) Immerse the immersible part of the probe into the disinfectant (see
Fig. 3). Set a clock to insure the recommended contact time which
is 5 minutes.
4) Rinse the immersible part of the probe with deionized water for 1
minute. (alternatively: immerse the immersible part of the probe
in a tray filled with deionized water (see Fig. 3) for 5 min.)
5) Visually check the outer surface of the probe for leavings of the
disinfectant. If necessary, repeat the rinsing.
Water,
Detergent,
Disinfectant
Fig. 3 Immersion of the probe

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4.4 Drying
1) Wipe the probe with a single-use, fluff-free wipe or towel to
remove moisture from the surface of the equipment.
2) Dry the probe naturally in an ambient temperature between
15-30°C for a minimum of 4 hours. Alternatively the probe can
be dried using a drying heater at a temperature of less than
40°C.
4.5 Inspection
Inspect the probe for any damage such as crack, scratch or
deformation. Do not use it if any damage is found.
4.6 Storage
Store the probe in a cool, dustproof and dark space to avoid high
temperature, humidity and direct sunlight. Limitations for the
time for sterilized equipment belong to package.
1) Do not sterilize this probe by pressurizing/ depressurizing
sterilization system such as ETO and Plasma system. If you sterilize
the probe by these systems, the membrane that seals the oil bursts
and the probe will not be functional.
2) Do not sterilize this probe by autoclave. If you autoclave the probe,
the probe suffers serious damage and will be not functional.
Drying
WARNING

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CAUTION
5. Daily Inspection (Maintenance)
(1) Visually inspect the surface of the probe head, the
housing, the cable and the connector for any crack,
scratch or denaturalization. If you find damage, do not
use the probe, and immediately contact a service support.
(2) Inspect the functionality of Real-time 3D mode. If you
find abnormalities such as abnormal noise, do not use the
probe, and contact immediately a service support.
6. Safety Precautions
For safe use of the probe, observe strictly all warnings and
cautions listed below.
(1) If you find that the probe head, the housing or cable are
cracked or damaged, do not use the probe, and immediately
contact a service support.
(2) For the patients suspected of having latex allergy, do not
use latex-containing medical devices. Latex may cause
allergic reactions such as itching, rubor, urticaria,
swelling, fever, anhelation, wheezing, depression of blood
pressure, and shock. If your patients shows any of
above-mentioned symptoms, stop using latex-containing
medical devices immediately and provide prompt treatment to
your patients.
(1) Start examination with acoustic power low and set the
acoustic power as low as possible for ultrasound examination
of an early pregnancy and minimize the ultrasound exposure
time.
(2) Disinfect the probe prior to the initial use since the probe
is not delivered disinfected.
(3) Use only detergents and disinfectants listed in “7.2
Suppliers list”.
(4) Use sterile acoustic coupling gel depending on the diagnostic
part. The acoustic coupling gel which is an accessory of
Hitachi Ultrasound diagnostic scanner is non-sterile
acoustic coupling gel.
(5) Do not hit or drop the probe because the inside of the probe
head is easily broken by mechanical shocks.
(6) Do not allow liquid to contact/enter the probe connector,
as the probe connector is not waterproof.
WARNING

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7. Specifications
7.1 Probe
Type: EUP-LV74
Center frequency: 7.5MHz
Technology: Linear phased Array
Dimensions: See Fig. 4
Weight:
A
pprox. 1.1kg (including cable and
connector)
Scanning Width: 38.4mm
Volume sweep angle: 25°
Probe materials: Biocompatible allergy free
materials
Acoustic output: Compliance with IEC 60601-2-37
Applicable ultrasound
diagnostic scanner:
Contact your local HITACHI
distributor for detail.
Classification: MDD classification IIa.
Applicable detergent: Detergent listed in
“7.2 Suppliers list”
Applicable disinfectant: Disinfectant listed in
“7.2 Suppliers list”
Operating condition
Ambient temperature: +10 to +35°C
Contact surface temperature: Max. 42°C (Temperature of
examinee)
Relative humidity: 30 to 85% (Non condensing)
Storage conditions
Temperature: -10 to +55°C
Relative humidity: 10 to 95% (Non condensing)