Hitachi EUP-V53W User manual

TransvaginalProbe
EUP‐V53W
INSTRUCTIONMANUAL
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.
Tokyo,Japan
Q1E‐EP0325‐15

©Hitachi,Ltd.2013,2017.Allrightsreserved.
0123

(1) Q1E-EP0325
Manufacturer:

Hitachi,Ltd.
2‐16‐1,Higashi‐Ueno,Taito‐ku,TOKYO,110‐0015,Japan
+81‐3‐6284‐3668
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:

(2) Q1E-EP0325
About this manual
This instruction manual contains safety precautions, the inspection,
the operation procedure and the reprocessing procedure of EUP-V53W.
Please read this manual thoroughly to ensure the safety operation. If
you have any questions concerning the operation of the probe, please
contact a service support.
The Symbols
The following conventions are used throughout the manual to denote
special emphasis.
WARNING: “Warning” indicates the presence of a hazard which may result
in severe personal injury, substantial
p
roperty damage, or
death if the warning is ignored.
CAUTION: “Caution” indicates the presence
o
f a hazard which will or
can cause minor personal injury or property damage if the
caution is ignored.
NOTICE: “Notice” indicates information of installation, operation,
or maintenance, 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/heal
thcare/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
S
tore the probe in a cool, dustproof and
dark, dry environment to avoid high
temperature and humidity and direct
sunlight.
Contains or
presence of
natural rubber
latex
Contains or presence of natural rubber
latex
Do not
re-sterilize
Do not re-sterilize
Do not reuse Do not reuse

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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. Introduction ················································· 1
1.1. Features ·················································· 1
1.2. Principles of operation ··································· 1
1.3. Intended Use ·············································· 2
1.4. Components ················································ 2
1.5. Accessories (Option) ······································ 2
1.6. Construction ·············································· 4
2. Inspection before Use ········································ 5
2.1. Inspection for Appropriate Connection ····················· 5
2.2. Inspection for Material Surface ··························· 5
3. Operation Procedure ·········································· 6
3.1. Connection and Settings ··································· 6
3.2. Use of Sterile Puncture Adapter (EZU-PA5V) ················ 7
3.3. Display of Needle Guide Line ······························ 8
4. Option of EUP-V53W ··········································· 9
4.1. Magnetic sensor (EZU-RV2S) ································ 9
4.2. Magnetic sensor (EZU-RV3S) ······························· 12
5. Reprocessing Procedure ······································ 15
5.1. Point of use (Pre-cleaning) ······························ 17
5.2. Containment and transportation ··························· 17
5.3. Manual Cleaning and disinfection ························· 17
5.4. Drying ··················································· 20
5.5. Inspection ··············································· 20
5.6. Packaging ················································ 20
5.7. Sterilization ············································ 21
5.8. Storage ·················································· 23
6. Maintenance and Safety Inspection ··························· 23
6.1. Daily Inspection ········································· 23
7. Safety Precautions ·········································· 24
8. Specifications ·············································· 25
8.1. Probe ···················································· 25
8.2. Sterile Puncture Adapter EZU-PA5V ························ 26
8.3. Suppliers List ··········································· 27
9. Disposal of the probe ······································· 27

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1. Introduction
1.1. Features
The transvaginal probe EUP-V53W is Convex Array electronic scanning.
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 operational manual
of each ultrasound scanner. This probe is categorized in class IIa
according to Directive 93/42/EEC.
According to IEC60601-1 the probe is classified as type BF.
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.

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WARNING
CAUTION
CAUTION
1.3. Intended Use
The Transvaginal Probe EUP-V53W is designed for observation and
diagnosis of the following regions mainly by connecting with the HITACHI
ultrasound diagnostic scanner.
General OB/GYN organs
Biopsy (with a Sterile Puncture Adapter)
Transrectal
Never use the probe for following regions.
1) The heart (Do not contact directly.)
2) The eyeball
1.4. Components
Components of EUP-V53W are as follows:
1) Transvaginal Probe EUP-V53W ·· 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
it.
1.5. Accessories (Option)
1.5.1. Sterile Puncture Adapter EZU-PA5V (Disposable)
Attachment for ultrasound guided transvaginal or transrectal
biopsy and aspiration of organs, cyst and tumor. The size of
available needle is 16 to 19G. Application requires special care.
Sterile Puncture Adapter EZU-PA5V is as follows:
Component Model Note
Sterile Puncture Adapter EZU-PA5V 24 pcs
NOTE: If you need Sterile Puncture Adapters, please contact a service
support.
A well-trained physician only should perform a biopsy.

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CAUTION
1.5.2. Mechanical Compression Unit for Elastography EZU-TEMC1 and
balloon set for Elastography EZU-TEBL2
This mechanical compression unit is used for tissue elasticity imaging,
by using the balloon attached to the probe that is connected to a
Hitachi's digital ultrasound scanner system and electronic scanning
ultrasound tomography system.
Please refer to the instruction manual of option about the method of
handling, cleaning and disinfection of EZU-TEMC1 and EZU-TEBL2.
1.5.3. Condom or Protection Sleeve for Single Use (Disposable)
To protect the probe against contamination, use only lubrication
free condom or protective tube sleeve, which is dry type.
Lubrication may cause a deterioration of the probe surface. And
latex rubber may create allergic reactions, use of non-allergic
condom or sleeve is strongly recommended.
Take care for the handling of used condom or protection sleeve.
1.5.4. Magnetic Sensor Attachment
Magnetic sensor attachment is used for Real-time Virtual Sonography
(RVS). By using the attachment, the magnetic sensor is attached to the
probe that is connected to a Hitachi digital ultrasound scanner system
and electronic scanning ultrasound tomography system.
1.5.5. Spacer for EZU-RV2S
Spacer for EZU-RV2S is used for Real-time Virtual Sonography (RVS) with
EZU-RV2S. By using the Spacer, the magnetic sensor for EZU-RV2S is
attached to the magnetic sensor attachment.
Sterilization has not been made to the Magnetic sensor attachment and
the Spacer for EZU-RV2S shipped from the factory. Prior to each use,
be sure to clean, disinfect and if necessary sterilize them following
this instruction manual.

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1.6. Construction
The external view of EUP-V53W 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 cannot be cleaned by water.
Fig. 1 External view
C
able
C
onnector
Un-immersible part
Immersible part (IPX7)
Spacer for EZU-RV2S
(Option)
Magnetic sensor attachment
(Option)
Applied part

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CAUTION
2. Inspection before Use
Prior to use, the probe and accessories must be carefully inspected
that they are appropriate for use. If you find any damage, do not use
them and contact a service support immediately.
2.1. Inspection for Appropriate Connection
1) Confirm that the system is correctly operating. Refer to the
instruction manual for the Main unit.
2) Do not attach or connect unauthorized devices or instruments on the
probe, such as unauthorized biopsy attachments.
3) Confirm that the Sterile Puncture Adapter and software version and
then settings of the scanner are appropriate for the probe. Attach
the Sterile Puncture Adapter on the probe. Set the main unit to
display the “Needle guide line”. (Refer to the operation manual for
the main unit.) Keep the probe head in the water and insert a puncture
needle in the Sterile Puncture Adapter. Then, confirm that the needle
is inserted smoothly and the echo of the needle is displayed on the
dot line “Needle guide line” on the monitor.
2.2. Inspection for Material Surface
1) Visually inspect the surface of the probe head, housing and cable
for any crack, scratch or denaturalization.
2) Visually inspect the envelope of the Sterile Puncture Adapter for
any break, deformation, crack or denaturalization. If you find any
damage, do not use the Sterile Puncture Adapter.
3) Visually inspect the Magnetic sensor attachment and the Spacer for
EZU-RV2S for any crack, deformation or denaturalization.
The Spacer for EZU-RV2S is small, please do not lose the Spacer.

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WARNING
3. Operation Procedure
3.1. Connection and Settings
1) Confirm that the probe is cleaned and disinfected and if necessary
sterilized. In case of using Real-time Virtual Sonography (RVS),
confirm that the Magnetic sensor attachment is cleaned and
disinfected and if necessary sterilized. In case of using RVS with
an EZU-RV2S, confirm that the Spacer for EZU-RV2S is also cleaned
and disinfected and if necessary sterilized.
2) It is recommended to use a disposable probe cover for preventing
a patient from infection and the probe cover should be allergy free
material to avoid allergic reaction.
3) Connect the probe to the ultrasound diagnostic scanner and operate
the scanner and adjust the image according to the instructions given
in the operation manual for the ultrasound diagnostic scanner.
4) Put proper quantity of sterilized
acoustic jelly on the probe head as a
couplant. (See Fig. 2.)
5) Put a probe cover on the probe and draw
the probe cover until the end of the
probe shaft. To avoid air bubbles, be
careful to press the probe cover
gently against probe head and to keep
jelly on the probe head. If air bubbles
appear on the probe head, remove air
bubbles by pushing jelly with finger.
(See Fig. 3 and Fig. 4.)
Be careful with a probe cover made out of latex. Latex may cause
such allergic reactions as itching, rubor, urticaria, swelling,
fever, anhelation, wheezing, and depression of blood pressure,
shock and so on.
If your patient shows any of above mentioned symptoms during
t
he
operation, stop the use of prot
e
ctive sleeve immediately and take
an appropriate treatment to the patient.
S
terilized acoustic jelly
Fig. 2
P
robe cover
A
ir bubble
Sterilized
acoustic jelly
F
ig. 3
Fig. 4

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6) Fix jelly on the top of the probe with
sterile adhesive tape. (See Fig. 5.)
7) Insert the probe gentry and adjust the probe’s position for a clear
view of the desired image. By turning or tilting the probe, a “turn
around” imaging is possible. If the image is unsufficient, use
sterile saline solution. This solution improves the contact between
probe and organ.
8) After using the probe, clean, disinfect and if necessary sterilize
the probe immediately and using RVS, also clean, disinfect and
sterilize the Magnetic sensor attachment. In case of using RVS with
an EZU-RV2S, also clean, disinfect and sterilize the Spacer for
EZU-RV2S.
9) Store the probe, the Magnetic sensor attachment and the Spacer for
EZU-RV2S in the environment indicated in “6. Maintenance and Safety
Inspection”.
3.2. Use of Sterile Puncture Adapter (EZU-PA5V)
The process of attaching the Sterile Puncture Adapter (EZU-PA5V) to
the probe is as follows. If the Sterile Puncture Adapter is used, careful
handling is necessary to avoid damage of the probe cover. During open
or minimal invasive surgery, use the protection sleeve to cover probe
and cable.
1) Attach a sterile probe cover to the probe. (See “3.1 Connection and
Settings”)
2) Put the picks of the Sterile
Puncture Adapter to the
grooves on the tip of the
probe. (See Fig. 6.)
3) Push the other end of the
Sterile Puncture Adapter until
fix the dents of the Sterile
Puncture Adapter to the
projection on the probe. (See
Fig. 7.)
Sterilized tape
F
ig. 5
Sterile Puncture Adapter
(EZU-PA5V)
P
robe cover
F
ig.
6
Fig. 7

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CAUTION
3.3. Display of Needle Guide Line
When puncture is to be conducted, the needle guideline can be displayed
by dot marks. Operation procedure for displaying the needle guideline
on the main unit must be referred to the part of “Needle guide line”
in the manual of the connected ultrasound scanner.
NOTE: The needle guide line will be displayed to provide a visual guide
to the direction of the puncture needle pathway. Be sure to check
the actual location of the needle on the ultrasound image when
performing the puncture operation.
The needle guide line can be displayed with this probe; however, some
image display may not be appropriate for puncture procedure according
to the location of observation field-of-view.
Use observation field-of-view that is appropriately according to the
location of puncture.

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4. Option of EUP-V53W
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-V53W, EZU-RV2S and
EZU-RV3S. EZU-RV2S and EZU-RV3S are shown in Fig.8 and Fig.13. The use
of EUP-V53W with both magnetic sensors enables the user to perform RVS
(Real-time Virtual Sonography).
4.1. Magnetic sensor (EZU-RV2S)
Magnetic sensor (EZU-RV2S) as shown in Fig. 8 is the magnetic sensor
(EZU-RV2S) for EUP-V53W.
4.1.1. How to attach magnetic sensor
The procedure of attaching magnetic sensor is as follow.
1) Confirm that the magnetic sensor attachment and the Spacer for
EZU-RV2S are cleaned, disinfected and 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.
8
E
ZU
-
R
V2S
Magnetic sensor
(black)
Projected part

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CAUTION
a) Attach the Spacer for
EZU-RV2S to Magnetic
sensor.
b) Insert Magnetic sensor
into the Magnetic
sensor attachment with
the correct direction
as shown in Fig. 9.
1) Never attach the magnetic sensor attachment to the probe in the
incorrect direction, otherwise it may result in false diagnosis.
2) Never forget to attach the Spacer for EZU-RV2S when using RVS with
magnetic sensor, otherwise it may result in false diagnosis.
a
)
Projected
part
Spacer for
EZU-RV2S
b
)
Fig. 9 How to attach the Magnetic sensor
P
rojected
part
Magnetic sensor
attachment
S
pacer
Magnetic sensor
(EZU-RV2S: Black)

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CAUTION
CAUTION
c) Attach the Magnetic sensor attachment to the probe as shown in Fig.10.
Do not put your fingers between the Magnetic Sensor Attachment and the
Probe when attaching the Magnetic sensor attachment to the probe.
4.1.2. How to release Magnetic sensor
The procedure of releasing Magnetic sensor is as follow.
1) Detach the Magnetic sensor attachment from the probe as shown Fig.11.
2) Detach the magnetic sensor and the Spacer for EZU-RV2S from the
Magnetic sensor attachment as shown Fig. 12.
Clean, disinfect and sterilize the Magnetic sensor attachment and the
Spacer for EZU-RV2S before the first use as there are not sterilized
in the factory.
Fig.10 How to attach the Magnetic sensor attachment
Fig.11
H
ow to release the Magnetic
sensor attachment from the probe
Fig. 12 How to release
m
agnetic sensor
from the Magnetic sensor attachment

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CAUTION
4.2. Magnetic sensor (EZU-RV3S)
Magnetic sensor as shown in Fig. 13 is the magnetic sensor for EUP-V53W.
4.2.1. How to attach Magnetic sensor
The procedure of attaching Magnetic sensor is as follow.
1) Confirm that the Magnetic sensor attachment is cleaned, disinfected
and 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) Insert Magnetic sensor into the Magnetic sensor attachment with
the correct direction as shown in Fig. 14.
Never attach the magnetic sensor attachment to the probe in the incorrect
direction, otherwise it may result in false diagnosis.
Direction mark
F
ig. 13
M
agnetic sensor (
E
ZU
-
R
V3S)
Magnetic Sensor
(EZU-RV3S: white)
Fig. 14 How to attach the Magnetic sensor
Direction mark of
EZU-RV3S
Magnetic sensor attachment
Magnetic sensor
(EZU-RV3S)

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CAUTION
b) Attach the Magnetic sensor attachment to the probe as shown in
Fig.15.
Do not put your fingers between the Magnetic sensor attachment and the
probe when attaching the Magnetic sensor attachment to the probe.
Fig.15 How to attach the Magnetic sensor attachment

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CAUTION
4.2.2. How to release Magnetic sensor
The procedure of releasing Magnetic sensor is as follow.
1) Detach the Magnetic sensor attachment from the probe as shown Fig.16.
2) Detach the magnetic sensor and the Spacer for EZU-RV3S from the
Magnetic sensor attachment as shown Fig. 17.
Clean, disinfect and sterilize the Magnetic sensor attachment before
the first use as there are not sterilized in the factory.
Fig.16 How to release the Magnetic
sensor attachment from the probe
Fig. 17 How to release
m
agnetic sensor
from the Magnetic sensor attachment