Hitachi EUP-O732T User manual

0123
Intraoperative Probe
EUP-O732T
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-EP1234-7
© Hitachi, Ltd. 2013,2017. All rights reserved

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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:
Address:
Hitachi Medical Systems Europe Holding AG
Sumpfstrasse 13 CH-6300 Zug, Switzerland
Local
Distributor:

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About this manual
This instruction manual contains safety precautions, the inspection,
the operation procedure and the reprocessing procedure of EUP-O732T.
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 following conventions are used throughout the manual to denote
information of special emphasis.
WARNING: “Warning” indicates the presence of a hazard which may
result in severe personal injury, substantial property
damage, or death if the warning is ignored.
CAUTION: “Caution” indicates the presence of 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/
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 place and keep
away from high temperature, high humidity,
or direct sunlight.
Contains or presence
o
f
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 Compositions········································ 2
1.5 Accessories (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. Option of EUP-O732T ···································· 7
4.1 Magnetic Sensor (EZU-RV2S)·························· 7
4.2 Magnetic Sensor (EZU-RV3S)·························· 9
5. Cleaning and Disinfection and Sterilization ············ 12
5.1 Point of use (Pre-cleaning)························· 15
5.2 Containment and transportation······················ 15
5.3 Manual Cleaning and disinfection···················· 15
5.4 Drying·············································· 18
5.5 Inspection·········································· 18
5.6 Packaging··········································· 18
5.7 Sterilization······································· 18
5.8 Storage············································· 20
6. Maintenance and Safety Inspection ······················ 21
6.1 Daily Inspection···································· 21
6.2 Store··············································· 21
7. Safety Precautions ····································· 22
8. Specifications ········································· 24
8.1 Probe··············································· 24
8.2 Supplier’s List of the Probe························ 25
8.3 Supplier’s List of the Magnetic Sensor
Attachment and the Spacer for EZU-RV2S·············· 25
9. Disposal of the Probe ·································· 26

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WARNING
WARNING
1. Introduction
1.1 Features
The Intraoperative Probe EUP-O732T is a probe for Convex Array
electronic scanning.
The acoustic output of this probe when connected to ultrasound
scanner was measured according to IEC 60601-2-37 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.
Direct contact to the heart.
Biopsy to the heart.
Never use the probe with (HF) surgical equipment.
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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1.3 Intended Use
The Intraoperative Probe EUP-O732T is designed for observation
and diagnosis of the following regions mainly by connecting with
the HITACHI ultrasound scanner.
Intraoperative
Never use the probe for following regions.
1) The heart (Do not contact directly.)
2) The eyeball
1.4 Compositions
Components of the EUP-O732T are as follows:
1) Probe······················ 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 them following this instruction
manual.
1.5 Accessories (Option)
1) Magnetic Sensor Attachment
Magnetic sensor attachment is used for Real-time Virtual
Sonography (RVS). It is used to fix the magnetic sensor to the
probe.
2) Spacer for EZU-RV2S
Spacer for EZU-RV2S is the spacer needed to fix the magnetic sensor
(EZU-RV2S) to the Magnetic sensor attachment.
The Magnetic sensor attachment and the Spacer for EZU-RV2S
are not sterilized when shipped from the factory. Prior to
use, be sure to clean, disinfect and sterilize them.
WARNING
CAUTION
CAUTION

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1.6 External View
The external view of EUP-O732T is shown in Fig.1.
Immersible
part:
This part can be immersed
i
n 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.
Immersible part (IPX
7
)
C
able
Connector
Un-immersible part
Fig.1 External View
Scan
head
Probe
housing
Applied part
Spacer for EZU-RV2S
(Option)
Magnetic sensor
attachment(Option)

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2. Inspection before Use
Prior to use, the probe and accessories must be carefully inspected
so 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. Please refer
to the instruction manual of the Main unit for the operation.
2) Confirm that any unauthorized devices or instruments such as
an unauthorized biopsy attachment is not attached or connected
to the probe.
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 Magnetic sensor attachment and the Spacer
for EZU-RV2S for any crack, deformation or denaturalization.
Beware of the Spacer for EZU-RV2S since it is so small.
CAUTION

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3. Operation Procedure
1) Confirm that the probe, the Magnetic sensor attachment and the
Spacer for EZU-RV2S are cleaned, disinfected and sterilized.
The Magnetic sensor attachment and the Spacer for EZU-RV2S are
needed for Real-time Virtual Sonography (RVS). Regarding the
option for RVS, please refer to “4.Option of EUP-O732T”.
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. Then adjust the image according to the
instructions given in the operation manual for the scanner.
4) The relationship between the direction of the probe and the
right-left orientation mark on image is shown in Fig. 2.
5) Use under sterile condition, protecting
t
he probe by using
covers is recommend. Some Latex material may create
allergic reaction. Please use allergy free material
covers.
Fig. 2 Relationship between direction of the
probe and Right-left orientation Mark
Probe
housing
Cable
H
Ⓗ: Right-left
orientation
mark
Scan head
I
ma
g
e

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6) After the use of the probe, clean and disinfect and sterilize
the probe immediately and using RVS, also clean and disinfect
and sterilize the Magnetic sensor attachment. In case of using
RVS with an EZU-RV2S, also clean and disinfect and sterilize
the Spacer for EZU-RV2S.
7) Store the probe, the Magnetic sensor attachment and the Spacer
for EZU-RV2S in the environment indicated in “6. Maintenance
and Safety Inspection”.
Do not use the probe if the image and the frequency do not match
the probe. An incorrect acoustic output can result in burns or
other injuries to the patient.
Scan for the minimum length of time necessary for the diagnosis
and at the lowest possible output. There is the possibility that
the patient’s tissues could be affected. For details about the
acoustic output, please refer to the operation manual of the
ultrasound diagnostic instrument.
The acoustic lens of the probe is very thin and delicate. So
if the surface of the acoustic lens is wiped for removing
remaining ultrasound jelly or cleaned, use the soft cloth or
tissue paper and handle with care.
CAUTION

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4. Option of EUP-O732T
In case of using RVS (Real-time Virtual Sonography), confirm that
type of the magnetic sensor. There are two types of the magnetic
sensors for EUP-O732T, EZU-RV2S and EZU-RV3S. EZU-RV2S and
EZU-RV3S are shown in Fig.3 and Fig.8. The uses of EUP-O732T with
wither of the 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.3 is the magnetic sensor
(EZU-RV2S) for EUP-O732T.
4.1.1 How to Attach the 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 disinfected and sterilized.
2) Connect the probe to the ultrasound diagnostic scanner and
operate the scanner. Then adjust the image according to the
instructions given in the operation manual for the scanner.
3) To use RVS (Real-time Virtual Sonography), attach the magnetic
sensor as shown below in the out of operative field.
a) Attach the Spacer for EZU-RV2S to Magnetic sensor. Then insert
Magnetic sensor into the Magnetic sensor attachment with the
correct direction as shown in Fig.4.
Fig.3
E
ZU
-
R
V2S
Magnetic sensor
(black)
Projected part
Magnetic sensor
(EZU-RV2S: Black)
Projected part
Magnetic sensor
attachment
Spacer for EZU-RV2S
Projected
part
Fig.4 How to attach the Magnetic sensor

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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 EZU-RV2S, otherwise it may result in false
diagnosis.
b) Attach the Magnetic sensor attachment to the probe as shown
in Fig.5.
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 the Magnetic Sensor
The procedure of releasing the Magnetic sensor is as follow.
1) Detach the Magnetic sensor attachment from the probe as shown
Fig.6 in the out of operative field.
Fig.5 How to attach the Magnetic
sensor attachment
Fig.6 How to release the Magnetic
sensor attachment from the probe
CAUTION
CAUTION

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2) Detach the magnetic sensor and the Spacer for EZU-RV2S from the
Magnetic sensor attachment as shown Fig.7 in the out of
operative field.
Clean, disinfect and sterilize the Magnetic sensor attachment
and the Spacer for EZU-RV2S before the first use as they are
not sterilized in the factory.
4.2 Magnetic Sensor (EZU-RV3S)
Magnetic sensor (EZU-RV3S) as shown in Fig.8 is the magnetic sensor
for EUP-O732T.
4.2.1 How to Attach the Magnetic Sensor EZU-RV3S
The procedure of attaching Magnetic sensor is as follow.
1) Confirm that the Magnetic sensor attachment is disinfected and
sterilized.
2) Connect the probe to the ultrasound diagnostic scanner and
operate the scanner. Then adjust the image according to the
instructions given in the operation manual for the scanner.
3) To use RVS (Real-time Virtual Sonography), attach the magnetic
sensor as shown below in the out of operative field.
Fig.7 How to release magnetic sensor fro
m
the Magnetic sensor attachment
Direction mark
Fig.8 Magnetic sensor (EZU-
R
V3S)
Magnetic Sensor
(EZU-RV3S: white)
CAUTION

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a) Insert Magnetic sensor into the Magnetic sensor attachment
with the correct direction as shown in Fig.9.
Never attach the magnetic sensor attachment to the probe in
the incorrect direction; otherwise it may result in false
diagnosis.
b) 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.
D
irection mark
of EZU-RV3S
Magnetic sensor
(EZU-RV3S: White)
Direction mark
of EZU-RV3S
Magnetic sensor
attachment
Fig.9 How to attach the Magnetic sensor
Fig.10 How to attach the Magnetic
sensor attachment
CAUTION
CAUTION

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4.2.2 How to Release the Magnetic Sensor
The procedure of releasing the Magnetic sensor is as follow.
1) Detach the Magnetic sensor attachment from the probe as shown
Fig.11 in the out of operative field.
2) Detach the magnetic sensor from the Magnetic sensor attachment
as shown Fig.12 in the out of operative field.
Clean, disinfect and sterilize the Magnetic sensor attachment
before the first use as it is not sterilized in the factory.
Fig.11 How to release the Magnetic
sensor attachment from the probe
Fig.12 How to release magnetic sensor from
the Magnetic sensor attachment
CAUTION

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5. Cleaning and Disinfection and Sterilization
The probe and accessory 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 60°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 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.

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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-O732T probe is classified as
critical.

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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
m
anual
cleaning
Manual Disinfection
Drying
Manual cleaning
and disinfection
Rinsing after manual
disinfection
P
acking
S
terilization
Containment and
transportation