Hitachi EUP-C532 User manual

Convex Array Probe
EUP-C532
INSTRUCTION MANUAL
Q1E-EP0416-8
© 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 contains safety precautions, the inspection, the
operation procedure, and the reprocessing procedure of EUP-C532.
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
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 place and keep away from
high temperature, high humidity, or 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 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-C532 ··································· 7
4.1 Magnetic Sensor (EZU-RV2S) ··········································7
4.2 Magnetic Sensor (EZU-RV3S) ·········································13
5. Reprocessing Procedure ········································ 18
5.1 Point of use (Pre-cleaning) ········································21
5.2 Containment and transportation ·····································21
5.3 Manual Cleaning and disinfection ···································21
5.4 Drying ·····························································24
5.5 Inspection ·························································25
5.6 Packaging ··························································25
5.7 Sterilization ······················································25
5.8 Storage ····························································27
6. Maintenance and Safety Inspection ····························· 28
7. Safety Precautions ············································ 29
8. Specifications ················································ 30
8.1 Probe ······························································30
8.2 Suppliers List ·····················································31
9. Disposal of the probe ········································· 32

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1. General
1.1 General
The EUP-C532 is a Convex Array Probe.
The acoustic output of the EUP-C532 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-C532 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.

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1.3 Intended Use
The EUP-C532 is designed for observation and diagnosis mainly
of the following regions by connecting with the Hitachi
ultrasound diagnostic scanner.
Neonatal
Pediatrics
Intra-operative
Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
1.4 Components
The components of the EUP-C532 are given below:
1) Probe EUP-C532....................... 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 if necessary sterilize the probe.
1.5 Option
1) Magnetic Sensor Attachment
2) Spacer for EZU-RV2S
3) Needle Guide Bracket EZU-PA532
Please refer to the instruction manual of EZU-PA532 for its
handling and reprocessing.
Sterilization has not been made to the Magnetic sensor attachment
and the EZU-PA532 shipped from the factory.
Prior to use them, be sure to clean, disinfect, and if
necessary sterilize them.
WARNING
CAUTION
CAUTION

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1.6 External View
The external view of the EUP-C532 is shown in Fig.1.
Immersible part (IPX7)
Head
C
onnector
Cable
U
n
-
i
mmersible part
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-C532
Magnetic sensor
attachment (with needle
guide bracket)
(Option)
Applied part

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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
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 for Material Surface
2.2.1 Visually inspect the surface of the probe and head, housing,
the cable and the connector for any crack, scratch or
denaturalization. If you find any damage, do not use the probe
and 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.
The Spacer for EZU-RV2S is small, please do not lose the Spacer.
CAUTION

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3. Operation Procedure
1) Confirm that the probe, the Magnetic sensor attachment, and the
Spacer for EZU-RV2S are disinfected and if necessary sterilized.
2) Attach the attachment to the probe according to the chapter 4.
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 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
o
f the probe
and the Right-left orientation mark

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CAUTION
5) 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.
6) Place the probe on the examination site and adjust the probe’s
position for a clear view of the desired image.
7) After using the probe, the Magnetic sensor attachment and the
Spacer for EZU-RV2S, perform the reprocessing procedure in
accordance with the procedure stated in “5. Reprocessing procedure”
every time immediately after completing the ultrasound
examination.
8) 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 suitable 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.

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4. Magnetic Sensor for EUP-C532
There are two types of magnetic sensors for the EUP-C532, the EZU-RV2S
and the EZU-RV3S.
The Magnetic sensor (EZU-RV2S) and the Magnetic sensor(EZU-RV3S) are
shown in Fig.3 and Fig.9.
The use of the EUP-C532 with either 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) as shown in Fig.3 is a magnetic
sensor for the EUP-C532.
4.1.1 How to attach the Magnetic Sensor
The Procedure of attaching the Magnetic sensor is as follows.
1) Confirm that the probe, the Magnetic sensor attachment and
the Spacer for EZU-RV2S are disinfected and if necessary
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 Real-time Virtual Sonography (RVS), attach the
Magnetic sensor as written in the next page.
Fig.3 Magnetic sensor (EZU-RV2S)
Magnetic sensor (black)
Projected part

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a) The Magnetic sensor attachment comes in two different types whether
or not to use the Needle guide bracket. Select one of the following
attachments.
b) Insert the magnetic sensor into the Magnetic sensor attachment with
correct direction as shown in Fig.5.
Use with the Needle guide bracket
Projected part of the
Magnetic sensor
Use without the Needle guide bracket
Slit of the Magnetic sensor attachment
Fig.5 How to attach the magnetic sensor
Magnetic sensor
attachment
Magnetic
sensor
Fit the insertion direction
Spacer for EZU-RV2S
Projected part of the magnetic
sensor attachment
Fit the insertion direction
Projected part of the
Magnetic sensor
Magnetic sensor
attachment
Spacer for EZU-RV2S
Magnetic
sensor
Use without the Needle guide bracket Use with the Needle guide bracket
“☆EUP-C532” indication “☆EUP-C532+GUIDE” indication
Fig.4 Selection of the Magnetic sensor attachment

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c) Attach the Magnetic sensor attachment to the probe with the correct
direction as shown in Fig.6.
Use with the Needle Guide Bracket
Use without the Needle Guide Bracket
Fig.6 How to attach the Magnetic sensor attachment
Index mark
Fit the insertion
direction
Slit of the
Magnetic sensor
attachment
Needle guide bracket
Projected part of
the Magnetic sensor
attachment
Fit the insertion
direction

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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.
CAUTION

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4.1.2 How to release the Magnetic Sensor
The procedure of releasing the Magnetic sensor from the probe
is as follow.
a) Push the Magnetic sensor attachment and release it from the probe
as shown in Fig.7.
Use without the Needle Guide Bracket Use with the Needle Guide Bracket
Push here Push here
Fig.7 How to release the Magnetic Sensor Attachment

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b) Release the Magnetic sensor from the Magnetic sensor attachment as
shown in Fig.8.
The Spacer for EZU-RV2S is small, please do not lose the spacer.
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.
Use without the Needle guide bracket Use with the Needle guide bracket
Fig.8 How to release the magnetic sensor
CAUTION
CAUTION

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4.2 Magnetic Sensor (EZU-RV3S)
The Magnetic sensor (EZU-RV3S) as shown in Fig.9 is also
applicable for the EUP-C532.
4.2.1 How to attach the EZU-RV3S
The procedure of attaching the Magnetic sensor is as follows.
a) The Magnetic sensor attachment comes in two different types whether
or not to use the Needle guide bracket. Select on of the following
attachment.
Direction mark
Fig.9 Magnetic sensor (EZU-RV3S)
Magnetic Sensor
(white)
Use without the Needle guide bracket Use with the Needle guide bracket
“☆EUP-C532” indication “☆EUP-C532+GUIDE” indication
Fig.10 Selection of the Magnetic sensor attachment

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b) Insert the magnetic sensor into the Magnetic sensor attachment with
correct direction as shown in Fig.11.
Never attach the Magnetic sensor attachment to the probe in the
incorrect direction, otherwise it may result in false diagnosis.
Projected part of the Magnetic sensor attachment
Magnetic sensor Direction mark of the Magnetic sensor
(Place the direction mark upward as shown
here.)
Fit the insertion direction
Magnetic sensor
attachment
Slit of the Magnetic sensor attachment
Magnetic sensor Direction mark of the Magnetic sensor
(Place the direction mark upward as shown
here.)
Fit the insertion direction
Magnetic sensor
attachment
Use without the Needle guide bracket
Use with the Needle guide bracket
Fig.11 How to attach the
M
a
gnetic sensor
CAUTION