Hitachi EUP-C715 User manual

Convex Array Probe
EUP-C715
INSTRUCTION MANUAL
Tokyo,Japan
Q1E-EP1011-7
© 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,
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, dustproof and dark, dry
place to avoid high temperature, 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 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-C715 ................................... 7
4.1 Magnetic Sensor (EZU-RV2S) ........................................................................................... 7
4.2 Magnetic Sensor (EZU-RV3S) ......................................................................................... 10
5. Cleaning, Disinfection and Sterilization ...................... 13
5.1 Point of use (Pre-cleaning) ....................................................................................... 16
5.2 Containment and transportation ................................................................................ 16
5.3 Manual Cleaning and disinfection ............................................................................ 17
5.4 Drying .................................................................................................................................... 20
5.5 Inspection ........................................................................................................................... 21
5.6 Packaging ............................................................................................................................. 21
5.7 Sterilization ..................................................................................................................... 22
5.8 Storage.................................................................................................................................. 24
6. Maintenance and Safety Inspection ............................. 25
7. Safety Precautions ............................................ 26
8. Specifications ................................................ 27
8.1 Probe ...................................................................................................................................... 27
8.2 Suppliers List................................................................................................................... 28
9. Disposal of the probe ......................................... 28

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1. General
1.1 General
EUP-C715 is a convex array probe.
The acoustic output of EUP-C715 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.
EUP-C715 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
EUP-C715 is designed for observation and diagnosis mainly of the
following regions by connecting with the Hitachi ultrasound
diagnostic scanner.
General abdominal organs
Biopsy (with Needle guide bracket)
Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
1.4 Components
The components of EUP-C715 are given below:
1) Probe EUP-C715 ....................... 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 the probe.
1.5 Option
1) Magnetic Sensor Attachment
2) Spacer for EZU-RV2S
3) Needle Guide Bracket EZU-PA7C1
Please refer to the instruction manual of the needle guide bracket
EZU-PA7C1 about the method of handling, cleaning and sterilizing
the needle guide bracket EZU-PA7C1.
Sterilization has not been made to the magnetic sensor
attachment, the spacer for EZU-RV2S and EZU-PA7C1 shipped from
the factory. Prior to use of them, be sure to clean, disinfect
and if necessary sterilize them following this instruction
manual.
A biopsy should be performed only by a well-trained physician.
WARNING
CAUTION
CAUTION
CAUTION

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1.6 External View
The external view of EUP-C715 is shown in Fig.1.
Immersible part (IP47)
Head
Connector
Cable
Un-immersible part
(IP40)
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 EUP-C715
A
p
plied part

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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 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 immediately.
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 immediately.

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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 if necessary
sterilized.
2) 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.
3) 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.
Fig.2 Relationship between the directions
o
f the probe
and the Right-left orientation mark
Right-left orientation mark
Index mark

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4) 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.
5) Place the probe on the examination site and adjust the probe’s
position for a clear view of the desire image.
6) 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.
7) Store the probe, the magnetic sensor attachment and the spacer
for EZU-RV2S in the environment indicated in “6.Maintenance and Safety
inspection”.

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4. Magnetic Sensor for EUP-C715
There are two types of magnetic sensors for EUP-C715, EZU-RV2S and
EZU-RV3S.
The magnetic sensor (EZU-RV2S) and the magnetic sensor (EZU-RV3S) are
shown in Fig.3 and Fig.8.
The use of EUP-C715 with either one 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) is shown in Fig.3.
4.1.1 How to attach the Magnetic Sensor
The procedure of attaching the magnetic sensor is as follows.
1) Attach the spacer for EZU-RV2S to the magnetic sensor.
2) Insert the magnetic sensor (EZU-RV2S) into the magnetic sensor
attachment with the correct direction as shown in Fig.4.
2)
1)
Magnetic sensor
(EZU-RV2S: black)
Sp
acer for EZU
-
R
V2S
Fit the insertion
direction
Projected part of the
Magnetic sensor
Projected part of
the Magnetic sensor attachment
Sp
acer for EZU
-
R
V2S
Magnetic sensor (EZU-RV2S: black)
Fig.4 How to attach the Magnetic sensor
Fig.3 Magnetic sensor (EZU-RV2S)
Sensor (black)
Projected part

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3) Place the magnetic sensor attachment in the index mark of the
probe.
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.
Fig.5 How to attach the Magnetic sensor attachment
Projected part of the
Magnetic sensor attachment
I
ndex mark
Fit the insertion direction
3)
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 follows.
1) Turn around the magnetic sensor attachment and release it from
the probe as shown in Fig.6.
2) Release the magnetic sensor from the magnetic sensor
attachment as shown in Fig.7 and release the spacer for
EZU-RV2S from the magnetic sensor.
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 they are not sterilized
in the factory.
Fig.7 How to release the Magnetic sensor
Fig.6 How to release Magnetic sensor attachment
CAUTION

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4.2 Magnetic Sensor (EZU-RV3S)
The magnetic sensor (EZU-RV3S) is shown in Fig.8.
4.2.1 How to attach the Magnetic Sensor
The procedure of attaching the magnetic sensor is as follows.
1) Attach the magnetic sensor into the probe with the correct
direction as shown in Fig.9.
Magnetic sensor (EZU-RV3S: White)
Direction mark of the Magnetic
sensor(Place the direction mark
upward as shown here.)
Projected part of
the Magnetic sensor attachment
Fit the insertion direction
Fig.9 How to attach the Magnetic sensor
Fig.8 Magnetic sensor (EZU-RV3S)
Sensor (white)
Direction mark

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2) Place the magnetic sensor attachment on the probe as shown
in Fig.10. 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 in the
incorrect direction, otherwise it may result in false diagnosis.
Fig.10 How to attach the Magnetic sensor attachment
Projected part of the
Magnetic sensor attachment
I
ndex mark
Fit the insertion
d
irection
CAUTION

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

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5. Cleaning, Disinfection and Sterilization
The probe and magnetic sensor attachment with spacer must be
reprocessed after each use. Refer to the reprocessing instruction
in this chapter.
Please refer to the instruction manual of needle guide bracket
EZU-PA7C1 about the method of cleaning, disinfecting and
sterilizing the needle guide bracket EZU-PA7C1.
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-
i
mmersible part should
be disinfected by wipe disinfection.
Transportation
before using
T
he probe should be packed in a sterile pouch or
container to transport from Central Sterile Supply
D
epartment (CSSD) to an operating room. Be careful not
t
o 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-C715 is classified as uncritical.