Hitachi EUP-C514 User manual

ConvexArrayProbe
EUP‐C514
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‐EP0428‐10

©Hitachi,Ltd.2013,2017.Allrightsreserved.
0123

(1) Q1E-EP0428
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:

(2) Q1E-EP0428
About this manual
This instruction manual shall provide instructions for using, cleaning,
disinfecting and/or sterilizing the HITACHI ultrasound probe. 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.

(3) Q1E-EP0428
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
S
tore the probe in a cool, dustproof and
dark, dry place to avoid high
temperature, humidity and direct
sunlight.

(4) Q1E-EP0428
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 1.7.
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.

(5) Q1E-EP0428
CONTENTS
Page
1. General ................................................... 1
1.1. General ..........................................................1
1.2. Principles of operation ..........................................1
1.3. Intended Use .....................................................2
1.4. Composition ......................................................2
1.5. Option ...........................................................3
1.6. Option of Hitachi ultrasound diagnostic scanner ..................3
1.7. External View ....................................................4
2. Inspection before Use ..................................... 5
2.1. Inspection for Appropriate Connection ............................5
2.2. Inspection for Material Surface ..................................5
3. Operation Procedure ....................................... 6
4. Option of Hitachi ultrasound diagnostic sensor ............ 7
4.1. Magnetic Sensor (EZU-RV2S) .......................................7
4.2. Magnetic Sensor (EZU-RV3S) ......................................10
5. Reprocessing Procedure ................................... 13
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
7. Safety Precautions ....................................... 22
8. Specification ............................................ 23
8.1. Probe ...........................................................23
8.2. Suppliers List ..................................................24
9. Disposal of the probe .................................... 24

-1- Q1E-EP0428
1. General
1.1. General
The EUP-C514 is a convex array probe.
The acoustic output of the EUP-C514 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-C514 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.

-2- Q1E-EP0428
WARNING
CAUTION
1.3. Intended Use
The EUP-C514 is designed for observation and diagnosis mainly of the
following regions by connecting with the Hitachi ultrasound diagnostic
scanner.
General abdominal organs
General OB/GYN organs
Biopsy (with Biopsy Attachment)
Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
1.4. Composition
The components of the EUP-C514 are given follows:
1) Probe EUP-C514 ··············· 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 and sterilize the probe.

-3- Q1E-EP0428
CAUTION
1.5. Option
1.5.1. Biopsy Attachment EZU-PA34T
The biopsy attachment EZU-PA34T is a dedicated tool for use as mounted
on a EUP-C514. The optional biopsy attachment EZU-PA34T components are
as follows:
1) Biopsy guide assembly ········ 1 piece
2) Needle guide
(14G, 18G and 21G) ··········· 1 each
3) Brush ························ 1 piece
4) Instruction manual ··········· 1 copy
5) Biopsy case ·················· 1 piece
Please refer to the instruction manual of option about the method of
handling, cleaning and sterilizing the biopsy attachment EZU-PA34T.
1.5.2. Needle Guide Bracket EZU-PA5C1
1) Needle guide bracket ········· 1 piece
2) Brush ························ 1 piece
3) Spring (Spare) ··············· 2 pieces
4) Instruction manual ··········· 1 copy
5) Biopsy case ·················· 1 piece
Please refer to the instruction manual of option about the method of
handling, cleaning and sterilizing the needle guide bracket EZU-PA5C1.
1.6. Option of Hitachi ultrasound diagnostic scanner
1.6.1. Magnetic Sensor Attachment
1) Magnetic sensor attachment
2) Spacer for EZU-RV2S
Please refer to this instruction manual about the method of handling,
cleaning and sterilizing the Magnetic sensor attachment.
The probe has not been sterilized when it was shipped from a factory.
So before using the probe, clean, disinfect and if necessary sterilize
the probe certainly.

-4- Q1E-EP0428
1.7. External View
Immersible part (IP47)
Un-Immersible part (IP40)
Applied part
Head
C
able
Connector
Spacer for EZU-RV2S
(Option of Hitachi
ultrasound diagnostic
scanner)
Magnetic sensor attachment
(
Option of Hitachi ultrasound
diagnostic scanner)
Fig. 1 External View
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.