Hitachi EUP-C524 User manual

Convex Array Probe
EUP-C524
INSTRUCTION MANUAL
Tokyo,Japan
Q1E-EP0385-6
© Hitachi, Ltd. 2013,2016. 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

(1) Q1E-EP0385
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 Ultrasound Logistics,
Zweigniederlassung der Hitachi Medical Systems Europe
Holding AG
Carl-Zeiss-Strasse 5, D-72555 Metzingen, Germany
EU Importer: Hitachi Medical Systems Europe Holding AG
Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland
Local Distributor:

(2) Q1E-EP0385
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.

(3) Q1E-EP0385
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 Ultrasound Logistics,
Zweigniederlassung der Hitachi Medical Systems
Europe Holding AG
Carl-Zeiss-Strasse 5,
D-72555 Metzingen, Germany
Keep away from
Sunlight
Store the probe in a cool, dustproof and dark, dry
place to avoid high temperature, humidity and direct
sunlight.

(4) Q1E-EP0385
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
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-EP0385
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 ······························································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. Cleaning, Disinfection and Sterilization ······················· 6
4.1 Point of use (Pre-cleaning) ·········································7
4.2 Containment and transportation ······································7
4.3 Cleaning and disinfection ···········································8
4.4 Drying ·····························································10
4.5 Inspection ·························································10
4.6 Packaging ··························································11
4.7 Sterilization ······················································12
4.8 Storage ····························································14
5. Maintenance and Safety Inspection ····························· 15
6. Safety Precautions ············································ 16
7. Specifications ················································ 17
7.1 Probe ······························································17
7.2 Suppliers List ·····················································18
8. Disposal of the probe ········································· 18

-1- Q1E-EP0385
1. General
1.1 General
The probe of Model EUP-C524 is Convex Array electronic scanning
type.
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
operation 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.

-2- Q1E-EP0385
1.3 Intended Use
The Convex Array Probe EUP-C524 is designed for observation and
diagnostic mainly of the following regions by connecting with
the HITACHI ultrasound scanner.
Abdominal
Pediatrics
Fetal
Small organ
1.4 Composition
The probe components of the EUP-C524 are as follows:
1) Probe EUP-C524...........1 piece
2) Instruction Manual.......1 copy
1.5 Option
Needle Guide Bracket EZU-PA5C2
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-PA5C2.

-3- Q1E-EP0385
1.6 External View
The external view of the EUP-C532 is shown in Fig.1.
Immersible part (IP47)
Head
Connector
Cable
Un-immersible part
(IP40)
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-C524
Applied part

-4- Q1E-EP0385
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.