Hitachi EUP-L53 Manuel utilisateur
Linear Array Probes
EUP-L53
EUP-L53S
EUP-L53L
EUP-L52
INSTRUCTION MANUAL
Tokyo, Japan
Q1E-EP0348-14
© 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
+81-3-6284-3668
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 warnings are 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
+81-3-6284-3668
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 dry environment 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.Introduction ................................................ 1
1.1Features ......................................................... 1
1.2Principles of operation .......................................... 1
1.3Intended Use ..................................................... 2
1.4Composition ...................................................... 2
1.5Accessories (OPTION) ............................................. 2
1.6Construction ..................................................... 6
2.Introduction ................................................ 7
2.1Inspection for Appropriate Connection ............................ 7
2.2Inspection for Material Surface .................................. 7
3.Operation Procedure ......................................... 8
4.Reprocessing Procedure ..................................... 10
4.1Point of use (Pre-cleaning) ..................................... 13
4.2Containment and transportation .................................. 13
4.3Manual Cleaning and disinfection ................................ 13
4.4Drying .......................................................... 16
4.5Inspection ...................................................... 16
4.6Packaging ....................................................... 16
4.7Sterilization ................................................... 16
4.8Storage ......................................................... 18
5.Maintenance and Safety Inspection .......................... 18
5.1Daily check ..................................................... 18
6.Safety Precautions ......................................... 19
7.Specifications ............................................. 20
7.1Probe ........................................................... 20
7.2Suppliers List .................................................. 21
8.Disposal of the probe ...................................... 22
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1. Introduction
1.1 Features
The probes of models EUP-L53, L53L, L53S and L52 are Linear Array
Electronic Scanning type.
The acoustic output of these probes 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
operational manual of each ultrasound scanner.
These probes are categorized in class IIa according to
Directive 93/42/EEC.
According to IEC 60601-1 EUP-L53, L53L, L53S and L52 are 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.
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1.3 Intended Use
The Linear Array Probes EUP-L53S, L53, L52 and L53L are designed
for observation and diagnosis mainly of the following regions by
connecting with the HITACHI ultrasound scanner.
Item EUP-L53S
EUP-L52
EUP-L53 EUP-L53L
Small organ ×××
Peripheral Vessel ×××
Pediatric ×××
Abdominal ×××
Biopsy (with coupler attachment
or biopsy attachment)
××
Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
Direct contact to the eye
1.4 Composition
Probe ...................... 1 piece
Instruction Manual ......... 1 copy
1.5 Accessories (OPTION)
1.5.1 Coupler attachment EZU-PA3C1 (Option)
(Applicable model: EUP-L53S and L52)
By attaching the coupler attachment EZU-PA3C1, the blood flow
in the shallow blood vessel can be detected, by keeping a
suitable angle.
The optional coupler attachment EZU-PA3C1 components are as
follows:
Component Model Note
1 Coupler attachment EZU-PA3C1 2 pieces
2 Instruction manual - 1 copy
WARNING
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1.5.2 Coupler attachment EZU-PA3C1H (Option)
(Applicable model: EUP-L53S and L52)
By attaching the coupler attachment EZU-PA3C1H, a biopsy
through the needle guide besides the function of the EZU-PA3C1
can be made.
The optional coupler attachment EZU-PA3C1H components are as
follows:
Component Model Note
1 Coupler attachment EZU-PA3C1H 2 pieces
2 Needle guide * - 2 pieces
3 Instruction manual - 1 copy
* A 20-22 gauge biopsy needle is available inside the needle guide.
1.5.3 Coupler attachment EZU-PA3C2 (Option)
(Applicable model: EUP-L53S and L52)
By attaching the coupler attachment EZU-PA3C2, a better image
for shallow parts by shifting of a focal zone to the parts is
achieved.
The optional coupler attachment EZU-PA3C2 components are as
follows:
Component Model Note
1 Coupler attachment EZU-PA3C2 2 pieces
2 Immobilizing band - 2 pieces
3 Instruction manual - 1 copy
Please refer to the instruction manual of each option about
the method of handling, cleaning, disinfection and sterilizing
it.
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1.5.4 Water bag EZU-WL2 (Option) (Applicable model: EUP-L53)
By attaching a water bag EZU-WL2 to the probe, better contact
with curved region such as mammary gland or thyroid gland can
be attained. The optional water bag EZU-WL2 components are as
follows:
Component Note
1 Outer case 1 piece
2 Balloon * 3 pieces
3 Syringe 1 piece
4 Instruction manual 1 piece
* The optional water bag EZU-WL2 is made of latex.
The latex may cause such allergic reactions as itching, rubor,
urticaria, swelling, fever, anhelation, wheezing, and
depression of blood pressure, shock and so on. For the patients
suspected of latex allergy, do not use the latex-containing
medical devices.
Please refer to the instruction manual of EZU-WL2 about the
method of handling, cleaning and disinfecting it.
1.5.5 Water bag EZU-WL3 (Option) (Applicable model: EUP-L53L)
By attaching a water bag EZU-WL3 to the probe, better contact
with curved region such as mammary gland can be attained.
The optional water bag EZU-WL3 components are as follows:
Component Note
1 Outer case 1 piece
2 Balloon * 10 pieces
3 Syringe 1 piece
4 Instruction manual 1 piece
WARNING
Ce manuel convient aux modèles suivants
3
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