Hitachi L34 Manuale utente
L34 Probe
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1361-7
© 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
(1) Q1E-EP1361
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:
(2) Q1E-EP1361
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 ultrasound diagnostic scanner,
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-EP1361
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, dark
and dry place and keep away from high
temperature, high humidity and direct
sunlight.
(4) Q1E-EP1361
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 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-EP1361
CONTENTS
Page
1. Introduction ................................................... 1
1.1 Features ............................................................1
1.2 Principles of operation .............................................1
1.3 Intended Use ........................................................2
1.4 Components ..........................................................2
1.5 Option ..............................................................3
1.6 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. Reprocessing Procedure ......................................... 8
4.1 Point of use (Pre-cleaning) ........................................11
4.2 Containment and transportation .....................................11
4.3 Manual Cleaning and disinfection ...................................11
4.4 Drying .............................................................14
4.5 Inspection .........................................................14
4.6 Packaging ..........................................................14
4.7 Sterilization ......................................................14
4.8 Storage ............................................................16
5. Maintenance and Safety Inspection ............................. 17
6. Safety Precautions ............................................ 18
7. Specifications ................................................ 19
7.1 Probe ..............................................................19
7.2 Suppliers List .....................................................20
8. Disposal of the probe ......................................... 20
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1. Introduction
1.1 Features
L34 Probe is a linear array electronic scanning type probe.
The acoustic output of these probes when connected to the ultrasound
diagnostic 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 diagnostic scanner.
This probe is categorized in class Ⅱa according to Directive
93/42/EEC.
According to IEC 60601-1, L34 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.
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1.3 Intended Use
L34 Probe is designed for observation and diagnosis mainly of the
following regions by connecting with the HITACHI ultrasound
diagnostic scanner.
Small organ
Peripheral Vessel
Pediatric
Abdominal
Biopsy (with coupler attachment)
Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
Direct contact to the eye
1.4 Components
The components of L34 Probe are given below:
1) Probe .................................. 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.
WARNIN
G
CAUTION
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1.5 Option
1.5.1 Coupler attachment EZU-PA3C1 (Option)
By attaching the coupler attachment EZU-PA3C1, detecting of the
blood flow in the shallow blood vessel is possible, 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
1.5.2 Coupler attachment EZU-PA3C1H (Option)
By attaching the coupler attachment EZU-PA3C1H, additionally to
the blood flow detection a biopsy through the needle guide is
possible.
The optional coupler attachment EZU-PA3C1H components are as
follows:
Component Part number Model Note
1 Coupler attachment - EZU-PA3C1H 2 pieces
2 Needle Guide * 7424250A - 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)
By attaching the coupler attachment EZU-PA3C2, the images for
shallow parts by shifting of a focal zone to the parts are
improved.
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 them.
A biopsy should be performed only by a well-trained physician.
Use only the authorized coupler attachment for performing a biopsy.
Before performing a biopsy, display the needle echo in sterile water,
and confirm that the needle echo at each angle overlaps with the
correspondent needle guideline. For the confirmation procedure in
detail, refer to the instruction manual of EZU-PA3C1H.
CAUTION
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1.6 External View
The external view of L34 Probe is shown in Fig. 1.
I
mmersible part (IP
X
7
)
Head
Connector
Cable
Un-
i
mmersible part
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
Applied part
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