Hitachi L44 Bedienungsanleitung
L44 Probe
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1370-5
© 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,
and 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.
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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, dry and dark place
and keep away from high temperature, high
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 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
1.1 General .......................................................... 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 of appropriate connection ............................. 5
2.2 Inspection of material surface ................................... 5
3. Operation Procedure ..........................................6
4. Option of L44 Probe ..........................................8
4.1 Elasto Coupler ................................................... 8
5. Reprocessing Procedure .......................................9
5.1 Point of use (Pre-cleaning) ..................................... 12
5.2 Containment and transportation .................................. 12
5.3 Manual Cleaning and disinfection ................................ 12
5.4 Drying .......................................................... 16
5.5 Inspection ...................................................... 16
5.6 Packaging ....................................................... 16
5.7 Sterilization ................................................... 16
5.8 Storage ......................................................... 18
6. Maintenance and Safety Inspection ...........................19
7. Safety Precautions ..........................................20
8. Specifications ..............................................21
8.1 Probe ........................................................... 21
8.2 Suppliers List .................................................. 22
9. Disposal of the probe .......................................22
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1. Introduction
1.1 General
L44 Probe is a linear array probe.
The acoustic output of L44 Probe 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.
L44 Probe is categorized in class IIa according to
Directive 93/42/EEC and classified as type BF according to IEC
60601-1.
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
L44 Probe is designed for observation and diagnosis mainly of the
following regions by connecting with the Hitachi ultrasound
diagnostic scanner.
Superficial region
Cervical region
Mammary gland
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 L44 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 the probe, be sure to clean, disinfect and
sterilize the probe.
WARNING
CAUTION
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1.5 Option
1.4.1 Elasto coupler (Part number: 7225446A)
1.4.2 Coupler Attachment EZU-PA7L1
1) Coupler attachment ········ 2 pieces
2) Needle Guide (18G) ········ 2 pieces
The needle of 20 to 22 gauge fits in the Needle guide (18G).
The diameter of a needle and its corresponding gauge size
is different for manufactures. Therefore some needle of 20
to 22 gauge may not fit in the Needle guide (18G).
3) Brush ····················· 5 pieces
4) Instruction manual ········ 1 copy
Please refer to the instruction manual of EZU-PA7L1 about the
method of handling, cleaning and sterilizing the EZU-PA7L1.
Sterilization has not been made to the elasto coupler and the
EZU-PA7L1 shipped from the factory. Prior to use of them, be sure
to clean, disinfect and sterilize them.
A biopsy should be performed only by a well-trained physician.
Use only the authorized coupler attachment for performing a
biopsy.
CAUTION
CAUTION
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1.6 External View
The external view of L44 Probe is shown in Fig. 1.
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
Head
I
mmersible part (IPX7)
Un-immersible part
Cable
C
onnector
Elasto coupler (Option)
Applied part
Inhaltsverzeichnis
Andere Hitachi Diagnosegeräte Handbücher
