Hitachi EUP-L65 User manual

Linear Array Probe
EUP-L65
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP0739-7
© Hitachi ,Ltd. 2013,2017. All rights reserved.
0123
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.

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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:

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About this manual
This instruction manual shall provide instructions for using, cleaning,
disinfecting 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.

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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
[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
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 1.7.
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 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. General..................................................... 1
1.1 General ......................................................... 1
1.2 Principles of operation ......................................... 1
1.3 Intended Use .................................................... 1
1.4 Components ...................................................... 2
1.5 Option .......................................................... 2
1.6 Option of Hitachi ultrasound diagnostic scanner ................. 3
1.7 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. Option of Hitachi ultrasound diagnostic scanner............. 7
4.1 Magnetic sensor EZU-RV2S ........................................ 7
4.2 Magnetic sensor EZU-RV3S ....................................... 10
4.3 Elasto Coupler ................................................. 13
5. Reprocessing Procedure..................................... 14
5.1 Point of use (Pre-cleaning) .................................... 17
5.2 Containment and transportation ................................. 17
5.3 Manual Cleaning and disinfection ............................... 17
5.4 Drying ......................................................... 21
5.5 Inspection ..................................................... 21
5.6 Packaging ...................................................... 21
5.7 Sterilization .................................................. 21
5.8 Storage ........................................................ 23
6. Maintenance and Safety Inspection.......................... 24
7. Safety Precautions......................................... 25
8. Specifications............................................. 26
8.1 Probe .......................................................... 26
8.2 Suppliers List ................................................. 27
9. Disposal of the Probe...................................... 27

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1. General
1.1 General
The EUP-L65 is a linear array probe.
The acoustic output of the EUP-L65 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-L65 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.
1.3 Intended Use
The EUP-L65 is designed for observation and diagnosis mainly
of the following regions by connecting with the Hitachi
ultrasound diagnostic scanner.
Mammary gland
Thyroid
Superficial organs
Never use the probe for following applications.
•Direct contact to the heart.
•Biopsy to the heart.
WARNING

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1.4 Components
The components of the EUP-L65 are given below:
1) Probe EUP-L65 .................. 1 piece
2) Instruction Manual ............. 1 copy
Disinfection has not been made to the probe, shipped from the
factory. Prior to use of the probe, be sure to clean and disinfect
the probe.
1.5 Option
1.5.1 Acoustic coupler for EUP-L65（EZU-TECPL1）
EZU-TECPL1 is used when the operator keeps a constant distance
between the probe and the living body, and/or it is used when
the operator compares the tissue elasticity of the living body
with the acoustic coupler’s one. To attach the acoustic coupler
EZU-TECPL1 to the probe, the acoustic coupler
attachmentEZU-TEATC1 is used.
1.5.2 Acoustic coupler attachment for EUP-L65（EZU-TEATC1）
EZU-TEATC1 fixes the EZU-TECPL1 to the probe.
Please refer to the instruction manual of the EZU-TEATC1 about
the method of handling, cleaning and disinfecting the
EZU-TECPL1 and EZU-TEATC1.
1.5.3 Needle Guide Bracket EZU-PA6L1
1) Needle guide bracket......... 1 piece
2) Brush........................ 1 piece
3) Spring (Spare)............... 2 pieces
4) Instruction manual........... 1 copy
5) Case......................... 1 piece
Please refer to the instruction manual of EZU-PA6L1 about the
method of handling, cleaning and disinfecting the needle guide
bracket EZU-PA6L1.
CAUTION

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1.6 Option of Hitachi ultrasound diagnostic scanner
1) Magnetic Sensor Attachment (Part No. 7349818A)
2) Spacer for EZU-RV2S
3) Elasto coupler (Part No. 7331474A)
Sterilization has not been made to the magnetic sensor attachment
and the Elasto coupler, shipped from the factory. Prior to use of
it, be sure to clean, disinfect and sterilize it.
1.7 External View
C
able
C
onnector
Head
Spacer for EZU-RV2S
(Option of the Hitachi
ultrasound diagnostic
scanner)
Fig. 1 External View
Magnetic sensor attachment
(Option of the Hitachi ultrasound
diagnostic scanner)
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.
Immersible
part（IPX7）
Elasto coupler
(Option of the Hitachi
ultrasound diagnostic
scanner)
Applied part
Un-Immersible part
CAUTION

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2. Inspection before Use
Prior to use, the probe must be carefully inspected that it is
appropriate for use. If you find any damage, do not use the probe
and immediately contact a service support.
2.1 Inspection of 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 nor instruments
on the probe, such as unauthorized biopsy attachments.
If a biopsy operation is required, refer to its instruction
manual for inspection, preparation, operation and cleaning
through sterilization.
2.2 Inspection of material Surface
2.2.1 Visually inspect that the surface of the probe and head,
housing, the cable and the connector for any crack, scratch
or denaturalization.
2.2.2 Visually inspect the magnetic sensor attachment and the
spacer for EZU-RV2S for any crack, deformation or
denaturalization.
2.2.3 Visually inspect the elasto coupler for any crack,
deformation or denaturalization. If you find any damage, do
not use the elasto coupler.