Hitachi EUP-L75 User manual

Linear Array Probe
EUP-L75
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1199-9
© 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
[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,
and 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.

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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, 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
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. General........................................................... 1
1.1 General................................................................... 1
1.2 Principles of operation................................................... 1
1.3 Intended Use.............................................................. 2
1.4 Composition............................................................... 2
1.5 Accessories............................................................... 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 EUP-L75................................................ 10
4.1 Magnetic sensor (EZU-RV2S)............................................... 10
4.2 Magnetic sensor (EZU-RV3S)............................................... 13
4.3 elasto coupler........................................................... 16
5. Reprocessing Procedure........................................... 17
5.1 Point of use (Pre-cleaning).............................................. 20
5.2 Containment and transportation........................................... 20
5.3 Manual Cleaning and disinfection......................................... 20
5.4 Drying................................................................... 24
5.5 Inspection............................................................... 24
5.6 Packaging................................................................ 24
5.7 Sterilization............................................................ 24
5.8 Storage.................................................................. 26
6. Maintenance and Safety Inspection................................ 27
7. Safety Precautions............................................... 28
8. Specifications................................................... 29
8.1 Probe.................................................................... 29
8.2 Suppliers List........................................................... 30
9. Disposal of the probe............................................ 31

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1. General
1.1 General
The probe of model EUP-L75 is a Linear Array 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 IEC 60601-1 the probe is classified as type BF.
Never use the probe for following applications.
1) Direct contact to the heart.
2) Biopsy to the heart.
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.
WARNING

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1.3 Intended Use
The Linear Array Probe EUP-L75 is designed for observation and
diagnosis mainly of the following regions by connecting with the
HITACHI ultrasound scanner.
Mammary gland
Thyroid
Superficial organs
1.4 Composition
The probe components of the EUP-L75 are as follows:
1) Probe EUP-L75 .......................... 1 piece
2) Instruction Manual ..................... 1 copy
Sterilization has not been made to the probe, the magnetic sensor
attachment, the spacer for RV2S and the elasto coupler shipped from
the factory.
Prior to use, be sure to clean, disinfect and sterilize them.
CAUTION

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1.5 Accessories
1.5.1 Magnetic Sensor Attachment (part number:7347816A)(Option)
1.5.2 Spacer for RV2S (Option)
1.5.3 elasto Coupler for EUP-L75 (part number:7230413A)(Option)
1.5.4 Needle Guide Bracket EZU-PA7L3 (Option)
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-PA7L3 about the
method of handling, cleaning and disinfecting the needle guide
bracket EZU-PA7L3.
1.5.5 Acoustic coupler attachment EZU-TEATC2 (Option)
1) Cover................................ 1 piece
2) Base................................. 1 piece
3) Instruction manual................... 1 copy
Acoustic coupler attachment EZU-TEATC2 fixes the acoustic coupler
(EZU-TECPL1 or SF-001) to the probe.
The SF-001 and EZU-TECPL1 are intended to be used for having a
clear superficial image by keeping a certain distance between the
probe and the skin.EZU-TECPL1 is used when the operator compares
the tissue elasticity of the living body with the Acoustic
coupler’s one.
Please refer to the instruction manual of EZU-TEATC2 about the
method of handling and cleaning EZU-TEATC2, EZU-TECPL1 and
SF-001.
A biopsy should be performed only by a well-trained physician.
CAUTION

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1.6 External View
Un-immersible part
Immersible part (IPX7)
Fig. 1 External View
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
b
e
c
leaned by water.
Head
Connector
C
able
elasto coupler for EUP-L75 (Option)
Spacer for EZU-RV2S (Option)
Magnetic sensor attachment
for EUP-L75 (Option)
Applied part
Acoustic coupler
attachment EZU-TEATC2
(Option)
Acoustic coupler
EZU-TECPL1 (Option)
or
Acoustic coupler
SF-001 (Option)