Hitachi L55 Probe User manual

L55 Probe
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1368-6
© 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,
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
[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, dark
and dry 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. General ........................................................ 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 for appropriate connection ................................................................... 5
2.2 Inspection for material surface ................................................................................ 5
3. Operation Procedure ............................................ 6
4. Option of L55 Probe ............................................ 8
4.1 Elasto Coupler..................................................................................................................... 8
4.2 Magnetic sensor................................................................................................................... 9
5. Reprocessing Procedure ........................................ 12
5.1 Point of use (Pre-cleaning) ....................................................................................... 15
5.2 Containment and transportation ................................................................................ 15
5.3 Manual Cleaning and disinfection ............................................................................ 15
5.4 Drying .................................................................................................................................... 19
5.5 Inspection ........................................................................................................................... 19
5.6 Packaging ............................................................................................................................. 19
5.7 Sterilization ..................................................................................................................... 19
5.8 Storage.................................................................................................................................. 21
6. Maintenance and Safety Inspection ............................. 22
7. Safety Precautions ............................................ 23
8. Specifications ................................................ 24
8.1 Probe ...................................................................................................................................... 24
8.2 Suppliers List................................................................................................................... 25
9. Disposal of the probe ......................................... 25

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1. General
1.1 General
L55 Probe is a Linear Array Probe.
The acoustic output of L55 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.
L55 Probe 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.

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1.3 Intended Use
L55 Probe 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.
Direct contact to the eye
1.4 Components
The components of L55 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
C
A
U
TI
O
N

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1.5 Option
1.4.1 Elasto Coupler
1.4.2 Needle Guide Bracket EZU-PA7L2
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-PA7L2 about
the method of handling, cleaning and sterilizing the needle
guide bracket EZU-PA7L2.
1.4.3 Magnetic Sensor Attachment
Sterilization has not been made to the elasto coupler, the
magnetic sensor attachment and the needle guide bracket
EZU-PA7L2 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 needle guide bracket EZU-PA7L2 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-PA7L2.
C
A
U
TI
O
N
CAUTION
C
A
U
TI
O
N

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1.6 External View
The external view of L55 Probe is shown in Fig. 1.
Immersible part (IPX7)
H
ead
Connector
Cable
U
n
-
i
mmersible part
Elasto coupler
(Option)
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 an
d
also can not be
c
leaned b
y
water.
Fig. 1 External view
Applied part
Magnetic sensor
attachment
（Option）

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2. Inspection before Use
Prior to use, the probe must be carefully inspected that it is
appropriate for use.
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 or
instruments on the probe, such as unauthorized biopsy
attachments.
2.2 Inspection of material surface
2.2.1 Visually inspect the surface of the probe head, housing,
the cable and the connector for any crack, scratch or
denaturalization. If you find any damage, do not use the
probe, and immediately contact a service support.
2.2.2 Visually inspect the elasto coupler for any crack,
deformation or denaturalization. If you find any damage,
do not use the elasto coupler and contact a service
support immediately.
2.2.3 Visually inspect the magnetic sensor attachment for any
crack, deformation or denaturalization. If you find any
damage, do not use the magnetic sensor attachment and
contact a service support immediately.

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3. Operation Procedure
1) Confirm that the probe, the magnetic sensor attachment and
the elasto coupler are cleaned and disinfected and/or
sterilized.
2) Connect the probe to the ultrasound diagnostic scanner,
operate the scanner, and adjust the image, all according to
the instructions given in the operation manual for the
ultrasound diagnostic scanner with which the probe is used
as connected.
3) Confirm the direction of the probe. The relationship between
the direction of the probe and image is shown in Fig. 2.
The Right-left orientation mark on the image indicates the
direction of the index mark of the probe.
R
ight
-
l
eft orientation mark
Index mark
Fig. 2 Relationship between the directions
o
f the probe
and the Right-left orientation mark

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4) Using a sterile probe cover to protect the probe is recommended.
The probe cover should be allergy free material to avoid
allergic reaction. Between the probe and the probe cover,
acoustic coupling gel is required as a couplant.
5) Place the probe on the examination site and adjust the probe’s
position for a clear view of the desire image.
6) After using the probe, the magnetic sensor attachment and the
elasto coupler, perform the reprocessing procedure in
accordance with the procedure stated in “5. Reprocessing
procedure” every time immediately after completing the
ultrasound examination.
7) Store the probe, the magnetic sensor attachment and the elasto
coupler in the environment indicated in “6. Maintenance and Safety
inspection”.

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4. Option of L55 Probe
4.1 Elasto Coupler
4.1.1 How to attach the Elasto Coupler
To use elastography, attach the elasto coupler as shown below.
Attach the elasto coupler on the probe as straight as possible
as shown in Fig. 3.
4.1.2 How to release the Elasto Coupler
Release the elasto coupler from the probe as shown in Fig. 10.
Elasto coupler
Fig. 4 How to attach the Elasto coupler
Elasto coupler
Fig. 3 How to attach the Elasto coupler

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4.2 Magnetic sensor
4.2.1 How to attach the Magnetic sensor
The procedure of attaching the magnetic sensor is as follows.
1) Confirm that the probe and the magnetic sensor attachment
are cleaned, disinfected and/or sterilized.
2) Connect the probe, operate the ultrasound diagnostic
scanner, and adjust the image according to the
instructions given in the operation manual for the
ultrasound diagnostic scanner.
3) To use Real-time Virtual Sonography (RVS), attach the
magnetic sensor as shown below.
a) Attach the magnetic sensor into the probe at the correct
direction as shown in Fig. 10.
b) Place the magnetic sensor attachment on the probe as
shown in Fig. 6. Fit the projected part of the magnetic
sensor attachment in the index mark of the probe.
Magnetic sensor
Direction mark of
the Magnetic sensor
Projected part of
the Magnetic sensor attachment
Fit the insertion direction
Fig. 5 How to attach the Magnetic sensor attachment

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Never attach the magnetic sensor attachment to the probe at the
incorrect direction, otherwise it may result in false diagnosis.
4.2.2 How to release attach the Magnetic sensor
The procedure of releasing the magnetic sensor is as follows.
1) Turn around the magnetic sensor attachment and remove it
from the probe as shown in Fig. 7.
Fig. 6 How to attach the Magnetic sensor attachment
Projected part of the
Magnetic sensor attachment
I
ndex mark
Fit the insertion
d
irection
C
A
U
TI
O
N
Fig. 7 How to release the Magnetic sensor
attachment from the probe

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2) Release the magnetic sensor from the magnetic sensor
attachment as shown Fig. 8
Fig. 8 How to release the Magnetic sensor from
the Magnetic sensor attachment

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5. Reprocessing Procedure
The probe and accessories must be reprocessed after each use. Refer
to the reprocessing instruction in this chapter. For reprocessing
of the needle guide bracket EZU-PA7L2 refer to the instruction
manual of the needle guide bracket.
WARNINGS
-The probe is delivered unsterile. Prior to the
first use, reprocess the probe.
-Temperature should not exceed 60°C during
reprocessing.
-Probe connector is not water resistant.
Limitations on
reprocessing
The probe is not completely submersible. The
immersible part is shown in Fig.1. The un-immersible
part should be disinfected b
y
wipe disinfection.
Transportation
before using
T
he probe should be packed in a sterile pouch or
c
ontainer to transport from Central Sterile Supply
D
epartment (CSSD) to an operating room. Be careful
n
ot to damage the sterile pouch or container during
transportation.

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Levels of reprocessing requirements:
Depending on the application of the product and with regard to risk
evaluation, the user has to classify the medical device according to
the current Medical Device Directive for processing of medical devices
as uncritical, semi-critical or critical. Supporting information
concerning this topic is listed in the table below. The user is
responsible for correct classification of the medical device.
Classification Definition Processing
uncritical
Application part only
contacts intact and
uninjured skin
Cleaning
Disinfection
semicritical
Application part contacts
mucosa (intracavitary
application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect)
critical
Application part contacts
intracorporeal tissue
directly (operative
application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect -
minimum)
Sterilization
According to the intended use, L55 probe is classified as uncritical.

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The flowchart of the reprocessing process of this probe is as follows.
Point of use (Pre-cleaning)
Manual Cleaning
Rinsing after manual
cleaning
Manual Disinfection
Drying
Manual cleaning and
disinfection
Rinsing after manual
disinfection
Packing
Sterilization
Containment and
transportation