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）