Hitachi EUP B715 User manual

BiopsyProbe
EUP‐B715
INSTRUCTIONMANUAL
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.
Tokyo,Japan
Q1E‐EP1245‐7

© Hitachi, Ltd. 2013,2017. All rights reserved.
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 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” indicates the presence of a hazard which may result
in severe personal injury, substantial
p
roperty damage, or
death if the warning is ignored.
CAUTION: “Caution” indicates
t
he presence of a hazard which will or
can cause minor personal
i
njury or property damage if the
caution is ignored.
NOTICE: “Notice” indicates information of installation, operation,
or maintenance, 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
S
tore the probe in a cool place and keep away
f
rom high temperature, high humidity, or
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.
Package of
Biopsy Attachment
Do not reuse
Package of
Biopsy Attachment
Do not re-sterilize

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CONTENTS
Page
1. Introduction ················································· 1
1.1 Features ··················································· 1
1.2 Principles of operation ···································· 1
1.3 Intended Use ··············································· 2
1.4 Components ················································· 2
1.5 Accessories (Option) ······································· 3
1.5.1 Biopsy Attachment······································ 3
1.5.2 Magnetic Sensor Attachment for EUP-B715 (Option)······· 3
1.5.3 Spacer for EZU-RV2S (Option)··························· 3
1.6 Construction ··············································· 4
2. Inspection before Use ········································ 6
2.1 Inspection for Material Surface ···························· 6
2.2 Inspection of the Biopsy Attachment ························ 6
2.3 Inspection for Appropriate Connection ······················ 7
3. Operation Procedure ·········································· 8
4. Attaching the Magnetic Sensor ······························· 18
4.1 Magnetic Sensor (EZU-RV2S) ································ 19
4.1.1 Attaching the Magnetic Sensor························· 19
4.1.2 Removing the Magnetic Sensor·························· 20
4.2 Magnetic Sensor (EZU-RV3S) ································ 21
4.2.1 Attaching the Magnetic Sensor························· 21
4.2.2 Removing the Magnetic Sensor·························· 22
5. Cleaning, Disinfection and Sterilization of the Probe, Biopsy
Attachment and Magnetic sensor attachment ··················· 23
5.1 Point of use (Pre-cleaning): ······························ 25
5.2 Manual Cleaning and Disinfecting: ························· 26
5.3 Drying: ··················································· 30
5.4 Packaging: ················································ 30
5.5 Sterilization: ············································ 30
6. Maintenance and Safety Inspection ··························· 32
7. Safety Precautions ·········································· 32
8. Specifications ·············································· 33
8.1 Probe ····················································· 33
8.2 Suppliers List ············································ 34
9. Disposal of the probe ······································· 34

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1. Introduction
1.1 Features
The probe of Model EUP-B715 has convex 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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CAUTION
1.3 Intended Use
The Biopsy Probe EUP-B715 is designed for observation and diagnosis
mainly of the following regions by connecting with the HITACHI
ultrasound scanner.
Biopsy (with Biopsy Attachment)
General abdominal organs
1.4 Components
The probe components of the EUP-B715 are as follows:
1) Biopsy Probe EUP-B715 ······························· 1 piece
2) Biopsy attachment for 12G-13G······················· 10 pieces
for 14G-16G······················· 10 pieces
for 17G-19G······················· 10 pieces
for 20G-23G······················· 10 pieces
for cool-tipTM (17G), LeVeenTM
SuperSlim Needle(17G)············· 10 pieces
3) Instruction Manual ·································· 1 copy
1) The biopsy attachment (Needle guide, Needle insert) is disposable.
Do not reuse. When the biopsy attachment is reused, it may run the
risk of exposing the patient to infectious diseases.
2) When using the needle cannula of the electrosurgical unit while using
the biopsy attachment as a guide, be careful not to damage the
insulation coating of the needle cannula. [When inserting or
removing the needle cannula into or from the biopsy attachment, you
may damage the insulation coating of the needle cannula, which may
cause a burn to tissue contacting the exposed section of the
insulation coating.]
1) Use appropriate biopsy attachment that is correspondent with the
needle that you use.
2) If you use Cool-tip17G or LeVeenSuperSlim needle 17G of RFA
needle, use the biopsy attachment EZU-PA7B1-C surely.
3) Sterilization has not been made to the probe and biopsy attachment
shipped from the factory.
Prior to use of them, be sure to clean and sterilize them.
4) Do not hold the needle cannula of the electrosurgical unit with metal
tweezers, forceps, and the like. [Doing so may damage the insulation
section of the needle cannula, and may cause a burn to a non-treated
area.]
5) A biopsy should be performed only by a well-trained physician.
WARNING

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1.5 Accessories (Option)
1.5.1 Biopsy Attachment
The biopsy attachment is disposable one.
If more biopsy attachment is needed, you are requested to place an order
with us or our authorized agent specifying the model required from the
following models.
EZU-PA7B1-1 for 12G-13G ··················· 10 pieces/pack
EZU-PA7B1-2 for 14G-16G ··················· 10 pieces/pack
EZU-PA7B1-3 for 17G-19G ··················· 10 pieces/pack
EZU-PA7B1-4 for 20G-23G ··················· 10 pieces/pack
EZU-PA7B1-C for Cool-tipTM (17G),
LeVeenTM SuperSlim Needle(17G) ············ 10 pieces/pack
1.5.2 Magnetic Sensor Attachment for EUP-B715 (Option)
1.5.3 Spacer for EZU-RV2S (Option)
Sterilization has not been made to the Magnetic sensor attachment and
the Spacer for EZU-RV2S shipped from the factory. Prior to use of the
probe, be sure to clean and sterilize it.
CAUTION

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1.6 Construction
Needle
guide
Needle
insert
B
iopsy Attachment
Cable
Applied part
Head
Immersible part (IPX7)
Un-immersible part
Connector
M
agnetic sensor attachment
for EUP-B715 (Option)
Spacer for
EZU-
R
V2S (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 and also cannot be
cleaned by water.
Fig.1 External view