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

(1) Q1E-EP1245
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:

(2) Q1E-EP1245
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.

(3) Q1E-EP1245
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

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Fig.2 External View of the Biopsy Attachment
Biopsy Attachment
(Needle guide)
Needle Insertion
Groove (30°)
Needle Insertion
Groove (0°)
Needle Insertion
Groove (15°)
Probe Biopsy Attachment
(Needle insert)
Biopsy Attachment
(Mounting arm)

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2. Inspection before Use
Prior to use, the probe must be carefully inspected that they are
appropriate for use. If you find any damage, do not use the probe and
immediately contact a service support.
2.1 Inspection for Material Surface
1) Visually inspect the surface of the probe head, housing and cable
for any crack, scratch or denaturalization.
2) Visually inspect the surface of the Magnetic sensor attachment and
the Spacer for EZU-RV2S for any crack, deformation or
denaturalization.
2.2 Inspection of the Biopsy Attachment
1) Check that any foreign article is not in the needle groove. Confirm
that the Needle insert can be mounted to the Needle guide.
2) Confirm that the biopsy attachment can be mounted to the probe and
detached from it.
Needle groove
N
eedle groove
Needle guideNeedle insert
Fig.3 Needle Groove Fig.4 Biopsy Attachment Assembly
Needle guide
N
eedle insert

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2.3 Inspection for Appropriate Connection
1) Check that the system is correctly operating. Refer to the
instruction manual for the Main unit.
2) Fill sterile water into a bucket and confirm that a biopsy guide
line and an echo image of test needle are overlapped correctly at
all selectable angles. (See Fig.5)
3) Relationship between the needle insertion groove and needle guide
line angle following “3. Operation Procedure” Fig.17. Also, Confirm
that the needle moves smoothly and there is no blurring between the
needle and biopsy attachment.
Before use, make sure there is no damage to the surface to which the
needle cannula is attached, and the biopsy attachment works properly.
Biopsy guide
line (A dotted
line)
Sterile water Test needle
N
eedle guide angle
Needle echo
(A solid line)
Fig.5 Echo image of test needle
Right-left
orientation mark
CAUTION

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3. Operation Procedure
1) Connect the probe, operate the Main unit, and adjust the image
according to the instructions given in the operation manual for the
main unit.
2) Confirm that the probe is disinfected or sterilized.
3) Confirm that the biopsy attachment is sterilized.
4) Confirm that the Magnetic sensor attachment and the Spacer for
EZU-RV2S are disinfected or sterilized.
5) Prepare the following probe cover.
CIV-Flex™ Transducer Cover (610-542) (Option)
Sterile 14 x 91.5cm telescopically-folded cover
6) To use Real-time Virtual Sonography (RVS), attach the Magnetic sensor
to the probe as shown in “4. Attaching the Magnetic Sensor”. Place
the probe cover to the probe, after attaching of the Magnetic sensor.
Do not attach the Magnetic sensor on top of the probe cover.
7) Place an appropriate amount of sterilized gel on the Probe head.
(See Fig.6)
Fig.6 Placing the sterilized gel
CIV-Flex cover
Probe head
Sterilized gel

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8) Pull the cover tightly over the probe face to remove wrinkles and
air bubbles, taking care to avoid puncturing the cover.
9) Secure cover to the groove portion of the probe housing with bands.
Fig.7 Hold the probe cover to the probe
B
and
Fig.8 Hold the probe cover to the probe

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10) Select a needle insert and needle guide to correspond with the needle
size intended to be used in the procedure. Needle size is engraved
on the needle insert and the needle guide. Slide the needle insert
into the needle guide. Be sure to using combination same needle
size. After insert into the needle guide, open outward mounting
arm in the direction of fig.10 to easy mount the biopsy attachment.
When use this probe EUP-B715 for biopsy purpose, use the biopsy
attachment (EZU-PA7B1-1,2,3,4,C) certainly.
Needle guide
Needle insert
Needle size
is engraved
Fig.9 Biopsy Attachment Assembly
Mounting arm
Fig.10 Mounting arm
O
p
en outward
CAUTION

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11) Mount the appropriate biopsy attachment in the probe. Follow the
next steps to mount the probe and biopsy attachment.
a) Place the biopsy attachment on the probe as shown in Fig. 11. Insert
the projected part of the attachment into the groove of the probe
on top of the probe cover.
Projected part of the attachment
Groove of the probe
Fig.11 Mounting the biopsy attachment

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b) The biopsy attachment tip to the direction of an arrow, secure the
biopsy attachment to the biopsy attachment mounting plate.
Biopsy attachment mounting plate
Tip Biopsy
attachment
Biopsy
attachment Biopsy
attachment
Fig.12 Mount
i
ng
t
he biopsy
a
ttachment

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c) The mounting arm tip to the direction of an arrow pulling the probe
cover with thumb. Then the mounting arm lock reduces wrinkling of
the probe cover.
d) Inspect the probe cover to ensure the needle path is clear of
obstructions.
Reduce wrinkling of
the probe cover
Lock
Fig.13 Mount
i
ng
t
he biopsy
a
ttachment
Mounting arm
Fig.14 Inspection of the probe cover
The needle path
is clear of
obstructions
The needle path
is clear of
obstructions.
Needle
Needle

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e) Confirm that the tip of the biopsy attachment is attached in the
correct position.
Fig.15 Inspect
i
on of
t
he
b
iopsy attachment
Incorrect
position
The tip of the biopsy attachment
Correct
position Incorrect
position