Hitachi C42 User manual

C42 Probe
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1359-6
© 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/in
dex.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 and dry
environment to avoid high temperature,
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 ..............................................................2
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 C42 Probe ............................................ 8
4.1Magnetic sensor .....................................................8
5.Reprocessing Procedure ........................................ 13
5.1Point of use (Pre-cleaning) ........................................16
5.2Containment and transportation .....................................16
5.3Manual Cleaning and disinfection ...................................16
5.4Drying .............................................................20
5.5Inspection .........................................................20
5.6Packaging ..........................................................20
5.7Sterilization ......................................................20
5.8Storage ............................................................22
6.Maintenance and Safety Inspection ............................. 23
7.Safety Precautions ............................................ 24
8.Specifications ................................................ 25
8.1Probe ..............................................................25
8.2Suppliers List .....................................................26
9.Disposal of the probe ......................................... 27

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1. General
1.1 General
C42 Probe is a Convex Array Probe.
The acoustic output of C42 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.
C42 Probe is categorized in class Ⅱa according to Directive
93/42/EEC and classified as type BF according to IEC60601-1.
Never use the probe for following applications.
Direct contact to the heart
Biopsy to the heart
Direct contact to the eye
Never use the probe with (HF) surgical equipment.
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.
WARNIN
G
WARNIN
G

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1.3 Intended Use
C42 Probe is designed for observation and diagnosis mainly of the
following regions by connecting with the Hitachi ultrasound
diagnostic scanner.
Neonatal
Pediatrics
Intra-operative
1.4 Components
The components of C42 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.
1.5 Option
1.5.1 Needle Guide Bracket EZU-PA532
1) Needle guide bracket············· 1 piece
2) Brush···························· 1 piece
3) Instruction manual··············· 1 copy
Please refer to the instruction manual of needle guide bracket
EZU-PA532 about the method of handling, cleaning, disinfecting
and sterilizing the needle guide bracket EZU-PA532.
1.5.2 Magnetic Sensor Attachment
Magnetic Sensor Attachment Part number
For using without Biopsy Guide Bracket 7349816A
For using with Biopsy Guide Bracket 7349817A
Sterilization has not been made to the Magnetic sensor attachment
and the EZU-PA532 shipped from the factory.
Prior to use of them, be sure to clean, disinfectt and
sterilize them.
C
A
U
TI
O
N
C
A
U
TI
O
N

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(1) A biopsy should be performed only by a well-trained
physician.
(2) Use only the authorized needle guide bracket for performing
a biopsy.
(3) Confirm that the name of the needle guide bracket to be
attached to the probe corresponds to the name of the bracket
displayed on the monitor. Otherwise there is a risk of injury
due to biopsy failure caused by the use of the wrong type
of needle guide bracket.
(4) “Puncture Adapter Select” window appears on the first use,
and the selected bracket is automatically selected after the
first use. If the bracket is changed to the other bracket,
please change the name of the bracket displayed on the monitor
to the name of the other bracket. Otherwise there is a risk
of injury due to biopsy failure caused by the use of the wrong
type of needle guide bracket.
(5) 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-PA532.
CAUTION
CAUTION

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1.6 External View
The external view of C42 Probe is shown in Fig. 1.
Connector
C
able
Un-immersible part
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 be cleaned by water.
Fig. 1 External view
Applied part
Immersible part (IPX7)
Head
Magnetic sensor
attachment (Option)
Magnetic sensor attachment
(with needle guide bracket)
(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 for 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 for Material Surface
2.2.1 Visually inspect the surface of the probe and head, housing,
the cable and the connector for any crack, scratch or
denaturalization. If you find any damage, do not use the probe
and contact a service support immediately.
2.2.2 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 and the magnetic sensor attachment are
cleaned, disinfected 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) Use a sterile probe cover to protect the probe.
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 desired image.
6) After using the probe and the magnetic sensor attachment, 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 and the Magnetic sensor attachment in the
environment indicated in “6. Maintenance and Safety inspection”.

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4. Option of C42 Probe
4.1 Magnetic sensor
4.1.1 How to attach the Magnetic sensor
The procedure of attaching the magnetic sensor is as follow.
1) Confirm that the probe and magnetic sensor attachment are
cleaned, disinfected 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) The magnetic sensor attachment is available in two different types
whether it is used with the needle guide bracket or not. Select on
of the following attachment.
When not using the Needle guide bracket When using the Needle guide bracket
“☆EUP-C532” indication “☆EUP-C532+GUIDE” indication
Fig. 3 Selection of the Magnetic sensor attachment

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b) Insert the magnetic sensor into the magnetic sensor attachment with
correct direction as shown in Fig. 4.
Never attach the magnetic sensor attachment to the probe in the
incorrect direction, otherwise it may result in false diagnosis.
Projected part of the Magnetic sensor attachment
Magnetic sensor Direction mark of the Magnetic sensor
(Place the direction mark upward as shown
here.)
Fit the insertion direction
Magnetic sensor
attachment
Slit of the Magnetic sensor attachment
Magnetic sensor Direction mark of the Magnetic sensor
(Place the direction mark upward as shown
here.)
Fit the insertion direction
Magnetic sensor
attachment
When not using the Needle guide bracket
When using the Needle guide bracket
Fig. 4 How to attach the
M
a
gnetic sensor
CAUTION

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c) Place the magnetic sensor attachment on the probe with the correct
direction as shown in Fig. 5.
When using a Needle Guide Bracket
When not using a Needle Guide Bracket
Fig. 5 How to attach the Magnetic sensor attachment
Index mark
Fit the insertion
direction
Slit of the
Magnetic sensor
attachment
Needle guide bracket
Projected part of
the Magnetic sensor
attachment
Fit the insertion
direction

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4.1.2 How to release the Magnetic sensor
The procedure of releasing the magnetic sensor from the probe
is as follows.
a) Push the magnetic sensor attachment and release it from the probe
as shown in Fig. 6.
When not using a Needle Guide Bracket When using a Needle Guide Bracket
Push here Push here
Fig. 6 How to release the Magnetic sensor attachment

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b) Release the magnetic sensor from the magnetic sensor attachment as
shown in Fig. 7.
When not using the Needle guide bracket When using the Needle guide bracket
Fig. 7 How to release the magnetic sensor

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5. Reprocessing Procedure
The probe and magnetic sensor attachment must be reprocessed after
each use. Refer to the reprocessing instruction in this chapter.
Take care about clean circumstances before using the probe and the
magnetic sensor attachment on the next patients. Please refer to
the instruction manual of needle guide bracket EZU-PA532 about the
method of cleaning, disinfecting and sterilizing the needle guide
bracket EZU-PA532
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
T
he probe is not completely submersible. The immersible
part is shown in Fig.1. The un-
i
mmersible part should
be disinfected by wipe disinfection.
Transportation
before using
The probe should be packed in a sterile pouch or
container to transport from Central Sterile Supply
D
epartment (CSSD) to an operating room. Be careful not
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