Hitachi C22P User manual

C22PProbe
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‐EP1457‐7

© Hitachi, Ltd. 2013,2017. All rights reserved.

0123

(1) Q1E-EP1457
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-EP1457
About this manual
This instruction manual shall provide instructions for using, cleaning,
and 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 im
p
ortant, but not hazard
related.

(3) Q1E-EP1457
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 place and keep
away from high temperature, high humidity,
or direct sunlight.

(4) Q1E-EP1457
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.

(5) Q1E-EP1457
CONTENTS Page
1. General ······················································· 1
1.1 Features ··················································· 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 ··········································· 8
3.1 Probe ······················································ 8
3.2 Attachment ················································· 9
3.3 Needle Guide Bracket EZU-PA7C2 ···························· 12
4. Reprocessing Procedure ······································· 20
4.1 Point of use (Pre-cleaning) ······························· 23
4.2 Containment and transportation ···························· 23
4.3 Manual Cleaning and disinfection ·························· 23
4.4 Drying ···················································· 26
4.5 Inspection ················································ 26
4.6 Packaging ················································· 26
4.7 Sterilization ············································· 26
5. Cleaning and Disinfection of EZU-PA7C2 ······················· 29
5.1 Point of use (Pre-cleaning) ······························· 31
5.2 Containment and transportation ···························· 31
5.3 Manual Cleaning and disinfection ·························· 31
5.4 Automated cleaning and disinfection ······················· 34
5.5 Drying ···················································· 35
5.6 Packaging ················································· 35
5.7 Assembly and Inspection ··································· 35
5.8 Storage ··················································· 35
6. Maintenance and Safety Inspection ···························· 35
7. Safety Precautions ··········································· 36
8. Specifications ··············································· 38
8.1 Probe ····················································· 38
8.2 Suppliers List of the Probe ······························· 39
8.3 Needle Guide Bracket EZU-PA7C2 ···························· 40
8.4 Suppliers list of the Needle Guide Bracket EZU-PA7C2 ······ 40
9. Disposal of the probe ········································ 41

-1- Q1E-EP1457
1. General
1.1 Features
C22P Probe is a Convex Array type.
The acoustic output of this probe when connected to ultrasound
diagnostic 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 diagnostic scanner.
This probe is categorized in class IIa according to Directive 93/42/EEC.
According to IEC60601-1 the probe is classified as type BF.
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.

-2- Q1E-EP1457
WARNING
1.3 Intended Use
C22P Probe is designed for observation and diagnosis mainly of the
following regions by connecting with the HITACHI ultrasound diagnostic
scanner.
Biopsy (with Biopsy Attachment)
General abdominal organs
Never use the probe for following applications.
1) Direct contact to the heart.
2) Biopsy to the heart.
3) Direct contact to the eye.
1.4 Components
The probe components of C22P are as follows:
1) Probe ······················ 1 piece
2) Attachment ················· 1 piece
3) Instruction Manual ········· 1 copy

-3- Q1E-EP1457
CAUTION
CAUTION
1.5 Option
1.5.1 Needle Guide Bracket EZU-PA7C2
1) Needle guide bracket ······· 1 piece
2) Brush ······················ 1 piece
3) Spring (Spare) ············· 2 pieces
4) Instruction manual ········· 1 copy
5) Case ······················· 1 piece
1.5.2 Attachment
It becomes easy to have the probe by attaching the attachment to the
probe and improves operability.
And the magnetic sensor can be fixed to the probe and it can be used
as the Attachment for Real-time Virtual Sonograpy(RVS).
1.5.3 GENERAL PURPOSE Ultra-Pro II™DISPOSABLE STERILE ULTRASOUND
NEEDLE GUIDE/COVER KIT (610-579 or 610-608).
Purchase the Ultra-Pro II™NEEDLE GUIDE/COVER KIT (610-579 or
610-608) directly from CIVCO MEDICAL INSTRUMENTS or an
authorized CIVCO distributor.
1.5.4 GENERAL PURPOSE Ultra-Pro 3™DISPOSABLE STERILE ULTRASOUND
NEEDLE GUIDE/COVER KIT (610-901) (Option).
1.5.5 Purchase the Ultra-Pro 3™NEEDLE GUIDE/COVER KIT (610-901)
directly from CIVCO MEDICAL INSTRUMENTS or an authorized CIVCO
distributor.
Sterilization has not been made to the probe, the attachment and the
Needle guide bracket shipped from the factory.
Prior to each use, be sure to clean, disinfect and if necessary sterilize
them following this instruction manual.
1) Do not attach the devices except for the Ultra-Pro II™or the
Ultra-Pro 3™NEEDLE GUIDE/COVER KIT to the Needle guide bracket
EZU-PA7C2.
2) A biopsy should be performed only by a well-trained physician.

-4- Q1E-EP1457
1.6 External View
The external view of C22P is shown in Fig. 1.
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.
C
able
Scan head
Immersible part (IPX7)
Attachment
Applied part
Needle Guide Bracket EZU-PA7C2
C
onnector
Un-immersible part
Fig. 1
E
xternal View

-5- Q1E-EP1457
2. Inspection before Use
Prior to use, the probe must be carefully inspected that it is
appropriate for use. If you find any damage, do not use the probe and
immediately contact a service support.
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 Probe
Visually check the surface of the probe head, the attachment, housing
and cable 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 Needle Guide Bracket EZU-PA7C2
1) Visually check the surface of the needle guide bracket for any crack,
scratch, denaturalization or deformation.
2) Fill a sterile container with sterile water. Water temperature
depends on the type of the ultrasound diagnostic scanner connected
to the probe. If the type of the scanner is EUB series, HI VISION
series, or Noblus, set water temperature at room temperature. For
the other type of the scanner, set it at 40 degrees Celsius.

-6- Q1E-EP1457
CAUTION
3) Put the probe in sterile water and confirm that the needle echo at
each angle overlaps with the correspondent biopsy guideline (See
Fig. 2).
Before use, make sure there is no damage to the surface to which the
needle cannula is attached, and the needle guide works properly.
9°
Test needle
Sterile water
(
Water
temperature, see
2.2.2 2))
Biopsy guide line
(a dotted line)
Right-left
orientation mark
Needle echo
(
a solid line)
Fig. 2 Echo image of the test needle

-7- Q1E-EP1457
4) Confirm that the needle guide angle corresponds to the angle
indicated on the monitor. The needle guide angle is engraved on
bracket. (See Fig. 3)
5) Visually inspect the cover to ensure that there are no defects or
holes. Do not use cover if it has any holes and tears.
21°
Needle
g
uide
angle is
engraved
Needle
guide
angle
Fig. 3 Needle guide angle

-8- Q1E-EP1457
3. Operation Procedure
3.1 Probe
1) Confirm that the probe and the attachment are cleaned, disinfected
and if necessary sterilized.
2) Attach the attachment to the probe according to 3.2.
3) 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.
4) The relationship between the direction of the probe and the image
is shown in Fig. 4. The right-left orientation mark on the image
indicates the index mark on the probe.
Index mark
Right-Left
o
rientation
mark
Probe
I
mage
Fig. 4 Relationship
b
etween the directions of the
probe and the Right-left orientation mark

-9- Q1E-EP1457
CAUTION
5) 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.
6) Place the probe on the examination site and adjust the probe’s
position for a clear view of the desire image.
7) After using the probe, perform the reprocessing procedure in
accordance with the procedure stated in “4. Reprocessing Procedure”
every time immediately after completing the ultrasound examination.
8) Store the probe and the attachment in the environment indicated in
“6. Maintenance and Safety Inspection”.
Do not use the probe if the image and the frequency do not match
the probe. An incorrect acoustic output can result in burns or other
injuries to the patient.
Scan for the minimum length of time necessary for the diagnosis and
at the lowest suitable output. There is the possibility that the
patient’s tissues could be affected. For details about the acoustic
output, please refer to the operation manual of the ultrasound
diagnostic instrument.
3.2 Attachment
Attach the attachment to the probe as indicated in Fig. 5. The attachment
can be released from the probe by sliding the attachment as indicated
in Fig. 6.
Fig. 5 How to attach
the attachment
Attachment
Push this part
Slide the
attachment
towards this
direction.
Fig. 6
H
ow to release the attachment

-10- Q1E-EP1457
CAUTION
The magnetic sensor enables Real-Time Virtual Sonography (RVS) when
it is attached to the probe.
3.2.1 Attaching the Magnetic Sensor
The procedure of attaching the Magnetic sensor is as follows.
1) Attach the Magnetic sensor into the attachment with the correct
direction as shown in Fig. 7.
2) Insert the hold of the attachment into the projected part of the
probe.
Never attach the Attachment to the probe in the incorrect direction,
otherwise it may result in false diagnosis.
Magnetic sensor
attachment
Magnetic
sensor
Direction mark of the
m
agnetic
sensor (Place the d
i
rection
mark upward as shown here)
.
Fig. 7 How to attach
t
he Magnetic
Sensor Attachment

-11- Q1E-EP1457
CAUTION
3.2.2 Removing the Magnetic Sensor
The procedure of releasing the Magnetic sensor from the probe is as
follows.
1) Press the area of the attachment shown with the arrow toward the
direction A, and then slide out the attachment toward the direction
B as shown in Fig. 8.
2) Release the Magnetic sensor from the groove of the attachment as
shown in Fig. 9.
Clean and sterilize the Magnetic sensor before the first use as it is
not sterilized in the factory.
Press this area
A
B
Fig. 8 How to release the attachment from the probe
S
lide the attachment
in this direction.
Fig. 9 How to release the Magnetic Sensor
from the groove of the probe

-12- Q1E-EP1457
3.3 Needle Guide Bracket EZU-PA7C2
1) Confirm that the needle guide bracket is cleaned and disinfected,
and the probe is cleaned and disinfected/ sterilized.
2) Fit the needle guide bracket to the probe following “3.3.1 Fitting
the needle guide bracket to the probe”. Never apply excessive force
to attach the needle guide bracket to the wrong position. It may
cause a hazard due to unstable biopsy.
3) Fit the CIV-Flex ™ cover to the probe following “3.3.2 Placing the
probe and bracket into a transducer cover”.
4) Attach the needle guide to the bracket following “3.3.3 Attaching
the needle guide to the bracket”.
5) Fit the needle insert corresponding to the gauge number of the needle
to be used to the needle guide following “3.3.3 Attaching the needle
guide to the bracket”.
6) Confirm that the needle guide angle corresponds to the angle
indicated on the monitor. The needle guide angle is engraved on
bracket following “3.3.4 Setting the needle guide angle”.
7) In the case of the CIVCO Ultra Pro II, when the needle is released
quickly from probe, press the tab on the needle insert toward the
bracket. Move bracket and needle guide away from the needle. (See
Fig. 10)
8) After the use of the needle guide bracket, it should be cleaned and
disinfected, then store it in an adequate place.
Tab on the
needle insert
Push
Needle
Fig. 10
R
elease the needle

-13- Q1E-EP1457
CAUTION
In the case of the CIVCO Ultra Pro 3™, push the green quick release
lever of the needle guide toward the bracket to open the needle insert,
and then remove the needle.
For details of the removing procedure of the needle, refer to the
Reference Guide each of the Ultra Pro II™ and Ultra Pro 3™.
1) Since the acoustic jelly accessory to the ultrasound diagnostic
scanner is not a sterilized one, never use it.
2) In order to make the dead angle of the needle as short as possible,
perform the biopsy operation with full display width. Regarding how
to adjust the display width refer to the operating manual of the
scanner.
3) 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.]

-14- Q1E-EP1457
WARNING
1) Warning in case of using probe covers which latex is contained to.
The latex may cause such allergic reactions as itching, rubor,
urticaria, swelling, fever, anhelation, wheezing, depression of
blood pressure, shock and so on.
For the patients suspected of latex allergy, do not use the
latex-containing medical devices. If you observe any of above
mentioned symptoms in your patient during the operation, stop the
use of the latex-containing medical devices immediately and take
an appropriate treatment to the patient.
2) The Ultra-Pro II™ or the Ultra-Pro3™ NEEDLE GUIDE/COVER KIT is
disposable and must not be reused.
3) Sterilize/disinfect the probe and disinfect the needle guide bracket
when a cover tears.
4) Confirm that the needle guide angle corresponds to the angle
indicated on the monitor. The needle guide angle is engraved on
bracket. Otherwise, the biopsy guide line becomes inconsistent with
the inserting position of the biopsy needle.
5) When using the needle cannula of the electrosurgical unit while using
the needle guide bracket 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 needle
guide, 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.]