Hitachi S21 User manual

S21 Probe
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1377-5
© Hitachi, Ltd. 2013,2017. All rights reserved.
Notes for operators and responsible maintenance personnel
䖩Please read through this Instruction Manual carefully prior to use.
䖩Keep this Instruction Manual together with the system with care to
make it available anytime.
0123

(䢢1䢢) Q1E-EP1377
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:

(䢢2䢢) Q1E-EP1377
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” 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 1.5
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. Introduction ................................................. 1
1.1 Features ................................................. 1
1.2 Principles of operation .................................. 1
1.3 Intended Use ............................................. 2
1.4 Composition .............................................. 2
1.5 External View ............................................ 3
2. Inspection before Use ........................................ 4
2.1 Inspection for Appropriate Connection .................... 4
2.2 Inspection for Material Surface .......................... 4
3. Operation Procedure .......................................... 5
4. Cleaning, Disinfection and Sterilization ..................... 6
4.1 Point of use (Pre-cleaning) .............................. 9
4.2 Containment and transportation ........................... 9
4.3 Manual Cleaning and disinfection ......................... 9
4.4 Drying .................................................. 12
4.5 Inspection .............................................. 12
4.6 Packaging ............................................... 12
4.7 Sterilization ........................................... 13
4.8 Storage ................................................. 15
5. Maintenance and Safety Inspection ........................... 15
6. Safety Precautions .......................................... 16
7. Specifications .............................................. 17
7.1 Probe ................................................... 17
7.2 Suppliers List .......................................... 18
8. Disposal of the probe ....................................... 18

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1. Introduction
1.1 Features
S21 probe is a phased array sector scanning type probe.
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 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.

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1.3 Intended Use
S21 Probe is designed for observation and diagnosis mainly of the
following regions by connecting with the HITACHI ultrasound
scanner.
xCardiac
xGeneral abdominal organs
xTranscranial
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 Composition
The probe components of S21 Probe are as follows:
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 it, be sure to clean, disinfect and sterilize
it.
WARNING
CAUTION

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1.5 External View
The external view of S21 Probe is shown in Fig. 1.
Un-immersible part
I
mmersible part (IP
X
7
)
Fig. 1 External View
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.
Head
Connector
C
able
Applied part

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2. Inspection before Use
Prior to use, the probe must be carefully inspected that it is
appropriate for use. If not, do not use the probe and immediately
contact a service support.
2.1 Inspection of appropriate connection
1) Confirm that the system is correctly operating. Refer to the
instruction manual for the ultrasound diagnostic scanner.
2) Do not attach or connect unauthorized devices nor instruments
on the probe, such as unauthorized biopsy attachments.
2.2 Inspection of material surface
Visually check the surface of the probe head, housing and cable
for any crack, scratch or denaturalization.

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3. Operation Procedure
1) Confirm that the probe is cleaned and disinfected and/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) Relationship between direction of the probe and the image is
shown in Fig. 2. The right-left orientation mark on the image
indicates the index mark on the probe.
4) Use under sterile condition, protecting the probe by using
covers is recommended. Some Latex material may create allergic
reaction. Please use allergy free material covers.
5) After the use of the probe, it should be cleaned and disinfected
and/or sterilized, then store it in an adequate place.
6) Store the probe in the environment indicated in “5 Maintenance
and Safety Inspection”.
Fig. 2 Relationship between direction Index Mark and
Ri
g
ht-Left orientation Mark
Index Mark
Right-Left orientation mark

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4. Cleaning, Disinfection and Sterilization
The probe must be reprocessed after each use. Refer to the
reprocessing instruction in this chapter.
WARNINGS
ǦThe probe is delivered unsterile. Prior to the
first use, reprocess the probe.
ǦTemperature should not exceed 60°C during
reprocessing
ǦProbe connector is not water resistant.
Limitations on
reprocessing
The probe is not completely submersible. The
immersible part is shown in Fig.1. The un-immersible
part should be disinfected by wipe disinfection.
Transportation
before using
The probe should be packed in a sterile pouch or
c
ontainer to transport from Central Sterile Supply
D
epartment (CSSD) to an operating room. Be careful
n
ot 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
According to the intended use, S21 probe is classified as uncritical.

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The flowchart of the reprocessing process of this probe is as follows.
Point of use
(Pre-cleaning)
Manual Cleaning
Rinsing after manual
cleaning
Manual Disinfection
D
rying
Manual cleaning and
disinfection
Rinsing after manual
disinfection
Packing
Sterilization
Containment and
transportation

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4.1 Point of use (Pre-cleaning)
Pre-cleaning should be done immediately after
each use. The procedure is as follows:
1) Remove the probe cover.
2) Clean the probe of all patient’s blood or fluid with running
tap water until the surface of the probe looks visually clean.
3) Wipe the whole surface of the probe with gauze pad and remove
superficial visible impurities.
4.2 Containment and transportation
Putting the contaminated equipment into
exclusive shock and damage proof container
for transportation is recommended. It is recommended that
instruments are reprocessed as soon as possible and not later
than 4 hours after usage.
4.3 Manual Cleaning and disinfection
Prepare following items before manual
cleaning and disinfection:
a) Detergent: Cidezyme® (Johnson &
Johnson, #2258) or another cleaning
agent with approved material
compatibility for this medical
device
b) Disinfectant: Cidex® OPA (Johnson
& Johnson, # 20391) or another
disinfectant with approved
material compatibility for this
medical device
c) Two tanks, one for cleaning and one
for disinfection - optional:
1 additional tank for rinsing with deionized/tap water
(sufficient size for immersion of the immersible part of the
probe at full length)
d) Soft, fluff free cloth or single use towel
e) Personal protective equipment (gloves, water repellent
protective skirt, face protection mask or protective glasses,
Point of use
(Pre-cleaning)
Containment and
transportation
Manual Cleaning
R
insing after manual
cleaning
Manual Disinfection
R
insing after manual
disinfection
M
anual cleaning and
disinfection

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see also instructions of the manufacturer for the detergent
and the disinfectant)
Manual Cleaning:
Prepare the detergent solution in a tank with cold water (please follow
the instructions of the detergent manufacturer regarding application,
dilution and contact time).
1) The temperature of the detergent solution should be between 15-30°C,
concentration is 1.6%. Please note the minimum contact time of the
detergent in the manufacturer’s instruction. If a differing
detergent is used, please also note the approved material
compatibility for the medical device.
2) Immerse the immersible part of the probe without connector into the
diluted detergent solution (see Fig 3). Wipe the immersible part
of the probe under the surface of the detergent solution with a soft
cloth to remove all visible soil. Be sure that all grooves of the
probe are implemented during the cleaning process.
3) The immersible part of the probe should be left in the detergent
solution according to the specified contact time of the detergent
manufacturer.
4) Wipe the un-immersible parts of the probe with a soft cloth dipped
with the detergent solution.
5) Rinse the probe with running tap water for 1 minute. (alternatively:
immerse the immersible part of the probe in a tray filled with
deionized water/tap water (see Fig.3) for 5 min.)
6) Visually check the outer surface of the probe for cleanness. If
necessary, use magnifying glass for visually check. If there is still
soil visible, repeat all above steps.

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Manual disinfection:
1) Prepare the disinfectant solution in a tank with cold water (please
follow the instructions of the disinfectant manufacturer regarding
application, concentration, microbiological efficiency, service
life and contact time).
2) Confirm the concentration of the disinfectant before immersing the
probe. Although Cidex® OPA does not need to be diluted, it is
recommended to use test strips to verify the concentration. The test
strips can indicate whether or not the concentration is above the
Minimum Effective Concentration (MEC). Please also note the
expiration date of the test stripes. Temperature of disinfectant
solution should be minimum 20°C. The minimum contact time is 5
minutes. If a different disinfectant is used, follow the
manufacturer’s instructions. Please also consider the material
compatibility for the medical device.
3) Immerse the immersible part of the probe into the disinfectant (see
Fig.3). Set a clock to insure the recommended contact time which
is 5 minutes.
4) Rinse the immersible part of the probe with deionized water for 1
minute. (alternatively: immerse the immersible part of the probe
in a tray filled with deionized water (see Fig. 3) for 5 min.)
5) Visually check the outer surface of the probe for leavings of the
disinfectant. If necessary, repeat the rinsing.
Water
Detergent
Disinfectant
Fig. 3
I
mmersion of the Probe

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4.4 Drying
1) Wipe the probe with a single-use, fluff-free wipe or towel
to remove moisture from the surface of the probe.
2) Dry the probe naturally in an ambient temperature between
15-30°C for a minimum of 4 hours. Alternatively the equipment
can be dried using a drying heater at a temperature of less
than 60°C.
4.5 Inspection
Inspect the equipment for any damage such as crack, scratch or
deformation. Do not use it if any damage is found.
4.6 Packaging
Pack the probe in a sterile barrier such as Polypropylene fleece
or transparent package made from Polyethylene film and Tyvek®,
and then place it into a tray. The tray should be also covered
with a sterile barrier.
Additionally the probe can be placed on plastic mesh wires
supplied for plasma sterilization and then packed as mentioned
above.
The probe can be packed in a simple or double packing.
Please note that the size of a sterile barrier should be large
enough to be able to pack the equipment leaving sufficient space
to seal it completely.
A sterile barrier should be sealed by an appropriate sealing
machine and it is important to confirm that the package is sealed
completely. If the sealing is not complete, pack and reseal again.
Drying
Packaging

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WARNING
4.7 Sterilization
The probe can be sterilized using either ethylen oxide gas (EtO)
sterilization or plasma sterilization (see table below).
Follow the manufacturer's instructions of the sterilizer
regarding usage, temperature and sterilization-time.
The sterilization method and operating conditions are as follows.
Sterilization Method Condition
Plasma Sterilization:
STERRAD® 50, 100S or 200 (*) Short Cycle
Plasma Sterilization:
Sterrad® NX or 100NX (*) Standard cycle
ETO Sterilization
¾Gas Type: 10% EO/ 90% HCFC
¾Temperature: 50-55°C
¾Exposure Time: More than 120 minutes
¾Pressurization: 162-200kPa
Depressurization: 13-8kPa
¾Relative humidity: 40-90%
¾Aeration is minimum 12 hours
* STERRAD® systems are manufactured by "Johnson & Johnson"
1) Before performing sterilization, check that the operation data
of sterilizer are in conjunction with min. and max. data applicable
for the probe.
2) Do not sterilize the probe by Steam Autoclaving. If you autoclave
it, it suffers serious damage and will be not functional.

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The packaging before sterilization is as follows.
1) Put the probe into TYVEK
pouch.
2) Seal the TYVEK Pouch using
a heat sealer. Ensure
that the seal is complete.
3) Put the sealed pouch into
a tray or plastic mesh wire
for sterilization.
TYVEK Pouch
Fig. 4 Packaging in the pouch
Probe
TYVEK Pouch
Sealed
Fig. 5 Sealing
Probe
Fig. 6 Packaging in a tray
Probe in
the Pouch
Tray for
sterilization