Hitachi C22K User manual

C22K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‐EP1389‐5

©Hitachi,Ltd.2013,2017.Allrightsreserved.

(1) Q1E-EP1389
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-EP1389
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 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.

(3) Q1E-EP1389
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.

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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 ··············································· 1
1.4 Components ················································· 2
1.5 Option ····················································· 2
1.5.1 Puncture adapter (MP-2781) ······························ 2
1.5.2 Puncture adapter (MP-2781-5) ···························· 2
1.5.3 Puncture adapter (MP-2781-25) ··························· 2
1.5.4 CIVCO Bracket (CIV-614-108) ····························· 2
1.6 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) ································ 7
4.2 Containment and transportation ····························· 7
4.3 Manual Cleaning and disinfection ··························· 8
4.4 Drying ····················································· 9
4.5 Inspection ················································· 9
4.6 Packaging ················································· 10
4.7 Sterilization ············································· 11
4.8 Storage ··················································· 13
5. Maintenance and Safety Inspection ··························· 13
6. Safety Precautions ·········································· 14
7. Specifications ·············································· 15
7.1 Probe ····················································· 15
8. Suppliers List ·············································· 15
9. Disposal of the probe ······································· 16

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WARNING
1. General
1.1 General
C22K Probe is a Convex Array Probe.
The acoustic output of this probe when connected to ultrasound scanner
was measured according to IEC 60601-2-37 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.
1) Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
Direct contact to the eye
2) 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.
1.3 Intended Use
C22K Probe is designed for observation and diagnosis mainly of the
following regions by connecting with the HITACHI ultrasound scanner.
Intraoperative

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CAUTION
CAUTION
1.4 Components
The components of C22K 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 Puncture adapter (MP-2781)
1) Puncture adapter (MP-2781-MB) ··········· 1 set
2) Needle guide G18 (MP-2781-G18) ·········· 1 piece
3) Needle guide knob (MP-2781-KNO-B) ······· 1 piece
4) Adjustment hexagon screwdriver ·········· 1 piece
5) Instruction manual ······················ 1 copy
1.5.2 Puncture adapter (MP-2781-5)
1) Puncture adapter unit (MP-2781-5-MB) ···· 1 set
2) Adjustment hexagon screwdriver ·········· 1 piece
3) Instruction manual ······················ 1 copy
1.5.3 Puncture adapter (MP-2781-25)
1) Puncture adapter unit (MP-2781-25-MB) ··· 1 set
2) Adjustment hexagon screwdriver ·········· 1 piece
3) Instruction manual ······················ 1 copy
1.5.4 CIVCO Bracket (CIV-614-108)
Please refer to the instruction manual of option about the method of
handling, cleaning, disinfection and sterilization.
1) Sterilization has not been made to the MP-2781, MP-2781-5 and
MP-2781-25 shipped from the factory. Prior to use of them, be sure
to clean and sterilize them.
2) A biopsy should be performed only by a well-trained physician. Use
only the authorized puncture adapter for performing a biopsy.

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1.6 External View
The external view of C22K Probe is shown in Fig. 1.
Fig.
1
E
xternal View
Immersible part (IPX7)
Cable
Connector
Un-immersible part
H
e
ad
/
A
pplied part
Immersible
part:
This part can be immersed in disinfectant
solution and also can be cleaned by water.
Un-immersible
part:
This
p
art should not be immersed in
disinfectant solution and also cannot be
cleaned by water.

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2. Inspection before Use
Prior to use, the probe must be carefully inspected that they are
appropriate for use.
2.1 Inspection for 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 or instruments on the
probe, such as unauthorized biopsy attachments.
2.2 Inspection for Material Surface
Visually inspect the surface of the probe head, housing, the cable and
the connector for any crack, scratch or denaturalization. If you find
any damage, do not use the probe, and immediately contact a service
support.

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CAUTION
3. Operation Procedure
1) Confirm that the probe is disinfected and sterilized.
2) It is recommended to use a disposable probe cover for preventing a
patient from infection.
3) When connecting 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) 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.
5) 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.
6) 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.
7) Store the probe in the environment indicated in “5. Maintenance and
Safety Inspection”.
The acoustic lens of the probe is very thin and delicate. So if the
surface of the acoustic lens is wiped for removing remaining ultrasound
jelly or cleaned, use the soft cloth or tissue paper and handle with
care.
Right-left
orientation mark
I
ndex mark
Fig. 2 Relationship between the
directions
o
f the probe and the
Right-left orientation mark

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4. Cleaning, Disinfection and Sterilization
The probe and accessory must be reprocessed after each use. Refer
to the reprocessing instruction in this chapter.
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
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
container to transport from
C
entral Sterile Supply
D
epartment (CSSD) to an operating room. Be careful
n
ot to damage the sterile pouch or container during
transportation.
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, C22K probe is classified as critical.

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The flowchart of the reprocessing process of this probe is as follows.
4.1 Point of use (Pre-cleaning)
Pre-cleaning should be done immediately after each
use. The procedure is as follows:
1) Remove the protective 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.
Point of use
(Pre-cleaning) Manual Cleaning
Rinsing after
m
anual
cleaning
Manual Disinfection
Drying
Manual cleaning and
disinfection
Rinsing after manual
disinfection
Packing
Sterilization
Containment and
transportation
Point of use
(Pre-cleaning)
Containment and
transportation

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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, 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 Figure 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.
M
anual Cleaning
R
insing after manual
cleaning
Manual Disinfection
R
insing after manual
disinfection
M
anual cleaning
and disinfection

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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.
4.4 Drying
1) Wipe the equipment with a single-use, fluff-free wipe
or towel to remove moisture from the surface of the equipment.
2) Dry the equipment 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.
Drying
Fig. 3 Immersion of
the probe
Water, Detergent
or Disinfectant

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4.6 Packaging
Pack the equipment 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 equipment can be placed on plastic mesh wires supplied
for plasma sterilization and then packed as mentioned above.
The equipment 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.
Packaging

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WARNING
4.7 Sterilization
The probe and accessory 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.
ETO Gas Sterilizer, closed system
Parameter Specification
Preconditioning None
Conditioning in
Chamber (Dwell)
Temperature: 122.0 - 131.0 °F (equivalent of 50 – 55 °C)
Humidity: 40 - 90 % RH
Prevacuum: 8 - 26 kPa
Time: 30 - 45 minutes
Exposure Temperature: 122.0 - 131.0 °F (equivalent of 50 – 55 °C)
Sterilant gas: 10 % EO / 90 % HCFC
Excess pressure: 162 - 200 kPa
Exposure time: 120 - 125 min (full cycle)
Post-vacuum 8 - 26 kPa, 2 times
Aeration Temperature: 50 – 55 °C
Time: min. 11 hours
Plasma sterilization
Sterilization Method Condition
Plasma Sterilization:
STERRAD® 50, 100S or 200 (*) Short Cycle
Plasma Sterilization:
Sterrad® NX or 100NX (*) Standard cycle
* 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 and the Magnetic sensor attachment.
2) Do not sterilize the probe and the Magnetic sensor attachment by Steam
Autoclaving. If you autoclave them, they suffers serious damage and
will be not functional.
Sterilization

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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

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4.8 Storage
Store the equipment in a cool, dustproof, dry, and dark
s
pace
to avoid high temperature, humidity and direct sunlight.
Limitations for the time for sterilized equipment belong to
package.
5. Maintenance and Safety Inspection
1) After using the probe, the probe should be cleaned and
disinfected and sterilized according to “4. Reprocessing
Procedure
”
, store the probe in a cool and dark space to avoid
high temperature, humidity and direct sunlight.
2) Visually inspect the surface of the probe head, the housing, the cable
and the connector for any crack, scratch or denaturalization. If you
find any damage, do not use the probe, and immediately contact
a
service support.

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CAUTION
WARNING
6. Safety Precautions
Never use the probe if the probe head, housing or cable are cracked
or damaged.
Warning is 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, and 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.
By examination of an early pregnancy the exposure time shall be as
short as possible. Start examination with acoustic output power set
to L (Low).
Do not expose the connector to water or other liquids. The connector
is not waterproof.
Do not hit or drop the probe. The probe is easily damaged by mechanical
shock.
Do not use detergents and disinfectants other than listed in “7.2
Suppliers list”.
Use a sterile probe cover to avoid staining or damaging the acoustic
lens.
Clean and sterilize the probe before the first use as it is not
sterilized in the factory.
Use only the soft cloth or tissue to clean the acoustic lens.
A biopsy should be performed only by a well-trained physician.
Do not attach unapproved devices to the probe.