HITACHI C41V User Manual

C41V 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  
Q1EEP13636  
© Hitachi, Ltd. 2013, 2017. All rights reserved.  
0123  
About this manual  
This instruction manual contains safety precautions, the inspection,  
the operation procedure and the reprocessing procedure of C41V Probe.  
Please read this manual thoroughly to ensure the safety operation.  
If you have any questions concerning the operation of the probe, please  
contact a service support.  
The following conventions are used throughout the manual to denote  
information of special emphasis.  
WARNING: “Warningindicatesthepresenceofahazardwhichmayresult  
in severe personal injury, substantial property damage, or  
death if the warning is ignored.  
CAUTION: “Caution” indicates the presence of a hazard which will or  
can cause minor personal injury or property damage if the  
caution is ignored.  
NOTICE: “Notice” indicates information of installation, operation,  
or maintenance, which is important, but not hazard related.  
(2)  
Q1E-EP1363  
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  
Descriptive Content  
Hitachi, Ltd.  
Symbol  
2-16-1, Higashi-Ueno,Taito-ku, TOKYO,  
110-0015, Japan  
+81-3-6284-3668  
thcare/index.html  
Manufacturer  
Company Name  
and Address  
Authorized  
Representative  
in The European  
Community  
Hitachi Medical Systems GmbH  
Otto-von-Guericke-Ring 3 D-65205  
Wiesbaden, Germany  
Store the probe in a cool, dustproof and  
dark,dryplacetoavoidhightemperature,  
humidity and direct sunlight.  
Keep away from  
Sunlight  
Contains or  
presence of  
natural rubber  
latex  
Contains or presence of natural rubber  
latex  
Do not  
re-sterilize  
Do not re-sterilize  
Do not reuse  
Do not reuse  
(3)  
Q1E-EP1363  
Definition of symbol  
The following symbol is also used for HITACHI Ultrasound Probes.  
Location Symbol  
Definition  
ThisinstrumentcomplieswithDirective93/42/EEC  
relating to Medical Device and Directive  
2011/65/EU relating to RoHS  
Probe  
connector  
Probe  
connector  
IPX7 mark  
See section 1.6.  
IPX7  
Probe  
connector  
Type BF APPLIED PART  
General warning sign  
Warning; dangerous voltage  
Probe  
connector  
Probe  
connector  
Probe  
connector  
Caution; Biohazard  
Follow the instruction manual to operate this  
instrument. If not avoided, may result in injury,  
property damage, or the equipment trouble.  
Probe  
connector  
Probe  
connector  
STERRAD sterilization compatibility mark  
Upper Limit of Temperature;  
Probe  
connector  
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  
By prescription only. U.S. Federal Law restricts  
this device to sale on order of a physician only.  
Rx Only  
(4)  
Q1E-EP1363  
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  
1.6 Construction··············································4  
2. Inspection before Use ········································5  
2.1 Inspection for Appropriate Connection·····················5  
2.2 Inspection for Material Surface···························5  
3. Operation Procedure ··········································6  
3.1 Connection and Settings···································6  
3.2 Use of Sterile Puncture Adapter (EZU-PA5V)················8  
3.3 Display of Needle Guide Line······························9  
4. Cleaning, Disinfection and Sterilization ····················10  
4.1 Point of use (Pre-cleaning)······························11  
4.2 Containment and transportation···························11  
4.3 Manual Cleaning and disinfection·························12  
4.4 Drying···················································13  
4.5 Inspection···············································13  
4.6 Packaging················································14  
4.7 Sterilization············································15  
4.8 Storage··················································16  
5. Maintenance and Safety Inspection ···························17  
5.1 Daily Inspection·········································17  
5.2 Storage··················································17  
6. Safety Precautions ··········································18  
7. Specifications ··············································19  
7.1 Probe····················································19  
7.2 Sterile Puncture Adapter EZU-PA5V························20  
7.3 Suppliers List···········································21  
8. Disposal of the probe ·······································21  
(5)  
Q1E-EP1363  
1. Introduction  
1.1 Features  
C41V Probe is a Convex Array Probe.  
The acoustic output of this probe when connected to ultrasound  
diagnosticscannerwasmeasuredaccordingtotheIEC60601-2-37standard.  
The table of measured acoustic output data is contained in the  
operational 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  
Thisprobeandtheultrasounddiagnosticscannerenableimagediagnosis  
using ultrasonic waves. This system operates under the principles  
described below.  
1) When an electric pulse signal is applied from the transmitter to  
thetransduceroftheprobe,thetransducerconvertselectricsignals  
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.  
Electricsignalsareconvertedtoshadesofbrightnessbybrightness  
modulation to obtain an image.  
-1-  
Q1E-EP1363  
1.3 Intended Use  
C41V Probe is designed for observation and diagnosis of the following  
regions mainly by connecting with the HITACHI ultrasound diagnostic  
scanner.  
General OB/GYN organs  
Biopsy (with a Sterile Puncture Adapter)  
Transvaginal/Transrectal  
WARNING  
Never use the probe for following regions.  
1) The heart (Do not contact directly.)  
2) The eyeball  
1.4 Components  
Components of C41V Probe are as follows:  
1) Probe························ 1 piece  
2) Instruction Manual··········· 1 copy  
CAUTION  
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  
it.  
-2-  
Q1E-EP1363  
1.5 Accessories (Option)  
1.5.1 Sterile Puncture Adapter EZU-PA5V (Disposable)  
Attachment for ultrasound guided transvaginal or transrectal  
biopsy and aspiration of organs, cyst and tumor. The size of  
available needle is 16 to 19G. Application requires special care.  
Sterile Puncture Adapter EZU-PA5V is as follows:  
Component  
Model Note  
Sterile Puncture Adapter EZU-PA5V 24 pcs  
NOTE: If you need Sterile Puncture Adapters, please contact a service  
support.  
CAUTION  
A well-trained physician only should perform a biopsy.  
1.5.2 Mechanical Compression Unit for Elastography EZU-TEMC1 and  
balloon set for Elastography EZU-TEBL2  
Thismechanicalcompressionunitisusedfortissueelasticityimaging,  
by using the balloon attached to the probe that is connected to a  
Hitachi's digital ultrasound scanner system and electronic scanning  
ultrasound tomography system.  
Please refer to the instruction manual of option about the method of  
handling, cleaning and disinfection of EZU-TEMC1 and EZU-TEBL2.  
1.5.3 Condom or Protection Sleeve for Single Use (Disposable)  
Toprotecttheprobeagainstcontamination,usingonlylubrication  
free condom or protective tube sleeve which is dry type is  
recommended.  
Lubrication may cause a deterioration of the probe surface. And  
latex rubber may create allergic reactions, use of non-allergic  
condom or sleeve is strongly recommended.  
Take care for the handling of used condom or protection sleeve.  
-3-  
Q1E-EP1363  
1.6 Construction  
The external view of C41V Probe is shown in Fig. 1.  
Immersible part (IPX7)  
Applied part  
Cable  
Connector  
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 cannot be  
cleaned by water.  
Fig. 1  
External view  
-4-  
Q1E-EP1363  
2. Inspection before Use  
Prior to use, the probe and accessories must be carefully inspected  
that they are appropriate for use. If you find any damage, do not use  
them and contact a service support immediately.  
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.  
3) Confirm that the Sterile Puncture Adapter and software version and  
then settings of the scanner are appropriate for the probe. Attach  
the Sterile Puncture Adapter on the probe. Set the ultrasound  
diagnostic scanner to display the “Needle guide line”. (Refer to  
the operation manual for the ultrasound diagnostic scanner.) Keep  
theprobeheadinthewaterandinsertapunctureneedleintheSterile  
PunctureAdapter. Then, confirmthattheneedleisinsertedsmoothly  
and the echo of the needle is displayed on the dot line “Needle guide  
line” on the monitor.  
2.2 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 envelope of the Sterile Puncture Adapter for  
any break, deformation, crack or denaturalization. If you find any  
damage, do not use the Sterile Puncture Adapter.  
-5-  
Q1E-EP1363  
3. Operation Procedure  
3.1 Connection and Settings  
1) Confirm that the probe is cleaned, disinfected and sterilized.  
2) It is recommended to use a disposable probe cover for preventing  
apatientfrominfectionandtheprobecovershouldbemadeofallergy  
free material to avoid allergic reaction.  
3) Connect the probe to the ultrasound diagnostic scanner and operate  
the scanner and adjust the image according to the instructions given  
in the operation manual for the ultrasound diagnostic scanner.  
4) Put proper quantity of sterilized acoustic jelly on the probe head  
as a couplant. (See Fig. 2.)  
Sterilized acoustic jelly  
Fig. 2  
5) Put a probe cover on the probe and draw the probe cover until the  
end of the probe shaft. To avoid air bubbles, be careful to press  
the probe cover gently against probe head and to keep jelly on the  
probe head. If air bubbles appear on the probe head, remove air  
bubbles by pushing jelly with finger. (See Fig. 3 and Fig. 4.)  
Probe cover  
Air bubble  
Sterilized acoustic jelly  
Fig. 3  
Fig. 4  
WARNING  
Be careful with a probe cover made out of latex. The latex may  
cause such allergic reactions as itching, rubor, urticaria,  
swelling, fever, anhelation, wheezing, and depression of blood  
pressure, shock and so on.  
If your patient shows any of the above mentioned symptoms during  
the operation, stop the use of protective sleeve immediately and  
take an appropriate treatment to the patient.  
-6-  
Q1E-EP1363  
6) Fix jelly on the top of the probe with sterile adhesive tape. (See  
Fig. 5.)  
Sterilized tape  
Fig. 5  
7) Insert the probe gentry and adjust the probe’s position for a clear  
view of the desired image. By turning or tilting the probe, a “turn  
around” imaging is possible. If the image is insufficient, use  
sterile saline solution. This solution improves the contact between  
probe and organ.  
8) After using the probe, clean, disinfect and sterilize the probe  
immediately.  
9) Store the probe in the environment indicated in “5 Maintenance and  
Safety Inspection”.  
-7-  
Q1E-EP1363  
3.2 Use of Sterile Puncture Adapter (EZU-PA5V)  
The process of attaching the Sterile Puncture Adapter (EZU-PA5V) to  
theprobeisasfollows.IftheSterilePunctureAdapterisused,careful  
handling is necessary to avoid damage of the probe cover. During open  
or minimal invasive surgery, use the protection sleeve to cover probe  
and cable.  
1) Attach a sterile probe cover to the probe. (See “3.1 Connection and  
Settings”)  
2) Put the picks of the Sterile Puncture Adapter to the grooves on the  
tip of the probe. (See Fig. 6.)  
Sterile Puncture Adapter (EZU-PA5V)  
Probe cover  
Fig. 6  
3) Push the other end of the Sterile Puncture Adapter until fix the  
dentsoftheSterilePunctureAdaptertotheprojectionontheprobe.  
(See Fig. 7.)  
Fig. 7  
-8-  
Q1E-EP1363  
3.3 Display of Needle Guide Line  
When puncture is to be conducted, the needle guideline can be displayed  
by dot marks. Operation procedure for displaying the needle guideline  
on the ultrasound diagnostic scanner must be referred to the part of  
“Needle guide line” in the manual of the connected the ultrasound  
diagnostic scanner.  
NOTE: Theneedleguidelinewillbedisplayedtoprovideavisualguide  
tothedirectionofthepunctureneedlepathway. Besuretocheck  
the actual location of the needle on the ultrasound image when  
performing the puncture operation.  
CAUTION  
The needle guide line can be displayed with this probe; however, some  
image display may not be appropriate for puncture procedure according  
to the location of observation field-of-view.  
Use observation field-of-view that is appropriately according to the  
location of puncture.  
-9-  
Q1E-EP1363  
4. Cleaning, Disinfection and Sterilization  
The probe and accessory must be reprocessed after each use. Refer  
to the reprocessing instruction in this chapter.  
The probe is delivered unsterile. Prior to the  
first use, reprocess the probe.  
Temperature should not exceed 60°C during  
reprocessing.  
WARNINGS  
Probe connector is not water resistant.  
The probe is not completely submersible. The  
immersible part is shown in Fig.1. The un-immersible  
part should be disinfected by wipe disinfection.  
Limitations on  
reprocessing  
The probe should be packed in a sterile pouch or  
container to transport from Central Sterile Supply  
Department (CSSD) to an operating room. Be careful  
not to damage the sterile pouch or container during  
transportation.  
Transportation  
before using  
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  
Cleaning  
Application part only  
contacts intact and  
uninjured skin  
uncritical  
Disinfection  
Cleaning  
Application part contacts  
mucosa (intracavitary  
application)  
Disinfection  
(Disinfectant with  
virucidal effect)  
semicritical  
critical  
Cleaning  
Disinfection  
(Disinfectant with  
virucidal effect -  
minimum)  
Application part contacts  
intracorporeal tissue  
directly  
(operative application)  
Sterilization  
Accordingtotheintendeduse,C41Vprobeisclassifiedassemicritical.  
-10-  
Q1E-EP1363  
The flowchart of the reprocessing process of this probe is as follows.  
Manual cleaning and  
disinfection  
Drying  
Packing  
Point of use  
(Pre-cleaning)  
Containment and  
transportation  
Sterilization  
Rinsingaftermanual  
disinfection  
4.1 Point of use (Pre-cleaning)  
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 and leavings of ultrasound jelly  
4.2 Containment and transportation  
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.  
-11-  
Q1E-EP1363  
4.3 Manual Cleaning and disinfection  
Manual cleaning  
and disinfection  
Prepare following items before manual  
cleaning and disinfection:  
Manual Cleaning  
a) Detergent: Cidezyme (Johnson & Johnson,  
#2258) or another cleaning agent with  
approvedmaterialcompatibilityforthis  
medical device  
Rinsing after manual  
cleaning  
b) Disinfectant: Cidex OPA (Johnson &  
Johnson, # 20391) or another  
Manual Disinfection  
disinfectant with approved material  
compatibility for this medical device  
Rinsingaftermanual  
disinfection  
c) Two tanks, one for cleaning and one for  
disinfection - optional:  
1 additional tank for rinsing with  
deionized/tapwater(sufficientsizefor  
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) Thetemperatureofthedetergentsolutionshouldbebetween15-30°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.8). 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) Rinsetheprobewithrunningtapwaterfor1minute. (alternatively:  
immerse the immersible part of the probe in a tray filled with  
deionized water/tap water (see Fig.8) for 5 min.)  
6) Visually check the outer surface of the probe for cleanness. If  
necessary,usemagnifyingglassforvisuallycheck.Ifthereisstill  
soil visible, repeat all above steps.  
-12-  
Q1E-EP1363  
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  
Water, Detergent  
or Disinfectant  
shouldbeminimum20°C.Theminimumcontact  
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.8). Set a  
clock to insure the recommended contact  
time which is 5 minutes.  
4) Rinsetheimmersiblepartoftheprobewith  
deionized water for 1 minute.  
(alternatively: immerse the immersible  
part of the probe in a tray filled with  
deionized water (see Fig.8) for 5 min.)  
5) Visually check the outer surface of the  
probe for leavings of the disinfectant. If  
necessary, repeat the rinsing.  
Fig.8 Immersionof  
the probe  
4.4 Drying  
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.  
-13-  
Q1E-EP1363  
Packaging  
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.  
-14-  
Q1E-EP1363  
Sterilization  
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.  
ETO Gas Sterilizer, closed system  
Parameter  
Specification  
Preconditioning None  
Conditioning in Temperature:122.0-131.0°F(equivalentof5055°C)  
Chamber (Dwell) Humidity: 40 - 90 % RH  
Prevacuum: 8 - 26 kPa  
Time: 30 - 45 minutes  
Exposure  
Temperature:122.0-131.0°F(equivalentof5055°C)  
Sterilant gas: 10 % EO / 90 % HCFC  
Excess pressure: 162 - 200 kPa  
Exposure time: 120 - 125 min (full cycle)  
8 - 26 kPa, 2 times  
Post-vacuum  
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"  
WARNING  
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 not be functional.  
-15-  
Q1E-EP1363  
The packaging before sterilization is as follows.  
1) Put the probe into TYVEK  
pouch.  
Probe  
TYVEK Pouch  
Fig. 9 Packaging in the pouch  
2) Seal the TYVEK Pouch using  
aheatsealer. Ensurethat  
the seal is complete.  
Sealed  
Probe  
Fig. 10 Sealing  
3) Put the sealed pouch into a  
tray or plastic mesh wire  
for sterilization.  
Tray for  
sterilization  
Probe in  
the Pouch  
Fig.11 Packaging in a tray  
4.8 Storage  
Store the equipment in a cool, dustproof, dry, and dark space  
to avoid high temperature, humidity and direct sunlight.  
Limitations for the time for sterilized equipment belong to  
package.  
-16-  
Q1E-EP1363  
5. Maintenance and Safety Inspection  
5.1 Daily Inspection  
Visually inspect the surface of the probe head, housing, cable and  
connector for any crack, scratch or denaturalization. If you find any  
damage, do not use the probe and contact a service support immediately.  
5.2 Storage  
After using the probe, it should be cleaned and disinfected and  
sterilized following “4. Cleaning, disinfection and  
Sterilization” immediately. Then store it in a cool and dark  
place avoid high temperature, humidity and direct sunlight.  
-17-  
Q1E-EP1363  
6. Safety Precautions  
WARNING  
1) Never use the probe if the probe head, shaft or cable are cracked  
or damaged.  
2) WhenuseC41VProbeforbiopsypurpose, useSterilePunctureAdapter  
EZU-PA5V (Option) certainly.  
3) Never use the Sterile Puncture Adapter if the adapter is deformed,  
cracked or damaged.  
4) Do not use the latex probe cover for latex sensitive patients. The  
probe cover, which contains latex, may cause allergic reactions as  
itching, rubor, urticaria, swelling, fever, anhelation, wheezing  
and depression of blood pressure, shock and so on.  
5) The ultrasound gel attached to the ultrasound scanner as one of  
accessories is not sterile. So never use it with C41V Probe.  
CAUTION  
1) By OB/GYN applications of the probe during surgical or  
minimal-invasiveprocedures,takecarethatelectrocauterydevices  
are out of range. In case of using defibrillation, take the probe  
out or away from the body.  
2) Keep the acoustic power low and minimize the ultrasound exposure  
time for the examination of an early pregnancy.  
3) Donotexposetheconnectortowaterorotherliquids.Theconnector  
is not waterproof.  
4) Do not hit or drop the probe. The probe is easily damaged by  
mechanical shock.  
5) Do not use detergents and disinfectants other than listed in “7.3  
Suppliers list”.  
6) Useasterileprobecovertoavoidstainingordamagingtheacoustic  
lens.  
7) Clean, disinfect and sterilize the probe before the first use as  
it is not sterilized in the factory.  
8) Use only the soft cloth or tissue to clean the acoustic lens.  
9) Only a well-trained physician should perform a biopsy.  
10) Do not attach unapproved devices to the probe.  
-18-  
Q1E-EP1363  
7. Specifications  
7.1 Probe  
Type:  
C41V Probe  
Acoustic working frequency: 6.5MHz  
Technology:  
Dimensions:  
Weight:  
Convex Array Probe  
See Fig. 12  
Approx.0.60kg (Including cable and  
connector)  
Probe materials:  
Acoustic output:  
Bio-compatible allergy free components  
According to IEC 60601-2-37 (See Main  
Unit manual.)  
Applicable system:  
Depending on production and upgrade  
status. For detailed information  
contact a service support.  
Classification:  
Cleaning:  
MDD classification IIa.  
Applicable detergents are listed in the  
suppliers list  
Disinfection:  
Sterilization:  
Applicable disinfectants are listed in  
the suppliers list  
ETO gas sterilization or Plasma  
sterilization  
Operating conditions:  
Ambient temperature:  
+10 – +35°C  
Contactsurfacetemperature max. 42°C  
(Temperature of examinee):  
Relative humidity:  
Storage conditions:  
Temperature:  
30 – 85%  
–10 – +55°C  
Relative humidity:  
10 – 95% (Subject to no condensation)  
-19-  
Q1E-EP1363  
7.2 Sterile Puncture Adapter EZU-PA5V  
Type:  
EZU-PA5V  
External view:  
See Fig. 13  
Acceptable needle gauge: 16G to 19G  
Materials:  
Bio-compatible allergy free components  
Classification:  
Package:  
MDD classification IIa  
24 Sterile Puncture Adapters for single use  
Sterilization method: Sterilized with gamma irradiation  
Operating conditions:  
Temperature:  
Storage conditions:  
Temperature:  
-10 – +40°C  
-10 – +40°C  
-20-  
Q1E-EP1363  
7.3 Suppliers List  
The products listed below are seriously tested and approved for use  
with C41V Probe.  
Product name  
Cidezyme®  
manufacturer  
Johnson & Johnson  
ANIOS  
purpose  
Enzymatic detergent  
Disinfectant  
Disinfectant  
Disinfectant  
Disinfectant  
Disinfectant  
STERANIOS 2%  
ANIOXYDE1000  
CIDEX  
ANIOS  
Johnson & Johnson  
CIDEX® plus™ 28 Johnson & Johnson  
CIDEX® OPA Johnson & Johnson  
HYAMINE SOLUTION RICCA CHEMICAL COMPANY Disinfectant  
STERIHYDE®  
Maruishi Pharmaceutical Disinfectant/sterilize  
Mediacal Chemical Corp Disinfectant/sterilize  
WAVICIDE-01  
Please contact your local distributor for a current version of the  
"Disinfectant/SterilizationMethodCompatibilityforUltrasoundProbe  
and Accessory List”  
8. Disposal of the probe  
RecycleordisposethisequipmentproperlyincompliancewiththeWaste  
Management and Public Cleansing Law.  
CAUTION  
Before disposing the equipment, disinfect or take other  
infection-prevention measures. Disposal of the equipment without  
taking the proper preventative measures can lead to infection.  
Waste Electrical and Electronic Equipment (WEEE) Directive  
The illustration on the right is required by the EU WEEE  
Directivetoappearonallelectricalandelectronicequipment.  
For proper disposal of this product in an EU nation, contact  
an EU office or agency and observe appropriate local and  
national regulations and laws.  
-21-  
Q1E-EP1363  
Unit: mm  
Fig. 12  
External view of C41V Probe  
-22-  
Q1E-EP1363  
Fig. 13  
External view of C41V Probe with  
Sterile Puncture Adapter (EZU-PA5V)  
E
-23-  
Q1E-EP1363  

Toshiba Eo1 33087 User Manual
Samsung Aq07pbge User Manual
Lg Iwave Microwave User User Manual
HP ELITEPAD 900 User Manual
HERTZ HP 3001 User Manual
GE AZR User Manual
FUJITSU FI 7460 User Manual
EPSON DS 575W User Manual
CRAFTSMAN 973.111350 User Manual
CRAFTSMAN 125.12004 User Manual