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Q1E-EP0386

8. Specifications

8.1

Probe
Type

: EUP-C516 Convex Array Probe

Center frequency

: 3.5MHz

Technology

: Convex Array Probe

Dimensions

: See Fig. 17

Weight :

Approx.

1.5kg

(incl. cable and connector)

Scanning angle

: 65°

Probe materials

: Bio-compatible allergy free

components

Acoustic output

: According to IEC60601-2-37

(See Main Unit manual.)

Applicable system

: Depending on production and upgrade

status. For detailed information
contact a service support.

Classification

: MDD classification IIa.

Cleaning

: Applicable detergents are listed in

the suppliers list.

Disinfection

: Applicable disinfectants are listed

in the suppliers list.

Sterilization

: ETO gas sterilization

Operating conditions :

Ambient temperature

; 25 – 35°C

Contact surface temperature
(temperature of examinee)

; max. 42°C

Relative humidity

; 30 – 85%

Storage conditions:

Temperature

; –10 – +55°C

Relative humidity

; 10 – 95%
(subject to no
condensation)

Содержание EUP-C516

Страница 1: ...86 9 Hitachi Ltd 2013 2017 All rights reserved Notes for operators and responsible maintenance personnel Please read through this Instruction Manual carefully prior to use Keep this Instruction Manual together with the system with care to make it available anytime 0123 ...

Страница 2: ...1 3 6284 3668 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 ...

Страница 3: ...stions 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 c...

Страница 4: ... Symbol Symbol Descriptive Content Manufacturer Company Name and Address Hitachi Ltd 2 16 1 Higashi Ueno Taito ku Tokyo 110 0015 Japan 81 3 6284 3668 http www hitachi com businesses healthcare index html Authorized Representative in The European Community Hitachi Medical Systems GmbH Otto von Guericke Ring 3 D 65205 Wiesbaden Germany Keep away from Sunlight Store the probe in a cool dustproof and ...

Страница 5: ...nnector 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 Upper Limit of Temperature The probes that are applicable to Ethylene Oxide Gas Sterilization use symbol of Upper Limit of Temperature 55 degrees Probe connector Do n...

Страница 6: ...ce 4 3 Operation Procedure 5 4 Option of Hitachi ultrasound diagnostic sensor 7 4 1 Magnetic Sensor EZU RV2S 7 4 2 Magnetic Sensor EZU RV3S 10 5 Reprocessing Procedure 13 5 1 Point of use Pre cleaning 16 5 2 Containment and transportation 16 5 3 Manual Cleaning and disinfection 16 5 4 Drying 19 5 5 Inspection 19 5 6 Packaging 19 5 7 Sterilization 19 5 8 Storage 21 6 Maintenance and Safety Inspecti...

Страница 7: ...he 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 ...

Страница 8: ...ponents are as follows 1 Biopsy guide assembly 1 piece 2 Needle guide 14G 18G 21G 1 each 3 Brush 1 piece 4 Instruction manual 1 copy 5 Biopsy case 1 piece Please refer to the instruction manual of the biopsy attachment about the method of handling cleaning disinfecting and sterilizing the biopsy attachment EZU PA34T 1 5 2 Needle Guide Bracket EZU PA5C1 1 Needle guide bracket 1 piece 2 Brush 1 piec...

Страница 9: ...ing and sterilizing the Magnetic sensor attachment 1 7 External View The external view of the EUP C516 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 can not be cleaned by water Connector Cable Un immersible part Immersible part IPX7 Head Spac...

Страница 10: ...es or instruments on the probe such as unauthorized biopsy attachments 2 2 Inspection for Material Surface 2 2 1 Visually inspect the surface of the probe and head housing the cable and the connector for any crack scratch or denaturalization If you find any damage do not use the probe and contact a service support immediately 2 2 2 Visually inspect the magnetic sensor attachment and the Spacer for...

Страница 11: ...he 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 Fig 2 R...

Страница 12: ...n accordance with the procedure stated in 5 Reprocessing procedure every time immediately after completing the ultrasound examination 8 After using the magnetic sensor attachment and the spacer for EZU RV2S perform the reprocessing procedure in accordance with the procedure stated in 5 Reprocessing procedure every time immediately after completing the ultrasound examination 9 Store the magnetic se...

Страница 13: ...agnetic Sensor EZU RV2S The magnetic sensor EZU RV2S as shown in Fig 3 is a magnetic sensor for the EUP C516 4 1 1 How to attach the Magnetic Sensor The procedure of attaching the magnetic sensor is as follows 1 Confirm that the probe the magnetic sensor attachment and the spacer for EZU RV2S are cleaned disinfected or sterilized 2 Connect the probe operate the ultrasound diagnostic scanner and ad...

Страница 14: ...be in the incorrect direction otherwise it may result false diagnosis Never forget to attach the spacer for EZU RV2S to the magnetic sensor otherwise it may result in false diagnosis Index mark Fit the insertion direction Fig 5 How to attach the Magnetic sensor attachment Hole of the Magnetic sensor attachment Fig 4 How to attach the Magnetic sensor Hole of the Magnetic sensor attachment Spacer fo...

Страница 15: ...ttachment and release it from the probe as shown in Fig 6 b Release the magnetic sensor from the magnetic sensor attachment as shown in Fig 7 and release the spacer for EZU RV2S from the magnetic sensor The spacer for EZU RV2S is small please do not lose the spacer Fig 6 How to release the Magnetic sensor attachment Fig 7 How to release the Magnetic sensor CAUTION ...

Страница 16: ... the ultrasound diagnostic scanner and adjust the image according to the instructions given in the operation manual for the ultrasound diagnostic scanner 3 To use RVS Real time Virtual Sonography attach the magnetic sensor as shown below a Attach the magnetic sensor into the probe with the correct direction as shown in Fig 9 Sensor white Direction mark Fig 8 Magnetic sensor EZU RV3S Fig 9 How to a...

Страница 17: ...gnetic sensor attachment in the index mark of the probe Never attach the magnetic sensor attachment to the probe in the incorrect direction otherwise it may result in false diagnosis Index mark Fit the insertion direction Fig 10 How to attach the Magnetic sensor attachment Hole of the Magnetic sensor attachment CAUTION ...

Страница 18: ...sor from the probe is as follow 1 Turn around the magnetic sensor attachment and release it from probe as shown in Fig 11 2 Release the magnetic sensor from the magnetic sensor attachment as shown in Fig 12 Fig 11 How to release the Magnetic sensor attachment Fig 12 How to release the Magnetic sensor ...

Страница 19: ...ed 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 c...

Страница 20: ...his 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 contac...

Страница 21: ...ocess of this probe is as follows Point of use Pre cleaning Manual Cleaning Rinsing after manual cleaning Manual Disinfection Drying Manual cleaning and disinfection Rinsing after manual disinfection Packing Sterilization Containment and transportation ...

Страница 22: ...sinfection 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...

Страница 23: ... a tray filled with deionized water tap water see Fig 13 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 B Magnetic sensor attachment and Spacer for EZU RV2S 1 The temperature of the detergent solution should be between 15 30 C concentration is 1 6 Please note the mini...

Страница 24: ...mersible part of the probe into the disinfectant see Fig 13 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 13 for 5 min 5 Visually check the outer surface of the probe for leavings of the disinfectant ...

Страница 25: ...e 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 conf...

Страница 26: ...ssurization 13 8kPa Relative humidity 40 90 Aeration 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 and the attachment 2 Do not sterilize the probe and the attachment by Steam Autoclaving If you autoclave them they suffer serious d...

Страница 27: ... plastic mesh wire for sterilization 5 8 Storage Store the equipment in a cool dustproof and dark space to avoid high temperature humidity and direct sunlight Limitations for the time for sterilized equipment belong to package Sealed Fig 15 Sealing TYVEK Pouch Tray for sterilization Fig 16 Packaging in a tray Probe in the Pouch ...

Страница 28: ...u find any damage do not use the probe and contact a service support immediately 3 After using the magnetic sensor attachment and the spacer for EZU RV2S should be cleaned and disinfected or sterilized according to 5 Reprocessing Procedure then store the magnetic sensor attachment and the spacer for EZU RV2S in a cool and dark space to avoid high temperature humidity and direct sunlight 4 Visually...

Страница 29: ...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 8 2 Supplier s list Use a sterile probe cover to avoid staining or damaging the acoustic lens Clean disinfect and sterilize the probe the magnetic sensor attachment before the ...

Страница 30: ...cable system Depending on production and upgrade status For detailed information contact a service support Classification MDD classification IIa Cleaning Applicable detergents are listed in the suppliers list Disinfection Applicable disinfectants are listed in the suppliers list Sterilization ETO gas sterilization Operating conditions Ambient temperature 25 35 C Contact surface temperature tempera...

Страница 31: ...OXYDE 1000 ANIOS Disinfectant Virkon S ANTEC Disinfectant ASPHENE SPRAY RIVADIS Disinfectant Laboratories Bacillol 25 BODE CHEMIE Disinfectant CIDEX Johnson Johnson Disinfectant CIDEX plus Johnson Johnson Disinfectant CIDEX OPA Johnson Johnson Disinfectant Gigasept FF Schülke Mayr Disinfectant Tristel 1 Day Tristel Company Disinfectant Tristel Multi Shot Tristel Company Disinfectant ALKACIDE ALKAP...

Страница 32: ...es 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 Directive to appear on all electrical and electronic equipment For proper disposal of this product in an EU nation contact an EU office or agency and observe appropriate local and nationa...

Страница 33: ... 27 Q1E EP0386 E Unit mm Fig 17 Dimensions ...

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