Hitachi EUP-V73W Instruction Manual Download Page 1 | Manualshive

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0123

Transvaginal

Probe

EUP

‐

V73W

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

‐

EP1430

‐

5

©

Hitachi,

Ltd.

2013,

2017.

All

rights

reserved.

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2
3
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Summary of Contents for EUP-V73W

Page 1: ...tors 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 EP1430 5 Hitachi Ltd 2013 2017 All rights reserved ...

Page 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 ...

Page 3: ...upport The following conventions are used throughout the manual to denote information of special emphasis WARNING Warning indicates the presence of a hazard which may result 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 ign...

Page 4: ...r Company Name and Address Hitachi Ltd 2 16 1 Higashi Ueno taito ku Tokyo 110 0015 Japan 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 dark dry environment to avoid high temperature humidity and direct sunlight Contains or presence of natural rubber ...

Page 5: ...ltage 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 Upper Limit of Temperature The probes that are applicable to Ethylene Oxide Gas Sterilization use symbol of Upper Limit of Temperature 55...

Page 6: ...dapter EZU PA7V 7 3 3 Display of Needle Guide Line 8 4 Option of EUP V73W 10 4 1 Magnetic sensor EZU RV2S 10 4 2 Magnetic sensor EZU RV3S 13 5 Reprocessing Procedure 16 5 1 Point of use Pre cleaning 18 5 2 Containment and transportation 18 5 3 Manual Cleaning and disinfection 18 5 4 Drying 21 5 5 Inspection 21 5 6 Packaging 21 5 7 Sterilization 22 5 8 Storage 24 6 Maintenance and Safety Inspection...

Page 7: ...e 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 ...

Page 8: ...ed in one set as follows Component Model Qty Sterile Puncture Adapter EZU PA7V 24 pcs NOTE If you need Sterile Puncture Adapters please contact your local HITACHI distributor Only a well trained physician should perform a biopsy 1 5 2 Condom or Protection Sleeve for Single Use Disposable To protect the probe against contamination use only lubrication free condom or dry type protective tube sleeve ...

Page 9: ... clean disinfect and if necessary sterilize them 1 6 External view The external view of EUP V73W is shown in Fig 1 Cable Connector Un immersible part Immersible part IPX7 Magnetic sensor attachment Option Spacer for EZU RV2S Option Applied 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 ...

Page 10: ...ing to 3 Operation Procedure Display the Needle guide line on the monitor Refer to the operation manual of the ultrasound diagnostic scanner Keep the probe head under sterile water and insert a puncture needle in the Sterile Puncture Adapter then confirm that the needle is inserted smoothly and the echo of the needle is displayed on the Needle guide line dot line on the monitor 2 2 Inspection for ...

Page 11: ...ion and the probe cover should be allergy 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 of the ultrasound diagnostic scanner The relationship between the direction of the probe and the right left orientation mark on the image is shown in Fig 2...

Page 12: ...atex protective sleeve immediately and take an appropriate treatment to the patient 6 Fix the probe cover with sterile adhesive tape as shown in Fig 5 Visually inspect the probe cover for any hole or tears 7 Insert the probe gentry and adjust the probe s position for a clear view of the desired image If the image is not clear enough use sterile saline solution to have a better image 8 After using ...

Page 13: ...t s tissues could be affected For details about the acoustic output please refer to the operation manual of the ultrasound diagnostic instrument 3 2 How to attach the Sterile Puncture Adapter EZU PA7V How to attach the Sterile Puncture Adapter EZU PA7V to the probe is instructed below 1 Put the picks of the Sterile Puncture Adapter to the projection on the probe See the top of Fig 6 2 Push the oth...

Page 14: ...ultrasound image when performing the puncture operation The needle guide line can be displayed for this probe but if the image is displayed at some angle see the figures below the image displayed may not be appropriate for biopsy Confirm that the image displayed is appropriate prior to biopsy Probe Puncture adapter Needle guide line Artifact of puncture adapter Guide line is effectively displayed ...

Page 15: ... the patient 2 The puncture adapter EZU PA7V and the recommended probe covers are disposable and must not be reused 3 Clean disinfect and sterilize the probe and the puncture adapter when the probe cover is torn 4 Be careful about the use of a needle cannula with the puncture adapter If the insulation coating of the needle cannula is damaged it may cause a burn to tissue 5 Use a needle whose size ...

Page 16: ...ptions needed for RVS are the Magnetic Sensor Attachment and the magnetic sensor The magnetic sensors available are EZU RV2S and EZU RV3S shown in Fig 7 and Fig 12 respectively 4 1 Magnetic sensor EZU RV2S EZU RV2S as shown in Fig 7 is the magnetic sensor for EUP V73W Fig 7 EZU RV2S Magnetic sensor black Projected part ...

Page 17: ...f Fig 8 3 Insert the magnetic sensor into the Magnetic Sensor Attachment in the correct direction as shown in the bottom of Fig 8 1 Never attach the magnetic sensor attachment to the probe in the wrong direction otherwise it may result in false diagnosis 2 Never forget to attach the Spacer for EZU RV2S to EZU RV2S otherwise it may result in false diagnosis Projected part Fig 8 How to attach the Ma...

Page 18: ...netic Sensor Attachment to the probe as shown in Fig 9 Do not put your fingers between the Magnetic Sensor Attachment and the Probe when attaching the Magnetic Sensor Attachment to the probe Fig 9 How to attach the Magnetic sensor attachment ...

Page 19: ...nt as shown Fig 11 Clean disinfect and sterilize the Magnetic Sensor Attachment and the Spacer for EZU RV2S prior to the first use as they are not sterilized when delivered 4 2 Magnetic sensor EZU RV3S EZU RV3S as shown in Fig 12 is the magnetic sensor for EUP V73W Fig 10 How to release the Magnetic sensor attachment from the probe Fig 11 How to release magnetic sensor from the Magnetic Sensor Att...

Page 20: ...n Fig 13 Never attach the Magnetic Sensor Attachment to the probe in the wrong direction otherwise it may result in false diagnosis 3 Attach the Magnetic Sensor Attachment to the probe as shown in Fig 14 Do not put your fingers between the Magnetic sensor attachment and the probe when attaching the Magnetic Sensor Attachment to the probe Fig 13 How to attach the Magnetic sensor Direction mark of E...

Page 21: ...he probe as shown Fig 15 2 Detach the magnetic sensor from the Magnetic Sensor Attachment as shown Fig 16 Clean disinfect and sterilize the Magnetic Sensor Attachment prior to the first use as it is not sterilized when delivered Fig 15 How to release the Magnetic Sensor Attachment from the probe Fig 16 How to release magnetic sensor from the Magnetic Sensor Attachment ...

Page 22: ...sportation 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 corr...

Page 23: ...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 ...

Page 24: ...ble and not later than 4 hours after usage 5 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 de...

Page 25: ...or 1 minute alternatively immerse the immersible part of the probe in a tray filled with deionized water tap water see Fig 17 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 Attachment 1 The temperature of the detergent solution should be between 15 30 C concentratio...

Page 26: ...atibility for the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 17 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 17 for 5 min 5 Visually check the outer surfa...

Page 27: ...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 s...

Page 28: ...t Cycle Plasma Sterilization Sterrad NX or 100NX Standard cycle ETO Sterilization Gas Type 10 EO 90 HCFC Temperature 50 55 C Exposure Time More than 120 minutes Pressurization 162 200kPa Depressurization 13 8kPa Relative humidity 40 90 Aeration is minimum 12 hours STERRAD systems are manufactured by ʺJohnson Johnsonʺ Before performing sterilization check that the operation data of sterilizer are i...

Page 29: ...ch 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 Probe Attachment Fig 18 Packaging in the pouch Sealed Probe Attachment Fig 19 Sealing TYVEK Pouch Tray for sterilization Fig 20 Packaging in a tray Probe in the Pouch ...

Page 30: ...24 Q1E EP1430 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 ...

Page 31: ...r for any crack scratch or denaturalization If you find any damage do not use the probe and contact a service support immediately 2 Visually inspect the surface of the Magnetic Sensor Attachment and the Spacer for EZU RV2S for any crack deformation or denaturalization If you find any damage do not use them and contact a service support immediately ...

Page 32: ...during examination Conducting examinations with the bare hands can expose the operator to a risk of infection 8 Do not use the probe fallen on to floor Otherwise there is a risk of infection Stop the operation and perform the inspection cleaning disinfection or sterilization according to section 2 ʺInspection before Useʺ and section 5 Reprocessing Procedureʺ 9 When using ultrasound contrast agent ...

Page 33: ...ens against staining or damaging 7 Clean disinfect and sterilize the probe Magnetic Sensor Attachment and Spacer for EZU RV2S prior to the first use as they are not sterilized when delivered 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 use the probe with other equipment except for those specifically approved in thi...

Page 34: ...n 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 or Plasma sterilization Operating conditions Ambient temperature 10 40 C Contact surface temperature Temperature of exa...

Page 35: ...ble needle gauge 16G to 19G Materials Bio compatible allergy free components Classification MDD classification Is Package 24 Sterile Puncture Adapters for single use Sterilization method Sterilized with gamma irradiation Operating conditions Temperature 10 40 C Storage conditions Temperature 10 40 C ...

Page 36: ...lease contact your local distributor for a current version of the ʺDisinfectant Sterilization Method Compatibility for Ultrasound Probe and Accessory List 9 Disposal of the probe Recycle or dispose equipment properly in compliance with your organizational rules and your local laws Before disposing equipment disinfect or take other infection prevention measures Disposal of equipment without taking ...

Page 37: ... 31 Q1E EP1430 Fig 21 External view of Probe EUP V73W Unit mm ...

Page 38: ... 32 Q1E EP1430 Fig 22 External view of the probe EUP V73W with Sterile Puncture Adapter EZU PA7V ...

Page 39: ... 33 E Q1E EP1430 Fig 23 External view of the probe EUP V73W with the Magnetic Sensor Attachment Option ...

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