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Q1E-EP0325

8.2.

Sterile Puncture Adapter EZU-PA5V

Type: EZU-PA5V
External view:

See Fig. 23

Acceptable needle gauge: 16G to 19G
Materials:

Bio-compatible allergy free components

Classification:

MDD classification IIa

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

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Содержание EUP-V53W

Страница 1: ...nd 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 EP0325 15 Hitachi Ltd 2013 2017 All rights reserved 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: ... support The Symbols The following conventions are used throughout the manual to denote 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 igno...

Страница 4: ...d 2 16 1 Higashi Ueno Taito ku TOKYO 110 0015 Japan 81 3 6284 3668 http www hitachi com businesses heal thcare 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 dark dry environment to avoid high temperature and humidity and direct sunlight Co...

Страница 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...

Страница 6: ...r EZU PA5V 7 3 3 Display of Needle Guide Line 8 4 Option of EUP V53W 9 4 1 Magnetic sensor EZU RV2S 9 4 2 Magnetic sensor EZU RV3S 12 5 Reprocessing Procedure 15 5 1 Point of use Pre cleaning 17 5 2 Containment and transportation 17 5 3 Manual Cleaning and disinfection 17 5 4 Drying 20 5 5 Inspection 20 5 6 Packaging 20 5 7 Sterilization 21 5 8 Storage 23 6 Maintenance and Safety Inspection 23 6 1...

Страница 7: ...trasonic 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...

Страница 8: ... 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 it 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 A...

Страница 9: ...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 1 5 4 Magnetic Sensor Attachment Magnetic sensor attachment is used for Real time Virtual Sonography RVS By using the attachment the magnetic sensor is attached to the probe that is connected to a Hitachi digita...

Страница 10: ... 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 Cable Connector Un immersible part Immersible part IPX7 Spacer for EZU RV2S Option Magnetic sensor attachment Option Applied part ...

Страница 11: ... the probe Set the main unit to display the Needle guide line Refer to the operation manual for the main unit Keep the probe head in the 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 dot line Needle guide line on the monitor 2 2 Inspection for Material Surface 1 Visually inspect th...

Страница 12: ...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 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 ...

Страница 13: ... Magnetic sensor attachment and the Spacer for EZU RV2S in the environment indicated in 6 Maintenance and Safety Inspection 3 2 Use of Sterile Puncture Adapter EZU PA5V The process of attaching the Sterile Puncture Adapter EZU PA5V to the probe is as follows If the Sterile Puncture Adapter is used careful handling is necessary to avoid damage of the probe cover During open or minimal invasive surg...

Страница 14: ...ner NOTE The needle guide line will be displayed to provide a visual guide to the direction of the puncture needle pathway Be sure to check the actual location of the needle on the ultrasound image when performing the puncture operation 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 observ...

Страница 15: ...c sensor EZU RV2S as shown in Fig 8 is the magnetic sensor EZU RV2S for EUP V53W 4 1 1 How to attach magnetic sensor The procedure of attaching magnetic sensor is as follow 1 Confirm that the magnetic sensor attachment and the Spacer for EZU RV2S are cleaned disinfected and sterilized 2 Connect the probe operate the ultrasound diagnostic scanner and adjust the image according to the instructions g...

Страница 16: ...he magnetic sensor attachment to the probe in the incorrect direction otherwise it may result in false diagnosis 2 Never forget to attach the Spacer for EZU RV2S when using RVS with magnetic sensor otherwise it may result in false diagnosis a Projected part Spacer for EZU RV2S b Fig 9 How to attach the Magnetic sensor Projected part Magnetic sensor attachment Spacer Magnetic sensor EZU RV2S Black ...

Страница 17: ...low 1 Detach the Magnetic sensor attachment from the probe as shown Fig 11 2 Detach the magnetic sensor and the Spacer for EZU RV2S from the Magnetic sensor attachment as shown Fig 12 Clean disinfect and sterilize the Magnetic sensor attachment and the Spacer for EZU RV2S before the first use as there are not sterilized in the factory Fig 10 How to attach the Magnetic sensor attachment Fig 11 How ...

Страница 18: ...e 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 Insert Magnetic sensor into the Magnetic sensor attachment with the correct direction as shown in Fig 14 Never attach the magnetic sensor attachment to the probe in the incorrect direction otherwise it may result in false diagnosis...

Страница 19: ...etic sensor attachment to the probe as shown in Fig 15 Do not put your fingers between the Magnetic sensor attachment and the probe when attaching the Magnetic sensor attachment to the probe Fig 15 How to attach the Magnetic sensor attachment ...

Страница 20: ...Fig 16 2 Detach the magnetic sensor and the Spacer for EZU RV3S from the Magnetic sensor attachment as shown Fig 17 Clean disinfect and sterilize the Magnetic sensor attachment before the first use as there are not sterilized in the factory Fig 16 How to release the Magnetic sensor attachment from the probe Fig 17 How to release magnetic sensor from the Magnetic sensor attachment ...

Страница 21: ...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...

Страница 22: ...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 23: ...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...

Страница 24: ...or 1 minute alternatively immerse the immersible part of the probe in a tray filled with deionized water tap water see Fig 18 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...

Страница 25: ...atibility for the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 18 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 18 for 5 min 5 Visually check the outer surfa...

Страница 26: ...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...

Страница 27: ... 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 Johnson Johnson 1 Before performing sterilization check that the operation data of sterilizer are in...

Страница 28: ...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 Fig 19 Packaging in the pouch Attachment Sealed Probe Attachment Fig 20 Sealing TYVEK Pouch Tray for sterilization Fig 21 Packaging in a tray Probe in the Pouch ...

Страница 29: ... 1 Daily Inspection 1 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 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 th...

Страница 30: ...gical or minimal invasive procedures take care that electro cauter devices 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 Do not expose the connector to water or other liquids The connector is not waterproof 4 Do not hit or drop the probe Th...

Страница 31: ...tem Depending on production and upgrade status For detailed information a service supports 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 25 35 C Contact surface temperature...

Страница 32: ...ble needle gauge 16G to 19G Materials Bio compatible allergy free components Classification MDD classification IIa 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 ...

Страница 33: ...HARM Cleaner Please contact your local distributor for a current version of the Disinfectant Sterilization Method Compatibility for Ultrasound Probe and Accessory List 9 Disposal of the probe Recycle or dispose the equipment properly in compliance with your organizational rules and your local laws Before disposing the equipment disinfect or take other infection prevention measures Disposal of equi...

Страница 34: ... 28 Q1E EP0325 Fig 22 Dimension of Probe EUP V53W Unit mm 19 24 142 289 2200 ...

Страница 35: ... 29 Q1E EP0325 Fig 23 External view of the probe EUP V53W with Sterile Puncture Adapter EZU PA5V ...

Страница 36: ... 30 E Q1E EP0325 145 53 Unit mm Fig 24 Dimension of the probe EUP V53W with the Magnetic Sensor Attachment Option ...

Страница 37: ......

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