Hitachi EUP-B512 Instruction Manual Download Page 1

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Biopsy Probe

EUP-B512

INSTRUCTION MANUAL

Tokyo , Japan

Q1E-EP0780-8

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.

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Summary of Contents for EUP-B512

Page 1: ...8 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 ...

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: ...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 ignor...

Page 4: ...on of 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 place and...

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: ...cessories for EUP B512 7 4 1 Magnetic Sensor EZU RV2S 7 4 2 Magnetic Sensor EZU RV3S 10 5 Cleaning Disinfection and Sterilization 12 5 1 Point of use Pre cleaning 15 5 2 Containment and transportation 15 5 3 Manual Cleaning and disinfection 16 5 4 Automated cleaning and disinfection 19 5 5 Drying 20 5 6 Inspection 21 5 7 Packaging 21 5 8 Sterilization 22 5 9 Storage 24 6 Maintenance and Safety Ins...

Page 7: ...is 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 r...

Page 8: ... Probe EUP B512 1 piece 2 Magnetic sensor attachment 1 piece 3 Spacer for EZU RV2S 3 pieces 4 Instruction Manual 1 copy Sterilization has not been made to the probe and the Magnetic sensor attachment shipped from the factory Prior to use of them be sure to clean disinfect and sterilize them 1 5 Optional Accessories 1 5 1 Needle Guide Bracket EZU PA5C4 1 Needle guide bracket 1 piece 2 Brush 1 piece...

Page 9: ...robe connector refer to the instruction manual of Waterproof box EZU WB1 1 6 External View The external view of the EUP B512 is shown in Fig 1 Immersible part IPX7 Head Connector Cable Un immersible part Magnetic sensor attachment Spacer for EZU RV2S 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 immers...

Page 10: ...ments on the probe such as unauthorized biopsy attachments 2 2 Inspection for Material Surface 2 2 1 Visually inspect that 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 immediately contact a service support 2 2 2 Visually inspect that the surface of the Magnetic sensor attachment and t...

Page 11: ...manual for the ultrasound diagnostic scanner with which the probe is used as connected 3 Confirm the direction of the probe The relationship between the direction of the probe and the image is shown in Fig 2 The Right left orientation mark on the image indicates the direction of the needle guide bracket mount part of the probe Right left orientation mark Needle guide bracket mount part Fig 2 The R...

Page 12: ... the procedure stated in 5 Cleaning Disinfection and Sterilization every time immediately after completing the ultrasound examination 7 Store the probe in the environment indicated in 6 Maintenance and Safety Inspection 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 Cleaning Disinfection and S...

Page 13: ...he EUP B512 enables RVS Real time Virtual Sonography There are two types of Magnetic sensors EZU RV2S and EZU RV3S The Magnetic sensor EZU RV2S and the Magnetic sensor EZU RV3S are shown in Fig 3 and Fig 7 4 1 Magnetic Sensor EZU RV2S The Magnetic sensor EZU RV2S as shown in Fig 3 is a Magnetic sensor for the EUP B512 Sensor black Projected part Fig 3 Magnetic sensor EZU RV2S ...

Page 14: ...the 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 to the Magnetic sensor otherwise it may result in false diagnosis 2 1 Magnetic sensor EZU RV2S Black Spacer for EZU RV2S Projected part of the EZU RV2S Place the projected part upward as shown here Spacer for EZU RV2S Magnetic sensor EZU...

Page 15: ... A and then slide out the attachment toward the direction B as shown in Fig 5 and release it from the probe b Release the Magnetic sensor from the groove of the probe as shown in Fig 6 and release the Spacer for EZU RV2S from the Magnetic sensor Fig 6 How to release the Magnetic sensor from the groove of the probe Slide the attachment in this direction B A Press this area Fig 5 How to release the ...

Page 16: ...the correct direction as shown in Fig 8 b Insert the slot of the attachment into the projected part of the probe Magnetic sensor attachment Magnetic sensor EZU RV3S white Probe Direction mark of the EZU RV3S Place the direction mark upward as shown here Groove of the probe Projected part of the probe Slot of the attachment Fig 8 How to attach the Magnetic sensor attachment Slot of the attachment P...

Page 17: ...with the arrow toward the direction A and then slide out the attachment toward the direction B as shown is Fig 9 and release it from the probe b Release the Magnetic sensor from the groove of the probe as shown in Fig 10 Clean and sterilize the Magnetic sensor before the first use as it is not sterilized in the factory Slide the attachment in this direction B A Press this area Fig 9 How to release...

Page 18: ... not water resistant When a washer disinfector is used the waterproof box MUST be used to cover the probe connector 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 Central...

Page 19: ...elow 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 ...

Page 20: ...s Point of use Pre cleaning Manual Cleaning Rinsing after manual cleaning Manual Disinfection Drying Automated Cleaning Manual cleaning and disinfection Washer Disinfector WD Automated Disinfection Rinsing after manual disinfection Packing Sterilization Containment and transportation ...

Page 21: ...Magnetic sensor attachment and the magnetic sensor from the probe Remove the Spacer for EZU RV2S from the magnetic sensor if the sensor is EZU RV2S 2 Immerse the Magnetic sensor attachment and the Spacer for EZU RV2S in sufficient amount of high quality tap water Scrub them using soft cloth to remove all visible soil from their surface 5 2 Containment and transportation Putting the contaminated eq...

Page 22: ...tergent solution in a tank with cold water please follow the instructions of the detergent manufacturer regarding application dilution and contact time A EUP B512 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 appr...

Page 23: ... differing detergent is used please also note the approved material compatibility for the medical device 2 Immerse the Magnetic sensor attachment and the Spacer for EZU RV2S into the diluted detergent solution Wipe them under the surface of the detergent solution with a soft cloth to remove all visible soil 3 The Magnetic sensor attachment and the Spacer for EZU RV2S should be left in the detergen...

Page 24: ...se also consider the material compatibility for the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 11 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 11 for 5 mi...

Page 25: ...5883 with chemo thermal program temperature max 60 C b Waterproof box EZU WB1 c Detergent Korsolex Endo Cleaner Bode Chemie 972 020 or another cleaning agent with approved material compatibility for this medical device d Disinfectant Korsolex Endo Disinfectant Bode Chemie 972 030 or another disinfectant with approved material compatibility for this medical device Fig 11 Immersion of the Probe the ...

Page 26: ...of the waterproof box EZU WB1 for detail information 3 Place the probe in the baskets of the washer disinfector 4 Close the door of the washer disinfector and start the chemo thermal program 5 Open the door after the process is done Take the probe out of the washer disinfector and check that it is dry If not dry them as described in the chapter drying 5 5 Drying 1 Wipe the equipment with a single ...

Page 27: ...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 app...

Page 28: ...rd 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 conjunction with min and max data applicable for the ...

Page 29: ...ging procedure 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 Probe TYVEK Pouch Probe TYVEK Pouch Sealed Fig 12 Packaging in the pouch Fig 13 Sealing ...

Page 30: ...r sterilization 5 9 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 Probe in the Pouch Tray for sterilization Fig 14 Packaging in a tray ...

Page 31: ...ized following 5 Cleaning Disinfection and Sterilization then store them in a cool and dark place avoid high temperature and humidity direct sunlight 3 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 4 Visually inspect the surface of...

Page 32: ...an early pregnancy 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 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 ...

Page 33: ... Unit manual Applicable system Depending on production and upgrade status 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 Plasma sterilization Operating conditions Ambient temperature 25 35 C Contact surface temperature max 42 C Temperatur...

Page 34: ...EX 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 ALKAPHARM Disinfectant ALKAZYME ALKAPHARM Cleaner Korsolex Endo Cleaner Bode Chemie Detergent Korsolex Endo Disinfectant Bode Chemie Disinfectant 610 002 Sterile 14 x 61cm 5 5 x 24 flat ...

Page 35: ...asures 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 nat...

Page 36: ... 30 Q1E EP0780 Unit mm Fig 15 Dimensions ...

Page 37: ... 31 E Q1E EP0780 Fig 16 External view with the Magnetic sensor attachment ...

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