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Hitachi EUP-B512 Instruction Manual

Biopsy probe
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Biopsy Probe
EUP-B512
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-EP0780-8
©Hitachi, Ltd. 2013,2017. All rights reserved.
0123

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Summary of Contents for Hitachi EUP-B512

  • Page 1 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-EP0780-8 ©Hitachi, Ltd. 2013,2017. All rights reserved. 0123...
  • Page 2 Manufacturer: 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 European Representative: Hitachi Medical Systems GmbH Otto-von-Guericke-Ring D-65205 Wiesbaden, Germany EU Importer: Hitachi Medical Systems Europe Holding AG Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland Local Distributor: ( 1 ) Q1E-EP0780...
  • Page 3 About this manual This instruction manual contains safety precautions, the inspection, the operation procedure and the reprocessing procedure of the EUP-B512. Please read this manual thoroughly to ensure safe operation. If you have any questions concerning the operation of the probe, please contact a service support.
  • Page 4 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...
  • Page 5 Definition of symbol The following symbol is also used for HITACHI Ultrasound Probes. Location Symbol Definition This instrument complies with Directive 93/42/EEC relating to Probe connector Medical Device and Directive 2011/65/EU relating to RoHS IPX7 IPX7 mark Probe connector See section 1.6.

  • Page 6: Table Of Contents

    Inspection for Appropriate Connection ......4 Inspection for Material Surface ........4 3 Operation Procedure ........... 5 4 Optional Accessories for EUP-B512 ......7 Magnetic Sensor (EZU-RV2S) ........7 Magnetic Sensor (EZU-RV3S) ........10 5 Cleaning, Disinfection and Sterilization ..... 12 Point of use (Pre-cleaning) ........

  • Page 7: Introduction

    Introduction General The EUP-B512 is a convex array probe. The acoustic output of the EUP-B512 was measured according to the IEC60601-2-37 standard and the measurement was conducted by operating with the Hitachi ultrasound diagnostic scanner. The measured acoustic output is listed in the instruction manual of the Hitachi ultrasound diagnostic scanner.

  • Page 8: Intended Use

    Intended Use The EUP-B512 is designed for observation and diagnosis mainly of the following regions by connecting with the Hitachi ultrasound diagnostic scanner. Biopsy (with Needle Guide Bracket)  General abdominal organs  WARNING Never use the probe for following applications.

  • Page 9: External View

    About how to connect this accessory to the probe connector, refer to the instruction manual of Waterproof box EZU-WB1 External View The external view of the EUP-B512 is shown in Fig.1. Immersible part (IPX7) Magnetic sensor attachment Head Cable...

  • Page 10: Inspection Before Use

    Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. Inspection for Appropriate Connection 2.1.1 Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner. 2.1.2 Do not attach or connect unauthorized devices nor instruments on the probe, such as unauthorized biopsy attachments.

  • Page 11: Operation Procedure

    Operation Procedure 1) Confirm that the probe and the Magnetic sensor attachment are disinfected or sterilized. 2) Connect the probe to the ultrasound diagnostic scanner, operate the 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.
  • Page 12 4) Use a sterile probe cover to protect the probe. The probe cover should be allergy free material to avoid allergic reaction. Between the probe and the probe cover, acoustic coupling gel is required as a couplant. 5) Place the probe on the examination site and adjust the probe’s position for a clear view of the desired image.

  • Page 13: Optional Accessories For Eup-B512

    Optional Accessories for EUP-B512 The usage of the EUP-B512 can be extended by applying the optional accessory. The accessory is the Magnetic sensor with which the EUP-B512 enables RVS (Real-time Virtual Sonography). There are two types of Magnetic sensors, EZU-RV2S and EZU-RV3S.
  • Page 14 4.1.1 How to attach the Magnetic Sensor The procedure of attaching the Magnetic sensor is as follows. 1) Attach the Spacer for EZU-RV2S to the Magnetic sensor. 2) Attach the Magnetic sensor into the probe with the correct direction as shown in Fig.4. 3) Insert the slot of the attachment into the projected part of the probe.
  • Page 15 4.1.2 How to release the Magnetic Sensor e procedure of releasing the Magnetic sensor from the probe is as follows. a) Press the area of the Magnetic sensor attachment shown with the arrow toward the direction A, and then slide out the attachment toward the direction B as shown in Fig.5 and it from the probe.

  • Page 16: Magnetic Sensor (Ezu-Rv3S)

    Magnetic Sensor (EZU-RV3S) The Magnetic sensor (EZU-RV3S) as shown in Fig.7 is also a Magnetic sensor for the EUP-B512. Direction mark Sensor（white） Fig.7 Magnetic sensor (EZU-RV3S) 4.2.1 How to attach the Magnetic Sensor The procedure of attaching the Magnetic sensor is as follows.
  • Page 17 CAUTION Never attach the Magnetic sensor attachment to the probe in the incorrect direction, otherwise it may result in false diagnosis. 4.2.2 How to release the Magnetic Sensor The procedure of releasing the Magnetic sensor from the probe is as follows. a) Press the area of the Magnetic sensor attachment shown with the arrow toward the direction A, and then slide out the attachment toward the direction B as shown is Fig.9 and...

  • Page 18: Cleaning, Disinfection And Sterilization

    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 ‐...
  • Page 19 (intracavitary (Disinfectant with application) virucidal effect) Cleaning Disinfection Application part contacts (Disinfectant with intracorporeal tissue critical virucidal effect - directly minimum) (operative application) Sterilization According to the intended use, EUP-B512 is classified as semicritical. - 13 - Q1E-EP0780...
  • Page 20 The flowchart of the reprocessing process of this probe is as follows. Point of use (Pre-cleaning) Containment and transportation Manual cleaning and disinfection Manual Cleaning Washer Disinfector (WD) Rinsing after manual Automated Cleaning cleaning Automated Disinfection Manual Disinfection Rinsing after manual disinfection Drying Packing...

  • Page 21: Point Of Use (Pre-Cleaning)

    (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: A) EUP-B512 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.

  • Page 22: Manual Cleaning And Disinfection

    Prepare the detergent solution in a tank with cold water (please follow the instructions of the detergent manufacturer regarding application, dilution and contact time). A) EUP-B512 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.
  • Page 23 Wipe the un-immergible parts of the probe with a soft cloth dipped with the detergent solution. Rinse the probe with running tap water for 1 minute. (alternatively: immerse the immersible part of the probe in a tray filled with deionized water/tap water (see Fig.11) for 5 min.) Visually check the outer surface of the probe for cleanness.
  • Page 24 Manual disinfection: A) EUP-B512 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.

  • Page 25: Automated Cleaning And Disinfection

    4) Visually check the outer surface of the Magnetic sensor attachment and the Spacer for EZU-RV2S for leavings of the disinfectant. If necessary, repeat the rinsing. Water, Detergent or Disinfectant Fig.11 Immersion of the Probe, the Magnetic sensor attachment and the Spacer for EZU-RV2S Automated cleaning and disinfection Washer Disinfector The following items must be provided prior...

  • Page 26: Drying

    1) The parameters of the cleaning and disinfection of the device are as follows: Program step Water (40 l) Dosage (ml/l) Temp. (°C) Time (min) Pre-Rinse Cold water Cleaning Deionized water 5 (0.5%) Rinse Deionized water Disinfection Deionized water 10 (1%) Rinse Deionized water Rinse...

  • Page 27: Inspection

    Inspection Inspect the equipment for any damage such as crack, scratch or deformation. Do not use it if any damage is found. Packaging Packaging Pack the equipment in a sterile barrier such as Polypropylene fleece or transparent package made from Polyethylene film and Tyvek®, and then place it into a tray.

  • Page 28: Sterilization

    Sterilization Sterilization The probe and accessory 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. Sterilization Method Condition Plasma Sterilization:...
  • Page 29 The packaging procedure is as follows. 1) Put the probe into TYVEK pouch. Probe TYVEK Pouch Fig.12 Packaging in the pouch 2) Seal the TYVEK Pouch using a heat sealer. Ensure that the seal is complete. Sealed TYVEK Pouch Probe Fig.13 Sealing - 23 - Q1E-EP0780...

  • Page 30: Storage

    3) Put the sealed pouch into a tray or plastic mesh wire for sterilization. Tray for Probe in sterilization the Pouch Fig.14 Packaging in a tray 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: Maintenance And Safety Inspection

    Maintenance and Safety Inspection 1) After using the probe, it should be cleaned and disinfected/sterilized following “5. Cleaning, Disinfection and Sterilization”, then store it in a cool and dark place avoid high temperature and humidity, direct sunlight. 2) After using the Magnetic sensor attachment and the Spacer for EZU-RV2S, they should be cleaned and disinfected/sterilized following “5.

  • Page 32: Safety Precautions

    Safety Precautions WARNING Never use the probe if the probe is damaged.  Do not use the latex probe cover for latex sensitive patients.  The probe cover, which contains latex, may cause allergic reactions such as itching, rubor, urticaria, swelling, fever, anhelation, wheezing, depression of blood pressure, and shock.

  • Page 33: Specifications

    Specifications Probe Type: EUP-B512 Biopsy probe Acoustic working frequency: 3.5MHz Technology: Convex Array Probe Dimensions: See Fig. 15. Weight: Approx. 0.69kg (Incl. cable and connector) Scanning angle: 78° Probe materials: Bio-compatible allergy free components Acoustic output: According to IEC60601-2-37 (See Main Unit manual.)

  • Page 34: Suppliers List

    Suppliers List The products listed bellow are seriously tested and approved for use with the Biopsy Probe EUP-B512. Product name manufacturer purpose Cidezyme Johnson & Enzymatic Johnson detergent Sagrosept Tissues Schülke & Mayr Disinfectant Meliseptol HBV-Tücher Braun Disinfectant Incidin Liquid...

  • Page 35: Disposal Of The Probe

    Disposal of the probe Recycle or dispose of this equipment properly in compliance with your organizational rules and your local laws. CAUTION Before disposing of the equipment, disinfect or take other infection-prevention measures. Disposal of the equipment without taking the proper preventative measures can lead to infection.
  • Page 36 Unit:mm Fig.15 Dimensions - 30 - Q1E-EP0780...
  • Page 37 Fig.16 External view (with the Magnetic sensor attachment) -31- Q1E-EP0780...

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