Hitachi EUP B715 Instruction Manual
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Hitachi EUP B715 Instruction Manual

Hitachi EUP B715 Instruction Manual

Biopsy probe
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Biopsy Probe 
EUP‐B715 
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‐EP1245‐7 
 
© Hitachi, Ltd. 2013,2017. All rights reserved. 
0123

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Summary of Contents for Hitachi EUP B715

  • Page 1 Biopsy Probe  EUP‐B715  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‐EP1245‐7    © 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 3 D-65205 Wiesbaden, Germany EU Importer: Hitachi Medical Systems Europe Holding AG Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland Local Distributor: Q1E-EP1245...
  • Page 3 About this manual This instruction manual shall provide instructions for using, cleaning, disinfecting and/or sterilizing the HITACHI ultrasound probes. It also describes safety considerations, maintenance. For instructions for operating the main unit, refer to the operation manual for it. Before using the probe, thoroughly read this manual and keep this book for future reference.
  • 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 mark IPX7 Probe connector See section 1.6.

  • Page 6: Table Of Contents

    CONTENTS Page 1. Introduction ················································· 1 Features ··················································· 1 Principles of operation ···································· 1 Intended Use ··············································· 2 Components ················································· 2 Accessories (Option) ······································· 3 1.5.1 Biopsy Attachment ······································ 3 1.5.2 Magnetic Sensor Attachment for EUP-B715 (Option) ······· 3 1.5.3 Spacer for EZU-RV2S (Option) ···························...

  • Page 7: Introduction

    1. Introduction 1.1 Features The probe of Model EUP-B715 has convex array type. The acoustic output of this probe when connected to ultrasound scanner was measured according to the IEC60601-2-37 standard. The table of measured acoustic output data is contained in the operation manual of each ultrasound scanner.

  • Page 8: Intended Use

    1.3 Intended Use The Biopsy Probe EUP-B715 is designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound scanner.  Biopsy (with Biopsy Attachment)  General abdominal organs 1.4 Components The probe components of the EUP-B715 are as follows: 1) Biopsy Probe EUP-B715 ·······························...

  • Page 9: Accessories (Option)

    1.5 Accessories (Option) 1.5.1 Biopsy Attachment The biopsy attachment is disposable one. If more biopsy attachment is needed, you are requested to place an order with us or our authorized agent specifying the model required from the following models.  EZU-PA7B1-1 for 12G-13G ···················...

  • Page 10: Construction

    1.6 Construction Cable Biopsy Attachment Needle Needle guide insert Magnetic sensor attachment for EUP-B715 (Option) Connector Spacer for EZU-RV2S (Option) 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 cannot be cleaned by water.
  • Page 11 Needle Insertion Groove (0°) Needle Insertion Groove (15°) Needle Insertion Groove (30°) Biopsy Attachment (Needle guide) Probe Biopsy Attachment (Needle insert) Biopsy Attachment (Mounting arm) Fig.2 External View of the Biopsy Attachment Q1E-EP1245...

  • Page 12: Inspection Before Use

    2. Inspection before Use Prior to use, the probe must be carefully inspected that they are appropriate for use. If you find any damage, do not use the probe and immediately contact a service support. 2.1 Inspection for Material Surface 1) Visually inspect the surface of the probe head, housing and cable for any crack, scratch or denaturalization.

  • Page 13: Inspection For Appropriate Connection

    2.3 Inspection for Appropriate Connection 1) Check that the system is correctly operating. Refer to the instruction manual for the Main unit. 2) Fill sterile water into a bucket and confirm that a biopsy guide line and an echo image of test needle are overlapped correctly at all selectable angles.

  • Page 14: Operation Procedure

    3. Operation Procedure 1) Connect the probe, operate the Main unit, and adjust the image according to the instructions given in the operation manual for the main unit. 2) Confirm that the probe is disinfected or sterilized. 3) Confirm that the biopsy attachment is sterilized. 4) Confirm that the Magnetic sensor attachment and the Spacer for EZU-RV2S are disinfected or sterilized.
  • Page 15 8) Pull the cover tightly over the probe face to remove wrinkles and air bubbles, taking care to avoid puncturing the cover. Fig.7 Hold the probe cover to the probe 9) Secure cover to the groove portion of the probe housing with bands. Band Fig.8 Hold the probe cover to the probe Q1E-EP1245...
  • Page 16 10) Select a needle insert and needle guide to correspond with the needle size intended to be used in the procedure. Needle size is engraved on the needle insert and the needle guide. Slide the needle insert into the needle guide. Be sure to using combination same needle size.
  • Page 17 11) Mount the appropriate biopsy attachment in the probe. Follow the next steps to mount the probe and biopsy attachment. a) Place the biopsy attachment on the probe as shown in Fig. 11. Insert the projected part of the attachment into the groove of the probe on top of the probe cover.
  • Page 18 b) The biopsy attachment tip to the direction of an arrow, secure the biopsy attachment to the biopsy attachment mounting plate. Biopsy attachment Biopsy Biopsy attachment attachment Biopsy attachment mounting plate Fig.12 Mounting the biopsy attachment -12- Q1E-EP1245...
  • Page 19 c) The mounting arm tip to the direction of an arrow pulling the probe cover with thumb. Then the mounting arm lock reduces wrinkling of the probe cover. Reduce wrinkling of the probe cover Lock Mounting arm Fig.13 Mounting the biopsy attachment d) Inspect the probe cover to ensure the needle path is clear of obstructions.
  • Page 20 e) Confirm that the tip of the biopsy attachment is attached in the correct position. The tip of the biopsy attachment Incorrect Correct Incorrect position position position Fig.15 Inspection of the biopsy attachment -14- Q1E-EP1245...
  • Page 21 12) Visually inspect the cover to ensure that there are no defects or holes. Do not use the cover if it has any holes. CAUTION Cover the probe by the CIV-Flex Cover certainly. If the probe is not covered by the CIV-Flex Cover, It becomes impossible to reuse them because they are contaminated by blood and body fluid.
  • Page 22 16) Insert a needle into the needle insertion groove of the biopsy attachment set corresponding to the display angle of the needle guide line, fix the probe and perform biopsy. Relationship between the needle insertion groove and needle guide line angle is shown in Fig.17.
  • Page 23 Follow the next steps to detach the probe and biopsy attachment. [3] Detach the Needle Needle insert from the needle guide. [2] Lift up the needle insert in the direction of an arrow. Needle insert Push the needle insert lever in the direction of an arrow.

  • Page 24: Attaching The Magnetic Sensor

    4. Attaching the Magnetic Sensor To use Real-time Virtual Sonography (RVS), attach the Magnetic sensor to the probe. There are two types of Magnetic sensors, for EZU-RV2S and EZU-RV3S. The Magnetic Sensor (EZU-RV2S) and the Magnetic Sensor (EZU-RV3S) are shown in Fig.19 and Fig.20. To attach the Magnetic sensor as shown in “4.1 Magnetic Sensor (EZU-RV2S)”...

  • Page 25: Magnetic Sensor (Ezu-Rv2S)

    4.1 Magnetic Sensor (EZU-RV2S) 4.1.1 Attaching the Magnetic Sensor To use Real-time Virtual Sonography (RVS), attach the Magnetic sensor as shown below. 1) Insert the Spacer for EZU-RV2S in the Magnetic sensor [1] and into the Magnetic sensor attachment with correct direction [2] as shown in Fig.21.

  • Page 26: Removing The Magnetic Sensor

    2) Place the Magnetic sensor attachment on the probe as shown in Fig.22. Insert the projected part of the attachment into the groove of the probe. Magnetic sensor attachment Projected part of the attachment （Inside of the attachment） Groove of the probe Fig.22 Attaching the Magnetic sensor attachment CAUTION...

  • Page 27: Magnetic Sensor (Ezu-Rv3S)

    4.2 Magnetic Sensor (EZU-RV3S) 4.2.1 Attaching the Magnetic Sensor To use Real-time Virtual Sonography (RVS), attach the Magnetic sensor as shown below. 1) Insert the Magnetic sensor into the Magnetic sensor attachment with correct direction as shown in Fig.23. Place the direction mark upward as shown in Fig.23.

  • Page 28: Removing The Magnetic Sensor

    2) Place the Magnetic sensor attachment on the probe as shown in Fig.24. Insert the projected part of the attachment into the groove of the probe. Magnetic sensor attachment Projected part of the attachment (Inside of the attachment） Groove of the probe Fig.24 Attaching the Magnetic sensor attachment CAUTION...

  • Page 29: Cleaning, Disinfection And Sterilization Of The Probe, Biopsy Attachment And Magnetic Sensor Attachment

    5. Cleaning, Disinfection and Sterilization of the Probe, Biopsy Attachment and Magnetic sensor attachment  Take care about clean circumstances before using the probe on the next patients. If processors reprocess this equipment, refer to these instructions.  Sterilization has not been made to the biopsy attachment EZU-PA7B1 shipped from the factory.
  • Page 30 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, semicritical or critical. Supporting information concerning this topic is listed in the table below.

  • Page 31: Point Of Use (Pre-Cleaning)

    INSTRUCTIONS 5.1 Point of use (Pre-cleaning): A) Biopsy probe EUP-B715 In the operating room after use of the probe. 1) Remove the biopsy attachment from the biopsy probe. 2) Flush the probe directly after use. 3) Flush patient’s blood or fluid by tap water until the surface looks visually clean.

  • Page 32: Manual Cleaning And Disinfecting

    5.2 Manual Cleaning and Disinfecting: Prepare following items before manual cleaning and disinfection. a) Detergent: Cidezyme®/ENZOL® (Johnson & Johnson)or another cleaning agent with approved material compatibility for this medical device. b) Disinfectant: Cidex® OPA (Johnson & Johnson)or another disinfectant with approved material compatibility for this medical device. c) Cleaning brushes if applicable, i.e.
  • Page 33 6) Alternatively to step 5 suspend the submergible part of the probe in a tray filled with deionized water/tap water for 5 min. 7) Visually check the cavity and the outer surface of the biopsy probe for cleanness. If necessary, use magnifying glass for visually check.
  • Page 34 C) Biopsy Attachment EZU-PA7B1 Sterilization has not been made to the biopsy attachment shipped from the factory. Prior to the first use, be sure to clean, disinfect and sterilize it. 1) The temperature of the detergent solution should be between 15-30 °C, concentration is 1.6%.
  • Page 35 B) Magnetic sensor attachment and spacer for EZU-RVS2 1) Before immersing the device, it is recommended to test the concentration of disinfectant solution before each usage. solution Cidex® OPA is ready for use and does not need to be diluted. Test strips to verify that the appropriate concentration of Cidex®...

  • Page 36: Drying

    5.3 Drying: 1) Wipe the device with single use, fluff free wipe or towel for removing moisture on the surface of the equipment. 2) Dry the cavities by an air gun with compressed air. The compressed air should be filtered with a sterile filter that removes air particles of less than 0.2 μm.
  • Page 37 Bag for sterilization Biopsy Attachment (Needle guide) Biopsy Attachment (Needle insert) Fig.28 Sterilization of Biopsy Attachment Sterile conditions of each method are as follows. Sterilization Method Condition Plasma Sterilization: STERRAD® 50, 100S or 200 Short Cycle Plasma Sterilization: Standard cycle Sterrad®...

  • Page 38: Maintenance And Safety Inspection

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

  • Page 39: Specifications

    8. Specifications 8.1 Probe Type: EUP-B715 Biopsy probe Acoustic working frequency: 3.5MHz Technology: Convex Array Probe Dimensions: See Fig.29 to 31 Weight: Approx. 0.78kg (incl. cable and connector) Scanning angle: 74 deg. Biopsy needle angle: 0, 15 and 30degree Biopsy attachment: 12-23G, Cool-tip™...

  • Page 40: Suppliers List

    8.2 Suppliers List The products listed below are seriously tested and approved for use with the biopsy probe EUP-B715. Suppliers List Product name Manufacturer Purpose CIV-Flex™ Transducer Cover CIVCO MEDICAL Sterile 14 X 91.5cm cover Cover INSTRUMENTS Telescopically-folded (610-542) Enzymatic Cidezyme™...
  • Page 41 Unit: mm Fig.29 Dimension -35- Q1E-EP1245...
  • Page 42 Fig.30 External view (with biopsy attachment) -36- Q1E-EP1245...
  • Page 43 Fig.31 External view (with the Magnetic sensor attachment) -37- Q1E-EP1245...

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