Hitachi EUP-B712 Instruction Manual
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Hitachi EUP-B712 Instruction Manual

Biopsy probe
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Biopsy Probe 
EUP‐B712 
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‐EP1412‐4 
 
©Hitachi, Ltd. 2013,2017. All rights reserved. 
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  • Page 1 Biopsy Probe  EUP‐B712  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‐EP1412‐4    ©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: Q1E-EP1412...
  • Page 3 About this manual This instruction manual shall provide instructions for using, cleaning, and disinfecting and/or sterilizing the HITACHI ultrasound probes. It also describes safety considerations, maintenance. For instructions for operating the ultrasound diagnostic scanner, refer to the operation manual for it.
  • 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 Probe relating to Medical Device and Directive connector 2011/65/EU relating to RoHS Probe IPX7 mark IPX7 connector See section 1.6.

  • Page 6: Table Of Contents

    CONTENTS Page 1. General ······················································ 1 Features ·················································· 1 Principles of operation ··································· 1 Intended Use ·············································· 2 Components ················································ 2 Option ···················································· 3 External View ············································· 4 2. Inspection before Use ········································ 5 Inspection for Appropriate Connection ····················· 5 Inspection for Material Surface ···························...

  • Page 7: General

    1. General 1.1 Features EUP-B712 Probe is a Convex Array type. The acoustic output of this probe when connected to ultrasound diagnostic scanner was measured according to the IEC60601-2-37 standard. The table of measured acoustic output data is contained in the operation...

  • Page 8: Intended Use

    1.3 Intended Use The Biopsy Probe EUP-B712 is designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound diagnostic scanner.  Biopsy (with Biopsy Attachment)  General abdominal organs WARNING WARNING Never use the probe for following applications.
  • Page 9 1.5 Option 1.5.1 Magnetic Sensor Attachment 1.5.2 Spacer for EZU-RV2S 1.5.3 Needle Guide Bracket EZU-PA7C2 1) Needle guide bracket ········· 1 piece 2) Brush ························ 1 piece 3) Spring (Spare) ··············· 2 pieces 4) Instruction manual ··········· 1 copy 5) Case ························· 1 piece 1.5.4 GENERAL PURPOSE Ultra-Pro II™...

  • Page 10: External View

    1.6 External View The external view of EUP-B712 is shown in Fig.1. Immersible part (IPX7) Scan head Cable Applied part Connector Option： Magnetic Sensor Attachment Option: Spacer for EZU-RV2S Option: Needle Guide Bracket EZU-PA7C2 Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water.

  • Page 11: Inspection Before Use

    2. Inspection before Use Prior to use, the probe and accessories 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 Appropriate Connection 1) Confirm that the system is correctly operating.
  • Page 12 CAUTION CAUTION Before use, make sure there is no damage to the surface to which the needle cannula is attached, and the needle guide works properly. 3) Confirm that the needle guide angle corresponds to the angle indicated on the monitor. The needle guide angle is engraved on bracket.

  • Page 13: Operation Procedure

    3. Operation Procedure 3.1 Probe 1) Confirm that the probe, the Magnetic Sensor Attachment and the Spacer for EZU-RV2S are cleaned, disinfected and if necessary 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 14: Needle Guide Bracket Ezu-Pa7C2

    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 and the Magnetic Sensor Attachment on the examination site and adjust the probe’s position for a clear view of the desire image.
  • Page 15 Tab on the needle insert Push Needle Fig. 5 Release the needle In the case of the CIVCO Ultra Pro 3™, push the green quick release lever of the needle guide toward the bracket to open the needle insert, and then remove the needle. For details of the removing procedure of the needle, refer to the Reference Guide each of the Ultra Pro II™...
  • Page 16 WARNING WARNING 1) Warning in case of using probe covers which latex is contained to. The latex may cause such allergic reactions as itching, rubor, urticaria, swelling, fever, anhelation, wheezing, depression of blood pressure, shock and so on. For the patients suspected of latex allergy, do not use the latex-containing medical devices.
  • Page 17 3.2.1 Fitting the needle guide bracket to the probe 1) Insert the recess of needle guide bracket to the needle guide bracket mount part. (See Fig. 6) Needle guide bracket Needle guide bracket mount part Needle guide attachment area Fig. 6 Position for mounting the needle guide bracket 2) Fit the recess of the bracket to the thumbscrew 1 and tighten the thumbscrew 1.
  • Page 18 3.2.2 Placing the probe and bracket into a transducer cover 1) Place an appropriate amount of gel inside the cover and/or on the Probe head. (See Fig. 8) CIV-FLEX cover Probe head Sterilized gel Fig. 8 Placing the gel 2) Insert the probe into the cover. 3) Pull the cover tightly over the probe face to remove wrinkles and air bubbles, taking care to avoid puncturing the cover.
  • Page 19 Attaching the needle guide to the bracket （Example: In the case 3.2.3 of CIVCO Ultra-Pro II™） 1) Place an appropriate amount of gel inside the cover and/or on the Probe head. (See Fig. 9) Needle guide attachment area Needle guide Lock Fig.
  • Page 20 3) Select a needle insert to correspond with the needle size intended to be used in the procedure. 4) Slide the needle insert into the needle guide by aligning the arrow tips. (See Fig. 11) Inspect the guide and cover assembly to ensure the needle path is clear of obstructions.
  • Page 21 3.2.4 Setting the needle guide angle Pull the knob(①) and release it into the recess of appropriate angle of the bracket(②). Needle guide angles are engraved on the bracket. (See Fig. 12) Recess of the bracket ① Knob ② Needle guide angle are engraved Fig.
  • Page 22 3.3 Magnetic Sensor Attachment The usage of the EUP-B712 can be extended by applying the optional accessory. The accessory is the Magnetic sensor with which the EUP-B712 enables RVS (Real-time Virtual Sonography). There are two types of Magnetic sensors, EZU-RV2S EZU-RV3S.
  • Page 23 3.3.1 Attaching the Magnetic Sensor (EZU-RV2S) 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 attachment with the correct direction as shown in Fig. 15. 3) Insert the hold of the attachment into the projected part of the probe.
  • Page 24 3.3.2 Removing the Magnetic Sensor (EZU-RV2S) The procedure of releasing the Magnetic sensor from the probe is as follows. 1) Press the area of the attachment shown with the arrow toward the direction A, and then slide out the attachment toward the direction B as shown in Fig.

  • Page 25: Magnetic Sensor Attachment

    3.3.3 Attaching the Magnetic Sensor (EZU-RV3S) The procedure of attaching the Magnetic sensor is as follows. 1) Attach the Magnetic sensor into the attachment with the correct direction as shown in Fig. 18. 2) Insert the hold of the attachment into the projected part of the probe.
  • Page 26 3.3.4 Removing the Magnetic Sensor (EZU-RV3S) The procedure of releasing the Magnetic sensor from the probe is as follows. 1) Press the area of the attachment shown with the arrow toward the direction A, and then slide out the attachment toward the direction B as shown in Fig.

  • Page 27: Reprocessing Procedure

    4. Reprocessing Procedure 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 WARNINGS reprocessing.

  • Page 28: Point Of Use (Pre-Cleaning)

    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.
  • Page 29 (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: A) EUP-B712 probe 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 30 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-B712 probe 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.
  • Page 31 Manual disinfection: A) EUP-B712 probe 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 32: Inspection

    Drying 4.4 Drying 1) Wipe the probe with a single-use, fluff-free wipe or towel to remove moisture from the surface of the probe. 2) Dry the probe naturally in an ambient temperature between 15-30°C for a minimum of 4 hours. Alternatively the equipment can be dried using a drying heater at a temperature of less than 55 °C.
  • Page 33 The sterilization method and operating conditions are as follows. Sterilization Method Condition Plasma Sterilization: Short Cycle STERRAD® 50, 100S or 200 (*) Plasma Sterilization: Standard cycle Sterrad® NX or 100NX (*) Gas Type: 10% EO/ 90% HCFC  Temperature: 50-55°C ...

  • Page 34: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK Pouch sealer. Ensure that the seal is Sealed complete. Attachment Probe Fig. 23 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for Tray for sterilization. sterilization Probe in the Pouch Fig.

  • Page 35: Cleaning And Disinfection Of Ezu-Pa7C2

    5. Cleaning and Disinfection of EZU-PA7C2 EZU-PA7C2 must be reprocessed after each use. Refer to the reprocessing instruction in this chapter.  EZU-PA7C2 is delivered unsterile. Prior to the first use, reprocess it.  The cavities and the spiral spring of the EZU-PA7C2 require particular attentions...

  • Page 36: Point Of Use (Pre-Cleaning)

    The flowchart of the reprocessing process of EZU-PA7C2 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 37: Automated Cleaning And Disinfection

    Point of use 5.1 Point of use (Pre-cleaning) (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: 1) Remove contaminated needle guide and probe cover from the probe with needle guide bracket and dispose them appropriately. 2) Remove the needle guide bracket from the probe.
  • Page 38 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 device c) Cleaning brushes if applicable...
  • Page 39 Manual Cleaning: Prepare the detergent solution in a tank with cold water (please follow the instructions of the detergent manufacturer regarding application, dilution and contact time). 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.
  • Page 40 Manual disinfection: 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) Immerse all parts of the needle guide bracket into the disinfectant (see Fig.

  • Page 41: Drying

    5.4 Automated cleaning and disinfection The following items must be provided prior to automated cleaning and disinfection: a) Washer disinfector: according to DIN EN ISO 15883 with chemo-thermal program (temperature: max. 60°C) b) Detergent: Korsolex® Endo-Cleaner (Bode Chemie; #972020) or another cleaning agent with approved material compatibility for this medical device c) Disinfectant: Korsolex®...

  • Page 42: Packaging

    Drying 5.5 Drying 1) Wipe all parts of the needle guide bracket with a single-use, fluff-free wipe or towel to remove moisture from the surface of them. 2) Dry all parts of the needle guide bracket naturally in an ambient temperature between 15-30°C for a minimum of 4 hours.

  • Page 43: Maintenance And Safety Inspection

    6. Maintenance and Safety Inspection 1) After using the probe, it should be cleaned and disinfected or sterilized according to “4. Reprocessing Procedure”, 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, it should be cleaned, disinfected or sterilized according to “4.

  • Page 44: Safety Precautions

    WARNING WARNING  Never use the probe if the probe head, housing or cable are cracked or damaged.  When use this Probe (EUP-B712) for biopsy purpose, use Needle Guide Bracket EZU-PA7C2 (Option) certainly. CAUTION CAUTION  By examination of an early pregnancy the exposure time shall be as short as possible.

  • Page 45: Specifications

    8. Specifications 8.1 Probe Type: EUP-B712 Biopsy Probe Acoustic working Frequency: 3.0MHz Technology: Convex Array Probe Dimensions: See Fig. 26. Weight: Approx. 0.70kg (Including cable and connector) Probe materials: Biocompatible allergy free components Acoustic output: According to IEC60601-2-37 (See Main Unit...

  • Page 46: Suppliers List Of The Probe

    8.2 Suppliers List of the Probe The products listed below are seriously tested and approved for use with EUP-B712. Product name manufacturer purpose Johnson & Cidezyme® Enzymatic detergent Johnson STERANIOS 2% ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant Johnson & CIDEX Disinfectant Johnson Johnson &...

  • Page 47: Needle Guide Bracket Ezu-Pa7C2

    8.3 Needle Guide Bracket EZU-PA7C2 Dimensions: See Fig. 28 and Fig. 29 Applicable probe: Convex Array Probe EUP-B712 Needle angle: 9 and 21 degree 8.4 Suppliers list of the Needle Guide Bracket EZU-PA7C2 Product name Manufacturer Purpose GENERAL PURPOSE Ultra-Pro II™...
  • Page 48 Fig. 26 Dimensions Unit: mm -42- Q1E-EP1412...
  • Page 49 Fig. 27 External view (with the Unit: mm Magnetic Sensor Attachment) -43- Q1E-EP1412...
  • Page 50 Fig. 28 Dimensions (with the Needle Guide Bracket) Unit: mm -44- Q1E-EP1412...
  • Page 51 Unit: mm Fig. 29 External view (with Ultra-Pro II Needle Guide / cover kit) -45- Q1E-EP1412...

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