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Hitachi EUP-V53W Instruction Manual

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Transvaginal Probe 
EUP‐V53W 
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‐EP0325‐15 
 
© Hitachi, Ltd. 2013, 2017. All rights reserved.
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Summary of Contents for Hitachi EUP-V53W

  • Page 1 Transvaginal Probe  EUP‐V53W  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‐EP0325‐15    © 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-EP0325...
  • Page 3 About this manual This instruction manual contains safety precautions, the inspection, the operation procedure and the reprocessing procedure of EUP-V53W. Please read this manual thoroughly to ensure the safety 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 Probe relating Medical Device Directive connector 2011/65/EU relating to RoHS Probe IPX7 mark IPX7 connector See section 1.6.

  • Page 6: Table Of Contents

    3.1. Connection and Settings ··································· 6 3.2. Use of Sterile Puncture Adapter (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.

  • Page 7: Introduction

    1. Introduction 1.1. Features The transvaginal probe EUP-V53W is Convex Array electronic scanning. 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 operational manual of each ultrasound scanner.

  • Page 8: Intended Use

    1.3. Intended Use The Transvaginal Probe EUP-V53W is designed for observation and diagnosis of the following regions mainly by connecting with the HITACHI ultrasound diagnostic scanner.  General OB/GYN organs  Biopsy (with a Sterile Puncture Adapter)  Transrectal WARNING Never use the probe for following regions.
  • Page 9 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 digital ultrasound scanner system and electronic scanning ultrasound tomography system. 1.5.5. Spacer for EZU-RV2S Spacer for EZU-RV2S is used for Real-time Virtual Sonography (RVS) with EZU-RV2S.

  • Page 10: Construction

    1.6. Construction The external view of EUP-V53W is shown in Fig. 1. Immersible part (IPX7) Applied part Cable Connector Magnetic sensor attachment (Option) Spacer for EZU-RV2S (Option) 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 them and contact a service support immediately. 2.1. Inspection for Appropriate Connection 1) Confirm that the system is correctly operating.

  • Page 12: Operation Procedure

    3. Operation Procedure 3.1. Connection and Settings 1) Confirm that the probe is cleaned and disinfected and if necessary sterilized. In case of using Real-time Virtual Sonography (RVS), confirm that the Magnetic sensor attachment is cleaned and disinfected and if necessary sterilized. In case of using RVS with an EZU-RV2S, confirm that the Spacer for EZU-RV2S is also cleaned and disinfected and if necessary sterilized.

  • Page 13: Use Of Sterile Puncture Adapter (Ezu-Pa5V)

    6) Fix jelly on the top of the probe with sterile adhesive tape. (See Fig. 5.) Sterilized tape Fig. 5 7) Insert the probe gentry and adjust the probe’s position for a clear view of the desired image. By turning or tilting the probe, a “turn around”...

  • Page 14: Display Of Needle Guide Line

    3.3. Display of Needle Guide Line When puncture is to be conducted, the needle guideline can be displayed by dot marks. Operation procedure for displaying the needle guideline on the main unit must be referred to the part of “Needle guide line” in the manual of the connected ultrasound scanner.

  • Page 15: Option Of Eup-V53W

    In case of using RVS (Real-time Virtual Sonography), confirm the type of the magnetic sensor. There are two types of the magnetic sensors for EUP-V53W, EZU-RV2S and EZU-RV3S. EZU-RV2S and EZU-RV3S are shown in Fig.8 and Fig.13. The use of EUP-V53W with both magnetic sensors enables the user to perform RVS (Real-time Virtual Sonography).
  • Page 16 a) Attach the Spacer for EZU-RV2S to Magnetic sensor. Spacer for Projected EZU-RV2S part b) Insert Magnetic sensor Magnetic sensor into the Magnetic (EZU-RV2S: Black) sensor attachment with the correct direction as shown in Fig. 9. Projected part Spacer Magnetic sensor attachment Fig.
  • Page 17 c) Attach the Magnetic sensor attachment to the probe as shown in Fig.10. Fig.10 How to attach the Magnetic sensor attachment CAUTION Do not put your fingers between the Magnetic Sensor Attachment and the Probe when attaching the Magnetic sensor attachment to the probe. 4.1.2.

  • Page 18: Magnetic Sensor (Ezu-Rv3S)

    4.2. Magnetic sensor (EZU-RV3S) Magnetic sensor as shown in Fig. 13 is the magnetic sensor for EUP-V53W. Direction mark Magnetic Sensor (EZU-RV3S: white) Fig. 13 Magnetic sensor (EZU-RV3S) 4.2.1. How to attach Magnetic sensor The procedure of attaching Magnetic sensor is as follow.
  • Page 19 b) Attach the Magnetic sensor attachment to the probe as shown in Fig.15. Fig.15 How to attach the Magnetic sensor attachment CAUTION Do not put your fingers between the Magnetic sensor attachment and the probe when attaching the Magnetic sensor attachment to the probe. -13- Q1E-EP0325...
  • Page 20 4.2.2. How to release Magnetic sensor The procedure of releasing Magnetic sensor is as follow. 1) Detach the Magnetic sensor attachment from the probe as shown Fig.16. Fig.16 How to release the Magnetic sensor attachment from the probe 2) Detach the magnetic sensor and the Spacer for EZU-RV3S from the Magnetic sensor attachment as shown Fig.

  • Page 21: Reprocessing Procedure

    Disinfection semicritical mucosa (intracavitary (Disinfectant with application) virucidal effect) Cleaning Application part contacts Disinfection intracorporeal tissue (Disinfectant with critical directly (operative virucidal effect - application) minimum) Sterilization According to the intended use, EUP-V53W probe is classified as semicritical. -15- Q1E-EP0325...
  • Page 22 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 Rinsing after manual cleaning Manual Disinfection Rinsing after manual disinfection Drying Packing Sterilization -16- Q1E-EP0325...

  • Page 23: Point Of Use (Pre-Cleaning)

    (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: A) EUP-V53W 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 24 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-V53W 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 25 Manual disinfection: A) EUP-V53W 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 26: Drying

    5.4. Drying 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 27: Sterilization

    Sterilization 5.7. Sterilization The probe and accessory can be sterilized using either ethylen oxide gas (EtO) sterilization or plasma sterilization (see table in the next page). 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 28 The packaging procedure is as follows. 1) Put the probe into TYVEK pouch. Probe Attachment TYVEK Pouch Fig. 19 Packaging in the pouch 2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Pouch Sealed complete.

  • Page 29: Storage

    5.8. 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. 6. Maintenance and Safety Inspection 6.1. Daily Inspection 1) Visually inspect the surface of the probe head, housing, cable and connector for any crack, scratch or denaturalization.

  • Page 30: Safety Precautions

    1) Never use the probe if the probe head, shaft or cable are cracked or damaged. 2) When use EUP-V53W for biopsy purpose, use Sterile Puncture Adapter EZU-PA5V (Option) certainly. 3) Never use the Sterile Puncture Adapter if the adapter is deformed, cracked or damaged.

  • Page 31: Specifications

    8. Specifications 8.1. Probe Type: EUP-V53W Transvaginal probe Center frequency: 6.5MHz Technology: High density Convex Array Probe Dimensions: See Fig. 22 Weight: Approx.1kg (Including cable and connector) Probe materials: Bio-compatible allergy free components Acoustic output: According to IEC 60601-2-37 (See Main Unit manual.)

  • Page 32: Sterile Puncture Adapter Ezu-Pa5V

    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 –...

  • Page 33: Suppliers List

    8.3. Suppliers List The products listed below are seriously tested and approved for use with the transvaginal probe EUP-V53W. Product name manufacturer purpose Cidezyme Johnson & Johnson Enzymatic detergent Meliseptol HBV-Tücher Braun Disinfectant Incidin Liquid Spray Henkel Hygiene GmbH Disinfectant...
  • Page 34 Unit: mm Fig. 22 Dimension of Probe EUP-V53W -28- Q1E-EP0325...
  • Page 35 Fig. 23 External view of the probe EUP-V53W with Sterile Puncture Adapter (EZU-PA5V) -29- Q1E-EP0325...
  • Page 36 Unit: mm Fig. 24 Dimension of the probe EUP-V53W with the Magnetic Sensor Attachment (Option) -30- Q1E-EP0325...

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