Hitachi EUP-O53T Instruction Manual
Hitachi EUP-O53T Instruction Manual

Hitachi EUP-O53T Instruction Manual

Intraoperative probe


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Intraoperative Probe
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
© Hitachi, Ltd. 2013,2017. All rights reserved 


Table of Contents

Summary of Contents for Hitachi EUP-O53T

  • Page 1 Intraoperative Probe EUP-O53T 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‐EP0403‐9 ...
  • Page 2 Manufacturer: Hitachi,Ltd 2-16-1, Higashi-Ueno, Taito-ku, Tokyo, 110-0015, Japan +81-3-6284-3668 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-EP0403...
  • Page 3 About this manual This instruction manual shall provide instructions for using, cleaning, disinfecting and/or sterilizing the Hitachi ultrasound probe. 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 Medical Device Probe connector 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 Composition ·············································· 2 Accessories (Option) ····································· 2 Construction ············································· 3 2. Inspection before Use ········································ 4 Inspection for Appropriate Connection ···················· 4 Inspection for Material Surface ··························...
  • Page 7: Introduction

    Introduction Features The probe of Model EUP-O53T has Linear Array electronic scanning 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

    Intended Use The Linear Array Probe EUP-O53T is designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound scanner.  Intraoperative  Biopsy (with biopsy attachment) Composition The probe components of the EUP-O53T are as follows: 1) Probe EUP-O53T ......
  • Page 9: Construction

    Construction Immersible part (IPX7) Index mark Cable Applied part Connector 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 can not be cleaned by water. Fig.1 External View Q1E-EP0403...
  • Page 10: Inspection Before Use

    Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. If not, do not use the probe and immediately contact a service support. Inspection for Appropriate Connection 2.1.1 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 is disinfected and sterilized. 2) Connect the probe, operate the main unit, and adjust the image according to the instructions given in the operation manual for the main unit. 3) Relationship between direction of the probe and the image is shown in Fig.2.
  • Page 12: Cleaning, Disinfection And Sterilization

    Application part contacts Disinfection semicritical mucosa (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-O53T probe is classified as critical. Q1E-EP0403...
  • Page 13: Point Of Use (Pre-Cleaning)

    The flowchart of the reprocessing process of this probe is as follows. Manual cleaning and disinfection Drying Point of use Manual Cleaning (Pre-cleaning) Packing Rinsing after manual Containment and cleaning transportation Sterilization Manual Disinfection Rinsing after manual disinfection 4.1 Point of use (Pre-cleaning) Point of use Pre-cleaning should be done immediately after each (Pre-cleaning)
  • Page 14: Manual Cleaning And Disinfection

    4.3 Manual Cleaning and disinfection Manual cleaning and disinfection Prepare following items before manual cleaning Manual Cleaning and disinfection: a) Detergent: Cidezyme (Johnson & Johnson, Rinsing after manual #2258) or another cleaning agent with cleaning approved material compatibility for this medical device Manual Disinfection b) Disinfectant: Cidex OPA (Johnson &...
  • Page 15: Drying

    5) 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.3) for 5 min.) 6) Visually check the outer surface of the probe for cleanness. If necessary, use magnifying glass for visually check.
  • Page 16: Inspection

    4.5 Inspection Inspect the equipment for any damage such as crack, scratch or deformation. Do not use it if any damage is found. Packaging 4.6 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 17: Sterilization

    4.7 Sterilization Sterilization The probe and accessory can be sterilized using either ethylene 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 18 The packaging before sterilization is as follows. 1) Put the probe into TYVEK pouch. Probe TYVEK Pouch Fig. 4 Packaging in the pouch 2) Seal the TYVEK Pouch using a heat sealer. Ensure that Sealed the seal is complete. Probe TYVEK Pouch Fig.
  • Page 19: Storage

    4.8 Storage Store the equipment in a cool, dustproof, dry, and dark space to avoid high temperature, humidity and direct sunlight. Limitations for the time for sterilized equipment belong to package. Maintenance and Safety Inspection After using the probe, it should be cleaned and disinfected or sterilized according to “4.Cleaning, Disinfection and Sterilization”, store the probe in a cool and dark space to avoid high temperature, humidity and direct sunlight.
  • Page 20: Safety Precautions

    Safety Precautions WARNING  Never use the probe if the probe head, housing or cable are cracked or damaged.  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.
  • Page 21: Specifications

    Specifications Probe Type : EUP-O53T Intraoperative Probe. Center : 7.5MHz Technology : Linear Array Probe. Dimensions : See Fig.4 Weight : Approx. 1.0kg (incl. cable and connector) Field of view : 57mm Probe materials : Bio-compatible allergy free components. Acoustic output...
  • Page 22: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with the Intraoperative Probe EUP-O53T. Product name manufacturer purpose CIDEZYME Johnson & Johnson Enzymatic detergent CIDEX plus Johnson & Johnson Disinfectant ALKACIDE ALKAPHARM Disinfectant ALKAZYME ALKAPHARM Cleaner Please contact your local distributor for a current version of the "Disinfectant/Sterilization Method Compatibility for Ultrasound...
  • Page 23 Unit:mm Fig.4 Dimensions -17- Q1E-EP0403...

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