Hitachi EUP-S50A Instruction Manual

Sector scanning probe
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Sector Scanning Probe
EUP-S50A
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-EP0659-6
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123

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  Summary of Contents for Hitachi EUP-S50A

  • 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-EP0659-6 © 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-EP0659...
  • 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 probe. For instructions for operating the main unit, 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 relating to Medical Device Probe connector and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.5.
  • Page 6: Table Of Contents

    CONTENTS Page Introduction ........... 1 1.1 Features ..........................1 1.2 Principles of operation ....................1 1.3 Intended Use ......................... 2 1.4 Composition ........................... 2 1.5 Construction ......................... 2 Inspection before Use .......... 3 2.1 Inspection for Appropriate Connection ..............3 2.2 Inspection for Material Surface ................
  • Page 7: Introduction

    Introduction Features The probe of Model EUP-S50A has phased array Sector 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 Sector Scanning Probe EUP-S50A is designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound scanner. ・Cardiac Composition The probe components of the EUP-S50A are as follows: 1) Probe EUP-S50A ....... 1 piece 2) Instruction Manual ....
  • Page 9: 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 Check that the system is correctly operating. Refer to the instruction manual for the Main unit.
  • Page 10: Operation Procedure

    Operation Procedure Confirm that the probe is disinfected and sterilized. Connect the probe, operate the Main unit, and adjust the image according to the instructions given in the operation manual for the Main unit. Relationship between direction of the probe and the image is shown in Fig.2.
  • Page 11: Cleaning, Disinfection And Sterilization

    Cleaning semicritical mucosa (intracavitary Disinfection (Disinfectant application) with virucidal effect) Cleaning Application part contacts Disinfection (Disinfectant intracorporeal tissue critical with virucidal effect - directly minimum) (operative application) Sterilization According to the intended use, EUP-S50A probe is classified as uncritical. Q1E-EP0659...
  • Page 12: 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 cleaning Containment and Sterilization transportation Manual Disinfection Rinsing after manual disinfection Point of use (Pre-cleaning) Point of use (Pre-cleaning) Pre-cleaning should be done immediately...
  • Page 13: Manual Cleaning And Disinfection

    Manual cleaning Manual Cleaning and disinfection and disinfection Prepare following items before manual Manual Cleaning cleaning and disinfection: a) Detergent: Cidezyme (Johnson & Rinsing after manual Johnson, #2258) or another cleaning cleaning agent with approved material compatibility for this Manual Disinfection medical device Rinsing after manual b) Disinfectant: Cidex OPA (Johnson &...
  • Page 14 3) The immersible part of the probe should be left in the detergent solution according to the specified contact time of the detergent manufacturer. 4) Wipe the un-immersible parts of the probe with a soft cloth dipped with the detergent solution. 5) Rinse the probe with running tap water for 1 minute.
  • Page 15: Drying

    Water Detergent Disinfectant Fig.3 Immersion of the probe 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.
  • Page 16: Packaging

    Packaging Packaging Pack the probe in a sterile barrier such as Polypropylene fleece or transparent package made from Polyethylene film and Tyvek®, and then place it into a tray. The tray should be also covered with a sterile barrier. Additionally the probe can be placed on plastic mesh wires supplied for plasma sterilization and then packed as mentioned above.
  • Page 17: Sterilization

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

    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. -13- Q1E-EP0659...
  • Page 20: Maintenance And Safety Inspection

    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. Visually inspect the surface of the probe head, the housing, the cable and the connector for any crack, scratch or denaturalization.
  • Page 21: Safety Precautions

    Safety Precautions WARNING  Never use the probe if the probe head, housing or cable are cracked or damaged.  Warning is 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 22: Specifications

    Specifications Probe Type : EUP-S50A Sector Scanning probe Center frequency : 2.5MHz Technology : Phased Array Probe Dimensions : See Fig.7. Weight : Approx. 0.64kg (incl. cable and connector) Scanning angle : 90° Probe materials : Bio-compatible allergy free components...
  • Page 23: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with the Sector Scanning probe EUP-S50A. Product name manufacturer purpose Cidezyme Johnson & Johnson Enzymatic detergent Meliseptol HBV-Tücher Braun Disinfectant Incidin Liquid Henkel Hygiene Disinfectant GmbH Incidur Spray...
  • Page 24: Disposal Of The Probe

    Disposal of the probe Recycle or dispose of equipment properly in compliance with your organizational rules and your local laws. CAUTION Before disposing of equipment, disinfect or take other infection-prevention measures. Disposal of equipment without taking the proper preventative measures can lead to infection.
  • Page 25 Unit:mm Fig.7 Dimensions -19- Q1E-EP0659...