Hitachi EUP-L54MA Instruction Manual
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Hitachi EUP-L54MA Instruction Manual

Linear array probe
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Linear Array Probe
EUP-L54MA
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-EP0995-6
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123

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  • 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-EP0995-6 © 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 3 D-65205 Wiesbaden, Germany EU Importer: Hitachi Medical Systems Europe Holding AG Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland Local Distributor: Q1E-EP0995...
  • 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 about 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 1.5.

  • Page 6: Table Of Contents

    CONTENTS Page Introduction ........... 1     1.1   Features ............1   1.2   Principles of operation ..........1   1.3   Intended Use ............1   1.4   Composition ............2   1.5   External View ............2   Inspection before Use ..........

  • Page 7: Introduction

    Introduction Features The probe model EUP-L54MA is a linear array type probe. 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: Composition

    Sterilization has not been made to the probe, shipped from the factory. Prior to use of the probe, be sure to clean, disinfect and sterilize the probe. External View The external view of EUP-L54MA is shown in Fig. 1. Immersible part (IPX7) Cable Head...

  • Page 9: Inspection Before Use

    Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. Inspection of appropriate connection 2.1.1 Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner. 2.1.2 Do not attach or connect unauthorized devices or instruments on the probe, such as unauthorized biopsy attachments.

  • Page 10: Operation Procedure

    Operation Procedure Confirm that the probe is cleaned, disinfected or 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.

  • Page 11: Reprocessing Procedure

    Reprocessing Procedure The probe 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. ‐ WARNINGS Temperature should not exceed 60°C during reprocessing.
  • Page 12 Application part contacts Disinfection semicritical mucosa (intracavitary (Disinfectant with application) virucidal effect) Cleaning Disinfection Application part contacts (Disinfectant with critical intracorporeal tissue directly virucidal effect - (operative application) minimum) Sterilization According to the intended use, EUP-L54MA probe is classified as uncritical. Q1E-EP0995...
  • Page 13 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 Q1E-EP0995...

  • Page 14: Point Of Use (Pre-Cleaning)

    4.1 Point of use (Pre-cleaning) Point of use Pre-cleaning should be done immediately after each use. (Pre-cleaning) The procedure is as follows: 1) Remove the probe 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 15 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 16 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) Confirm the concentration of the disinfectant before immersing the probe.

  • Page 17: Drying

    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 probe can be dried using a drying heater at a temperature of less than 60°C.
  • Page 18 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 19: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig. 5 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for sterilization. Tray for sterilization Probe in the Pouch Fig.

  • 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. Reprocessing Procedure”, 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 cables 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, and depression of blood pressure, shock and so on.

  • Page 22: Specifications

    Specifications Probe Type : EUP-L54MA Linear Array Probe Center frequency : 9.75MHz Technology : Linear Array Probe Dimensions : See Fig. 7. Weight : Approx. 0.9kg (incl. cable and connector) Scanning angle : 50mm 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 Linear Array Probe EUP-L54MA. manufacturer purpose Product name Johnson & Johnson Enzymatic detergent Cidezyme® Braun Disinfectant Meliseptol HBV-Tücher Henkel Hygiene GmbH Disinfectant Incides Henkel Hygiene GmbH...

  • Page 24: Disposal Of The Probe

    Disposal of the probe Recycle or dispose the equipment properly in compliance with your organizational rules and your local laws. CAUTION Before disposing the equipment, disinfect or take other infection-prevention measures. Disposal of the equipment without taking the proper preventative measures can lead to infection.
  • Page 25 Unit:mm Fig. 7 Dimensions -19- Q1E-EP0995...

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