Hitachi EUP-L73S Instruction Manual
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Hitachi EUP-L73S Instruction Manual

Hitachi EUP-L73S Instruction Manual

Linear array probe
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Linear Array Probe
EUP-L73S
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-EP1019-9
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123
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Summary of Contents for Hitachi EUP-L73S

  • 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-EP1019-9 © 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: ( 1 ) Q1E-EP1019...
  • 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 about 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 Probe connector Medical Device and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.6.

  • Page 6: Table Of Contents

    Inspection for Appropriate Connection ......4   2.2   Inspection for Material Surface ........4   Operation Procedure ........... 5     Magnetic Sensor for EUP-L73S ........7     4.1   Magnetic sensor EZU-RV2S ......... 7   4.2  ...

  • Page 7: Introduction

    Introduction General The EUP-L73S is a linear array probe. The acoustic output of the EUP-L73S was measured according to the IEC60601-2-37 standard and the measurement was conducted by operating with the Hitachi ultrasound diagnostic scanner. The measured acoustic output is listed in the instruction manual of the Hitachi ultrasound diagnostic scanner.

  • Page 8: Intended Use

    Intended Use The EUP-L73S is designed for observation and diagnosis mainly of the following regions by connecting with the Hitachi ultrasound diagnostic scanner.  Superficial region  Cervical region  Mammary gland  Biopsy (with Coupler Attachment) WARNING Never use the probe for following applications.

  • Page 9: External View

    External View The external view of the EUP-L73S is shown in Fig. 1. Immersible part (IPX7) Cable Head Applied part Connector Magnetic sensor attachment (Option) Elasto coupler Spacer for EZU-RV2S (Option) (Option) Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water.

  • Page 10: 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 nor instruments on the probe, such as unauthorized biopsy attachments.

  • Page 11: Operation Procedure

    Operation Procedure 1) Confirm that the probe, the magnetic sensor attachment, the spacer for EZU-RV2S and the elasto coupler are cleaned, disinfected and/or 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 12 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 on the examination site and adjust the probe’s position for a clear view of the desired image.

  • Page 13: Magnetic Sensor For Eup-L73S

    EZU-RV3S. The magnetic sensors EZU-RV2S and EZU-RV3S are shown in Fig.3 and Fig.8. The use of the EUP-L73S with either one of the magnetic sensors enables the user to perform RVS (Real-time Virtual Sonography). Magnetic sensor EZU-RV2S The magnetic sensor EZU-RV2S is shown in Fig. 3.
  • Page 14 Magnetic sensor (EZU-RV2S: Black) Spacer for EZU-RV2S Spacer for EZU-RV2S Projected part of the EZU-RV2S Fit the insertion direction Magnetic sensor (EZU-RV2S: Black) Projected part of the Magnetic sensor attachment Fig. 4 How to attach the Magnetic sensor attachment Projected part of the Magnetic sensor attachment Fit the insertion direction Index mark...
  • Page 15 4.1.2 How to release the Magnetic sensor The procedure of releasing the magnetic sensor from the probe is as follows. 1) Turn around the magnetic sensor attachment and release it from the probe as shown in Fig. 6. Fig. 6 How to release the Magnetic sensor attachment from the probe 2) Release the magnetic sensor from the magnetic sensor...

  • Page 16: Magnetic Sensor Ezu-Rv3S

    Magnetic sensor EZU-RV3S The EZU-RV3S is shown in Fig. 8. Direction mark Sensor（white） Fig. 8 Magnetic sensor EZU-RV3S 4.2.1 How to attach the Magnetic sensor The procedure of attaching the magnetic sensor is as follows. 1) Attach the magnetic sensor into the probe with the correct direction as shown in Fig.
  • Page 17 Projected part of the Magnetic sensor attachment Fit the insertion direction Index mark Fig. 10 How to attach the Magnetic sensor attachment CAUTION Never attach the magnetic sensor attachment to the probe in the incorrect direction, otherwise it may result in false diagnosis. - 11 - Q1E-EP1019...
  • Page 18 4.2.2 How to release the Magnetic sensor The procedure of releasing the magnetic sensor from the probe is as follows. 1) Turn around the magnetic sensor attachment and release it from the probe as shown in Fig. 11. Fig. 11 How to release the Magnetic sensor attachment from the probe 2) Release the magnetic sensor from the magnetic sensor attachment as shown in Fig.

  • Page 19: Elasto Coupler

    Elasto Coupler 4.3.1 How to attach the Elasto Coupler To use elastography, attach the elasto coupler as shown below. Attach the elasto coupler on the probe as straight as possible as shown in Fig. 13. Elasto coupler Fig. 13 How to attach the Elasto coupler 4.3.2 How to release the Elasto Coupler Release the elasto coupler from the probe as shown in Fig.

  • Page 20: Reprocessing Procedure

    Reprocessing Procedure The probe, magnetic sensor attachment and spacer for EZU-RV2S must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. Please refer to the instruction manual of EZU-PA7L1 about the method of handling, cleaning and sterilizing the coupler attachment EZU-PA7L1.
  • Page 21 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 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-EP1019...

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

    5.1 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 and any accessories from the probe. 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-L73S 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 If there is still soil visible, repeat all above steps. Manual disinfection: A) EUP-L73S 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).
  • Page 26 Magnetic sensor attachment and Spacer for EZU-RV2S 1) Prepare the disinfectant solution as stated in the procedure for the probe. 2) Immerse the magnetic sensor attachment and the spacer for EZU-RV2S into the disinfectant (see Fig. 15). Set a clock to insure the recommended contact time which is 5 minutes.

  • Page 27: Drying

    Drying Drying 1) Wipe the equipment with a single-use, fluff-free wipe or towel to remove moisture from the surface of the equipment. 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 28 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 29: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig. 17 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for Tray for sterilization. sterilization Probe in the Pouch Fig.

  • Page 30: Maintenance And Safety Inspection

    Maintenance and Safety Inspection 1) After using the probe, the magnetic sensor attachment, the spacer for EZU-RV2S and the elasto coupler, it should be cleaned and disinfected or sterilized following “5. Reprocessing Procedure”, then store it in a cool and dark place avoid high temperature and humidity, direct sunlight.

  • Page 31: Safety Precautions

    Safety Precautions WARNING Never use the probe if the probe is damaged.  Do not use the latex probe cover for latex sensitive patients.  The probe cover, which contains latex, may cause allergic reactions such as itching, rubor, urticaria, swelling, fever, anhelation, wheezing, depression of blood pressure, and shock.

  • Page 32: Specifications

    Specifications 8.1 Probe Type : EUP-L73S Linear Array Probe Center Frequency : 6.5MHz Technology : Linear Array Probe Dimensions : See Fig. 19. Weight : Approx. 0.78kg (Including cable and connector) Scanning width : 38mm Probe materials : Biocompatible allergy free components...

  • Page 33: 8.2 Suppliers List

    8.2 Suppliers List The products listed below are seriously tested and approved for use with the Linear Array Probe EUP-L73S. Product name Manufacturer Purpose Cidezyme Johnson & Johnson Enzymatic detergent Meliseptol HBV-Tücher Braun Disinfectant Incides Henkel Hygiene Disinfectant GmbH Incidin Liquid...

  • Page 34: 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 35 Unit:mm Fig. 19 Dimensions - 29 - Q1E-EP1019...
  • Page 36 Fig. 20 External view (with the Magnetic sensor attachment) - 30 - Q1E-EP1019...
  • Page 37 Fig. 21 External view (with the Elasto coupler) - 31 - Q1E-EP1019...

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