Hitachi EUP-L75 Instruction Manual
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Hitachi EUP-L75 Instruction Manual

Linear array probe
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Linear Array Probe
EUP-L75
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-EP1199-9
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123

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Summary of Contents for Hitachi EUP-L75

  • 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-EP1199-9 © Hitachi, Ltd. 2013,2017. All rights reserved. 0123...
  • Page 2 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: ( 1 ) Q1E-EP1199...
  • 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 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 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

    2. Inspection before Use..........5 Inspection of appropriate connection ........5 Inspection of material surface ..........5 3. Operation Procedure..........6 4. Option of EUP-L75..........10 Magnetic sensor (EZU-RV2S) ..........10 Magnetic sensor (EZU-RV3S) ..........13 elasto coupler ............16 5.

  • Page 7: General

    1. General General The probe of model EUP-L75 is a Linear Array 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-L75 is designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound scanner. Mammary gland  Thyroid  Superficial organs  Composition The probe components of the EUP-L75 are as follows: 1) Probe EUP-L75 ......

  • Page 9: Accessories

    Accessories 1.5.1 Magnetic Sensor Attachment (part number:7347816A)(Option) 1.5.2 Spacer for RV2S (Option) 1.5.3 elasto Coupler for EUP-L75 (part number:7230413A)(Option) 1.5.4 Needle Guide Bracket EZU-PA7L3 (Option) 1) Needle guide bracket ....1 piece 2) Brush ........ 1 piece 3) Spring (Spare) ....... 2 pieces 4) Instruction manual ....

  • Page 10: External View

    External View Applied part Immersible part (IPX7) Cable Head Connector elasto coupler for EUP-L75 (Option) Magnetic sensor attachment for EUP-L75 (Option) Spacer for EZU-RV2S (Option) Acoustic coupler Acoustic coupler EZU-TECPL1 (Option) attachment EZU-TEATC2 (Option) Acoustic coupler SF-001 (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 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 12: Operation Procedure

    3. Operation Procedure Confirm that the probe, the magnetic sensor attachment, the spacer for RV2S and the elasto coupler are cleaned, disinfected and/or sterilized. It is recommended to use a disposable probe cover for preventing a patient from infection. 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 13 Marking Assist as shown in Fig. 3 is the function to help marking the surface of the body. Marking Assist Fig. 3 Marking Assist Use under sterile condition, protecting the probe by using covers is recommended. Some Latex material may create allergic reaction. Please use allergy free material covers.
  • Page 14 CAUTION The Marking Assist is intended to be used to mark. The scale of Marking Assist does not correspond to the display scale and the width of the probe does not correspond to the image width displayed in the image (see the Figure below). The scale of the Marking Assist The width of the...
  • Page 15 Caution in case of wiping off the ultrasound jelly or cleaning the surface of the acoustic lens. CAUTION The acoustic lens of the probe is manufactured very thin and delicate to get the high resolution. Therefore, in case of wiping off the ultrasound jelly or cleaning the surface of the acoustic lens, please use a soft cloth or tissue paper and handle with care.

  • Page 16: Option Of Eup-L75

    EUP-L75, EZU-RV2S and EZU-RV3S. EZU-RV2S and EZU-RV3S are shown in Fig. 5 and Fig. 10. The use of the EUP-L75 with either one of the magnetic sensors enables the user to perform RVS (Real-time Virtual Sonography). Magnetic sensor (EZU-RV2S) Magnetic sensor (EZU-RV2S) for EUP-L75 is shown in Fig.
  • Page 17 a) Attach the spacer for RV2S to the magnetic sensor. b) Insert the magnetic sensor into the magnetic sensor attachment at the correct direction as shown in Fig. 6. Spacer for EZU-RV2S Magnetic sensor (EZU-RV2S) Magnetic sensor (EZU-RV2S) Projected part of the magnetic sensor Fit the insertion direction...
  • Page 18 4.1.2 How to release the Magnetic sensor The procedure of releasing the magnetic sensor is as follows. 1) Turn around the magnetic sensor attachment and remove it from the probe as shown in Fig. 8. Fig. 8 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: Magnetic Sensor (Ezu-Rv3S)

    Magnetic sensor (EZU-RV3S) Magnetic sensor for EUP-L75 is shown in Fig. 10. Direction mark Magnetic Sensor (EZU-RV3S: white) Fig. 10 Magnetic sensor (EZU-RV3S) 4.2.1 How to attach the Magnetic sensor The procedure of attaching the magnetic sensor is as follows.
  • Page 20 a) Attach the Magnetic sensor into the probe at the correct direction as shown in Fig. 11. Direction mark of the Magnetic sensor Fit the insertion direction Projected part of the Magnetic sensor attachment. Fig. 11 How to attach the Magnetic sensor b) Place the magnetic sensor attachment on the probe as shown in Fig.
  • Page 21 4.2.2 How to release the Magnetic sensor The procedure of releasing the magnetic sensor is as follows. 1) Turn around the magnetic sensor attachment and remove it from the probe as shown in Fig. 13. Fig. 13 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 22: 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. 15. elasto coupler Fig. 15 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 23: 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-TEATC2 about the method of reprocessing EZU-TEATC2 and EZU-TECPL1. Please refer to the instruction manual of the needle guide bracket EZU-PA7L3 about the method of reprocessing it.
  • Page 24 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 25 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 - 19 - Q1E-EP1199...

  • Page 26: 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. 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 27 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-L75 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 28 If there is still soil visible, repeat all above steps. Manual disinfection: A) EUP-L75 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 29 probe. 2) Immerse the magnetic sensor attachment and the spacer for EZU-RV2S into the disinfectant (see Fig. 17). Set a clock to insure the recommended contact time which is 5 minutes. 3) Rinse the magnetic sensor attachment and the spacer for EZU-RV2S with deionized water for 1 minute.

  • Page 30: 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 31 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 32: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig. 19 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for Tray for sterilization. sterilization Probe in the Pouch Fig.

  • Page 33: Maintenance And Safety Inspection

    6. Maintenance and Safety Inspection 1) Visually inspect the surface of the probe head, housing, cable and connector for any crack, scratch or denaturalization. If you find any damage, do not use the probe and contact a service support immediately. 2) Visually inspect the surface of the magnetic sensor attachment and the spacer for RV2S for any crack, deformation or denaturalization.

  • Page 34: Safety Precautions

    Never use the probe if the probe head, housing or cable are cracked  or damaged. When using this probe (EUP-L75) for biopsy purpose,  use the needle guide bracket EZU-PA7L3 (Option) certainly. Warning in case of using probe covers which latex is contained ...

  • Page 35: Specifications

    8. Specifications Probe Type: EUP-L75 linear Array probe Acoustic working frequency: 10MHz Technology: Linear Array Probe Dimensions: See Fig. 21. Weight: Approx. 0.72kg (Including cable and connector) Probe materials: Biocompatible allergy free components Acoustic output: According to IEC60601-2-37 (See Main Unit manual)

  • Page 36: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with the Linear Array Probe EUP-L75. Product name Manufacturer Purpose Cidezyme Johnson & Johnson Enzymatic detergent Meliseptol HBV-Tücher Braun Disinfectant Incides Henkel Hygiene GmbH Disinfectant Incidin Liquid...

  • Page 37: Disposal Of The Probe

    9. 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 38 Unit:mm Fig. 21 Dimensions - 32 - Q1E-EP1199...
  • Page 39 Fig. 22 External view (with the Elast coupler) - 33 - Q1E-EP1199...
  • Page 40 Fig. 23 External view (with the Magnetic sensor attachment) - 34 - Q1E-EP1199...
  • Page 41 Fig.24 External View (with the Acoustic coupler attachment EZU-TEATC2 and the Acoustic coupler (EZU-TECPL1 or SF-001)) - 35 -...

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