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Hitachi EUP-L65 Instruction Manual

Linear array probe
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Linear Array Probe
EUP-L65
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-EP0739-7
© Hitachi ,Ltd. 2013,2017. All rights reserved.
0123
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Summary of Contents for Hitachi EUP-L65

  • Page 1 ★ 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-EP0739-7 © 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: ( 1 ) Q1E-EP0739...
  • Page 3 About this manual This instruction manual shall provide instructions for using, cleaning, disinfecting the HITACHI ultrasound probes. 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 1.7.

  • Page 6: Table Of Contents

    1.2 Principles of operation ......... 1   1.3 Intended Use ............ 1   1.4 Components ............2   1.5 Option ............2   1.6 Option of Hitachi ultrasound diagnostic scanner ....3   1.7 External View ........... 3   2. Inspection before Use ........4  ...

  • Page 7: General

    1. General General The EUP-L65 is a linear array probe. The acoustic output of the EUP-L65 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: Components

    Components The components of the EUP-L65 are given below: Probe EUP-L65 ....1 piece Instruction Manual ..... 1 copy CAUTION Disinfection has not been made to the probe, shipped from the factory. Prior to use of the probe, be sure to clean and disinfect the probe.

  • Page 9: Option Of Hitachi Ultrasound Diagnostic Scanner

    Option of Hitachi ultrasound diagnostic scanner Magnetic Sensor Attachment (Part No. 7349818A) Spacer for EZU-RV2S Elasto coupler (Part No. 7331474A) CAUTION Sterilization has not been made to the magnetic sensor attachment and the Elasto coupler, shipped from the factory. Prior to use of it, be sure to clean, disinfect and sterilize it.

  • Page 10: Inspection Before Use

    2. Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. If you find any damage, do not use the probe and immediately contact a service support. Inspection of appropriate connection 2.1.1 Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner.

  • Page 11: Operation Procedure

    3. Operation Procedure Confirm that the probe is cleaned and disinfected. 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. Confirm the direction of the probe.
  • Page 12 After using the magnetic sensor attachment, the spacer for EZU-RV2S and the elasto coupler, perform the reprocessing procedure in accordance with the procedure stated in “5.Reprocessing procedure” every time immediately after completing the ultrasound examination. Store the probe, the magnetic sensor attachment, the spacer for EZU-RV2S and the elasto coupler in the environment indicated in “6.Maintenance and Safety inspection”.

  • Page 13: Option Of Hitachi Ultrasound Diagnostic Scanner

    EUP-L65, the EZU-RV2S and the EZU-RV3S. The magnetic sensors EZU-RV2S and EZU-RV3S are shown in Fig. 3 and Fig. 8. The use of the EUP-L65 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.
  • Page 14 c) Place the magnetic sensor attachment on the probe as shown in Fig. 5. Fit the projected part of the magnetic sensor attachment in the index mark of the probe. Index mark Fit the insertion direction Projected part of the Magnetic sensor attachment Fig.
  • Page 15 4.1.2 How to release the Magnetic sensor The procedure of releasing the magnetic sensor from the probe is as follows. Push the magnetic sensor attachment and release it from the probe as shown in Fig. 6. Push here Fig. 6 How to release the Magnetic sensor attachment from the probe Release the magnetic sensor from the magnetic sensor attachment as shown in Fig.

  • Page 16: Magnetic Sensor Ezu-Rv3S

    Magnetic sensor EZU-RV3S The magnetic sensor EZU-RV3S is shown in Fig. 8. Direction mark Magnetic 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) Confirm that the probe and the magnetic sensor attachment are cleaned, disinfected and/or sterilized.
  • Page 17 b) Place the magnetic sensor attachment on the probe as shown in Fig. 10. Fit the projected part of the magnetic sensor attachment in the index mark of the probe. Index mark Fit the insertion direction Projected part of the Magnetic sensor attachment Fig.
  • Page 18 4.2.2 How to release the Magnetic sensor The procedure of releasing the magnetic sensor is as follows. Push the magnetic sensor attachment and release it from the probe as shown in Fig. 11. Push here Fig. 11 How to release the Magnetic sensor attachment from the probe 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. 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

    5. 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. For reprocessing of the needle guide bracket EZU-PA6L1, the acoustic coupler EZU-TECPL1 and the acoustic coupler attachment EZU-TEATC1 please refer to the corresponding instruction manuals.
  • 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-EP0739...

  • 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. 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-L65 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-L65 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

    5.4 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 40°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

    6. Maintenance and Safety Inspection After using of the probe, it should be cleaned and disinfected according to “5. Reprocessing Procedure”, store the probe in a cool and dark space to avoid high temperature, humidity and direct sunlight. After using the magnetic sensor attachment, the spacer for EZU-RV2S and the elasto coupler, the magnetic sensor attachment, the spacer for EZU-RV2S and the elasto coupler should be cleaned and disinfected and/or sterilized according to “5.

  • Page 31: Safety Precautions

    7. Safety Precautions WARNING  Never use the probe if the probe head 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

    8. Specifications Probe Type : EUP-L65 Linear Array Probe Acoustic working : 10MHz±30% frequency Technology : Linear Array Probe Dimensions : See Fig. 19 Weight : Approx. 0.9kg (incl. cable and connector) Scanning width : 38mm Probe materials : Bio-compatible allergy free components...

  • Page 33: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with the Linear Array Probe EUP-L65. Product name Manufacturer Purpose STERANIOS 2% ANIOS Disinfectant CIDEX Johnson & Johnson Disinfectant CIDEX plus Johnson & Johnson Disinfectant CIDEX OPA Johnson &...
  • Page 34 Unit:mm Fig. 19 Dimensions - 28 - Q1E-EP0739...

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