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Hitachi EUP-C715 Instruction Manual

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Convex Array Probe
EUP-C715
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-EP1011-7
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123
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Summary of Contents for Hitachi EUP-C715

  • 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-EP1011-7 © 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: Q1E-EP1011...
  • 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 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 Probe connector 93/42/EEC relating to Medical Device and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.6.

  • Page 6: Table Of Contents

    2.1 Inspection for Appropriate Connection ..............4 2.2 Inspection for Material Surface ................4 Operation Procedure ..........5 Magnetic Sensor for EUP-C715 ........7 4.1 Magnetic Sensor (EZU-RV2S) ................... 7 4.2 Magnetic Sensor (EZU-RV3S) ..................10 Cleaning, Disinfection and Sterilization ...... 13 5.1 Point of use (Pre-cleaning) ..................

  • Page 7: General

    General General EUP-C715 is a convex array probe. The acoustic output of EUP-C715 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 EUP-C715 is designed for observation and diagnosis mainly of the following regions by connecting with the Hitachi ultrasound diagnostic scanner.  General abdominal organs  Biopsy (with Needle guide bracket) WARNING Never use the probe for following applications.

  • Page 9: External View

    External View The external view of EUP-C715 is shown in Fig.1. Immersible part (IP47) Cable Head Connector Applied part Spacer for EZU-RV2S (Option) Magnetic sensor attachment (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 for 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 11: Operation Procedure

    Operation Procedure Confirm that the probe, the magnetic sensor attachment and the spacer for EZU-RV2S are cleaned, disinfected and if necessary sterilized. 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 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. Place the probe on the examination site and adjust the probe’s position for a clear view of the desire image.

  • Page 13: Magnetic Sensor For Eup-C715

    EZU-RV3S. The magnetic sensor (EZU-RV2S) and the magnetic sensor (EZU-RV3S) are shown in Fig.3 and Fig.8. The use of EUP-C715 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 3) Place the magnetic sensor attachment in the index mark of the probe. Projected part of the Magnetic sensor attachment Fit the insertion direction Index mark Fig.5 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 false diagnosis.
  • 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 Magnetic sensor attachment 2) Release the magnetic sensor from the magnetic sensor attachment as shown in Fig.7 and release the spacer for EZU-RV2S from the magnetic sensor.

  • Page 16: Magnetic Sensor (Ezu-Rv3S)

    Magnetic Sensor (EZU-RV3S) The magnetic sensor (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.9.
  • Page 17 2) 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. Projected part of the Magnetic sensor attachment Fit the insertion direction Index mark Fig.10 How to attach the Magnetic sensor attachment CAUTION...
  • 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 probe as shown in Fig.11. Fig.11 How to release the Magnetic sensor attachment 2) Release the magnetic sensor from the magnetic sensor attachment as shown in Fig.12.

  • Page 19: Cleaning, Disinfection And Sterilization

    Cleaning, Disinfection and Sterilization The probe and magnetic sensor attachment with spacer must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. Please refer to the instruction manual of needle guide bracket EZU-PA7C1 about the method of cleaning, disinfecting and sterilizing the needle guide bracket EZU-PA7C1.
  • Page 20 Application part contacts Disinfection semicritical mucosa (intracavitary (Disinfectant with application) virucidal effect) Cleaning Application part contacts Disinfection intracorporeal tissue (Disinfectant with critical directly virucidal effect - minimum) (operative application) Sterilization According to the intended use, EUP-C715 is classified as uncritical. -14- Q1E-EP1011...
  • Page 21 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 -15- Q1E-EP1011...

  • Page 22: Point Of Use (Pre-Cleaning)

    (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: A) EUP-C715 Remove any accessories from the probe like probe cover, magnetic sensor attachment and needle guide bracket. Clean the probe of all patient’s blood or fluid with running tap water until the surface of the probe looks visually clean.

  • Page 23: Manual Cleaning And Disinfection

    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-C715 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 24 to remove all visible soil. Be sure that all grooves of the probe are implemented during the cleaning process. The immersible part of the probe should be left in the detergent solution according to the specified contact time of the detergent manufacturer.
  • Page 25 Manual disinfection: A) EUP-C715 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 26: Drying

    B) 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 spacer for EZU-RV2S into the disinfectant (see Fig. 13). Set a clock to insure the recommended contact time which is 5 minutes.

  • Page 27: Inspection

    Inspection Inspect the equipment for any damage such as crack, scratch or deformation. Do not use it if any damage is found. 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.

  • Page 28: Sterilization

    Sterilization Sterilization The probe and accessory 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. Sterilization Method Condition Plasma Sterilization:...
  • Page 29 The packaging procedure is as follows. 1) Put the probe into TYVEK pouch. Probe TYVEK Pouch Fig.14 Packaging in the pouch 2) Seal the TYVEK Pouch using a heat sealer. Ensure that the seal is complete. Sealed Probe TYVEK Pouch Fig.15 Sealing -23- Q1E-EP1011...

  • Page 30: Storage

    3) Put the sealed pouch into a tray or plastic mesh wire for sterilization. Tray for Probe in sterilization the Pouch Fig.16 Packaging in a tray Storage Store the equipment in a cool, dustproof and dark space to avoid high temperature, humidity and direct sunlight. Limitations for the time for sterilized equipment belong to package.

  • Page 31: Maintenance And Safety Inspection

    Maintenance and Safety Inspection After using the probe, the magnetic sensor attachment and the spacer for EZU-RV2S, it should be cleaned and disinfected or sterilized according to “5. Cleaning, Disinfection and Sterilization”, then store the probe in a cool and dark space to avoid high temperature, humidity and direct sunlight.

  • Page 32: 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 33: Specifications

    Specifications Probe Type : EUP-C715 Convex Array Probe Acoustic working frequency : 3.0MHz Technology : Convex Array Probe Dimensions : See Fig.17. Weight : Approx. 0.78kg (incl. cable and connector) Scanning angle : 70° Probe materials : Bio-compatible allergy free components...

  • Page 34: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with the Convex Array Probe EUP-C715. Product name manufacturer purpose Cidezyme Johnson & Johnson Enzymatic detergent Meliseptol HBV-Tücher Braun Disinfectant Incidin Liquid Henkel Hygiene Disinfectant GmbH Incidur Spray...
  • Page 35 Unit:mm Fig.17 Dimensions -29- Q1E-EP1011...
  • Page 36 Fig.18 External view (with the Magnetic sensor attachment) -30- Q1E-EP1011...

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