Hitachi EUP-C514 Instruction Manual
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Hitachi EUP-C514 Instruction Manual

Convex array probe
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Convex Array Probe 
EUP‐C514 
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‐EP0428‐10 
 
© Hitachi, Ltd. 2013,2017. All rights reserved. 
0123
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  • Page 1 Convex Array Probe  EUP‐C514  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‐EP0428‐10    © 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-EP0428...
  • Page 3 About this manual This instruction manual shall provide instructions for using, cleaning, disinfecting and/or sterilizing the HITACHI ultrasound probe. 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 Probe connector Medical Device and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.7.

  • Page 6: Table Of Contents

    1.3. Intended Use ............. 2 1.4. Composition ............2 1.5. Option ............3 1.6. Option of Hitachi ultrasound diagnostic scanner ....3 1.7. External View ............ 4 2. Inspection before Use ........5 2.1. Inspection for Appropriate Connection ......5 2.2.

  • Page 7: General

    1. General 1.1. General The EUP-C514 is a convex array probe. The acoustic output of the EUP-C514 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

    1.3. Intended Use The EUP-C514 is designed for observation and diagnosis mainly of the following regions by connecting with the Hitachi ultrasound diagnostic scanner.  General abdominal organs  General OB/GYN organs  Biopsy (with Biopsy Attachment) WARNING Never use the probe for following applications.

  • Page 9: Option Of Hitachi Ultrasound Diagnostic Scanner

    1.5. Option 1.5.1. Biopsy Attachment EZU-PA34T The biopsy attachment EZU-PA34T is a dedicated tool for use as mounted on a EUP-C514. The optional biopsy attachment EZU-PA34T components are as follows: 1) Biopsy guide assembly ········ 1 piece 2) Needle guide (14G, 18G and 21G) ···········...

  • Page 10: External View

    Spacer for EZU-RV2S (Option of Hitachi ultrasound diagnostic scanner) Magnetic sensor attachment (Option of Hitachi ultrasound diagnostic scanner) Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water. Un-immersible part: This part should not be immersed in disinfectant solution and also cannot 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. If you find any damage, do not use the probe and immediately contact a service support. 2.1. Inspection for Appropriate Connection 1) Confirm that the system is correctly operating.

  • Page 12: Operation Procedure

    3. Operation Procedure 1) Confirm that the probe is cleaned, disinfected and if necessary sterilized. Index mark 2) Confirm that the Magnetic sensor attachment and the Spacer for EZU-RV2S is disinfected or sterilized, when use RVS (Real-time Virtual Sonography). 3) Connect the probe to the ultrasound diagnostic scanner, operate the scanner, and adjust the image, all according to the...

  • Page 13: Option Of Hitachi Ultrasound Diagnostic Sensor

    The Magnetic sensor (EZU-RV2S) and the Magnetic sensor (EZU-RV3S) are shown in Fig. 3 and Fig.8. The use of the EUP-C514 with either of the magnetic sensors enables the user to perform RVS (Real-time Virtual Sonography). 4.1. Magnetic Sensor (EZU-RV2S) The Magnetic sensor (EZU-RV2S) as shown in Fig.3 is a magnetic sensor...
  • Page 14 a) Attach the Spacer for EZU-RV2S to the Magnetic sensor. b) Insert the Magnetic sensor (EZU-RV2S) into the Magnetic sensor attachment with the correct direction as shown in Fig. 4. Magnetic sensor Spacer for EZU-RV2S (EZU-RV2S: Black) Projected part of the Magnetic sensor Fit the insertion direction...
  • Page 15 4.1.2. How to release the Magnetic Sensor The procedure of releasing the Magnetic sensor from the probe is as follow. 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 2) Release the Magnetic sensor from the Magnetic sensor attachment as shown in Fig.

  • Page 16: Magnetic Sensor (Ezu-Rv3S)

    4.2. Magnetic Sensor (EZU-RV3S) The Magnetic sensor (EZU-RV3) as shown in Fig. 8 is also the Magnetic sensor for the EUP-C514. 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.
  • 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 Hole of the Magnetic sensor attachment Fig.
  • Page 18 4.2.2. How to release the Magnetic Sensor The procedure of releasing the Magnetic sensor from the probe is as follow. 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.

  • Page 19: Reprocessing Procedure

    5. Reprocessing Procedure The probe and accessory 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.  Temperature should not exceed 60°C during WARNINGS reprocessing.
  • Page 20 The flowchart of the reprocessing process of this probe is as follows. Manual cleaning and disinfection Manual Cleaning Drying Point of use (Pre-cleaning) Rinsing after manual Packing cleaning Containment and transportation Sterilization Manual Disinfection Rinsing after manual disinfection -14- Q1E-EP0428...

  • Page 21: Point Of Use (Pre-Cleaning)

    5.1. Point of use (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: A) EUP-C514 probe 1) Remove the protective 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 22 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-C514 probe 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 23 Manual disinfection: A) EUP-C514 probe 1) Prepare the disinfectant solution in a tank Water, with cold water (please follow the Detergent or Disinfectant 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 24: Drying

    5.4. 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 equipment can be dried using a drying heater at a temperature of less than 55 °C.
  • Page 25 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 26: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK Pouch sealer. Ensure that the seal is Sealed complete. Probe Attachment Fig. 15 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for Tray for sterilization. sterilization Fig.

  • Page 27: Maintenance And Safety Inspection

    6. Maintenance and Safety Inspection 1) After using the probe, the probe should be cleaned and disinfected or sterilized according to “5. Reprocessing Procedure of the probe”, store the probe in a cool and dark space to avoid high temperature, humidity and direct sunlight. 2) Visually inspect the surface of the probe head, the housing, the cable and the connector for any crack, scratch or denaturalization.

  • Page 28: Safety Precautions

    7. 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 29: Specification

    8. Specification 8.1. Probe Type: EUP-C514 Convex Array probe Center frequency: 3.5MHz Technology: Convex Array Probe Dimensions: See Fig. 17 Weight: Approx. 0.9kg (incl. cable and connector) Scanning angle: 90° Probe materials: Bio-compatible allergy free components Acoustic output: According to IEC60601-2-37 (See Main Unit manual.)

  • Page 30: Suppliers List

    8.2. Suppliers List The products listed below are seriously tested and approved for use with the convex array probe EUP-C514. Product name manufacturer purpose ALKACIDE ALKAPHARM Disinfectant ALKAZYME ALKAPHARM Cleaner ANIOXYDE 1000 ANIOS Disinfectant CIDEX Johnson & Johnson Disinfectant CIDEX OPA Johnson &...
  • Page 31 Unit: mm Fig. 17 Dimensions -25- Q1E-EP0428...

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