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Hitachi EUP-C516 Instruction Manual
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Hitachi EUP-C516 Instruction Manual

Hitachi EUP-C516 Instruction Manual

Convex array probe
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Convex Array Probe
EUP-C516
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-EP0386-9
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123

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  • 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-EP0386-9 © 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 3 D-65205 Wiesbaden, Germany EU Importer: Hitachi Medical Systems Europe Holding AG Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland Local Distributor: Q1E-EP0386...
  • 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 1.7.

  • Page 6: Table Of Contents

    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   Inspection before Use .......... 4  ...

  • Page 7: General

    General General The EUP-C516 is a convex array probe. The acoustic output of the EUP-C516 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

    Option 1.5.1 Biopsy Attachment EZU-PA34T The biopsy attachment EZU-PA34T is a dedicated tool for use as mounted on a EUP-C516. The optional biopsy attachment EZU-PA34T components are as follows: Biopsy guide assembly ..... 1 piece Needle guide (14G,18G,21G) ..1 each Brush ......

  • Page 9: Option Of Hitachi Ultrasound Diagnostic Scanner

    Please refer to the instruction manual of EUP-C514 about the method of handling, cleaning, disinfecting and sterilizing the Magnetic sensor attachment. External View The external view of the EUP-C516 is shown in Fig.1. Immersible part (IPX7) Cable Head Applied part...

  • 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 is cleaned, disinfected or sterilized. Confirm that the magnetic sensor attachment and the spacer for EZU-RV2S are cleaned, disinfected or sterilized, when using RVS (Real-time Virtual Sonography). 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 If a biopsy method is required, refer to its instruction manual. Under sterile condition, protect the probe by using covers (ref. To Suppliers List). Some Latex material may create allergic reaction. Please use allergy free material covers. After using the probe, perform the reprocessing procedure in accordance with the procedure stated in “5.

  • 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-C516 with either of the magnetic sensors enables the user to perform RVS (Real-time Virtual Sonography). Magnetic Sensor (EZU-RV2S) The magnetic sensor (EZU-RV2S) as shown in Fig.
  • Page 14 Attach the spacer for EZU-RV2S to the magnetic sensor. 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 Hole of the Magnetic sensor...
  • Page 15 4.1.2 How to release the Magnetic Sensor The procedure of releasing the magnetic sensor from the probe is as follow. 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 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) as shown in Fig. 8 is also the magnetic sensor for the EUP-C516. Direction mark Sensor (white) Fig. 8 Magnetic sensor (EZU-RV3S) 4.2.1 How to attach the EZU-RV3S 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. 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 Release the magnetic sensor from the magnetic sensor attachment as shown in Fig.

  • Page 19: Reprocessing Procedure

    Reprocessing Procedure The probe and the magnetic sensor attachment and spacer must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. For reprocessing the biopsy attachment EZU-PA34T and the needle guide bracket EZU-PA5C1 refer to the instruction manuals of EZU-PA34T and EZU-PA5C1.
  • Page 20 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 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-EP0386...

  • Page 22: 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 any accessories from the probe, like probe covers, biopsy attachment, magnetic sensor attachment or needle guide bracket. 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 23 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-C516 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 24 Manual disinfection: A) EUP-C516 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 25: Drying

    Water Detergent Disinfectant Fig. 13 Immersion of the probe, the magnetic sensor attachment and the spacer for EZU-RV2S 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.
  • Page 26 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 27: Storage

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

  • Page 28: Maintenance And Safety Inspection

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

  • Page 29: Safety Precautions

    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 30: Specifications

    Specifications Probe Type : EUP-C516 Convex Array Probe Center frequency : 3.5MHz Technology : Convex Array Probe Dimensions : See Fig. 17 Weight : Approx. 1.5kg (incl. cable and connector) Scanning angle : 65° Probe materials : Bio-compatible allergy free...

  • Page 31: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with the Convex Array Probe EUP-C516. Product name manufacturer purpose Cidezyme Johnson & Johnson Enzymatic detergent Meliseptol HBV-Tücher Braun Disinfectant Incides Henkel Hygiene Disinfectant GmbH Incidin Liquid...

  • Page 32: Disposal Of The Probe

    Disposal of the probe Recycle or dispose this equipment properly in compliance with the Waste Management and Public Cleansing Law. 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 33 Unit:mm Fig. 17 Dimensions -27- Q1E-EP0386...

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